The Food and Drug Administration is asking farms and facilities it oversees for food safety to let the agency know if COVID-19 forced them to close temporarily or slow production.
The FDA’s Center for Food Safety and Applied Nutrition issued guidance Wednesday for facilities that handle food for human consumption and farms on challenges they face during the pandemic. The FDA gained oversight of farms for the safe growing, harvesting, packing and holding of fruits and vegetables under a 2011 law.
Reporting is voluntary, and restaurants and retail food establishments are excluded from the guidance.
Memorandum of understanding
The notice comes a little more than a week after the FDA and the Agriculture Department announced a memorandum of understanding to keep the nation’s food chain intact by making food facilities regulated by the FDA potentially subject to the USDA’s use of a 1950 law known as the Defense Production Act to keep the U.S. food supply flowing.
The guidance doesn’t mention the memorandum, but it notes news reports of closures of some FDA-regulated facilities. The center says information provided would help the agency “understand the status of FDA-regulated food establishments and the food supply in light of circumstances associated with the pandemic.”
The center says facilities that submit reports won’t generate additional FDA scrutiny.
The center also says COVID-19 challenges at FDA-regulated operations may have been overshadowed by reports of temporarily closed meat and poultry plants, where thousands of workers have tested positive for the virus that causes COVID-19 or become ill. In early May, the Centers for Disease Control and Prevention reported nearly 5,000 cases at meat and poultry plants in 19 states, with 20 deaths.
The closures and spot shortages of meat laid the groundwork for an April 28 executive order from President Donald Trump that invoked the Defense Production Act, declared meat and poultry processing and packing plants to be critical infrastructure and said the plants were to follow nonbinding guidelines to limit the spread of COVID-19 among workers. Those guidelines were issued April 26 by the CDC and the Occupational Safety and Health Administration. The agencies issued further guidance on May 12.
The executive order authorized the USDA as the lead federal agency to take “all appropriate action to ensure that meat and poultry processors continue operations consistent with the guidance for their operations jointly issued by the CDC and OSHA.”
USDA expands reach
The April order also gave Agriculture Secretary Sonny Perdue the ability to put more of the food supply chain under the Defense Production Act, with language that he “may identify additional specific food supply chain resources that meet” the criteria of the law.
The USDA has not invoked the Defense Production Act to prevent meat and poultry plants from closing, focusing instead on getting closed plants reopened.
The May 19 USDA-FDA memorandum lays out procedures for the agencies to communicate about processing and packing facilities under FDA’s authority. The announcement cited fruit and produce packing and processing facilities as a concern.
The USDA and the FDA are the primary federal food regulators. The USDA oversees most meat, poultry and catfish, while the FDA has jurisdiction over produce, dairy products, processed foods, seafood and shellfish.
Gavin Gibbons, spokesman for the National Fisheries Institute, said his industry welcomed the USDA-FDA agreement.
“We think this is forward-looking where two regulators are coming together and looking ahead,” Gibbons said. FDA regulates the industry for food safety.
Jennifer McEntire, food safety and technology vice president for the United Fresh Produce Association, told the association’s membership that the agreement would allow the USDA to intervene using the Defense Production Act “if there is a risk of supply chain disruption for FDA-regulated foods, not just meat and poultry. Collaboration between USDA and FDA is a good thing, but I hope we never need to call upon this MOU.”
If FDA raises concerns or reports back to the USDA about circumstances that could lead to closure of a facility, the department has the option to step in and keep the facility open under the Defense Production Act.
“It extends the secretary of Agriculture’s authority to function under the Defense Production Act in terms of considering those operations to be critical, and presumably there are certain contractual decisions that could be made consistent with the act that you could not otherwise do,” said Robert G. Hibbert, a partner at the Morgan Lewis law firm.
“They sort of came in through a side door. In that initial executive order there’s language about the secretary of Agriculture’s potential additional authority to do other things in the food chain,” Hibbert said. “The MOU kind of drops the other shoe in terms of saying, OK, we understand these would be FDA-regulated products, but the secretary of Agriculture has been granted the authority so he’s the one to exercise it, but he should do that in consultation with the FDA.”
John Dillard, an attorney with Olsson Frank Weeda Terman Matz PC, said there’s a gray area about how much liability protection the USDA could extend to a facility by placing it under the Defense Production Act. The law includes immunity provisions for a facility in a breach of contract dispute with a commercial client if it falls behind in fulfilling an agreement because of work for the government, Dillard said.
He said if the USDA extended the Defense Production Act to an FDA-inspected facility, the protection for a business under the law in cases involving worker safety or health would be limited, with the most likely defense being that the facility made a good-faith compliance with the OSHA guidance on COVID-19 workplace safety.
“If a worker gets sick, I don’t see there being rock-solid liability protection,” he added.