"(33) Interment--The disposition of pathological waste using the process of cremation, entombment, burial, or placement in a niche or by using the process of cremation followed by placement of the ashes in a niche, grave, or scattering of ashes as authorized by law, unless prohibited by this subchapter."

Comment: The American Congress of Obstetricians and Gynecologists commented that there is no evidence that the current disposition methods are unsafe or disrespectful of fetal tissue and that limiting fetal tissue disposal to only interment by burial or cremation does nothing to improve the health and safety of Texans. The commenter stated that "the department has bypassed the normal rule-making process even though there was no existing emergency." The commenter states that the current laws and professional standards already require safe and respectful disposition of medical waste. The commenter indicates that in some situations, fetal tissue is sent to a laboratory for pathological testing and that this material may not be returned and poses the question of how the rules would apply in this situation. The commenter states that the rules interfere with the patient/doctor relationship, especially in the case of miscarriage, ectopic or molar pregnancies when, frequently, there is little to no discernable tissue found. The commenter states that 15% to 20% of pregnancies result in miscarriage which may occur at home, at work or at a physician's office and that mandating that fetal tissue be collected for cremation or internment could become a cruel mandate on a woman who lost a very wanted pregnancy. The commenter states that requiring a death certificate for every cremation or interment of fetal tissue could skew vital statistics data used to improve health and well-being of women and children in Texas. The commenter states that fetal deaths registered with the Vital Statistics Unit are public record and raises concerns over making public very private medical histories of women. The data collected in fetal death registrations provide valuable data when collected for the purpose of improving patient health and the advancement of medical and scientific progress. These rules do not further these goals. The commenter states that the rules appear to be conflict with HB 635, which allows parents to request the remains of a miscarried fetus from hospitals or other health care-related facilities.

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 Office of the Secretary of State for publication in the Texas Register as required by Chapter 2001 of the Texas Government Code, 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. 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 its responses, and additional required elements set forth in Texas Government Code, §2001.033, in its adoption of the rules.

The department notes that the current rules already apply to clinical, diagnostic, and pathological laboratories, and these facilities would still be responsible for treatment and disposition of all materials under the proposed rules. The department stresses that the rules do not apply to a patient who miscarries outside a health care-related facility and notes that the facility, not the patient, is responsible for treatment and disposition of fetal tissue. 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, and no changes have been made to the rules requiring notice or other changes to the physician's care of the patient. Additionally, the rules do not apply to individual patients, and the disposition of fetal tissue is the responsibility of the health care-related facility. Additionally, the rules have not included previously, and do not now impose, a requirement that a woman be informed of the method of disposition or choose that method of disposition. The proposed rules do not require that fetal death certificates be issued for every miscarriage, abortion or ectopic pregnancy in the state-meaning vital statistics reporting results will not be affected. The adopted rules do not require or authorize a patient's private information to become part of the state's public record. Under current law, 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). 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. 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. Because hospitals are currently responsible for disposition of fetal tissue, it is very likely that many are already using methods authorized by this rule. To further safeguard patient privacy, and clarify the issues relating to death certificates, the department added the following language to rule §1.134. Application: "(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."

The department agrees that the impact of HB 635, needs to be clarified. HB 635 added Texas Health and Safety Code, §241.010, requiring a hospital to release fetal remains to a parent upon request. 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. 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 "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."

Comment: The National Abortion Federation submitted comments stating that the rules are not medically necessary and lack any health or safety benefit and do not adequately protect the privacy of patients, but rather create a significant burden on healthcare providers. Adding onerous disposal requirements while lacking a public health and safety benefit clearly show that these rules are a means for the State of Texas to continue its attack on access to abortion care. The requirement for facilities to obtain fetal death certificates raises serious concerns for patient privacy. The intrusive nature of the questions that must be answered to obtain a fetal death certificate are of concern as the rules provide no privacy protection to ensure this identifying information remains private, rather all of this information is presumably available as an open record under the Texas Public Information Act. Patients are targeted for harassment and there is a history of anti-abortion extremists seeking patient information in order to deter women from seeking abortion care and shame those that do. Likewise, abortion providers are often the targets of violence. If the rules do not require fetal death certificates, the commenter asks how the department will circumvent this requirement.

Response: The commission respectfully disagrees. The rule amendments, like the rules currently in effect for treatment and disposition, are targeted to prevent the spread of communicable disease. There are a variety of methods by which public health objectives can be furthered. The amendments to the rules eliminate unused or rarely used methods and also prohibit disposition of fetal tissue in a landfill, which is in line with the Legislature's policy objective of ensuring the dignity for the unborn articulated in a number of Texas laws. To further clarify, the rules do not impinge on the privacy of patients because the rules apply to health care-related facilities and not to individuals. To further safeguard patient privacy, the department added the following language to rule §1.134. Application: "(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." The department also disputes that the proposed rules are onerous or create a significant burden on healthcare providers, which are already subject to regulation in this area. Many health care-related facilities are already in compliance with the rules as adopted. The proposed rules discontinue certain methods of treatment and disposition while allowing additional methods to remain part of the rules. The department received cost data from waste disposal companies, private and public landfills, FCAT (comments as noted above), 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 some current methods of disposition. The department believes this cost to be minimal and absorbable by each health care-related facility. The current and proposed rules are not meant to, and do not, create a substantial obstacle to a woman seeking an abortion. Instead, the rules govern the treatment and disposition of special waste, including fetal tissue, from health care-related facilities.

Comment: The National Latina Institute for Reproductive Health submitted comments and states that rules create medically unnecessary burdens which can disproportionately impact the Texas "Latinx" community and perpetuate the stigma surrounding abortion care by regulating a private matter that should be left to patients. The commenter states that the rules institute unneeded procedures and complications for healthcare providers without contributing to the health and safety of Texans. The commenter states that the department does not provide information on who is to bear the additional cost burden or how women who miscarry at home are expected to properly dispose of fetal waste. The commenters asks the department to withdraw the rules and avoid the costs of unnecessary litigation.

Response: The commission respectfully disagrees and notes that the health care-related facilities are responsible for the costs of compliance. However, the department received cost data from waste disposal companies, private and public landfills, FCAT (comments as noted above), the Funeral Services Commission, TCEQ and 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 some current methods of disposition. The department believes this cost to be minimal and absorbable by each healthcare facility. The proposed rules are necessary to protect the health and safety of the public in a manner that preserves the dignity of the unborn. As noted elsewhere, the proposed rules do not apply to women who miscarry outside of health care-related facilities, but to the facilities themselves. To further address this concern, 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{.}" The commission declines to withdraw the proposed rules and believes they will withstand legal scrutiny.

Comment: Physicians for Reproductive Health submitted comments stating that current procedures are safe, sanitary and in line with standard medical practice and the proposed rules are medically unnecessary. The commenter states that, from a medical perspective, there is no basis to single out fetal tissue for special disposition. The commenter states that the rules take away the right of patients to determine the manner of disposition, and that in doing so the department is being intrusive and stigmatizing to patients. The commenter also stated that the state is interfering with patient care, engaging in shaming women and possibly breaching their privacy in order to complete forms necessary to cremate or inter fetal tissue. The commenter completes the comments with a concern that the rules substantially burden women and are similar in nature to the rules in Whole Woman's Health which were invalidated by the U.S. Supreme Court.

Response: The commission respectfully disagrees and contends the rules balance protecting the public health with comporting with the state's policy of recognizing the dignity of the unborn. The commission notes these rules have always required that the health care-related facility be responsible for the manner of disposition, not individual patients. However, there is no requirement contained in the rules that requires the disclosure or collection or private or sensitive personal information. To address that concern and to further protect patient privacy, the following provision has been added to the rules as adopted in §1.134. Application: "(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." The rules do not contain a notice requirement for a patient to be notified of the disposition methods. The proposed rules do not create a substantial obstacle to an individual seeking an abortion because they place responsibility for compliance upon health care-related facilities. Furthermore, the proposed rules, regulating treatment and disposition of fetal tissue, are different from the rules regarding admitting privileges and ambulatory surgical center standards that the Supreme Court overturned in Whole Woman's Health. The adopted rules relate to the disposition of fetal tissue from health care-related facilities that results from an induced or spontaneous abortion. It applies to multiple types of health care-related facilities, not just induced abortion facilities. The rules that were the subject of Whole Woman's Health related to the care and treatment and the treatment environment of patients undergoing induced abortions in licensed abortion facilities and ambulatory surgical centers.

Comment: The Teaching Hospitals of Texas asked several questions about the proposed rules: (1) The commenter noted that for fetal remains massing less than 350 grams, separating fetal remains from other tissue may not be possible, and asked if all tissue may be treated consistently with the requirements or if fetal remains must be separated from other tissue; (2) The commenter also asked if a family chose not to receive remains, would individual cremation or interment be required, and what interment would be required following cremation and whether it would be under the purview of funeral homes or determined by regulations; and (3) The commenter asked if, under the proposed rules, would all methods of disposal require hospitals to engage with a funeral home or similar service for cremation or interment. The commenter also stated that the economic impact analysis should account for the costs of individual cremation, interment, pathology time, storage, transportation to a funeral home, and disposition by the funeral home. The commenter requested a clearer definition of fetal tissue, interment, Cont'd...