The U.S. Food and Drug Administration last Friday published draft guidance that provides recommendations related to its regulatory oversight activities for food products imported from countries whose food safety systems the FDA has recognized in Systems Recognition Arrangements (SRAs).
According to the FDA’s new policy, it intends to deprioritize sampling and inspection activities for imported foods covered by an SRA, such as Canada. The FDA says this and other proposed changes will allow it “leverage the work done by foreign competent authorities to help ensure the safety of imported foods.”
Systems recognition involves reviewing a foreign country’s domestic food safety regulatory system to determine if it has legal authorities and regulatory tools that together provide public health outcomes comparable to those provided by the FDA.
SRAs allow the FDA and participating agencies to prioritize resources in a more risk-based manner and improve and expand information sharing on food safety issues.
Currently, the FDA has signed SRAs with food safety agencies in three countries: Canada, Australia, and New Zealand. The SRA with Canada, recognizing each other’s food safety systems as comparable to each other, was signed in 2016.
Under the new policy, with regards to food products covered by an SRA and imported from a country with an active SRA, FDA intends to adjust its regulatory oversight activities as follows:
In-country Food Establishment Inspections: FDA does not intend to prioritize foreign establishment inspections in countries with an SRA. FDA says this means that inspections of goods from these countries “will be rare,” although it still intends to continue conducting inspections in countries with SRAs in certain situations when necessary.
Automated Screening and Risk Targeting: FDA intends to adjust its risk-based screening and targeting criteria for import entries of food products covered by an SRA.
Examination and Sampling of Imported Food: Generally, FDA will not prioritize import samples and field examinations of food products covered by an SRA. However, the FDA indicates there will still be some limited situations where it will prioritize sampling a shipment of food products from a country with an SRA (e.g., sampling on a surveillance basis of a particular commodity involving both domestic and imported products).
Importer Verification Program: For imported foods covered by an SRA, FDA does not intend to prioritize inspections of importers for compliance with Foreign Supplier Verification Programs (FSVP) requirements, or with juice and seafood Hazard Analysis Critical Control Point (HACCP) importer requirements.
Interested stakeholders are invited to submit either electronic or written comments on the draft guidance by September 10, 2021, prior to the FDA beginning work on the finalized version. Additional details about submitting comments can be found in the Federal Register notice here.