Food Production is a Risky Business

3. Food Production is a Risky Business • Competitive Markets • Wall Street and Stockholder Pressures for Increasing Profits • Lack of Clear Reward For Marketing and Practicing Food Safety • Brand Awareness • Risk of Litigation

4. To Put Things in Perspective According to the CDC, microbial pathogens in food cause an estimated 76 million cases of human illness annually in the United States 325,000 hospitalized Cause up to 5,000 deaths

5. Strict Product Liability • Strict Liability • Are you a manufacturer? • Was the product unsafe? • Did product cause injury? • Negligence • Are you a product seller? • Did you act “reasonably”? • Punitive Damages/Criminal Liability • Did you act with conscious disregard of a known safety risk?

6. Who is a Manufacturer? A “manufacturer” is defined as a “product seller who designs, produces, makes, fabricates, constructs, or remanufactures the relevant product or component part of a product before its sale to a user or consumer.” RCW 7.72.010(2); see alsoWashburn v. Beatt Equipment Co., 120 Wn.2d 246 (1992)

7. The only defense is prevention It does not matter if you took all reasonable precautions If you manufacture a product that makes someone sick you are going to pay Wishful thinking does not help It’s called STRICT Liability for a Reason

8. Why Strict Liability? Is it Unfair? It puts pressure on those that most likely could correct the problem in the first place It puts the cost of settlements and verdicts directly on to those that profit from the product

9. Litigation as Incentive Odwalla Jack in the Box

10. Worthless Excuse No. 1 If a document contains damning information, the jury will assume you read it, understood it, and ignored it “I never read the memo.”

15. ConAgra 2002 On June 30, 2002, the USDA Food Safety and Inspection Service announced the recall of 354,200 poundsof ground beef manufactured at the ConAgra Beef Company plant in Greeley, Colorado. The contaminated ground beef was produced at the plant on May 31, thirty days prior to the recall, and was distributed nationally to retailers and institutions. E. coli O157:H7 was found at the Greeley slaughterhouse on May 9, 2002, yet they apparently did nothing with this information. The bacteria were detected several more times at the slaughterhouse over the next month, the last time being June 20, 2002. Over 19 Million Pounds of meat recalled. • More than 40 sickened, 5 HUS and 1 Death. • In November 2002, the ConAgra plant in Greeley closed, due to repeated failures to prevent fecal contamination of carcasses.

16. 2004-2007 Peanut Butter Salmonella Outbreak CDC Figures as of June, 2007 714 culture-positive illnesses from 44 states 71 hospitalized Illnesses reported 2005 to late 2007

17. 2004-2007 Peanut Butter Salmonella Outbreak CDC estimates that over 30 times the number of confirmed cases are never reported. Likely number of cases from peanut butter: 38.6 X 714 = 27,560

18. What ConAgra Should Have Known

19. Establishment Inspection Report February 23, 2005 “Inspection revealed the following concerns:2 areas on production lines where filled containers of peanut butter were not completely covered from overhead contamination, an accumulation of spillage and or dust at wall/floor juncture around air handling cabinet in the ingredients room, and a temporary baffle made of cardboard in use on an empty jar line.”

20. Establishment Inspection Report February 23, 2005 “. . . Inspection found the lot in question had been shipped and management cited corporate policy in refusing to allow review of production and shipping records. The current inspection was conducted in response to several complaints including most recently, number 29134, an anonymous complaint alleging poor sanitation, poor facilities maintenance, and poor quality program management. Specifics in that complaint include an alleged episode of positive findings of Salmonella in peanut butter in October of 2004 that was related to new equipment and that the firm didn’t react to, insects in some equipment, water leaking onto product, & inability to track some product.”

21. Establishment Inspection Report February 23, 2005 These complaints include: 29134 dated 1/13/05, an anonymous complaint reporting several issues at the firm that in summary allege poor sanitation practices, poor quality program management and poor facilities maintenance.

22. Pot Pies 272 isolates of Salmonella I 4,[5],12:i:- with an indistinguishable genetic fingerprint have been collected from ill persons in 35 states. To date, three of these patients’ pot pies have yielded Salmonella I 4,[5],12:i:- isolates with a genetic fingerprint indistinguishable from the outbreak pattern

23. What ConAgra Should Have Known The documentation that you have provided does not support your decision that vegetative pathogens including salmonella are not reasonably likely to occur when receiving ingredients in each of your processes. Therefore, you have failed to meet the requirements of 9 CFR 417.5(a)(1). There is no processing cooking step to eliminate vegetative pathogens that may be the line blended with the fully cooked meat and gravy. Lethality is addressed through the handling and cooking instructions on the finished product package. Your validation records did not explain why the labels would indicate four minutes on the front of some brands of product and six minutes on the front of the Great Value brand. Your validation documentation did not indicate if you had taken into consideration how the consumer is likely to interpret the cooking instructions or if the consumer will actually prepare the product according to the instructions under normal conditions of use, especially with the statements on the front of the packages which do not reflect the need to let the products stand after heating.

24. What ConAgra Should Have Known Your establishment has not provided documentation to support that some of the temperatures reported in your cooking instruction validation documentation for frozen dinners will provide an adequate lethality. Your establishment has failed to demonstrate that the biological hazard of vegetative pathogens including Salmonella are not reasonably likely to occur and will not affect the safety of the products for human consumption. This precludes FSIS from determining that the food safety hazards are being controlled and that the products are not adulterated.

25. Planning AGAINSTLitigation – What Is Really Important 1. Identify Hazards HACCP Do you have qualified and committed people? What is the Culture? Involve Vendors and Suppliers Do they really have a plan? Ever visit them?

26. Planning AGAINSTLitigation – Establish Relationships They are your best friends!

27. Lessons Learned From An Outbreak You can insure the brand’s and the company’s reputation Arm yourself with good, current information Since you have a choice between doing nothing or being proactive, be proactive Make food safety part of everything you do Treat your customers with respect

28. What Will a Jury Think? A Jury 12 Consumers =

29. Questions?