On March 17, 2020, the U.S. Food and Drug Administration (“FDA”) issued a Temporary Policy regarding preventive controls and food supplier verification audit requirements during the COVID-19 public health emergency. This guidance explains the current intent of FDA to not enforce onsite audit requirements in certain circumstances related to the impact of COVID-19. Such onsite audit requirements can be found in three important food regulations:

  1. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 CFR Part 117);
  2. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507); and
  3. Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (21 CFR Part 1 Subpart L).

The Agency has stated that this temporary guidance will become effective immediately, without comment from the public, due to the exigent circumstances surrounding this ongoing public health threat.

The following is a list of circumstances in which onsite audit requirements will not be enforced:

  1. A receiving facility or Food Supplier Verification Program (“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 foreign supplier verification program;
  2. 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;
  3. In light of a government 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 (e.g., a receiving facility or FSVP importer is unable to obtain the services of a qualified auditor in the impacted country or region or travel to the foreign supplier to conduct the onsite audit); and
  4. 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 foreign supplier verification program to incorporate the alternative activity or activities. The alternative verification activity(ies) is designed, in consideration of the temporary unavailability of supplier onsite audits, to provide sufficient 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 intends to provide timely notice about the withdrawal of this policy but asks facilities and FSVP importers to resume onsite audits within a reasonable period of time once it becomes practicable to do so.  Facilities and importers should also update their food safety plans and foreign supplier verification programs accordingly.

The Agency also plans to conduct a phone briefing later this week to discuss the impacts of COVID-19 on the food industry.[1] We will provide updates as more information becomes available.

[1] https://www.fda.gov/food/cfsan-constituent-updates/fda-issues-temporary-covid-19-policy-receiving-facilities-and-fsvp-importers-meeting-fsma-supplier