TITLE 22. EXAMINING BOARDS

PART 10. TEXAS FUNERAL SERVICE COMMISSION

CHAPTER 206. ANATOMICAL FACILITIES, NON-TRANSPLANT ANATOMICAL DONATION ORGANIZATIONS, AND WILLED BODY PROGRAMS

The Texas Funeral Service Commission (Commission) adopts new §206.16, relating to Standard for Bloodborne Pathogen Screening of Anatomical Donors. Section 206.16 is adopted with changes as published in the August 28, 2026, issue of the Texas Register (51 TexReg 5630). The rule will be republished.

REASONED JUSTIFICATION. Bodies and derived specimens used or distributed in an unembalmed, fresh, or fresh-frozen state present a different infection-control profile than bodies that have been embalmed and fixed with formalin. Based on the information presented to the State Anatomical Advisory Committee at its July 8 and July 29, 2026, meetings, the Commission finds that a uniform, risk-based screening standard is needed to protect students, faculty, licensees, and other personnel who handle anatomical donations, and to establish consistent donor-eligibility and documentation practices among the willed body programs and non-transplant anatomical donation organizations the Commission regulates.

The new section requires bloodborne pathogen screening by a qualified laboratory for every donor whose body or derived specimens are intended for use or distribution in an unembalmed state; does not require serologic screening as an infection-control measure for donors used only after documented formalin fixation and embalming; requires standard precautions regardless of testing status; makes serologic testing one component of, and not a substitute for, donor-eligibility review; and requires records sufficient to demonstrate compliance. The requirements are rationally connected to that factual basis: testing is required where fixation has not reduced infectious risk, is not required where it has, and is supplemented in every case by standard precautions and medical-history exclusion.

CHANGES TO THE PROPOSED TEXT. On the recommendation of the State Anatomical Advisory Committee, the Commission made the following changes to the proposed text. Changes (2) through (5) respond to the comments summarized below. Change (1) and the typographical correction in change (3) are nonsubstantive corrections made by the Commission.

(1) Subsection (c) is changed to provide that the definitions apply "when used in this section" rather than "when used in this chapter," so that the definitions do not alter the meaning of terms elsewhere in Chapter 206.

(2) Subsection (d)(3) is changed to require documentation of the postmortem interval when known or reasonably ascertainable, and to provide that separate documentation of the interval is not required when the organization documents the date and time of death and the date and time of specimen collection.

(3) Subsection (d)(4)(A) is changed to permit nucleic acid testing (NAT) as an alternative to Hepatitis B surface antigen testing, consistent with the NAT alternative already provided in subparagraphs (B) and (C), and a typographical error in the reference to a CLIA-certified laboratory in subsection (d)(4) is corrected.

(4) New subsection (d)(7) permits a non-transplant anatomical donation organization or willed body program to satisfy the testing requirements of subsection (d)(4) by relying on results obtained by a medical examiner, organ procurement organization, eye bank, or tissue bank, if the testing was performed by a qualifying laboratory, the specimen was collected after death or not more than seven days before death and was evaluated for plasma dilution when the donor received a transfusion or infusion, and the results, their source, and the collection date and time are documented in the donor eligibility record.

(5) Subsection (g)(3) is changed to conform the recordkeeping requirement to the change in subsection (d)(3).

Each change either clarifies the proposed text or reduces the burden it imposes. No change subjects any person to the rule who was not subject to it as proposed, and no change imposes a new requirement. The changes are a logical outgrowth of the proposal and of the comments received, and they do not require republication of the rule as a new proposal.

SUMMARY OF COMMENTS AND AGENCY RESPONSE. The Commission received one written comment on the proposed rule during the comment period, from Science Care, Inc., by letter dated September 17, 2026. The Commission also received one oral comment at its October 8, 2026, open meeting, from Kurt Clark, of UT Health Houston, speaking as a member of the State Anatomical Advisory Committee. Science Care supported adoption of the rule. It stated that it supports the Commission's efforts to establish clear standards for infectious disease testing and documentation, and it requested three revisions.

COMMENT: Science Care requested that the rule permit nucleic acid testing (NAT) to satisfy the testing requirement for Hepatitis B virus, as the proposal did for Hepatitis C and HIV. It proposed that subsection (d)(4)(A) read: "Hepatitis B surface antigen (HBsAg) testing or Nucleic Acid Testing (NAT);".

RESPONSE: The Commission agrees and has revised subsection (d)(4)(A) as the commenter proposed.

COMMENT: Science Care requested that the rule expressly allow a non-transplant anatomical donation organization to rely on qualified serologic and NAT results obtained by an organ procurement organization, whether from antemortem specimens collected immediately before death or from postmortem specimens. It stated that requiring duplicate testing would increase cost, delay the donation process, and create operational burden without a corresponding public health benefit when the original testing was conducted in accordance with applicable standards.

RESPONSE: The Commission agrees and has added subsection (d)(7). Science Care asked that reliance be conditioned on testing performed in compliance with applicable regulations and standards, and noted that shared results may come from antemortem specimens. The Commission adopted that condition by stating it in the rule. The testing must be performed by a laboratory meeting subsection (d)(4). The specimen must be collected after death or not more than seven days before death. If the donor received a transfusion or infusion before collection, the specimen must have been evaluated for plasma dilution in accordance with applicable standards. The results, their source, and the collection date and time must be documented in the donor eligibility record. The specimen-timing and plasma-dilution conditions are drawn from the federal donor-testing standards that apply to the organ procurement organizations and tissue banks whose results will be relied on (21 CFR §1271.80(b) and (d)(2)). Stating them in the rule allows the Commission to verify the reliability of shared results on inspection.

COMMENT: Kurt Clark, of UT Health Houston, speaking as a member of the State Anatomical Advisory Committee, commented at the Commission's October 8, 2026, meeting that the reliance provision should also include results obtained by medical examiners.

RESPONSE: The Commission agrees. Subsection (d)(7) applies to willed body programs as well as non-transplant anatomical donation organizations, and it covers results obtained by a medical examiner, eye bank, or tissue bank as well as an organ procurement organization. The rationale for avoiding duplicate testing applies equally to testing performed by those entities, and the conditions stated in subsection (d)(7) apply to every source.

COMMENT: Science Care noted that subsection (d)(3) required documentation of the postmortem interval in every case, while subsection (g)(3) required records of the interval only "when known." It proposed revised text for subsection (d)(3).

RESPONSE: The Commission agrees. It has adopted subsection (d)(3) in the form the commenter proposed and has conformed subsection (g)(3).

OTHER SUBMISSIONS. The Commission's public-comment workbook contains three web-form entries recorded in fields labeled for §206.16 or §206.18: from Maverick Medical Education (July 28, 2026), Texas Tech University Health Sciences Center-Lubbock (August 7, 2026), and Anatomy Gifts Registry (August 9, 2026). Each was submitted before this rule was published for comment. In each, the commenter's own rule selection and text address §206.12 or §206.14. The Commission has treated those entries as comments on those sections, not as comments on this rule.

STATUTORY AUTHORITY. The new section is adopted under Texas Health and Safety Code §691.022(c), which requires the Commission to "adopt rules, establish procedures, and prescribe forms necessary to administer and enforce this chapter, including rules establishing registration and inspection requirements and procedures"; §691.022(b), which requires the Commission to "adopt rules to ensure that each body and anatomical specimen is treated with respect while in the custody of the commission or person authorized to receive the body or specimen"; §691.034(a-2), which requires the Commission to inspect and authorizes it to approve willed body programs and anatomical facilities "for the receipt and use of bodies and anatomical specimens"; §691.034(g), which requires the Commission to "adopt rules and procedures necessary to administer this section"; and Texas Occupations Code §651.005, which requires the Commission to regulate willed body programs, non-transplant anatomical donation organizations, and anatomical facilities as provided by Chapter 691.

The Commission interprets these provisions as authorizing it to set the conditions under which registered and approved entities receive, distribute, and use bodies and anatomical specimens. A condition that an unembalmed body be screened before it is distributed for use, and that the screening be documented, is a registration and inspection standard within §691.022(c) and §691.034(g), and a standard for the handling of bodies by persons authorized to receive them within §691.022(b). As applied to non-transplant anatomical donation organizations, the rule establishes a substantive standard and does not alter the accreditation-based verification process described by §691.034(a-3).

The adopted rule affects Texas Health and Safety Code Chapters 691 and 692A and Texas Occupations Code Chapter 651.

Statutory Authority: Health and Safety Code §§691.022(b), (c), 691.034; Occupations Code §651.005. Cross-reference to Statute: Health and Safety Code Chapters 691 and 692A; Occupations Code Chapter 651.

§206.16. Standard for Bloodborne Pathogen Screening of Anatomical Donors.

(a) Purpose. The purpose of this section is to establish minimum health and safety standards for the screening and use of anatomical donors to reduce the risk of occupational exposure to bloodborne pathogens while recognizing the effectiveness of proper embalming and formalin fixation in reducing infectious risk.

(b) Applicability. This section applies to all entities participating in the procurement, acceptance, storage, distribution, and use of human anatomical donations under the authority of the Commission.

(c) Definitions. The following words and terms, when used in this section, have the following meanings unless the context clearly indicates otherwise:

(1) "Embalmed" means a donor preserved using accepted arterial and cavity embalming techniques with sufficient formaldehyde fixation.

(2) "CLIA-certified laboratory" means a laboratory certified under the Clinical Laboratory Improvement Amendments.

(d) Screening Requirements for Unembalmed Donors.

(1) A Non-Transplant Anatomical Donation Organization or Willed Body Program shall require bloodborne pathogen screening for every donor whose body or derived specimens are intended for use or distribution in an unembalmed state.

(2) Blood specimens shall be collected as soon after death as practicable.

(3) The organization shall document the postmortem interval between death and specimen collection when known or reasonably ascertainable. Where the organization documents the date and time of death of the donor and the date and time of specimen collection from that donor, separate documentation of the postmortem interval is not required.

(4) Serologic testing shall be performed by a CLIA-certified laboratory or by a laboratory operated by an accredited medical school, hospital, or other qualified laboratory that meets applicable federal and state standards, and shall include, at a minimum:

(A) Hepatitis B surface antigen (HBsAg) testing or Nucleic Acid Testing (NAT);

(B) Hepatitis C antibody (anti-HCV) or Nucleic Acid Testing (NAT); and

(5) Documentation of testing results shall accompany the donor or be maintained in the donor eligibility record.

(6) Donors whose required testing cannot be completed shall not be distributed or used as unembalmed anatomical specimens unless otherwise authorized by applicable federal or state law.

(7) Notwithstanding paragraph (2) of this subsection, a Non-Transplant Anatomical Donation Organization or Willed Body Program may satisfy the testing requirements of paragraph (4) of this subsection by relying on test results obtained by a medical examiner, organ procurement organization, eye bank, or tissue bank if:

(A) the testing was performed by a laboratory meeting the requirements of paragraph (4) of this subsection;

(B) the specimen was collected after death or not more than seven days before death and, if the donor received a transfusion or infusion before collection, was evaluated for plasma dilution in accordance with applicable standards; and

(C) the results, the identity of the organization that obtained them, and the date and time of specimen collection are documented in the donor eligibility record.

(e) Embalmed Donors.

(1) Bloodborne pathogen serologic screening is not required as an infection-control measure for donors whose bodies or derived specimens will be used only after documented formalin fixation and embalming.

(2) Organizations shall maintain documentation demonstrating that embalming and formalin fixation have been completed prior to use or distribution.

(3) Regardless of donor testing status, organizations shall implement standard precautions, including appropriate personal protective equipment, safe sharps practices, environmental decontamination, and donor exclusion based on medical history, including known or suspected prion disease.

(f) Donor Eligibility.

(1) Serologic testing is one component of the donor eligibility determination and shall not be used as a substitute for medical history review, or other donor exclusion criteria established by the Commission or applicable law.

(2) Donors presenting known or suspected conditions that pose unacceptable infectious risks, including prion diseases where applicable, shall be excluded in accordance with applicable law and accepted medical standards.

(g) Documentation. Each participating organization shall maintain records of:

(1) Laboratory test results;

(2) Date and time specimens were collected;

(3) Postmortem interval at specimen collection, or the dates and times of death and specimen collection, when known or reasonably ascertainable;

(4) Embalming and fixation records, when applicable; and

(5) Donor eligibility determinations.

(h) The Commission may require documentation demonstrating compliance with this section as a condition of participation in anatomical donation programs under its oversight.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on October 12, 2026.

TRD-202604338

Maria Haynes

Executive Director

Texas Funeral Service Commission

Effective date: November 1, 2026

Proposal publication date: August 28, 2026

For further information, please call: (512) 936-2488

22 TAC §206.18

The Texas Funeral Service Commission (Commission) adopts new §206.18, relating to Registration and Disposition of Commercially Acquired Plastinated Human Remains. Section 206.18 is adopted without changes as published in the August 28, 2026, issue of the Texas Register (51 TexReg 5633). The rule will not be republished.

REASONED JUSTIFICATION. Plastinated human remains are parts of human corpses that have been preserved by replacing water and lipids with curable polymers. They enter this state through producers, distributors, and vendors and are held by educational, healthcare-training, governmental, museum, and research recipients. Before this rule, no Commission rule required that commercially acquired plastinated remains be registered, tracked from acquisition through final disposition, or disposed of in a manner consistent with the treatment required for other anatomical material regulated under Chapter 691. The Commission finds that this gap prevents it from verifying the lawful acquisition and donor authorization of human remains used for teaching in this state and from ensuring their dignified final disposition.

The new section requires the direct producer or providing vendor to register each plastinated specimen with the Commission, including donor-authorization documentation and a unique identifier that remains with the specimen; requires recipients to keep records and to notify the Commission of possession and of later transfers, relocations, or changes in use within 30 days; exempts from registration specimens a recipient possessed before the effective date of the section; requires disposition in accordance with the disposition requirements of Chapter 206, including §206.14, with post-disposition notice to the Commission; and requires record retention for seven years after final disposition. Each requirement serves the identified purpose: registration and the unique identifier establish provenance and donor authorization, recipient notices maintain chain of custody, and the disposition requirement ensures dignified final disposition.

Scope of the rule as adopted. The preamble to the proposed rule referred to commercially acquired human skeletal material and listed definitions of terms that do not appear in the rule text. The rule as proposed and as adopted applies only to commercially acquired plastinated human remains. Commercially acquired skeletal material remains outside Chapter 206 under §206.1(b)(4).

SUMMARY OF COMMENTS AND AGENCY RESPONSE. The Commission received no comments on the proposed rule. The staff summary of public comments presented to the Commission at its October 8, 2026, meeting reflects that no comment on §206.18 was received during the comment period, which closed September 27, 2026. Because no comments were received, there are no submissions or proposals with which the Commission disagrees.

STATUTORY AUTHORITY. The new section is adopted under Texas Health and Safety Code §691.022(c), which requires the Commission to "adopt rules, establish procedures, and prescribe forms necessary to administer and enforce this chapter, including rules establishing registration and inspection requirements and procedures"; §691.022(b), which requires the Commission to adopt rules to ensure that each body and anatomical specimen is treated with respect while in the custody of a person authorized to receive it; §691.031(a)(3), which requires the Commission to adopt rules ensuring that "each person who has control or possession of a body or anatomical specimen" completes, maintains, and transfers a chain-of-custody form prescribed by the Commission; §691.033(a), which limits the use of bodies and anatomical specimens to further medical or forensic science to a willed body program, non-transplant anatomical donation organization, anatomical facility, or other person designated by the Commission; §691.034(b), which authorizes the Commission to investigate any "other person" it has reason to believe has improperly used a body or anatomical specimen; and Texas Occupations Code §651.005.

The Commission interprets these provisions as follows. Health and Safety Code §691.001(3) defines "anatomical specimen" as "a part of a human corpse." Plastination preserves, but does not change, the character of the material as part of a human corpse, so commercially acquired plastinated remains are anatomical specimens within Chapter 691. Section 691.031(a)(3) applies to each person who has control or possession of a body or anatomical specimen; the registration, unique-identifier, notice, and record requirements of the new section are the chain-of-custody form and records the Commission prescribes for plastinated specimens. Because §691.033(a) permits use of anatomical specimens to further medical or forensic science only by registered entities or persons designated by the Commission, registration of a specimen and its recipient under the new section is the means by which the Commission designates and tracks recipients that use plastinated specimens for education. Section 691.022(b) and the disposition requirements of Chapter 206 authorize the Commission to require that plastinated remains, like other anatomical specimens, receive dignified final disposition.