At the PulseNet conference here in Chicago there was a lot of discussion as to what happened to Stewart Parnell, the CEO of the Peanut Corporation of America (PCA), who was responsible for 714 ill and nine deaths, which until this DeCoster Egg recall, was one of the larger Salmonella outbreaks in recent memory. Nearly two years after the PCA outbreak Stewart Parnell does not sit behind bars where many think he should reside.
Now, Mary Clare Jalonick of AP and Philip Brasher of the Des Moines Register both reported this morning that Wright County Egg and Hillandale Farms, the two Iowa farms at the center of a salmonella outbreak and massive egg recall, have been visited by federal agents – again. It is unclear whether this new investigation is the first step in a criminal probe.
The FDA has jurisdiction to investigate crimes involving adulterated food, coordinating with the Justice Department. The 483 reports released this week by the FDA show sources of contamination at both farms, including rodent, bug and wild bird infestation, uncontained manure, holes in walls and other problems that could have led to the outbreak. Positive samples of the type of salmonella linked to the illnesses have been found at both farms.
So, will the egg man DeCoster join Parnell the peanut man in the big house? Frankly, I highly doubt it given the government’s failure to prosecute Parnell. However, if they did, here are the laws that they would have to work with.
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).