FDA Issues Temporary Policy For FSMA Onsite Audit Requirements During COVID-19
Source U.S. Food and Drug Administration
March 17, 2020 -- Today, the U.S. Food and Drug Administration took steps to help prevent disruptions in the food supply-chain by issuing a temporary policy for FDA Food Safety Modernization Act (FSMA) supplier verification onsite audit requirements during the coronavirus (COVID-19) public health emergency.
“While our grocery stores are facing unprecedented demand, we are working with industry to minimize disruptions in the supply-chain due to COVID-19 related travel restrictions,” said FDA Commissioner Stephen M. Hahn, M.D. “The policy released today will help to minimize disruptions so that the food industry can meet the demand while also continuing to conduct supplier verification activities that are designed to ensure food safety and following government travel restrictions and advisories. While we are confident that stores will remain open and supply will continue to meet demand nationwide, we ask all Americans to only purchase enough food and essentials for the week ahead.”
Three of the regulations created to implement FSMA - the Preventive Controls for Human Food (PC Human Food) rule, Preventive Controls for Animal Food (PC Animal Food) rule, and Foreign Supplier Verification Programs (FSVP) rule – require receiving facilities and importers to conduct supplier verification activities based on the hazard analysis conducted as part of their written Food Safety Plan or FSVP. When receiving facilities and importers develop their Food Safety Plans or FSVP, they sometimes determine onsite audits to be the most appropriate supplier verification activity.
However, the travel restrictions and advisories associated with the novel coronavirus may make some audits temporarily impractical to conduct. Therefore, the policy announced today states that the agency will temporarily not enforce FSMA supplier verification onsite audit requirements if other appropriate supplier verification methods are used instead. Other supplier verification methods, such as sampling and testing or a review of food safety records, would be designed to provide sufficient assurance that hazards have been significantly minimized or prevented during the period of onsite audit delay.
The FDA anticipates that receiving facilities and FSVP importers will resume onsite audits within a reasonable period of time after it becomes practicable to do so, and update their food safety plans and FSVPs accordingly.
The FDA intends to provide timely notice before withdrawing this policy.
Separately, the FDA, in collaboration with industry and our federal and state partners, is closely monitoring the food supply chain for any shortages. We are in regular contact with food manufacturers and grocery stores.
There are no nationwide shortages of food, although in some cases the inventory of certain foods at your grocery store might be temporarily low before stores can restock. Food production and manufacturing are widely dispersed throughout the U.S. and there are currently no wide-spread disruptions reported in the supply chain.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
