Because the department has determined that any additional costs associated with complying with these rules can be absorbed by the health care-related facility, there should be no undue burden placed on women in terms of increased costs of abortion or lack of access to a facility. Absent an undue burden on the ability to obtain an abortion, the State may act to provide dignity to the unborn. The Supreme Court ruling in Whole Woman's Health is unrelated to whether the department has statutory authority to issue rules for the treatment and disposition of fetal tissue from health care-related facilities. Texas Health and Safety Code, §12.001 gives the Executive Commissioner of the commission, which oversees the department, general supervision and control over all matters relating to the health of the citizens of this state, including enforcement authority over health care-related facilities.

5. Access to Abortion Services.

Commenters expressed concern that these rules were politically motivated and proposed for no other reason than to limit, and eventually eliminate, access to abortion in Texas. Commenters also stated the proposed rules would impact the poor, minors, the disabled, and "genderqueer with uteruses." Other commenters remarked that the rules will increase emotional trauma and are intended to shame or punish women seeking abortions. A commenter noted restrictions under HB 2 already mean that women must travel out of state for abortions and have longer wait times, and that there has been an increase in second trimester abortions. Another commenter noted the proposed rules bear a noticeable similarity to model legislation being pushed by Americans United for Life, a group which describes itself as the "legal architect of the pro-life movement."

Response: The commission respectfully disagrees that the rules are intended to shame or punish women or limit access to abortion. 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-related facility. Because the department has determined that health care-related facilities can absorb any additional costs associated with these rules, it anticipates no change in access to abortion services.

6. Donation, Research and Testing.

Commenters were split between allowing donation for medical and scientific research as one positive outcome of a difficult choice, and others who felt that no human remains should be treated in any way other than funeral/burial. Other commenters were concerned about how the proposed rules would affect pathological or genetic testing of fetal tissue from miscarriages.

Response: The commission appreciates the comments. Neither the current nor the proposed rules prohibit donation for research. Human tissue, including fetal tissue, that is donated for research or teaching purposes is exempt from the treatment and disposition requirements under both the current and proposed versions of §1.133. There is no requirement, nor prohibition, in the rules for a funeral service. The proposed rules are not intended to prevent or otherwise have an adverse impact genetic or pathological testing. The previous rules have not adversely affected testing in the past, and no language was added in the proposed or adopted amendments that would change that impact or effect.

7. Death Certificates.

Commenters questioned whether a cremation or burial facility would accept fetal tissue without a death certificate and whether this requirement would require a coroner on duty to issue a death certificate. Commenters also expressed concern that this would increase expense to the woman or that the funeral services industry would need to alter their processes. One commenter noted the open nature of death records would make public a woman's failure to carry a pregnancy to term. Another commenter stated that the collection of data from fetal death certificates issued for purposes of the rules would render the data useless, creating a barrier to the advancement of medical and scientific progress, and may very well impede our understanding of the state's recent uptick in the rate of maternal mortality and morbidity and obstruct the ability to correct it.

Response: The commission appreciates the comments. Chapter 651 of the Texas Occupations Code applies to disposition of a human body for which a birth and death certificate is required. A certificate of fetal death (fetal death certificate) is only required for a fetus weighing 350 grams or more, or if the weight is unknown, a fetus aged 20 weeks or more as calculated from the start date of the last normal menstrual period. See 25 TAC §181.7(a). Based on an exemption that was contained in the previous rules, fetal deaths subject to the fetal death certificate requirement are exempt from the adopted rules pursuant to §1.133(a)(2)(F). Also in response to public comments, to make the applicability of the exemption more evident to the reader, the department has added a cross reference to the exemption in three places in the rules: (1) §1.132(42)(B) regarding the definition of "pathological waste;" (2) §1.136(a)(4)(A)(v) regarding "fetal tissue, regardless of the period of gestation;" and (3) §1.136(a)(4)(B)(i) regarding "fetal tissue, regardless of the period of gestation." The department retained that exemption in these rules, and has not modified it in the proposed or adopted rules. As a result, vital statistics data collection and reporting results will not be affected nor does it impact maternal mortality and morbidity data. Furthermore, the adopted rules do not require or authorize a patient's private information to become part of the state's public record. This rule does not create a new requirement for a birth or death certificate, and thus there is no additional privacy concerns created by the rule nor is there a requirement for a ceremonial burial or application of the cremation requirements in Texas Occupations Code, Chapter 651 or rules that implement that chapter. A crematory requires a death certificate or other death record under 22 TAC, §205.11 in order to perform a cremation of "deceased human remains." The rule retains many options currently used for disposition of fetal tissue. To help clarify these issues, the department has added language to §1.134 of the rules, which states: "(a) This subchapter may not 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. This subchapter does not require the issuance of a birth or death certificate for the proper disposition of special waste from health-care related facilities. 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."

8. Funerals.

Some commenters stated that the proposed rule amendments would require funerals for the disposition of fetal tissue.

Response: The commission respectfully disagrees. Funeral services are not required under these rules or other laws in Texas, nor are they prohibited under these rules. None of the amendments adopted in the rules are intended to invoke a requirement for funeral services to be performed by health care-related facilities to be able to properly dispose of fetal tissue in compliance with the rules.

9. Burial Sites at Risk.

Commenters are worried that the proposed rules will create new physical sites of social unrest as the burial places for these fetuses become grounds for protests and counter-protests. Others are worried that health care-related facilities would be unable to locate a crematory or cemetery willing to accept fetal tissue.

Response: The commission appreciates the comments. The rules do not designate any particular type or location for interment of fetal tissue or other applicable material.

10. Religious Considerations; Separation of Church and State.

Commenters stated that forcing women to take part in a religious ritual in the form of a funeral is a violation of their rights. Commenters voiced concerns at the attempt to legislate values and rituals regarding loss, in that there is a need for separation of church and state. Still others were in support of the proposed rules as consistent with their Christian beliefs in the dignity of life.

Response: The commission respectfully disagrees. The department notes that the proposed rules do not require regulated facilities or individuals to take part in a funeral or any other religious ritual for the health care-related facility to be able to properly dispose of fetal tissue in compliance with the rules. 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. The health care-related facility that is subject to the rules must determine where and how it will arrange for disposition of the fetal tissue, including choosing an authorized method of interment. Facilities may already use a disposition method involving burial with a religious organization, but that is not now, nor will it be under the rules, either required or proscribed by the regulations. Nothing in the adopted rules dictate the nature or form of disposition that must be chosen (secular or non-secular) in relation to interment, including burial or cremation, in conjunction with a disposition method authorized by the rules.

11. Privacy Concerns.

Commenters were concerned that if women had to commission funeral services or obtain death certificates, their information would be required and therefore, their privacy would be compromised and that the rules are "a violation of HIPAA."

Response: The commission respectfully disagrees. The rules do not require individuals to commission funeral services. Nothing in the rules requires the release of patient identifying information or other personally sensitive information. The current rules do not require the issuance of a death certificate for the disposition of medical waste. The adopted amendments did not add any language that was intended to invoke any requirement that would result in the need for a death certificate. To help clarify these issues, the department has added language to §1.134 of the rules, which states: "This subchapter may not 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. This subchapter does not require the issuance of a birth or death certificate for the proper disposition of special waste from health care-related facilities. 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."

12. Removal of Grinding and Disposition in Sewer System and Landfill.

Some commenters approved of the removal of grinding as a disposition option. Commenters were split on the issue of landfill disposition. Many felt that it reduced the dignity of a human life as trash, others noted that this is the method commonly used for all other types of medical waste and this was no different. One commenter noted that rather than eliminating the use of the grinding process entirely, the proposed rules subjectively delete it for one type of tissue while continuing to codify its use for other tissues.

Response: The commission appreciates the comments. The rule removes outdated methods, methods rarely used such as "grinding" and "chlorine disinfection/maceration" and ensures the proper and dignified treatment and disposition of fetal tissue, including prohibiting the disposal of fetal tissue in a landfill, which affords the protection and dignity to unborn children consistent with many state laws and the Legislature's expression of its intent to respect life and protect the dignity of the unborn. 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.

13. Water and Air Quality.

Commenters were concerned about disposition via the sewer system and that it would negatively impact water quality and would possibly expose the public to HIV/AIDS and other infectious disease.

Response: The commission respectfully disagrees. The disposition of certain special waste into the sanitary sewer system has been in rule for decades. It is not possible to transmit HIV/AIDS through these means. These rules eliminate the option of disposition of fetal tissue via the sanitary sewer system.

14. Costs.

Commenters expressed concern that these rules would increase the cost of an abortion for women and/or that these rules would result in more litigation which would cost taxpayers money to defend. Another commenter stated that the small and micro-business impact analysis and economic costs to persons statement is wholly insufficient. Other commenters stated that abortion providers should absorb the costs and noted that low-cost burials and group burials are available and that home burial or burial through counties' indigent burial programs are other available alternatives.

Response: The commission respectfully disagrees with the first set of comments and supports the assertions of the second set of comments. The department received cost data from waste disposal companies, private and public landfills, FCAT, the Funeral Service 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. The department believes there are a number of regulated facilities that are already in compliance with these rules. 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 each health care-related facility.

15. Impact on Low-Income Women and Women Who Live in Rural Areas.

Commenters argued that the increased cost would disproportionately affect low-income women and women who lived in rural areas.

Response: The commission respectfully disagrees. The department's cost estimate indicates that the annual increased cost to health care-related facilities will be minimal and absorbable, thereby eliminating the need to pass on any additional cost to patients. The department received cost data from waste disposal companies, private and public landfills, FCAT, the Funeral Service Commission, TCEQ, and 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 not already disposing of fetal tissue through cremation and burial, the cost of any of the new available methods would be off-set by the elimination of the cost of landfill disposition. The department believes this cost to be minimal and absorbable by each health care-related facility, whether in an urban or rural area.

16. Rulemaking Procedure.

Commenters stated that the department circumvented the standard rule-making process and tried to sneak this rule set by the public or ask if the rules are being shepherded through using an emergency or expedited process and felt that some remarks from the initial comment period were taken into account, while others were not. Other commenters questioned whether the department would take into account all comments received. At least one commenter stated that they submitted comments in response to the first proposed set of rules but the comments were disregarded, seemingly without consideration, along with a reported 12,000 other comments submitted.

Response: The commission respectfully disagrees. The department complied with the requirements of the Administrative Procedure Act, Chapter 2001 of the Texas Government Code. The department gave at least 30 days' notice of its intent to adopt the proposed rules: It twice filed notice of the proposed rules with the secretary of state for publication in the Texas Register as required by Chapter 2001, giving the public two 30-day periods for comment. The first set of proposed rules was filed on June 20, 2016 and the second on September 19, 2016. The same rules were proposed each time. Both notices for the proposed rules included the information required by Texas Government Code, §2001.024, and the department gave all interested persons an opportunity to submit oral and written comments as required by Texas Government Code, §2001.029. Two public hearings were held on August 4, 2016, and November 9, 2016, in compliance with Texas Government Code, §2001.029 in which the department received oral and written public comments. The department received more than 35,000 comments on the proposed rules. Therefore, the department, on behalf of the commission, voluntarily considered and is responding in this adoption preamble to 20,000 comments from the first publication, public comment period and public hearing regarding the proposed rules. There is no legal requirement to consider and respond to the first set of comments, but the department felt it important to include the initial comments. The department has fully considered both the first and second set of public comments and includes it responses, and additional required elements set forth in Texas Government Code, §2001.033, in its adoption of the rules.

17. Health and Safety and Public Health Impact.