Texas Register Preamble

Response: The commission declines to add the suggested language because the department does not have the authority to regulate medical waste transporters, waste treatment facilities, or final disposal facilities. Instead, the TCEQ regulates medical waste transport, treatment, and disposition. The commission also declines to remove rules in §1.136(a)(4)(A)(v)(II) and (III), as these are practices and methods currently utilized by health care-related facilities for disposition of fetal tissue and do not adversely impact the balance of considerations the department was trying to achieve in the rules relating to the dignity of the unborn and public health protections and cost. The commission believes the methods allowed by the rules will protect the public by preventing the spread of disease while also preserving the dignity of the unborn in a manner consistent with Texas laws. The commission understands that many health care-related facilities already segregate fetal tissue from medical waste and, therefore, the rule would not impose additional requirements on those facilities.

Comment: FCAT submitted initial comments stating that the proposal for the rule changes appears to be incomplete in that it does not complete the small and micro-business impact analysis nor does it identify a fiscal impact to state or local governments. The commenter expressed their disappointment that a public hearing has not been called and that the exclusion of stakeholders, particularly women, is ethically negligent. The commenter states that proposed rules will forcibly increase the cost of abortion by requiring cremation or interment of all fetuses by state-licensed funeral establishments who charge a basic fee of $2,000. The commenter calculated the annual cost for 48,000 - 54,000 total abortions, typically occurring at 13 weeks, to add up to $96 million. The commenter assumes that the facilities will not bear this cost and will force the woman to pay, and if the woman cannot pay, the cost will be borne by county governments or that a woman would be put in jail for not paying. The commenter states that the proposed rules will force women into a narrower set of emotional and financial choices with no added benefit. This newly regulated life event will effect social, psychological, financial and pastoral services, with little to no experience on how to support the woman. The rule appears to force women to reveal to family, friends, and the community, her very personal choice as it requires the assistance of a funeral establishment or asking friends and family's support with fetal disposition. The commenter stated that women will be forced to "shop and trade in the dizzying emotional dither of the deathcare business," or dispose of the fetus themselves. FCAT submitted additional comments stating that cremation and burial are terms specified by the Texas Funeral Service Commission and only regulate the burial and cremation of "dead human bodies." Funeral directors are not regulated or ethically allowed to participate in the disposition of aborted fetuses. This apparent exclusion is positive to a woman's health as it protects her privacy and does not force her to assign disposition responsibility to a publicly accessible business and by eliminating actual or pass through costs from a funeral business. FCAT offered that under the legal definition of cremation, 89% of aborted fetuses can be cremated under current code by using a $17 hand held propane torch from the hardware store. FCAT views cremation as being as insufferable to women as the grinding and discharging of a fetus in a commercial garbage disposer. The commenter recommends that earth burial be the only disposition method allowed. Simple earth burial requires no special skills or extra expense. A fetus or embryo burial place would not fit the definition of cemetery because a cemetery is defined as a place of interment with one "dead human body" or more, thus a fetus or embryo burial place provides a simple and less costly burial method and location than a designated and regulated cemetery. The proposed rule should state the process to follow, in detail, for burial of a human fetus or embryo; listing the choices a woman must make and the expected results. To do otherwise would result in multiple interpretations. Practically speaking, an earth burial can be respectful, easy and an economical choice for women. Since the rules allow for group burial, the cubic volume of 89% of the aborted fetuses in Texas, in one year, would be 3x3x3 yards, the size of a very small bedroom. Spread out across 254 counties, the anticipated volume of fetal remains in a year for a large metropolitan area would be the size of a large household refrigerator. The commenter recommends that the woman bury the fetus on private property with the location recorded in the property deed, or, the woman choose for the county to bury in a designated location in the county with a simple durable marker. As each county already is required to have a policy for indigent burial, it is assumed that a county employee is budgeted and assigned this task as part of those duties.

Response: The commission respectfully disagrees. The department republished the rules with a more comprehensive small and micro-business impact analysis. 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. 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 also determined that there will be no fiscal implications for state or local governments during the first five years that the proposed rules will take effect. The department further notes that it has conducted a public hearing on the proposed rules that were withdrawn and another public hearing on the proposed rules at issue. The proposed rules will not narrow the choices of women, because the proposed rules apply to health care-related facilities and not to individuals. The proposed rules do not require a patient or a health care-related facility to obtain funeral services. The commission appreciates the suggestion but declines to eliminate cremation as a method of disposition of fetal tissue. The department agrees that Chapter 651 of the Texas Occupations Code does not apply to fetal tissue that does not meet the definition of a "dead human body." Cremation was an option under the previous rules and continues to be an option in these rules. These are practices and methods currently utilized by health care-related facilities for disposition and 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 proposed rules already specify which processes are authorized, and the department notes that it is the responsibility of facilities, not patients, to comply with the rules. The department has no authority to require an individual to bury a fetus in a certain location. 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 and the Legislature's expressed intent.

Comment: The Texas House Women's Health Caucus submitted comments regarding the justifiable reasoning for the proposed changes; the lack of identified health benefit; the uncertainty around the full impact of the rules; the fiscal impact, and the potential violation of privacy of Texas women and their families. The department has not provided information on why the current methods being removed from the rule do not provide a safe and effective manner to dispose of tissue. Nor has the department explained why the disposition of fetal tissue should be different from any other human tissue and how one endangers public health and safety more than another. The commenter states that the department is required to provide a reasoned justification and factual basis for the need to change the rule and it has not. Additionally, the department has not provided any research or evidence to explain how it developed the new rules and whether they meet medical standards. The emotional damage that may result from implementation of these new requirements cannot be known. The requirement that a grieving mother have to choose incineration or cremation after losing a pregnancy through miscarriage or due to an ectopic pregnancy where there is no hope of viability and the fetus is removed to save the mother's life, is cruel and intrusive. Many miscarriages occur outside of a clinical setting. Are these women required to carry the fetal tissue to a healthcare facility? If the rules apply at any gestational age, does this include a fertilized egg, and if so, will these rules apply to families undergoing in vitro fertilization? The commenter questions the fiscal impact of the rules and states that although the department indicated that there would be some absorbable costs associated with compliance, FCAT has stated that the average basic services fee for professional services starts at $2,000. FCAT indicates that the rules will bring an additional $96 million in revenue to the Texas funeral business. The commenter asks who will be responsible for the cost if the woman and her family are unable to pay. The commenter questions whether the department can ensure sufficient vendor availability to provide these additional services. The commenter asks for clarity on whether the rules will require a fetal death certificate and if so, privacy issues are a concern. The Texas Public Information Act protects death records from being publicly available until the 25th anniversary of the date of death, however, an unknown decedent's death record is public after only one year. The commenter further states that fetal death certificate data is used for a variety of health-related studies in the pursuit of improving patient health and advancing medical science. Requiring death certificates for fetal tissue will skew these numbers. The commenters go on to state that the rules would impose a heavy burden on women seeking abortion care in Texas and do not offer a proportional benefit, as required by the United States Constitution and further clarified in Whole Woman's Health. The commenter expresses concern that these rules will likely result in costly litigation in a budget cycle where agencies have been told to tighten their belts. These funds could be better spent on education or health care rather than wastefully litigating unconstitutional regulations.

Response: The commission respectfully disagrees with the commenter's assertions and responds accordingly. The department has the statutory authority to promulgate rules to protect the public from the spread of communicable disease pursuant to Texas Health and Safety Code, Chapters 12 and 81. In doing so, the department undertook the review of outdated rules in conjunction with this authority while trying to balance cost considerations, public benefit, and the Legislature's intent and history of the protection of the unborn. These considerations resulted in the amended rules. Inclusion of a reasoned justification is required on adoption pursuant to Texas Government Code, §2001.033, and is included in this adoption preamble under the section entitled "Background and Justification" above. The department stresses that the proposed amendments apply only to health care-related facilities and not to individuals, so the rules do not impose requirements on a individual who suffers a miscarriage or induced abortions; those requirements fall solely on the health care-related facility. The rules do not now, nor have they ever, imposed a requirement that a patient be informed of the method of disposition. The department notes that the proposed rules do not prohibit mass cremation (including mass incineration) and interment, and believes such options are currently used. 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, the estimated cost of using such services would be no more than $450 per year, per facility, a cost of business that facilities should be able to absorb. There should, therefore, be no undue burden placed on a woman seeking an abortion. 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. To further clarify the impact of the rules, 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, the rules do not unduly burden women seeking abortions, as the department estimates that the costs for health care-related facilities to comply will be sufficiently low such that the costs can be absorbed by facilities as part of their operating costs while providing a public health benefit by ensuring the proper disposal of fetal tissue. 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.

Comment: The Texas Medical Association and Texas Hospital Association (TMA/THA) submitted joint comments and reiterated their comments from the earlier publishing of the rules. The commenters stated that the rules should not apply to miscarriages, ectopic or molar pregnancies regardless of the location of the woman at the end of her pregnancy. The commenters state that forcing a woman who miscarries at home to bring fetal tissue to her physician or whose ectopic or molar pregnancy was ended in a hospital setting, would make a difficult situation even more difficult. The commenters also inquire whether physicians and hospitals will be subject to penalties if their patients do not deliver fetal tissue to them after a pregnancy that ends outside of a health care setting. Should the department decide not to make the recommended exceptions stated above, TMA/THA suggested that the department should provide printed materials to Texas physicians and hospitals detailing the rule requirements and associated costs as well as who will be responsible for paying those costs. The commenters inquire who will be responsible for the costs and note that one hospital estimates that an average of 140 fetal tissue specimens under 350 grams are disposed of each month from spontaneous miscarriages or ectopic pregnancies. The commenters inquire whether the rules apply to miscarriages that occur outside of a healthcare facility, and if so, in what time frame is the woman expected to carry the fetal tissue to the healthcare facility. The commenters ask who would be responsible for the $1,500 to $4,000 cremation cost and the $7,000 to $10,000 funeral service fees; and whether the department has done a cost estimate or established a governmental resource or exceptional item to cover the added process and procedure costs. The commenters state that 10% to 15% of women who know they are pregnant have a spontaneous miscarriage, usually during the first trimester, and question whether the department has conducted any research as to how the rules will affect health care-related facilities' and providers' processes relating to storage, cremation, interment and responsibility for cremated remains. The commenters ask whether a study has been conducted on the impact to rural health facilities where tissue disposal alternatives are limited or for high volume obstetric hospitals. TMA/THA state that funeral directors must have a fetal death certificate to accept fetal tissue and that the rules are in conflict with this requirement and inquire whether funeral directors' involvement is required. Additionally, burial transit permits are required and cemeteries are required to register plots so they know who is buried in each plot. The commenters state that the rules require fetal death certificates and that including miscarriages, ectopic and molar pregnancies in the recording of fetal death certificates and other required reporting will skew public health data. The commenters express concern about lack of awareness and the need to enter into new contractual arrangements and request a delayed implementation date to allow for such arrangements. The commenters also express concern over how these rules comport with HB 635 for the release of fetal remains to parents, if requested. The commenters inquire as to how third-party vendors will comply with the rules. The commenters inquire who will be responsible for the cremated remains.


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