MFRPS 10 Laboratory Support: Relationship to the Sampling Agreement Requirement

1. MFRPS 10 Laboratory Support: Relationship to the Sampling Agreement Requirement Steven M. Sobek Director - Bureau of Laboratory Services State of Wisconsin Department of Agriculture, Trade and Consumer Protection 03/10/2014 1:30 pm

2. Standard 10-Laboratory Support Key Elements • d. The State program utilizes laboratories that have a current A2LA accreditation • e. Or, the State program utilizes laboratories that have quality assurance programs that incorporate management and technical requirements found in ISO/IEC 17025:2005

3. A2LA Accreditation • American Association of Laboratory Accreditation (A2LA) • Intent- Accreditation to a recognized standard by a recognized accrediting body • A2LA accredits food testing laboratories to international standards – ISO 17025

4. ISO/IEC 17025:2005 • Standards which prescribe the processes a lab must have in place • Standards which prescribe how the laboratory must document its practices and procedures • Standards which prescribe the activities needed to assure the laboratory processes function as described

5. ISO/IEC 17025:2005

6. ISO/IEC 17025:2005

7. Standard 10 • Or – Have quality assurance programs that incorporate the requirements found in ISO\IEC 17025:2005 • Can be compliant without accreditation.

8. Food Safety Modernization Act (FSMA) • Sec. 202 – Laboratory Accreditation for Analyses of Foods “food testing shall be conducted by Federal laboratories or non-Federal laboratories that have been accredited for the appropriate sampling or analytical testing methodology or methodologies by a recognized accreditation body”

9. Food Safety Modernization Act (FSMA)Sec 202 • Also has a goal of increasing the number of accredited laboratories • Also requires progress toward implementing a national food emergency response network…which can provide ongoing surveillance, rapid detection, surge capacity for food related emergencies

10. Funding Opportunity RFA-FD-12-008 Also known as ISO 17025 Grants • Food analyses performed on behalf of State manufactured food regulatory programs be conducted by ISO/IEC 17025:2005 accredited laboratories • Advancement towards a national integrated food safety system • Increase laboratory analyses from accredited labs, adding to FDA capacity • Lab data will be available to FDA • Also assist State manufactured food regulatory programs achieve conformance with MFRPS.

11. Funding Opportunity RFA-FD-12-008 Also known as ISO 17025 Grants • Accreditation objective links MFRPS to FSMA • Year One - 31 labs receive grants, 8 of the labs hold ISO 17025 Accreditation • Year Two – additional objective embedded in the grant renewal document “The laboratory must develop and execute a detailed Sampling Agreement, which will fulfill the commitment to analyze surveillance samples.”

12. Funding Opportunity RFA-FD-12-008 Also known as ISO 17025 Grants

13. FDA-MFRPS and Sampling Plans • “Successful programs will exhibit integrated planning and enhanced/routine communications between the Laboratory and Food program regarding sampling.” • “Sampling Agreements requires and enhances communications among state (Food and Laboratory) agencies for improved State and Federal routine and emergency food safety response and actions.”

14. FDA Goals – 2013 Sampling Agreement • “The Sampling Agreement must be developed in conjunction with the State manufactured food regulatory program supported by the laboratory and FDA.” • The sampling agreement must be risk-based and support the food safety priorities of FDA. • “Must support the food safety priorities of FDA, State manufactured foods program, and laboratory.”

15. Systems Approach • “Institute a holistic quality assurance and standardization program.”

16. The Good • The ISO accreditation standards are rigorous, yet achievable. FDA support to labs through the grant process is good. • Objective of enhancing communication between the inspection side of the system with the laboratory side of the system is good. • The concept of a sampling plan promotes risk based sampling and testing.

17. The Disconnect • Labs don’t drive the discussion about what the inspection side inspects and samples. It is driven by risk assessment, which is in the domain of the inspection side of the house. • Laboratory side of the house is about support providing capability, capacity, and confidence

18. MFRPS and Sampling Plans • MFRPS- Standard 10 does not mention sampling plans, nor found in Standards 1-9 • FDA auditors doing state program audits of MFRPS standards are not auditing for the presence of a sampling plan • Sampling plan is an artifact of ISO accreditation grants, not an artifact of MFRPS standards.

19. Food for Thought • The labs will get accredited, and the ISO grants will end. • If the idea of a sampling plan is to be sustainable, the MFRP standards should include the concept. • A sampling plan is neither wholly a lab function, nor wholly an inspection function • A communication component and a documentation component should be reflected in the standards.

20. Holistic is a Good Word • The totality of something is much greater than the sum of its component parts and they cannot be understood by the isolated examination of their parts • A well conceived sampling plan requires the separate parts to be treated as one within the surveillance system.

21. Plans can be agreements that cover more than just sampling

22. Plans can be agreements that cover more than just sampling

23. Plans can be agreements that cover more than just sampling

24. Agreement

25. QUESTIONS?

26. Contact Information Steven M. Sobek Director - Bureau of Laboratory Services State of Wisconsin Department of Agriculture, Trade and Consumer Protection steve.sobek@wisconsin.gov