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Texas Register Preamble


Response: The commission appreciates the comments but respectfully disagrees with the commenters. Each health care-related facility is responsible for complying with the rules, regardless of whether it actually provides the disposition of fetal tissue or contracts with a third party vendor. The department has considered the impact of the proposed rules on costs and determined that they are absorbable by health care-related facilities required to comply with the rules. 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. 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. Health care-related facilities will be responsible for ensuring that the cremated remains are handled in compliance with the rules. The commission emphasizes that the proposed rules do not require a individual who miscarries to deliver fetal tissue to a physician or a hospital and notes that the rules apply to health care-related facilities and not to individuals. The commission declines to change the proposed rules to exclude miscarriages, ectopic or molar pregnancies regardless of the location of the individual at the end of her pregnancy. The commission again notes that the rules apply to health care-related facilities and not to individual patients. The commission does not at this time see a need for printed materials for Texas physicians and hospitals detailing the rule requirements. The rules were published in the Texas Register as required by the Administrative Procedure Act and also made available on the department's website. If it becomes necessary in implementation of the rules, the department will consider issuing guidance documents to all facilities required to comply. The department does not regulate costs of treatment and disposition of special waste, as these costs are the responsibility of each facility. The commission notes that Texas Occupations Code, Chapter 651 does not apply to fetal tissue weighing less than 350 grams or requires consent for comingling during cremation of fetal tissue, thus compliance with Chapter 651 or Funeral Service Commission's rules will not increase costs or limit currently available methods of disposition that are consistent with respect for life. 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 the language of the exemption in the proposed or adopted rules. 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." Additionally, to further clarify the impact of the rules, the commission 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." Although the commenter expressed concern about lack of awareness of the proposed rules, there is evidence to the contrary that shows that the public is aware of and has commented on the rules. More than 35,000 comments were received by the department, including oral and written comments received at two public hearings conducted by the department and during two separate 30-day public comment periods on proposed rules that were substantially the same which followed a June 20, 2016 initial posting. Therefore, the commission declines to delay the implementation date.

The commission agrees that the commenters' concerns regarding whether the rules comport with HB 635 need to be addressed. 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. 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."

Many health care-related facilities are already in compliance with the rules as adopted. Facilities will be responsible for disposition of cremated remains in a manner not otherwise prohibited by law. Regarding the comment pertaining to a burial transit permit, the rules do not invoke any new requirements that require a burial transit permit be issued. A fetal death certificate is only required for a fetus that weighs 350 grams or is 20 weeks or more. If fetal death meets this threshold age or weight requiring a death certificate, the fetal death is exempt from the rule pursuant to §1.133(a)(2)(F). If no fetal death certificate is required, due to age or weight, there is no requirement for a funeral director, who assumes custody of a fetus, to file a report; or to provide such documentation in order to cremate fetal tissue, as defined in this subchapter.

Comment: Three Planned Parenthood entities joined in submitting comments: Planned Parenthood of Greater Texas, Inc., Planned Parenthood South Texas Surgical Center, and Planned Parenthood Center for Choice, Inc. The commenters state that the rules go beyond the limits of statutory authority and do not further the aims of the department to protect and enhance public health and safety. The rules eliminate safe and effective disposal methods without any authority to adopt rules in order "to better preserve the dignity of these unborn lives." The commenters cite the statutory requirement that the department provide a summary of the factual basis for the rule as adopted which demonstrates a rational connection between the factual basis for the rule and the rule as adopted, and states that no such factual basis has been provided. The commenters ask for citations to studies or other documentary evidence that indicate that the methods of disposal that were removed from the rule endangered the safety of the public. The rules are another attempt to restrict access to abortion and shame, judge and stigmatize women in the process. The commenters state that the department has not provided any evidence that the proposed rules ensure current best practices or why this pathological waste should be treated different from other pathological waste. The commenters note that there is no practical difference between incineration and cremation beyond the administrative requirements. The commenters stated that the rules are silent as to where cremated tissue must be deposited. Incinerated material deposited in a landfill is subject to Texas statutes relating to solid waste management by controlling access and disease vectors and by preventing windblown waste. The commenters state that the department has not provided information as to how this is less safe than scattering cremated ash. Even assuming that scattering of cremated tissue might somehow be safer than depositing incinerated tissue in a sanitary landfill, the resulting ash - from either cremation or incineration - poses little or no risk to the public. Texas and federal law deem cremated or incinerated tissue no longer medical or infectious waste. The commenters state that the department has no statutory authority to base regulation amendments on a desire to preserve the dignity of "unborn lives" and to do so is likely unconstitutional. The commenter looks to the federal court's decision in Planned Parenthood of Ind. & Ky, Inc. v. Comm'r, Ind. State Dep't of Health, No. 1:16cv-00763-TWP-DML WL 3556914 at *11 (S.D. Ind. June 30, 2016) and Margaret S. v. Edwards, 488 F.Supp. 181, 222 (E.D. La. 1980) and Margaret S. v. Treen, 597 F.Supp. 636, 671 (E.D. La. 1984). The commenter states that courts have upheld the limits of state interest in the disposition of fetal tissue to those that ensure the sanitary disposal of fetal tissue. The commenter expresses concern over the apparent requirement that fetal death certificates be issued for every miscarriage, abortion or ectopic pregnancy in the state, leading to private medical histories becoming part of Texas public record. The publication of the names and other identifying information of individual women is of grave concern. The commenter disagrees with the fiscal impact statement made by the department and states that the department did not provide details as to how it determined that the costs incurred will be offset and quotes the TMA/THA comment of a cost between $1,500 and $4,000 for cremation and from $7,000 to $10,000 for a traditional funeral. The commenter states that the department's statement that private parties offered to bury fetal remains without charge is wishful at best and specious at worst. The commenter expresses concern over being required to contract with such parties and that in doing so they would have to break patient privacy.

Response: The commission respectfully disagrees. The department has statutory authority to amend the rules to protect the public from the spread of communicable disease pursuant to numerous chapters of the Texas Health and Safety Code and other Texas laws, as cited in the Background and Justification Section above and the Statutory Authority Section below. These rules are necessary to maintain the 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 department undertook the review of outdated rules in conjunction with this authority and with the goal of balancing cost considerations, public benefit and the Legislature's policy objective of ensuring the dignity for the unborn, which is articulated in a number of Texas laws. The proposed rules do not restrict access to abortion, but impose requirements on health care-related facilities regulated by the department. The department has reviewed the proposed rules with the above goals in mind. The rule does not require a funeral, it simply limits how fetal tissue may ultimately be disposed to exclude methods of disposition, such as grinding and placement in a landfill, that are contrary to demonstrating dignity for the unborn. Based on this and other comments regarding incineration versus cremation, the department has amended at adoption the proposed rules to clarify this matter and allow disposition in a manner that preserves the public health while affording dignity to the unborn. Cremation is a method of disposition under current rules and continues to be available under the adopted rules. The term was included under current rules as a form of interment under §1.132(31), which relates to the definition of "Interment" stated as "The disposition of pathological waste by cremation, entombment, burial or placement in a niche." (emphasis added). The department did not modify that definition in the proposed rules. The department did separate out the term "cremation" in the proposed rules under proposed changes to §1.136(a)(4)(A)(v) and (B)(i) but in response to public comments that read this to give "cremation" more emphasis than "incineration," which was not intended, the department determined a revision to the rules was warranted. As a result, the department has amended these provisions in the adopted rules and deleted the stand alone reference to "cremation." Cremation will continue to exist as a form of interment, as it did in the previous rules. Additionally, in response to these public comments the department has added the term "incineration" to the forms of cremation that can occur for waste disposition by including it in the definition of "cremation" under adopted §1.132(18):

"(18) Cremation--The irreversible process of reducing tissue or remains to ashes or bone fragments through extreme heat and evaporation. Under this subchapter, this term includes the process of incineration."

The department disagrees that it does not have a statutory basis to propose rules based on preserving the dignity of the unborn. The Legislature has expressed its intent and policy to protect the unborn in several chapters of the Health and Safety Code, including Chapter 170 (regarding third-trimester abortions), Chapter 171 (requiring informed consent for abortions), Chapter 241, §241.010 (requiring hospitals to release to a parent remains of an unborn child who dies as a result of an unintended intrauterine death), and Chapter 245 (regulating abortion facilities). The rules are consistent with that expression of intent in the legislative history. The commenter cites the federal court injunction against Indiana's House Enrolled Act 1337 in Planned Parenthood of Ind. & Ky, Inc. v. Comm'r, Ind. State Dep't of Health. 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 other cases the commenter cites, Margaret S. v. Edwards and Margaret S. v. Treen, overturned laws requiring a woman to decide on the disposal method for the fetal tissue. The proposed rules, on the other hand, leave that decision to the facility. The department stresses that the proposed rules will not require that fetal death certificates be issued for every miscarriage, abortion or ectopic pregnancy in the state and do not require or authorize an individual's private information to become part of the state's public record. 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). 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 section of the rules in three places: (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{.}" Regarding costs, the department received cost data from waste disposal companies, private and public landfills, FCAT (comments as noted above), the Funeral Service 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. 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. The department further notes that it would be facilities that would contract for disposition, not individuals, and patient privacy is not implicated by the proposed rules. 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." Additionally, in response to public comments which stated that the department had not specified what disposition follows cremation as it had for other methods of disposition, the department has clarified the definition of interment to include disposition of ashes resulting from cremation (and incineration) as authorized by current law, excluding placement of ashes in a landfill. The adopted language includes the process of scattering ashes as part of that particular method of disposition (which now includes incineration) as well as other disposition of ashes Cont'd...


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