Background

The Food and Drug Administration is seeking input by May 23 on a proposed determination that the European Union food safety control system for raw bivalve molluscan shellfish intended for export into the U.S. provides at least the same level of sanitary protection as the U.S. system and is therefore equivalent. If finalized, this determination would permit the importation of shellfish harvested from certain production areas and processed by establishments that have been listed by the FDA on the Interstate Certified Shellfish Shippers List.

The proposed determination would only apply to EC Class A growing areas (approved for the harvesting of shellfish for direct consumption) where additional controls have been implemented to satisfy specific U.S. food safety concerns. Currently, the only shellfish growing areas in the EU that have been determined to be implementing these additional controls are in the Netherlands and Spain, but the FDA proposal describes the process whereby the agency may recognize additional growing areas and list additional processing facilities on the ICSSL in the future.

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