The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes amendments to §1.132, concerning Definitions; §1.133, concerning Scope, Covering Exemptions and Minimum Parametric Standards for Waste Treatment Technologies Previously Approved by the Texas Department of State Health Services; §1.134, concerning Application; and §1.136, concerning Approved Methods of Treatment and Disposition.

BACKGROUND AND PURPOSE

Senate Bill 8, 85th Legislature, 2017, Regular Session, added Texas Health and Safety Code, Chapter 697, relating to the disposition of embryonic and fetal tissue remains and excluding this material from the definition of pathological waste. HHSC adopted rules to implement Chapter 697 in 25 TAC Chapter 138 concerning Disposition of Embryonic and Fetal Tissue Remains, effective on February 1, 2018. The amendments to Subchapter K will delete references to fetal tissue, because Chapter 138 now applies to this material.

SECTION-BY-SECTION SUMMARY

In §1.132, the definition of "Embryonic and Fetal Tissue Remains" is added based on the statutory definition in Chapter 697 and the definition of "Fetal Tissue" is removed. Minor editorial revisions are included in the definitions of "Executive Commissioner" and "Incineration." Also, the definition of "Pathological Waste" is revised by noting it does not include embryonic and fetal tissue remains and by removing subparagraph (B) concerning products of spontaneous or induced human abortions.

In §1.133(a)(2), the text phrases "human fetal tissue as defined in the Texas Health and Safety Code, Chapter 173, and donated in accordance with that chapter" and "embryonic and fetal tissue remains subject to Texas Health and Safety Code, Chapter 697" are added to the list of exemptions in subparagraphs (B) and (I) for regulation of special waste from health care-related facilities. Also, language is amended to clarify other exemptions which included removing the text "including fetal tissue" in new subparagraph (F). The language "the remains of an unintended, intrauterine fetal death" is added and "fetal remains" is removed in new subparagraph (G). Also, subparagraph (F) concerning "disposition of fetal remains of a single pregnancy…" is deleted from the list of exemptions because this material is already exempted under the category of "embryonic and fetal tissue remains."

In §1.134(a), the text is revised to state that "This subchapter does not apply to embryonic and fetal tissue remains subject to Texas Health and Safety Code, Chapter 697" as the rules implementing that statute are adopted in 25 TAC Chapter 138.

In §1.136(a)(4)(A)(i) - (iii) and (B), the text concerning pathological waste treatment and disposal is revised to state "other than embryonic and fetal tissue remains" because these rules no longer apply to embryonic and fetal tissue. The text in §1.136(a)(4)(A)(v) and (B)(i) referencing fetal tissue is removed, as the rules relating to disposition of that material are now adopted in 25 TAC Chapter 138.

FISCAL NOTE

Donna Sheppard, DSHS Chief Financial Officer, has determined that for each year of the first five years that the sections will be in effect, there will be no fiscal implications to state or local governments as a result of enforcing and administering the sections as proposed.

GOVERNMENT GROWTH IMPACT STATEMENT

DSHS has determined that during the first five years that the sections will be in effect:

(1) the proposed rules will not create or eliminate a government program;

(2) implementation of the proposed rules will not affect the number of employee positions;

(3) implementation of the proposed rules will not require an increase or decrease in future legislative appropriations;

(4) the proposed rules will not affect fees paid to the agency;

(5) the proposed rules will not create new rules;

(6) the proposed rules will not expand existing rules;

(7) the proposed rules will not change the number of individuals subject to the rules; and

(8) the rules are unlikely to have a significant impact on the state's economy because fetal tissue disposition is currently regulated.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS AND ECONOMIC COSTS TO PERSONS

Mr. Jonathan R. Huss, DSHS Associate Commissioner, Consumer Protection Division, has determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities required to comply with the sections as proposed. The rules do not impose any additional costs to small businesses, micro-businesses, or rural communities.

IMPACT ON LOCAL EMPLOYMENT

There is no anticipated negative impact on local employment.

COSTS TO REGULATED PERSONS

Texas Government Code, §2001.0045 does not apply to these rules because the rules are necessary to implement Senate Bill 8, 85th Legislature, 2017, Regular Session.

PUBLIC BENEFIT

Mr. Huss has also determined that for each year of the first five years the sections are in effect, the public benefit anticipated as a result of amending these rules is to conform to new Texas Health and Safety Code, Chapter 697, as adopted in Senate Bill 8, 85th Legislature, 2017, Regular Session, requiring the dignified disposition of embryonic and fetal tissue remains and removing embryonic and fetal tissue from the definition of pathological waste. Rules required under Chapter 697 have been adopted and can be found at 25 TAC Chapter 138.

REGULATORY ANALYSIS OF MAJOR ENVIRONMENTAL RULES

DSHS has determined that this proposal is not a "major environmental rule" as defined by Texas Government Code, §2001.0225. "Major environmental rule" is defined to mean a rule the specific intent of which is to protect the environment or reduce risk to human health from environmental exposure and that may adversely affect, in a material way, the economy, a sector of the economy, productivity, competition, jobs, the environment or the public health and safety of a state or a sector of the state. This proposal is not specifically intended to protect the environment or reduce risks to human health from environmental exposure.

TAKINGS IMPACT ASSESSMENT

DSHS has determined that the proposal does not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Texas Government Code, §2007.043.

PUBLIC COMMENT

Comments on the proposal may be submitted to the Consumer Protection Division, Department of State Health Services, Mail Code 1949, P.O. Box 149347, Austin, Texas 78714-9347, or by email to CPDRuleComments@dshs.texas.gov. Please specify "Comments on Chapter 1 Proposed Rules" in the subject line. DSHS intends by this section to invite public comment on each of the rule amendments.

To be considered, comments must be submitted no later than 30 days following publication of the proposal in the Texas Register. If the last day to submit comments falls on a weekend or a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be considered.

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 and removes embryonic and fetal tissue from the definition of pathological waste. These rules are now in conflict with Texas Health and Safety Code, Chapter 697 and are being amended to conform to the new Chapter 697. Texas Government Code, §531.0055, Texas Health and Safety Code, §12.001, and Texas Health and Safety Code, §1001.075 authorize the Executive Commissioner to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Texas Health and Safety Code, Chapter 1001.

The amendments are authorized by Texas Health and Safety Code, Chapters 12, 697 and 1001; and Texas Government Code, Chapter 531.