FDA Issues Temporary COVID-19 Policy for Foreign Supplier Verification Programs
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FDA issues Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency: Guidance for Industry
In response to the ongoing COVID-19 public health emergency, the Food and Drug Administration (FDA) has issued guidance to temporarily suspend enforcement of supplier verification onsite audit requirements for receiving facilities and importers under the Food Safety Modernization Act (FSMA). Instead, facilities should use other supplier verification methods.
This recent guidance is in response to global travel restrictions in place to prevent the spread of COVID-19. It applies to
- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 CFR part 117),
- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food For Animals (21 CFR part 507), and
- Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (21 CFR part 1 subpart L).
The FDA does not plan to enforce onsite audit requirements in the following circumstances:
- A receiving facility or FSVP importer has determined that an onside 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 or activities are designed to provide temporary assurance that the hazard requiring a supply-chain-applied control (or, for FSVP, the hazards that is being controlled by the foreign supplier) has been significantly minimized or prevented during the period of onsite audit delay.
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. FDA intends to provide timely notice before withdrawing this policy.
Stay tuned to FDA updates for when this policy will be withdrawn.
Read the complete guidance: Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency: Guidance for Industry
If you have questions about animal food safety, please contact Marissa Herchler.