1. ISO Sampling Agreement Requirements and National Sampling Plan Guy F. Delius CSO FDA Tim McGrath Acting Deputy Director ORS-FDA March 10, 2014 1:15-1:45 pm

2. Why Sample food? Other than primitive visual and organoleptic methods, Food sampling through sound collection methods and proven laboratory processes is the only way to isolate/identify contaminants in food/determine the safety of the food and 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 inspections, routine surveillance, etc.

3. Why sample food in a standardized and appropriate manner? Standardized proven methods of sample collection and analysis: – Statistically relevant – produce meaningful and accurate results – legally defensible – Necessary for an integrated uniform system for sampling and analysis – Necessary for mutual acceptance of data

4. 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 - there is an opportunity to further integrate the food safety programs with the food safety laboratories regarding sampling.

5. 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.

6. Sampling Plan Development The development of the sampling plan requires proactive dialogue, communication and planning between the food safety program and the food safety laboratory. 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.

7. Timeframes for Development of Plan Laboratory and Manufactured Food Program Sampling Agreement due date: Extended until April 1, 2014. Laboratory and Manufactured food program to finalize the Implementation Strategy by Sept. 1, 2014.

8. Sampling Webinar December 2013 we 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.

9. Sampling Webinar Highlights Discussed a Sampling protocol document which outlined the types of Samples that would be appropriate for this initiative (Provided in your handouts) Discussed an example of a Sampling Plan Agreement Template (Provided in your handouts) Discussed a Sampling Resources document (Provided in your handouts)

10. Future Sampling Assignments Potential tie-ins to: – Integrated Food Safety System – Food Safety Modernization Act – MFRPS – Food Emergency Response Network – etc

11. Future Sampling Assignments Still in development Not a substitute for developing a sampling plan Assignments to be developed in spring/summer ‘14 Sampling/analysis to begin FY’15

12. Future Sampling Assignments Envisioned assignments to be developed in consultation with other FDA Centers Suggested proposals currently include – Large-scale surveillance assignments Large number of samples – Large-Scale Produce Testing Similar to USDA Microbiological Data Program (MDP) Pre-arranged scheduling – National Events Surveillance Testing Political conventions, etc.

13. Large-Scale Surveillance Assignments Food Safety Modernization Act (FSMA) calls for a more risk- informed and preventive approach to FDA activities This effort builds upon risk ranking activity completed by a multidisciplinary group from FDA New initiatives to better understand hazard, identify mitigation strategies, and determine the effectiveness of FDA activities. Improved sampling processes can assist with these initiatives

14. Large-Scale Surveillance Assignments FDA seeks to: – develop a roadmap to utilize data to inform more targeted surveillance sampling – focus on those commodities that align to the highest public health risk – produce an adequate number of samples and data points to inform the agency’s inspectional, policy and research programs

15. Large-Scale Surveillance Assignments Past surveillance sampling efforts may not have consistently yielded statistically-significant data that could be used to: – Proactively fill knowledge gaps related to contamination of high-risk foods – Ensure adequate monitoring – Support regulatory actions; establish policy Large numbers of samples to be analyzed (1200+) Will require utilization of State agencies (labs)

16. Future Sampling Assignments Still under construction Great opportunities to bring together many federal-state initiatives and programs Helps to show value of such programs (and the funding) As the opportunities develop, we will seek input and feedback Stay tuned… Thanks

17. Contact Information Tim McGrath Acting Deputy Director FDA ORA ORS Guy F. Delius CSO FDA ORA OP Email: guy.delius@fda.hhs.govguy.delius@fda.hhs.gov Email: Timothy.McGrath@fda.hhs.govTimothy.McGrath@fda.hhs.gov Email: Ruiqing.Pamboukian@fda.hhs.govRuiqing.Pamboukian@fda.hhs.gov Email: Erin Wooden-Coleman@fda.hhs.govWooden-Coleman@fda.hhs.gov