TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 73. LABORATORIES

25 TAC §73.11, §73.52

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes the repeal of §73.11, concerning Certification of Milk and Shellfish Laboratories; and the repeal of §73.52, concerning Fees for the Certification of Milk and Shellfish Laboratories.

BACKGROUND AND PURPOSE

The purpose of the proposal is to remove the DSHS State Laboratory rules in Chapter 73, concerning Laboratories, and create new rules in Texas Administrative Code Title 25, Chapter 218, concerning Evaluation of Milk and Shellfish Laboratories.

Currently, the responsibility for the evaluation of milk and shellfish laboratories resides with the DSHS Consumer Protection Division through its Milk and Dairy program. However, the rules are located in Chapter 73, as the DSHS State Laboratory Services Section was previously responsible for the program.

New §§218.1 - 218.7, concerning Evaluation of Milk Laboratories, and new §§218.21 - 218.26, concerning Evaluation of Shellfish Laboratories are published elsewhere in this issue of the Texas Register. The new rules in Chapter 218 reflect updated language and laboratory practices concerning the Milk and Dairy program and the Seafood and Aquatic Life program.

SECTION-BY-SECTION SUMMARY

The proposed repeal of §73.11 and §73.52 will remove the rules from Chapter 73, Laboratories.

FISCAL NOTE

Donna Sheppard, Chief Financial Officer, has determined that for each year of the first five years that the repeals will be in effect, enforcing or administering the rules does not have foreseeable implication relating to costs or revenues of state or local governments.

GOVERNMENT GROWTH IMPACT STATEMENT

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

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

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

(3) implementation of the proposed rules will result in no assumed change in future legislative appropriations;

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

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

(6) the proposed rules will repeal existing rules;

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

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

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

The rules do not impose any additional costs on small businesses, micro-businesses, or rural communities that are required to comply with the rules.

Donna Sheppard has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities.

LOCAL EMPLOYMENT IMPACT

The proposed rules will not affect a local economy.

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; and the rules do not impose a cost on regulated persons.

PUBLIC BENEFIT AND COSTS

Stephen Pahl, Associate Commissioner, Consumer Protection Division, has determined that for each year of the first five years the rules are in effect, the public will benefit from adoption of the sections. The public will benefit from the updated laboratory language reflecting current laboratory practices.

Donna Sheppard has also determined that for the first five years the repeals are in effect, there are no anticipated economic costs to persons who are required to comply with the proposed rules.

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

Questions about the content of this proposal may be directed to Sofia Stifflemire, R.S., at (512) 834-6758 in the DSHS Policy, Standards & Quality and Assurance, Milk and Dairy Unit.

Written comments on the proposal may be submitted to Sofia Stifflemire, Milk and Dairy Unit, Texas Department of State Health Services, P.O. Box 149347, Mail Code 1987, Austin, Texas 78714-9347, street address 8407 Wall Street, Austin Texas 78754; fax (512) 834-6756; or by email to milk.regulatory@dshs.texas.gov. Please indicate "Comments on Chapter 218 Proposed Evaluation of Milk and Shellfish Laboratories."

To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be: (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period; or (3) faxed or emailed before midnight on the last day of the comment period. If last day to submit comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted.

STATUTORY AUTHORITY

The repeals are authorized under Texas Health and Safety Code, Chapter 12 because DSHS will not collect fees for services. The proposed rules are also authorized by Texas Government Code, §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services system, including by DSHS. Under Texas Health and Safety Code, Chapter 1001, the DSHS Commissioner is authorized to assist the Executive Commissioner in the development of rules relating to the matters with DSHS jurisdiction.

The repeals will implement Texas Health and Safety Code, Chapter 12.

§73.11.Certification of Milk and Shellfish Laboratories.

§73.52.Fees for the Certification of Milk and Shellfish Laboratories.

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 July 20, 2020.

TRD-202002955

Barbara L. Klein

General Counsel

Department of State Health Services

Earliest possible date of adoption: August 30, 2020

For further information, please call: (512) 834-6758


CHAPTER 218. EVALUATION OF MILK AND SHELLFISH LABORATORIES

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes new §§218.1 - 218.7, concerning Evaluation of Milk Laboratories; and new §§218.21 - 218.26, concerning Evaluation of Shellfish Laboratories.

BACKGROUND AND PURPOSE

The purpose of the proposal is to remove the rules from the DSHS State Laboratory Services Section in Chapter 73, concerning Laboratories, and create new Texas Administrative Code Title 25, Chapter 218, concerning Evaluation of Milk and Shellfish Laboratories.

Currently, the responsibility for the evaluation of milk and shellfish laboratories resides with the DSHS Consumer Protection Division through its Milk and Dairy program. However, the rules are located in Chapter 73, as the DSHS State Laboratory Services Section was previously responsible for the program. The repeal of §73.11, concerning Certification of Milk and Shellfish Laboratories, and the repeal of §73.52, concerning Fees for the Certification of Milk and Shellfish Laboratories, are published elsewhere in this issue of the Texas Register.

The new rules in Chapter 218 reflect updated language and laboratory practices concerning the Milk and Dairy program and the Seafood and Aquatic Life program.

SECTION-BY-SECTION SUMMARY

Proposed new Subchapter A, §§218.1 - 218.7, outlines language concerning the Evaluation of Milk Laboratories to reflect the laboratory practices of the Milk and Dairy program.

Proposed new §218.1, Purpose, provides the purpose of the subchapter that establishes the procedures for milk laboratories to become accredited or approved laboratories.

Proposed new §218.2, Definitions, adds definitions to reflect updated milk laboratory practices.

Proposed new §218.3, Evaluation of Milk Laboratories, includes the adoption of Evaluation of Milk Laboratories, published by the U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, and the National Conference on Interstate Milk Shipments as a reference for the procedures for the evaluation of milk laboratories.

Proposed new §218.4, Accreditation or Approval Application, describes the application process and includes the current categories of milk laboratories.

Proposed new §218.5, Standards, contains the minimum standards for laboratories applying for or renewing accreditation or approval and includes Milk and Dairy Unit contact information.

Proposed new §218.6, Inspections, adds the language for laboratory inspections for compliance with minimum standards.

Proposed new §218.7, Withdrawal of Accreditation or Approval, adds language for the withdrawal of accreditation or approval.

Proposed new Subchapter B, §§218.21 - 218.26, outlines language concerning the Evaluation of Shellfish Laboratories to reflect the laboratory practices of the Seafood and Aquatic Life program.

Proposed new §218.21, Purpose, provides the purpose of the subchapter that establishes the procedures for shellfish laboratories to be conforming under state law.

Proposed new §218.22, Definitions, adds definitions to reflect updated shellfish laboratory practices.

Proposed new §218.23, National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish, includes the adoption of the National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish, published by the U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, and the Interstate Shellfish Sanitation Conference as a reference for the procedures for the evaluation of shellfish laboratories.

Proposed new §218.24, Standards, adds the minimum standards for laboratory conformance and includes Seafood and Aquatic Life Unit contact information.

Proposed new §218.25, Inspections, adds the language for laboratory inspections for compliance with minimum conformance standards.

Proposed new §218.26, Withdrawal of Conforming Status, adds language for the withdrawal of conformance.

FISCAL NOTE

Donna Sheppard, Chief Financial Officer, has determined that for each year of the first five years that the rules will be in effect, enforcing or administering the rules does not have foreseeable implication relating to costs or revenues of state or local governments.

GOVERNMENT GROWTH IMPACT STATEMENT

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

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

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

(3) implementation of the proposed rules will result in no assumed change in future legislative appropriations;

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

(5) the proposed rules will create new rules;

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

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

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

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

The rules do not impose any additional costs on small businesses, micro-businesses, or rural communities that are required to comply with the rules.

Donna Sheppard has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities.

LOCAL EMPLOYMENT IMPACT

The proposed rules will not affect a local economy.

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; and the rules do not impose a cost on regulated persons.

PUBLIC BENEFIT AND COSTS

Stephen Pahl, Associate Commissioner, Consumer Protection Division, has determined that for each year of the first five years the rules are in effect, the public will benefit from adoption of the sections. The public will benefit from the updated laboratory language reflecting current laboratory practices.

Donna Sheppard, has also determined that for the first five years the rules are in effect, there are no anticipated economic costs to persons who are required to comply with the proposed rules.

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

Questions about the content of this proposal may be directed to Sofia Stifflemire, R.S., at (512) 834-6758 in the DSHS Policy, Standards & Quality and Assurance, Milk and Dairy Unit.

Written comments on the proposal may be submitted to Sofia Stifflemire, Milk and Dairy Unit, Texas Department of State Health Services, P.O. Box 149347, Mail Code 1987, Austin, Texas 78714-9347, street address 8407 Wall Street, Austin Texas 78754; fax (512) 834-6756 or by email to milk.regulatory@dshs.texas.gov. Please indicate "Comments on Chapter 218 Proposed Evaluation of Milk and Shellfish Laboratories."

To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be: (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period; or (3) faxed or emailed before midnight on the last day of the comment period. If last day to submit comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted.

SUBCHAPTER A. EVALUATION OF MILK LABORATORIES

25 TAC §§218.1 - 218.7

STATUTORY AUTHORITY

The new rules are authorized under Texas Health and Safety Code, Chapters 12 and 435. Texas Health and Safety Code, §435.003 allows DSHS to define what constitutes Grade "A" raw milk, Grade "A" raw milk products, Grade "A" pasteurized milk, Grade "A" pasteurized milk products, milk for manufacturing, and dairy products; and provides specifications for the production and handling of milk and milk products listed in Texas Health and Safety Code, §435.003 Subdivision (1). The rules must also be based on, and consistent with, the most recent federal definitions, specifications, rules, and regulations relating to milk and milk products. The rules are also authorized by Texas Government Code, §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services system, including by DSHS. Under Texas Health and Safety Code, Chapter 1001, the DSHS Commissioner is authorized to assist the Executive Commissioner in the development of rules relating to the matters with DSHS jurisdiction.

The new rules will implement Texas Health and Safety Code, Chapter 435.

§218.1.Purpose.

This subchapter establishes the procedures for milk laboratories to become accredited or approved laboratories under state law, Texas Health and Safety Code, Chapters 12 and 435.

§218.2.Definitions.

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

(1) Accreditation--An official approval granted by the department to a laboratory. The accreditation only permits analysis of milk and dairy samples in accordance with the applicable rules based on the process outlined in this subchapter. Accreditation is granted to a laboratory that is capable of correctly performing the analyses for which it is accredited. Accreditation does not imply that the department certifies the results produced by the accredited laboratory.

(2) Antibiotic milk laboratory--A laboratory only authorized to screen for antibiotics in milk manufacturing.

(3) Approval--An official approval granted by the department to a laboratory. The approval only permits analysis of milk samples for antibiotic testing in accordance with applicable rules based on the process outlined in this subchapter. Approval is granted to a laboratory that is capable of correctly performing analyses for which it is approved. Approval does not imply that the department certifies the results produced by the approved laboratory.

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

(5) Evaluation--An onsite inspection performed by the department that includes a fact-finding process in which information and observations are collected for the purpose of evaluation of the laboratory's compliance with established accreditation or approval standards.

(6) Officially designated laboratory--A commercial laboratory or a milk industry laboratory officially designated by the department for the analysis of milk, milk products, milk for manufacturing, or frozen desserts.

(7) Official laboratory--A biological, chemical, or physical laboratory, which is under the direct supervision of the department for the analysis of milk, milk products, milk for manufacturing, or frozen desserts. Official laboratories include full service laboratories.

(8) Split samples--An annual proficiency testing program that includes bacterial count, coliform count, somatic cell count, presence of antibiotics, presence of phosphatase, and presence of added water, contingent on the milk laboratory accreditation or approval, which is coordinated by the Milk and Dairy Unit, Department of State Health Services, 8407 Wall Street, Austin, Texas 78754, to determine if the milk laboratory is qualified in performing the analyses.

§218.3.Evaluation of Milk Laboratories.

The department adopts by reference the document entitled, Evaluation of Milk Laboratories, as amended, published by the U.S. Department of Health and Human Services, Public Health Service, U.S. Food and Drug Administration, and the National Conference on Interstate Milk Shipments. The document provides the procedures for the evaluation of milk laboratories. Copies are available online at http://www.dshs.texas.gov/milk and for review during normal business hours in the Milk and Dairy Unit, Department of State Health Services, 8407 Wall Street, Austin, Texas 78754.

§218.4.Accreditation or Approval Application.

(a) A laboratory must submit an application for accreditation or approval to the department on a form specified by the department at http://www.dshs.texas.gov/milk.

(b) A laboratory may apply for accreditation in a single category or any combination of categories from the following list:

(1) antibiotic milk laboratory;

(2) milk industry laboratory; or

(3) full service milk laboratory.

(c) A laboratory may apply for approval as an antibiotic milk laboratory.

(d) The department shall perform an evaluation for each milk laboratory applying for accreditation or approval.

§218.5.Standards.

(a) The requirements specified in §218.3 of this title (relating to Evaluation of Milk Laboratories) are minimum standards for a laboratory applying for or renewing accreditation or approval in Texas. These specifications are available online at http://www.dshs.texas.gov/milk and for review during normal business hours at the Milk and Dairy Unit, Department of State Health Services, 8407 Wall Street, Austin, Texas 78754.

(b) Each applicant laboratory will be evaluated, at a minimum on the following factors:

(1) milk testing procedure performance of staff;

(2) quality assurance plan;

(3) manuals of procedures;

(4) performance on split samples;

(5) equipment;

(6) calibrations and standards;

(7) methodology;

(8) facilities;

(9) sample acceptance policies;

(10) sample tracking;

(11) record keeping;

(12) reporting; and

(13) interpretation of results.

(c) A laboratory must meet all minimum standards, pass annual split samples, and pass an onsite inspection at least biennially to be accredited or approved.

§218.6.Inspections.

The department may conduct onsite inspections of laboratories to ascertain adherence to minimum standards as specified in §218.3 of this title (relating to Evaluation of Milk Laboratories) and the effectiveness of the accreditation or approval standards. For laboratories for which the department serves as both the evaluating and accreditation or approval authority, onsite inspections will be conducted at least biennially.

§218.7.Withdrawal of Accreditation or Approval.

(a) A laboratory that fails to meet requirements may be placed on provisionally accredited or approved status:

(1) by scoring outside the acceptable limits on a set of split samples;

(2) by having serious deficiencies at the time of an onsite inspection; or

(3) by failing to notify the department within 30 days of major changes which might impair analytical capability (personnel, equipment, or location).

(b) Failure on two consecutive split samples or failure to correct major deficiencies following an onsite inspection, within 60 days, may result in the withdrawal of accreditation or approval. Withdrawal of accreditation or approval shall remain in effect until measures are taken by the laboratory to attain compliance and an additional onsite inspection determines that the major deficiencies are corrected at a time that is agreeable for both parties.

(c) Accreditation or approval may be suspended or revoked immediately if the minimum standards of the U.S. Food and Drug Administration require suspension or revocation, or if continued operation of the laboratory will jeopardize public health.

(d) Accreditation or approval shall be revoked for a laboratory that submits as its own work the results for analysis of any split samples that was analyzed by a different laboratory. The laboratory may not reapply for accreditation or approval for a period of not less than three years.

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 July 20, 2020.

TRD-202002956

Barbara L. Klein

General Counsel

Department of State Health Services

Earliest possible date of adoption: August 30, 2020

For further information, please call: (512) 834-6758


SUBCHAPTER B. EVALUATION OF SHELLFISH LABORATORIES

25 TAC §§218.21 - 218.26

STATUTORY AUTHORITY

The new rules are authorized under Texas Health and Safety Code, Chapters 12 and 435. Texas Health and Safety Code, §435.003 allows DSHS to define what constitutes Grade "A" raw milk, Grade "A" raw milk products, Grade "A" pasteurized milk, Grade "A" pasteurized milk products, milk for manufacturing, and dairy products; and provides specifications for the production and handling of milk and milk products listed in Texas Health and Safety Code, §435.003 Subdivision (1). The rules must also be based on, and consistent with, the most recent federal definitions, specifications, rules, and regulations relating to milk and milk products. The rules are also authorized by Texas Government Code, §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services system, including by DSHS. Under Texas Health and Safety Code, Chapter 1001, the DSHS Commissioner is authorized to assist the Executive Commissioner in the development of rules relating to the matters with DSHS jurisdiction.

The new rules will implement Texas Health and Safety Code, Chapter 435.

§218.21.Purpose.

This subchapter establishes the procedures for shellfish laboratories to be conforming under state law, Texas Health and Safety Code, Chapters 12 and 435.

§218.22.Definitions.

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

(1) Conforming status--An official status granted by the department to a laboratory. The official status permits the analysis of shellfish samples in accordance with applicable rules based on the process outlined in this subchapter. Conforming status means that a laboratory has been found to be capable of correctly performing the analyses for which it is approved.

(2) Critical nonconformity--A deviation of a laboratory requirement which has the highest likelihood of adversely affecting the quality of the analytical results.

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

(4) Evaluation--A fact-finding process performed by the department in which information and observations are collected for the purpose of evaluating the laboratory's compliance with established standards. Evaluation includes an onsite inspection but can, under a certain circumstance, be conducted by desk audit.

(5) Key nonconformity--A deviation of laboratory requirement that has a significant potential to adversely affect the quality of the analytical results.

(6) Other nonconformity--A deviation of a laboratory requirement which does not normally compromise the quality of the analytical results, but generally serves to enhance the overall operation of the laboratory.

§218.23.National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish.

The department adopts by reference the document entitled, National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish, as amended, published by the U.S. Department of Health and Human Services, Public Health Service, U.S. Food and Drug Administration, and the Interstate Shellfish Sanitation Conference. The document provides the procedures for the evaluation of shellfish laboratories. Copies are available online at http://www.dshs.texas.gov/seafood and for review during normal business hours at the Seafood and Aquatic Life Unit, Department of State Health Services, 8407 Wall Street, Austin, Texas 78754.

§218.24.Standards.

(a) The minimum standards for conforming status are specified in §218.23 of this title (relating to National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish), and the U.S. Food and Drug Administration Shellfish Laboratory Evaluation Checklists. These specifications are available online at http://www.dshs.texas.gov/seafood and for review during normal business hours at the Seafood and Aquatic Life Unit, Department of State Health Services, 8407 Wall Street, Austin, Texas 78754.

(b) Each laboratory will be evaluated, at a minimum on the following factors:

(1) credentials and performance of staff;

(2) quality assurance plan;

(3) manuals of procedures;

(4) staff training program;

(5) corrective action for any deficiencies and nonconformities;

(6) performance on proficiency test samples;

(7) equipment;

(8) calibrations and standards;

(9) methodology;

(10) facilities;

(11) sample acceptance policies;

(12) sample tracking;

(13) record keeping;

(14) reporting; and

(15) interpretation of results.

(c) A laboratory must meet all minimum standards and pass an inspection at a minimum of every three years to maintain conforming status.

(d) Laboratory status is determined by the number and types of nonconformities found in the evaluation using the specifications in §218.23 of this title (relating to National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish), and the standardized criteria contained in the U.S. Food and Drug Administration Shellfish Laboratory Evaluation Checklists.

§218.25.Inspections.

The department may conduct onsite inspections of laboratories to ascertain adherence to minimum standards as specified in §218.23 of this title (relating to National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish) and the U.S. Food and Drug Administration Shellfish Laboratory Evaluation Checklists. Inspections will be conducted on at least a three-year basis.

§218.26.Withdrawal of Conforming Status.

(a) A laboratory found to be in conforming status, with noted nonconformities, has up to 90 days to successfully correct all nonconformities noted in the evaluation. After this period, the laboratory's status will be downgraded to nonconforming if any key nonconformities remain to be successfully corrected. As a result, data being generated by the laboratory will no longer be acceptable for use in support of the National Shellfish Sanitation Program.

(b) A laboratory found to be in provisionally conforming status has up to 60 days to successfully correct all nonconformities noted in the evaluation. After this period, the laboratory's status will be assigned to one of the following.

(1) Conforming status if all critical and key nonconformities have been successfully corrected.

(2) Nonconforming status if any critical or key nonconformities remain to be successfully corrected. As a result, data generated by the laboratory will no longer be acceptable for use in support of the National Shellfish Sanitation Program.

(c) A laboratory found to be in nonconforming status has up to 30 days to demonstrate successful correction of all nonconformities found. After this period, the laboratory's status will be assigned to one of the following.

(1) Conforming status if all critical and key nonconformities have been successfully corrected.

(2) Nonconforming status if any critical or key nonconformities remain to be successfully corrected. As a result, data generated by the laboratory will no longer be acceptable for use in support of the National Shellfish Sanitation Program.

(d) If a laboratory is found to be in nonconforming status for failure to successfully implement the required corrective action, or for having repeated critical or key nonconformities in consecutive evaluations, then the department will ensure that an action plan is developed to correct the situation in an acceptable and expeditious manner or discontinue use of the laboratory to support the National Shellfish Sanitation Program.

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 July 20, 2020.

TRD-202002957

Barbara L. Klein

General Counsel

Department of State Health Services

Earliest possible date of adoption: August 30, 2020

For further information, please call: (512) 834-6758