June 29, 2022

Volume XII, Number 180

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June 29, 2022

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FDA Publishes Guidance on Oversight of Food Covered by SRAs

  • On June 21, the FDA published a final guidance for FDA staff entitled “FDA Oversight of Food Covered by Systems Recognition Agreements” (SRAs). The guidance covers FDA’s regulatory oversight activities for food covered by SRAs between FDA and foreign regulatory counterparts. SRAs establish a regulatory partnership between the FDA and the Agency’s regulatory counterpart. At present, FDA has signed SRAs with food safety agencies in Australia, Canada, and New Zealand.

  • Systems Recognition (SR) take into account whether (1) another country’s food safety system provides a similar, though not necessarily identical, system of food safety protections as the US, and (2) another country’s food safety authority provides similar oversight and monitoring activities for food produced in their jurisdiction as FDA provides. In short, SRAs are based on the conclusion that food safety systems with similar levels of oversight lead to similar food safety outcomes.

  • SR allows FDA to avoid duplicating certain food safety-related work in countries with an SRA. For food imported from a country with an active SRA, FDA intends to adjust its regulatory oversight, including as follows:

    • FDA’s routine inspections of foreign food establishments for food covered by an SRA will be rare (except for certain situations), allowing FDA to allocate its risk-based foreign inspection resources more efficiently and effectively.

    • FDA intends to adjust its risk-based screening and targeting criteria for import entries of food covered by an SRA to reflect FDA’s determination of the comparability of the regulatory system covered by an SRA

    • FDA will not prioritize import samples and field examinations of food covered by an SRA.

    • With respect to imported foods covered by an SRA, FDA does not intend to prioritize inspections of importers for FSVP compliance or compliance with juice and seafood HACCP importer requirements.

© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 173
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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