It has been a busy past several weeks for public health investigators (and lawyers) and uncomfortable (and sometimes deadly) for food poisoning victims, as well as for the management of several companies. Here are just a few of the outbreaks hitting the news:
Salmonella Cucumbers: As of Nov. 18, 2015, 838 people infected with the outbreak strains of Salmonella Poona have been 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).
Four deaths have been reported from Arizona (1), California (1), Oklahoma (1), and Texas (1). On Sept. 4, 2015, Andrew & Williamson Fresh Produce voluntarily recalled all cucumbers sold under the “Limited Edition” brand label during the period from Aug. 1, 2015, through Sept. 3, 2015, because they may be contaminated with Salmonella.
E. coli Chipotle: Forty-five people infected with the outbreak strain of STEC O26 have been reported from six states. The majority of illnesses have been reported from Washington and Oregon. The number of ill people reported from each state is as follows: California (2), Minnesota (2), New York (1), Ohio (1), Oregon (13), and Washington (26).
The epidemiological evidence available to investigators at this time suggests that a meal item or ingredient served at Chipotle Mexican Grill restaurants in several states is a likely source of this outbreak. The investigation has not identified what specific food item is linked to the illnesses.
E. coli Costco Chicken Salad: A total of 19 people infected with the outbreak strain of Shiga toxin-producing STEC O157:H7 have been reported from seven states. The majority of illnesses have been reported from western states. The number of ill people reported from each state is as follows: California (1), Colorado (4), Missouri (1), Montana (6), Utah (5), Virginia (1), and Washington (1).
The epidemiological evidence available to investigators at this time suggests that rotisserie chicken salad made and sold in Costco stores is a likely source of this outbreak. The Montana Public Health Laboratory tested a sample of celery and onion diced blend collected from a Costco location. Preliminary results indicated the presence of E. coli O157:H7. Laboratory testing is ongoing to isolate the E. coli bacteria and then determine the DNA fingerprint. The celery and onion diced blend was supplied to Costco by Taylor Farms Pacific Inc. and was used to make the Costco rotisserie chicken salad eaten by people sickened in this outbreak.
Could a person in a “position of responsibility or authority in a firm” face criminal sanctions in connection with these outbreaks? Perhaps. Should they? That is a debate to have. It would make me nervous if I sat in a position of authority with one of the companies above or one of their suppliers.
By way of background, Congress passed the Federal Food, Drug, and Cosmetic Act (FDCA) in 1938 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 whether it 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 — prevented the tainted product from entering interstate commerce. Again, unlike a felony, a misdemeanor charge is a crime with no intent. Convictions under the misdemeanor provisions are punishable by not more than one year, or a fine of not more than $250,000, or both.
Here are four recent cases where prosecutors brought criminal charges. The first three were misdemeanor charges and the last was a felony charge:
In 2012, Eric Jensen, 37, and Ryan Jensen, 33, brothers who owned and operated Jensen Farms, a fourth-generation cantaloupe operation 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’s 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 more than 147 people in 28 states, killing more than 33 of them, in the fall of 2011. The Jensens faced up to six years in jail and $1,500,000 in fines each. They eventually pleaded guilty and were sentenced to five years of probation.
In 2013, Austin “Jack” DeCoster and his son, Peter DeCoster, both faced charges stemming from a Salmonella outbreak caused in 2010 by their Iowa egg farms. The Salmonella outbreak ran from May 1 to Nov. 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 paid $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 2006-07 nationwide outbreak that sickened more than 700 people. 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 2006-07 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, GA, plant, faced a federal jury in Albany, GA. 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 had earlier pleaded guilty. The felony charges of introducing adulterated food into interstate commerce, “with the intent to defraud or mislead,” stemmed from a 2008-09 Salmonella outbreak that sickened 714 people and left nine of them dead. Stewart Parnell was sentenced to 28 years in prison, and Michael Parnell was sentenced to 20 years in prison. Mary Wilkerson was sentenced to five years in prison. All three are appealing their convictions and sentences.
So, are the producers of cucumbers, chicken salad or burritos (or ingredient suppliers) likely to face criminal prosecution? Perhaps not, given the recent history of no prosecutions in similar cases. Here are four outbreaks where no charges have been brought, at least not yet:
Glass 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). Thirty-two percent of ill persons were hospitalized. Two ill persons developed hemolytic uremic syndrome (HUS), but no deaths were reported. Epidemiological 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, were the likely source of this outbreak of E. coli O157:H7 infections. On Nov. 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 Jan. 6, 2015, Bidart Bros. of Bakersfield, CA, recalled Granny Smith and Gala apples because environmental testing revealed contamination with Listeria monocytogenes at the firm’s apple-packing facility.
2015 Blue Bell Ice Cream Listeria Outbreak: A total of 10 people with Listeriosis related to this outbreak were reported from four 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, which found significant food safety violations.
So, what are your thoughts?
