Dealing with Uncertainty – Peanut Butter Case Study Jenny Scott FDA CFSAN Office of Food Safety

The Outbreak 714 reported cases of Salmonella Typhimurium 46 states + 1 Canada case Illnesses for confirmed cases: September 1, March 31, 2009 <1 yr – 98 yr, median 16 yr

CDC, 2009

Detection of the Outbreak November 10, 2008 PulseNet staff notes a cluster of 13 Salmonella Typhimurium isolates –Unusual PFGE pattern – not previously seen –12 states November 25, 2008 CDC’s OutbreakNet team begins epidemiologic assessment –Now 35 isolates December 2, 2008 Assessment of 2 nd cluster of 41 isolates (1 st noticed November 24). Patterns similar, clusters similar epidemiologically, so investigations merged

Case Control Studies January 3-4, 2009 – peanut butter likely source January 17-19, 2009 – peanut butter crackers (2 brands) were associated with illnesses

Between the Two Studies January 7, 2009 – CDC reports 388 people infected with Salmonella Typhimurium in 42 states January 7 - CDC, FDA and MN Dept of Health hold conference call to discuss peanut butter as source of OB Based on preliminary data from a MN Dept of Health investigation of a cluster of cases associated with institutional settings, FDA inspects King Nut, whose brand of institutional peanut butter is associated with the clusters –Determines producer is Peanut Corporation of America (PCA)

Between the Two Studies January 9, 2009 –MN Dept of Ag isolates Salmonella from an opened can of King Nut institutional peanut butter January 9 – FDA begins investigation of PCA, the producer of King Nut peanut butter, in GA January 9 – PCA ceases production and shipment of peanut butter and peanut paste

Between the Two Studies January 10, 2009 –King Nut recalls its PB January 12 – MN Dept of Health confirms the outbreak strain January 12 – FDA begins to post company press releases about recalls on its web site January 13 - PCA recalls 21 specific lots of peanut butter/peanut paste produced on or after July 1, 2008

Between the Two Studies January 14 – Kellogg’s announces hold on 2 brands of PB crackers January 16 – CT Dept of Health, MI Dept Community Health and GA Dept of Agriculture independently find Salmonella in unopened 5-lb containers of King Nut PB –PCA expands recall - all peanut butter produced on or after August 8, 2008 and all paste produced on or after September 26, 2008 –Kellogg’s recalls 2 brands of peanut butter crackers January 17 – CDC & FDA issue advisory regarding PB and PB containing products January 18 – after FDA notifies PCA of state testing results, PCA expands recall to PB and PP produced on or after July 1, 2008

By Mid-Jan, What did we know? Growing multistate outbreak - Salmonella Typhimurium associated with King Nut peanut butter and Austin and Keebler brands of PB crackers PB was produced by PCA in GA

By Mid-Jan, What didn’t we know? Were peanut butter/peanut paste from PCA the only contaminated ingredients? How extensive was the contamination event? –What products should be recalled? What is the scope (timeframe) of the recall? Who received contaminated peanut butter/peanut paste? How were the ingredients used? How many products were affected? Were these causing illnesses? What to tell consumers.

Recalls Continue Based on PCA expanded recalls, more products containing peanut butter and peanut paste were being recalled. January 21, FDA announces recalls now include pet food products containing peanut paste made by PCA.

FDA Inspection – PCA, Blakely, GA Company retested products found positive for Salmonella and shipped the products after receiving a negative. Salmonella was detected by PCA in multiple products, including peanut paste, peanut butter, peanut meal, peanut granules, roasted peanuts, chopped peanuts Equipment line was not cleaned following detection of Salmonella in product Multiple serotypes of Salmonella were detected in environmental swabs by FDA

FDA Inspection – PCA, Blakely, GA Many GMP deficiencies –Roasting process not validated –Evidence of water leaks into production and packaging room –Lack of segregation of raw peanuts from finished peanut products –Ventilation system not designed to prevent cross contamination –Lack of pest controls

The Saga Continues January 28, 2009 – PCA expands recall to all products produced since January 1, 2007 and stops all production January 29 – NC Dept of HHS confirms isolation of Salmonella Typhimurium from a tanker truck at a cracker processing facility (CDC confirms as OB strain Feb 2) January 30 – CO Dept of Health reports 3 cases from consumption of in-store ground PB purchased at different stores of a single chain – Peanuts from PCA

The Saga Continues The Colorado cases expands the investigations, as it leads to implication of PCA’s Texas plant. February 6, 2009 – OR Dept of Health reports laboratory-confirmed case of Salmonella Typhimurium in a dog –OB strain isolated from recalled dog biscuits from dog’s household

PCA, Plainview, Texas Facility February 12, 2009 – TX Dept of State Health Services issues order for PCA, Plainview TX facility to stop production and distribution of all products and to recall all products manufactured since March, February 20 – PCA issues a statement informing customers to cease distribution and use of products from GA and TX plants.

FDA Inspection – PCA, Plainview, TX Many GMP deficiencies –Lack of pest controls –Product residue buildup on equipment food contact surfaces –Roof leaks –Aflatoxin-positive lots used in production Received products from the GA facility

Recalls – 3918 entries 1 Brownie Products Cake and Pie Products Candy Products Cereal Products Cookie Products Cracker Products Donut Products Dressing and Seasoning Products Fruit and Vegetable Products Ice Cream Products Peanut Products Peanut Butter Products Peanut Paste Products Pet Food Products Pre-Packaged Meals Snack Bar Products Snack and Snack Mix Products Topping Products 1 As of October 28, 2009

How do we communicate to consumers in a way that they take recalls seriously? Recall of all PCA ingredients occurred January 28, Illnesses continued through the end of March. PB crackers were recalled January 16, 2009 –Illnesses continued to be reported among people eating recalled brands of PB crackers after the recall.

Other Uncertainty Issues What to tell consumers to do with product? (Stores did not want contaminated product coming back to them.) How do you reach consumers in today’s multi- media society? How do you communicate what products are involved in the recall without implicating products that are not, especially when the situation is evolving?

Other Uncertainty Issues How to address products made with the recalled ingredients – were there adequate kill steps (e.g., peanut butter cookies)? –How could we judge adequacy of processes when manufacturers had no data? Could peanut butter/peanut paste be reconditioned? What was the impact of introducing contaminated powders (e.g., peanut meal) into a facility?

Other Uncertainty Issues How could plants be restored to a “pathogen- free” state when they were not designed for wet cleaning? Could processes such as running hot oil through the system remove contaminated peanut butter/ peanut paste?

Dealing with Uncertainty The one thing that is certain about uncertainty is that there will be plenty of it in events like these, especially when ingredients are the source of the contaminant. Regardless of the uncertainty, decisions have to be made and communicated. We must recognize uncertainty, use all the information we can to minimize it and collect information to reduce it. Communicate, communicate, communicate –What we know –What we don’t know

Thank You