Michelle D. Motsinger MFRPS Specialist Office of Partnerships

1. U.S. Food and Drug AdministrationOffice of Regulatory AffairsManufactured Food Regulatory Program Standards (MFRPS-ISO Sampling Agreements) Michelle D. Motsinger MFRPS Specialist Office of Partnerships

2. Objectives • Provide background on ISO Agreements & MFRPS • Provide an overview of the requirement for sampling agreements • Discuss the importance of these agreements • Detail some of the requirements • Provide resources • Provide an update & next steps

3. ISO/IEC 17025:2005 State Laboratory Accreditation • Purpose: Microbiological and chemical food analyses performed on behalf of State manufactured food regulatory programs conducted within the scope of an ISO/IEC 17025:2005 accredited laboratory • 30 programs participating • Lab programs must: • Submit a self assessment of laboratory accreditation progress/status, and a cost proposal • Provide quality management personnel to ensure accreditation success • Develop an Action Plan • Develop a Proficiency Testing Plan • Obtain training necessary to obtain accreditation • Obtain and maintain accreditation

4. ISO Funding Background • 30 State Labs currently have the funding • Requirement for sampling agreement deliverable was added to the NGAs in 2013 in year 2 of the funding • This new deliverable will be required moving forward

5. Manufactured Food Regulatory Program Standards

6. MFRPS Background • Manufactured Food Regulatory Program Standards • Arose from FDA OIG Audit in 2000 • 10 Standards for Improvement of State Manufactured food programs • 40 State Programs enrolled/participating • FDA supports via staff assistance and funding

7. Program Standards Regulatory Foundation Training Inspection Program Inspection Audit Program Food-related Illness and Outbreaks and Response Compliance and Enforcement Industry and Community Relations Program Resources Program Assessment Laboratory Support Manufactured Food Regulatory Program Standards (MFRPS) • 10 Standards to establish a uniform foundation for the design and management of state programs responsible for regulating food plants • Institute a holistic quality assurance and standardization program • FDA Program-Assessment Validation Audits (PAVAs) will be conducted at 18, 36, and 60 months

8. Manufactured Food Regulatory Program Standards (MFPRS) • 40 programs in 39 States

9. Why sample food? • It is the only way to: • isolate/identify contaminants in food • determine the safety of the food • ensure the food is what the product label declares • Our public health system demands a safe food supply • Food may be sampled due to consumer complaint, reported illness, routine inspection/surveillance

10. Why ISO/MFRPS and Sampling? • Propels State food laboratory programs forward • Enhanced communications amongst state agencies • Integrated planning • Advance MFRPS and ISO Sampling • Standardized food sampling methods • An Integrated Food Safety System needs to include sampling and State laboratories • Is a great tool for those with and without ISO funding

11. Importance of Sampling Agreement • Supports laboratory in obtaining or expanding scope of ISO 17025 accreditation • Supports manufactured food program in achieving conformance with MFRPS • Meets the goals of the RFA • Lab commitment to analyze surveillance and emergency samples • Sharing lab results through eLEXNET • Increase national lab capacity and enhance efforts to protect the food supply

12. How are the ISO Sampling Agreements & MFRPS Connected? • ISO standards (Sampling in particular) relate to several MFRPS Standards - Specifically • Standard 3 – Inspections Program • Standard 4 – Inspection Audit Program • Standard 5 – FBI and Outbreak Response • Standard 8 – State Resources • Standard 10 – Laboratory Support

13. ISO Sampling Plan Requirement • Requirements are written into the ISO Cooperative Agreement • Charges the program to develop & execute a detailed sampling agreement • Requires the plan to be developed in conjunction with the State MFRPS supported by the lab and FDA • Recommends agreements should outline the minimum # of samples, types of analysis and frequency of testing annually, including sample collection methods

14. Getting Started… • Requires proactive dialogue, communication & planning between the food safety program and the laboratory • Requires agencies working together to develop the plan which will outline what, when, who, why where, how much, etc. in a mutually acceptable manner to create the foundation of their sampling agreement

15. Getting Started- Sampling Webinar • December 2013 – provided a MFRPS national webinar on the topic of Sampling Agreements • Attendees were State MFRPS and ISO lab grant enrollees, FDA and related association participants

16. ISO-MFRPS Sampling Protocol Guidance

17. Acceptable Samples • Manufactured Foods under the purview of FDA • Manufactured Foods under the purview of State Inspection, if also under FDA jurisdiction • Environmental Samples • Routine Manufactured Food samples • Seafood samples • Processed Shellfish • Bottled Water only (not municipal water) • Samples collected in FBI Outbreaks and on Complaints • *Produce, if it is washed and processed

18. Unacceptable Samples • Grade A Dairy products (Milk) • Food produced in a retail setting • Environmental Samples from retail settings • Municipal Water • USDA regulated products • Foods intended for animals • Raw shellfish

19. Types of Acceptable Analysis • Include, but not limited to: • Chemical • Pesticides • Biological • Physical (foreign matter)-filth • Allergens • Metals • Toxins • Contaminants • Specie Substitution/confirmation • Confirmation of product identity - example (Honey).

20. Sampling Agreement Example

21. Sampling Resources

22. Updates • April 1, 2014: Sampling Agreements due • All 30 were submitted • Review • Feedback • Commonalities

23. Next Steps • Laboratory and Manufactured food programs to finalize their Implementation Strategy by Sept. 1, 2014 • Agreements cover 1 year and are reviewed & revised in the following year • Practice should be sustained when funding is no longer available • Future funding

24. Additional Resources • Office of Regulatory Science assistance Ruiquing Pamboukian, FDA ORS Ruiquing.pamboukian@fda.hhs.gov 301-796-8157 • FoodSHIELD, MFRPS Workgroup Contact your State’s SIS representative • AFDO Portal

25. AFDO Portal • Interested in becoming accredited? http://www.aphl.org/aphlprograms/food/laboratory-accrediation/pages/default.aspx • Contact: Dare Akingbade, APHL for access to the Discussion Board dare.akingbade@aphl.org

26. Question and Answers I nailed that presentation!!!

27. Contacts Cooperative Agreement Funding Erin Woodom-Coleman, Contracts Project Officer Erin.Woodom-Coleman@fda.hhs.gov 240-205-1606 Food Program SIS Representative Guy Delius Angela Kohls Tressa Madden Michelle Motsinger Priscilla Neves Laboratory Sampling Plan Office of Regulatory Science CFSAN-ORS@fda.hhs.gov

28. SIS Contacts Guy Delius- Green Guy.Delius@fda.hhs.gov Angela Kohls- Tan Angela.Kohls@fda.hhs.gov Tressa Madden- Pink Tressa.Madden@fda.hhs.gov Michelle Motsinger- Purple Michelle.Motsinger@fda.hhs.gov Priscilla Neves- Blue Priscilla.Neves@fda.hhs.gov