U.S – The U.S. Food and Drug Administration (FDA) has published a notice of a new draft guidance document on FDA Oversight of Food Products Covered by Systems Recognition Arrangements, specifically adjustments to activities that include inspections, screening and sampling to enhance the safety of imported foods.
A Systems Recognition Arrangement (SRA) establishes a regulatory partnership between FDA and another food safety authority, in countries with systems the regulatory body has concluded operate comparable regulatory programs that yield similar food safety outcomes.
It is not only an efficient way to help ensure that safe food is imported into the U.S., it also contributes to a safer global food supply.
The new draft guidance details modifications to FDA’s regulatory oversight activities for food products covered by an SRA and imported from a country with an active SRA.
It does not affect activities for food exported from a country whose food safety system is covered by an SRA while the specific type of food is not covered by the SRA or “for-cause” activities concerning food products covered by an SRA.
The FDA can leverage regulatory partners’ food safety systems, reallocate resources in a more risk-based manner, and improve and expand information sharing on food safety issues.
In addition, it can improve efficiency as it avoids duplicating food safety-related work in countries that have been determined to produce similar food safety outcomes through an assessment and recognition process.
The SR program is voluntary and not a requirement for a country to export foods to the United States.
According to the adjustments, In-country food establishment inspections will be rare in countries with an SRA.
Automated screening and risk-targeting and review of imported food will be adjusted, although foods subject to Detention Without Physical Examination (DWPE) under an existing Import Alert (IA) will not be automatically removed from the IA when an SRA is signed.
An IA list is based upon FDA surveillance of imported products and detected patterns of noncompliance.
Most listings take the form of a Red List Import Alert, in which specific firms from a certain country have a pattern of non-compliance and thus are added to the Alert.
In addition, imported food covered by an SRA will generally not be prioritized for examination and sampling unless it is a commodity subject to routine surveillance sampling that targets both domestic and import samples.
Further, the FDA does not intend to prioritize inspections of importers for Foreign Supplier Verification Program (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.
With respect to regulatory compliance actions, FDA may issue warning letters, add establishments or food products to DWPE, refuse products offered for import, or take other regulatory actions as appropriate when food covered by an SRA that appears violative is offered for import and/or is intended for use in the United States.
Stakeholders are called upon to submit comments on the new draft guidance by September 10, 2021 to ensure consideration before FDA begins work on the final version of the guidance.