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Questions and Answers on Shellfish Traded Between the United States and Certain Member States of the European Union

Shellfhish U.S and E.U

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These questions and answers provide information about the implementation, operation, and maintenance of an equivalence determination for food safety measures related to shellfish traded between the European Union (EU) and the United States. The Food and Drug Administration (FDA or we) announced in a Federal Register Notice publishing on September 24, 2020, a final determination that the adoption and implementation by Spain and the Netherlands of the EU’s system of food safety control measures, along with their application of additional measures specifically adopted for this purpose, for raw bivalve molluscan shellfish (“shellfish”) for export to the United States, as evaluated by FDA, provides at least the same level of sanitary protection as comparable food safety measures in the United States and is therefore equivalent.  The European Commission (EC) has finalized its equivalence determination of the U.S. system of food safety control measures for shellfish after completing a technical assessment of two U.S. participants implementing the National Shellfish Sanitation Program (NSSP participants),[1]Massachusetts and Washington.  These equivalence determinations will enable exports of shellfish from Massachusetts and Washington to the EU and from Spain and the Netherlands to the United States.  Upon request by FDA, the EC will consider whether to permit importation from additional NSSP participants and FDA will evaluate additional EU Member States for equivalence according to procedures described below.

Information for U.S. Shippers and NSSP Participants Based on the EC’s Equivalence Determination

Information for EU Shippers and EU Member States Based on FDA’s Equivalence Determination

Other Information

[1] The National Shellfish Sanitation Program (NSSP) is the federal/state cooperative program recognized by FDA and the Interstate Shellfish Sanitation Conference (ISSC) for the sanitary control of shellfish produced and sold for human consumption.  NSSP participants refers to authorities from shellfish producing and non-producing States responsible for implementing the NSSP.

[2] In the United States, the term “growing area” means any site which supports or could support the propagation of shellstock by natural or artificial means.  National Shellfish Sanitation Program (NSSP), Guide for the Control of Molluscan Shellfish (2017 Revision) (NSSP Guide), p. 6.  “Approved” means a classification used to identify a growing area where harvest for direct marketing is allowed.  NSSP Guide, p. 3.

[3] Commission Implementing Decision (EU) 2018/1668 of November 6, 2018 amending Annex I to Decision 2006/766/EC as regards the entry for the United States of America in the list of third countries and territories from which imports of live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods for human consumption are permitted.

[5]These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).  The collections of information associated with the Interstate Shellfish Dealer’s Certificate have been approved under OMB Control No. 0910-0021.  The collections of information in 21 CFR part 123 have been approved under OMB Control No. 0910-0354.  Other collections of information have been approved under OMB Control No. 0910-0509.

[6] The EC uses the term “production area” and defines it as “any sea, estuarine or lagoon area, containing either natural beds of bivalve molluscs or sites used for the cultivation of bivalve molluscs, and from which live bivalve molluscs are taken.”  Commission Regulation (EC) No. 853/2004, Annex I, 2.5 (April 29, 2004).  EC-identified “Class A” production area means the production area is approved for the harvesting of shellfish for direct consumption.


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