Criminal Consequences of New Human Illness Standard

More recently, Dole prepackaged salads were linked to a LM outbreak that caused 18 illnesses and one death. Reportedly, FDA cultured Listeria from Dole’s processing facility that matched the outbreak strain. Here too, although neither Dole nor its employees knew they were selling contaminated products, DOJ and FDA launched a criminal investigation. In the event criminal charges are issued, FDA will likely argue that Dole failed to adequately test and control for LM within its facility.

Intensive Investigations

But these aren’t the only companies in the FDA spotlight. Every company that falls under FDA jurisdiction is at risk. The agency is now conducting microbiological profiling inside all food processing facilities during routine inspections. The agency is also testing vast amounts of food at retail. If FDA finds that a company’s products (at retail) or environment (in its facility) are contaminated, it will compare those strains against the PulseNet database to determine whether they can be linked to any unsolved illnesses occurring within the last 10 years. If so, those companies will face a massive recall and their executives and QA managers could find themselves in jail. Indeed, under FDA’s new approach, even the failure to effectively eliminate sporadic LM findings in the environment completely could potentially expose company employees to criminal liability. Food companies need to take action now to prevent becoming the next Blue Bell, Chipotle, or Dole.

And, moving forward, it’s clear that neither FDA nor DOJ will relent. DOJ’s Benjamin Mizer recently made it clear that the use of criminal sanctions against the food industry remains a priority. In particular, he explains that “aggressive enforcement of the FDCA and other food safety laws helps to ensure that making safe food is not only the best ethical and moral decision, but also the best business decision,” and concluded by confirming that FDA and DOJ “are committed to continuing to vigorously prosecute food safety cases.”

There are a large number of actions companies can take now to better protect themselves from the consequences of criminal investigation. In addition to enhancing environmental monitoring and control programs, food company executives and managers should consult with legal experts to make sure their food safety programs will withstand scrutiny from FDA criminal investigators. Being self-critical now will enable a company to survive the scrutiny and criticisms of FDA during the next routine or investigational inspection.

While most insiders have long believed that FDA’s success in overhauling the safety of the food supply rests with FSMA, under the new Human Illness Standard, the agency’s success may instead be driven by the Park Doctrine and industry’s fear of prison.

Stevens is a global food safety lawyer and founding member of Food Industry Counsel LLC. He also speaks regularly to national and international audiences on a wide variety of emerging scientific, regulatory, and legal food safety trends. Reach him at [email protected].