The changes specifically concern the oversight of food products produced in or imported from countries that are covered by Systems Recognition Arrangements (SRA). An SRA is a partnership between the FDA and a foreign regulatory equivalent, in which the two agencies agree that they operate comparable regulatory programs that yield similar food regulation outcomes.
According to the agency, the strategy reflects a greater risk-based approach in ensuring compliance for importers, allowing the FDA to reallocate resources in a “more risk-based manner.”
“It is not only an efficient way to help ensure that safe food is imported into the United States, it also contributes to a safer global food supply,” said Frank Yiannas, the deputy commissioner for food policy and response at the FDA, in a statement. “We can improve efficiency as we avoid duplicating food safety-related work in countries that have been determined to produce similar food safety outcomes through an assessment and recognition process.”
New Regulations Expected
The new draft guidance details the adjustments expected for the FDA’s regulations on food products covered by an SRA and imported from a country with an active SRA partnership with the United States—currently, these countries are Australia, Canada, and New Zealand.
Under the new proposed regulation, in-country food establishment inspections will be rare in these countries for foods that are covered by the SRA. Imported food covered by an SRA will usually not be prioritized for examination and sampling, unless it is a commodity that usually undergoes routine surveillance of both domestic and import samples.
Automated screening and review of imported food will also be adjusted, though foods currently under an import alert will not be automatically removed from that distinction when an SRA is enacted.
In terms of regulatory compliance actions, the FDA can still issue warning letters and take regulatory action when food covered by an SRA is found to be in violation.
Stakeholders must submit comments to the FDA by September 10 in order to ensure consideration by the FDA before the agency works on the final version of the guidance.
Danny Flynn is assistant editor at Compliance Chief 360°.