TITLE 22. EXAMINING BOARDS
PART 10. TEXAS FUNERAL SERVICE COMMISSION
CHAPTER 206. ANATOMICAL FACILITIES, NON-TRANSPLANT ANATOMICAL DONATION ORGANIZATIONS, AND WILLED BODY PROGRAMS
22 TAC §206.31, §206.33The Texas Funeral Service Commission (Commission) proposes new rules to Texas Administrative Code (TAC), Title 22, Part 10, in new Chapter 206, Non-Transplant Anatomical Donations: Inspections, §206.31 and §206.33, regarding the inspection procedures for individuals and entities applying for authorization or registration or currently authorized or registered to receive, use, distribute or transport non-transplant whole body donations for the advancement of medical and forensic science.
This section establishes the regulatory framework governing inspections conducted by the Commission for entities involved with non-transplant anatomical specimens. It outlines when inspections are required, including initial authorization, renewals, ownership changes, and routine compliance reviews, as well as the Commission's authority to perform unannounced inspections. The rule further defines the responsibilities of inspected entities, including cooperation, access to records and personnel, and participation in entrance and exit conferences. It also details the process for addressing deficiencies through formal notification and submission of a Plan of Correction, ensuring ongoing compliance with applicable statutes and regulations.
EXPLANATION OF AND JUSTIFICATION FOR THE RULES
The proposed rules under 22 TAC, Chapter 206, implement Texas Health and Safety Code §§ 691.012(a)(2)-(3), 691.022(b)-(c), and 691.034 which authorizes the Commission by rule to administer its duties to regulate the receipt, use, transport, and distribution of decedent non-transplant whole human body or body part donations for medical or forensic science.
Each proposed rule described below is in regard to the receipt, use, transport and distribution of non-transplant donations of whole human bodies or body parts for advancing medical or forensic science for purposes allowed under Texas Health and Safety Code chapter 691, unless stated otherwise.
Proposed new 22 TAC §206.31 requires the Commission to conduct an inspection of an individual or entity applying for initial authorization or registration to operate in Texas, undergoing an ownership change, relocating to a new facility or undergoing major renovations to pass the onsite inspection prior to receiving approval from the Commission. The Commission will conduct onsite inspections, which may be unannounced, of authorized entities once every three years, unless the entity is expressly exempted by statute. The inspections may be conducted at reasonable times, including when a lab or event using human bodies or body parts is occurring. Unannounced inspections may also occur to inspect, investigate or evaluate an entity's compliance with or to prevent a violation of the law; a Plan of Correction; order by the Commissioners, executive director or executive director's designee; court order for injunctive relief; or other regulatory purpose. The proposed rule establishes the scenarios in which the commission's inspections are for evaluating the individual's or entity's compliance.
The proposed rule further requires the individual or entity being inspected to cooperate with the Commission, including allowing entry to grounds and records, opportunity to interview and request a written statement from certain individuals, make copies of requested records, and if necessary, opportunity to remove records. The Commission must make reasonable effort to return any removed records in a timely manner. If the inspection purpose is to ensure compliance, the Commission must give the individual or entity opportunity to submit relevant information. Any records considered confidential or proprietary subject to the inspection will be maintained as consistent with applicable law, and released in accordance with statute.
The Commission will hold an entrance and exit conference to discuss the inspection nature, scope, time frame, findings, and possible deficiencies or violations. If deficiencies or violations are found, the individual or entity will be given an opportunity to provide information to show compliance. A report will be sent to the individual or entity seven days after the exit conference ended.
Proposed new 22 TAC §206.33 establishes procedures for a Plan of Correction should the Commission find deficiencies when inspecting an individual or entity. The plan must be sent to the individual/entity within 15 business days after the exit conference by physical or electronic mail. The recipient has 15 calendar days to respond to each cited deficiencies, propose timeframes for compliance and provide evidence of compliance. The Commission may or may not accept the recipient's Plan of Correction. If it does not accept, the recipient is given an additional 15 business days to submit a modified Plan of Correction. Even with a Plan of Correction, at any time, the Commission may take enforcement action against the individual or entity.
Advisory Committee: State Anatomical Advisory Committee were held on December 20, 2023, January 17, 2024, and July 26, 2024, and stakeholder meetings were held on January 17, 2024 and July 24-25, 2024, to discuss the rules on the implementation of Senate Bill 2040, 88th Regular Legislative Session, and Texas Health and Safety Code chapter 691. These meetings involved discussion and rule recommendations on the inspection for anatomical facilities, non-transplant anatomical donation organizations, and willed body programs. Suggestions and comments made during those meetings were considered into developing the proposed rules.
FISCAL NOTE: The Commission has determined that for the first five-year period the proposed rules are in effect, the proposed rules do not have foreseeable implications relating to cost or revenues of the state or local governments.
PUBLIC BENEFIT-COST NOTE: The Commission has also determined that for the first five-year period the proposed rules are in effect, the public benefit anticipated as a result of the proposed rules will be the protection of public safety and welfare. There is no probable economic cost to individuals and entities required to comply with the proposed rules.
SMALL AND MICRO-BUSINESS, RURAL COMMUNITY IMPACT STATEMENT: The proposed rules have no anticipated adverse economic effect on small businesses, micro-businesses, or rural communities. Therefore, an economic impact statement is not required.
TAKINGS IMPACT ASSESSMENT: The proposed rules do not impose a burden on private real property and, therefore, do not constitute a taking under Texas Government Code §2007.043.
GOVERNMENT GROWTH IMPACT STATEMENT: The Commission has determined that for the first five-year period the proposed rules are in effect, the following government growth effects apply:
(1) The proposed rules do not create or eliminate a government program.
(2) Implementation of the proposed rules do not require the creation or elimination of employee positions.
(3) Implementation of the proposed rules do not require an increase or decrease in future appropriations.
(4) The proposed rules do not require an increase in fees paid to the agency.
(5) The proposed rules do create new regulations. As mentioned previously, Senate Bill 2040, 88th regular legislative session (SB 2040), abolished the Anatomical Board of the State of Texas and transferred its duties to the Commission. Also pursuant to SB 2040, the prior Anatomical Board rules continued in effect until superseded by a rule of the Commission. Since the Commission did not have prior authority or regulations to inspect individuals or entities regarding the receipt, use, distribution and transport of non-transplant whole body donations, the proposed rules do create new regulations.
(6) The proposed rules do not expand an existing regulation. As stated above, prior to SB 2040, the Commission did not have rules governing inspections of non-transplant whole body donation receipt, use, distribution or transport. In addition, the proposed rules are to supersede and replace the prior Anatomical Board rules.
(7) The proposed rules do not increase the number of individuals subject to the rule's applicability. The rules are to implement procedures of those individuals and entities now subject to the Commission's statutory jurisdiction per SB 2040.
(8) The proposed rules do not positively or adversely affect the state's economy.
PUBLIC COMMENTS: Comments on the proposed rules may be submitted to Maria Haynes, Interim Executive Director, 1801 Congress Avenue, Suite 11.800, Austin, Texas 78701, or by email to legal@tfsc.texas.gov. The deadline for receipt of comments is 5:00 p.m., Central Time, on May 13, 2026, which is at least 30 days from the date of publication of this proposal in the Texas Register.
STATUTORY AUTHORITY: The proposed rules are pursuant to Texas Health and Safety Code §691.022(b)-(c), which gives the Commission authority to adopt rules necessary to administer and enforce the receipt, use, distribution, and transport of a decedent's non-transplant whole body or body part donation and other activities under Texas Health and Safety Code chapter 691.
Statutes affected by the proposed rules are Texas Health and Safety Code §§ 691.022, 691.031, 691.033, and 691.034.
§206.31.
(a) The Commission shall conduct an inspection of each applicant prior to the issuance of an initial authorization or registration certificate, and may conduct an inspection of each authorized entity applying for a renewal prior to issuing a renewal authorization or registration certificate.
(b) An individual or entity undergoing an ownership change, relocation to a new facility, or major renovations must pass an on-site inspection prior to receiving Commission approval for authorization or registration to operate in Texas.
(c) Onsite inspections of authorized entities shall occur at least once every three years, unless exempt by statute. If exempt under statute, inspections shall be conducted pursuant to the statute's inspection requirements.
(d) The Commission may conduct an unannounced, on-site inspection of an applicant or authorized entity at any reasonable time, including when a lab, training, course or other event is occurring in which donor whole bodies or anatomical specimen are being received, used, stored, distributed or transported.
(e) The Commission may also conduct unannounced inspections to inspect, to investigate or to evaluate compliance with or prevent a violation of:
(1) any applicable statute or rule;
(2) plan of correction;
(3) an order or special order of the Commissioners, executive director or the executive director's designee;
(4) a court order granting injunctive relief; or
(5) for other purposes relating to regulation of the applicant or authorized entity.
(f) Commission inspections to evaluate an individual's or entity's compliance may include:
(1) initial, change of ownership, renovations or relocation inspections for the issuance of a new license;
(2) routine inspections, which may be conducted without notice and at the Commission's discretion, or prior to renewal;
(3) follow-up on-site inspections, conducted to evaluate implementation of a Plan of Correction for previously cited deficiencies;
(4) inspections to determine if an unauthorized or unregistered individual or entity is operating, receiving, using, handling, transferring or engaging in other activities involving non-transplant donor whole bodies or anatomical specimen; and
(5) entry in conjunction with any other federal, state, or local agency's entry.
(g) An individual or entity shall cooperate with any Commission inspection and shall permit the Commission to examine the individual's or entity's grounds, buildings, books, records, video surveillance, and other documents and information maintained by or on behalf of the individual or entity, unless prohibited by law.
(h) An individual or entity subject to an inspection under this section shall permit the Commission access to interview members of the governing body, personnel, instructors, demonstrators, students, trainees, or event attendees, including the opportunity to request a written statement.
(i) An individual or entity shall permit the Commission to inspect and copy any requested information, unless prohibited by law. If it is necessary for the Commission to remove documents or other records from the individual or entity, the Commission must provide a written description of the information being removed and when it is expected to be returned. The Commission must make a reasonable effort, consistent with the circumstances, to return any records removed in a timely manner.
(j) During the inspection, the Commission representative must give the individual or entity representative an opportunity to submit information and evidence relevant to matters of compliance being evaluated.
(k) Any records or information subject to the inspection that is considered confidential or proprietary will be maintained as confidential under applicable law. The individual or entity claiming the information is proprietary or confidential must reference the appropriate statute or rule. Such information may be released in the manner and method authorized by statute.
(l) Upon entry, the Commission inspector holds an entrance conference with the individual or entity's designated representative to explain the nature, scope, and estimated duration of the inspection.
(m) When an inspection is complete, the Commission inspector holds an exit conference with the individual or entity representative to inform them of any preliminary findings of the inspection, including possible concerns, deficiencies and violations. The individual or entity may provide any final documentation regarding compliance during the exit conference. Any preliminary or final report discussed during the exit conference will be provided to the individual or entity subject to the inspection at or within 7 days following the conclusion of the exit conference.
§206.33.
(a) An individual, applicant or authorized entity is deemed to have received any Commission correspondence on the date of receipt, or three business days after mailing, whichever is earlier.
(b) When the Commission finds deficiencies:
(1) The Commission provides the individual or entity with a written Statement of Deficiencies within 15 business days after the exit conference via U.S. Postal Service or electronic mail.
(2) Within 15 calendar days after the individual's or entity's receipt of the Statement of Deficiencies, the individual or entity shall return a written Plan of Correction to the Commission that addresses each cited deficiency, including timeframes for corrections, together with any additional evidence of compliance.
(3) The Commission determines if a Plan of Correction and proposed timeframes are acceptable, and, if accepted, notifies the individual or entity in writing.
(4) If the Commission does not accept the Plan of Correction, the Commission notifies the individual or entity in writing and requests the individual or entity submit to a modified Plan of Correction to the Commission, and any additional evidence of compliance, no later than 15 business days after the Commission notifies the individual or entity in writing.
(c) Regardless of an individual's or entity's compliance with this section or the Commission's acceptance of an individual's or entity's Plan of Correction, the Commission may, at any time, propose to take enforcement action as appropriate under applicable statute and agency rule.
The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.
Filed with the Office of the Secretary of State on April 10, 2026.
TRD-202601579
Maria Haynes
Interim Executive Director
Texas Funeral Service Commission
Earliest possible date of adoption: May 24, 2026
For further information, please call: (512) 936-2474