law-book-gavel-620x412So, when to prosecute and when to not? What are the criteria, if any, that the Justice Department now uses to decide to prosecute? For those that are prosecuted, does the punishment fit the crime? And, what happens when similar “crimes” are not prosecuted at all?

We have just learned that Blue Bell is now under investigation by the justice department. A total of 10 people with Listeriosis related to the 2015 Blue Bell Ice Cream Listeria Outbreak were reported from 4 states: Arizona (1), Kansas (5), Oklahoma (1), and Texas (3). All ill people were hospitalized. Three deaths were reported from Kansas (3). On April 21, CDC reported that whole genome sequencing confirmed that the people from Arizona (1) and Oklahoma (1) were part of the outbreak, bringing the total case count to 10. On May 7, 2015, FDA released the findings from recent inspections at the Blue Bell production facilities that found significant food safety violations.

First, for a bit of background history.

In 1938 Congress passed the Federal Food, Drug, and Cosmetic Act (FDCA) in reaction to growing public food 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, including food, 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. Chapter III of the Act addresses prohibited acts, subjecting violators to both civil and criminal liability.

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. The key here is an intentional act.

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.

Here are four recent cases[1] where prosecutors brought criminal charges:

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.

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 might 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.

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.

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.
And, here are four where no charges have been brought – at least as of yet:

2013 Class Onion E. coli Outbreak: A total of 33 persons infected with the outbreak strain of E. coli O157:H7 were reported from four states. The number of ill persons identified in each state was as follows: Arizona (1), California (28), Texas (1), and Washington (3). 32% of ill persons were hospitalized. Two ill persons developed hemolytic uremic syndrome (HUS), and no deaths were reported. Epidemiologic and traceback investigations conducted by local, state, and federal officials indicated that consumption of two ready-to-eat salads, Field Fresh Chopped Salad with Grilled Chicken and Mexicali Salad with Chili Lime Chicken, produced by Glass Onion Catering and sold at grocery store locations, was the likely source of this outbreak of E. coli O157:H7 infections. On November 10, 2013, Glass Onion Catering recalled numerous ready-to-eat salads and sandwich wrap products that may be contaminated with E. coli O157:H7.

2013 Townsend Farms/Costco Hepatitis A Outbreak: A total of 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 (23), California (79), Colorado (28), Hawaii (8), New Hampshire (1), New Jersey (1), New Mexico (11), Nevada (6), Utah (3), and Wisconsin (2). The major outbreak strain of hepatitis A virus, belonging to genotype 1B, was found in clinical specimens of 117 people in nine states. This genotype is rarely seen in the Americas but circulates in North Africa and the Middle East. This genotype was identified in a 2013 outbreak of hepatitis A virus infections in Europe linked to frozen berries and a 2012 outbreak in British Columbia related to a frozen berry blend with pomegranate seeds from Egypt.

2014 Bidart Brothers Listeria Apple Outbreak: A total of 35 people infected with the outbreak strains of Listeria monocytogenes were 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). Of these, 34 people were hospitalized. Listeriosis contributed to at least three of the seven deaths reported. 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. On January 6, 2015, Bidart Bros. of Bakersfield, California, recalled Granny Smith and Gala apples because environmental testing revealed contamination with Listeria monocytogenes at the firm’s apple-packing facility.

2015 Andrew and Williamson[2] Cucumber Salmonella Outbreak: A total of 838 people infected with the outbreak strains of Salmonella Poona were reported from 38 states. The number of ill people reported from each state is as follows: Alabama (1), Alaska (17), Arizona (129), Arkansas (13), California (232), Colorado (19), Connecticut (1), Florida (1), Hawaii (1), Idaho (24), Illinois (9), Indiana (5), Iowa (7), Kansas (2), Kentucky (1), Louisiana (5), Maryland (1), Minnesota (40), Missouri (14), Montana (16), Nebraska (8), Nevada (16), New Hampshire (1), New Mexico (32), New York (6), North Dakota (8), Ohio (3), Oklahoma (13), Oregon (22), Pennsylvania (2), South Carolina (10), South Dakota (3), Texas (42), Utah (58), Virginia (1), Washington (25), Wisconsin (43), and Wyoming (7). Among people for whom information is available, illnesses started on dates ranging from July 3, 2015 to November 1, 2015. Ill people range in age from less than 1 year to 99, with a median age of 18. Fifty percent of ill people are children younger than 18 years. Fifty-seven percent of ill people are female. Among 601 people with available information, 165 (27%) report being hospitalized. Four deaths have been reported from Arizona (1), California (1), Oklahoma (1), and Texas (1). The cucumbers were distributed by Andrew & Williamson Fresh Produce. The San Diego County Health and Human Services Agency isolated one of the outbreak strains of Salmonella Poona from cucumbers collected from the Andrew & Williamson Fresh Produce facility.

Admittedly, I have been a booster for increased food crime prosecutions – both misdemeanor and felony. In all the four cases above where prosecutions happened, I have helped prosecutors understand the science behind the outbreaks and explained to them the devastation suffered by the victims and families.

Yet, looking at the above outbreaks together, I find it a bit hard to parse out why some have been targeted – OK, perhaps the Parnell prosecution is a bit easier because it was so clearly intentional – and some have not, or at least not yet.

Honestly, what are the differences in prosecuting the Jensens, DeCosters and ConAgra and leaving the others – so far – unmolested by section 402(a)(4) of the FDCA? Is it the number of sick, the number of dead? Is it the economic consequences? What really are the criteria, or, should it simply be left to the discretion of the prosecutor as to who or what feels the sting of the criminal justice system?

It is time for prosecutors to set forth clear guidelines for who is prosecuted and who is not. People (and corporations if you do not quite agree with some who do not see the difference) should know what the rules are and how they are going to be enforced and that they will be enforced consistently and fairly.
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[1] In 1998 in what was the first criminal conviction in a large-scale food-poisoning outbreak, 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.

[2] According to the CDC, in March 1997, a total of 153 cases of hepatitis A were reported in Calhoun County, Michigan. 151 case-patients were students or staff of schools in four different school districts. A case-control and cohort study conducted in two different school districts established a strong association between illness and consumption of food items containing frozen strawberries. The strawberries associated with illness were reportedly from Mexico; a company in southern California processed, packed, and froze the strawberries in 30-pound containers for commercial use and then distributed the strawberries to U.S. Department of Agriculture (USDA)-sponsored school lunch programs.

Later that year the Justice Department announced that a federal probe into the sale of hepatitis A-tainted strawberries ended in November with criminal and civil pleas by a strawberry distributor and its president. The March, 1997 outbreak contaminated 198 school children and teachers in Michigan, as well as others in Maine and Wisconsin.

Andrew and Williamson Sales Co., Inc. (“A&W”), and its president, Frederick L. Williamson, admitted their role in the fraudulent sale of 1,742,280 pounds of Mexican grown strawberries to the USDA’s school lunch program. As part of a parallel civil settlement, the company has agreed to pay the government $1.3 million in civil damages. The indictment charges A&W with attempting to disguise the fact that the strawberries it was supplying to the USDA were not grown domestically, as required by the agency. Also, Richard H. Kershaw, the sales representative in charge of A&W’s frozen strawberry business entered a guilty plea.

Both defendants pleaded guilty to violations of conspiracy to defraud the United States, making a false statement, and making a false claim.  Frederick L. Williamson, 61, president of Andrew and Williamson Co., spent five months in prison and five months in home custody. The federal judge also ordered Williamson’s company to pay $150,000 in restitution and a $200,000 fine. The company agreed to pay $1.3 million to the federal government.