Criminal Consequences of New Human Illness Standard

Following the passage of the Food Safety Modernization Act (FSMA), FDA was tasked with the enormous responsibility of overhauling the safety of the nation’s food supply. Virtually overnight, the agency found itself in the unenviable position of needing to author, and eventually enforce, sweeping new regulations aimed at the safety of imported and domestic foods without adequate funding or nearly enough inspectors. In turn, FDA’s ultimate success or failure would be judged by consumers and Washington by the numbers of recalls and foodborne illness outbreaks being reported in the news. To bridge the vast gap between tremendously limited resources and seemingly unreachable goals, the agency worked tirelessly to identify creative new tools to enable it to accomplish its new charge. FDA’s solution, it now appears, is to make any food company (or food company employee) that makes a customer sick a criminal target.

Outbreak Overload

FDA’s new policy aimed at reducing the numbers of annual foodborne illness outbreaks flows from a long history of federal food safety regulation. Immediately following a massive E. coli O157:H7 foodborne illness outbreak on the West Coast in the early 1990s, food safety was elevated to a prominent role in our nation’s dialogue. The federal government announced more stringent standards governing the safety of raw animal foods, and also worked closely with CDC and the states to develop a national foodborne illness surveillance system (PulseNet) designed to quickly detect, and in many cases solve, emerging outbreaks. As the system became more capable, the government began identifying an increasing number of annual foodborne illness outbreaks, and it quickly became clear to both industry and regulators alike that many of the foods sold in commerce were at risk of becoming contaminated with harmful pathogens.

Initially, industry responded to the increasing numbers of outbreaks by requiring more microbiological testing of incoming ingredients and finished products. In 2009, FDA joined the fight, and created the Reportable Food Registry (RFR) to help identify and contain contaminated ingredients in the food supply. Prior to the RFR, if a food company found that the ingredients it received from a supplier tested positive for a pathogen, the company would simply reject the shipment and return it to the supplier. Once the RFR was created, however, any food company which received ingredients that tested positive would be required to file a report with FDA. The agency would then take regulatory action against the original supplier, and require that all ingredients or products from all potentially affected lots be recalled. Because the RFR allowed FDA to immediately see and track contaminated food ingredients and products already in the food supply, the system caused a massive spike in the numbers of recalls being announced.

Creation of Human Illness Standard

Driven by the large numbers of outbreaks and recalls triggered by PulseNet and the RFR, it suddenly appeared to consumers that the foods they were buying were becoming increasingly unsafe. In response to the negative perceptions surrounding the safety of the national food supply, Congress enacted FSMA. And, as noted, with the passage of FSMA, FDA was told, with extremely limited resources, to overhaul the safety of the food supply and make foodborne illness outbreaks go away. Without the resources to merely “regulate” safety into food, the agency instead adopted a bold new policy stance that essentially created zero-tolerance for human illness. Under this new “Human Illness Standard,” the agency will work with the U.S. Department of Justice (DOJ) to determine whether criminal sanctions are appropriate whenever a company’s food product is linked to a consumer illness.

Indeed, DOJ recently acknowledged its partnership with FDA and the agencies’ policy of initiating criminal investigations against any company (or its employees) that sells a product that causes human illness. Benjamin C. Mizer, principal deputy assistant attorney, explains that “one of the government’s highest obligations is to protect citizens when they cannot protect themselves.” According to the agency, and the development of recent policy, FDA and DOJ view any human illness caused by a food product as a potential violation of the law. “In deciding whether to use our civil or our criminal enforcement tools,” explains Mizer, “prosecutors [will] evaluate the nature and seriousness of the offense, the deterrent effect of the prosecution and the culpability of the individuals or entities involved.”