Criminal Consequences of New Human Illness Standard

Under this new Human Illness Standard, a food company executive, manager, or employee can be charged with a crime even if they didn’t know they were selling product that was contaminated or making people sick. According to Mizer, “Congress has made the prohibition on introducing adulterated food into interstate commerce a strict liability offense, meaning that a company or individual violates the law and can face misdemeanor charges whether or not it intended to distribute adulterated food.” And, “make no mistake,” says Mizer, misdemeanor violations can mean serious penalties. Indeed, a single misdemeanor violation (for selling just one contaminated product) can equate to a $250,000 fine and a year in prison.

Criminal Past

The FDA’s power to bring criminal charges against corporate executives and employees originates from a 1975 Supreme Court Case. In United States v. Park, 421 U.S. 658 (1975), the Supreme Court upheld the conviction of the president of a major grocery chain. In that case, the president was found to be criminally liable for the insanitary conditions of a warehouse, where the conditions of the warehouse could have led to the shipment of adulterated product (adulteration was never proven), notwithstanding his argument that he had delegated the responsibility for maintaining the cleanliness of the warehouse to his subordinates.

The Supreme Court concluded that if a company ships adulterated food, the executives or managers of that company can be charged, even if they had no direct knowledge or intent. Under this standard, a company executive or QA manager can be charged simply if he or she is aware of a condition within his or her facility that could possibly lead to a foodborne illness, and then fails to take action to correct it. In each case, FDA will consider the individual’s position within the company and his or her relationship to the violation. Following the Supreme Court’s 1975 decision, the doctrine was rarely used by FDA, lying dormant for decades.

By virtue of apparent increase in the numbers of outbreaks and recalls, however, including the FDA’s charge to overhaul the safety of the food supply and the its search for creative new enforcement tools, the doctrine has been resurrected. In turn, the government has proven it is neither hesitant nor shy about launching criminal investigations against food companies as demonstrated in a series of recent high-profile examples.

Indeed, following the Jensen Farms Listeria Monocytogenes (LM) cantaloupe outbreak, company owners were investigated by FDA, criminally charged, and then sentenced to six months of home detention and individual fines of $150,000. Following the Quality Egg Salmonella outbreak, company executives were sentenced to three months in jail and assessed substantial fines. Notable, in each of these cases, neither the companies nor their employees knew that they were selling contaminated food. And, these are not the only cases where the government has targeted companies where knowledge was not a factor. More recently, FDA and DOJ have launched criminal investigations against Blue Bell, Chipotle, and Dole for unknowingly selling food that made people sick.

In Blue Bell, FDA linked positive samples from Blue Bell’s processing facilities to 10 case patients in the PulseNet database who carried the same strain of LM. What makes the investigation concerning for industry is that the outbreak spanned approximately five years, and no one from Blue Bell knew that their products were causing illnesses. Nevertheless, FDA is conducting a criminal investigation and seeking a wide-range of company records and emails. If FDA brings criminal charges, it will likely argue that Blue Bell should have done more to eliminate LM from its processing environment.

In Chipotle, the national restaurant chain struggled for months in 2015 to contain and manage numerous foodborne illness outbreaks allegedly linked to food served at its restaurants. Although the source of many of the illnesses remains uncertain, Chipotle confirmed in public filings that it was served with a grand jury subpoena by DOJ requiring it to produce documents to FDA investigators related to company-wide food safety matters dating back to Jan. 1, 2013. In addition to attempting to determine the cause of the recent 2015 outbreaks, FDA is apparently “fishing” for examples of possible misconduct dating as far back to 2013.