1. NTF Annual Conference February 16, 2012 Dr. Regina Tan Director, Applied Epidemiology Division Office of Public Health Science Food Safety and Inspection Service Regina.Tan@fsis.usda.gov

2. Potential Changes in Information Sharing Special-emphasis Salmonella As you can imagine, our members will also be especially interested in Salmonella, but you wouldn’t have to talk policy – Dan E. is speaking the next day so I can make sure those type of questions are directed towards him. If you are available, I’m happy to send over a formal invite. The meeting runs from 1-5pm and we can work around your schedule as to which specific time would be best. This slide contains quotes from the original presentation request. It’s purpose is only to ensure the presentation is written to meet the needs of the audience. The slide will be deleted prior to presentation delivery.

3. Proposed Agenda Bottom Line Up Front Foodborne Illness Investigations – Directive 8080.3 – Anatomy of an investigation – Information-sharing opportunities – Example traceback Consumer Complaints – Directive 5610.1 – Anatomy of a complaint investigation – Information-sharing opportunities

4. Bottom Line Up Front Partners in prevention Shared importance in safety of food Shared importance in consumer trust Always opportunities to improve Welcome conversations to do so

5. ILLNESS INVESTIGATIONS

6. Directive 8080.3 Key Points : Factors determining whether to submit a product sample Collecting, preparing, and shipping product samples Field activities during a foodborne illness investigation (Environmental assessment) Procedures for analyzing data Agency responses to the findings of a foodborne illness investigation Key Points : Factors determining whether to submit a product sample Collecting, preparing, and shipping product samples Field activities during a foodborne illness investigation (Environmental assessment) Procedures for analyzing data Agency responses to the findings of a foodborne illness investigation FSIS Homepage search “8080.3”

7. Anatomy of an Investigation Notification Local/State Territorial DOH CDC or FDA Internal Surveillance Media reports Other parts of FSIS Evaluation Is it FSIS- regulated product? Is there a link to illness? Are methods scientifically valid? Are lab/epi/ environmental findings consistent? * Product Sampling Consider availability and integrity of sample Collect sample Notify affected firm Continuous PFGE review Was the sample intact? Did it suffer temperature abuse? Was it properly stored to avoid cross-contamination? Are the product labels available for product identification? Was the sample intact? Did it suffer temperature abuse? Was it properly stored to avoid cross-contamination? Are the product labels available for product identification? *Initiate Investigation

8. Anatomy of an Investigation OPEER: Traceback & Traceforward In commerce Product sampling Product info Locate/detain product Product tampering OFO: Traceback & Traceforward Under est. control Product sampling Supplier info Same- or like- coded product OPHS: Analysis and Assessment Population- descriptive information Common source Geographic and temporal distribution w.r.t. product distribution Alternative hypotheses Biological plausability Did exposure precede illness? Was illness consistent with known clinical characteristics? Do Traceback/Forward suggest common source? Are findings consistent with Agency experience? Was disease confirmed by laboratory analysis? Did exposure precede illness? Was illness consistent with known clinical characteristics? Do Traceback/Forward suggest common source? Are findings consistent with Agency experience? Was disease confirmed by laboratory analysis? Concurrent activities require constant communication

9. Example Traceback

10. Points of Communication Directive 8080.3 – CDC leads public health coordination – OPHS AED leads internal FSIS coordination – OFO leads coordination with establishment Discussion: Potential opportunities for communication

11. CONSUMER COMPLAINTS

12. Directive 5610.1: Origins March 2001 OIG Investigation Report CCMS established in November 2001 – Provide centralized mean of managing consumer complaints.

13. Directive 5610.1 FSIS Directive 5610.1 – Procedures to Implement the Consumer Complaint Monitoring System

14. CCMS The System The CCMS System: Electronic database – Records Consumer Complaints for documentation – Triages Complaints for evaluation – Tracks and coordinates investigation Purpose: Facilitate detection of potential public health threats in the nation’s food supply and enable rapid response to mitigate such threats.

15. FNS, ODIFP, OPPD and other USDA Program Areas CCMS System CCMS Team FSIS OPHS AED

16. Investigation Information  Consumer Contact Information  Complaint  Type: Foreign object, Allergy, Illness, Other  Description (symptoms, symptom onset time, known allergies, etc)  Food history, medical history, etc.  Product Information  Brand  Establishment number  Lot codes/sell by dates, package size and type  Point of Purchase Information  Name & location  Purchase date

17. Issues Not Entered in CCMS Whistle-blower Industry complaints initiated by a competitor Retail-prepared product Product tampering Criminal violations of the FMIA, PPIA or EPIA National School Lunch Program complaints NOT involving an FSIS product Quality issues involving meat cuts and grades General concerns or comments

18. CCMS Issues Initiated by a consumer or on the consumer’s behalf Directly related to an FSIS-inspected product Imported products re- inspected by FSIS at the port of entry Complaint types: – Illness – Foreign Object – Injury – Allergic Reaction – Improper Labeling – Poor Quality – Economic Adulteration Pictures from the USDA Kitchen Companion

19. BACK-UP SLIDES

20. Multiple Locus VNTR Analysis Protocol http://www.pulsenetinternational.org/SiteCollectionDocuments/mlva/MLVA_overview.pdf

21. Current State of MLVA http://www.aphl.org/conferences/proceedings/Documents/2007_11th_Annual_PulseNet_Upda te_Meeting/MLVA_Protocol%20Update.pdf

22. Limitations of MLVA Use To date, several schemes for MLVA subtyping of S. enteritidis have been published. However, the use of: Different loci in each protocol (or different promers for the same loci) Different sequencer platforms Dye chemistries and size standards used for fragment analysis Differences in interpretation of loci where incomplete TRs or TRs of heterogeneous sequence occur, and Different ways of assigning allele numbers means comparison of data between laboratories can be problematic.