Today, the U.S. Food and Drug Administration (FDA) and the European Commission (EC), have taken important steps to open the market for the sale of molluscan shellfish, including oysters, clams, mussels and scallops, from both the United States and the European Union to their consumers. Initially, certain firms in Washington and Massachusetts will have access to the EU market. U.S. firms in other states soon will have an opportunity to be considered, using a streamlined process established by FDA and the EC.

Today, the FDA announced its first-ever equivalence determination with a notice in the Federal Register. The equivalence determination will enable Spain and the Netherlands to export raw bivalve molluscan shellfish to the United States. Specifically, FDA’s equivalence determination finds that the adoption and implementation by Spain and the Netherlands of the European Union’s (EU’s) system of food safety control measures for raw bivalve molluscan shellfish, along with their application of additional measures specifically adopted for export to the United States, provides at least the same level of sanitary protection as comparable food safety measures in the United States and is therefore equivalent. The FDA and the EU have not allowed the import of raw molluscan shellfish from each other since 2010.

Today’s equivalence determination finalizes the proposed determination that FDA  published a notice in the Federal Register on March 9, 2018. In response to that notice, the FDA received approximately 25 comments, most of which generally supported the proposed equivalence determination and the technical basis for the FDA’s conclusion. 

FDA will host a Webinar with the Interstate Shellfish Sanitation Conference for the shellfish industry and state shellfish control authorities on-or-about October 1, 2020. Details will be posted on Workshops, Meetings & Webinars on Food and Dietary Supplements.

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