By David Fairfield, Senior Vice President, Feed
The U.S. Food and Drug Administration (FDA) on March 17 issued guidance to communicate the agency’s intention temporarily not to enforce supplier verification onsite audit requirements for receiving facilities and importers under the Food Safety Modernization Act (FSMA) in response to the global COVID-19 pandemic if other supplier-verification methods are used instead.
Three of the FSMA-related regulations – the Preventive Controls for Human Foods (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 if they rely on suppliers to control hazards within their food safety plans. These verification activities generally include onsite audits, sampling and testing, or a review of food safety records.
Given the travel restrictions and advisories associated with COVID-19, FDA says that supplier audits temporarily may be impractical to conduct. Therefore, the agency’s new guidance outlines the circumstances under which FDA does not intend to enforce the requirement to conduct or obtain an onsite audit of a food supplier when the food supplier is in a country or region covered by a government travel restriction or advisory related to COVID-19.
Specifically, FDA announced it does not intend to enforce the requirement for an onsite audit in the following circumstances:
- A receiving facility or FSVP importer has determined that an onsite audit is the appropriate verification activity for an approved supplier, as reflected by its written food safety plan or FSVP;
- The supplier that is due for an onsite audit is in a region or country covered by a government travel restriction or travel advisory related to COVID-19;
- Because of the travel restriction or travel advisory, it is temporarily impracticable for the receiving facility or FSVP importer to conduct or obtain the onsite audit of the supplier; and
- The receiving facility or FSVP importer temporarily selects an alternative verification activity or activities, such as sampling and testing food or reviewing relevant food safety records, and modifies its food safety plan or FSVP to incorporate the alternative activity or activities. The alternative verification activity(ies) are designed to provide temporary assurance that the hazard requiring a supply chain-applied control (or, for FSVP, the hazard that is being controlled by the foreign supplier) has been significantly minimized or prevented during the period of onsite audit delay.
FDA said receiving facilities and FSVP importers should resume onsite audits within a reasonable period of time after it becomes practicable to do so, and should update their food safety plans and foreign supplier verification programs accordingly. FDA also said the agency intends to provide timely notice about the withdrawal of its new temporary policy.