2016 ceha speech

Slide 1

Current Issues in Foodborne Illness Outbreaks and Investigations

William D. Marler

Food Production is a Risky Business

Competitive MarketsStockholder Pressures for Increasing Profits over Long-term SafetyLack of Clear RewardFor Marketing and Practicing Food SafetyBrand Awareness Risks

It is a Global Food Economy

To Put Things in PerspectiveMicrobial 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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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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Gross-Out Claims

I opened a box of Buffalo wings and saw an unusually shaped piece of chicken and I picked it up. When I saw that the piece had a beak, I got sick to my stomach. My lunch and diet coke came up and I managed to christen my carpet, bedding and clothing. I want them to at least pay for cleaning my carpet etc.

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



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



Epidemiologic investigation

Public Health Laboratory

Environmental investigation

Product Trace Back

Product Recall

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Investigative PartnersLaboratory investigatorsMicrobiologic diagnosisVirology/Parasitic LabsMolecular analysis

Epidemiologic investigatorsIndividual case interviewsOutbreak investigationCohort studiesCase/control studies

Environmental investigatorsFacility investigationEnvironmental samplingProduct traceback

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EpidemiologyBasic Tools of the TradeSymptomsIncubationDurationFood HistoryMedical AttentionSuspected sourceOthers IllReal-time interviewing with a broad-based exposure questionnaire

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Pulsed Field Gel Electrophoresis (PFGE)Process separates chromosomal fragments of intact bacterial genomic DNA grown from patient isolateResults in 10 to 20 DNA fragments which distinguish bacterial strainsGenetic relatedness among strains is based on similarities of the DNA patternsOutbreak strains are those that are epidemiologically linked AND genetically linked

A Powerful Outbreak Detection Tool

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Whole Genomic Sequencing

Questions to Consider in Assessing PFGE ClustersHow common is thePFGE subtype?How many cases are there?Over what time frame did cases occur?What is the geographic distribution of cases?What are the case demographics? Do any of the cases have a red flag exposure?

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An Example of Outbreak DetectionSeptember 27, 2005Three E. coli O157:H7 isolates with indistinguishable PFGE patterns identified by Minnesota Public Health LaboratoryPFGE pattern new in Minnesota, rare in United States0.35% of patterns in National DatabasePatients reported eating prepackaged salad; no other potential common exposures evident

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E. coli O157:H7 Cases Associated with Dole Prepackaged Lettuce

Date of Onset 2005

1516171819202122232425Number of Cases26272829301234141234567

SeptemberOctober

Initial cluster of 3 isolates among MN residents identified.

19This epicurve shows the illness onsets for the initial 10 cases, which were included in the case-control study.

The initial PFGE cluster of 3 isolates was first identified on Tuesday, Sept. 27.

Outbreak Investigation - MethodsSeptember 2829, 2005Additional O157 isolates received at the MDOH and subtyped by PFGE 7 isolates demonstrated outbreak PFGE subtype Supplemental interview form createdCase-control study initiated

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Date of Onset 2005

1516171819202122232425Number of Cases26272829301234141234567

SeptemberOctoberInitial cluster of 3 isolates among MN residents identified.

Case-control study initiated.

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Date of Onset 2005

1516171819202122232425Number of Cases26272829301234141234567



Case-control study implicated Dole salad.

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Date of Onset 2005

1516171819202122232425Number of Cases26272829301234141234567




CDC, FDA notified.

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Date of Onset 2005

1516171819202122232425Number of Cases26272829301234141234567




CDC, FDA notified.

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MinnesotaAdditional statesDate of Onset 2005

1516171819202122232425Number of Cases26272829301234141234567

SeptemberOctober

WI

WI

ORE. coli O157:H7 Cases Associated with Dole Prepackaged Lettuce (N=26)

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Shared common "Best if Used By Date and production codeDole Classic Romaine Salad Recovered from Case-Households

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Product Traceback

Single processing plant (Soledad, CA)Production Date of September 7, 2005Lettuce harvested from any 1 of 7 fields

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PFGE Patterns of E. coli O157:H7 Isolates from LettuceSource

Initial Minnesota Case-patientClassic RomaineBag #2Classic RomaineBag #1

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Litigation as Incentive 23 Years Later

Odwalla

Jack in the Box

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

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Things are Different Today

It Started with just a Little Salmonella714 persons infected with the outbreak strain of Salmonella Typhimurium were reported from 46 states.. Additionally, one ill person was reported from Canada.Among the persons with confirmed, reported dates available, illnesses began between September 1, 2008 and March 31, 2009. Patients ranged in age from

Law

2016 ceha speech