TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 138. DISPOSITION OF EMBRYONIC AND FETAL TISSUE REMAINS

25 TAC §§138.1 - 138.8

The Health and Human Services Commission (HHSC) adopts new Chapter 138, Disposition of Embryonic and Fetal Tissue Remains, including new rules §138.1, concerning Purpose; §138.2, concerning Definitions; §138.3, concerning Scope, Exemptions; §138.4, concerning Application of this Chapter; §138.5, concerning Approved Methods of Treatment and Disposition; §138.6, concerning Storage, Handling, and Transport Authorization; §138.7, concerning Storage, Handling, and Transport Requirements; and §138.8, concerning Burial or Cremation Assistance Registry. Sections 138.1 - 138.3 and 138.5 - 138.8 are adopted with changes to the proposed text as published in the November 17, 2017, issue of the Texas Register (42 TexReg 6469). Section 138.4 is adopted without changes to the proposed text and, therefore, will not be republished.

BACKGROUND AND JUSTIFICATION

The rules are required by Senate Bill 8, 85th Legislature, 2017, Regular Session, which added Texas Health and Safety Code, Chapter 697, relating to the disposition of embryonic and fetal tissue remains. This legislation requires HHSC to adopt rules to implement Chapter 697.

COMMENTS

HHSC has reviewed and considered comments regarding the proposed rules that were submitted during the 30-day comment period and at a public hearing held on December 11, 2017. HHSC received approximately 1,150 written and oral public comments.

The Texas Hospital Association requested clarification regarding the rules.

The following interested groups and/or associations provided comments in favor of the rules: Diocese of Austin; Texas Catholic Conference of Bishops; Texas Right to Life; and Representative Tom Craddick.

The following interested groups and/or associations provided comments that were opposed to the rules: Center for Reproductive Rights; Jane's Due Process; National Council of Jewish Women Texas; Planned Parenthood of Greater Texas Surgical Health Services, Planned Parenthood Center for Choice, and Planned Parenthood South Texas Surgical Center; Physicians for Reproductive Health; Texas District of the American Congress of Obstetricians and Gynecologists and the Texas Association of Obstetricians and Gynecologists; and Texas Medical Association.

HHSC responds below, according to the various issues raised by these commenters.

Comment: The Texas Hospital Association requests clarification of certain definitions in the rule, seeks clarification that §138.5(a) does not supersede current law, and asks what "facility" is being referenced in §138.5(d) and (e). The commenter also seeks clarification that the rules do not apply to inter- or intra- health care facility transport and states that these facilities are incapable of meeting these requirements. The commenter suggests modifying the title of §138.7 to: "Storage, Handling, and Transport Requirements for Final Disposition."

Response: HHSC appreciates the comments. The term hospital has the common meaning; however, the word "medical" before "clinic" has been added to provide clarification in §138.2(13)(D). Additional language has been added to §138.2(13)(E) to clarify the term "emergency medical services" to state that "facilities that provide emergency medical services as defined by Texas Health and Safety Code, §773.003."

HHSC agrees with the need for clarification to §138.5(d) and (e) and has amended the language to clarify that the subsections (d) and (e) refer to a facility that receives the embryonic and fetal tissue remains for treatment. Section 138.5(a) specifically references the exemptions in §138.3 relating to vital statistics requirements as well as the right of parents of unintended intrauterine death to choose a disposition method consistent with existing law, as allowed under Texas Health and Safety Code, §241.010.

Section 138.7(c) has been edited to clarify that these rules apply to disposition of tissue only and do not address the movement of tissue for other purposes, such as to and from a pathology lab.

Comment: The Diocese of Austin commented in support of the proposed rules.

Response: HHSC appreciates the comment.

Comment: The Texas Catholic Conference of Bishops commented in support of the rules stating that the remains of unborn children should be afforded dignity and respect extending beyond religious, cultural, or societal norms for the sacred nature of the human person. They also state their gratitude for the registry which allows free or financial assistance with burial, and they will continue to work with Catholic cemeteries and funeral homes to provide burial assistance throughout the state.

Response: HHSC appreciates the comment.

Comment: Texas Right to Life commented in support of the proposed rules and suggested a substitution of the term "elective abortion," as defined in Title 1, Texas Administrative Code, §382.5(9), for the undefined term "induced abortion" in the proposed rules.

Response: HHSC appreciates the comment; however, the term "induced abortion" does not appear in the proposed rules so no changes will be made to the rule text.

Comment: Representative Tom Craddick submitted a comment in support of the proposed rules.

Response: HHSC appreciates the comment.

Comment: The Center for Reproductive Rights comments that the rules would unduly burden patients seeking abortion care while providing no health or safety benefit and are unconstitutionally vague. The commenter states that the rules will result in logistical challenges and may significantly increase costs for health care providers and that there is no record of any entities offering complete burial or cremation services free of charge. Offers from religious entities to offset the cost of burial do not change the constitutional argument and reliance upon sectarian organizations creates an imposition on religious freedom that goes beyond the requirements of Senate Bill 8. The commenter adds that the rules fail to provide legally sufficient clarity as to whether they are intended to apply to disposition of tissue across state lines. In addition, the commenter states that it is not clear to what extent the prior regulations remain in force and that the rules are unclear as to the source of authorization that allows the interment or scattering of ashes.

Response: HHSC respectfully disagrees. The rules do not restrict access to abortion and do not address any aspect of abortion services other than final disposition of embryonic and fetal tissue remains. HHSC is implementing the rules pursuant to the requirements of Senate Bill 8. The rules impose an obligation on facilities, not on individuals, and as a result do not encroach on the religious freedom of women seeking abortions. The rules do not unduly burden health care facilities performing abortion services. HHSC, consistent with prior estimates offered by providers, estimates that the costs for health care facilities to comply will be sufficiently low such that the costs can be absorbed by facilities as part of their operating costs. Written testimony submitted by plaintiffs' economist, Anne Layne-Farrar, PhD, in Whole Woman's Health v. Hellerstedt (II) stated that the cost would range between $0.52 and $1.56 per patient. The rules also do not require any facility to accept the offer of a religious entity to assist with the disposition of embryonic and fetal tissue remains and, therefore, do not impose any particular religious rite. The commenter does not specify in what respect the rules are vague, and HHSC maintains the rules are not unconstitutionally vague because they specify the authorized methods and the facilities to which they apply. With regard to the issue of whether the rules are intended to apply to disposition across state lines, regardless of where the disposition occurs, the health care facility remains responsible for ensuring that the fetal tissue disposition is in compliance with these rules. As part of the compliance process, the health care facility will need to demonstrate to HHSC that it has provided for disposition in compliance with the rules. HHSC has received a statement from the Texas Council of Catholic Bishops that they are offering free burial in cemeteries across the state, free of charge. The health care facility need only transport the remains to the cemetery. As clarified in the rules for adoption, health care facilities are authorized to transport remains generated at their own facility without the need for any additional licensing, permitting or other authorization. Regarding prior regulations, §138.3(b) specifies that Chapter 138 prevails. HHSC is charged with creating these rules under Senate Bill 8.

Comment: Jane's Due Process commented that additional costs to patients who struggle to pay for services will be passed on to patients by clinics, resulting in some patients continuing unwanted pregnancies. The commenter states that women who want to have a burial or cremation after a miscarriage or stillbirth can do so, and women who don't want that additional trauma shouldn't be required to do so. The commenter requests that HHSC refrain from the temptation to intrude into people's personal lives.

Response: HHSC respectfully disagrees. The rules do not restrict access to abortion because they apply to health care facilities, not to individuals and do not address any aspect of abortion services other than final disposition of embryonic and fetal tissue remains. Furthermore, HHSC estimates that the costs for facilities to comply will be sufficiently low such that the costs can be absorbed by facilities as part of their operating costs. As stated above, previous testimony in Whole Woman's Health v. Hellerstedt (II) stated that any increased cost for these methods of disposition would range between $0.52 and $1.56 per patient.

Comment: National Council of Jewish Women Texas commented that the proposed rules infringe on its members' First Amendment rights because cremation of fetal remains is contrary to Jewish law. The organization stated that Judaism does not allow formal mourning rituals for a baby less than 30 days old, and mandating a certain method of disposal of fetal tissue resulting from induced or spontaneous abortions, or from procedures to benefit the welfare of the mother are contrary to members' religious tenets, unduly stressful, and emotionally cruel. The organization also stated that the addition of non-medical requirements to current medical practice interferes with a patient's autonomy and decision-making in her own medical care. The organization further commented that instead of complicating patients' decisions regarding abortion and forcing them to consider burial rituals, the focus should be on making sure that women are supported and respected in their decision to have an abortion.

Response: HHSC respectfully disagrees that the rules infringe on the First Amendment rights of patients. The rules do not require an individual to perform any sort of mourning or other ritual for embryonic and fetal tissue remains, nor do they prohibit anyone from doing so. Instead, the rules set out the methods that facilities, not patients, must use to dispose of embryonic and fetal tissue remains in accordance with Senate Bill 8, including incineration, which was an option prior to this legislation, and prohibit disposition of the ashes in a landfill or sewer. As stated by the Legislature, this statute was enacted in order to express the state's profound respect for the life of the unborn by providing for a dignified disposition of embryonic and fetal tissue remains.

Comment: Planned Parenthood of Greater Texas Surgical Health Services, Planned Parenthood Center for Choice, and Planned Parenthood South Texas Surgical Center commented that the stated purpose of the rules, "to express the state's profound respect for the life of the unborn," lacks a public health and safety justification or promotion of a legitimate state interest. The commenter points to case law and previous legal challenges to urge the unconstitutionality and lack of necessity for the proposed rules. The commenter also expresses concern that the fiscal analysis of the proposed rules is unsupported by data. It asserts that the removal of other previously available methods for disposal of fetal tissue will present unaccounted challenges and costs, and that an organization identified to provide free burial services had no experience with the disposition of fetal tissue and could not be relied upon to make a cost projection. Specifically, the commenter takes issue with the elimination of sanitary landfills as a disposal method, pointing out that sanitary landfills are subject to regulation to prevent scattering of waste, while cremated tissue disposal is not. The commenter also indicates that while the statute states that embryonic and fetal tissue are not "waste," the definition of incinerator holds that the use of an incinerator is to combust waste. The commenter is concerned that this will create confusion for operators of incinerators who may believe that they may not accept the remains for incineration.

Response: HHSC respectfully disagrees. The rules do not restrict access to abortion and do not address any aspect of abortion services other than final disposition of embryonic and fetal tissue remains. HHSC is implementing the rules pursuant to the requirements of Senate Bill 8. The fiscal analysis and background data are a matter of public record and submitted as oral and written testimony in Whole Woman's Health v. Hellerstedt (II). At least one entity has offered to provide free common burial of embryonic and fetal tissue remains. The rules also clarify that a health care facility where the tissue is generated may transport those remains without the need for additional permits or licenses. Rule §138.2 specifically defines incineration under these rules to include burning embryonic and fetal tissue remains in an incinerator. Incinerator operators who are confused as to their ability to accept remains may look to Chapter 697 of the Texas Health and Safety Code for direction.

Comment: Physicians for Reproductive Health commented that the proposed rules provide no public health or safety benefit and that current procedures for disposition of embryonic or fetal tissue are sanitary and minimize exposure to pathogens and risk of infection. The commenter indicates that the rule needlessly singles out embryonic and fetal tissue as different than other bodily tissue. The commenter states that some patients may request a certain type of disposition of embryonic or fetal tissue based on personal belief or religious tradition, and the proposed rules deprive the patients of that choice.

Response: HHSC respectfully disagrees. The rules are promulgated as required by Senate Bill 8 to express the state's profound respect for the life of the unborn by providing for a dignified disposition of embryonic and fetal tissue remains. If a patient experiences an unintended intrauterine death and requests a certain type of disposition based on personal belief or religious tradition, she is allowed to do so as stated in §241.010 of the Texas Health and Safety Code.

Comment: The Texas District of the American Congress of Obstetricians and Gynecologists and the Texas Association of Obstetricians and Gynecologists stated that the rules compromise compassionate conversations between doctors and patients and that including spontaneous abortions, ectopic pregnancies, molar pregnancies and other situations where pregnancy cannot or will not continue, may create confusion and unnecessary obstacles for women and an undue burden on physicians. The commenter also stated that there are also times when tissue is passed that will need to be sent for pathology and asked for clarification on application of the rules in that situation. The commenter stated that miscarriage can occur at home, work or at a physician's office.

Response: HHSC appreciates the comment. Prior to the passage of Senate Bill 8, these remains were required to be handled, treated and disposed by one of seven methods. Senate Bill 8, and therefore these rules, have reduced the acceptable methods to four, but all of these methods have always been available and proper treatment and disposition has always been required, so HHSC is unable to identify any undue burden on physicians or women. The rules only apply to health care facilities that provide health or medical care to a pregnant woman and where the tissue was passed or delivered; these rules do not apply to pathological or forensic laboratories unless they meet these criteria. Additionally, these rules do not apply to embryonic and fetal tissue that is passed in any location other than a health care facility that provides health and medical care to a pregnant woman.

Comment: The Texas Medical Association stated that it is unaware of any published research that identifies cremation or burial of embryonic and fetal tissue as a solution to a specific personal health or public health concern.

Response: HHSC respectfully disagrees. The rules are promulgated as required by Senate Bill 8 to express the state's profound respect for the life of the unborn by providing for a dignified disposition of embryonic and fetal tissue remains.

Comments by Individuals.

Numerous comments were also received from interested individuals. The responses to the comments appear by topic below.

Some comments received included matters outside the scope of the proposed rules, and other comments included vituperative language and political statements. For these comments HHSC offers no response.

The comments related to 17 general topics are 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;

3. Concerns about criminalization;

4. Woman's constitutional right to terminate a pregnancy; Supreme Court ruling in Whole Woman's Health v. Hellerstedt; potential lawsuits;

5. Access to abortion services, stigmatization;

6. Donation, research and testing;

7. Death certificates;

8. Funerals;

9. Religious considerations; separation of church and state;

10. Privacy concerns;

11. Removal of grinding and disposition in sewer system and landfill;

12. Costs;

13. Health and safety and public health impact;

14. Existing laws sufficient for disposal of tissue;

15. Use of public funds;

16. Expansion of government; and

17. Separation of remains.

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

Commenters expressed approval of the rules based on their stated belief that fetuses are human beings and their remains should be treated with the same dignity as all other human remains. Other commenters noted that the proposed rules may help women who have questions or regrets after an abortion or help them process grief.

Response: HHSC appreciates the comments. HHSC is implementing these rules to carry out the Legislature's express intent, as stated in Senate Bill 8, to express the state's profound respect for the life of the unborn by providing for a dignified disposition of embryonic and fetal tissue remains.

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

Commenters expressed concern that the rules could cause additional trauma to women who suffered miscarriages, while others stated the rules would provide solace in those cases. Others noted that in an early-pregnancy miscarriage, fetal tissue may not be easily identifiable.

Response: HHSC appreciates the comments and notes that §138.3(c)(5) exempts from the rules "human tissue, including embryonic and fetal tissue, that is expelled or removed from the human body once the person is outside of a health-care facility." Thus, a miscarriage that occurs outside of a health care facility is not subject to these rules and thus is not subject to the disposition requirements in the rules. HHSC further notes that §138.3(d) allows the umbilical cord, placenta, gestational sac, blood, or body fluids from the pregnancy to be disposed of in the same manner as and with the embryonic and fetal tissue remains from that pregnancy. Therefore, facilities will not have to segregate embryonic and fetal tissue remains from other products of a pregnancy for separate disposition.

3. Concerns About Criminalization.

Some commenters were concerned that the rules criminalize the process of seeking an abortion.

Response: HHSC respectfully disagrees. The 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 facilities. The rules do not apply to individual patients and are intended to ensure that embryonic and fetal tissue subject to the rules is disposed of in a proper manner by facilities as mandated by the Legislature.

4. Woman's Constitutional Right to Terminate a Pregnancy; Supreme Court Ruling in Whole Woman's Health v. Hellerstedt; Potential Lawsuits.

Commenters felt that the proposed rules would violate a woman's constitutional right or 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 in Whole Woman's Health v. Hellerstedt or that the state was promulgating unnecessary regulations. Commenters also voiced concerns that the rules would result in additional lawsuits.

Response: HHSC respectfully disagrees. The rules are required by the Legislature as expressed by Senate Bill 8. They are intended to ensure proper disposition of embryonic and fetal tissue remains from health care facilities without imposing a substantial burden on a woman's access to abortion. The rules do not apply to individuals, but rather to health care facilities, which are already subject to specified methods of disposition of fetal tissue and other material. As previous court testimony has indicated, the estimated cost of compliance with these rules would range between $0.52 and $1.56 per patient. Because this cost would be instead of, not in addition to, current methods, HHSC believes this cost to be minimal and absorbable by each health care facility. Because HHSC has determined that any additional costs associated with complying with these rules can be absorbed by the health care 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.

5. Access to Abortion Services; Stigmatization.

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 and minors. Other commenters remarked that the rules will increase emotional trauma and are intended to shame or punish women seeking abortions.

Response: HHSC 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 embryonic and fetal tissue remains from health care facilities, which are already subject to rules regarding the disposition of fetal tissue. These rules implement Senate Bill 8, which eliminates methods not currently in use and retain some of the existing methods. Final disposition no longer includes depositing disinfected fetal tissue in landfills or grinding and discharging in a sanitary sewer system, but rather allows more dignified methods. HHSC believes the costs for compliance with these rules will be minimal based on cost data provided by parties opposed to previous disposition rules. As noted above, an economist hired by the plaintiffs in Whole Woman's Health v. Hellerstedt (II) stated that the cost of compliance would range between $0.52 and $1.56 per patient, an amount offset by the elimination of current methods of disposition. Because HHSC has determined that health care facilities can absorb any additional costs associated with these rules, it anticipates no change in access to abortion services.

6. Donation, Research and Testing.

Some commenters stated that fetal tissue should be allowed to be donated for medical and scientific research as one positive result to come from a difficult choice.

Response: HHSC appreciates the comments and notes that Senate Bill 8 also added Chapter 173, which regulates the donation of human fetal tissue, to the Texas Health and Safety Code. Section 173.005(b) prohibits the donation of human fetal tissue obtained from an elective abortion.

7. Death Certificates.

Some commenters were concerned that the rules would require issuance of a birth certificate and a death certificate for disposition of all embryonic and fetal tissue remains.

Response: HHSC appreciates the comments. A certificate of fetal death 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). Fetal deaths subject to the fetal death certificate requirement are exempt from the Chapter 138 rules because they are not included in the definition of embryonic and fetal tissue remains in §138.2(10). In addition, §138.4(b) provides that nothing in the rules requires the issuance of a birth or death certificate or a burial transit permit for the proper disposition of embryonic and fetal tissue remains from health care facilities.

8. Funerals.

Some commenters asked whether the proposed new rules would require funerals for the disposition of embryonic and fetal tissue remains. Others stated the disposition rules are contrary to their religious beliefs.

Response: HHSC appreciates the comments. Funeral services are not required in order for health care facilities to properly dispose of embryonic and fetal tissue remains under these rules, nor are they prohibited under these rules. Furthermore, the rules provide several options for the disposition of embryonic and fetal tissue remains.

9. 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 or that the state is relying too much on the Catholic Church to help facilities address disposition requirements. Commenters voiced concerns at the attempt to force a certain religious view or 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: HHSC respectfully disagrees with the first set of commenters and notes that, first, the rules apply to facilities and not to individuals, and second, the rules do not require facilities to take part in any sort of ritual, religious or otherwise. This decision is the responsibility of the health care facility. Although some facilities may choose a disposition method involving burial with a religious organization, such a method is neither required nor prohibited by the rules. Instead, the rules specify which methods a health care facility may use for the disposition of embryonic and fetal tissue remains.

10. Privacy Concerns.

Some commenters were concerned that the rules violate a woman's right to privacy regarding her medical decisions.

Response: HHSC respectfully disagrees. The rules do not impinge on a patient's medical decisions because the rules apply to health care facilities that provide health or medical care to a pregnant woman. The rules do not require a patient to provide any medical information, to choose the method of disposition or even to be notified of the method. The rules also do not require health care facilities to provide any patient information in relation to disposition methods. Responsibility for complying with these rules falls on facilities, not individuals.

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

Some commenters approved of the removal of grinding and discharging into a sanitary sewer system or disposition into a landfill because these methods reduce the dignity of human life as trash, while others noted that this is the method commonly used for all other types of medical waste and this was no different.

Response: HHSC appreciates the comments. Senate Bill 8 determined the acceptable methods of disposition and those methods are incorporated into these rules.

12. Costs.

Commenters expressed concern that these rules would increase the cost of an abortion for women and disproportionately affect low-income women; that the rules would impose a burden on hospitals that would have to store embryonic and fetal tissue until it could be disposed of; that the state should not rely on one or two organizations that have offered to provide services or offset costs when the total costs are still not known; or that these rules would result in more litigation which would cost taxpayers money to defend. Other commenters stated that abortion providers should absorb the costs or noted that low-cost burials, group burials, and other forms of assistance are available.

Response: HHSC respectfully disagrees with the first set of comments and supports the assertions of the second set of comments. Prior to litigation over earlier fetal tissue disposition rules in Whole Woman's Health v. Hellerstedt (II), the Department of State Health Services (DSHS) received cost data from waste disposal companies, private and public landfills, the Funeral Consumers Alliance of Central Texas, the Funeral Service Commission, Texas Commission on Environmental Quality, 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, DSHS determined that the annual cost per facility would be approximately $450. Furthermore, the plaintiff's own expert witness in that case provided written testimony that the cost of compliance would range between $0.52 and $1.56 per patient. In addition, HHSC believes there are a number of regulated facilities that are already in compliance with these rules. For those health care facilities not already disposing of embryonic and fetal tissue remains through cremation and burial, the cost of any of the currently available methods would be offset by the elimination of the cost of landfill disposition. Based on the above information, HHSC believes this cost to be minimal and absorbable by each health care facility.

13. Health and Safety and Public Health Impact.

Some commenters stated that the rules did not have any public health purpose or medical benefit.

Response: HHSC respectfully disagrees and notes that the rules are adopted in order to implement the requirements of Senate Bill 8, which expresses "the state's profound respect for the life of the unborn by providing for a dignified disposition of embryonic and fetal tissue remains." These rules do so while also carrying out HHSC's duty to protect public health. In protecting public health, HHSC must do so in a manner that is consonant with the state's respect for life and the dignity of the unborn. These rules are the means by which HHSC is able to meet that objective.

14. Existing Laws Sufficient for Disposal of Tissue.

Some commenters stated there is no valid reason to adopt the rules, that facilities are already following sanitary methods of waste disposal, or that it is hypocritical to have a separate set of rules just for the disposition of fetal tissue. Other commenters stated that current law allows the inhumane disposition of the unborn and needs to be changed.

Response: HHSC respectfully disagrees with the first set of comments and addresses both sets of comments by noting that the Legislature passed Senate Bill 8, which added Chapter 697 to the Texas Health and Safety Code relating to the disposition of embryonic and fetal tissue remains. This legislation requires HHSC to adopt rules to implement the requirements of Chapter 697. As the stated purpose of Chapter 697 "is to express the state's profound respect for the life of the unborn by providing for a dignified disposition of embryonic and fetal tissue remains," these rules are adopted to carry out that intent. The disposition methods for embryonic and fetal tissue remains differ from other material to ensure the dignified treatment of fetal tissue consistent with Chapter 697 and with other Texas laws.

15. Use of Public Funds.

Commenters wanted the funds being expended to change the rules, enforce the new rules, and/or on anticipated litigation resulting from the new rules, to be redirected to more direct public health impacts such as education, caring for special needs children, protecting abused children, treating the uninsured, public health and sanitation, birth control, and sex education.

Response: HHSC respectfully disagrees and again notes these rules are required by Senate Bill 8. Calls for HHSC to redirect funds to programs that other agencies oversee are beyond the scope of these rules and of HHSC's authority. Calls for HHSC to redirect funds to programs that HHSC does oversee are also beyond the scope of these rules, which explicitly address the treatment and disposition of embryonic and fetal tissue remains from health care facilities. HHSC further notes that adopting and implementing these rules, and defending them if necessary, will not adversely impact any other program that HHSC oversees.

16. Expansion of Government.

Some commenters were concerned about government overreach into a private matter between a patient and physician.

Response: HHSC respectfully disagrees, as these rules apply to health care facilities already subject to regulation and do not impinge on the doctor-patient relationship. HHSC is not expanding its authority to include any new topic or regulated entity or person, and the disposition of embryonic and fetal tissue remains is still the responsibility of the health care facility. Additionally, the rules do not require that a patient be informed of or choose the disposition method. Instead, the proposed rules pertain only to the treatment and disposition of embryonic and fetal tissue remains generated by health care facilities.

17. Separation of Remains.

Comment: A commenter stated that requiring the separation of embryonic and fetal tissue remains from the other products of a pregnancy, such as blood and placental tissue would be a waste of time and resources.

Response: Facilities are not required to separate embryonic and fetal tissue remains from the other products of a pregnancy; §138.3(d) allows for the disposition of the umbilical cord, placenta, gestational sac, blood, or body fluids from a pregnancy in the same manner as and with the embryonic and fetal tissue remains from that same pregnancy.

In response to HHSC staff comments, HHSC made the following revisions to the proposed text for clarification or consistency.

In §138.1, concerning Purpose, the word "Texas" was added to read as "Texas Health and Safety Code."

In §138.2, concerning Definitions, the word "must" was removed from the introductory paragraph. Also, in §138.2(13) "Health care facilities--Include" was revised to "Health care facility--Includes."

In §138.3(c)(5), concerning Scope, Exemptions, "health-care facility" was revised to "health care facility."

In §138.5(f), concerning Approved Methods of Treatment and Disposition, the word "transportation" was added.

In §138.6(a) and (b), concerning Storage, Handling, and Transport Authorization, "in accordance with this chapter" was added. Also, subsection (c) was added authorizing any health care facility that generates embryonic and fetal tissue remains to store, handle, or transport the remains.

In §138.8, Burial or Cremation Assistance Registry, the word "transportation" was added in the first paragraph.

STATUTORY AUTHORITY

Texas Health and Safety Code, Chapter 697, as adopted in Senate Bill 8, 85th Legislature, 2017, Regular Session, requires the dignified disposition of embryonic and fetal tissue remains. New Texas Health and Safety Code, §697.009 requires the Executive Commissioner to adopt rules governing new Chapter 697. Texas Government Code, §531.0055, authorizes the Executive Commissioner to adopt rules and policies necessary for the operation and provision of health and human services.

In addition to the express authority of Chapter 697 of the Health and Safety Code, HHSC took into consideration a variety of statutes that express the Legislature's will to afford the level of protection and dignity to unborn children as state law affords to adults and children. See, e.g., Texas Penal Code, §1.07(26) (defining "individual" to include "an unborn child at every stage of gestation from fertilization until birth"); Texas Civil Practice and Remedies Code, §71.001(4) (defining "individual" in the wrongful death statute to include "an unborn child at every stage of gestation from fertilization until birth"); Texas Estates Code, §1002.002 (allowing for appointment of attorney ad litem for an unborn person in a guardianship proceeding); Texas Health and Safety Code, §241.010 (requiring hospitals to release to a parent remains of an unborn child who dies as a result of an unintended, intrauterine death). The rules carry out the agency's duty to protect public health in a manner that is consonant with the state's respect for life and dignity of the unborn. The agency accomplished this through amendments to the rules and inclusion of new provisions in the rules, including prohibiting the disposal of fetal tissue in a landfill and eliminating grinding as a method of fetal tissue disposition, that afford protection and dignity to the unborn consistent with the Legislature's expression of its intent. These rules provide a comparable level of protection to public health, while eliminating disposition options that are clearly incompatible with the Legislature's articulated objective of protecting the dignity of the unborn. The adopted rules meet HHSC's duties under law, while properly weighing considerations regarding public health, overall public benefit, and costs.

Additional provisions considered include: Texas Penal Code, §1.07(26), relating to criminal penalties for harm to unborn person; Texas Civil Practice and Remedies Code, §71.001(4), relating to civil liability for killing unborn person; Texas Estates Code, §1054.007, relating to guardianship representation for unborn persons in a guardianship proceeding; Texas Estates Code, §1002.002, regarding the definition of "attorney ad litem" which includes representation of an "unborn person;" Texas Property Code, §115.014, relating to authority of a court to appoint a guardian ad litem to represent the interest of an unborn; Texas Health and Safety Code, §241.010, relating to requirement that hospitals release to a parent remains of an unborn child who dies as a result of an unintended, intrauterine death; Preamble of House Bill (HB) 2, 83rd Legislature, Second Called Session, 2013, effective October 29, 2013, relating to the compelling state interest in protecting the lives of unborn children from the stage at which substantial medical evidence indicates that an unborn child is capable of feeling pain is intended to be separate from and independent of the compelling state interest in protecting the lives of unborn children from the stage of viability, and neither state interest is intended to replace the other; Texas Health and Safety Code, §170.002, relating to the prohibition against a person intentionally or knowingly performing an abortion on a woman who is pregnant with a viable unborn child during the third trimester of the pregnancy; and Texas Health and Safety Code, §171.012, relating to requirement for sonograms of pre-viable unborn children before abortion.

§138.1.Purpose.

The purpose of this chapter is to implement the Texas Health and Safety Code, Chapter 697, which requires the dignified disposition of embryonic and fetal tissue remains.

§138.2.Definitions.

The following words and terms, when used in this chapter, have the following meanings unless the context clearly indicates otherwise.

(1) Burial--The act of depositing embryonic and fetal tissue remains in a grave, crypt, vault, or tomb, or at sea.

(2) Burial park--A tract of land that is used or intended to be used for the interment of embryonic and fetal tissue remains in graves.

(3) Cemetery--A tract of land that is used or intended to be used for the permanent interment of embryonic and fetal tissue remains, and includes:

(A) a burial park for earth interments;

(B) a mausoleum for crypt or vault interments;

(C) a columbarium for cinerary interments; or

(D) a combination of one or more of subparagraphs (A) - (C) of this paragraph.

(4) Columbarium--A structure or room or other space in a building or structure of most durable and lasting fireproof construction; or a plot of earth, containing niches, used, or intended to be used, to contain cremated embryonic and fetal tissue remains.

(5) HHSC--The Texas Health and Human Services Commission.

(6) Cremation--The irreversible process of reducing tissue or remains to ashes or bone fragments through direct flame, extreme heat, and evaporation.

(7) Crematory--A building or structure containing one or more furnaces used, or intended to be used, for the reduction (by burning) of human remains or embryonic and fetal tissue remains to cremated remains.

(8) Crypt or vault--The chamber in a mausoleum of sufficient size to inter the uncremated embryonic and fetal tissue remains.

(9) Entombment--The permanent interment of embryonic and fetal tissue remains in a crypt or vault.

(10) Embryonic and fetal tissue remains--An embryo, a fetus, body parts, or organs from a pregnancy that terminates in the death of the embryo or fetus and for which the issuance of a fetal death certificate is not required by state law. The term does not include the umbilical cord, placenta, gestational sac, blood, or body fluids.

(11) Executive Commissioner--The Executive Commissioner of the Health and Human Services Commission.

(12) Grave--A space of ground in a burial park that is used, or intended to be used for the permanent interment in the ground of embryonic and fetal tissue remains.

(13) Health care facility--Includes the following:

(A) ambulatory surgical centers;

(B) abortion clinics;

(C) birthing centers;

(D) medical clinics;

(E) facilities that provide emergency medical services as defined by Texas Health and Safety Code, §773.003;

(F) freestanding emergency medical care facilities;

(G) hospitals;

(H) professional offices, including the offices of physicians; and

(I) other health care-related facilities that provide health or medical care to a pregnant woman.

(14) Incineration--The process of burning embryonic and fetal tissue remains in an incinerator as defined in Title 30, Texas Administrative Code, Chapter 101 under conditions in conformance with standards prescribed in Title 30, Texas Administrative Code, Chapter 111 by the Texas Commission on Environmental Quality.

(15) Interment--The disposition of embryonic and fetal tissue remains by entombment, burial, or placement in a niche.

(16) Mausoleum--A structure or building of most durable and lasting fireproof construction used, or intended to be used, for the entombment of embryonic and fetal tissue remains.

(17) Niche--A recess or space in a columbarium used, or intended to be used, for the permanent interment of the cremated remains of embryonic and fetal tissue remains.

(18) Steam disinfection--The act of subjecting embryonic and fetal tissue remains to steam under pressure under those conditions which effect disinfection.

§138.3.Scope, Exemptions.

(a) Unless specifically exempted, all embryonic and fetal tissue remains from health care facilities must be treated as provided in this chapter.

(b) To the extent this chapter conflicts with Title 25, Texas Administrative Code, Chapter 1, Subchapter K, this chapter prevails.

(c) This chapter does not apply to:

(1) placentas designated for sale and obtained from a licensed hospital or a licensed birthing center;

(2) in vitro tissue cultures;

(3) human fetal tissue donated in accordance with Texas Health and Safety Code, Chapter 173;

(4) disposition of embryonic and fetal tissue remains of a single pregnancy, body parts, or tissue (including bulk blood), transferred for disposition to a licensed funeral director in accordance with Texas Health and Safety Code, Chapter 711, and Title 25, Texas Administrative Code Chapter 181 (relating to Vital Statistics), with the consent of the person or persons authorized to consent to the disposition of the fetal remains, body parts, or tissue (including bulk blood);

(5) human tissue, including embryonic and fetal tissue, that is expelled or removed from the human body once the person is outside of a health care facility;

(6) embryonic and fetal tissue required to be released to the parent of an unborn child pursuant to Texas Health and Safety Code, §241.010; and

(7) a placenta removed from a hospital or birthing center pursuant to Texas Health and Safety Code, Chapter 172.

(d) Notwithstanding any other law or rule, the umbilical cord, placenta, gestational sac, blood, or body fluids from a pregnancy terminating in the death of the embryo or fetus for which the issuance of a fetal death certificate is not required by state law may be disposed of in the same manner as and with the embryonic and fetal tissue remains from that same pregnancy as authorized by this chapter.

§138.5.Approved Methods of Treatment and Disposition.

(a) Embryonic and fetal tissue remains, regardless of the period of gestation, except as provided by §138.3 of this chapter (relating to Scope, Exemptions), must be subjected to one of the following methods of treatment and disposal:

(1) interment;

(2) cremation;

(3) incineration followed by interment; or

(4) steam disinfection followed by interment.

(b) Embryonic and fetal tissue remains that undergo cremation must be placed in a cremation container that:

(1) is made of combustible materials suitable for cremation;

(2) provides a complete covering of the remains;

(3) is resistant to leakage or spillage; and

(4) protects the health and safety of crematory personnel.

(c) The ashes resulting from the cremation or incineration of embryonic and fetal tissue remains:

(1) may be interred or scattered in any manner authorized by law for human remains; and

(2) may not be placed in a landfill or sewer system.

(d) Any facility that receives embryonic and fetal tissue remains for treatment must maintain records to document the method and conditions of treatment in accordance with Title 30, Texas Administrative Code, Chapter 326.

(e) Any facility that receives embryonic and fetal tissue remains for treatment is responsible for establishing the conditions necessary for operation of each method used at the facility to ensure the reduction of microbial activity of any embryonic and fetal tissue remains.

(f) A health care facility responsible for disposing of embryonic and fetal tissue remains may coordinate with an entity in the registry established under §138.8 of this chapter (relating to Burial or Cremation Assistance Registry), in an effort to reduce the cost associated with transportation, burial, or cremation of the embryonic and fetal tissue remains.

§138.6.Storage, Handling, and Transport Authorization.

(a) Any person or entity that is licensed, permitted or otherwise authorized by the Texas Funeral Services Commission to store, handle or transport human remains is authorized to store, handle or transport embryonic and fetal tissue remains in accordance with this chapter.

(b) Any person or entity that is licensed, permitted or otherwise authorized by the Texas Commission on Environmental Quality to store, handle or transport special waste from health care facilities is authorized to store, handle or transport embryonic and fetal tissue remains in accordance with this chapter.

(c) Any health care facility that generates embryonic and fetal tissue remains is authorized to store, handle, or transport embryonic and fetal tissue remains generated at that facility in accordance with this chapter.

§138.7.Storage, Handling, and Transport Requirements.

(a) A container which contains untreated embryonic and fetal tissue remains must be placed in an outer container that is leak resistant, impervious to moisture, of sufficient strength to prevent tearing and bursting under normal conditions of use and handling, and sealed to prevent leakage.

(b) The outer container holding untreated embryonic and fetal tissue remains must be labeled with a warning legend in English and in Spanish, along with the international symbol for biohazardous material on the sides of the container. The wording of the warning legend must be substantially similar to the following: "CAUTION, contains material which may be biohazardous" and "PRECAUCIÓN, contiene material que pueden ser peligro biológico."

(c) Untreated embryonic and fetal tissue remains being transported for disposition in accordance with these rules shall be transported using units that:

(1) have a fully enclosed, leak-proof remains storage area;

(2) protect the remains from mechanical stress or compaction;

(3) carry spill cleanup equipment; and

(4) have a compartment where remains are transported that must:

(A) be maintained in a sanitary condition;

(B) be locked when the vehicle or trailer is in motion;

(C) be locked or secured when remains are present in the compartment except during loading or unloading of remains;

(D) have a floor and sides made of an impervious, nonporous material;

(E) have all discharge openings securely closed during operation of the vehicle or trailer;

(F) maintain a temperature of 45 degrees Fahrenheit or less for remains transported for longer than 72 hours during post-collection storage period; and

(G) be disinfected before being used to transport any material other than remains or untreated medical waste.

(d) Cremated embryonic and fetal tissue remains may be transported in any manner in this state and must be disposed of in accordance with this chapter.

§138.8.Burial or Cremation Assistance Registry.

The registry is created to identify persons or entities who choose to provide financial or other assistance for the transportation, cremation, or burial of embryonic or fetal tissue remains.

(1) The following persons or entities may apply for inclusion on the registry by submitting an application on a form prescribed by HHSC:

(A) participating funeral homes and cemeteries willing to provide free common burials or free or low-cost private burials that certify that they will do so in compliance with applicable law; and

(B) private nonprofit organizations that will provide financial assistance for the costs associated with burial or cremation of embryonic and fetal tissue remains.

(2) An application will be approved if the applicant meets the requirements of paragraph (1) of this section.

(3) An application will be disapproved if the applicant has:

(A) not met the requirements in paragraph (1) of this section; or

(B) failed or refused to properly complete or submit any application form, or deliberately presented false information on any form or document required by HHSC.

(4) Upon approval of an application, the applicant's name will be placed on the registry. HHSC will provide notice of placement on the registry to each approved applicant.

(5) A person or entity may be removed from the registry at the sole discretion of HHSC upon evidence that a registrant has failed to provide the services for which it was placed on the registry. HHSC will notify, in writing, a registrant of its removal from the registry. The denial or removal from the registry is not subject to Texas Government Code, Chapter 2001.

(6) A request under this section will not be considered a petition for the adoption of rules.

(7) Obtaining Registry Information.

(A) HHSC will make the registry information available upon request to a physician, a health care facility, or the agent of a physician or health care facility.

(B) A request from a physician, a health care facility, or the agent of a physician or health care facility must be submitted to HHSC on a form prescribed by HHSC.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on January 11, 2018.

TRD-201800080

Karen Ray

Chief Counsel

Department of State Health Services

Effective date: February 1, 2018

Proposal publication date: November 17, 2017

For further information, please call: (512) 424-6530