TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 1. MISCELLANEOUS PROVISIONS

SUBCHAPTER K. DEFINITION, TREATMENT, AND DISPOSITION OF SPECIAL WASTE FROM HEALTH CARE-RELATED FACILITIES

25 TAC §§1.132 - 1.137

The Executive Commissioner of the Health and Human Services Commission, on behalf of the Department of State Health Services (department), proposes amendments to §§1.132 - 1.137, concerning the definition, treatment, and disposition of special waste from health care-related facilities.

BACKGROUND AND PURPOSE

The rule amendments provide language and offer clarification to enhance the understanding of the rules, as well as to update outdated references, terminology, and methods. Government Code, §2001.039 requires a review of rules, including an assessment of whether the reasons for initially adopting the rules continue to exist. Chapter 1, Subchapter K of Title 25 of the Texas Administrative Code was originally adopted in 1989, and amendments were made in 1991 and 1994. Additionally, the department has reviewed §§1.131 - 1.137 and has determined that the reasons for adopting the rules continue to exist because the rules on this subject are needed. However, there are no changes being proposed to §1.131 in this rulemaking.

SCOPE OF THE PROPOSED RULES

The scope of the proposed rules encompasses the following provisions of the rules in Subchapter K of Chapter 1, Miscellaneous Provisions, relating to special waste from health care-related facilities:

§1.132 Definitions.

§1.133 Scope, Covering Exemptions and Minimum Parametric Standards for Waste Treatment Technologies Previously approved by the Texas Department of Health.

§1.134 Application.

§1.135 Performance Standards for Commercially-Available Alternate Treatment Technologies for Special Waste from Health Care-Related Facilities.

§1.136 Approved Methods of Treatment and Disposition.

§1.137 Enforcement.

SECTION-BY-SECTION SUMMARY

Amendments to §1.132, Definitions, are proposed to update references to the department; define the terms cremation, executive commissioner, and fetal tissue; remove the definition for the term cremated remains; update references to Texas Commission on Environmental Quality (TCEQ); correct a mathematical unit for "log10;" and necessitates the renumbering of paragraphs.

Amendments to §1.133, Scope, Covering Exemptions and Minimum Parametric Standards for Waste Treatment Technologies Previously Approved by the Texas Department of Health, are proposed to update references to the department and a legal reference.

Amendments to §1.134, Application, are proposed to update references to facilities providing mental health and intellectual disability services; and add freestanding emergency medical care facilities to the list of health care-related facilities to which this rule applies.

Amendments to §1.135, Performance Standards for Commercially-Available Alternate Treatment Technologies for Special Waste from Health Care-Related Facilities, are proposed to update references to the department and correct a mathematical unit to "log10"

Amendments to §1.136, Approved Methods of Treatment and Disposition, are proposed to update references to the department; update terminology regarding the Texas Administrative Code; update references to TCEQ and its rules; clarifying disposition methods for fetal tissue; clarifying disposition methods for fetal tissue and other tissues that are products of spontaneous or induced human abortion; and clarifying that disposition methods for anatomical remains are established in 25 TAC §479.4.

Amendments to §1.137, Enforcement, are proposed to reflect the Executive Commissioner's role in rulemaking; remove home and community support services agencies from the list of the department's regulatory programs; and add end-stage renal disease facilities and freestanding emergency medical centers to the list of the department's regulatory programs.

FISCAL NOTE

Renee Clack, Director, Health Care Quality Section, has determined that for each year of the first five years that the sections will be in effect, there will not be fiscal implications to state or local governments as a result of enforcing and administering the sections as proposed.

SMALL AND MICRO-BUSINESS IMPACT ANALYSIS AND ECONOMIC COSTS TO PERSONS

Ms. Clack has also determined that the department has identified a potential fiscal impact but does not have information sufficient to quantify the impact as the proposed changes to the rules reflect disposition methods that were previously available. It is presumed that there was a cost to all of the previously available disposition methods and the department has no information to suggest that the cost of implementing the proposed changes would result in any greater cost to small and micro businesses or to persons who are required to comply with the rules.

IMPACT ON LOCAL EMPLOYMENT

There is no anticipated impact on local employment.

PUBLIC BENEFIT

Ms. Clack has determined that for each year of the first five years the sections are in effect, the public benefit anticipated as a result of adopting and enforcing these rules will be enhanced protection of the health and safety of the public.

REGULATORY ANALYSIS

The department has determined that this proposal is not a "major environmental rule" as defined by 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 intended to protect the environment or reduce risks to human health from environmental exposure.

TAKINGS IMPACT ASSESSMENT

The department 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 Government Code, §2007.043.

PUBLIC COMMENT

Comments on the proposal may be submitted to Allison Hughes, Health Facilities Rules Coordinator, Health Care Quality Section, Division of Regulatory Services, Department of State Health Services, Mail Code 2822, P.O. Box 149347, Austin, Texas 78714-9347, (512) 834-6775 or by email to allison.hughes@dshs.state.tx.us. Please specify "Comments on special waste from health care-related facilities" in the subject line. The department intends by this section to invite public comment on each of the amendments to the rules. Comments are accepted for 30 days following publication of the proposal in the Texas Register.

LEGAL CERTIFICATION

The Department of State Health Services General Counsel, Lisa Hernandez, certifies that the proposed rules have been reviewed by legal counsel and found to be within the state agencies' authority to adopt.

STATUTORY AUTHORITY

The amendments are authorized by Government Code, §531.0055, Health and Safety Code, §12.001, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001. The amendments are also authorized by Health and Safety Code, §81.004, which authorizes the Executive Commissioner to adopt rules necessary for the effective administration of Health and Safety Code, Chapter 81, concerning the control of communicable disease; by Health and Safety Code, Chapter 241, concerning the licensing of hospitals; by Chapter 243, concerning the licensing of ambulatory surgical centers; by Chapter 244, concerning the licensing of birthing centers; by Chapter 245, concerning the licensing of abortion facilities; by Chapter 251, concerning the licensing of end stage renal disease facilities; by Chapter 254, concerning the licensing of freestanding emergency medical care facilities; and by Chapter 773, concerning the licensing of emergency medical services. Review of the rules implements Government Code, §2001.039.

The amendments implement Government Code, Chapter 531; and Health and Safety Code, Chapters 12, 81, 241, 243, 244, 245, 251, 254 and773.

§1.132.Definitions.

The following words and terms, when used in this subchapter [undesignated head], shall have the following meanings unless the context clearly indicates otherwise.

(1) - (2) (No change.)

(3) Approved alternate treatment process--A process for waste treatment which has been approved by the department [Texas Department of Health] in accordance with §1.135 of this title (relating to Performance Standards for Commercially-Available Alternate Treatment Technologies for Special Waste from Health Care-Related Facilities).

(4) - (17) (No change.)

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

[(18) Cremated remains--The bone fragments remaining after the cremation process, which may include the residue of any foreign materials that were cremated with the pathological waste.]

(19) - (26) (No change.)

(27) Executive Commissioner--In this title, Executive Commissioner means the Executive Commissioner of the Health and Human Services Commission.

(28) Fetal Tissue--A fetus, body parts, organs or other tissue from a pregnancy. This term does not include the umbilical cord, placenta, gestational sac, blood or body fluids.

(29) [(27)] 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 pathological waste.

(30) [(28)] Grinding--That physical process which pulverizes materials, thereby rendering them as unrecognizable, and for sharps, reduces the potential for the material to cause injuries such as puncture wounds.

(31) [(29)] Immersed--A process in which waste is submerged fully into a liquid chemical agent in a container, or that a sufficient volume of liquid chemical agent is poured over a containerized waste, such that the liquid completely surrounds and covers the waste item(s) in the container.

(32) [(30)] Incineration--That process of burning SWFHCRF in an incinerator as defined in 30 TAC Chapter 101 under conditions in conformance with standards prescribed in 30 TAC Chapter 111 by the Texas Commission on Environmental Quality [Texas Natural Resource Conservation Commission].

(33) [(31)] Interment--The disposition of pathological waste by cremation, entombment, burial, or placement in a niche.

(34) [(32)] Log10 [Log[sub]10[/sub]]--Logarithm to the base ten.

(35) [(33)] Log10 [Log[sub]10[/sub]] reduction--A mathematically defined unit used in reference to level or degree of microbial inactivation. A 4 log10 [log[sub]10[/sub]] reduction represents a 99.99% reduction in the numbers of active microorganisms, while a 6 log10 [log[sub]10[/sub]] reduction represents a 99.9999% reduction in the numbers of active microorganisms.

(36) [(34)] Mausoleum--A structure or building of most durable and lasting fireproof construction used, or intended to be used, for the entombment pathological waste.

(37) [(35)] Microbial inactivation--Inactivation of vegetative bacteria, fungi, lipophilic/hydrophilic viruses, parasites, and mycobacteria at a 6 log10 [log[sub]10[/sub]] reduction or greater; and inactivation of Bacillus subtilis endospores or Bacillus stearothermophilus endospores at a 4 log10 [log[sub]10[/sub] ] reduction or greater.

(38) [(36)] Microbiological waste--Microbiological waste includes:

(A) discarded cultures and stocks of infectious agents and associated biologicals;

(B) discarded cultures of specimens from medical, pathological, pharmaceutical, research, clinical, commercial, and industrial laboratories;

(C) discarded live and attenuated vaccines, but excluding the empty containers thereof;

(D) discarded, used disposable culture dishes; and

(E) discarded, used disposable devices used to transfer, inoculate or mix cultures.

(39) [(37)] Moist heat disinfection--The subjection of:

(A) internally shredded waste to moist heat, assisted by microwave radiation under those conditions which effect disinfection; or

(B) unshredded waste in sealed containers to moist heat, assisted by low-frequency radiowaves under those conditions which effect disinfection, followed by shredding of the waste to the extent that the identity of the waste is unrecognizable.

(40) [(38)] Niche--A recess or space in a columbarium used, or intended to be used, for the permanent interment of the cremated remains of pathological waste.

(41) [(39)] Parametric controls--Measurable standards of equipment operation appropriate to the treatment equipment including, but not limited to pressure, cycle time, temperature, irradiation dosage, pH, chemical concentrations, or feed rates.

(42) [(40)] Pathological waste--Pathological waste includes but is not limited to:

(A) human materials removed during surgery, labor and delivery, autopsy, embalming, or biopsy, including:

(i) body parts;

(ii) tissues or fetuses;

(iii) organs; and

(iv) bulk blood and body fluids;

(B) products of spontaneous or induced human abortions, regardless of the period of gestation, including:

(i) body parts;

(ii) tissues or fetuses;

(iii) organs; and

(iv) bulk blood and body fluids;

(C) laboratory specimens of blood and tissue after completion of laboratory examination; and

(D) anatomical remains.

(43) [(41)] Saturated--Thoroughly wet such that liquid or fluid flows freely from an item or surface without compression.

(44) [(42)] Sharps--Sharps include, but are not limited to the following materials:

(A) when contaminated:

(i) hypodermic needles;

(ii) hypodermic syringes with attached needles;

(iii) scalpel blades;

(iv) razor blades, disposable razors, and disposable scissors used in surgery, labor and delivery, or other medical procedures;

(v) intravenous stylets and rigid introducers (e.g., J wires);

(vi) glass pasteur pipettes, glass pipettes, specimen tubes, blood culture bottles, and microscope slides;

(vii) broken glass from laboratories; and

(viii) tattoo needles, acupuncture needles, and electrolysis needles;

(B) regardless of contamination:

(i) hypodermic needles; and

(ii) hypodermic syringes with attached needles.

(45) [(43)] Shredding--That physical process which cuts, slices, or tears materials into small pieces.

(46) [(44)] Special waste from health care-related facilities--A solid waste which if improperly treated or handled may serve to transmit an infectious disease(s) and which is comprised of the following:

(A) animal waste;

(B) bulk blood, bulk human blood products, and bulk human body fluids;

(C) microbiological waste;

(D) pathological waste; and

(E) sharps.

(47) [(45)] Steam disinfection--The act of subjecting waste to steam under pressure under those conditions which effect disinfection. This was previously called steam sterilization.

(48) [(46)] Thermal inactivation--The act of subjecting waste to dry heat under those conditions which effect disinfection.

(49) [(47)] Unrecognizable--The original appearance of the waste item has been altered such that neither the waste nor its source can be identified.

§1.133.Scope, Covering Exemptions and Minimum Parametric Standards for Waste Treatment Technologies Previously Approved by the Texas Department of State Health Services.

(a) Exemptions.

(1) (No change.)

(2) These sections do not apply to:

(A) (No change.)

(B) human tissue, including fetal tissue, donated for research or teaching purposes, with the consent of the person authorized to consent as otherwise provided by law, to an institution of higher learning, medical school, a teaching hospital affiliated with a medical school, or to a research institution or individual investigator subject to the jurisdiction of an institutional review board required by 42 United States Code [Codes] 289;

(C) - (F) (No change.)

(b) Minimum parametric standards for waste treatment technologies previously approved by the department [Texas Department of Health].

(1) - (5) (No change.)

§1.134.Application.

These sections apply to special waste from health care-related facilities generated by the operation of the following publicly or privately owned or operated health care-related facilities, including but not limited to:

(1) - (11) (No change.)

(12) freestanding emergency medical care facilities;

(13) [(12)] funeral establishments;

(14) [(13)] home and community support services agencies;

(15) [(14)] hospitals;

(16) [(15)] long term care facilities;

(17) [(16)] facilities providing mental health and intellectual disability services, [mental health and mental retardation facilities,] including but not limited to hospitals, schools, and community centers;

(18) [(17)] minor emergency centers;

(19) [(18)] occupational health clinics and clinical laboratories;

(20) [(19)] pharmacies;

(21) [(20)] pharmaceutical manufacturing plants and research laboratories;

(22) [(21)] professional offices, including but not limited to the offices of physicians, [and] dentists, and acupuncturists;

(23) [(22)] special residential care facilities;

(24) [(23)] tattoo studios; and

(25) [(24)] veterinary clinical and research laboratories.

§1.135.Performance Standards for Commercially-Available Alternate Treatment Technologies for Special Waste from Health Care-Related Facilities.

All manufacturers of commercially-available alternate technologies, equipment, or processes designed or intended for the treatment of special waste from health care-related facilities, except those meeting the standards of §1.133(b) of this title (relating to Scope, Covering Exemptions and Minimum Parametric Standards for Waste Treatment Technologies Previously Approved by the Texas Department of State Health Services), shall apply to the department [Texas Department of Health (department)] on forms prescribed by the department for approval of said technologies, equipment, or processes to ensure that established performance standards are met.

(1) Levels of microbial inactivation.

(A) (No change.)

(B) All manufacturers of commercially-available alternate technologies, equipment, or processes designed and intended for the treatment of special waste from health care-related facilities shall provide specific laboratory evidence that demonstrates:

(i) inactivation of representative samples of vegetative bacteria, mycobacteria, lipophilic/hydrophilic viruses, fungi, and parasites at a level of 6 log10 [log[sub]10[/sub]] reduction or greater, as determined by the department; and

(ii) inactivation of Bacillus stearothermophilus endospores or Bacillus subtilis endospores at a level of 4 log10 [log[sub]10[/sub]] reduction or greater, as determined by the department.

(C) - (E) (No change.)

(2) Documentation requirements.

(A) (No change.)

(B) Documentation must be submitted to the department [Texas Department of Health, Bureau of Environmental Health] on [those] forms provided by the department.

(3) - (4) (No change.)

§1.136.Approved Methods of Treatment and Disposition.

(a) Introduction. The following treatment and disposition methods for special waste from health care-related facilities are approved by the department [Texas Board of Health (board)] for the waste specified. Where a special waste from a health care-related facility is also subject to the sections in Chapter 289 of this title (relating to Radiation Control), the sections in Chapter 289 shall prevail over the sections in this subchapter [undesignated head]. Disposal of special waste from health care-related facilities in sanitary landfills or otherwise is under the jurisdiction of the Texas Commission on Environmental Quality [Texas Natural Resource Conservation Commission] and is governed by its rules found in 30 TAC Chapter 326 (relating to Medical Waste Management) and Chapter 330 (relating to Municipal Solid Waste) [Title 30, Texas Administrative Code, Chapter 330].

(1) - (2) (No change.)

(3) Microbiological waste. Microbiological waste shall be subjected to one of the following methods of treatment and disposal.

(A) - (C) (No change.)

(D) Discarded disposable culture dishes shall be subjected to one of the following methods of treatment and disposal.

(i) All discarded, unused disposable culture dishes shall be disposed of in accordance with 30 TAC Chapters 326 and 330 [Title 30, Texas Administrative Code, Chapter 330].

(ii) (No change.)

(E) (No change.)

(4) Pathological waste. Pathological waste shall be subjected to one of the following methods of treatment and disposal.

(A) Human materials removed during surgery, labor and delivery, autopsy, embalming, or biopsy shall be subjected to one of the following methods of treatment and disposal:

(i) body parts, other than fetal tissue:

(I) interment;

(II) incineration followed by deposition of the residue in a sanitary landfill;

(III) steam disinfection followed by interment;

(IV) moist heat disinfection, provided that the grinding/shredding renders the item as unrecognizable, followed by deposition in a sanitary landfill;

(V) chlorine disinfection/maceration, provided that the grinding/shredding renders the item as unrecognizable, followed by deposition in a sanitary landfill; or

(VI) an approved alternate treatment process, provided that the process renders the item as unrecognizable, followed by deposition in a sanitary landfill;

(ii) tissues, other than fetal tissue [or fetuses]:

(I) incineration followed by deposition of the residue in a sanitary landfill;

(II) grinding and discharging to a sanitary sewer system;

(III) interment;

(IV) steam disinfection followed by interment;

(V) moist heat disinfection followed by deposition in a sanitary landfill;

(VI) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or

(VII) an approved alternate treatment process, provided that the process renders the item as unrecognizable, followed by deposition in a sanitary landfill;

(iii) organs, other than fetal tissue:

(I) incineration followed by deposition of the residue in a sanitary landfill;

(II) grinding and discharging to a sanitary sewer system;

(III) interment;

(IV) steam disinfection followed by interment;

(V) moist heat disinfection followed by deposition in a sanitary landfill;

(VI) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or

(VII) an approved alternate treatment process, provided that the process renders the item as unrecognizable, followed by deposition in a sanitary landfill;

(iv) bulk human blood and bulk human body fluids removed during surgery, labor and delivery, autopsy, embalming, or biopsy:

(I) discharging into a sanitary sewer system;

(II) steam disinfection followed by deposition in a sanitary landfill;

(III) incineration followed by deposition of the residue in a sanitary landfill;

(IV) thermal inactivation followed by deposition in a sanitary landfill;

(V) thermal inactivation followed by grinding and discharging into a sanitary sewer system;

(VI) chemical disinfection followed by deposition in a sanitary landfill;

(VII) chemical disinfection followed by grinding and discharging into a sanitary sewer system;

(VIII) moist heat disinfection followed by deposition in a sanitary landfill;

(IX) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or

(X) an approved alternate treatment process, provided that the process renders the item as unrecognizable, followed by deposition in a sanitary landfill;[.]

(v) fetal tissue, regardless of the period of gestation:

(I) interment;

(II) cremation;

(III) incineration followed by interment; or

(IV) steam disinfection followed by interment.

(B) The products of spontaneous or induced human abortion shall be subjected to one of the following methods of treatment and disposal:

(i) fetal tissue, [body parts, tissues, or organs] regardless of the period of gestation:

[(I) grinding and discharging to a sanitary sewer system;]

(I) [(II)] incineration followed by interment [deposition of the residue in a sanitary landfill];

(II) [(III)] steam disinfection followed by interment;

(III) [(IV)] interment; or

(IV) cremation;

[(V) moist heat disinfection followed by deposition in a sanitary landfill;]

[(VI) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or]

[(VII) an approved alternate treatment process, provided that the process renders the item as unrecognizable, followed by deposition in a sanitary landfill;]

(ii) blood and body fluids:

(I) discharging into a sanitary sewer system;

(II) steam disinfection followed by deposition in a sanitary landfill;

(III) incineration followed by deposition of the residue in a sanitary landfill;

(IV) thermal inactivation followed by deposition in a sanitary landfill;

(V) thermal inactivation followed by grinding and discharging into a sanitary sewer system;

(VI) chemical disinfection followed by deposition in a sanitary landfill;

(VII) chemical disinfection followed by grinding and discharging into a sanitary sewer system;

(VIII) moist heat disinfection followed by deposition in a sanitary landfill;

(IX) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or

(X) an approved alternate treatment process, provided that the process renders the item as unrecognizable, followed by deposition in a sanitary landfill;

(iii) any other tissues, including placenta, umbilical cord and gestational sac:

(I) grinding and discharging to a sanitary sewer system;

(II) incineration followed by deposition of the residue in a sanitary landfill;

(III) steam disinfection followed by interment;

(IV) interment;

(V) moist heat disinfection followed by deposition in a sanitary landfill;

(VI) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or

(VII) an approved alternate treatment process, provided that the process renders the item as unrecognizable, followed by deposition in a sanitary landfill.

(C) Discarded laboratory specimens of blood and/or tissues shall be subjected to one of the following methods of treatment and disposal:

(i) grinding and discharging into a sanitary sewer system;

(ii) steam disinfection followed by deposition in a sanitary landfill;

(iii) steam disinfection followed by grinding and discharging into a sanitary sewer system;

(iv) incineration followed by deposition of the residue in a sanitary landfill;

(v) moist heat disinfection followed by deposition in a sanitary landfill;

(vi) chlorine disinfection/maceration followed by deposition in a sanitary landfill; or

(vii) an approved alternate treatment process, provided that the process renders the item as unrecognizable, followed by deposition in a sanitary landfill.

(D) Anatomical remains shall be disposed of in a manner specified by §479.4 of this title (relating to Final Disposition of the Body and Disposition of Remains). [subjected to one of the following methods of treatment and disposal:]

[(i) interment;]

[(ii) incineration followed by interment; or]

[(iii) steam disinfection followed by interment.]

(5) Sharps.

(A) All discarded unused sharps shall be disposed of in accordance with 30 TAC Chapters 326 and 330 [Title 30, Texas Administrative Code, Chapter 330].

(B) (No change.)

(b) Records. The facility treating the wastes shall maintain records to document the treatment of the special waste from health care-related facilities processed at the facility as to method and conditions of treatment in accordance with 30 TAC [Title 30, Texas Administrative Code,] Chapter 326 [330].

(c) (No change.)

§1.137.Enforcement.

The appropriate regulatory programs of the department shall incorporate the definition and methodology contained in these provisions into their respective general program rules and shall formulate and present for the Executive Commissioner's [board's] consideration such additional rules as are necessary for the internal collection, storage, handling, movement, and treatment of special waste from health care-related facilities generated within or by the following facilities or activities:

(1) abortion clinics;

(2) ambulatory surgical centers;

(3) birthing centers;

(4) emergency medical service providers;

(5) end stage renal disease facilities;

(6) freestanding emergency medical care facilities;

[(5) home and community support services agencies;]

(7) [(6)] hospitals;

(8) [(7)] special residential care facilities; and

(9) [(8)] tattoo studios.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 20, 2016.

TRD-201603119

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: July 31, 2016

For further information, please call: (512) 776-6972


CHAPTER 169. ZOONOSIS CONTROL

SUBCHAPTER B. CARE OF ANIMALS BY CIRCUSES, CARNIVALS, AND ZOOS

25 TAC §§169.41 - 169.48

The Executive Commissioner of the Health and Human Services Commission, on behalf of the Department of State Health Services (department), proposes the repeal of §§169.41 - 169.48, concerning the care of animals by circuses, carnivals, and zoos.

BACKGROUND AND PURPOSE

Texas Occupations Code, Chapter 2152, "Regulation of Circuses, Carnivals, and Zoos," §§2152.051 - 2152.054, provided the Executive Commissioner of the Health and Human Services Commission with the authority to adopt standards for the operation of circuses, carnivals, and zoos, prescribe qualifications for its inspection agents, and prescribe the amount of each fee required by this chapter. Senate Bill (SB) 219, 84th Texas Legislature, Regular Session, 2015, repealed Texas Occupations Code, Chapter 2152. Therefore, §§169.41 - 169.48 are no longer required due to the repeal of the authorizing statute.

SECTION-BY-SECTION SUMMARY

The repeal of §§169.41 - 169.48 is necessary because SB 219 repealed Texas Occupations Code, Chapter 2152, which was the legal mandate for these rules.

FISCAL NOTE

Ms. Imelda Garcia, Director, Infectious Disease Prevention Section, 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 repealing the sections as proposed.

SMALL AND MICRO-BUSINESS IMPACT ANALYSIS

Ms. Garcia has also determined that there will be no adverse impact on small businesses or micro-businesses required to comply with the sections as proposed because the sections are no longer necessary. This was determined by interpretation of the rules that small businesses and micro-businesses will not be required to alter their business practices in order to comply with the proposed repeal of the sections.

ECONOMIC COSTS TO PERSONS AND IMPACT ON LOCAL EMPLOYMENT

There are no anticipated economic costs to persons who are required to comply with the proposed repeal of the sections. There will be no anticipated negative impact on local employment.

PUBLIC BENEFIT

In addition, Ms. Garcia has determined that for each year of the first five years the repeal of the sections is in effect, the public will benefit from the adoption of the repeals. The public benefit anticipated is to eliminate possible confusion caused by outdated policies and procedures being presented in the rules and by rules for which there is no longer statutory authority being located in the Texas Administrative Code.

REGULATORY ANALYSIS

The department has determined that this proposal is not a "major environmental rule" as defined by 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

The department 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 Government Code, §2007.043.

COMMENT

Comments on the proposal may be submitted to Tom Sidwa, DVM, MPH, Department of State Health Services, Infectious Disease Prevention Section, Zoonosis Control Branch, Mail Code 1956, P.O. Box 149347, Austin, Texas 78714-9347, or by email to Tom.Sidwa@dshs.state.tx.us. Comments will be accepted for 30 days following publication of the proposal in the Texas Register.

LEGAL CERTIFICATION

The Department of State Health Services General Counsel, Lisa Hernandez, certifies that the proposed rules have been reviewed by legal counsel and found to be within the state agencies' authority to adopt.

STATUTORY AUTHORITY

The repeals are authorized under Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to make decisive actions on rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001.

The repeals affect Government Code, Chapter 531; and Health and Safety Code, Chapter 1001.

§169.41.Purpose.

§169.42.Definitions.

§169.43.Facilities for Housing the Animals.

§169.44.Transportation of Animals.

§169.45.Food and Water Requirements in Transit.

§169.46.Care in Transit.

§169.47.Licenses.

§169.48.State Inspection Agents.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 15, 2016.

TRD-201603037

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: July 31, 2016

For further information, please call: (512) 776-6972


PART 4. ANATOMICAL BOARD OF THE STATE OF TEXAS

CHAPTER 477. DISTRIBUTION OF BODIES

25 TAC §§477.1, 477.2, 477.4, 477.5, 477.7

The Anatomical Board of the State of Texas (Board) proposes to amend §§477.1, 477.2, 477.4, 477.5, and 477.7, concerning the rules and procedures for the distribution of cadavers and/or anatomical specimens to recognized search organizations.

The Board's proposed amendments are to implement Health and Safety Code §691.030 and §692A.011 as amended by Senate Bill 1214 in the 84th Legislative Session. The amendments to §691.030 and §692A.011 provide that the use of cadavers and/or anatomical specimens by recognized search organizations must be coordinated through the Anatomical Board of the State of Texas.

The amendment to §477.1 defines the term "search organizations" to be organizations described in §691.030(a)(3) of the Health and Safety Code.

Amendments to §477.2 necessitate that search organizations meet the requirements described in §691.030(a)(3) of the Health and Safety Code.

Amendments to §477.4 set forth the circumstances under which a cadaver or anatomical specimen may be transferred to a recognized search organization.

Amendments to §477.5 relate to the procedure for a recognized search organization to request transfer of cadavers and/or anatomical specimens, the procedure for approval of the transfer, availability of cadavers and/or anatomical specimens, and the procedure for return of cadavers and/or anatomical specimens.

The amendment to §477.7 requires a recognized search organization receiving cadavers and/or anatomical specimens to file a yearly cadaver procurement and use report.

Vaughan Lee, Chairman of the State Anatomical Board, has determined that for each fiscal year of the first five years the sections are in effect, there will be no fiscal implications to the state as a result of enforcing or administering the sections as proposed.

Dr. Lee has also determined that there are no anticipated economic costs to small businesses or micro-businesses required to comply with the sections as proposed.

Dr. Lee has also determined that for each year of the first five years the sections are in effect, the public will benefit from adoption of the sections. The public benefit as a result of enforcing or administering the sections is to effectively regulate the disposition of bodies in Texas, all of which will protect and promote public health, safety, and welfare.

Comments on the proposal may be submitted in writing either in person or by courier to Stephen Luk, Secretary-Treasurer, Anatomical Board of the State of Texas, P.O. Box 20745, Houston, Texas 77225-0745. Comments will be accepted for 30 days following publication of the proposal in the Texas Register.

The proposed amendments are authorized by the Board's general rulemaking power under Health and Safety Code §691.022(b).

The proposed amendments affect the Texas Administrative Code, Title 25, Chapter 477.

§477.1.Definition and Jurisdiction of the Board.

(a) Definitions [Definition].

(1) Whenever the terms human "body" or "bodies" or "parts of human body" or "parts of human bodies" are used in Chapters 477 - 485, the terms include anatomical specimens, defined as parts of a human corpse in §691.001 of the Health and Safety Code.

(2) Whenever the term "search organization" is used in Chapters 477 - 485, the term includes search and rescue organizations and recovery teams that use human remains detection canines as described in §691.030(a)(3) of the Health and Safety Code.

(b) (No change.)

§477.2.Institutional Requirements.

(a) Institution accreditation. Institutions applying to be authorized to receive and hold bodies, or parts thereof, must show evidence of accreditation by the accrediting board for that profession. This applies to tissue banks authorized to receive donations under Chapter 692A of the Health and Safety Code[, Chapter 692A]. Search organizations must show evidence that they fulfill the requirements described in §691.030(a)(3) of the Health and Safety Code.

(b) - (c) (No change.)

§477.4.Transport, Importation and Exportation of Bodies.

(a) Transport of Bodies. The transfer and transport of bodies or anatomical specimens from one institution to another, or for export from the state, shall be done in an appropriate, secured vehicle operated by a licensed funeral establishment, ambulance service, member institution, search organization, or public carrier. A label with the statement "CONTENTS DERIVED FROM DONATED HUMAN TISSUE" shall be affixed to the container in which the body or anatomical specimen is transported. Violations may result in revocation of authorization to receive and hold bodies.

(b) Transfer to search organizations. Cadavers and anatomical specimens may be transferred to search organizations or forensic science programs if:

(1) the deceased donated his body in compliance with Section 691.028 of the Health and Safety Code and at the time of the donation authorized use for search organizations or forensic science programs;

(2) the body was donated in compliance with Chapter 692A of the Health and Safety Code and the person authorized to make the donation under Section 692A.009 authorized use for search organizations or forensic science programs;

(3) the body was received by a member institution because it had not been claimed.

(c) [(b)] Importation. Notification of the intent to import a body or bodies from outside of the State of Texas shall be given to the board in writing. Such bodies shall fall under the jurisdiction of the board upon entering the State of Texas, and all rules regulating such material shall apply.

(d) [(c)] Exportation. No body under the jurisdiction of the board including donations to tissue banks authorized by Health and Safety Code, Chapter 692A, shall be shipped out of the State of Texas, unless permission in writing for such shipment has been granted by the board acting through its secretary-treasurer. If the secretary-treasurer is an employee of the institution that is to make the shipment, secondary approval must be given by the chair.

(1) The board may grant approval of exportation of a body if it or its secretary-treasurer or chair determines that:

(A) a written request has been received from an institution that is in the approved categories described in §479.1(a) of this title (relating to Institutions Authorized to Receive and Hold Bodies) that describes the need for the body and the facilities available for holding the body.

(B) the supply of bodies exceeds the needs of the institutions in this state; and

(C) the donor authorized out-of-state shipment.

(2) If, in the opinion of the appropriate official of the holding institution or the secretary-treasurer, a site visit to the requesting institution is desirable or necessary, such a visit shall be made and a report made to the secretary-treasurer before approving the transfer. The expenses incurred by such a site visit shall be reimbursed by the potential receiving institution before application is considered.

(e) [(d)] Proscription of local removal. Bodies shall not be removed or relocated from the designated premises of the institution or individual which have been authorized by this board to receive, hold, or dispose of bodies without the written permission of the secretary-treasurer.

(f) [(e)] Violation of this rule. Should it appear that an organization, institution, or individual may be in violation of any section regarding the transportation of a body, the board shall proceed as required by §483.1 of this title (relating to Hearing Procedures).

§477.5.Transfer of Bodies.

(a) Application for transfer. Institutions or search organizations desiring the transfer of a body [to their institution] must make written request to the secretary-treasurer of the board. Reasons for the need for a body must be stated.

(b) (No change.)

(c) Availability. While the secretary-treasurer of the board shall make diligent efforts to locate a source of bodies for transfer, final authorization for such transfer shall be dependent on the willingness of a member institution to provide the required body or bodies. Costs of the body and for transportation shall be borne by the institution or search organization receiving the transferred body.

(d) Disposal of transferred bodies. Unless other suitable arrangements have been made and approved by the secretary-treasurer or the board in advance, transferred bodies on which dissection has been completed shall be returned to the institution originally providing the body for final disposition within one calendar year.

(e) Extension. The secretary-treasurer may approve extensions beyond the one calendar year time limit. Written requests for an extension must be submitted prior to the expiration of the term, and reasons for the extension must be stated.

§477.7.Board Forms.

(a) (No change.)

(b) Yearly cadaver procurement and use report. Each institution which has received, directly or by transfer, and/or used a body during the prior year shall complete, sign and file with the secretary-treasurer the yearly cadaver procurement and use report prescribed by the board. This report shall be filed not later than August 31 of each year for the prior annual period August 1 through July 31. Tissue banks and search organizations receiving donations as authorized by Health and Safety Code Chapter 692A will file a cadaver procurement and transfer form as prescribed by the board.

(c) (No change.)

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 21, 2016.

TRD-201603138

Stephen Luk

Secretary-Treasurer

Anatomical Board of the State of Texas

Earliest possible date of adoption: July 31, 2016

For further information, please call: (214) 648-5469


CHAPTER 479. FACILITIES: STANDARDS AND INSPECTIONS

25 TAC §§479.1 - 479.3, 479.5

The Anatomical Board of the State of Texas (Board) proposes to amend §§479.1 - 479.3 and 479.5, concerning the rules and procedures for the distribution of cadavers and/or anatomical specimens to recognized search organizations.

The Board's proposed amendments are to implement Health and Safety Code §691.030 and §692A.011 as amended by Senate Bill 1214 in the 84th Legislative Session. The amendments to §691.030 and §692A.011 provide that the use of cadavers and/or anatomical specimens by recognized search organizations must be coordinated through the Anatomical Board of the State of Texas.

Amendments to §479.1 allow recognized search organizations and forensic science programs to receive and hold cadavers and/or anatomical specimens.

Amendments to §479.2 relate to the procedure for a search organization to apply to receive and hold cadavers and/or anatomical specimens. This section also relates to the inspection of the facilities of a search organization.

Amendments to §479.3 allow recognized search organizations and forensic science programs to use anatomical specimens in specific field locations provided that certain conditions are met.

Amendments to §479.5 provide a limited exception to Texas Penal Code §42.10 for recognized search organizations and forensic science programs to use human cadaveric materials for training purposes under strict circumstances.

Vaughan Lee, Chairman of the State Anatomical Board, has determined that for each fiscal year of the first five years the sections are in effect, there will be no fiscal implications to the state as a result of enforcing or administering the sections as proposed.

Dr. Lee has also determined that there are no anticipated economic costs to small businesses or micro-businesses required to comply with the sections as proposed.

Dr. Lee has also determined that for each year of the first five years the sections are in effect, the public will benefit from adoption of the sections. The public benefit as a result of enforcing or administering the sections is to effectively regulate the disposition of bodies in Texas, all of which will protect and promote public health, safety, and welfare.

Comments on the proposal may be submitted in writing either in person or by courier to Stephen Luk, Secretary-Treasurer, Anatomical Board of the State of Texas, P.O. Box 20745, Houston, Texas 77225-0745. Comments will be accepted for 30 days following publication of the proposal in the Texas Register.

The proposed amendments are authorized by the Board's general rulemaking power under Health and Safety Code §691.022(b).

The proposed amendments affect the Texas Administrative Code, Title 25, Chapter 479.

§479.1.Institutions Authorized to Receive and Hold Bodies.

(a) Approved categories. Institutions or organizations authorized by the board to receive and hold bodies include accredited medical schools or colleges, dental schools or colleges, health science centers, hospitals, schools of mortuary science, chiropractic schools or colleges, osteopathic medical schools or colleges, search organizations, and forensic science programs. Tissue banks receiving donations under Health and Safety Code, Chapter 692A may only transfer those donations to institutions in approved categories.

(b) (No change.)

§479.2.Application and Inspection of Facilities.

(a) (No change.)

(b) Search organizations applying for authorization to receive and hold bodies have additional requirements:

(1) documents demonstrating authorization by a sponsoring local or county law enforcement agency for the search organization's use of human remains detection canines;

(2) documents demonstrating the search organization's exemption from federal taxation under 501(c) of the Internal Revenue Code of 1986;

(3) documents demonstrating the search organization's protocols for the handling and storage of bodies or parts thereof.

(c) [(b)] Inspection.

(1) The inspection team.

(A) New facilities. An inspection subcommittee of the board, composed of at least two members of the board, shall visit all new facilities, including any existing facilities that have undergone major renovation. Such inspections shall be made within 60 days of the receipt of a request for inspection.

(B) Inspection. Approved facilities. All approved facilities shall be reinspected from time to time on a periodic basis not more [less] than every five years by at least one member of the board from an institution other than the facility being inspected. Search organizations and forensic science programs utilizing WBP specimens shall be reinspected from time to time on a periodic basis not more than every three years. Advance notice of such reinspections shall be given.

(C) Facilities where deficiencies have been cited. All facilities which have been disapproved, or where a deficiency has been cited on inspection or reinspection, may be visited by a reinspection subcommittee composed of at least one member of the board from an institution other than the facility being reinspected. This reinspection, when deemed necessary, shall be made within 60 days of notice to the secretary-treasurer that the corrections have been accomplished. Advance notice of such reinspections shall be given.

(2) Reports of inspection and reinspection.

(A) Approved facilities. Where the inspection subcommittee finds no reason to deny approval of the inspected facilities, they so report in writing to the secretary-treasurer. Upon acceptance of the report by a majority of the board, the secretary-treasurer shall notify the institution concerned of such approval of its facilities and authorize it to receive and hold bodies.

(B) Disapproved facilities.

(i) Needed corrections cited in writing. When the inspection subcommittee notes deficiencies which require remedy before approval can be granted, they shall so report, in detail, in writing to the secretary-treasurer of the board, who shall notify the institution promptly of these deficiencies. It would be well if the inspection subcommittee discussed deficiencies found with the concerned institution personnel before departing from the site.

(ii) Requirement for immediate action. When an institution is advised of deficiencies uncovered by an inspection subcommittee, it is obligated to effect immediate correction of the deficiency or deficiencies. Delay in effecting the required corrections will delay granting approval of new facilities and may threaten continued approval of existing facilities.

(iii) Suspension of authorization. Unnecessary delay in making required correction(s) of deficiencies uncovered by inspection or reinspection may, by majority vote of the board, result in denial or withdrawal of approval of the facility and withholding or suspension of authorization to receive and hold bodies. Shall an organization, institution, or individual object to such determination by the board, it may request a hearing pursuant to §483.1 of this title (relating to Hearing Procedures).

(3) Costs of inspection and reinspection. All costs attendant on the program of inspection and reinspection shall be borne by the board.

§479.3.Standards for Facilities.

(a) - (b) (No change.)

(c) Public welfare.

(1) Visibility. All areas where human bodies are handled must not be visible from the outside of the building or so located that the public has ready visibility of transport, preparation, or dissection in progress.

(2) Accessibility. All areas used for receipt and preparation, storage, or dissection of human bodies must be unaccessible and inadmissible to the general public and all unauthorized personnel. All areas must have appropriate locks. Only personnel concerned with the preparation of cadavers should have access to storage and preparation areas. Storage areas should be securely locked at all times when bodies are not being placed in or removed from storage. Search organizations and forensic science programs may use anatomical specimens in field locations provided that those locations are not accessible to the public, and access is restricted to search organization personnel while the anatomical specimens are in use.

§479.5.Abuse of a Corpse.

(a) Definition. Abuse of a corpse is defined in Texas Penal Code §42.10. In the code dissection in an authorized institution by authorized persons is specifically exempted from this provision. The board has determined:

(1) dissection of human cadaveric materials in health science, and related, education and research, and activities found by the board to be related to dissection (see paragraph (2) of this subsection) are a special privilege and are legally authorized for members and students of the health, and related, professions for the purpose of the advancement of knowledge in these fields. Exercise of this authority is accompanied by solemn obligations to conduct all activities related to such dissection with respect and dignity. Authorized dissection shall take place under supervision of trained and qualified persons, and only in specified locations that have been approved by the board and which meet the standards set forth in §479.3 of this title (relating to Standards for Facilities). Bodies [bodies], or parts of a body, shall not be removed from the specified locations without permission of the board or of an authorized representative of the board;

(2) the following activities are integrally related to dissection:

(A) procurement of bodies:

(i) removal from the place of death, hospital, morgue, medical examiner's office, or mortuary; and transfer to a proper site for embalming;

(ii) transfer to storage site or dissecting facility approved by the board;

(B) distribution of bodies: removal from one storage site and transfer to another approved facility designated by the board;

(C) handling of bodies:

(i) embalming;

(ii) placement in storage;

(iii) removal from storage;

(iv) placement on dissecting table in a facility designated approved by the board;

(D) dissection: cutting or otherwise separating body components for the purpose of demonstrating or investigating structural relationships of tissues, organs, or systems.

(E) use of bodies in biomedical research: removal of body parts or constituents and subjection thereof to further manipulation for the purpose of advancing scientific knowledge;

(F) disposal of remains:

(i) removal from the dissecting table;

(ii) transfer to crematory or burial site;

(iii) cremation or burial;

(iv) final disposition of cremains.

(3) use of human cadaveric materials in training human remains detection canines and other forensic science procedures are a special privilege and are legally authorized for active members of search organizations and forensic science programs. Exercise of this authority is accompanied by solemn obligations to conduct all activities related to such training with respect and dignity. Authorized activities shall take place under supervision of trained and qualified persons, and only in specified locations that have been approved by the board and which meet the standards set forth in §479.3 of this title (relating to Standards for Facilities).

(b) (No change.)

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 21, 2016.

TRD-201603139

Stephen Luk

Secretary-Treasurer

Anatomical Board of the State of Texas

Earliest possible date of adoption: July 31, 2016

For further information, please call: (214) 648-5469