Speech before the California Environmental Health Association

1. Current Issues in Foodborne
Illness Outbreaks and
Investigations
William D. Marler

2. Food Production is a Risky Business
• Competitive Markets
• Stockholder Pressures
for Increasing Profits
over Long-term Safety
• Lack of Clear Reward
For Marketing and
Practicing Food Safety
• Brand Awareness Risks

3. It is a Global Food Economy

4. To Put Things in Perspective
• Microbial pathogens
in food cause an
estimated 48 million
cases of human
illness annually in
the United States
• 125,000 hospitalized
• Cause up to 3,000
deaths

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

7. 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)

8. • 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

9. “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.”

10. Pathway of a Foodborne Illness
Investigation

11. Pathway of a Foodborne Illness
Investigation
If there are more ill persons
than expected, an
OUTBREAK might be
underway.

12. Pathway of a Foodborne Illness
Investigation

13. Investigative Partners
• Laboratory investigators
– Microbiologic diagnosis
– Virology/Parasitic Labs
– Molecular analysis
• Epidemiologic investigators
– Individual case interviews
– Outbreak investigation
• Cohort studies
• Case/control studies
• Environmental investigators
– Facility investigation
– Environmental sampling
– Product traceback

14. Epidemiology–Basic Tools of the Trade
• Symptoms
• Incubation
• Duration
• Food History
• Medical Attention
• Suspected source
• Others Ill
Real-time interviewing with a broad-based
exposure questionnaire

15. Pulsed Field Gel Electrophoresis (PFGE)
• Process separates
chromosomal fragments of
intact bacterial genomic DNA
grown from patient isolate
• Results in 10 to 20 DNA
fragments which distinguish
bacterial strains
• Genetic relatedness among
strains is based on similarities
of the DNA patterns
• Outbreak strains are those
that are epidemiologically
linked AND genetically linked
A Powerful Outbreak Detection Tool

16. Whole Genomic Sequencing

17. Questions to Consider in Assessing
PFGE Clusters
• How common is the
PFGE 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?

18. An Example of Outbreak Detection
September 27, 2005
• Three E. coli O157:H7 isolates with
indistinguishable PFGE patterns identified by
Minnesota Public Health Laboratory
• PFGE pattern new in Minnesota,
rare in United States
– 0.35% of patterns in National Database
• Patients reported eating prepackaged salad;
no other potential common exposures evident

19. E. coli O157:H7 Cases Associated
with Dole Prepackaged Lettuce
Date of Onset 2005
15 16 17 18 19 20 21 22 23 24 25
NumberofCases
26 27 28 29 30 1 2 3 414
1
2
3
4
5
6
7
September October
Initial cluster of 3 isolates
among MN residents
identified.

20. Outbreak Investigation - Methods
September 28–29, 2005
• Additional O157 isolates received
at the MDOH and subtyped by PFGE
– 7 isolates demonstrated outbreak PFGE
subtype
• Supplemental interview form created
• Case-control study initiated

21. E. coli O157:H7 Cases Associated
with Dole Prepackaged Lettuce
Date of Onset 2005
15 16 17 18 19 20 21 22 23 24 25
NumberofCases
26 27 28 29 30 1 2 3 414
1
2
3
4
5
6
7
September October
Initial cluster of 3 isolates
among MN residents
identified.
Case-control study initiated.

22. E. coli O157:H7 Cases Associated
with Dole Prepackaged Lettuce
Date of Onset 2005
15 16 17 18 19 20 21 22 23 24 25
NumberofCases
26 27 28 29 30 1 2 3 414
1
2
3
4
5
6
7
September October
Initial cluster of 3 isolates
among MN residents
identified.
Case-control study initiated.
Case-control study implicated Dole salad.

23. E. coli O157:H7 Cases Associated
with Dole Prepackaged Lettuce
Date of Onset 2005
15 16 17 18 19 20 21 22 23 24 25
NumberofCases
26 27 28 29 30 1 2 3 414
1
2
3
4
5
6
7
September October
Initial cluster of 3 isolates
among MN residents
identified.
Case-control study initiated.
Case-control study implicated Dole salad.
CDC, FDA notified.

24. E. coli O157:H7 Cases Associated
with Dole Prepackaged Lettuce
Date of Onset 2005
15 16 17 18 19 20 21 22 23 24 25
NumberofCases
26 27 28 29 30 1 2 3 414
1
2
3
4
5
6
7
September October
Initial cluster of 3 isolates
among MN residents
identified.
Case-control study initiated.
Case-control study implicated Dole salad.
CDC, FDA notified.

25. Minnesota
Additional states
Date of Onset 2005
15 16 17 18 19 20 21 22 23 24 25
NumberofCases
26 27 28 29 30 1 2 3 414
1
2
3
4
5
6
7
September October
WI
WI
OR
E. coli O157:H7 Cases Associated with
Dole Prepackaged Lettuce (N=26)

26. Shared common "Best if Used By”
Date and production code
Dole Classic Romaine Salad Recovered
from Case-Households

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

28. PFGE Patterns of E. coli O157:H7
Isolates from Lettuce
Source
Initial Minnesota
Case-patient
Classic Romaine
Bag #2
Classic Romaine
Bag #1

29. Litigation as Incentive – 23 Years Later
Odwalla
Jack in the
Box

30. 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.”

36. Things are Different Today

37. It Started with just a Little Salmonella
• 714 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 <1
to 98 years. The median age of patients
was 16 years which means that half of ill
persons were younger than 16 years.
21% were age <5 years, 17% were >59
years. 48% of patients were female.
Among persons with available
information, 24% reported being
hospitalized.
• Nine deaths: Idaho (1), Minnesota (3),
North Carolina (1), Ohio (2), and Virginia
(2).

38. Then there were Congressional Hearings
• “Turn them loose,” Parnell had told his
plant manager in an internal e-mail
disclosed at the House hearing. The e-
mail referred to products that once were
deemed contaminated but were cleared in
a second test last year.
• Parnell ordered products identified with
salmonella to be shipped and quoting his
complaints that tests discovering the
contaminated food were “costing us huge
$$$$$.”
• Parnell insisted that the outbreak did not
start at his plant, calling that a
misunderstanding by the media and public
health officials. “No salmonella has been
found anywhere else in our products, or in
our plants, or in any unopened containers
of our product.”
• Parnell complained to a worker after they
notified him that salmonella had been
found in more products. “I go thru this
about once a week,” he wrote in a June
2008 e-mail. “I will hold my breath ……….
again.”

39. Now a 76 Count Federal Indictment
• Stewart Parnell, the former
owner of Peanut Corp. of
America
• Michael Parnell, who is
Stewart Parnell’s brother
and a former supervisor
• Samuel Lightsey, a onetime
plant operator
• Mary Wilkerson, a former
quality-assurance manager
• Daniel Kilgore, plant
manager
• Allegations Include:
• Mail Fraud
• Wire Fraud
• Introduction of Adulterated
and Misbranded Food into
Interstate Commerce with
Intent to Defraud or
Mislead
• Conspiracy

40. What the Future Holds - Marler said:
• “These charges will make other food
executives take notice.
• “In 20 years, this is the first time I’ve seen a
criminal indictment of this magnitude,
however, I have also been contacted by
federal law-enforcement officials investigating
a 2010 salmonella outbreak linked to eggs
from Iowa and a 2011 Colorado listeria
outbreak linked to cantaloupes.”
• “These indictments will have a far reaching
impact on the food industry.”
• “Corporate executives and directors of food
safety will need to think hard about the safety
of their product when it enters the stream of
commerce. Felony counts like this one are
rare, but misdemeanor charges that can
include fines and jail time can and should
happen.”
• “If I were an executive of a company, today
I’d be asking my lawyers, how does this not
happen to me?”

41. And, It Does Not Always Require Intent
• A 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.

42. An Auditor’s Duty to Consumers?
Recent Federal Court ruling:
While the degree of certainty of harm to Mr. Beach is not decisively
in favor of imposing a duty in this instance, there is certainly moral blame
that can be attached to Primus Group's conduct due to the alleged large
oversights committed during the July 25, 2011 audit. Additionally, there is
clearly a need to prevent future harm in situations like this, where innocent
consumers eat what they think to be healthy food, which turns out to be
contaminated with a potentially lethal pathogen. Further, imposing such a
duty neither places an inordinately heavy burden on food safety auditors, nor
causes great consequences to the community. In fact, the burden placed on
food safety auditors remains unchanged-had the audit not reflected that the
packing facility was in total compliance with food safety standards when it
allegedly was not, Primus Group presumably would not have been named as
a party in this case, if this case would even have been filed. Finally, although
not briefed on the issue, it certainly stands to reason that there is insurance
available for food safety auditors in conducting food safety audits, just as
there is malpractice insurance for doctors or lawyers.

43. Planning AGAINST Litigation –
What Is Really Important
• 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?

44. Planning AGAINST Litigation –
Establish Relationships
They are your best friends!

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

46. Questions?