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and the cremation process to aid health care-related providers in implementing the proposed rules. They also ask that the department allow providers up to November 1, 2016 to comply with the proposed rules.

Response: The commission appreciates the commenter's questions and responds as follows: (1) Fetal tissue need not be separated from other tissue as long as all the tissue is treated and disposed of in a manner consistent with the requirements for fetal tissue and other tissue. (2) If parents do not request the release of remains under Texas Health and Safety Code, §241.010, then the facility is responsible for treatment and disposition in compliance with the proposed rules. (3) The proposed rules do not require any health care-related facility subject to the rules to engage the services of a funeral director or crematory; instead, facilities will be responsible for disposition of fetal tissue by one of the methods specified by the rules. The commission also notes regarding economic impact that the department received cost data from waste disposal companies, private and public landfills, FCAT (comments as noted above), the Funeral Service Commission, TCEQ, the University of Texas System, and others to determine the minimum cost in complying with the rules. The department found that based upon the lowest stated costs of each entity able to provide cost estimates, the annual cost per facility would be approximately $450. For those health care-related facilities not already disposing of fetal tissue through cremation and burial, the cost of any of the new available methods would be offset by the elimination of the cost of landfill disposition. The department believes this cost to be minimal and absorbable by health care-related facilities. In response to this and other comments, the department has clarified the definitions of cremation and interment in the proposed rules and declines to make any further changes to definitions. The commission does not see a need to delay implementation of the rules as they were initially published on July 1, 2016, and were unchanged in the subsequent publication on September 30, 2016. Once filed in the Texas Register as adopted, an additional 20 days will be given before the rules go into effect. As a result, there has been ample time to prepare to comply with the rules. The commission declines to delay the implementation date of the rules.

Comment: The American Civil Liberties Union submitted comments stating that the rules place unnecessary regulations upon abortion providers not imposed upon other health care-related facilities. The commenter states that the rules do not advance public health and create precisely the sort of impediments to accessing abortion care rejected by the Supreme Court in Whole Woman's Health. The commenter states that the proposed regulations eliminate current safe and sanitary disposal methods, imposing burial and cremation as the only permissible options for abortion providers. The commenter states that there is no evidence that the current disposition methods pose any risk to public health or that cremation would improve public health, nor is there a basis for treating fetal tissue different from other human tissue. The commenter states that while the department has authority to promulgate rules related to public health, it has no legal authority to regulate in the interest of dignity. The commenter refers to the Indiana federal court that rejected similar regulations. The commenter identified the requirement to cremate and inter fetal tissue as making it more difficult for women to access abortion care by increasing the cost. The commenter states that nearly half of abortion patients in the United States are poor and another 26% are low-income, therefore even a modest increase in the cost can pose an insurmountable hurdle. Abortion providers unable to find a crematorium or cemetery willing to accept fetal tissue may have to close their doors. The closure of even one more clinic means access to abortion care would be substantially eroded.

Response: The commission respectfully disagrees. The proposed rules apply to twenty-four other types of health care-related facilities-including ambulatory surgical centers, hospitals, and clinical and research laboratories-in addition to abortion clinics. The proposed rules are intended to safeguard public health by providing for the safe treatment and disposition of fetal tissue in a manner that preserves the dignity of the unborn. They do not place a substantial obstacle to an individual seeking abortion because the proposed rules apply to health care-related facilities. These options provide for the safe disposal of fetal tissue while conforming with the state's policy of preserving the dignity of the unborn. The commission maintains that statutory authority to preserve the dignity of the unborn exists within the Texas Health and Safety Code, including §241.010 (requiring a hospital to release to a parent remains of an unborn child who died from an unintended, intrauterine death), §170.002 (prohibiting, with certain exceptions, third-trimester abortions), and §171.012 (requiring sonograms prior to abortion). The department notes that the Indiana statute enjoined by the federal court in Planned Parenthood of Ind. & Ky, Inc. v. Comm'r, Ind. State Dep't of Health is different 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 material that includes fetal tissue. 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 tissue but still protect the dignity of the unborn. The department disagrees that the proposed rules will make it more difficult for a woman to access abortion services. The department has determined that the annual cost per facility would be approximately $450, which would be offset by the elimination of a current disposition method. The department believes this cost to be minimal and absorbable by each health care-related facility.

Comment: Our Lady of the Rosary Cemetery and Prayer Gardens submitted a comment stating that it is in support of the rules which reflect the dignity of human life by requiring humane burial. The commenter stated its willingness to provide a reverent place of burial for fetal tissue and is open to all faiths. The commenter states that it has been providing quarterly services for babies who died before birth at St. David's Hospital in Round Rock and in Georgetown.

Response: The commission appreciates the comment, which illustrates the support for protecting the dignity of the unborn that exists among Texans and demonstrates that various options authorized by the rule are currently utilized.

Comment: Texas Right to Life submitted comments applauding the department for its work to improve the disposal procedures for fetal tissue. The proposed changes will improve upon existing disposition rules to ensure a more sanitary treatment but also afford dignity to deceased preborn children. The commenter asks for a change to existing language specifically clarifying that the rules do not apply to miscarriages that occur in homes, whether they be induced or spontaneous.

Response: The commission appreciates the comment and agrees with the need for the suggested amendment. To address concerns raised by this and other comments, the department has added subsection (a)(2)(G) to §1.133. Scope, Covering Exemptions and Minimum Parametric Standards for Waste Treatment Technologies Previously Approved by the Texas Department of State Health Services, which states that the rules do not apply to "human tissue, including fetal tissue, that is expelled or removed from the human body once the person is outside of a health care-related facility{.}"

Comment: The Texas House Republican Caucus submitted comments expressing its full support of the proposed rule change to allow for the humane disposal of aborted babies' remains. The commenter states that the changes follow thousands of years of societal tradition in ensuring dignified treatment. The commenter specifically agrees with the elimination of grinding and discharging as a method of disposal. The commenter states that grinding is an abhorrent practice contrary to fundamental human dignity and how we value human life, regardless of its developmental stage. The commenter notes that opponents will claim a limitation on access but disputes this assertion and states that many abortion providers already use medical waste disposal companies and every hospital has a facility for cremation of human body parts with whom abortion facilities could enter into affordable agreements. The commenter also states that almost every state in the nation requires a more sensitive handling of these human remains and that Texas needs to update its standard of practice to rightfully ensure every sacred human life is treated with the utmost care and respect.

Response: The commission appreciates the comment and agrees that facilities that are not already in compliance with the rules will be able to absorb any additional costs of compliance with the proposed rules. The commission appreciates the support for the rules and information on the current practices relating to this issue, which are consistent with the information available to the department.

Comment: The Texas Catholic Conference stated the rule changes are long overdue and provide a more appropriate method for the disposal of human remains than current rules by affording the same dignity and respect as any other human body. The commenter notes that cadavers donated to science are afforded respect and honor including cremation ceremonies to memorialize their donation. The commenter states that the same respect should be shown for those lives that end before taking a breath. The proposed rules allow for disposition procedures that are practiced worldwide and are known as "sensitive disposal." These rules honor a universal respect, beyond religious, cultural or societal norms, for the sacred nature of the human person. The written testimony further provides that the bodies of unborn humans should be afforded the same dignity and respect as humans who have progressed in age. This respect conforms to the principles of Christians and people of good will across the world, who treat the dead with respect and charity.

Response: The commission appreciates the comment and remains committed to balancing the need to protect the public health with the state's policy of preserving the dignity of the unborn.

Comment: The Texans for Life Committee submitted comments applauding the department for righting an old wrong. The commenter states that it has worked hard to foster greater respect for human life at all stages and recognize fetal remains as human remains. The commenter notes that the Texas Legislature has passed legislation in recent years to increase respect and protection for the unborn. The commenter states that Planned Parenthood already contracts with companies that cremate the remains and it is only independent providers who object, based on cost; however, any additional cost, measured by weight, is negligible. As confirmed by the peer-reviewed Christchurch Health and Development Study, many women regret their abortion decisions and experience depression, anxiety, suicidal behaviors and substance use. The commenter states that trauma should not be increased by the haunting possibility that the remains of their babies were ground beyond recognition in a commercial garbage disposal. The commenter states that fetal remains deserve no less respect than bodies donated for medical research.

Response: The commission appreciates the comments and remains committed to balancing the need to protect the public health with the state's policy of preserving the dignity of the unborn.

Comment: The Texas Alliance for Life submitted a comment strongly supporting the proposed rules as a very good first step to require abortion facilities to treat the remains of the victims of abortion in a humane manner through cremation and burial and by banning the "grinding and discharging into a sanitary sewer system."

Response: The commission appreciates the comment and notes that the proposed rules will continue to protect the public health while providing for the disposition of fetal tissue in a dignified manner.

Comment: The Diocese of San Angelo submitted comments supporting the proposed rules to prevent facilities from using garbage disposals and flushing remains into municipal sewer systems. The commenter states that current law allows abortion providers to dispose of the bodies of the precious unborn in that very inhumane manner. The commenter states that each abortion is a tragedy and the state should not allow the victims to be treated like medicinal waste.

Response: The commission appreciates the comments and remains committed to balancing the need to protect the public health with the state's policy of preserving the dignity of the unborn.

Comment: NARAL Pro-Choice Texas submitted comments and stated that burial or cremation of fetal tissue is unnecessary and intended to restrict access to abortion care. The commenter states that healthcare facilities already follow standards for the sanitary disposal of medical waste, including embryonic tissue. The commenter states that the politically motivated attacks on Texans' access to reproductive health care must stop and that the department should not interfere with the doctor-patient relationship.

Response: The commission respectfully disagrees. The proposed rules do not interfere with the doctor-patient relationship, because they do not apply to individuals. Instead, the proposed rules regulate the treatment and disposition of material, including fetal tissue, generated by health care-related facilities. The department is not expanding its authority to include any new topic or regulated entity or person. Additionally, 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 the responsibility of the health-care-related facility. 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. The proposed rules are not intended to restrict access to abortion, but to protect the public health while affording dignity to the unborn. The proposed 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 allows other methods. The department received cost data from waste disposal companies, private and public landfills, FCAT, the Funeral Services Commission, 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 healthcare facilities can absorb any additional costs associated with these rules, it anticipates no change in access to abortion services.

Comment: The Justice Foundation submitted comments supporting the proposed regulations as in accordance with the treatment given to other human remains. The commenter states that they have collected statements from over 4,500 women hurt by abortion and that 600-700 of these women were Texas residents or had their abortions in Texas. The commenter states that many women have complaints of severe trauma after taking RU 486, the medical abortion pill, when they see the remains of the human fetus in their hands or in their toilets after the dead child is expelled from the womb. The commenter states that women have stated, "They lied to me, they said it wasn't a baby, but it is." The commenter states that women have asked if they can bury their baby in the back yard to give it more dignity than being flushed down a toilet.

Response: The commission appreciates the comment and notes that the proposed rules do not apply to fetal tissue that is expelled or removed from the human body once the person is outside of a health care-related facility. To address concerns raised by this and other comments, the department has added subsection (a)(2)(G) to §1.133. Scope, Covering Exemptions and Minimum Parametric Standards for Waste Treatment Technologies Previously Approved by the Texas Department of State Health Services, which states that the rules do not apply to "human tissue, including fetal tissue, that is expelled or removed from the human body once the person is outside of a health care-related facility{.}"

Comment: The Lilith Fund submitted comments in opposition to the proposed rules. The commenter states that they provide financial assistance to primarily low-income women of color who already have children, working multiple jobs to make ends meet while caring for their families. The commenter states that abortion coverage is out of their reach due to lack of insurance, underinsurance, or due to the Medicaid ban under the Hyde Amendment. The commenter states that these barriers to coverage have pushed women who contact them into dire health care gaps that are both unacceptable and ethically unjust. The commenter states that the proposed rules requiring cremation or burial will further stigmatize women and increase costs, potentially by thousands of dollars, further burdening low-income Texans. The commenter states that this cost increase could effectively prevent them from accessing safe, legal abortion care altogether. The commenter states there is no discernible public health reason for these rules but rather the rules are an attempt to interfere with a patient's reproductive autonomy and further disenfranchise marginalized communities. The commenter states that if public health and "respect for life" are true motivators there should be more access to comprehensive reproductive health care for low-income communities. The commenter states that the department should focus on ensuring all people have the power, resources and community support to make their reproductive decision a reality and that individuals seeking abortion Cont'd...


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