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  1. CFSAN Constituent Updates

FDA Publishes Proposed Determination that European Union’s Shellfish Safety Program is Equivalent to U.S. System

Constituent Update

March 8, 2018

The U.S. Food and Drug Administration (FDA) is inviting public comment in a Federal Register notice on a proposed determination that the European Union (EU) food safety control system for raw bivalve molluscan shellfish intended for export into the U.S. is equivalent to the U.S. system because it provides at least the same level of sanitary protection as the U.S. system.

The proposed equivalence determination is based on the FDA’s in-depth review of the EU’s food safety controls, including certain provisions critical for ensuring the food safety of molluscan shellfish. If finalized, it would permit the importation of shellfish harvested from selected production areas (initially, only in the Netherlands and Spain) and processed by establishments that have been listed by the FDA on its Interstate Certified Shellfish Shippers List (ICSSL).

In a separate action, described briefly in the Federal Register Notice, the European Commission (EC) is in the process of finalizing its proposed equivalence determination regarding the U.S. food safety control system for shellfish. The EC’s proposed determination, if finalized, would permit the importation of shellfish harvested from approved growing areas in Massachusetts and Washington states initially, although other states may be added over time.

These actions when finalized would open the EU market to shellfish exports from the U.S. and vice versa. U.S. shellfish imports have not been allowed by the EC since 2010. FDA has not permitted the import of live, fresh, or fresh-frozen molluscan shellfish from the EU since the 1980s.

The FDA asks for information and public comment on the proposed determination set forth in the Federal Register notice. The comment period for the Federal Register notice opens March 9, 2018, and runs for 75 days. Submit electronic comments through http://www.regulations.gov. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2018-N-0810, as listed in the notice of availability that publishes in the Federal Register.

For additional information not covered in the Federal Register notice that relates to the EC’s proposed equivalence determination of the U.S. shellfish safety system, including eligibility to export U.S. shellfish to the EU, the procedures for adding new U.S. states, as well as other steps relating to the implementation of the equivalence determinations, see Supplementing Information on International and Interagency Coordination/International Cooperation/Equivalence.

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