On 11 March 2020, the outbreak of coronavirus disease (COVID-19) has been declared a global pandemic by the World Health Organization as the virus has spread to many countries. It’s the first time the WHO has called an outbreak a pandemic since the H1N1 “swine flu” in 2009. What is confirmed is that the virus…
Temporary COVID-19 Policy for Receiving Facilities in Meeting FSMA Supplier Verification Onsite Audit Requirements
As the global pandemic of COVID-19 continues to bring about turmoil and health threats, the U.S. Food and Drug Administration issued guidance to communicate the temporarily drop of the supplier verification onsite audit requirements for receiving facilities and importers under the FDA Food Safety Modernization Act (FSMA) provided other supplier verification methods are used instead.
The Preventive Controls for Human Food (PC Human Food) rule requires receiving facilities to conduct supplier verification activities based on the hazard analysis conducted as part of their written Food Safety Plan. These verification activities generally include onsite audits, sampling and testing, or a review of food safety records.
Receiving facilities may determine onsite audits to be the most appropriate supplier verification activity. However, many governments have taken strict measures to limit unnecessary inland and out-land travels in an effort to curb the spread of the COVID-19 coronavirus. Such much needed restrictions may impact the ability of receiving facilities to conduct or obtain onsite audits of their suppliers. Therefore, the 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.
The FDA anticipates that receiving facilities will resume onsite audits within a reasonable period of time after it becomes practicable to do so, and update their food safety plans accordingly. FDA intends to provide timely notice before withdrawing this policy.
Specifically, FDA does not intend to enforce the requirement for
an onsite audit in the following circumstances:
- A receiving facility 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 to conduct or obtain the onsite audit of the supplier; and
- The receiving facility 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 to incorporate the alternative activity or activities. The alternative verification activity or activities are designed to provide temporary assurance that the hazard requiring a supply-chain-applied control has been significantly minimized or prevented during the period of onsite audit delay.
FDA anticipates that receiving facilities will resume onsite audits within a reasonable period of time after it becomes practicable to do so, and update their food safety plans accordingly. FDA intends to provide timely notice before withdrawing this policy.
Sources: The Center for Food Safety and Applied Nutrition Constituent Update