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FDA Statement

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

For Immediate Release:
Statement From:
Scott Gottlieb, M.D.


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.

These critical determinations are a result of a multi-year, in-depth and cooperative review of shellfish safety systems in the U.S. and the EU, in which technical experts on both sides of the Atlantic have concluded that many of the safety controls in the EU and the U.S are equivalent. Both governments recommended these actions after reviewing existing food safety programs, safety measures for molluscan shellfish, and on-site audits to verify each other’s systems.

The proposed shellfish equivalence determination will help to unlock economic opportunity for both U.S. and EU exporters by creating new market access as well as making a wider selection of healthy and safe shellfish options available to consumers. It will also ensure American consumers that imported molluscan shellfish from Europe is as safe as what we produce in the U.S.

The U.S. and the EU worked with individual states and European countries to determine interest in participating in the initial equivalence evaluation, which required them to be subject to on-site audits. The FDA worked with the Interstate Shellfish Sanitation Conference as well as the Pacific Coast and East Coast shellfish associations to identify interested U.S. states that volunteered to participate. If the determination becomes final, Massachusetts and Washington state will once again be able to send bivalve molluscan shellfish to the European market – a first since 2010. Shellfish exporters from Spain and the Netherlands will also be able to sell raw bivalve shellfish in the U.S. market – a first since the 1980s. These states and countries are just the first, and we are committed to continuing to work with the EU on procedures to add more states and European countries. We share a goal to see other U.S. states subsequently added to the list of eligible exporters in an efficient way, following the completion of this important step.

I plan to announce more over the coming year about this proposed equivalence determination as we continue to work with the EU on the details for resuming mutually beneficial trade in this area. In the meantime, I’m committed to taking new approaches like this to maximize our shared resources and create greater efficiency in the trade of molluscan shellfish.

This bilateral effort shows that food safety and market access can go hand-in-hand. It’s another great case of the FDA collaborating with U.S. trade agencies and working with a trusted international partner to better prioritize resources, ensure food safety and facilitate mutually beneficial trade.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.



Peter Cassell

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