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Lessons from the Food Safety Front: What if you had used peanut butter in 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

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

Timeline 1/28/09 Recall expands to include all peanut products made in GA firm 2/12/09 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 2/20/09 PCA (TX and GA) informs customers to stop using all products 4/04/09 Last illness reported 5/12/09 Last recall initiated

Impact of PCA Peanut Butter Recall • Public health – US: 9 deaths and 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

Impact of PCA Peanut Butter Recall • Economic impact – US: Estimated >$1 BILLION 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

Why did the recall last for months? Why did the recall last for months?

All Firms Receiving PCA Peanut Ingredients Requested to Voluntarily Recall Product • No validated 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

New Science Yesterday: Growth Today: Survival • Water activity < 0. 9 • p. New Science Yesterday: Growth Today: Survival • Water activity < 0. 9 • p. H < 4. 6 • Heat to approx 140 -150◦F. (pasteurization) • Drying • • • Survives Aw < 0. 3 Survives in acid foods Resistant to heat Resistant to drying Known to survive many months or more 9

Lessons Learned • Firms must adapt to new findings in food science and regulations 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?

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

Lessons Learned • Some firms were not receiving the original Certificate of Analysis (C 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?

Lessons Learned • Some firms were re-testing presumptive positive test results? – Again, how 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?

Lessons Learned • Many ingredient and finished product manufacturers were secondary and tertiary receivers 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?

Lessons Learned • While different lots of product existed, there was no clean break 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 copacker?

Lessons Learned • Our regulatory and inspection strategy needed to change – We now 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

QUESTIONS? QUESTIONS?