2016 Michigan State Speech on the Risk of Criminal Prosecutions in Food Production. This will be an overview of cases in the last several years when CEO's and others have been prosecuted for violations of the Federal Food Drug and Cosmetic Act

1. The Risk of Criminal
Sanctions are Real in
the Production of Food
William D. Marler, Esq.

2. 1938 Federal Food, Drug & Cosmetic Act
• Congress passed the Federal Food, Drug, and Cosmetic Act in 1938 in reaction to
growing public safety demands. The primary goal of the Act was to protect the
health and safety of the public by preventing deleterious, adulterated or
misbranded articles from entering interstate commerce. Under section 402(a)(4)
of the Act, a food product is deemed “adulterated” if the food was “prepared,
packed, or held under insanitary conditions whereby it may have become
contaminated with filth, or whereby it may have been rendered injurious to
health.” A food product is also considered “adulterated” if it bears or contains any
poisonous or deleterious substance, which may render it injurious to health. The
1938 Act, and the recently signed Food Safety Modernization Act, stand today as
the primary means by which the federal government enforces food safety
standards.
• Chapter III of the Act addresses prohibited acts, subjecting violators to both civil
and criminal liability. Provisions for criminal sanctions are clear:
Felony violations include adulterating or misbranding a food, drug, or device, and
putting an adulterated or misbranded food, drug, or device into interstate
commerce. Any person who commits a prohibited act violates the FDCA. A person
committing a prohibited act “with the intent to defraud or mislead” is guilty of a
felony punishable by years in jail and millions in fines or both.

3. How Are Things are Different Today?

4. It Started with a Little Salmonella
• In 2009 714 persons infected with the
outbreak strain of Salmonella
Typhimurium were reported from 46
states. 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).

5. 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.”

6. Now – Guilty And Sentenced
• Stewart Parnell, the former
owner of Peanut Corp. of
America – 28 Years
• Michael Parnell, who is
Stewart Parnell’s brother
and a former supervisor -
20 Years
• Samuel Lightsey, a onetime
plant operator – 3 Years
• Mary Wilkerson, a former
quality-assurance manager
– 5 Years
• Daniel Kilgore, plant
manager – 6 Years
• Convictions Included:
• Mail Fraud
• Wire Fraud
• Introduction of Adulterated
and Misbranded Food into
Interstate Commerce with
Intent to Defraud or
Mislead
• Conspiracy

7. 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.

8. First Listeria Outbreak Linked to Cantaloupe
• In 2011, 147 persons infected with any of
the four outbreak-associated strains of
Listeria monocytogenes.
• Alabama (1), Arkansas (1), California (4),
Colorado (40), Idaho (2), Illinois (4),
Indiana (3), Iowa (1), Kansas (11),
Louisiana (2), Maryland (1), Missouri (7),
Montana (1), Nebraska (6), Nevada (1),
New Mexico (15), New York (2), North
Dakota (2), Oklahoma (12), Oregon (1),
Pennsylvania (1), South Dakota (1), Texas
(18), Utah (1), Virginia (1), West Virginia
(1), Wisconsin (2), and Wyoming (4).
• Thirty deaths were reported: Colorado (8),
Indiana (1), Kansas (3), Louisiana (2),
Maryland (1), Missouri (3), Nebraska (1),
New Mexico (5), New York (2), Oklahoma
(1), Texas (2), and Wyoming (1).
• Seven of the illnesses were related to a
pregnancy; three were diagnosed in
newborns and four were diagnosed in
pregnant women.
• Jensen brothers sentences to five years
probation.

9. The DeCosters, Salmonella & Eggs
• Austin “Jack” DeCoster and his son, Peter
DeCoster acknowledge that, in August
2010, while they were in positions of
authority at Quality Egg, they introduced
shell eggs into interstate commerce that
were adulterated because they contained
a poisonous or deleterious substance in
the form of Salmonella that may have
rendered them injurious to health – nearly
2,000 sickened
• In exchange for their guilty pleas, the
DeCosters received three months in jail
each (being appealed) and personal fines
to $100,000.
• Jack DeCoster will also plead guilty to
three counts, including felony bribery of a
USDA inspector, on behalf of Quality Egg,
LLC, which owned the two egg production
facilities responsible for the largest shell
egg recall in U.S. history.
• In the plea agreement, Quality Egg agrees
to pay a fine of about $6.8 million for the
counts of bribery of a public official (a
USDA egg inspector) and introducing
misbranded food into interstate
commerce. The company will pay another
$100,000 fine for introducing adulterated
food into interstate commerce.

10. $11.2 Million Fine in Criminal Misdemeanor
• Federal criminal misdemeanor
charges related to the shipment of
adulterated peanut butter produced
in 2007 in Sylvester, GA, against
ConAgra Foods Inc.
• In 2007 Peter Pan and Great Value
peanut butters produced by ConAgra
at the Sylvester plant were recalled
because they were associated with a
multi-state Salmonella outbreak.
The contaminated peanut butter was
blamed for over 700 foodborne
illnesses in 39 states.
• The immediate investigation focused
on a faulty roof on the Sylvester
plant that may have allowed
moisture to invade the production
process.
• A criminal investigation was
launched in 2011 in a joint venture
between the U.S. Attorney’s Office
for Georgia and DOJ’s Consumer
Protection Branch.

11. What About Townsend Farms?
• 165 people were confirmed to have
become ill from hepatitis A linked to
pomegranate arils contained in ‘Townsend
Farms Organic Antioxidant Blend’ in 10
states: Arizona (24), California (80),
Colorado (29), Hawaii (8), New Hampshire
(1), New Jersey (1), New Mexico (11),
Nevada (6), Utah (3), and Wisconsin (2).
[Note: The cases reported from Wisconsin
resulted from exposure to the product in
California, the cases reported from New
Hampshire reported fruit exposure during
travel to Nevada, and the case reported in
New Jersey was a household contact of a
confirmed case from Colorado.] Eight of
the confirmed cases were household
contacts of confirmed cases (secondary
cases).
• These pomegranate seeds were used by
Townsend Farms to make the Townsend
Farms and Harris Teeter Organic
Antioxidant Blends and by Scenic Fruit
Company to make the Woodstock Frozen
Organic Pomegranate Kernels.

12. What About Bidart Apples?
• On January 10, 2015, the CDC
reports a total of 35 people infected
with the outbreak strains of Listeria
monocytogenes had been reported
from 12 states: Arizona (5),
California (3), Colorado (1),
Minnesota (4), Missouri (5), Nevada
(1), New Mexico (6), North Carolina
(1), Texas (4), Utah (1), Washington
(1), and Wisconsin (3).
• Thirty-one ill people have been
hospitalized, and seven deaths have
been reported. Listeriosis
contributed to at least three of these
deaths.
• Eleven illnesses were pregnancy-
related (occurred in a pregnant
woman or her newborn infant), with
one illness resulting in a fetal loss.
• Three invasive illnesses (meningitis)
were among otherwise healthy
children aged 5–15 years.
• PFGE match between ill people,
apples and Bidart Bros. Plant

13. What About Blue Bell Ice Cream?
• As of April 21, 2015, a total of ten
patients infected with several strains of
Listeria monocytogenes were reported
from four states: Arizona (1), Kansas
(5), Oklahoma (1), and Texas (3).
Illness onset dates ranged from
January 2010 through January 2015.
The patients with illness onsets ranging
from 2010-2014 were identified
through a retrospective review of the
PulseNet database for DNA fingerprints
that were similar to isolates collected
from Blue Bell ice cream samples.
Since the last update on April 8, 2015,
two additional patients, one each from
Arizona and Oklahoma, were confirmed
to be a part of the outbreak by whole
genome sequencing. All ten (100%)
patients were hospitalized. Three
deaths were reported from Kansas.
• Blue Bell ice cream has tested positive
for Listeria.

14. What About Andrew & Williamson?
• The CDC reported that as of September
15, 2015, a total of 418 illnesses from
Salmonella Poona have been reported
from 31 states. The victims of the
outbreak include: Alaska (10), Arizona
(72), Arkansas (6), California (89),
Colorado (16), Hawaii (1), Idaho (14),
Illinois (6), Indiana (2), Kansas (1),
Kentucky (1), Louisiana (4), Minnesota
(20), Missouri (8), Montana (13),
Nebraska (2), Nevada (9), New Mexico
(22), New York (4), North Dakota (2),
Ohio (2), Oklahoma (10), Oregon (8),
Pennsylvania (2), South Carolina (8),
Texas (20), Utah (37), Virginia (1),
Washington (15), Wisconsin (9), and
Wyoming (4). There are deaths in Arizona
(1) California (1) and Texas (1). The
illnesses are linked to Salmonella-tainted
cucumbers soured by Andrew &
Williamson Fresh Produce, Inc., a
corporation based in San Diego, California
and grown in Mexico.

15. 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.
• Perhaps also another three state outbreak
(unreported)?

16. Questions?