Slide 1

The Future of Food Regulation in Time of Government Deficits and Downsizing

Kenneth G. AndersonWilliam D. Marler

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

3

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?

5

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)

6

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

7

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

9

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.

10

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

11

Investigative PartnersLaboratory investigatorsMicrobiologic diagnosisVirology/Parasitic LabsMolecular analysis

Epidemiologic investigatorsIndividual case interviewsOutbreak investigationCohort studiesCase/control studies

Environmental investigatorsFacility investigationEnvironmental samplingProduct traceback

12

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

13

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 strainsOutbreak strains are those that are epidemiologically linked AND genetically linkedA Powerful Outbreak Detection Tool

14

Genomic Sequencing

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

16

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.

17This 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

18

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

Date of Onset 2005

1516171819202122232425Number of Cases26272829301234141234567

SeptemberOctoberInitial cluster of 3 isolates among MN residents identified.

Case-control study initiated.

19

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

Date of Onset 2005

1516171819202122232425Number of Cases26272829301234141234567

SeptemberOctoberInitial cluster of 3 isolates among MN residents identified.

Case-control study initiated.

Case-control study implicated Dole salad.

20

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

Date of Onset 2005

1516171819202122232425Number of Cases26272829301234141234567

SeptemberOctoberInitial cluster of 3 isolates among MN residents identified.

Case-control study initiated.

Case-control study implicated Dole salad.

CDC, FDA notified.

21

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

Date of Onset 2005

1516171819202122232425Number of Cases26272829301234141234567

SeptemberOctoberInitial cluster of 3 isolates among MN residents identified.

Case-control study initiated.

Case-control study implicated Dole salad.

CDC, FDA notified.

22

MinnesotaAdditional statesDate of Onset 2005

1516171819202122232425Number of Cases26272829301234141234567

SeptemberOctober

WI

WI

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

23

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

24

Product Traceback

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

25

What we all want to Avoid

Litigation as Incentive 22 Years Later

Odwalla

Jack in the Box

28

29

30

31

32

How Are Things are Different Today?

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.

Even Comedians Like Safe Food

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

36

Companies: Planning AGAINST Litigation Establish RelationshipsThey are your best friends!

Companies: Lessons LearnedYou can insure the customer, the brands and the companys reputationArm yourself with good, current informationSince you have a choice between doing nothing or being proactive, be proactiveMake food safety part of everything you, your suppliers and customers do

38

Questions?

3683.2712XXX -