1. Sampling Agreements & Surveillance Maria Ishida, PhD Bureau Chief March 10, 2014 1:45 pm Matt Colson Environmental Administrator Richard Stephens Environmental Scientist III Florida Department of Agriculture and Consumer Services

2. Department Overview and Jurisdiction The Florida Department of Agriculture and Consumer Services (FDACS) is one of several food regulatory authorities in the state Over 46,000 permitted food establishments ranging from mobile vendors to major food processors and distribution centers

3. Department Overview and Jurisdiction Bureau of Food and Meat Inspection Responsible for inspecting retail and manufactured food establishments ~ 5,000 manufactured food establishments Majority are storage and distribution, but also a large variety of processors

4. Map of Districts

5. Map of Manufactured Food Firms

6. Department Overview and Jurisdiction 110 field inspectors All inspectors conduct retail and manufactured food inspections – Only inspectors with appropriate training conduct processing and specialized inspections All inspectors collect samples

7. State Food Contract Overview Conduct contract inspections under State authority FDA food contract breakdown – 360 Food Safety/ GMP inspections – 130 seafood HACCP inspections – 200 environmental samples – 34 state contract audits per year

8. Department MFRPS Background One of original 9 RRT states, enrolled in the MFRPS in 2008 First PAVA conducted in May 2010 FDA contract MFRPS option 2011 MFRPS cooperative agreement 2013 Most recent audit in January 2014

9. Food Laboratories Overview Bureau of Food Laboratories is part of Division of Food Safety – Laboratories are onsite ISO/IEC 17025:2005* Receive ~ 10,000 samples per year *The Bureau of Food Laboratories maintains A2LA accreditation to ISO/IEC 17025 for the specific tests listed in A2LA certificates 2534.01 and 2534.02

10. Sampling Program - Overview Regular meetings between lab and inspection staff to develop surveillance sampling plan Samples are collected for many reasons: – Surveillance – Follow-up due to prior adulterated/ misbranded – Inspection indicate need for collection – Consumer complaints – FBI investigation – Environmental samples for food contract – Other

11. Sampling Program - Overview All samples input into our food inspection database (FIMS) FIMS communicates with laboratory management system (FSLIMS) Laboratory receives sample and pulls sample information from FIMS to FSLIMS Laboratory runs analyses Results input into FIMS/ FSLIMS

12. FIMS Sample Collection Screen

13. FIMS Sample Collection Laboratories notifies inspections staff of priority sample results Violative sample results appear as alert on FIMS dashboard Laboratory liaison coordinates compliance actions

14. FIMS Sample Collection

15. Sample Collection Report

16. Sample Statistics (FY 2011 - 2012) Total number of samples collected: 10,270 – 6,512 regulatory samples – 2,470 USDA MDP – 1,288 Others Number of analysis performed: 41,370 Adulterated/Misbranded: 496 – Compliance Rate: 92.38%

17. Types of Samples Routine/Survey Finished Product Environmental Swabs Electronic (pictures) Foodborne Illness

18. Survey Samples Plan developed in conjunction with laboratory and inspections – Quarterly meeting to discuss needs, capabilities, projects, etc – Agree on samples types, and amounts, and create draft plan – Final review and dissemination to district supervisors

19. Quarterly Sampling Plan

20. Environmental Samples FDA Contract – 200 samples total per year Split as 100 samples X 2 events Generally conduct at a firm tied to an adulterated product Requires prior coordination with laboratory Performed by RRT members under ICS

21. Environmental Sampling Sampling Team – 6 members, each with a unique roll lead swabber, assistant swabber, scribe, photographer, data entry, runner ICS Structure – Each team member is assigned an ICS position Primary Positions: Incident Commander, Logistics Chief, Planning Chief Pre-event meeting and AAR

22. Food Borne Illness Investigations Multiple agencies involved Coordination with state Department of Health for epidemiological services – Statutory authority – MOU to meet requirements of Standard 5 Sample collection is coordinated between other agencies, laboratory, and inspections

23. Example – L. mono in Sandwiches Product Samples Routine sample collection Analysis Adulterated with L. mono Regulatory Action STOP SALE and recall Environmental Samples Surface swabs per FDA contract Analysis PFGE match with product isolate Regulatory Action Stop Use, Stop Sale, Test & Hold

24. Outlines Bureau of Food Laboratories Location Organization Collaboration & Cooperative Agreements Laboratory Capacity Analytical Methods Reporting How ISO CAP Sampling Agreement will Affect Us

25. Tallahassee www.city-data.com Location – Conner Complex Bureau of Food and Meat Inspections Bureau of Food Laboratories https://maps.google.com

26. Organization Food Safety Testing Consumer Protection Testing Food Safety Testing Preparedness/Molecular Testing

27. Collaboration & Cooperative Agreements FDA Contract FDA MFRPS CAP (Standard #10) FDA RRT CAP Cooperative Agreements FSIS FERN CAP (Microbiology) FDA FERN CAP (Microbiology) FDA ISO Accreditation*

28. Laboratory Capacity 44,000 analyses/year

29. Analytical Methods 61 analytical methods (chemistry, microbiology, and molecular testing) Biological Testing (16) *The Bureau of Food Laboratories maintains A2LA accreditation to ISO/IEC 17025 for the specific tests listed in A2LA certificates 2534.01 and 2534.02

30. Chemistry Testing (15) Analytical Methods *The Bureau of Food Laboratories maintains A2LA accreditation to ISO/IEC 17025 for the specific tests listed in A2LA certificates 2534.01 and 2534.02

31. Reporting

32. Reporting

33. How FDA ISO CAP Sampling Agreement Will Affect Us? Sample Type (ISO CAP Sampling Agreement ) Sample Type (Bureau of Food Laboratories) Manufactured Foods Under the Purview of FDASandwich Environmental Samples of Manufactured Food (MF) production/storage and transport facilities. Environmental Swaps (RRT and MFRPS CAP) Routine Manufactured Food Samples Prepared Salad, Sandwich, Canned Food, Dried Fruit or Vegetables, Candies Seafood samplesSmoked fish, Fish Processed ShellfishXXX Bottled Water only (not municipal water)Vended Water and Ice Non-routine Manufactured Food Samples Planned for and Collected During Alleged Illness Investigations and Complaints. YES ??? ProduceFresh Produce, Sprouts and Vegetables

34. How FDA ISO CAP Sampling Agreement Will Affect Us? Analytes (ISO CAP Sampling Agreement ) Analytes (Bureau of Food Laboratories ) Chemical Artificial Colors*, Fat Analysis*, Total Arsenic, Organic Acid, Coumarin, Ethyl Vanillin, Vanillin, Sugars*, Total Protein*, Sulfite*, Total Moisture* PesticidesXXX Biological Bacillus cereus, Escherichia coli (generic*, STEC, EHEC*), Listeria monocytogenes*, Salmonella*, and Staphylococcus aureus*, Vibrio PhysicalForeign Material (Filth) AllergensAllergens/ Label review MetalsHeavy Metals ToxinsAflatoxin*, Staphylococcal Enterotoxin B Contaminants??? Species Substitution/ConfirmationFish Speciation* Confirmation of Product IdentityLabel review, Standard of Identity * Method on ISO 17025 scope

35. Some Questions… What is the minimum of acceptable sample type to be include into the FDA ISO sampling agreement? What is the minimum of acceptable analytes to be include into the FDA ISO sampling agreement? Does the testing need to be under ISO 17025? How report samples from this agreement? What paperwork do we need to capture/retain for this sampling agreement under “Sampling Agreement Addendum”?

36. Acknowledgements

37. Contact Information Matt Colson Environmental Administrator of Bureau of Food and Meat Inspections Florida Department of Agriculture and Consumer Services Matthew.Colson@freshfromflorida.com Richard Stephens Environmental Specialist III of Bureau of Food and Meat Inspections Florida Department of Agriculture and Consumer Services Richard. Stephens@freshfromflorida.com Maria L. Ishida Bureau Chief of Food Laboratories Florida Department of Agriculture and Consumer Services Maria.Ishida@freshfromflorida.com