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Why food safety is important

To Put Things in PerspectiveAccording to the CDC, microbial pathogens in food cause an estimated 48 million cases of human illness annually in the United States125,000 hospitalizedCause up to 3,000 deaths

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It is a Global Food Economy

Strict Product LiabilityNegligenceAre you a product seller?Did you act reasonably?Strict LiabilityAre you a manufacturer?Was the product unsafe?Did product cause injury?Punitive Damages/Criminal LiabilityDid you act with conscious disregard of a known safety risk?

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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 also Washburn v. Beatt Equipment Co., 120 Wn.2d 246 (1992)

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The only defense is preventionIt does not matter if you took all reasonable precautionsIf you manufacture a product that makes someone sick you are going to payWishful thinking does not helpIts called STRICT Liability for a Reason

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Ill person

Specimen collection

Pathway of a Foodborne Illness Investigation

Health Care Provider

Organism identified

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Ill person

Organism identified

Specimen collection

Pathway of a Foodborne Illness Investigation

Health Care Provider

Epidemiologic investigation

Public Health Laboratory

If there are more ill persons than expected, an OUTBREAK might be underway.

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Ill person

Organism identified

Specimen collection

Pathway of a Foodborne Illness Investigation

Health Care Provider

Epidemiologic investigation

Public Health Laboratory

Environmental investigation

Product Trace Back

Product Recall

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Litigation as Incentive 20 Years Later

Odwalla

Jack in the Box

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How Are Things are Different Today?

Now a 76 Count Federal IndictmentStewart Parnell, the former owner of Peanut Corp. of AmericaMichael Parnell, who is Stewart Parnells brother and a former supervisorSamuel Lightsey, a onetime plant operatorMary Wilkerson, a former quality-assurance managerDaniel Kilgore, plant managerAllegations Include:Mail FraudWire FraudIntroduction of Adulterated and Misbranded Food into Interstate Commerce with Intent to Defraud or MisleadConspiracy

And, It Does Not Always Require IntentA misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even of knowing or willful conduct. Rather, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation.Convictions under the misdemeanor provisions are punishable by not more than one year or fined not more than $250,000 or both.

Chipotle?

Seattle E. coli O157:H7, July 2015 (unreported), five sick people;Simi Valley, Calif. Norovirus, August 2015, 234 people;Minnesota Salmonella Newport, August and September 2015, 64 sick people, source was tomatoes;Nine states E. coli O26, began October 2015 and declared over Feb. 1, 55 sick people, states involved are California, Delaware, Illinois, Kentucky, Maryland, Minnesota, New York, Ohio, Oregon, Pennsylvania and Washington;Boston Norovirus, December 2015, 151 sick people;Three states E. coli O26, began December 2015 declared over Feb. 1, five sick people, states involved are Kansas, Oklahoma and Nebraska.

I.M. Healthy and Dixie Dew E. coli 483

investigators observed grossly insanitary conditions that cause your firms soy nut butter products to be adulterated;food contact surfaces, floors, walls, and ceilings in the soy nut butter processing and packaging rooms were heavily coated with soy nut butter build-up from previous production runs.firm does not routinely wash and sanitize smaller pipes, pipe fittings, gaskets, seals, or the rubber _____ plug when broken down following a production run;firm does not conduct a kill step for SoyNut Butter product remaining in your firms mixing kettle leftover from a production run;plant manager and maintenance supervisor reported your _____ machine, used for fine mixing of the SoyNut Butter and ________, routinely shuts off during processing. Your Plant Manager stated this occurs one to two times per day and, this problem has persisted for approximately 15 years despite repeated maintenance intended to correct the problem;firm monitors the SoyNut ______ with a ______ thermometer, but plant manager stated he has never verified the accuracy of this instrument;you and your plant manager report, your temperature probe and chart recorder, initially engineered to verify and record _____ of product in the large mixing kettle, is not functioning properly and has not been used for well over a year.FDA inspectors also noted problems with Dixie Dews food safety testing program, noting the companys failure to perform microbial testing where necessary to identify possible food contamination. Inspectors found the testing materials on hand at Dixie Dew had expired in July 2016 and October 2015.Problems in the Dixie Dew quality control lab were described in detail by FDA inspectors.An apparent fly infestation in your firms Quality Control and Product Development Laboratory was observed on 3/13/2017. Small apparent flies and fly larvae, too numerous to count, were inside an unplugged chest freezer, according to the 483 report.

Planning AGAINST Litigation What Is Really ImportantIdentify HazardsHACCPDo you have qualified and committed people?What is the Culture?Involve Vendors and SuppliersDo they really have a plan?Ever visit them?

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Planning AGAINST Litigation Establish RelationshipsThey are your best friends!

Questions?

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