FDA Issues Final Guidance on Systems Recognition Arrangements
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The U.S. Food and Drug Administration (FDA) has issued a final guidance, titled, FDA Oversight of Food Covered by Systems Recognition Arrangements: Guidance for Food and Drug Administration Staff, that addresses adjustments FDA has made to its regulatory oversight activities for imported food products covered by a Systems Recognition Arrangement (SRA). SRAs are made between another country’s food safety authority and FDA when the other country has proven to produce similar food safety outcomes to the U.S. through an FDA assessment.
SRAs allow FDA to leverage regulatory partners’ food safety systems, reallocate resources based on risk, and enhance information-sharing related to food safety issues. FDA has signed SRAs with participating agencies in Australia, Canada, and New Zealand, and is currently assessing food safety systems of certain countries in the European Union.
The final guidance outlines adjustments to FDA’s regulatory oversight activities for covered foods imported from a country with an active SRA, such as:
- Inspections of food establishments in countries with an active SRA
- Automated screening, risk targeting, and review of imported food
- Examination and sampling of imported food
- Relevance of importer verification programs
- Regulatory compliance actions.
FDA expresses that Systems Recognition advances the New Era of Smarter Food Safety initiatives and reflects the agency’s larger effort to develop a risk-based approach to food safety, consistent with the Food Safety Modernization Act (FSMA) and with FDA’s Strategy for the Safety of Imported Food.
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