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The Risk of Criminal
Sanctions are Real
in Production of
Food
William D. Marler, Esq.
.
1938 Federal Food, Drug & Cosmetic Act
• Congress passed the Federal Food, Drug, and Cosmetic Act in 1938 in reaction to
g...
How Are Things are Different Today?
It Started with a Little Salmonella
• In 2009 714 persons infected with the
outbreak strain of Salmonella
Typhimurium were...
Then there were Congressional Hearings
• “Turn them loose,” Parnell had told his
plant manager in an internal e-mail
discl...
Now – Guilty After Two Month Trial
• Stewart Parnell, the former
owner of Peanut Corp. of
America
• Michael Parnell, who i...
And, It Does Not Always Require Intent
• A misdemeanor conviction
under the FDCA, unlike a
felony conviction, does not
req...
First Listeria Outbreak Linked to Cantaloupe
• In 2011, 147 persons infected with any of
the four outbreak-associated stra...
The DeCosters, Salmonella & Eggs
• Austin “Jack” DeCoster and his son, Peter
DeCoster acknowledge that, in August
2010, wh...
$11.2 Million Fine in Criminal Misdemeanor
• Federal criminal misdemeanor
charges related to the shipment of
adulterated p...
What About Bidart Apples?
• On January 10, 2015, the CDC
reports a total of 35 people infected
with the outbreak strains o...
What About Blue Bell Ice Cream?
• As of April 21, 2015, a total of ten
patients infected with several strains of
Listeria ...
Questions?
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Criminal Sanctions - A Real Risk in Food Production

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An upcoming talk on the risk of food manufacturers to criminal sanctions for the production and distribution of adulterated food.

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Criminal Sanctions - A Real Risk in Food Production

  1. 1. The Risk of Criminal Sanctions are Real in Production of Food William D. Marler, Esq. .
  2. 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. 3. How Are Things are Different Today?
  4. 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. 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. 6. Now – Guilty After Two Month Trial • 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 • Convictions Included: • Mail Fraud • Wire Fraud • Introduction of Adulterated and Misbranded Food into Interstate Commerce with Intent to Defraud or Mislead • Conspiracy
  7. 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. 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. 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. 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. 11. 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
  12. 12. 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.
  13. 13. Questions?

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