Response: The commission respectfully disagrees that the proposed rules impose an undue burden on women seeking abortions. They are not intended to shame patients and do not limit a patient's right to any procedure. The proposed rules do not impinge on the doctor-patient relationship. Rather, the rules regulate the treatment and disposition of material, including fetal tissue, from health care-related facilities. The commission further disagrees that the proposed rules will result in increased costs to patients. The department estimates that the costs for health care-related facilities to comply with the proposed rules will be sufficiently low such that the costs can be absorbed by facilities as part of their operating costs while still providing a public health benefit by ensuring the proper disposal of fetal tissue. The commission also disputes that the proposed rules are unnecessary and contends that they balance protecting the public health and comporting with the state's policy of protecting the dignity of the unborn.

Comment: Public Leadership Institute/Fund Texas Choice stated that the proposed rules pose an undue burden intended to shame and stigmatize women. The commenter stated that taxpayers' money should be spent more efficiently and effectively and that the fiscal note is implausible. The commenter stated that the state has already spent $1.6 million on two special sessions and additional money defending their anti-abortion agenda. The commenter stated that Texas should spend money on healthcare, child protective services and to fund foster care instead of this ruse to stigmatize abortion.

Response: The commission respectfully disagrees that the proposed rules create an undue burden on women seeking abortions because any additional costs associated with complying with these rules can be absorbed by the health care-related facility. The sources for the department's small and micro-business impact analysis include waste disposal companies, private and public landfills, FCAT, the Funeral Service Commission, TCEQ, the University of Texas System, and others. The department notes that the cost of compliance with the proposed rules would be offset by the elimination of current disposition methods. The department also notes that the proposed rules are not intended to shame or stigmatize women. They apply to health care-related facilities and not to individual patients.

Comment: Trinity Legal Center supports the proposed rules. The commenter stated that a human being is sacred and the unborn should be treated with dignity and respect and not like medical waste.

Response: The commission appreciates the comment. The proposed rules are intended to balance the desire to treat the unborn with dignity and the need to protect the public health.

Comment: Cathedral of Our Lady of Walsingham Catholic Church and Shrine stated that it is appalling that the bodies of children are disposed of like common waste, instead of buried with dignity. The commenter also stated that if we are legally murdering them, we can at least honor their passing with a caring burial.

Response: The commission appreciates the comment and agrees that the proposed rules should comport with the state's policy of ensuring the dignity of the unborn.

Comment: The Southern Baptists of Texas Convention strongly supports the proposed rules so that unborn human beings will not be treated like medical waste. The commenter stated that medical, biological, and scientific writings agree that the development of a human being begins with fertilization, marking the beginning of a unique individual. With the science and technology of today, we know that it is not "just a clump of cells." The commenter would be horrified to find the body of an abandoned baby in the garbage or elsewhere and would never consider turning a blind eye, stating that we should not turn a blind eye to the unborn now or ever, but do the right thing by giving them a proper burial.

Response: The commission appreciates the comment and agrees that the proposed rules should comport with the state's policy of ensuring the dignity of the unborn.

Comment: The Mercy Ministry of the Prince of Peace Catholic Community stated that they are appalled and sickened that fetal tissue may be disposed of by grinding and discharging into a sanitary sewer system and deposition in a sanitary landfill and support ending these methods.

Response: The commission appreciates the comments. The proposed rules would eliminate these disposition methods and preserve the dignity of the unborn.

Comment: The Catholic Pro-Life Committee of North Texas supports the proposed rules. The commenter noted that women who have abortions face many consequences, and the knowledge that their child's body was not thrown away as trash but treated with respect and buried will only ease their suffering. There is a common-law right to a decent burial. The trauma of abortion affects the mother's ability to make a rational choice in relation to her aborted child, even though she has a vested interest in the remains. The general public also has a vested interest that the fetal remains be treated with respect. The aborted child is entitled to a burial.

Response: The commission appreciates the comment. The proposed rules address the concerns raised by this commenter.

Comment: Catholic Healthcare Professionals of Houston stated it supports the comments submitted by the Texas Catholic Conference.

Response: The commission appreciates this comment.

Comment: SA Pregnancy Care Center stated it supports the proposed rules. The commenter stated that Texas needs to align treatment of the remains of the born and unborn with the belief of the majority of Texans that they should be treated with dignity and respect. Our state cannot allow them to be equivalent to clinical waste or trash.

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: 3d Houston stated that the rules should contain provisions for these deceased children to be claimed for burial. The commenter would like to see records of family lineage and date of death, and independent autopsy to verify they were not murdered, a chance to be named, a proper funeral service, and burial where their family can find them. The commenter noted that a gravesite provides healing for the living and dignity for the deceased. We do not treat executed criminals with the contempt and dishonor that the unborn receive. Let churches, funeral homes, and charitable organizations care for the dead, not abortion clinics.

Response: The commission notes that the proposed rules do not require or prohibit any funeral service and may not be used to require the disclosure of any personally identifiable or personally sensitive information. While the commission agrees that the dignity of the unborn should be protected, it declines to enact any of the additional requirements suggested by this commenter.

Comment: St. Clair of Assisi Catholic Church requested a decent burial for the unborn.

Response: The commission believes the proposed rules allow for the respectful disposition of fetal tissue in a manner that preserves privacy and protects public health.

Comment: The League of Women Voters of Texas submitted a comment in opposition of the fetal tissue rules.

Response: The commission respectfully disagrees but offers no further response as the basis for the commenter's opposition is not specified.

Comment: The National Association of Social Workers stated that it serves Texas residents across the state and reproductive health services, including abortion services, must be legally, economically and geographically accessible. The commenter states that denying people with low income access to contraception and abortion perpetuates poverty and dependence upon welfare programs, resulting in a status quo of class stratification. Fetal burial services can cost between $250 and $3,000: that equates to one week to two months of salary for a minimum-wage worker. The commenter states that the proposed policy change would create additional financial barriers, effectively making abortion inaccessible for some low-income Texans. The commenter goes on to state that healthcare providers follow medical standards for sanitary disposal of fetal tissue which is handled respectfully and safely. The commenter stated that they promote the right of clients to self-determination and non-medical ritual interferes with the doctor-patient relationship. The commenter closed by stating that we should value patients' dignity and worth by supporting and respecting their decision.

Response: The commission respectfully disagrees that the proposed rules would create any significant financial obstacles. 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. For those health care-related facilities now 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 commission believes any cost of compliance with the proposed rules to be minimal and absorbable by health care-related facilities. The commission disagrees that current rules are sufficiently respectful of the dignity of the unborn; which is why it has proposed these amended rules. The commission also disagrees that the rules interfere with the doctor-patient relationship. The proposed rules apply to health care-related facilities, not to individual patients.

Comments by Individuals.

Numerous comments were also received from interested individuals. The department received comments on topics concerning the substance of the rules, other comments relating to legal issues and issues concerning the preamble to the proposed rules. The responses to the comments appear by topic below.

Some comments received included matters that were outside the scope of the proposed rules. The department offers responses to clarify some of the most common misconceptions about the amended rules and their application, but otherwise offers no response regarding comments that are irrelevant to the rule amendments or outside of the scope of the proposed rules. For example, the department does clarify that the rule changes do not affect the use of tissue donated for medical research as this use is exempt from the application of the rules pursuant to §1.133(a)(2)(B) and that the rules do not create a requirement for ceremonial funeral services, but does not respond to comments relating to the patient booklet or laws relating to Woman's Right to Know, as the rules do not relate to these laws or booklet.

Other comments included vituperative language and political statements; for those comments the department offers no response.

The comments related to 24 general topics contained in the following categories: (1) Dignity in the treatment of the remains of the unborn; (2) Impact on miscarriages and other procedures, other tissue and body parts; (3) Concerns about criminal prosecution; (4) Woman's constitutional right to terminate a pregnancy; constitutionality of rules after the Supreme Court's ruling in Whole Woman's Health; potential lawsuits; (5) Access to abortion services; (6) Donation, research and testing; (7) Death certificates; (8) Funerals; (9) Burial sites at risk; (10) Religious considerations; separation of church and state; (11) Privacy concerns; (12) Removal of grinding and disposition in sewer system and landfill; (13) Water and air quality; (14) Costs; (15) Impact on low-income women and women who live in rural areas; (16) Rulemaking procedure; (17) Health and safety and public health impact; (18) Other legislation that impacts rules; (19) Existing laws sufficient for disposal of tissue; (20) Use of public funds; (21) Other states' laws; (22) Authority to adopt rules; (23) Expansion of government; (24) Enforcement of rules.

1. Dignity in the Treatment of the Remains of the Unborn.

Commenters generally approved of the new disposition requirements. They stated that fetuses are human beings and their remains should be treated with the same dignity as all other human remains. One commenter noted that even terrorists receive a proper burial. Others noted that the proposed rules may help women who have questions or regrets after an abortion or help them process grief.

Response: The commission appreciates the comments. The department has approached these rules such that its exercise of authority to protect public health be done in conformity with the view expressed in state law that similar dignity should be afforded unborn children. 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.

2. Impact on Miscarriages and Other Procedures, Other Tissue and Body Parts.

Commenters generally did not want the rules to apply to miscarriages, especially those occurring outside a health care-related facility. Some stated the proposed rules infringe on patient autonomy or will have a chilling effect that might keep a woman who miscarried from attempting another pregnancy. Others noted that in an early-pregnancy miscarriage, fetal tissue may not be easily identifiable. Other commenters questioned the effect of the proposed rules on in vitro fertilization.

Response: The commission appreciates the comments. In response to these concerns, the department 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{.}" A miscarriage that occurs outside of a health care-related facility is not subject to these rules and thus is not subject to the disposition requirements in the rules. Miscarriages, referenced as "spontaneous abortions" are included in the rules as these procedures result in fetal tissue. The inclusion of the procedure and methods do not adversely impact the balance of considerations the department was trying to achieve in the rules relating to the dignity of the unborn with the public health protections and cost. The department believes the methods allowed by the rules will protect the public by preventing the spread of disease while preserving the dignity of the unborn in a manner consistent with Texas laws.

The amendments to the rules do not change the impact of the rules for in vitro fertilization. Pursuant to §1.132(28), the term "Fetal Tissue" is defined as "a fetus, body parts, organs or other tissue from a pregnancy" and does not include "the umbilical cord, placenta, gestational sac, blood or body fluids." This term was added in the proposed rules and has not been amended at adoption. The rule amendments relating to fetal tissue do not apply prior to pregnancy. Once a pregnancy occurs, the rules application is the same to both the in vitro fertilized pregnancy and an unassisted natural pregnancy, if there is an induced or spontaneous abortion of the pregnancy.

3. Concerns About Criminal Prosecution.

Commenters were concerned about women being prosecuted for inappropriately dealing with a miscarriage at home, and questioned why requirements for disposition of fetal tissue differ from requirements for disposition of other pathological waste.

Response: The commission respectfully disagrees with the comments and responds to the question posed as follows. The proposed rules are not criminal in nature but instead are administrative rules for the regulation of the treatment and disposition of material from certain health care-related facilities that may only be enforced by appropriate health care-related facility regulatory programs. The rules do not apply to individual patients and do not apply to miscarriages that occur outside of a healthcare facility, as stated in §1.133(a)(2)(G). 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 by the facility. 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.

4. Woman's Constitutional Right to Terminate a Pregnancy; Constitutionality of Rules After the Supreme Court's Ruling in Whole Woman's Health; Potential Lawsuits.

Commenters felt that the proposed rules would violate a woman's constitutional right or would be an infringement upon that right, or would place an undue burden on an individual seeking an abortion. Commenters also stated that the proposed rules were in conflict with the court's decision or that the "state hadn't learned its lesson" and was promulgating more unnecessary regulations after losing at the Supreme Court. Commenters also voiced concerns that the rules would result in additional lawsuits as either being contrary to the ruling in Whole Woman's Health or as serving no public health purpose. Rather than unnecessarily plunge the department into yet another legal challenge, the department should immediately withdraw consideration of the new rules.

Response: The commission respectfully disagrees. The proposed rule amendments pertain to the disposition of fetal tissue from health care-related facilities and are intended to ensure fetal tissue is disposed of in a proper manner, without presenting a substantial obstacle to women seeking abortions. The rules do not apply to individuals, but only to health care-related facilities, which are already subject to specified methods of disinfection and disposition of fetal tissue. 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.