FDA on effort to resume shellfish trade with the EU.

FDA seek view on European Union’s Shellfish Safety Program to resume trade

UNITED STATES
Friday, March 16, 2018, 11:00 (GMT + 9)

Food safety control system for raw bivalve molluscan shellfish (“shellfish”) intended for export into the United States, as administered by the European Commission (EC), provides at least the same level of sanitary protection as the United States' 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 FDA on the Interstate Certified Shellfish Shippers List (ICSSL). This notice also briefly describes the processes whereby other EU Member States (EUMS) may be approved in the future.

Comments must be received on or before May 23, 2018 to ensure consideration before the equivalence determination is finalized.

Commissioner of the U.S. Food and Drug Administration (FDA) Scott Gottlieb

The Commissioner Scott Gottlieb, M.D., has make a Statement from FDA on effort to help bolster U.S. shellfish market by taking mutually beneficial steps to resume shellfish trade with the EU:

"Seafood is an important part of a healthy diet and a high-quality source of nutrients, so it’s not surprising that seafood is one of the most highly-traded commodities in the world. I recognize that a lot of work happens between catching a fish or harvesting shellfish to when it gets to our plates for our families to safely enjoy. Bringing fish to Americans begins with the harvesters and fishers and involves shuckers, processors, distributors and retailers that all work with regulatory agencies to make sure standards of food safety are met whether fish is harvested at home or abroad. These supply chains are critical because the American seafood industry contributes more than $90 billion to the U.S. economy, according to the Brookings Institution, and supports about 1.5 million jobs.

Roughly three-quarters of the world’s purchasing power and more than 95 percent of the world’s consumers are outside of America's borders. That makes trade a significant engine of growth for our economy and important for American businesses. This is especially true when it comes to seafood. Fish products account for more than $5 billion in total value of U.S. exports, and roughly one-third of that is shellfish. With a 6 percent share of global trade, the U.S. represents the sixth-largest supplier of fish and seafood products to the world market. Moreover, American businesses have seen a steady growth in seafood exports over the last decade with one of the largest export markets being the European Union (EU).

Yet for nearly eight years, the U.S. and EU have not traded any raw molluscan shellfish products, meaning consumers have been missing out on choices in the market place and businesses in both the U.S. and EU have missed opportunities for new commerce. U.S. shellfish imports have not been allowed to enter the EU by the European Commission (EC) since 2010 and the U.S. Food and Drug Administration has not permitted the import of live, fresh or fresh-frozen molluscan shellfish from the EU since the 1980s. In order to help break down this trade barrier and ensure the safety of imported shellfish products in both markets, the U.S. and the EU have been actively working to move an equivalence determination process forward.

That’s why I’m pleased to announce today that the FDA and the EU have set in motion steps that will allow molluscan shellfish trade – or what you may know as clams, mussels, oysters and scallops, among others – between the U.S. and the EU for the first time in years. Specifically, the FDA has published a proposed determination that the safety controls in the EU are equivalent to those of the U.S. In a separate but complementary action, the EC is completing administrative procedures for its own proposed determination that U.S. safety controls are equivalent to those in the EU, a necessary step towards resuming trade."

editorial@seafood.media

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