1. Lessons from the Food Safety Front: What if you had used peanut butter in your products? Wendy Campbell, Food Defense Coordinator Food & Drug Protection Division

2. Timeline Earliest onset of illness, according to CDC 9/08/08 CDC monitors illnesses in 12 states 11/10/08 MN identifies Salmonella in King Nut peanut butter 1 st recall by PCA initiated 1/10/09 FDA finds 12 instances of PCA shipping contaminated product 1/13/09 PCA expands recall to include all peanut paste 1/18/091/16/09 PCA expands peanut butter recall

3. Timeline 1/28/09 Recall expands to include all peanut products made in GA firm 2/12/09 PCA in TX initiates recall of peanut products PCA (TX and GA) informs customers to stop using all products 2/20/094/04/09 Last illness reported 5/12/09 Last recall initiated

4. Impact of PCA Peanut Butter Recall Public health –US: 9 deaths and 714 illnesses –NC: 1 death and 6 illnesses Consumer confidence eroded –US: Over 3,000 food products recalled –NC: 3 food and 2 animal feed manufacturers directly impacted

5. Impact of PCA Peanut Butter Recall Economic impact –US: Estimated >$1 BILLION impact –US: 20% decline in peanut butter consumption in January –NC: 23% decline in peanuts planted –NC: Substantial number of employees laid-off

6. Why did the recall last for months?

8. All Firms Receiving PCA Peanut Ingredients Requested to Voluntarily Recall Product No validated processes to achieve 5-log kill for Salmonella One firm chose not to recall product –FDA issued Consumer Advisory –Other potential enforcement tools: Embargo Injunction

9. New Science Yesterday: Growth Water activity < 0.9 pH < 4.6 Heat to approx 140- 150 ◦ F. (pasteurization) Drying Today: Survival Survives Aw < 0.3 Survives in acid foods Resistant to heat Resistant to drying Known to survive many months or more 9

10. Lessons Learned Firms must adapt to new findings in food science and regulations –How often are your processes evaluated? –How do you keep aware of new findings? –How do you keep aware of new regulations?

11. Lessons Learned PCA was receiving laboratory results after shipping product –What are your testing and reporting requirements for your suppliers?

12. Lessons Learned Some firms were not receiving the original Certificate of Analysis (C of A) –Do you require your supplier to share results on the original C of A? –How is the sampling and testing conducted? Is the sample representative of the lot? Is the laboratory accredited? What is the testing procedure being used?

13. Lessons Learned Some firms were re-testing presumptive positive test results? –Again, how do you require your ingredient suppliers to report laboratory results? –Do you conduct testing of any of your ingredients or finished product?

14. Lessons Learned Many ingredient and finished product manufacturers were secondary and tertiary receivers of PCA products –Do you know where your ingredients originated from? –How quickly do you find out?

15. Lessons Learned While different lots of product existed, there was no clean break –How do you ensure there is a clean break between different lots and products? –What requirements do you have of your co- packer?

16. Lessons Learned Our regulatory and inspection strategy needed to change –We now conduct environmental and finished product sampling in firms producing low moisture foods –We now understand the transportation and processing of peanut paste better –Extremely difficult to decontaminate a facility

17. QUESTIONS?