NCDA&CS Sampling Agreement

1. NCDA&CS Sampling Agreement Jim Melvin Assistant Director of Regulatory Programs Audrey Pilkington Assistant Director of Laboratory Services North Carolina Department of Agriculture & Consumer Services Food & Drug Protection Division March 10, 2014

2. The Sampling Agreement… • must be developed in conjunction with the State manufactured food regulatory program • must outline a minimum number of samples, types of analyses, and frequency of testing that will be performed in support of the manufactured food regulatory program on an annual basis • consideration should also be given to sample collection • must support the laboratory achieving, maintaining or expanding the scope of ISO 17025 accreditation and the goals of the cooperative agreement program • must be risk-based and support the food safety priorities of FDA • manufactured food products regulated by FDA

4. Lab / Customer Relationship • Communication, Communication, Communication • Establish a point of contact • Establish a communication process • Email, conference calls, online meetings, face-to-face meetings

9. Risk-Based Surveillance Sampling Surveillance vs. Inspectional Sampling Surveillance Sampling - Sampling conducted to take a random snapshot of targeted products. Lot size unknown and the number of samples/subsamples is dependent on volume of product needed to perform analysis Inspectional Sampling - Sampling conducted to validate possible violative conditions observed during an inspection or an investigation. Sample size and sampling plan critical to assure the the sample is representative of the lot being sampled.

10. NC Risk-Based Surveillance Sampling

11. NC Risk-Based Surveillance Sampling

12. NC Risk-Based Surveillance Sampling

13. Sample Collection Surveillance Sampling Process Inspector Reference the Target Survey Schedule • Review the Target Survey Sample Schedule for the assigned list of products to be collected. • Some assignments may require specific direction from the Surveillance Program Supervisor. This will be noted on the schedule.

14. Sample Collection Surveillance Sampling Process Collect Samples • Collect the assigned type of sample and the appropriate number of sub-samples. • Use aseptic sampling technique when collecting unpackaged samples that will be submitted for Micro testing. • Unpackaged Retail Raw Ag products, Cilantro, and Packaged Raw Ag products without adequate code information on the package must be collected from an unopened case in the produce cooler so that complete product information can be recorded. Do not collect directly from the retail display case.

15. Sample Collection Surveillance Sampling Process Complete submission information and submit sample • Enter all sample information into the Sample collection database. • Complete the Chain of Custody Record • Pack and transport the sample per the Shipping Refrigerated and Frozen Sample Procedure

16. Sample Collection - Chain of Custody

17. NCDA&CS Sampling Plan Questions?

18. Contact Information Jim Melvin Assistant Director of Regulatory Programs NC Department of Agriculture & Consumer Services jim.melvin@ncagr.gov Audrey Pilkington Assistant Director of Laboratory Services NC Department of Agriculture & Consumer Services audrey.pilkington@ncagr.gov