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Texas Register Preamble


Commenters were split. Some felt that the rules were necessary to protect the health and safety of women. Others commented that the rules were an ill-advised crusade that did nothing to improve public health outcomes and actively worked against the public interest, served no public health purpose or had no medical benefit, or there is no indication that public health has been jeopardized by the rules as they exist today.

Response: The commission appreciates the comments. The proposed rules protect the health and safety of the public and serve a public health purpose by ensuring the proper treatment and disposition of fetal tissue from health care-related facilities. 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 the dignity of the unborn. The adopted rules are the means by which the department is able to meet that objective, while balancing the need to address considerations regarding public health, public benefit, and costs through amendments to the rules and inclusion of new provisions in the rules that afford the protection and dignity to unborn children consistent with the Legislature's expression of its intent.

18. Other Legislation that Impacts Rules.

Commenters stated that the rules would impact other rules that touch on the issue including the placenta legislation from last session and that the quandary is made more apparent when recognizing the Legislature's recent passage of HB 635.

Response: The commission appreciates the comments. House Bill 1670 (Acts 2015, 84th Legislature, Regular Session, Chapter 740) added Chapter 172 to the Texas Health and Safety Code. This legislation 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 §1.133(a)(2)(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. Also in response to comments, the department has added a cross-reference to the exemption in §1.133(a)(2)(I) to §1.136(a)(4)(A)(v) and (B)(i) regarding "fetal tissue, regardless of the period of gestation."

House Bill 635 (Acts 2015, 84th Legislature, Regular Session, Chapter 342) added §241.010 to the Texas Health and Safety Code. This statute requires a hospital to release the remains of an unintended, intrauterine fetal death, including remains that weigh less than 350 grams, on the request of a parent, in a manner appropriate under law and the hospital's policy. In response to public comments and to conform with the impact of HB 635, the department has added subsection (a)(2)(H) to §1.133, which states that the rules do not apply to "fetal remains required to be released to the parent of an unborn child pursuant to Texas Health and Safety Code, §241.010{.}" Also in response to comments, the department has added a cross-reference to the exemption in §1.133 to §1.136(a)(4)(A)(v) and (B)(i) regarding "fetal tissue, regardless of the period of gestation."

19. Existing Laws Sufficient for Disposal of Tissue.

Commenters were against the proposed rules stating that current law is sufficient that there is no valid reason to amend the rules, that a patient already has the right to control the disposition of fetal tissue, or that facilities are already following sanitary methods of waste disposal. Some commenters stated that it is hypocritical to have a separate set of rules just for the disposition of fetal tissue.

Response: The commission respectfully disagrees. Under Texas Government Code, §2001.039, each state agency must review and consider for readoption each of its rules. The department has done so in this case in accordance with Texas Government Code, §2001.039 and determined that amendment to the rules is necessary to remove outdated methods, methods rarely used such as "grinding" and "chlorine disinfection/maceration" and ensure the proper and dignified treatment and disposition of fetal tissue, including prohibiting the disposal of fetal remains in a landfill, which affords the protection and dignity to unborn children consistent with the Legislature's expression of its intent. The adopted rules are the means by which the department is able to conform its rules to that expression of intent, while accommodating the need to address considerations regarding public health, public benefit and costs. The proposed rules are intended to ensure that fetal tissue that is the product of spontaneous or induced human abortion, and is subject to the rule, is disposed of in a proper manner. The disposition methods for fetal tissue differ from other pathological waste to ensure the dignified treatment of fetuses consistent with other laws in Texas. The department's intent is to balance considerations of cost, public health and providing dignity to the unborn. The rules do not now, nor have they ever, imposed a requirement that a patient be informed of the method of disposition.

20. Use of Public Funds.

Commenters wanted the funds being expended to change the rules, enforce the new rules, and/or on anticipated litigation resulting from the new rules to be redirected to more direct public health impacts such as Zika prevention, education, caring for special needs children, protecting abused children, treating the uninsured, and public health and sanitation. Commenters stated that funds would be better utilized for birth control and sex education. At least one commenter complained of a waste of staff time regarding the new rules.

Response: The commission respectfully disagrees. The department has made fighting the spread of the Zika virus a priority. The department's actions in relation to this rule set will not impact its focus or budgeting related to Zika control and elimination efforts or other public health, or women's health services. These rules also have no relation to or impact on the state's focus on children's protective services. Any funding or resources needed for the enforcement or defense of these rules, if parties choose to challenge these rules, does not adversely impact the availability of funding for other public health and sanitation programs that the department oversees. Other areas, such as education, special needs services, care for the uninsured, and protection of abused children, fall outside of the department's authority. The rules address the treatment and disposition of fetal tissue from health care-related facilities, which are already subject to rules regarding the disposition of fetal tissue. These rules eliminate methods not currently in use and retain some of the existing methods. Final disposition no longer includes depositing disinfected fetal tissue in landfills, but rather requires it to be interred. The department received cost data from waste disposal companies, private and public landfills, the Funeral Consumers Alliance, FCAT, TCEQ, the University of Texas System, and others to determine the minimum cost in complying with the rules. Based upon the lowest stated costs of each entity able to provide cost estimates, the department has determined that the annual cost per facility would be approximately $450. This cost would be offset by the elimination of the current method of disposition. The department believes this cost to be minimal and absorbable by each health-care facility. Because the department has determined that health care-related facilities can absorb any additional costs associated with these rules, there should be no change in access to abortion services.

21. Other States' Laws.

Commenters cited other states' laws similar to the proposed rules and how they have been struck down or enjoined, and asked why the decision was made to move ahead with these rules now, rather than waiting to see the outcome of the federal court case against an Indiana law with similar subject matter.

Response: The commission appreciates the comments. The department notes that measures in other states are distinguishable from the proposed rules.

The State of Indiana passed House Enrolled Act 1337, which would require that a miscarried or aborted fetus be interred or cremated by a facility having possession of the remains and would exclude the final disposition of a miscarried or aborted fetus from the law governing the treatment of infectious or pathological waste. Although the Indiana law has been preliminarily enjoined by a federal court from taking effect, it is different from the department's adopted rules, which explicitly encompass treatment and disposition of special waste, including pathological waste. The federal court also determined that Indiana had no interest in treating the unborn with dignity. Here, however, the Texas Legislature has enacted numerous statutes demonstrating its interest in the dignity of the unborn. The rule provides many options for disposition, many of which are already in use, that do not increase the cost of disposition of fetal remains, but still protect the dignity of the unborn.

The State of Louisiana passed HB 815, which would require burial or cremation of remains resulting from abortion. This provision is being challenged in federal court, where a request for preliminary injunction alleged that its requirements would constitute an effective ban on first trimester medication abortion. However, unlike the Louisiana statute, the department's rules do not apply to individuals; they apply only to health care-related facilities and are therefore the rules do not affect access, and there is no undue burden.

The State of Michigan enacted Public Health Code, §333.2836, which requires fetal remains from abortions to be disposed of by interment or cremation or by incineration by a person other than a cemetery. This provision has not been challenged in court. The department's rules are less restrictive than the Michigan law and as the rules allow for disposition by interment, incineration followed by interment, or steam disinfection followed by interment.

22. Authority to Adopt Rules.

Commenters questioned the department's authority to adopt rules beyond those necessary for public health and infectious disease control. Others noted that they are asking legislators to codify the proposed rules in statute. One commenter observed that the proposal takes a new policy direction, but does not result from a directive of the Texas Legislature as a whole.

Response: The commission appreciates the comments. The department has regulated special waste generated by health care-related facilities since 1989. These rules are necessary to ensure protection of the health and safety of the public by ensuring that the disposition methods specified in the rules continue to be limited to methods that prevent the spread of disease. The commission disagrees that the proposed rules do not result from a directive of the entire Legislature. Through these amendments to the rule, as set out in the reasoned justification and statutory authority sections, the department is exercising its policy discretion in a manner that more closely conforms to the many state laws that already protect the dignity of the unborn. 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 and legislative intent and history of the protection of the unborn. These considerations resulted in the amended rules.

23. Expansion of Government.

Commenters were concerned about government expansion into areas they shouldn't be and stated that the government should leave women alone. Other commenters said the proposed rules would interfere with the doctor-patient relationship.

Response: The commission respectfully disagrees. The department notes that these rules apply to health care-related facilities already subject to these rules. The department is not expanding its authority to include any new topic or regulated entity or person. The proposed rules do not interfere with the doctor-patient relationship, because they do not apply to individual patients and the disposition of fetal tissue remains the responsibility of the health-care-related facility. Additionally, the rules have not included previously, and do not now impose a requirement that a patient be informed of the method of disposition or choose that method of disposition. Instead, the proposed rules regulate the treatment and disposition of special waste, including fetal tissue, generated by health care-related facilities. The proposed rules are not intended to restrict access to abortion, but to protect the public health while affording dignity to the unborn. While the rules eliminate certain outdated methods or methods of disposition that are clearly incompatible with demonstrating dignity for the unborn, the rules do not create a new type of regulation or regulate additional entities. Many health care-related facilities will be unaffected by these rules because those facilities' current disposition practices are already in compliance with the rules. These rules are necessary to ensure protection of the health and safety of the public by ensuring that the disposition methods specified in the rules continue to be limited to methods that prevent the spread of disease while providing dignity to the unborn. 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 and legislative intent and history of the protection of the unborn. These considerations resulted in the amended rules.

24. Enforcement of Rules.

Comment: Some commenters asked how the department will enforce the new rules and asked whether there will be penalties for noncompliance.

Response: The department currently inspects health care-related facilities subject to the rules, which are within its jurisdiction, for compliance by reviewing documentation, practices, and procedures used by the facility for the disposition of medical waste. This may include the review of contracts with third-party waste companies to determine what methods of disposition are being utilized. The rules do not adopt additional enforcement actions, and the department intends to continue its current practice for the purposes of enforcing these rules. Any issues of noncompliance identified as part of this continuing practice of enforcement, and any proposed penalties or sanctions resulting from noncompliance, will be handled the same as any previous issues of noncompliance with these rules, or other applicable rules or statutes, including affording facilities due process in the assessment of penalties or other non-monetary sanctions.

PUBLIC BENEFIT

Ms. Sims has determined that for each year of the first five years the sections are in effect, the public benefit anticipated as a result of adopting and enforcing these rules will be the continued protection of the health and safety of the public by ensuring that the disposition methods specified in the rules continue to be limited to methods that prevent the spread of disease. Additional public benefit will be realized in bringing up-to-date the department's rules to reflect the Legislature's articulated policy objectives of respect for life and protecting the dignity of the unborn. This will be accomplished by enforcing these rules in health care-related settings subject to the rules that handle special waste to ensure the rules are applied and followed consistently, which protects patients and staff of the facility, as well as the public.

LEGAL CERTIFICATION

The Department of State Health Services General Counsel, Lisa Hernandez, certifies that the rules, as adopted, have been reviewed by legal counsel and found a valid exercise of the agencies' legal authority.

STATUTORY AUTHORITY

The rule review and amendments are authorized by Texas Government Code, §2001.039, requiring that each agency periodically review its rules to determine that the reason for the rules continue to exist; Texas Health and Safety Code, §12.001; Texas Government Code, §531.0055 and Texas Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Texas Health and Safety Code, Chapter 1001. The rule review and amendments are also authorized by Texas Health and Safety Code, §81.004, which authorizes the Executive Commissioner to adopt rules necessary for the effective administration of Texas Health and Safety Code, Chapter 81, concerning the control of communicable disease to ensure the health and safety of the public through, among many things, the proper disposition of tissue from health care-related facilities. The regulation of these health care-related facilities subject to the rules is governed by Texas Health and Safety Code, Chapter 241, concerning the licensing of hospitals; by Chapter 243, concerning the licensing of ambulatory surgical centers; by Chapter 244, concerning the licensing of birthing centers; by Chapter 245, concerning the licensing of abortion facilities; by Chapter 251, concerning the licensing of end stage renal disease facilities; by Chapter 254, concerning the licensing of freestanding emergency medical care facilities; and by Chapter 773, concerning the licensing of emergency medical services.

The rule review and amendments implement Texas Government Code, Chapter 531 and §2001.039; and Texas Health and Safety Code, Chapters 12, 81, 241, 243, 244, 245, 251, 254 and 773.

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. Additional provisions considered in ensuring the department's exercise of its authority was consistent with other state laws, include: Texas Penal Code, §1.07(26) relating to criminal penalties for harm to unborn persons; Texas Civil Practice and Remedies Code, §71.001(4) relating to civil liability for killing unborn persons; Texas Estates Code, §1054.007 relating to guardianship representation for unborn persons in a guardianship proceeding; Texas Estates Code, §1002.002 regarding the definition of "attorney ad litem" which includes representation of an "unborn person;" Texas Property Code, §115.014 relating to authority of a court to appoint a guardian ad litem to represent the interest of an unborn person; Texas Health and Safety Code §241.010 relating to requirement that hospitals release to a parent remains of an unborn child who dies as a result of an unintended, intrauterine death; Preamble of HB 2, 83rd Legislature, Second Called Session, 2013, effective October 29, 2013, relating to the compelling state interest in protecting the lives of unborn children from the stage at which substantial medical evidence indicates that an unborn child is capable of feeling pain is intended to be separate from and independent of the compelling state interest in protecting the lives of unborn children from the stage of viability, and neither state interest is intended to replace the other; Texas Health and Safety Code, §170.002 relating to the prohibition against a person intentionally or knowingly performing an abortion on a woman who is pregnant with a viable unborn child during the third trimester of the pregnancy; and Texas Health and Safety Code, §171.012 relating to requirement for sonograms of pre-viable unborn children before abortion.



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