During Coronavirus Outbreak, FDA Issues Temporary Policy on FSMA On-Site Audits

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During Coronavirus Outbreak, FDA Issues Temporary Policy on FSMA On-Site Audits

By Bridget Goldschmidt - 03/18/2020
During Coronavirus Outbreak, FDA Issues Temporary Policy on FSMA On-Site Audits
While asking U.S. shoppers not to stockpile products, FDA Commisioner Stephen Hahn said he was "confident that stores will remain open and supply will continue to meet demand nationwide"

The U.S. Food and Drug Administration (FDA) has issued a temporary policy for FDA Food Safety Modernization Act (FSMA) supplier verification on-site audit requirements during the coronavirus (COVID-19) pandemic, with the goal of helping to prevent disruptions in the food supply chain.

“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,” noted FDA Commissioner Stephen M. Hahn. “The policy … 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. Sometimes, an FSVP will determine that an on-site audit is the most appropriate supplier verification activity.

The travel restrictions and advisories associated with the coronavirus outbreak may make some audits temporarily impractical to conduct, however, the temporary policy enables the federal agency not to enforce FSMA supplier verification on-site audit requirements if other appropriate supplier verification methods, such as sampling and testing or a review of food safety records, are implemented instead.

The FDA said it expected receiving facilities and FSVP importers would resume on-site audits “within a reasonable period of time after it becomes practicable to do so, and update their food safety plans and FSVPs accordingly.” The federal agency added that it planned to provide timely notice before rescinding the temporary measure.

Additionally, the FDA, together with food industry members and its federal and state partners, is closely monitoring the food supply chain for any shortages, remaining in regular contact with food manufacturers and grocery stores. 

According to the agency: “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 widespread disruptions reported in the supply chain.”