Food Production is a Risky Food Production is a Risky BusinessBusiness

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

To Put Things in PerspectiveTo Put Things in Perspective

According to the CDC, microbial pathogens in food According to the CDC, microbial pathogens in food cause an estimated 40 million cases of human cause an estimated 40 million cases of human illness annually in the United Statesillness annually in the United States

125,000 hospitalized125,000 hospitalized Cause up to 3,000 deathsCause up to 3,000 deaths

Strict Product LiabilityStrict Product Liability

NegligenceNegligence• Are you a product seller?Are you a product seller?• Did you act Did you act ““reasonablyreasonably””??

Strict LiabilityStrict Liability• Are you a manufacturer?Are you a manufacturer?• Was the product unsafe?Was the product unsafe?• Did product cause injury?Did product cause injury?

Punitive Damages/Criminal LiabilityPunitive Damages/Criminal Liability• Did you act with conscious disregard of a Did you act with conscious disregard of a

known safety risk?known safety risk?

Who is a Manufacturer?Who is a Manufacturer?

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

The only defense is The only defense is preventionprevention

It does not matter if It does not matter if you took all you took all reasonable reasonable precautionsprecautions

If you manufacture a If you manufacture a product that makes product that makes someone sick you are someone sick you are going to paygoing to pay

Wishful thinking does Wishful thinking does not helpnot help

ItIt’’s called s called STRICTSTRICT Liability for a Liability for a ReasonReason

Litigation as IncentiveLitigation as Incentive

Jack in the BoxJack in the Box OdwallaOdwalla

Worthless Excuse No. 1Worthless Excuse No. 1

If a document If a document contains damning contains damning information, the information, the jury will assume jury will assume you read it, you read it, understood it, and understood it, and ignored itignored it

““I never read the I never read the memo.memo.””

An Example - ConAgra 2002An Example - ConAgra 2002

On June 30, 2002, the USDA Food Safety On June 30, 2002, the USDA Food Safety and Inspection Service announced the and Inspection Service announced the recall of 354,200 poundsrecall of 354,200 poundsof ground beef manufactured at the of ground beef manufactured at the ConAgra Beef Company plant in Greeley, ConAgra Beef Company plant in Greeley, Colorado. Colorado.

The contaminated ground beef was The contaminated ground beef was produced at the plant on May 31, thirty produced at the plant on May 31, thirty days prior to the recall, and was days prior to the recall, and was distributed nationally to retailers and distributed nationally to retailers and institutions.institutions.

E. coli E. coli O157:H7 was found at the Greeley O157:H7 was found at the Greeley slaughterhouse on May 9, 2002, yet they slaughterhouse on May 9, 2002, yet they apparently did nothing with this apparently did nothing with this information. The bacteria were detected information. The bacteria were detected several more times at the slaughterhouse several more times at the slaughterhouse over the next month, the last time being over the next month, the last time being June 20, 2002. June 20, 2002.

Over 19 Million Pounds of meat recalled.Over 19 Million Pounds of meat recalled.

More than 40 sickened, More than 40 sickened,

5 HUS and 1 Death.5 HUS and 1 Death. In November 2002, the In November 2002, the

ConAgra plant in ConAgra plant in Greeley closed, due to Greeley closed, due to repeated failures to repeated failures to prevent fecal prevent fecal contamination of contamination of carcasses. carcasses.

2004-2007 Peanut Butter 2004-2007 Peanut Butter SalmonellaSalmonella OutbreakOutbreak

CDC Figures as CDC Figures as of June, 2007of June, 2007

• 714 culture-714 culture-positive positive illnesses from illnesses from 44 states44 states

• 71 hospitalized71 hospitalized

• Illnesses Illnesses reported reported 2005 to late 2005 to late 20072007

2004-2007 Peanut Butter 2004-2007 Peanut Butter SalmonellaSalmonella OutbreakOutbreak

CDC estimates that over CDC estimates that over 30 times the number of 30 times the number of confirmed cases are confirmed cases are never reported. Likely never reported. Likely number of cases from number of cases from peanut butter:peanut butter:

38.6 X 714 = 27,56038.6 X 714 = 27,560

What ConAgra Should Have What ConAgra Should Have KnownKnown

Establishment Inspection Report Establishment Inspection Report February 23, 2005February 23, 2005

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

““. . . Inspection found the lot in question had been shipped . . . Inspection found the lot in question had been shipped and management cited corporate policy in refusing to and management cited corporate policy in refusing to allow review of production and shipping records.allow review of production and shipping records.

The current inspection was conducted in response to The current inspection was conducted in response to several complaints including most recently, number several complaints including most recently, number 29134, an anonymous complaint alleging poor sanitation, 29134, an anonymous complaint alleging poor sanitation, poor facilities maintenance, and poor quality program poor facilities maintenance, and poor quality program management. Specifics in that complaint include an management. Specifics in that complaint include an alleged episode of positive findings of Salmonella in alleged episode of positive findings of Salmonella in peanut butter in October of 2004 that was related to new peanut butter in October of 2004 that was related to new equipment and that the firm didnequipment and that the firm didn’’t react to, insects in t react to, insects in some equipment, water leaking onto product, & inability some equipment, water leaking onto product, & inability to track some product.to track some product.””

Establishment Inspection Report Establishment Inspection Report February 23, 2005February 23, 2005

These complaints include:These complaints include:

29134 dated 1/13/05, an anonymous complaint 29134 dated 1/13/05, an anonymous complaint reporting several issues at the firm that in reporting several issues at the firm that in summary allege poor sanitation practices, poor summary allege poor sanitation practices, poor quality program management and poor facilities quality program management and poor facilities maintenance.maintenance.

Establishment Inspection Report Establishment Inspection Report February 23, 2005February 23, 2005

Pot Pies - 2008Pot Pies - 2008

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

What ConAgra Should Have KnownWhat 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.

What ConAgra Should Have KnownWhat 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.

Planning Planning AGAINSTAGAINST Litigation – Litigation – What Is Really ImportantWhat Is Really Important

1. 1. Identify HazardsIdentify Hazards• HACCPHACCP• Do you have Do you have

qualified and qualified and committed people?committed people?

2.2. What is the Culture?What is the Culture?

3.3. Involve Vendors Involve Vendors and Suppliersand Suppliers

• Do they really Do they really have a plan?have a plan?

• Ever visit them?Ever visit them?

Planning Planning AGAINSTAGAINST Litigation – Litigation – Establish RelationshipsEstablish Relationships

They are your best They are your best friends!friends!

Lessons Learned From An Lessons Learned From An OutbreakOutbreak

You You cancan insure the brand insure the brand’’s and the companys and the company’’s s reputationreputation

1.1. Arm yourself with good, current informationArm yourself with good, current information

2.2. Since you have a choice between doing nothing Since you have a choice between doing nothing or being proactive, be proactiveor being proactive, be proactive

3.3. Make food safety part of everything you doMake food safety part of everything you do

4.4. Treat your customers with respectTreat your customers with respect

Questions?Questions?