FDA Announces Temporary Changes to Onsite Audit Obligations Under FSMA for Receiving Facilities and FSVP Importers

On March 17, 2020, in light of the ongoing global public health emergency and associated travel restrictions, the FDA announced a temporary policy adjustment for food facilities with certain supplier verification obligations under the Federal Food Safety Modernization Act and its implementing regulations.

Receiving facilities and FSVP importers that, as part of their Food Safety Plan or Foreign Supplier Verification Program, have determined to use onsite audits as the supplier verification activity are temporarily not required to conduct those onsite audits if certain criteria are met. According to the Guidance Document, the FDA does not intend to enforce the requirement for an onsite audit in the following circumstances:

1. 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 foreign supplier verification program;
   
   
2. The supplier is due for an onsite audit 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 to 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 activities are designed to provide temporary assistance to provide sufficient assurances 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.

Companies that use onsite audits as a supplier verification activity should:

1. Determine which (if any) of their suppliers are in a region or country covered by a travel restriction or ban (note: this will require frequent reevaluation, as the countries under a government travel ban or restriction evolve);
   
   
2. Determine whether it is temporarily impracticable to conduct the onsite audit even if using a qualified auditor in that country or region; and
   
   
3. If it is impracticable to conduct an onsite audit, select a different verification activity or activities for those suppliers and update the company’s Food Safety Plan or foreign supplier verification program to reflect that change. Make sure that any temporary changes to the Food Safety Plan or foreign supplier verification program are signed and dated.

The FDA notes that it will provide "timely notice" about the eventual withdrawal of this policy.

Links to FDA COVID-19 Resources:

• Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency: Guidance for Industry (March 2020)
• FDA, Coronavirus Disease 2019 (COVID-19)

The facts, laws, and regulations regarding COVID-19 are developing rapidly. Since the date of publication, there may be new or additional information not referenced in this advisory. Please consult with your legal counsel for guidance.

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