The Food and Drug Administration is accepting comments through Sept. 10 on a draft guidance on the FDA’s regulatory oversight activities for food products imported from countries whose food safety systems the FDA has recognized in systems recognition arrangements.
An SRA establishes a regulatory partnership between the FDA and its regulatory counterpart in an exporting country when each side has concluded that the other has (1) a food safety system that provides a similar, though not necessarily identical, system of protections as its own and (2) a food safety authority or authorities that provide similar oversight and monitoring activities for food produced under its jurisdiction. To date the FDA has signed SRAs with food safety agencies in Australia, Canada, and New Zealand.
For food products covered by an SRA and imported from a country with an active SRA, the FDA intends to adjust its regulatory oversight activities as follows.
- Routine inspections of foreign food establishments for such foods will be rare and import samples and field exams of food products covered by an SRA will not be prioritized. However, inspections and sampling will be conducted for foods not covered by the SRA or when necessary to address specific food safety issues or public health concerns.
- The FDA will not generally prioritize inspections of importers for Foreign Supplier Verification Program compliance or compliance with juice and seafood Hazard Analysis and Critical Control Point importer requirements with respect to imported foods covered by an SRA.
- Risk-based screening and targeting criteria for imports of food products covered by an SRA will be adjusted to reflect the FDA’s comparability determination.
- Food products and establishments subject to detention without physical examination under an existing import alert will not be automatically removed from the alert when an SRA is signed.
- The FDA may pursue regulatory actions such as warning letters, import alerts, and refusing imports when food covered by an SRA that appears violative is offered for import into the U.S. and/or intended for use in the U.S.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report on July 21, 2021.