FDA Temporarily Postpones All US Routine Surveillance Plant Inspections

The US Food and Drug Administration (FDA) on Wednesday announced that, in response to the coronavirus pandemic, it is temporarily postponing all domestic routine surveillance facility inspections.

Stephen M. Hahn, FDA’s commissioner, said FDA was postponing these inspections for the health and well-being of its staff and those who conduct inspections for the agency under contract at the state level, and because of industry concerns about visitors.

The inspections that are being postponed are facility inspections that FDA traditionally conducts every few years based on a risk analysis, Hahn explained. All domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical.

During this interim period, FDA is evaluating additional ways to conduct its inspectional work that would not jeopardize public safety and protecting both the firms and FDA staff, Hahn said. This can include, among other things, evaluating records in lieu of conducting an onsite inspection on an interim basis when travel is not permissible, when appropriate.

Also this week, FDA issued guidance to communicate the agency’s intention to temporarily not enforce supplier verification onsite audit requirements for receiving facilities and importers under the FSMA in response to the global coronavirus pandemic. FDA said it does not intend to enforce the onsite audit requirements if other supplier verification methods are used instead.

Three of the regulations created to implement FSMA — the preventive controls for human food rule, preventive controls for animal food rule, and Foreign Supplier Verification Programs (FSVP) rule — require receiving facilities and importers to conduct supplier verification activities based on the hazards analysis conducted as part of their written food safety plan or FSVP, FDA noted. These verification activities generally include onsite audits, sampling and testing, or a review of food safety records.

When receiving facilities and importers develop their food safety plans or FSVP, they sometimes determine onsite audits to be the most appropriate supplier verification activity, FDA noted. However, the travel restrictions and advisories associated with the coronavirus pandemic may make some audits temporarily impractical to conduct.

Therefore, the guidance released by FDA this week outlines the circumstances under which the agency does not intend to enforce the requirement to conduct or obtain an onsite audit of a food supplier when the supplier is in a country or region covered by a government travel restriction or advisory related to coronavirus.

In other federal government food-related developments, the AMS announced that its Commodity Procurement Program (CPP) will remain fully operational, and it plans to continue to work with federal, state, and local partners to purchase and distribute food to participants in domestic and international nutrition assistance programs.

Many schools and institutions are closed across the US, and there may be other disruptions at warehouses, ports, and distribution centers, AMS noted. This may result in requests to delay or divert deliveries or provide other flexibilities.

To avoid delivery issues and challenges, AMS said all contracted vendors should: make and confirm delivery appointments prior to shipping; and communicate with CPP contract specialists or contracting officers for any deviation to contractual requirements.

The Department of Transportation’s Federal Motor Carrier Safety Administration (FMCSA) issued a national emergency declaration to provide hours-of-service regulatory relief to commercial vehicle drivers transporting emergency relief in response to the coronavirus outbreak.
FMCSA’s declaration provides for regulatory relief for commercial motor vehicle operations providing direct assistance supporting emergency relief efforts intended to meet immediate needs for, among other things, food for emergency restocking of stores.

The FMCSA issued an expanded national emergency declaration to provide hours-of-service regulatory relief to commercial vehicle drivers transporting emergency relief. The declaration provides relief for commercial vehicle operations that provide efforts to meet needs forthings like, food, paper products and other groceries for restocking of distribution centers or stores. Direct assistance does not include routine commercial deliveries..

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