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Texas Register Preamble


The Executive Commissioner of the Health and Human Services Commission (commission), on behalf of the Department of State Health Services (department), adopts amendments to §§1.132 - 1.137, concerning the definition, treatment, and disposition of special waste from health care-related facilities. Sections 1.132, 1.133, 1.134 and 1.136 are adopted with changes to the proposed text as published in the September 30, 2016 issue of the Texas Register (41 TexReg 7659). Sections 1.135 and 1.137 are adopted without changes to the proposed text and will not be published in the Texas Register.

BACKGROUND AND JUSTIFICATION

The rule amendments provide language and offer clarification to enhance the understanding of the rules, as well as to update outdated references, terminology, and disposition methods. Government Code, §2001.039 requires a review of rules, including an assessment of whether the reasons for initially adopting the rules continue to exist. Chapter 1, Subchapter K, Title 25 of the Texas Administrative Code (TAC) was originally adopted in 1989, and amendments were made in 1991 and 1994. The department also reviewed §§1.131 - 1.137 and determined that the reasons for adopting the rules continue to exist because the rules on this subject are needed. The department not only addressed outdated terms and methods but its charge to ensure the health and safety of the public pursuant to Texas Health and Safety Code, Chapters 12 and 81 through, among many things, the proper disposition of tissue that results from spontaneous and induced abortions. In conjunction with its review, the department also considered and gave great weight to the Legislature's policy objective of ensuring dignity for the unborn, which is articulated in a number of Texas laws. In undertaking this review, the department took into consideration a variety of statutes that express the Legislature's will to afford the level of protection and dignity to unborn children as state law affords to adults and children. See, e.g., Texas Penal Code, §1.07(26) (defining "individual" to include "an unborn child at every stage of gestation from fertilization until birth"); Texas Civil Practice and Remedies Code, §71.001(4) (defining "individual" in the wrongful death statute to include "an unborn child at every stage of gestation from fertilization until birth"); Texas Estates Code, §1002.002 (allowing for appointment of attorney ad litem for an unborn person in a guardianship proceeding); Texas Health and Safety Code, §241.010 (requiring hospitals to release to a parent remains of an unborn child who dies as a result of an unintended, intrauterine death). The rules carry out the department's duty to protect public health in a manner that is consonant with the State's respect for life and dignity of the unborn. The department accomplished this through amendments to the rules and inclusion of new provisions in the rules, including prohibiting the disposal of fetal tissue in a landfill and eliminating grinding as a method of fetal tissue disposition, that afford protection and dignity to the unborn consistent with the Legislature's expression of its intent. These rules provide a comparable level of protection to public health, while eliminating disposition options that are clearly incompatible with the Legislature's articulated objective of protecting the dignity of the unborn. The adopted rules meet the department's duties under law, while properly weighing considerations regarding public health, overall public benefit, and costs.

SECTION-BY-SECTION SUMMARY

Amendments to §1.132, Definitions, are modified at adoption in response to comments to achieve greater clarity while updating references to the department; define the terms cremation, executive commissioner, and fetal tissue; remove the definition for the term cremated remains; amend the definition of interment; update references to the Texas Commission on Environmental Quality (TCEQ); correct a mathematical unit for "log10 ;" and necessitate the renumbering of paragraphs. Paragraph (18) has been amended at adoption in response to comments received stating that the rule was not clear regarding the difference between incineration and cremation and that the rules appeared to emphasize cremation over incineration. The department has modified the definition to clarify that the term "cremation" in this subchapter includes the process of incineration. Paragraph (21) has been amended at adoption to update the term "Department" to read "Texas Department of State Health Services" instead of the outdated "Texas Department of Health" contained in the proposed rule. This update was inadvertently omitted while this reference was updated in all other parts of the proposed rules. Paragraph (33) has been amended at adoption in response to comments received stating that the rules did not provide direction on what to do with ashes after cremation. As a result, the definition of "interment" has been amended to include language regarding disposition of ashes after the process of cremation (and incineration) as authorized by law, unless prohibited by the adopted rules. The adopted rules prohibit the disposition of fetal tissue in a sanitary landfill, and the language added to paragraph (33) on adoption is subject to that limitation, prohibiting the scattering of ashes in a landfill. Paragraph (42) has been amended at adoption in response to comments received stating that the rules apply "at any gestational age" however, the rules contain exemptions that limit that application. As a result, paragraph (42)(B) under the definition of "pathological waste" in reference to "products of spontaneous or induced human abortion, regardless of period of gestation" contains a cross-reference to the exemptions in §1.133 that was added at adoption to assist the reader in applying the exemptions, which limit the applicability of the language in paragraph (42)(B).

Amendments to §1.133, Scope, Covering Exemptions and Minimum Parametric Standards for Waste Treatment Technologies Previously Approved by the Texas Department of Health, are adopted to update references to the department and a legal reference. New subparagraph (G) has been added at adoption in response to comments received stating that the rule should be clarified to state that fetal tissue which results from a miscarriage or other abortion that occurs at home, whether induced or spontaneous, is not subject to the rules. An exemption was added at adoption under new subparagraph (G) that exempts from the rule's requirements human tissue, including fetal tissue, that is expelled or removed from the human body once the person is outside of a healthcare facility. New subparagraph (H) has been added at adoption in response to comments received stating that the rule did not comport with House Bill (HB) 635 (Acts 2015, 84th Legislature, Regular Session, Chapter 342), which requires a hospital to release the remains of an unintended, intrauterine fetal death on the request of a parent of the unborn child. An exemption was added at adoption under new subparagraph (H) that exempts from the rule's requirements fetal remains required to be released to the parent of an unborn child pursuant to Texas Health and Safety Code, §241.010. New subparagraph (I) has been added at adoption in response to comments received stating that the rule did not comport with HB 1670 (Acts 2015, 84th Legislature, Regular Session, Chapter 740), which added Chapter 172 to the Texas Health and Safety Code and requires a hospital or birthing center to allow a woman who gave birth in the facility to take the placenta from the facility in certain circumstances. Language was added under new subparagraph (I) at adoption which creates an exemption from the rules applicability when a placenta is removed from a hospital or birthing center pursuant to Texas Health and Safety Code, Chapter 172.

Amendments to §1.134, Application, are adopted to update references to facilities providing mental health and intellectual disability services; and add freestanding emergency medical care facilities to the list of health care-related facilities to which this rule applies. New subsection (a) has been added at adoption in response to comments received stating that the rule would require that confidential and/or private information regarding an individual be part of public information and/or vital statistics data collected by the department and that a death certificate would be required to dispose of fetal tissue. To clarify the intended impact of the rules, language was added to this section at adoption to state that the rules are not to be used to require or authorize disclosure of confidential information, including personally identifiable or personally sensitive information, not permitted to be disclosed by state or federal privacy or confidentiality laws, and that the rules do not require the issuance of a birth or death certificate for the proper disposition of special waste from health care-related facilities, and that this subchapter does not extend or modify requirements of Texas Health and Safety Code, Chapters 711 and 716 or Texas Occupations Code, Chapter 651 to disposition of fetal tissue.

Amendments to §1.135, Performance Standards for Commercially-Available Alternate Treatment Technologies for Special Waste from Health Care-Related Facilities, are adopted to update references to the department and correct a mathematical unit to "log10 ."

Amendments to §1.136, Approved Methods of Treatment and Disposition, are adopted to update references to the department; update terminology regarding the TAC; update references to TCEQ and its rules; clarify disposition methods for fetal tissue; clarify disposition methods for fetal tissue and other tissues that are products of spontaneous or induced human abortion; and clarify that disposition methods for anatomical remains are established in 25 TAC §479.4. Subsection (a)(4)(A)(v) and (B)(i) have been amended at adoption in response to comments received stating that the rules apply "at any gestational age" however, the rules contain exemptions that limit that application. As a result, subsection (a)(4)(A)(v) regarding "fetal tissue, regardless of period of gestation" and subsection (a)(4)(B)(i) regarding "fetal tissue, regardless of period of gestation" contain a cross-reference to the exemptions in §1.133 that was added at adoption to assist the reader in applying the exemptions, which limit the applicability of the language in paragraph (4)(A) and (B). Subsection (a)(4)(A)(v)(II) and (B)(i)(IV) have been amended at adoption in response to comments received stating that the rule was not clear regarding the difference between incineration and cremation and that the rules appeared to emphasize cremation over incineration. The stand-alone term "cremation" was deleted at adoption in both subsection (a)(4)(A)(v)(II) and (B)(i)(IV). This term already existed as a form of interment, and thus was included as method of disposition in the previous rules. It is retained in the adopted rules under the term "interment" along with the amendments made to §1.132(18) specified above.

Amendments to §1.137, Enforcement, are adopted to reflect the Executive Commissioner's role in rulemaking; remove home and community support services agencies from the list of the department's regulatory programs; and add end-stage renal disease facilities and freestanding emergency medical centers to the list of the department's regulatory programs.

COMMENTS

The department, on behalf of the commission, has reviewed and prepared responses to comments regarding the proposed rules that were submitted during two 30-day comment periods and at two public hearings, held on August 4, 2016 and November 9, 2016, which the commission has reviewed and considered. A total of 35,663 written and oral public comments were received.

The following interested groups and/or associations provided comments in favor of the rules: Texas House Republican Caucus, Texas Alliance for Life, Texas Right to Life, American Academy of Fertility Care Professionals, Houston Coalition for Life, Texans for Life Committee, Roman Catholic Diocese of Austin, Young Women for America and Concerned Women for America Legislative Action Committee, Choose Life Midland, Birth Choice Dallas, Woman to Woman Pregnancy Resource Center, Texas Catholic Conference, Life Choices Medical Clinic of San Antonio, Texas Values, St. Ignatius Martyr Catholic Parish, Southern Baptists of Texas Convention, Justice Foundation, Operation Outcry, Students for Life of America, Pro-Life Organization of Grimes and Waller Counties, Office of Life Charity and Justice of Roman Catholic Church, Our Lady of the Rosary Cemetery and Prayer Garden, Diocese of San Angelo, Trinity Legal Center, Cathedral of Our Lady of Walsingham Catholic Church and Shrine, Mercy Ministry of the Prince of Peace Catholic Community, Catholic Pro-Life Committee of North Texas, Catholic Healthcare Professionals of Houston, SA Pregnancy Care Center, 3d Houston, and St. Clair of Assisi Catholic Church.

The following interested groups and/or associations provided comments that were opposed to the rules: Texas House Women's Health Caucus, Texas Medical Association and Texas Hospital Association, American Civil Liberties Union, Center for Reproductive Rights, Funeral Consumers Alliance of Texas (FCAT), NARAL Pro-Choice Texas, Medical Students for Choice, Unite Women Texas, Planned Parenthood of Greater Texas, Inc., Planned Parenthood South Texas Surgical Center, Planned Parenthood Center for Choice, Inc., Planned Parenthood of Texas Votes, Lilith Fund, Austin National Organization for Women, Texas Equal Access Fund, Public Leadership Institute/Fund Texas Choice, National Abortion Federation, National Latina Institute for Reproductive Health, Physicians for Reproductive Health, Healthcare Waste Institute of the National Waste and Recycling Association, American Congress of Obstetricians and Gynecologists, League of Women Voters of Texas, Teaching Hospitals of Texas, and National Association of Social Workers.

The department, on behalf of the commission, acknowledges these comments and responds below, according to the various issues raised by these commenters.

Comment: The Center for Reproductive Rights stated that the department lacks statutory authority to promulgate the amendments; the amendments would unduly burden patients seeking abortion care while providing no health or safety benefit; are unconstitutionally vague and further shame and stigmatize women seeking reproductive health care. The commenter states that the rules do not confer any additional public health benefit to the patients or the general public and the fact that the new rules apply only to fetal tissue confirms as much. The commenter states that the U.S. Supreme Court held in Whole Woman's Health v. Hellerstedt, 136 S.Ct. 2292 (2016) (Whole Woman's Health), that a state's justification for an abortion restriction must be supported by credible medical evidence which the state has not brought forth. Offers from religious entities to offset the cost of burial do not change the constitutional argument and fail to respect the diversity of faith and secular traditions and beliefs Texans hold. The commenter states that the rule is unconstitutionally vague in that it does not clarify whether the regulations apply to the transport and disposition of embryonic and fetal remains and do not adequately define interment or cremation. The commenter adds that the rules fail to provide legally sufficient clarity as to whether they are intended to apply to disposition of tissue across state lines. The commenter states that the amendments will burden abortion access and miscarriage management by mandating its own moral code upon Texas women.

Response: The commission respectfully disagrees. The rule does not restrict access to abortion. The department has the statutory authority to promulgate rules to protect the public from the spread of communicable disease pursuant to Texas Health and Safety Code, Chapters 12 and 81. In doing so, the department undertook the review of outdated rules in conjunction with this authority while trying to balance cost considerations, public benefit, legislative intent, and the state's history of protection of the unborn. These considerations resulted in the amended rules. The rules impose an obligation on facilities, not on individuals, and as a result do not shame or stigmatize women seeking abortions. The rules do not unduly burden individuals seeking abortions, as the department estimates that the costs for health care-related facilities to comply will be sufficiently low such that the costs can be absorbed by facilities as part of their operating costs while providing a public health benefit by ensuring the proper disposal of fetal tissue. The rules also do not require any facility to accept the offer of a religious entity to assist with the disposition of fetal tissue and, therefore, do not impose any particular faith or tradition on an individual. The rules are not unconstitutionally vague because they specify the procedures used and the facilities to which they apply. With regard to the issue of whether the rules are intended to apply to disposition across state lines, regardless of where the disposition of waste occurs, the health care-related facility remains responsible for ensuring that the fetal tissue disposition is in compliance with these rules. The department does not have jurisdiction over disposition methods in other states or across state lines. The health care-related facility will need to demonstrate to the department that it has provided for disposition in compliance with the rules.

Comment: The Healthcare Waste Institute of the National Waste and Recycling Association stated that the rules require the generator to separate out waste materials for proper handling. Most healthcare facilities use off-site waste management companies to dispose of regulated medical waste. These commercial facilities do not have the ability to segregate materials received. Even attempting to do so would place employees at great risk. The commenter states that compliance by the healthcare waste management industry is impractical, if not impossible and requests that the department remove "incineration followed by interments {and} steam disinfection followed by interment" from the proposed rules. The commenter also suggested that the department add the following language:

"Any transporter, treatment or final disposal facility who unknowingly fails to comply with subsections of this section because such waste has not been properly segregated or separated from other solid wastes by the generating facility is not guilty of a violation under this rule."

Cont'd...

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