FDA Set to Deprioritize Inspections, Sampling for Imported Foods From SRA Countries
The FDA looks set to deprioritize its sampling and inspection activities for imported foods covered by systems recognition arrangements (SRA) between the FDA and foreign food safety authorities, according to a draft guidance document released by the agency July 9. Foreign food facilities would see fewer establishment inspections, and the FDA would adjust its screening and targeting criteria, import sampling and Foreign Supplier Verification Program inspections to account for SRAs, it said.
“Under an SRA, FDA intends to rely on the food safety oversight of the foreign competent authority, which then helps FDA refine its risk-based decisions about the scope and frequency of its oversight activities related to imported products, including foreign facility inspections, import field exams, and import sampling,” the agency said. “Systems recognition allows FDA to avoid duplicating certain food safety-related work in countries with an SRA.”
For foreign establishments located in countries with an SRA, “FDA does not intend to prioritize” inspections, it said in the draft guidance. “Therefore, FDA’s routine inspections of foreign food establishments for food products covered by an SRA will be rare, allowing FDA to allocate its risk-based foreign inspection resources more efficiently and effectively.” Inspections would continue apace for foods not covered by the SRA, inspections on a for-cause basis, or inspections requested by a foreign authority, FDA said.
The FDA also “intends to adjust its risk-based screening and targeting criteria for import entries of food products covered by an SRA to reflect FDA’s determination of the comparability of the regulatory system covered by an SRA, and to allow for more efficient and effective use of FDA’s import investigation and screening resources,” the agency said. However, an SRA would not automatically affect a food’s listing on import alert, it said.
The agency would not prioritize samples and field examinations of food products covered by an SRA “generally,” it said. However, the FDA would continue to prioritize sampling of shipments from countries with an SRA if the food is targeted for FDA surveillance, the specific food is not covered by an SRA, or on a for-cause basis.
Finally, the “FDA does not intend to prioritize inspections of importers for [Foreign Supplier Verification Programs (FSVP)] compliance or compliance with juice and seafood [Hazard Analysis Critical Control Point (HACCP)] importer requirements with respect to imported foods covered by an SRA,” the agency said. “However, FDA may periodically verify that importers of food products covered by an SRA are in compliance with FSVP and HACCP importer requirements,” it said.