1. U.S. Food and Drug Administration Office of Regulatory Affairs Office of Partnerships Standards Implementation Staff Guy F. Delius, R.S., CSO ISO-MFRPS Sampling Agreements: “Do you know what your State is sampling and why?” March 11, 2015 – San Diego, California 1

2. Objectives Provide awareness of MFRPS-ISO Provide awareness of MFRPS-ISO grant deliverables regarding developing a sampling agreement Provide awareness of food samples submitted from 2013-current via eLEXNET Provide benefits of MFRPS-ISO sampling agreements Share examples of MFRPS-ISO comments from States. Introduce State Presenters 2

3. MFRPS-ISO MFRPS – Set of voluntary standards to establish and improve strong State food safety systems/programs. ISO – Set of voluntary laboratory standards to establish and improve strong State food laboratory systems/programs Separate cooperative agreements/deliverables/staff for the two sets of standards – but they are tightly intertwined. Both are systems of improvement and integration MFRPS needs ISO and ISO needs MFRPS 3

4. Manufactured Food Regulatory Program Standards

5. MFRPS 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 5

6. 6 Manufactured Food Regulatory Program Standards (MFPRS) 40 programs in 39 States

7. MFRPS-ISO and Sampling MFRPS-ISO and Sampling Agreements propel state food laboratory programs forward by supporting public health missions and response frameworks, harmonizing the direction of an integrated food safety system. 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.

8. Integrated Food Safety Systems and Sampling National movement towards an Integrated Food Safety System (IFSS). More State Food Safety programs are enrolled in Manufactured Food Regulatory Program Standards (MFRPS) and/or Retail Standards. More Food Safety State Laboratory programs are funded to achieve ISO accreditation or are already accredited. Now – through this initiative we have further integrated the food safety programs with the food safety laboratories regarding sampling. 8

9. ISO Sampling Plan Requirement The requirement is written in your ISO Cooperative Agreement: Charges the program to develop and execute a detailed sampling agreement. Requires the plan to be developed in conjunction with the State MFRP supported by the lab and FDA. Recommends agreements should outline minimum # of samples, types of analysis and frequency of testing annually, including sample collection methods. 9

10. 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

11. Coordination Needed Successful programs will exhibit integrated planning and enhanced/routine communications between the Laboratory and Food program regarding sampling. A robust ISO-sampling program is needed to advance the MFRPS. As is a strong MFRPS program is needed to advance ISO and sampling. These agencies together, develop the plan outlining what, when, who, why, where, how much, etc., in a mutually acceptable manner. This is the foundation of their Sampling Agreement

12. Upfront Guidance and Sampling Webinar December 2013 FDA 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. Discussed and provided a Sampling protocol document which outlined the types of Samples that would be appropriate for this initiative Discussed and provided an example of a Sampling Plan Agreement Template Discussed/provided a Sampling Resources document 12

13. 1st Year of Effort September 2014, 33 ISO grant programs and the corresponding MFRPS food programs finalized their sampling agreements. Agreements covered what foods to be collected, when they would be collected, how much to be collected and how they would be collected and how they would be transported to the laboratory and by whom Many meetings – calls took place and great effort was expended to fine tune the MFRPS-ISO sampling agreements. These were developed by the state programs to fit their specific needs under the manufactured food programs and laboratory capabilities/needs. 13

14. MFRPS-ISO Sampling Agreements From September 2014 until now, 33 state food safety and laboratory programs actually instituted their plans (sampling agreements). State Programs took the plans from the paper to reality and began collecting samples. This process was not new for some state programs, but for others, it was a new process. Focus is on quality-not quantity 14

15. MFRPS-ISO Sampling 2013 State agencies submitted 43,684 total food samples for microbiological, chemical and other analysis (9-1-2013 and 8-31-2014) 2014 State Agencies submitted 19,941 total food samples for microbiological, chemical and other analysis (9-1-2014 to 2-24-2015) 15

16. Example of Findings SC DHEC: DHEC’s MFRPS – ISO Sampling Agreement included the planned sampling of frozen dessert products - which are in part, under the authority of DHEC’s regulatory jurisdiction. Testing for Salmonella and Listeria 2 initial positive sample results for Listeria M. Prompt work with corresponding state where the product was manufactured Result: Product recall initiated CDC/FDA PFGE patterning and more work ongoing 16

17. MFRPS-ISO Sampling; Is the juice worth the squeeze? Absolutely! Promoted discussion and dialogue between food safety programs and Laboratory professionals Promoted planning and determined capabilities (food safety program and laboratory) Encouraged staff training/sampling awareness (food safety staff and laboratory staff Tested the system during times of calm Created opportunity for system improvements based on findings and experiences 17

18. MFRPS-ISO State Comments Some State comments: –Lab: “Helped us preplan for samples to be run” saved us from reacting to samples arriving at our door.” –Lab: “Helped us know what samples were coming in - when (generally speaking), and helped us plan for lab staffing/what testing reagents and media to have available. This helped us be more efficient/effective.” –Lab: “This helped us better understand the complexities of collecting the samples, proper transportation and the limitations sometimes of sample amounts.” 18

19. MFRPS-ISO State Comments Additional State comments –Food Safety Program: “This helped us better understand the needs of the laboratory. We have a better appreciation of what all is involved with sample testing and the need to talk upfront, instead of after sample drop off”. –Food Safety Program: “This initiative has helped us test our sample collection systems, and we have updated our process to reflect what we’ve learned.” –Food Safety Program: “We have always collected samples, but we (food safety and laboratory) are collectively stronger now, because of developing this plan, discussing the processes and initiating the protocols.” 19

20. MFRPS-ISO Sampling The MFRPS-ISO Sampling Agreement has been a valuable initiative This initiative has helped us improve our sample collection/packaging/transportation/receiving/records and analysis systems Improvements are evident at State and Federal levels. We hope this initiative has, and will continue to help improve your food safety/laboratory sampling systems 20

21. Contact Information Contact us via: –Office of Partnerships: (301) 796-5390 –OP-ORA@fda.hhs.govOP-ORA@fda.hhs.gov Guy F. Delius CSO FDA ORA OP Email: guy.delius@fda.hhs.govguy.delius@fda.hhs.gov 21