FOOD INDUSTRY COUNSEL LLC

By SHAWN K. SteveNS

In most cases, criminal charges are predicated on the accused acting with “scienter.”  That is, the criminal conduct must be intentional. Certain criminal misdemeanor offenses, however, are excepted from the scienter requirement — these are known as strict-liability offenses.

With strict-liability offenses, it does not matter whether the perpetrator was aware of or intended to commit the violation. Speeding is an example of a strict liability offense. It does not matter whether the driver intended to speed or knew they were speeding. Similarly, shipping contaminated food in violation of the Food Drug and Cosmetic Act (FDCA) is a strict-liability offense.

Unbeknownst to many, food industry executives can thus be criminally charged for violating the FDCA, especially when it involves shipping adulterated product into commerce. This is true even if they were completely unaware of the adulteration. To make matters worse, convictions may be punishable by large fines and/or significant jail time.    

As readers of this column well know, it is illegal to introduce adulterated foods into interstate commerce.  In turn, any company that does so has violated 21 U.S.C. § 331(a). When such a violation occurs, the company’s officers can be charged criminally under the Responsible Corporate Officer Doctrine (RCOD), also known as the Park Doctrine.

In U.S. v. Dotterweich, the U.S. Supreme Court established that corporate officers could be prosecuted for violating the FDCA, even without knowledge or awareness of the violation. The Supreme Court reasoned that, “In the interest of the larger good (the RCOD) puts the burden of acting at hazard upon a person otherwise innocent but standing in responsible relation to a public danger.” In the decades since Dotterweich was decided, DOJ prosecutors have routinely prosecuted food company executives for violating the FDCA.

In U.S. v. Park (hence the Park Doctrine) the Supreme Court held that to sustain a conviction, prosecutors need only prove that the corporate officer had “responsibility and authority either to prevent in the first instance, or promptly to correct, the violation complained of, and that [the officer] failed to do so.”  Upon conviction, each violation (i.e., the shipment of each case of offending product) is punishable by up to one year in jail or a $100,000 fine.

In a recent decision, a Court of Appeals affirmed that the government “need not prove that defendant knew that he (or she) was violating the law or that he (or she) intended to violate the law.” Rather, the prosecution merely needs to establish that the defendant was aware of a condition that “could” lead to harm, and that the defendant failed to take appropriate steps to correct or prevent it.

As federal agencies exercise increasingly aggressive inspection oversight, conduct swab-a-thons, and continue looking for connections between food companies and emerging outbreaks, more companies and by extension, more officers, could face criminal liability.

Perhaps counterintuitively, the incredible job that industry is doing may actually enhance the risk faced by corporate officers.  From an optics standpoint, the diminishing number of food-related recalls and outbreaks may foster the impression — in the eyes of both prosecutors and the public — that any foodborne illness outbreak is inherently the result of some culpable wrongdoing. In turn, if your company is among the very few unfortunate enough to be tied to an outbreak, the scrutiny you face will be all the more intense.  

In the end, if the Food and Drug Administration or U.S. Department of Agriculture finds harmful pathogens in your facility and links those findings to human illness, you may be subject to criminal charges. The best way to bail yourself out of future trouble is to bolster your food safety programs and decisively respond to any food safety issues today.

www.provisoneronline.com   |   september 2022