Can a food company executive be sentenced to a year (or more) in prison if the company he or she works for unknowingly sells contaminated food? The stark answer is, "yes."

In recent years, we have continued to witness instances in which, if a company produces and sells a product which makes people sick, the U.S. Department of Justice has become intimately involved. Over the course of the last five years, we have watched numerous instances in which DOJ has investigated, threatened or actually brought criminal charges against a food company for unknowingly selling or distributing a harmful food.

Under federal law, namely 21 U.S.C. § 331(a), it is illegal to introduce adulterated foods into interstate commerce. The million-dollar question (in some cases) then becomes, if DOJ were to seek criminal sanctions against a food company or its executives for doing so, does DOJ need to prove that the company or the executives had knowledge that the food they were shipping was contaminated?

Under the law as it exists today — and as it has existed for decades — DOJ does not need to demonstrate knowledge or intent to obtain a conviction. Instead of bringing felony charges against the company or its executives, DOJ can instead bring a strict liability misdemeanor charge, which does not require DOJ to establish the elements of knowledge or intent. All DOJ is required to establish is that a company executive or high-level food safety professional: (1) was aware of a circumstance that could lead to food product contamination, (2) was in a position to eliminate the condition, and (3) failed to do so. If DOJ can prove these elements, then each violation (i.e., the shipment of each case of offending product) can support up to a year in prison or a $100,000 fine.

So, what does it mean to be aware of a circumstance that could lead to product contamination? Well, in the past, the awareness of positive Listeria or Salmonella findings in the food processing environment (be it Zone, 1, Zone 2, Zone 3 or Zone 4) has been argued to be knowledge of a condition that could lead to product contamination (intermittent findings of Listeria in the environment). In turn, if it is later discovered, through Whole Genome Sequencing (“WGS”), that the strain of Listeria found by FDA in the food processing environment is the same as clinical isolates obtained from consumers who purchased the products, FDA will be able to argue that the food company, or its executives, or its food safety professionals, “failed to eliminate the condition” which ultimately led to illness. And, thus, criminal charges or a even a conviction could be born.

In a recent Court of Appeals decision, the court held that, under existing law, 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, DOJ merely needs to show that the defendant was aware of a condition that “could” lead to harm, and that the defendant failed to take appropriate steps to remedy the circumstance.

As FDA (and to a lesser extent, USDA) are exiting hibernation after two years of modified inspection intensity, we predict that the FDA inspections and USDA Food Safety Assessments will be more intense than ever before. As the agencies continue down the path of increasingly aggressive inspections and swab-a-thons, and continue looking for connections between food companies and emerging outbreaks, more companies and their products will likely be implicated.

In the end, if FDA or USDA finds harmful pathogens in your facility and links those findings to human illness, you could have exposure. Take steps now to bolster your food safety programs and your decisive response to positive environmental findings. Doing so, will protect you from the exposures detailed above.

Failing to do so, however, will leave you exposed. In the end, nobody (and I really mean nobody) looks good in orange.

Nobody looks good in orange

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