Riddle me this – with over 1,000 sickened by Cyclospora in 2 years, should Fresh Express be worried about criminal prosecution?

Perhaps a “trip down criminal lane” might give us a clue?

Chipotle Mexican Grill Inc. paid $25 million to resolve criminal charges related to the company’s involvement in foodborne illness outbreaks that sickened more than 1,100 people between 2015 and 2018, the Department of Justice announced in April 2020. (Press Release)

A month later, in May 2020, Texas-based ice cream manufacturer Blue Bell Creameries L.P. agreed to plead guilty to charges it shipped contaminated products linked to a 2015 listeriosis outbreak that sickened 10 with 4 deaths.  In a plea agreement filed with a criminal information in federal court in Austin, Texas, Blue Bell agreed to plead guilty to two misdemeanor counts of distributing adulterated ice cream products and pay a criminal fine and forfeiture amount totaling $17.25 million.  Blue Bell also agreed to pay an additional $2.1 million to resolve civil False Claims Act allegations regarding ice cream products manufactured under insanitary conditions and sold to federal facilities. (Press Release)

In 1998 in what the first criminal conviction in a large-scale food-poisoning outbreak was, Odwalla Inc. pleaded guilty to violating Federal food safety laws and agreed to pay a $1.5 million fine for selling tainted apple juice that killed a 16-month-old girl and sickened 70 other people in several states in 1996. Odwalla, based in Half Moon Bay, California pleaded guilty to 16 counts of unknowingly delivering ”adulterated food products for introduction into interstate commerce” in the October 1996 outbreak, in which a batch of its juice infected with the toxic bacteria E. coli O157:H7 sickened people in Colorado, California, Washington and Canada. Fourteen children developed a life-threatening disease (hemolytic uremic syndrome -HUS) that ravages kidneys. At the time, the $1.5 million penalty was the largest criminal penalty in a food poisoning case.  Odwalla also was on court-supervised probation for five years, meaning that it had to submit a detailed plan to the food and drug agency demonstrating its food safety precautions and that any subsequent violations could have resulted in more serious charges. (Odwalla)

In 2012 Eric Jensen, age 37, and Ryan Jensen, age 33, brothers who owned and operated Jensen Farms, a fourth-generation cantaloupe operation, located in Colorado, presented themselves to U.S. marshals in Denver and were taken into custody on federal charges brought by the U.S. Attorney’s Office with the Food and Drug Administration – Office of Criminal Investigation. According to the six-count indictment, Eric and Ryan Jensen unknowingly introduced adulterated (Listeria-tainted) cantaloupe into interstate commerce. The indictment further stated that the cantaloupe was prepared, packed and held under conditions, which rendered it injurious to health.  The outbreak sickened over 147, killing over 33 in 28 states in the fall of 2011.  The Jensen’s faced up to six years in jail and $1,500,000 in fines each. The eventually pleaded guilty and were sentenced to five years probation. (Eric Jensen Plea and Ryan Jensen Plea)

In 2013, Austin “Jack” DeCoster and his son, Peter DeCoster, both faced charges stemming from a Salmonella outbreak caused by their Iowa egg farms in 2010.  The Salmonella outbreak ran from May 1 to November 30, 2010 and prompted the recall of more than a half-billion eggs. And, while there were 1,939 confirmed infections, statistical models used to account for Salmonella illnesses in the U.S. suggested that the eggs may have sickened more than 62,000 people. The family business, known as Quality Egg LLC, pleaded guilty in 2015 to a federal felony count of bribing a USDA egg inspector and to two misdemeanors of unknowingly introducing adulterated food into interstate commerce. As part of the plea agreement, Quality Egg paid a $6.8-million fine and the DeCosters $100,000 each, for a total of $7 million.  Both DeCosters were sentenced to three months in jail. They are appealing the jail sentence. (Austin “Jack” DeCoster Plea and Peter DeCoster Plea)

In 2014 former Peanut Corporation of America owner Stewart Parnell, his brother and one-time peanut broker, Michael Parnell, and Mary Wilkerson, former quality control manager at the company’s Blakely, Georgia, plant, faced a federal jury in Albany, Georgia. The 12-member jury found Stewart Parnell guilty on 67 federal felony counts, Michael Parnell was found guilty on 30 counts, and Wilkerson was found guilty of one of the two counts of obstruction of justice charged against her. Two other PCA employees earlier pleaded guilty. The felony charges of introducing adulterated food into interstate commerce, “with the intent to defraud or mislead,” stemmed from a 2008 to 2009 Salmonella outbreak that sickened 714 and left nine dead. All defendants will be sentenced in July of this year. Stewart and Michael are facing decades in jail. (Parnell Jury Verdict)

In 2015 ConAgra Foods agreed to plead guilty and pay $11.2 million in connection with the shipment of Salmonella contaminated peanut butter linked to a 2006 through 2007 nationwide outbreak of that sickened over 700. ConAgra signed a plea agreement admitting that it unknowingly introduced Peter Pan and private label peanut butter contaminated with Salmonella into interstate commerce during the 2006 through 2007 outbreak. (ConAgra Plea)

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.

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.

The legal jargon aside, if you are a producer of food and knowingly or not sell adulterated food, you can (and should) face fines and jail time.

If I were Fresh Express, I would “lawyer up.”

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.