Earlier this month, Henry’s Farm, Inc., located in Woodford, Virginia, and its owner Soo C. Park, was put out of business after the U.S. Food and Drug Administration documented multiple violations of federal food safety laws and regulations. The resulting Federal consent decree prohibits Henry’s Farm, Inc. from receiving, processing, manufacturing, preparing, packing, holding and distributing ready-to-eat soybean and mung-bean sprouts. The U.S. Department of Justice (DoJ) sought the consent decree on behalf of the FDA.
While the government agencies have long sought to prosecute companies whose practices after food recalls, the tough action against Henry’s Farm reflects a higher level of government food safety oversight, an attitude embodied in the new Food Safety Modernization Act (FSMA). The consent decree was imposed even though there were no reported incidents of foodborne illness from Henry’s Farm’s sprouts.
For the food industry, the message couldn’t be clearer. Companies need to demonstrate a firm commitment to food safety in all facets of their operations, or face severe consequences. Put another way, it is too late to start your food safety program after the U.S.Federal Marshals arrive to deliver court orders shutting down the business. The FDA has the power to take action when there are concerns about potential health risks exist and the possibility of health. With the cooperation of the Justice Department, the power to head off foodborne illness outbreaks enables the FDA to not only shut down an offending business, but also bring criminal charges.
“Insanitary conditions at food processing facilities can pose well-known risks to consumers, but such risks can be effectively mitigated if companies handling food take proper precautions,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “The Department of Justice will continue to work aggressively with the FDA to combat and deter conduct that leads to the distribution of adulterated food to consumers.”
In that regard, one of the tools the Justice Department may employ under FSMA is a standard of liability, called the Park Doctrine, which extends civil and criminal liabilities to executives who fail to actively monitor food safety practices. The standard derives from a Supreme Court case in 1975, in which a supermarket company executive, John Park, was fined and imprisoned for poor sanitation in some company warehouses. The executive argued that he had delegated responsibility for sanitation to others, but the Justices ruled that as the responsible executive, Park was culpable. The resulting standard, called the Park Doctrine, lay fallow for years but now has been resurrected as new food safety rules take effect.
Its significance can’t be understated. One attorney, commenting on the Park Doctrine in 2009, summarized the decision this way: “Park was found guilty under the theory that people who manage businesses that make and sell products regulated by the FDA have an affirmative duty to ensure the safety of the products.”
Faced with the prospect of fines, pubic humiliation and even the closing down of the business, what can food executives do to avoid running afoul of FSMA?
The best course, industry sources agree, is to double down on food safety best practices in every aspect of food manufacturing and distribution. Senior management must support food safety efforts by providing a facility and equipment that is suitable for production and packaging of safe products. They should also make sure that key management staff is trained and capable to oversee safe food production. Companies should see to it that managers and supervisors be required to read the Park Doctrine as a way to emphasize that they bear a personal responsibility to insure a safe food production environment. By the same token, CEOs must fully commit to fostering and maintaining a safe food production environment.
Fortunately, FSMA lays out specific steps manufacturers can implement to create and maintain a safe production process. Each plant is required to undertake a hazard analysis of existing procedures, from which the companies must create a comprehensive Food Safety Plan that lays out in minute detail how every possible hazard is addressed. (See more details here and here).
In short, the FDA under FSMA is placing more responsibility for food safety squarely on those in charge. It is saying to executives: do your job and make food safety a top management priority. Or suffer the consequences.