With nearly 3,000 (and likely many, many more) sickened and over 40 killed, it is amazing that the owners of these establishments who poisoned and killed their customers are not sitting in a jail cell. For those who have forgotten the facts:
Jensen Farms Outbreak – As of December 8, 2011, 146 persons infected with any of the four outbreak-associated strains of Listeria monocytogenes were reported to CDC from 28 states. 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). In addition, one woman pregnant at the time of illness had a miscarriage. Since December 8th an additional six people have died after suffering Listeria infections.
During the inspection, we also collected environmental swabs from various locations and surfaces throughout your packing facility. FDA conducted laboratory analyses, which determined that 13 of the 39 total environmental swabs were positive for outbreak strains of Listeria monocytogenes. PFGE analysis determined that eleven of the positive swabs matched the strain of Listeria monocytogenes represented by cluster #2, one positive swab matched the strain of Listeria monocytogenes represented by cluster #4, and one positive swab matched the strain of Listeria monocytogenes represented by cluster #3. Further, one swab was positive for a strain of Listeria monocytogenes that did not match any of the outbreak strains. These positive swabs were taken from different locations throughout the washing and packing areas in your facility, all of which were either food contact surfaces or areas adjacent to food contact surfaces. This significant percentage of swabs that tested positive for outbreak strains of Listeria monocytogenes demonstrates widespread contamination throughout your facility and indicates poor sanitary practices in the facility.
In addition, in its inspection report, the FDA identified the following factors as those that most likely contributed to the introduction, spread, and growth of Listeria monocytogenes in the cantaloupes:
- There could have been low level sporadic Listeria monocytogenes in the field where the cantaloupe were grown, which could have been introduced into the packing facility
- A truck used to haul culled cantaloupe to a cattle operation was parked adjacent to the packing facility and could have introduced contamination into the facility
- The packing facility’s design allowed water to pool on the floor near equipment and employee walkways;
- The packing facility floor was constructed in a manner that made it difficult to clean
- The packing equipment was not easily cleaned and sanitized; washing and drying equipment used for cantaloupe packing was previously used for postharvest handling of another raw agricultural commodity.
- There was no pre-cooling step to remove field heat from the cantaloupes before cold storage. As the cantaloupes cooled there may have been condensation that promoted the growth of Listeria monocytogenes.
Wright County Egg Outbreak – The CDC identified a nationwide sustained increase in the number of Salmonella Enteritidis. From May 1 to November 30, 2010, approximately 1,939 illnesses were reported that are likely to be associated with Jack DeCoster’s Wright County Egg in Iowa.
• Chicken manure located in the manure pits below the egg laying operations was observed to be approximately 4 feet high to 8 feet high at the following locations: Layer 1 – House 1; Layer 3 – Houses 2, 7, 17, and 18. The outside access doors to the manure pits at these locations had been pushed out by the weight of the manure, leaving open access to wildlife or domesticated animals.
• Un-baited, unsealed holes appearing to be rodent burrows located along the second floor baseboards were observed inside Layer 1 – Houses 1-9 and 11-13; Layer 2 – Houses 7 and 11; Layer 3 – Houses 1, 3, 4, 5, and 6; Layer 4 – House 3.
• Dark liquid which appeared to be manure was observed seeping through the concrete foundation to the outside of the laying houses at the following locations: Layer 1 – Houses 1, 2, 3, 4, 5, 8, 11, 12, and 14; and Layer 3 – Houses 1, 8, 13, and 17.
• Standing water approximately 3 inches deep was observed at the southeast corner of the manure pit located inside Layer 1 – House 13.
• Un-caged birds (chickens having escaped) were observed in the egg laying operations in contact with the egg laying birds at Layer 3 – Houses 9 and 16. The un-caged birds were using the manure, which was approximately 8 feet high, to access the egg laying area.
• Layer 3 – House 11, the house entrance door to access both House 11 and 12 was blocked with excessive amounts of manure in the manure pits.
• There were between 2 to 5 live mice observed inside the egg laying Houses 1, 2, 3, 5, 7, 9, 10, 11, and 14.
• Live and dead flies too numerous to count were observed at the following locations inside the egg laying houses: Layer 1 – Houses 3, 4, 6, 8, 9, 11, and 12; Layer 2 – Houses 7 and 11; Layer 3 – Houses 3, 4, 4, 5, 7, 8, 15, 16, 17, and 18. The live flies were on and around egg belts, feed, shell eggs and walkways in the different sections of each egg laying area. In addition, live and dead maggots too numerous to count were observed on the manure pit floor located in Layer 2 – House 7.
Peanut Corporation of America Outbreak – As April 20, 2009, 714 persons infected with the outbreak strain of Salmonella Typhimurium have been reported from 46 states. Infection may have contributed to nine deaths: Idaho (1), Minnesota (3), North Carolina (1), Ohio (2), and Virginia (2).
“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.”
The Law – The Federal Food, Drug, and Cosmetic Act was passed by Congress in 1938 in reaction to the growing public safety demands. The primary goal of the Act is 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, inter alia, 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. If, however, the “poisonous or deleterious” substance is not an added substance, the food is not considered adulterated if the quantity of the substance in the particular food item does not ordinarily render the food injurious to health.
The Act authorizes factory inspections and added injunctions to the enforcement tools at the Food and Drug Administration’s (FDA) disposal. Following hearings in the early 1950s, a series of laws addressing pesticide residues (1954), food additives (1958), and color additives (1960) gave the FDA much tighter control over the growing list of chemicals entering the food supply, putting the onus on manufacturers to establish their safety. The Act stands today as one of the primary means by which the federal government enforces food and pharmaceutical safety standards.
Chapter III of the Act addresses prohibited acts, subjecting violators to both civil and criminal liability. Provisions for criminal sanctions state that:
* 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 three years imprisonment.
* 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 up to one-year imprisonment or a $1000 fine.
The Act also includes provisions for individual liability, specifically. Individuals who are responsible for criminal behavior are normally named as defendants along with corporate entities through which crimes are committed. A corporate defendant’s willingness to enter a plea of guilty is accordingly not a basis for dismissal of charges against an individual. Individual defendants are generally the highest-ranking officials in a firm who made decisions that violated the law, along with others who actively participated in fraudulent activity. Thus, presidents of corporations and managers of facilities where violations take place are often appropriate defendants.
1. Carol Benjamin and Betsy J. Floman, Federal Food and Drug Act Violations, 31 Am. Crim. L. Rev. 629 (1994).
2. 21 U.S.C. §331.
3. 21 U.S.C. §333(a)(2).
4. See United States v. Park, 421 U.S. 658, 674-77 (1975); United States v. Dotterweich, 320 U.S. 277, 280-81 (1943).
5. See United States v. Marcus, 82 F.3d 606 (4th Cir. 1996) (President/CEO of generic drug manufacturing firm prosecuted for altering heart medication formula without adequate testing or FDA approval); United States v. James V. Mays, 77 F.3d 906 (6th Cir. 1996); United States v. Samuel and Patsy Mays, 69 F.3d 116 (6th Cir. 1995), cert. denied, 116 S. Ct. 2504 (1996) (President, Secretary/Treasurer, and Operations Manager of juice concentrate company prosecuted for secretly adding 20,000,000 pounds of sugar to product sold as pure 100% orange concentrate).
Can you say “jail time?”