TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 95. PRESCRIPTION DRUG DONATION PROGRAM

25 TAC §§95.1 - 95.9

The Executive Commissioner of the Health and Human Services Commission, (HHSC) on behalf of the Department of State Health Services (DSHS), proposes new §95.1, concerning Purpose; new §95.2, concerning Definitions; new §95.3, concerning Participating Provider Eligibility; new §95.4, concerning Standards and Procedures for Donating or Accepting Prescription Drugs; new §95.5, concerning Standards and Procedures for Inspecting and Storing Donated Prescription Drugs; new §95.6, concerning Standards and Procedures for Dispensing Donated Prescription Drugs; new §95.7 concerning Liability; new §95.8, concerning Handling Fee; and new §95.9, concerning Recordkeeping Requirements for Participating Providers.

BACKGROUND AND PURPOSE

House Bill (HB) 2561, 85th Legislature, Regular Session, 2017, added Health and Safety Code, Chapter 442, Donation of Prescription Drugs. Health and Safety Code, §442.002 grants the Executive Commissioner of HHSC the authority to develop rules to adopt standards and procedures for accepting, storing, labeling and dispensing donated prescription drugs to be consistent with public health and safety standards.

The new rules will establish the Prescription Drug Donation Program (program) and allow individuals to donate unused prescription drugs to participating providers, who will distribute them to eligible recipients. Participation in the program by a health care facility or pharmacy is voluntary.

The new rules will include definitions; participating provider, donor, and recipient form requirements; information on participating providers; liability information; an elective handling fee; and a database of participating providers.

SECTION-BY-SECTION SUMMARY

Proposed new §95.1 describes the purpose of the chapter.

Proposed new §95.2 contains relevant definitions for the program.

Proposed new §95.3 describes the eligibility criteria for entities to become participating providers in the Prescription Drug Donation Program. Also, this new section states that DSHS will also establish, maintain, and post a database of participating providers on the program's website.

Proposed new §95.4 describes the standards and procedures that donors and participating providers must follow in order to donate or accept prescription drugs.

Proposed new §95.5 describes the standards and procedures that participating providers must follow to inspect and store donated prescription drugs.

Proposed new §95.6 describes the standards and procedures that a participating provider must comply with in order to dispense donated prescription drugs. This new rule also includes language that the prescription drugs under this program shall not be resold.

Proposed new §95.7 describes the limitation of liability for donors and participating providers.

Proposed new §95.8 describes the handling fee that the participating provider may charge to cover the costs of inspecting, storing, labeling, and dispensing the donated prescription drug.

Proposed new §95.9 describes the recordkeeping requirements for participating providers.

FISCAL NOTE

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 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 create a government program and participation in the program by a health care facility or pharmacy is voluntary;

(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 create new rules to comply with HB 2561 and is a voluntary program;

(6) the proposed rules will not expand, limit, or repeal an existing rule;

(7) the proposed rules will not change the number of individuals subject to the rules because this is a voluntary program; and

(8) DSHS has insufficient information to determine the proposed rules' effect on the state's economy because this is a voluntary program.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Ms. Garcia has also 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 apply to small businesses or micro-businesses, or rural communities. Participation in the program by a health care facility or pharmacy is voluntary.

ECONOMIC COSTS TO PERSONS AND IMPACT ON LOCAL EMPLOYMENT

There are no anticipated economic costs to persons who are required to comply with the sections as proposed.

There is no anticipated negative impact on local employment.

COSTS TO REGULATED PERSONS

Government Code, §2001.0045 does not apply to these rules because the rules are necessary to implement legislation that does not specifically state that Government Code, §2001.0045 applies to the rules.

PUBLIC BENEFIT

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, the public will benefit from adoption of the sections. The public benefit anticipated as a result of enforcing or administering the sections will be that under this program, eligible prescription drugs that would normally be discarded can be donated to participating providers. Individuals who would normally be unable to obtain these prescription drugs due to financial hardship could receive them from participating providers at a maximum of $20, if the participating provider elects to charge a handling fee.

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 Government Code, §2007.043.

PUBLIC COMMENT

Written comments on the proposal may be submitted to Francela Brazil Williams, Operations Specialist, Department of State Health Services-Pharmacy Branch, 1100 West 49th Street, W-140B; Mail Code 4544, Austin, Texas, 78759 by fax to (512) 776-7489 or by email to francela.williams@dshs.texas.gov within 30 days of publication of this proposal in the Texas Register.

STATUTORY AUTHORITY

The new sections are authorized by Health and Safety Code, §442.002, which states that the Executive Commissioner may adopt rules to implement Chapter 442; §442.052 states the Executive Commissioner by rule shall adopt standards and procedures for accepting, storing, labeling, and dispensing donated prescription drugs, and inspecting donated prescription drugs to determine whether the drugs are adulterated and whether the drugs are safe and suitable for redistribution; §442.058, requires DSHS to establish, maintain and post a database of participating providers on the DSHS program's website; and by Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of HHSC to adopt rules and policies necessary for the operation of and provision of health and human services by DSHS and for the administration of Health and Safety Code, Chapter 1001.

The new sections are authorized by Health and Safety Code, Chapters 442 and 1001; and Government Code, Chapter 531.

§95.1.Purpose.

The purpose of this chapter is to establish rules in accordance with the Health and Safety Code, Chapter 442, Donation of Prescription Drugs, which creates the Prescription Drug Donation Program. Under this Program, individuals may donate unused unit-dose prescription drugs to participating providers, who may redistribute eligible drugs to willing recipients.

§95.2.Definitions.

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

(1) Adulterated Drug or Device--As defined in the Texas Food, Drug and Cosmetic Act, Health and Safety Code, §431.111.

(2) Controlled Substance--As defined in the Health and Safety Code, §481.002.

(3) Department--The Department of State Health Services.

(4) Dispense--To prepare, package, compound, or label in the course of professional practice, a prescription drug or device for delivery to an ultimate user or the user's agent under a practitioner's lawful order.

(5) Donor--An individual who donates unused, unit-dose packaged prescription drugs under Health and Safety Code, Chapter 442, to a participating provider.

(6) Health Care Facility--A facility that provides health care services to patients and maintains a pharmacy in the facility. The term includes the following facilities if a pharmacy is maintained in the facility:

(A) a general or special hospital as defined by Health and Safety Code, Chapter 241;

(B) an ambulatory surgical center licensed under Health and Safety Code, Chapter 243; and

(C) an institution licensed under Health and Safety Code, Chapter 242.

(7) Health Care Professional--An individual licensed, certified, or otherwise authorized to administer health care and prescribe prescription drugs, for profit or otherwise, in the ordinary course of business or professional practice. The term does not include a health care facility.

(8) Manufacturer--A person who is a designer, formulator, constructor, rebuilder, fabricator, producer, compounder, processor, or assembler of any product or any component part thereof and who places the product or any component part thereof in the stream of commerce.

(9) Participating Provider--A health care facility or pharmacy, or a pharmacist who is an employee of the facility or pharmacy that elects to participate in the collection and redistribution of donated prescription drugs under Health and Safety Code, Chapter 442.

(10) Pharmacist--A person licensed under Occupations Code, Chapter 558.

(11) Pharmacy--An entity licensed under Occupations Code, Chapter 560.

(12) Prescription Drug--As defined under Occupations Code, §551.003.

(13) Program--Prescription Drug Donation Program.

(14) Recipient--An individual who voluntarily receives donated prescription drugs under Health and Safety Code Chapter 442.

(15) Tamper-Evident--Packaging that allows for detection of unauthorized access to a prescription drug.

(16) Unit-Dose--A dose of medicine prepared in an individual packet by a licensed facility for convenience, safety, or monitoring.

§95.3.Participating Provider Eligibility.

(a) Participation in the Prescription Drug Donation Program by a health care facility or pharmacy is voluntary.

(b) To be eligible for participation in the Program, a participating provider must be in compliance with all applicable federal and state laws relating to the inspection, storage, labeling, and dispensing of prescription drugs and shall maintain appropriate active, non-restricted state-issued licenses or registrations.

(c) A participating provider electing to participate in the Program shall complete and return a Participating Provider Form prescribed by the Department and available on the Program's website, http://www.dshs.texas.gov/pharmacy/default.shtm, designating a responsible contact and verifying it meets and will comply with the requirements of the Program.

(d) A pharmacy or health care facility may withdraw from participation in the Program at any time by providing written notice to the Department on a Participating Provider Form prescribed by the Department, and available on the Program's website referenced in subsection (c) of this section.

(e) The Department shall establish and maintain an electronic database that lists each participating provider. The Department shall post the database on Program's Internet website referenced in subsection (c) of this section.

§95.4.Standards and Procedures for Donating or Accepting Prescription Drugs.

(a) Donor Requirements.

(1) No drugs that require storage temperatures other than normal room temperature as specified by the manufacturer or United States Pharmacopoeia (USP) shall be donated or accepted as part of the Prescription Drug Donation Program. Drugs that require storage temperatures other than normal room temperature as specified by the manufacturer or USP shall not be donated or accepted because of the increased potential for these drugs to become adulterated.

(2) Controlled substances shall not be donated or accepted. Pursuant to federal and state laws, a controlled substance cannot be returned or reused once the drug has been dispensed to a patient.

(3) Drugs previously purchased by Medicaid shall not be donated.

(4) All donated drugs must:

(A) be approved by the Food and Drug Administration (FDA);

(B) be dispensed only by prescription;

(C) bear the federal legend "Rx Only" or "Caution," Federal Law Prohibits Dispensing Without Prescription;"

(D) be packaged into unit-dose packages; and

(E) be intended for human use.

(5) The donor must sign a Donor Form prescribed by the Department stating that:

(A) the donor is the owner of the donated prescription drug;

(B) the donated prescription drug has been properly stored and the container has not been opened or tampered with;

(C) the donated prescription drug has not been adulterated or misbranded; and

(D) the donor is voluntarily donating the prescription drug.

(b) Participating Provider Requirements.

(1) Upon the Department's confirmed receipt of the Participating Provider Form, a participating provider may accept legally obtained prescription drugs from a donor in the Program if the drugs meet the requirements of this rule, as determined by a pharmacist who is employed by or under contract with the participating provider and the donor has completed a Donor Form as prescribed by the Department.

(2) The participating provider may accept a prescription drug only if all of the following requirements are met:

(A) the drug is in its original sealed and tamper-evident unit-dose packaging. However, a drug in a single-unit dose or blister pack with the outside packaging opened may be accepted if the single-unit-dose packaging is undisturbed;

(B) the drug has been stored according to manufacturer or USP storage requirements;

(C) the packaging contains the lot number and expiration date of the drug. If the lot number is not retrievable, all specified medications will be destroyed;

(D) the drug has an expiration date that is more than six months after the date that the drug was donated. However, a donated prescription drug bearing an expiration date that is six months or less after the date the prescription drug was donated may be accepted and distributed if the drug is in high demand, as determined by the participating provider, and can be dispensed for use prior to the drug's expiration date;

(E) the drug and the packaging does not have any physical signs of tampering or adulteration, and there is no reason to believe that the drug is adulterated; and

(F) all drugs shall be inventoried by the participating provider. The inventory shall include the name of the drug, strength of the drug, quantity of the drug, lot number, and the date of donation.

§95.5.Standards and Procedures for Inspecting and Storing Donated Prescription Drugs.

(a) A licensed pharmacist employed by or under contract with the participating provider shall inspect donated prescription drugs to determine, to the extent reasonably possible in the judgement of the pharmacist, that the drugs are not adulterated or misbranded, are safe and suitable for dispensing, and are not ineligible drugs.

(b) Donated drugs may not be stored with non-donated inventory. When donated drugs are not inspected immediately upon receipt, the participating provider shall quarantine the donated drugs separately from all dispensing stock until the donated drugs have been inspected and approved for dispensing.

(c) The participating provider shall destroy donated non-controlled substances that are not suitable for dispensing and make a record of such destruction.

(d) The pharmacist-in-charge shall develop and implement a written procedure for proper management of drug recalls by the manufacturer. Such procedures shall include, where appropriate, contacting patients to whom the recalled drug products have been dispensed.

(e) The pharmacist-in-charge shall reasonably ensure that a recalled drug has been removed from inventory no more than 24 hours after receipt of the recall notice, and quarantined until proper disposal or destruction of the drug.

§95.6.Standards and Procedures for Dispensing Donated Prescription Drugs.

(a) Donated drugs may be dispensed only if the drugs are prescribed by a health care professional for use by an eligible recipient and are dispensed by a licensed pharmacist who has determined that the drugs are of an acceptable integrity.

(b) The recipient must sign a Recipient Form prescribed by the Department stating that the recipient:

(1) understands that the drugs are donated;

(2) accepts any risk associated with accidental mishandling of the drugs; and

(3) acknowledges that the donor and the participating provider are acting in good faith and are therefore released from liability.

(c) The participating provider shall dispense donated prescription drugs in compliance with applicable federal and state laws and regulations for dispensing prescription drugs, including all requirements relating to packaging, labeling, record keeping, drug utilization review and patient counseling.

(d) The participating provider shall remove the original donor's identification and the name of the original dispensing pharmacy from the package prior to dispensing the drugs.

(e) The participating provider shall be responsible for drug recalls and shall have an established mechanism to notify recipients in the event of a drug recall.

(f) Prescription drugs donated under this Program shall not be resold.

(g) All participating providers shall comply with the laws and rules pertaining to dispensing of prescription drugs as contained in the Occupations Code, Chapters 551-566, and 569 (relating to the Texas Pharmacy Act); and Title 22 Texas Administrative Code, Chapters 281, 283, 291, 295, 297, 303, 305, 309, and 311 (relating to the Texas State Board of Pharmacy).

§95.7.Liability.

Donors and participating providers in the Prescription Drug Donation Program are not criminally liable and are not subject to professional disciplinary action if they act in good faith in donating, accepting, storing, labeling, distributing, and dispensing prescription drugs under Health and Safety Code, Chapter 442. Donors and participating providers are not civilly liable for damages for bodily injury, death, or property damage that arises from donating, accepting, storing, labeling, distributing, or dispensing prescription drugs under the Health and Safety Code, Chapter 442, unless the injury, death, or damage arises from the donor or participating provider's recklessness or intentional conduct.

§95.8.Handling Fee.

The participating provider may charge a handling fee not to exceed $20.00 to a recipient to cover the costs of inspecting, storing, labeling, and dispensing the donated prescription drug.

§95.9.Recordkeeping Requirements for Participating Providers.

Records required as part of this Program shall be maintained pursuant to Occupations Code, Chapter 554.

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 October 24, 2017.

TRD-201704294

Barbara L. Klein

Interim General Counsel

Department of State Health Services

Earliest possible date of adoption: December 10, 2017

For further information, please call: (512) 776-7489


CHAPTER 133. HOSPITAL LICENSING

The Health and Human Services Commission (HHSC) proposes amendments to §133.41, concerning Hospital Functions and Services, and §133.163, concerning Spatial Requirements for New Construction.

BACKGROUND AND PURPOSE

In October 2015, the Department of State Health Services (DSHS) updated retail food safety rules by repealing 25 TAC §§229.161 - 229.171 (relating to Texas Food Establishments) and replacing them with 25 TAC Chapter 228 (relating to Retail Food). When these rules were repealed and replaced, rules in Title 25, Chapter 133 (relating to Hospital Licensing) that incorporated the Texas Food Establishment rules by reference were not updated to refer to the new rules in Chapter 228. Consequently, DSHS was unable to enforce violations of food safety rules by licensed hospitals. This lack of authority to enforce food safety rule violations by licensed hospitals presented a peril to the health, safety, and welfare of the public. Under Texas Government Code, §2001.034, emergency rules were adopted to update §133.41 and §133.163 to include the references to Chapter 228. The emergency rules were adopted on August 24, 2017, and will expire on December 21, 2017, with an option to extend the rules for another 60 days. Therefore, amendments to §133.41 and §133.163 are proposed for the permanent adoption of the rule reference updates.

The purpose of the rule amendments is to update references to the current food safety rules in the hospital licensing rules, thereby allowing HHSC to enforce the hospital licensing rules relating to food safety in order to protect the health, safety, and welfare of the public.

SECTION-BY-SECTION SUMMARY

The proposed amendments to §133.41(d) and §133.163(e) replace the rule references to §§229.161 - 229.171 of this title (relating to Texas Food Establishments) with the new rule references to Chapter 228 of this title (relating to Retail Food).

FISCAL NOTE

Donna Sheppard, 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

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

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

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

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

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

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

(6) the proposed rule amendments will not expand, limit, or repeal existing rules;

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

(8) the proposed rule amendments will not affect the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Patrick Waldron, Branch Manager, has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities. The rules do not impose any additional costs on small businesses, micro-businesses, or rural communities that are required to comply with the rules.

ECONOMIC COSTS TO PERSONS AND IMPACT ON LOCAL EMPLOYMENT

There are no anticipated economic costs to persons who are required to comply with the sections as proposed.

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 protect the health, safety, and welfare of the residents of Texas.

PUBLIC BENEFIT

Mr. Waldron 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 anticipated as a result of enforcing or administering the sections will be allowing HHSC to enforce the hospital licensing rules relating to food safety in order to protect the health, safety, and welfare of the public.

REGULATORY ANALYSIS

HHSC 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

HHSC 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

Written comments on the proposal may be submitted to Patrick Waldron, Branch Manager, Health Care Quality Section, Mail Code 1949, P.O. Box 149347, Austin, Texas 78714-9347; by fax to (512) 834-6653; or by email to Patrick.Waldron@hhsc.state.tx.us within 30 days of publication of this proposal in the Texas Register.

SUBCHAPTER C. OPERATIONAL REQUIREMENTS

25 TAC §133.41

STATUTORY AUTHORITY

Texas Health and Safety Code, §241.026, requires HHSC to develop, establish, and enforce standards for the construction, maintenance, and operation of licensed hospitals. 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.

The amendments are authorized by Texas Health and Safety Code, Chapter 241, and Texas Government Code, Chapter 531.

§133.41.Hospital Functions and Services.

(a) - (c) (No change.)

(d) Dietary services. The hospital shall have organized dietary services that are directed and staffed by adequate qualified personnel. However, a hospital that has a contract with an outside food management company or an arrangement with another hospital may meet this requirement if the company or other hospital has a dietitian who serves the hospital on a full-time, part-time, or consultant basis, and if the company or other hospital maintains at least the minimum requirements specified in this section, and provides for the frequent and systematic liaison with the hospital medical staff for recommendations of dietetic policies affecting patient treatment. The hospital shall ensure that there are sufficient personnel to respond to the dietary needs of the patient population being served.

(1) (No change.)

(2) Director. The director shall:

(A) - (D) (No change.)

(E) maintain authority and responsibility for the following, but not be limited to:

(i) - (vii) (No change.)

(viii) ensuring compliance with Chapter 228 of this title (relating to Retail Food) [§§229.161 - 229.171 of this title (relating to Texas Food Establishments)].

(3) (No change.)

(e) - (y) (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 October 27, 2017.

TRD-201704358

Karen Ray

Chief Counsel

Department of State Health Services

Earliest possible date of adoption: December 10, 2017

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


SUBCHAPTER I. PHYSICAL PLANT AND CONSTRUCTION REQUIREMENTS

25 TAC §133.163

Texas Health and Safety Code, §241.026, requires HHSC to develop, establish, and enforce standards for the construction, maintenance, and operation of licensed hospitals. 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.

The amendments are authorized by Texas Health and Safety Code, Chapter 241, and Texas Government Code, Chapter 531.

§133.163.Spatial Requirements for New Construction.

(a) - (d) (No change.)

(e) Dietary suite.

(1) Architectural requirements.

(A) General. Construction, equipment, and installation shall comply with Chapter 228 of this title (relating to Retail Food) [§§229.161 - 229.171 of this title (relating to Texas Food Establishments)].

(B) - (E) (No change.)

(2) - (5) (No change.)

(f) - (ff) (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 October 27, 2017.

TRD-201704345

Karen Ray

Chief Counsel

Department of State Health Services

Earliest possible date of adoption: December 10, 2017

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


CHAPTER 134. PRIVATE PSYCHIATRIC HOSPITALS AND CRISIS STABILIZATION UNITS

The Health and Human Services Commission (HHSC) proposes amendments to §134.41, concerning Facility Functions and Services, and §134.123, concerning Spatial Requirements for New Construction.

BACKGROUND AND PURPOSE

In October 2015, the Department of State Health Services (DSHS) updated retail food safety rules by repealing 25 TAC §§229.161 - 229.171 (relating to Texas Food Establishments) and replacing them with 25 TAC Chapter 228 (relating to Retail Food). When these rules were repealed and replaced, rules in Title 25, Chapter 134 (relating to Private Psychiatric Hospitals and Crisis Stabilization Units) that incorporated the Texas Food Establishment rules by reference were not updated to refer to the new rules in Chapter 228. Consequently, DSHS was unable to enforce violations of food safety rules by private psychiatric hospitals. This lack of authority to enforce food safety rule violations by private psychiatric hospitals presented a peril to the health, safety, and welfare of the public. Under Texas Government Code, §2001.034, emergency rules were adopted to update §134.41 and §134.123 to include the rules references to Chapter 228. The emergency rules were adopted on August 24, 2017, and will expire on December 21, 2017, with an option to extend the rules for another 60 days. Therefore, amendments to §134.41 and §134.123 are proposed for the permanent adoption of the rule reference updates.

The purpose of the rule amendments is to update references to the current food safety rules in the private psychiatric hospital rules, thereby allowing HHSC to enforce the private psychiatric hospital rules relating to food safety in order to protect the health, safety, and welfare of the public.

SECTION-BY-SECTION SUMMARY

The proposed amendments to §134.41(b) and §134.123(d) replace the rule references to §§229.161 - 229.171 of this title (relating to Texas Food Establishments) with the new rules references to Chapter 228 of this title (relating to Retail Food).

FISCAL NOTE

Donna Sheppard, 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

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

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

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

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

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

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

(6) the proposed rule amendments will not expand, limit, or repeal existing rules;

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

(8) the proposed rule amendments will not affect the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Patrick Waldron, Branch Manager, has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities. The rules do not impose any additional costs on small businesses, micro-businesses, or rural communities that are required to comply with the rules.

ECONOMIC COSTS TO PERSONS AND IMPACT ON LOCAL EMPLOYMENT

There are no anticipated economic costs to persons who are required to comply with the sections as proposed.

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 protect the health, safety, and welfare of the residents of Texas.

PUBLIC BENEFIT

Mr. Waldron 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 anticipated as a result of enforcing or administering the sections will be allowing HHSC to enforce the private psychiatric hospital rules relating to food safety in order to protect the health, safety, and welfare of the public.

REGULATORY ANALYSIS

HHSC 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

HHSC 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

Written comments on the proposal may be submitted to Patrick Waldron, Branch Manager, Health Care Quality Section, Mail Code 1949, P.O. Box 149347, Austin, Texas 78714-9347; by fax to (512) 834-6653; or by email to Patrick.Waldron@hhsc.state.tx.us within 30 days of publication of this proposal in the Texas Register.

SUBCHAPTER C. OPERATIONAL REQUIREMENTS

25 TAC §134.41

STATUTORY AUTHORITY

Texas Health and Safety Code, §577.010, requires HHSC to develop, establish, and enforce standards for the construction, maintenance, and operation of private mental hospitals. Texas Government Code, §531.0055, authorizes 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.

The amendment is authorized by Texas Health and Safety Code, Chapter 557, and Texas Government Code, Chapter 531.

§134.41.Facility Functions and Services.

(a) (No change.)

(b) Dietary services. The facility shall have organized dietary services that are directed and staffed by adequate qualified personnel. However, a facility that has a contract with an outside food management company or an arrangement with another facility may meet this requirement if the company or other facility has a dietitian who serves the facility on a full-time, part-time, or consultant basis, and if the company or other facility maintains at least the minimum requirements specified in this section, and provides for the frequent and systematic liaison with the facility medical staff for recommendations of dietetic policies affecting patient treatment. The facility shall ensure that there are sufficient personnel to respond to the dietary needs of the patient population being served.

(1) (No change.)

(2) Director. The director shall:

(A) - (D) (No change.)

(E) maintain authority and responsibility for the following, but not be limited to:

(i) - (vi) (No change.)

(vii) ensuring compliance with Chapter 228 of this title (relating to Retail Food) [§§229.161 - 229.171 of this title (relating to Texas Food Establishments)].

(3) (No change.)

(c) - (p) (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 October 27, 2017.

TRD-201704346

Karen Ray

Chief Counsel

Department of State Health Services

Earliest possible date of adoption: December 10, 2017

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


SUBCHAPTER G. PHYSICAL PLANT AND CONSTRUCTION REQUIREMENTS

25 TAC §134.123

Texas Health and Safety Code, §577.010, requires HHSC to develop, establish, and enforce standards for the construction, maintenance, and operation of private mental hospitals. Texas Government Code, §531.0055, authorizes 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.

The amendment is authorized by Texas Health and Safety Code, Chapter 557, and Texas Government Code, Chapter 531.

§134.123.Spatial Requirements for New Construction.

(a) - (c) (No change.)

(d) Dietary suite.

(1) Architectural requirements.

(A) General. Construction, equipment, and installation shall comply with the standards specified in Chapter 228 of this title (relating to Retail Food) [§§229.161-229.171 of this title (relating to Rules on Food Service Sanitation)].

(B) - (E) (No change.)

(2) - (5) (No change.)

(e) - (p) (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 October 27, 2017.

TRD-201704347

Karen Ray

Chief Counsel

Department of State Health Services

Earliest possible date of adoption: December 10, 2017

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


CHAPTER 137. BIRTHING CENTERS

SUBCHAPTER D. OPERATIONAL AND CLINICAL STANDARDS FOR THE PROVISION AND COORDINATION OF TREATMENT AND SERVICES

25 TAC §137.36

The Health and Human Services Commission (HHSC) proposes an amendment to §137.36, concerning Physical and Environmental Requirements For Centers.

BACKGROUND AND PURPOSE

In October 2015, the Department of State Health Services (DSHS) updated retail food safety rules by repealing 25 TAC §§229.161 - 229.173 (relating to Texas Food Establishments) and replacing them with 25 TAC Chapter 228 (relating to Retail Food). When these rules were repealed and replaced, the rule in Title 25, Chapter 137 (relating to Birthing Centers) that incorporated the Texas Food Establishment rules by reference was not updated to refer to the new rules in Chapter 228. Consequently, DSHS was unable to enforce violations of food safety rules by birthing centers. This lack of authority to enforce food safety rule violations by birthing centers presented a peril to the health, safety, and welfare of the public. Under Texas Government Code, §2001.034, an emergency rule was adopted to update §137.36 to include the reference to Chapter 228. The emergency rule was adopted on August 24, 2017, and will expire on December 21, 2017, with an option to extend the rule for another 60 days. Therefore, the amendment to §137.36 is proposed for the permanent adoption of the rule reference update.

The purpose of the rule amendment is to update the reference to the current food safety rules in the birthing center rule, thereby allowing HHSC to enforce the birthing center rule relating to food safety in order to protect the health, safety, and welfare of the public.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §137.36(2) replaces the reference to §§229.161 - 229.173 of this title (relating to Texas Food Establishments) with the new reference to Chapter 228 of this title (relating to Retail Food).

FISCAL NOTE

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

GOVERNMENT GROWTH IMPACT STATEMENT

HHSC has determined that during the first five years that the section will be in effect:

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

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

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

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

(5) the proposed rule amendment will not create a new rule;

(6) the proposed rule amendment will not expand, limit, or repeal an existing rule;

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

(8) the proposed rule amendment will not affect the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Patrick Waldron, Branch Manager, has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities. The rule does not impose any additional costs on small businesses, micro-businesses, or rural communities that are required to comply with the rules.

ECONOMIC COSTS TO PERSONS AND IMPACT ON LOCAL EMPLOYMENT

There are no anticipated economic costs to persons who are required to comply with the section as proposed.

There is no anticipated negative impact on local employment.

COSTS TO REGULATED PERSONS

Texas Government Code, §2001.0045 does not apply to these rule because the rule is necessary to protect the health, safety, and welfare of the residents of Texas.

PUBLIC BENEFIT

Mr. Waldron has also determined that for each year of the first five years the section is in effect, the public will benefit from adoption of the section. The public benefit anticipated as a result of enforcing or administering the section will be allowing HHSC to enforce the birthing center rule relating to food safety in order to protect the health, safety, and welfare of the public.

REGULATORY ANALYSIS

HHSC 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

HHSC 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

Written comments on the proposal may be submitted to Patrick Waldron, Branch Manager, Health Care Quality Section, Mail Code 1949, P.O. Box 149347, Austin, Texas 78714-9347; by fax to (512) 834-6653; or by email to Patrick.Waldron@hhsc.state.tx.us within 30 days of publication of this proposal in the Texas Register.

STATUTORY AUTHORITY

Texas Health and Safety Code, §244.010, requires HHSC to develop, establish, and enforce standards for birthing centers. 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.

The amendment is authorized by Texas Health and Safety Code, Chapter 244, and Texas Government Code, Chapter 531.

§137.36.Physical and Environmental Requirements for Centers.

The physical and environmental requirements for a center are as follows.

(1) (No change.)

(2) The center must have the capacity to provide clients with liquid nourishment. The center may provide commercially packaged food to clients in individual servings. If other food is provided by the center, it will be subject to the requirements of Chapter 228 of this title (relating to Retail Food) [§§229.161 - 229.173 of this title (relating to Texas Food Establishments)].

(3) - (7) (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 October 27, 2017.

TRD-201704348

Karen Ray

Chief Counsel

Department of State Health Services

Earliest possible date of adoption: December 10, 2017

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


CHAPTER 139. ABORTION FACILITY REPORTING AND LICENSING

SUBCHAPTER D. MINIMUM STANDARDS FOR LICENSED ABORTION FACILITIES

25 TAC §139.48

The Health and Human Services Commission (HHSC) proposes an amendment to §139.48, concerning Physical and Environmental Requirements.

BACKGROUND AND PURPOSE

In October 2015, the Department of State Health Services (DSHS) updated retail food safety rules by repealing 25 TAC §§229.161 - 229.171 (relating to Texas Food Establishments) and replacing them with 25 TAC Chapter 228 (relating to Retail Food). When these rules were repealed and replaced, the rule in Title 25, Chapter 139 (relating to Abortion Facility Reporting and Licensing) that incorporated the Texas Food Establishment rules by reference was not updated to refer to the new rules in Chapter 228. Consequently, DSHS was unable to enforce violations of food safety rules by abortion facilities. This lack of authority to enforce food safety rule violations by abortion facilities presented a peril to the health, safety, and welfare of the public. Under Texas Government Code, §2001.034, an emergency rule was adopted to update §139.48 to include the rule reference to Chapter 228. The emergency rule was adopted on August 24, 2017, and will expire on December 21, 2017, with an option to extend the rule for another 60 days. Therefore, the amendment to §139.48 is proposed for the permanent adoption of the rule reference update.

The purpose of the rule amendment is to update references to the current food safety rules in the abortion facility rule, thereby allowing HHSC to enforce the abortion facility rule relating to food safety in order to protect the health, safety, and welfare of the public.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §139.48(1) replaces the reference to §§229.161 - 229.171 of this title (relating to Texas Food Establishments) with a new reference to Chapter 228 of this title (relating to Retail Food).

FISCAL NOTE

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

GOVERNMENT GROWTH IMPACT STATEMENT

HHSC has determined that during the first five years that the section will be in effect:

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

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

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

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

(5) the proposed rule amendment will not create a new rule;

(6) the proposed rule amendment will not expand, limit, or repeal an existing rule;

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

(8) the proposed rule amendment will not affect the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Patrick Waldron, Branch Manager, has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities. The rule does not impose any additional costs on small businesses, micro-businesses, or rural communities that are required to comply with the rule.

ECONOMIC COSTS TO PERSONS AND IMPACT ON LOCAL EMPLOYMENT

There are no anticipated economic costs to persons who are required to comply with the section as proposed.

There is no anticipated negative impact on local employment.

COSTS TO REGULATED PERSONS

Texas Government Code, §2001.0045 does not apply to this rule because the rule is necessary to protect the health, safety, and welfare of the residents of Texas.

PUBLIC BENEFIT

Mr. Waldron has also determined that for each year of the first five years the section is in effect, the public will benefit from adoption of the section. The public benefit anticipated as a result of enforcing or administering the section will be allowing HHSC to enforce the abortion facility rule relating to food safety in order to protect the health, safety, and welfare of the public.

REGULATORY ANALYSIS

HHSC 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

HHSC 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

Written comments on the proposal may be submitted to Patrick Waldron, Branch Manager, Health Care Quality Section, Mail Code 1949, P.O. Box 149347, Austin, Texas 78714-9347; by fax to (512)-834-6653; or by email to Patrick.Waldron@hhsc.state.tx.us within 30 days of publication of this proposal in the Texas Register.

STATUTORY AUTHORITY

Texas Health and Safety Code, §245.010, requires HHSC to develop, establish, and enforce standards for abortion facilities. 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.

The amendment is authorized by Texas Health and Safety Code, Chapter 245 and Texas Government Code, Chapter 531.

§139.48.Physical and Environmental Requirements.

The physical and environmental requirements for a licensed abortion facility are as follows.

(1) A facility shall:

(A) - (E) (No change.)

(F) have the capacity to provide patients with liquids. The facility may provide commercially packaged food to patients in individual servings. If other food is provided by the facility, it shall be subject to the requirements of Chapter 228 of this title (relating to Retail Food) [§§229.161 - 229.171 of this title (relating to Texas Food Establishments)];

(G) - (I) (No change.)

(2) - (3) (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 October 27, 2017.

TRD-201704349

Karen Ray

Chief Counsel

Department of State Health Services

Earliest possible date of adoption: December 10, 2017

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


CHAPTER 229. FOOD AND DRUG

The Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes amendments to Chapter 229 Food and Drug, Subchapter K, Texas Food Establishments, §229.177, concerning Certification of Food Managers in Areas Under the Department of State Health Services Permitting Jurisdiction; and §229.178, concerning Accreditation of Food Handler Education or Training Programs; Subchapter U, Permitting Retail Food Establishments, §229.371 concerning Definitions; §229.372, concerning Permitting Fees and Procedures; and §229.373, concerning Minimum Standards for Permitting and Operation; Subchapter Z, Inspection Fees for Retail Food Establishments, §229.471, concerning Definitions; §229.473, concerning Minimum Standards for Permitting and Operation; and §229.474, concerning Refusal of Inspection Request; Administrative Penalties; Subchapter EE, Cottage Food Production Operation, §229.661, concerning Cottage Food Production Operations; and Subchapter FF, Farmers' Markets, §229.702, concerning Definitions; and §229.704, concerning Temperature Requirements.

BACKGROUND AND PURPOSE

In October 2015, DSHS updated retail food safety rules by repealing 25 TAC §§229.161 - 229.171 and §§229.173 - 229.175 (relating to Texas Food Establishments) and replacing them with Title 25, Chapter 228 (relating to Retail Food). When these rules were repealed and replaced, rules elsewhere in Title 25, Chapter 229 (relating to Food and Drug) that incorporated the Texas Food Establishment rules by reference were not updated to refer to the new rules in Chapter 228. Consequently, DSHS was unable to enforce violations of food safety rules by food establishments, cottage food production operations, and farmers' markets. This lack of authority to enforce food safety rule violations by food establishments, cottage food production operations, and farmers' markets presented a peril to the health, safety, and welfare of the public. Under Texas Government Code, §2001.034, emergency rules were adopted to update §§229.177, 229.178, 229.371 - 229.373, 229.471, 229.473, 229.474, 229.661, 229.702, and §229.704 to include the rules references to Chapter 228. The emergency rules were adopted on August 24, 2017, and will expire on December 21, 2017, with an option to extend the rules for another 60 days. Therefore, amendments to §§229.177, 229.178, 229.371 - 229.373, 229.471, 229.473, 229.474, 229.661, 229.702, and §229.704 are proposed for the permanent adoption of the rule reference updates.

The purpose of the rule amendments is to update references to the current food safety rules in food establishments, cottage food production operations, and farmers' markets, thereby allowing DSHS to enforce rules relating to food safety in order to protect the health, safety, and welfare of the public. The new rules in Chapter 228 are based on the current 2013 United States Food and Drug Administration Model Food Code, which allows the Texas food rules to be in conformity with the rest of the country.

SECTION-BY-SECTION SUMMARY

Subchapter K. Texas Food Establishments.

The proposed amendments to §229.177(c) replace the rule reference §229.162(74) with the new rule reference to §228.2. Also, the potentially hazardous foods definition was replaced with the definition of Time/Temperature Control for Safety (TCS) food--(formerly Potentially Hazardous Food (PHF)).

The proposed amendments to §229.178(c) replace the rule references to §229.163 with Chapter 228, Subchapter B; replaces the rule references to §229.164 with Chapter 228, Subchapter C; and replaces the rule reference to §229.165 with Chapter 228, Subchapter D.

Subchapter U. Permitting Retail Food Establishments.

The proposed amendments to §229.371(6) replace the rule reference to §229.162 of this title (relating to Definitions) under the Texas Food Establishment Rules with §228.2 of this title (relating to Definitions) under the Retail Food rules.

The proposed amendments to §229.372(a) replace the rule references to §229.169 of this title (relating to Mobile Food Establishments) with §228.221 of this title (relating to Mobile Food Units). Also, §229.372(i) is amended by replacing the rule references §§229.161 - 229.171 and §§229.173 - 229.175 of this title (relating to Texas Food Establishments) with Chapter 228 of this title (relating to Retail Food).

The proposed amendments to §229.373 replace the rule references to §§229.161 - 229.171 and §§229.173 - 229.175 of this title (relating to Texas Food Establishments) with Chapter 228 of this title (relating to Retail Food).

Subchapter Z. Inspection Fees For Retail Food Establishments.

The proposed amendments to §229.471(5)(C) replace the rule reference to §229.162 with §228.2. Section 229.471(5)(D) is amended to replace the rule reference to §229.162 of this title (relating to Texas Food Establishments) with Chapter 228 of this title (relating to Retail Food).

The proposed amendments to §229.473 replace the rules references to §§229.161 - 229.171 and §§229.173 - 229.175 of this title (relating to Texas Food Establishments) with Chapter 228 of this title (relating to Retail Food). Also, the website for the Retail Food Establishments is updated to www.dshs.texas.gov/foodestablishments.

The proposed amendments to §229.474 replace the rules references to §§229.161 - 229.171 and §§229.173 - 229.175 of this title (relating to Texas Food Establishments) with Chapter 228 of this title (relating to Retail Food).

Subchapter EE. Cottage Food Production Operation.

The proposed amendments to §229.661(b) replace the rule reference to §229.162 with §228.2.

Subchapter FF. Farmers' Markets

The proposed amendments to §229.702(3) replace the rule reference to §229.162 with §228.2. Also, §229.702(10) is amended to replace the definition of "Potentially hazardous food (time/temperature control for safety food--As defined in §229.162 of this title" with "Time/Temperature Control for Safety (TCS) food--(formerly Potentially Hazardous Food)--As defined in §228.2 of this title."

The proposed amendments to §229.704(d) replace the rule reference to §229.162(115) with §228.2. Also, §229.704(f) is amended to replace the rule reference to §229.164(c)(1)(C) of this title (relating to Specifications for Receiving Food) with §228.63 of this title (relating to Specifications for Receiving).

FISCAL NOTE

Donna Sheppard, 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 rule amendments will not create or eliminate a government program;

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

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

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

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

(6) the proposed rule amendments will not expand, limit, or repeal existing rules;

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

(8) the proposed rule amendments will not affect the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Jon Huss, Associate Commissioner, has determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities. The rules do not impose any additional costs on small businesses, micro-businesses, or rural communities that are required to comply with the rules.

ECONOMIC COSTS TO PERSONS AND IMPACT ON LOCAL EMPLOYMENT

There are no anticipated economic costs to persons who are required to comply with the sections as proposed.

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 protect the health, safety, and welfare of the residents of Texas.

PUBLIC BENEFIT

Mr. Huss has also determined that for each year of the first five years the rules are in effect, the public will benefit from the adoption of the rules. The anticipated public benefit will be allowing DSHS to enforce the food establishments, cottage food production operations, and farmers' markets rules relating to food safety in order to protect the health, safety, and welfare of the public.

REGULATORY ANALYSIS

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

Written comments on the proposal may be submitted to Cheryl Wilson, Interim Manager, Standards and Quality Assurance Section; Department of State Health Services, Mail Code 1987, P.O. Box 149347, Austin, Texas 78714-9347; by fax to (512) 834-6707 Fax; or by email to Cheryl.Wilson@dshs.texas.gov within 30 days of publication of this proposal in the Texas Register.

SUBCHAPTER K. TEXAS FOOD ESTABLISHMENTS

25 TAC §229.177, §229.178

STATUTORY AUTHORITY

The amendments are authorized by Texas Health and Safety Code, §437.0056, which requires DSHS to adopt rules for granting and maintaining retail food permits in areas not regulated by counties and public health districts; Texas Health and Safety Code, §437.0193, which requires DSHS to adopt rules for labeling of foods produced by cottage food production operations; Texas Health and Safety Code, §437.0202, which authorizes DSHS to implement rules relating to food temperature requirements and permits at farmers' markets; and Texas Government Code, §531.0055, and Texas Health and Safety Code, §1001.075, which authorize the Executive Commissioner of HHSC to adopt rules and policies necessary for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code, Chapter 1001.

The amendments are authorized by Texas Health and Safety Code, Chapters 437 and 1001, and Texas Government Code, Chapter 531.

§229.177.Certification of Food Managers in Areas Under the Department of State Health Services Permitting Jurisdiction.

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

(c) Food manager certification exemptions. The following food establishments are exempt from the requirements in subsection (b) of this section:

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

(3) establishments that do not prepare or handle exposed Time/Temperature Control for Safety (TCS) food--(formerly Potentially Hazardous Food (PHF)), [potentially hazardous foods] as defined in §228.2 [§229.162(74)] of this title (relating to Definitions); or

(4) (No change.)

(d) - (f) (No change.)

§229.178.Accreditation of Food Handler Education or Training Programs.

(a) - (b) (No change)

(c) Food handler education and training program. The department may accredit an education or training program for basic food safety. The program shall include employee knowledge, responsibilities and training as required in the Texas Food Establishment Rules (TFER).

(1) Education or training course curriculum. A food handler training or education course shall include the following basic food safety principles.

(A) Foodborne disease outbreak. Instruction on foodborne disease outbreak shall include the definition of foodborne disease outbreak, the causes and preventive measures, including employee reporting requirements as defined in Chapter 228, Subchapter B [§229.163 ] of this title (relating to Management and Personnel).

(B) Good hygienic practices. Instruction on good hygienic practices shall include the procedures as required in Chapter 228, Subchapter B [§229.163] of this title.

(C) Preventing contamination by employees. Instruction shall include the training as required in Chapter 228, Subchapter C [§229.164(e)(1)(D)] of this title (relating to Food), regarding the training requirements for contact with ready to eat food with their bare hands.

(D) Cross Contamination. Instruction on cross contamination shall include procedures on the prevention of cross-contamination of foods, sanitization methods and corrective actions as required in Chapter 228, Subchapter C of this title and Chapter 228, Subchapter D [§229.164 of this title and §229.165] of this title (relating to Equipment, Utensils, and Linens).

(E) Time and temperature. Instruction shall include time and temperature control of foods to limit pathogen growth or toxin production as required in Chapter 228, Subchapter C [§229.164] of this title.

(2) - (4) (No change.)

(d) - (l) (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 October 27, 2017.

TRD-201704350

Barbara L. Klein

Interim General Counsel

Department of State Health Services

Earliest possible date of adoption: December 10, 2017

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


SUBCHAPTER U. PERMITTING RETAIL FOOD ESTABLISHMENTS

25 TAC §§229.371 - 229.373

The amendments are authorized by Texas Health and Safety Code, §437.0056, which requires DSHS to adopt rules for granting and maintaining retail food permits in areas not regulated by counties and public health districts; Texas Health and Safety Code, §437.0193, which requires DSHS to adopt rules for labeling of foods produced by cottage food production operations; Texas Health and Safety Code, §437.0202, which authorizes DSHS to implement rules relating to food temperature requirements and permits at farmers' markets; and Texas Government Code, §531.0055, and Texas Health and Safety Code, §1001.075, which authorize the Executive Commissioner of HHSC to adopt rules and policies necessary for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code, Chapter 1001.

The amendments are authorized by Texas Health and Safety Code, Chapters 437 and 1001, and Texas Government Code, Chapter 531.

§229.371.Definitions.

The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise:

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

(6) Food establishment--An operation that stores, prepares, packages, serves, or otherwise provides food for human consumption such as: a food service establishment; retail food store; satellite or catered feeding location; catering operation if the operation provides food directly to a consumer or to a conveyance used to transport people; market; remote catered operations; conveyance used to transport people, institution; or food bank; and that relinquishes possession of food to a consumer directly, or indirectly through a delivery service such as home delivery of grocery orders or restaurant takeout orders, or delivery service that is provided by common carriers.

(A) - (B) (No change.)

(C) All definitions found in §228.2 [§229.162] of this title (relating to Definitions) under the Retail Food rules [Texas Food Establishment Rules] are applicable to these sections except that, for purposes of obtaining a permit and payment of fees only, the term "food establishment" does not include:

(i) - (xi) (No change.)

(7) - (18) (No change.)

§229.372.Permitting Fees and Procedures.

(a) Permitting fees.

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

(3) A person who operates a mobile food unit shall obtain a permit from the department for each mobile food unit operated.

(A) Each mobile food unit shall be inspected and be in compliance with §228.221 of this title (relating to Mobile Food Units) [§229.169 of this title (relating to Mobile Food Establishments)], and pay a nonrefundable permit fee before a permit is issued. If a request for inspection is not received or if the mobile food unit does not meet the minimum standards contained in §228.221 of this title [§229.169 of this title (relating to Mobile Food Establishments)] within one year of paying the permit fee, a new fee shall be paid.

(B) (No change.)

(4) - (8) (No change.)

(b) - (h) (No change.)

(i) Issuance of a permit. The department may issue a permit or a renewal permit for an establishment based on compliance specified in Chapter 228 of this title (relating to Retail Food) [§§229.161 - 229.171 and §§229.173 - 229.175 of this title (relating to Texas Food Establishments)], and payment of all fees. Copies of the permit application may be obtained from the department, 1100 West 49th Street, Austin, Texas 78756-3182 or online at http://www.dshs.state.tx.us/license.shtm.

(1) - (3) (No change.)

(j) Renewal of a permit.

(1) (No change.)

(2) The department may renew a permit if the applicant is in compliance with Chapter 228 of this title [§§229.161 - 229.171, and §§229.173 - 229.175 of this title], and all fees are paid.

(3) (No change.)

(k) - (l) (No change.)

§229.373.Minimum Standards for Permitting and Operation.

All food establishments shall be operated in accordance with the requirements specified in Chapter 228 of this title (relating to Retail Food). [§§229.161 - 229.171 and §§229.173 - 229.175 of this title (relating to Texas Food Establishments).] Copies may be obtained from the department, 1100 West 49th Street, Austin, Texas 78756-3182, or may be downloaded from the following website: http://www.dshs.state.tx.us/license.shtm.

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 October 27, 2017.

TRD-201704352

Barbara L. Klein

Interim General Counsel

Department of State Health Services

Earliest possible date of adoption: December 10, 2017

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


SUBCHAPTER Z. INSPECTION FEES FOR RETAIL FOOD ESTABLISHMENTS

25 TAC §§229.471, 229.473, 229.474

The amendments are authorized by Texas Health and Safety Code, §437.0056, which requires DSHS to adopt rules for granting and maintaining retail food permits in areas not regulated by counties and public health districts; Texas Health and Safety Code, §437.0193, which requires DSHS to adopt rules for labeling of foods produced by cottage food production operations; Texas Health and Safety Code, §437.0202, which authorizes DSHS to implement rules relating to food temperature requirements and permits at farmers' markets; and Texas Government Code, §531.0055, and Texas Health and Safety Code, §1001.075, which authorize the Executive Commissioner of HHSC to adopt rules and policies necessary for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code, Chapter 1001.

The amendments are authorized by Texas Health and Safety Code, Chapters 437 and 1001, and Texas Government Code, Chapter 531.

§229.471.Definitions.

The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise:

(1) - (4) (No change.)

(5) Food establishment--

(A) - (B) (No change.)

(C) Food establishment does not include:

(i) - (v) (No change.)

(vi) a Bed and Breakfast Limited facility as defined in §228.2 [§229.162] of this title (relating to Definitions); or

(vii) (No change.)

(D) All definitions found in Chapter 228 of this title (relating to Retail Food) [§229.162 of this title under the Texas Food Establishment Rules] are applicable to these sections except that, for purposes of inspection or payment of inspection fees only, the term "food establishment" does not include:

(i) - (vi) (No change.)

(6) - (15) (No change.)

§229.473.Minimum Standards for Permitting and Operation.

All food establishments shall be operated in accordance with the requirements specified in Chapter 228 of this title (relating to Retail Food). [§§229.161 - 229.171 and §§229.173 - 229.175 of this title (relating to Texas Food Establishments).] Copies may be obtained from the department, 1100 West 49th Street, Austin, Texas 78756-3182, or may be downloaded from the following website: www.dshs.texas.gov/foodestablishments. [www.dshs.state.tx.us/foodestablishments.shtm.]

§229.474.Refusal of Inspection Request; Administrative Penalties.

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

(c) Administrative penalties. Administrative penalties, as provided in the Health and Safety Code, §437.018, and in §229.261 of this title (relating to Assessment of Administrative Penalties), may be assessed for violation of these sections or requirements specified in Chapter 228 of this title (relating to Retail Food). [§§229.161 - 229.171, and §§229.173 - 229.175 of this title (relating to Texas Food Establishments).]

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 October 27, 2017.

TRD-201704353

Barbara L. Klein

Interim General Counsel

Department of State Health Services

Earliest possible date of adoption: December 10, 2017

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


SUBCHAPTER EE. COTTAGE FOOD PRODUCTION OPERATION

25 TAC §229.661

The amendment is authorized by Texas Health and Safety Code, §437.0056, which requires DSHS to adopt rules for granting and maintaining retail food permits in areas not regulated by counties and public health districts; Texas Health and Safety Code, §437.0193, which requires DSHS to adopt rules for labeling of foods produced by cottage food production operations; Texas Health and Safety Code, §437.0202, which authorizes DSHS to implement rules relating to food temperature requirements and permits at farmers' markets; and Texas Government Code, §531.0055, and Texas Health and Safety Code, §1001.075, which authorize the Executive Commissioner of HHSC to adopt rules and policies necessary for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code, Chapter 1001.

The amendment is authorized by Texas Health and Safety Code, Chapters 437 and 1001, and Texas Government Code, Chapter 531.

§229.661.Cottage Food Production Operations.

(a) (No change.)

(b) Definitions. The following words and terms when used in this subchapter shall have the following meanings unless the context clearly indicates otherwise.

(1) - (6) (No change.)

(7) Food establishment--

(A) - (B) (No change.)

(C) Food establishment does not include:

(i) - (v) (No change.)

(vi) a Bed and Breakfast Limited establishment as defined in §228.2 [§229.162] of this title (relating to Definitions) concerning food establishments;

(vii) - (viii) (No change.)

(8) - (11) (No change.)

(c) - (h) (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 October 27, 2017.

TRD-201704354

Barbara L. Klein

Interim General Counsel

Department of State Health Services

Earliest possible date of adoption: December 10, 2017

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


SUBCHAPTER FF. FARMERS' MARKETS

25 TAC §229.702, §229.704

The amendments are authorized by Texas Health and Safety Code, §437.0056, which requires DSHS to adopt rules for granting and maintaining retail food permits in areas not regulated by counties and public health districts; Texas Health and Safety Code, §437.0193, which requires DSHS to adopt rules for labeling of foods produced by cottage food production operations; Texas Health and Safety Code, §437.0202, which authorizes DSHS to implement rules relating to food temperature requirements and permits at farmers' markets; and Texas Government Code, §531.0055, and Texas Health and Safety Code, §1001.075, which authorize the Executive Commissioner of HHSC to adopt rules and policies necessary for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code, Chapter 1001.

The amendments are authorized by Texas Health and Safety Code, Chapters 437 and 1001, and Texas Government Code, Chapter 531.

§229.702.Definitions.

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

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

(3) Fish--As defined in §228.2 [§229.162 ] of this title (relating to Definitions).

(4) - (9) (No change.)

(10) Time/Temperature Control for Safety (TCS) food--(formerly Potentially Hazardous Food) [Potentially hazardous food (time/temperature control for safety food)]--As defined in §228.2 [§229.162] of this title.

§229.704.Temperature Requirements.

(a) - (c) (No change.)

(d) Cooking of raw animal foods. Raw animal foods shall be cooked to heat all parts of the food to the following temperatures:

(1) - (4) (No change.)

(5) a raw or undercooked whole-muscle, intact beef steak may be served if:

(A) the steak is labeled to indicate that it meets the definition of "whole-muscle, intact beef" as defined in §228.2 [§229.162(115)] of this title (relating to Definitions); or

(B) (No change.)

(6) (No change.)

(e) (No change.)

(f) Eggs. A farmer or egg producer that sells eggs directly to the consumer at a farm or farmers' market shall maintain the eggs at an ambient air temperature of 7 degrees Celsius (45 degrees Fahrenheit) as specified in §228.63 [§229.164(c)(1)(C) ] of this title (relating to Specifications for Receiving [Food]).

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 October 27, 2017.

TRD-201704355

Barbara L. Klein

Interim General Counsel

Department of State Health Services

Earliest possible date of adoption: December 10, 2017

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


CHAPTER 265. GENERAL SANITATION

SUBCHAPTER B. TEXAS YOUTH CAMPS SAFETY AND HEALTH

25 TAC §265.13

The Executive Commissioner of the Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes an amendment to §265.13, concerning Site and Physical Facilities.

BACKGROUND AND PURPOSE

In October 2015, DSHS updated retail food safety rules by repealing 25 TAC §§229.161 - 229.171 (relating to Texas Food Establishments) and replacing them with Title 25, Chapter 228 (relating to Retail Food). When these rules were repealed and replaced, the rule in Title 25, Chapter 265, Subchapter B (relating to Texas Youth Camps Safety and Health) that incorporated the Texas Food Establishment rules by reference was not updated to refer to the new rules in Chapter 228. Consequently, DSHS was unable to enforce violations of food safety rules by youth camps. This lack of authority to enforce food safety rule violations by youth camps presented a peril to the health, safety, and welfare of the public. Under Texas Government Code, §2001.034, an emergency rule was adopted to update §265.13 to include the rules references to Chapter 228. The emergency rule was adopted on August 24, 2017, and will expire on December 21, 2017, with an option to extend the rule for another 60 days. Therefore, the amendment to §265.13 is proposed for the permanent adoption of the rule reference update.

The purpose of the rule amendment is to update the reference to the current food safety rules in the youth camp rule, thereby allowing DSHS to enforce the youth camp rule relating to food safety in order to protect the health, safety, and welfare of the public, and to refer to a playground safety handbook that contains updated safety standards.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §265.13(t) replaces the rule references to Chapter 229, Subchapter K, §§229.161 et seq., of this title (relating to Texas Food Establishments), with the new rules reference to Chapter 228 of this title (relating to Retail Food). Section 265.13(u) is also amended to refer to the most recent version of the "Public Playground Safety Handbook" publication concerning the standards for playgrounds and playground equipment.

FISCAL NOTE

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

GOVERNMENT GROWTH IMPACT STATEMENT

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

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

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

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

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

(5) the proposed rule amendment will not create a new rule;

(6) the proposed rule amendment will not expand, limit, or repeal an existing rule;

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

(8) the proposed rule amendment will not affect the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Jon Huss, Associate Commissioner, has determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities. The rule does not impose any additional costs on small businesses, micro-businesses, or rural communities that are required to comply with the rule.

ECONOMIC COSTS TO PERSONS AND IMPACT ON LOCAL EMPLOYMENT

There are no anticipated economic costs to persons who are required to comply with the section as proposed.

There is no anticipated negative impact on local employment.

COSTS TO REGULATED PERSONS

Texas Government Code, §2001.0045 does not apply to this rule because the rule is necessary to protect the health, safety, and welfare of the residents of Texas.

PUBLIC BENEFIT

Mr. Huss has determined that for each year of the first five years the section is in effect, the public will benefit from adoption of the section. The public benefit anticipated as a result of enforcing or administering the section will be allowing DSHS to enforce the youth camp rule relating to food safety in order to protect the health, safety, and welfare of the public.

REGULATORY ANALYSIS

DSHS 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

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 Government Code, §2007.043.

PUBLIC COMMENT

Written comments on the proposal may be submitted to Cheryl Wilson, Interim Manager, Standards and Quality Assurance Section; Department of State Health Services, Mail Code 1987, P.O. Box 149347, Austin, Texas 78714-9347; by fax to (512) 834-6707 Fax; or by email to Cheryl.Wilson@dshs.texas.gov within 30 days of publication of this proposal in the Texas Register.

STATUTORY AUTHORITY

Texas Health and Safety Code, §141.009, requires DSHS to establish health and safety standards for youth camps. Texas Government Code, §531.0055, and Texas Health and Safety Code, §1001.075, authorize the Executive Commissioner of HHSC to adopt rules and policies necessary for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code, Chapter 1001.

The amendment is authorized by Texas Health and Safety Code, Chapters 141 and 1001; and Texas Government Code, Chapter 531.

§265.13.Site and Physical Facilities.

(a) - (s) (No change.)

(t) Permanent food preparation, storage and service areas. Permanent food preparation, storage and service areas shall be maintained in compliance with Chapter 228 of this title (relating to Retail Food) [229, Subchapter K, §§229.161 et seq., of this title (relating to Texas Food Establishments), as amended]. Items inspected may include, but are not limited to:

(1) - (26) (No change.)

(u) Playgrounds and equipment. Playgrounds and playground equipment shall meet the standards set forth in the U.S. Consumer Product Safety Commission Publication Number 325, "Public Playground Safety Handbook," November 2010 ["Handbook for Public Playground Safety," April 2008 (http://www.cpsc.gov/CPSCPUB/PUBS/325.pdf) as amended]. Equipment that does not meet these standards may not be used by campers.

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 October 27, 2017.

TRD-201704356

Barbara L. Klein

Interim General Counsel

Department of State Health Services

Earliest possible date of adoption: December 10, 2017

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


CHAPTER 295. OCCUPATIONAL HEALTH

SUBCHAPTER G. SANITATION AT TEMPORARY PLACES OF EMPLOYMENT

25 TAC §295.169

The Executive Commissioner of the Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes an amendment to §295.169, concerning Standards for Food Service.

BACKGROUND AND PURPOSE

In October 2015, DSHS updated retail food safety rules by repealing 25 TAC §§229.161 - 229.171 (relating to Texas Food Establishments) and replacing them with Title 25, Chapter 228 (relating to Retail Food). When these rules were repealed and replaced, the rule in Title 25, Chapter 295, Subchapter G (relating to Sanitation at Temporary Places of Employment) that incorporated the Texas Food Establishment rules by reference was not updated to refer to the new rules in Chapter 228. Consequently, DSHS was unable to enforce violations of food safety rules by temporary places of employment. This lack of authority to enforce food safety rule violations by temporary places of employment presented a peril to the health, safety, and welfare of the public. Under Texas Government Code, §2001.034, an emergency rule was adopted to update §295.169 to include the rules references to Chapter 228. The emergency rule was adopted on August 24, 2017, and will expire on December 21, 2017, with an option to extend the rule for another 60 days. Therefore, the amendment to §295.169 is proposed for the permanent adoption of the rule reference update.

The purpose of the rule amendment is to update the reference to the current food safety rules in the temporary places of employment rule, thereby allowing DSHS to enforce the temporary places of employment rule relating to food safety in order to protect the health, safety, and welfare of the public.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §295.169 replaces the rules reference to §§229.161 - 229.171 of this title (relating to Food Service Sanitation), with the new rules reference to Chapter 228 of this title (relating to Retail Food).

FISCAL NOTE

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

GOVERNMENT GROWTH IMPACT STATEMENT

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

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

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

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

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

(5) the proposed rule amendment will not create a new rule;

(6) the proposed rule amendment will not expand, limit, or repeal an existing rule;

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

(8) the proposed rule amendment will not affect the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Jon Huss, Associate Commissioner, has determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities. The rule does not impose any additional costs on small businesses, micro-businesses, or rural communities that are required to comply with the rule.

ECONOMIC COSTS TO PERSONS AND IMPACT ON LOCAL EMPLOYMENT

There are no anticipated economic costs to persons who are required to comply with the section as proposed.

There is no anticipated negative impact on local employment.

COSTS TO REGULATED PERSONS

Texas Government Code, §2001.0045 does not apply to this rule because the rule is necessary to protect the health, safety, and welfare of the residents of Texas.

PUBLIC BENEFIT

Mr. Huss has also determined that for each year of the first five years the rule is in effect, the public will benefit from the adoption of the rule. The anticipated public benefit will be allowing DSHS to enforce the temporary places of employment rule relating to food safety in order to protect the health, safety, and welfare of the public.

REGULATORY ANALYSIS

HHSC 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

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 Government Code, §2007.043.

PUBLIC COMMENT

Written comments on the proposal may be submitted to Cheryl Wilson, Interim Manager, Standards and Quality Assurance Section; Department of State Health Services, Mail Code 1987, P.O. Box 149347, Austin, Texas 78714-9347; by fax to (512) 834-6707 Fax; or by email to Cheryl.Wilson@dshs.texas.gov within 30 days of publication of this proposal in the Texas Register.

STATUTORY AUTHORITY

Texas Health and Safety Code, §341.002, authorizes HHSC to establish standards and procedures for the management and control of sanitation and for health protection measures. Texas Government Code, §531.0055, and Texas Health and Safety Code, §1001.075, authorize the Executive Commissioner of HHSC to adopt rules and policies necessary for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code, Chapter 1001.

The amendment is authorized by Texas Health and Safety Code, Chapters 341 and 1001; and Texas Government Code, Chapter 531.

§295.169.Standards for Food Service.

The preparation, storage, and dispensing of food at any temporary place of employment shall be accomplished according to Chapter 228 of this title (relating to Retail Food) [§§229.161-229.171 of this title (relating to Food Service Sanitation)] as administered by the health authority having local jurisdiction.

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 October 27, 2017.

TRD-201704357

Barbara L. Klein

Interim General Counsel

Department of State Health Services

Earliest possible date of adoption: December 10, 2017

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