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collage of three photos featuring closeups of oysters and clams and wide shot of an FDA inspector overseeing a person sorting harvested oysters

By: Mark Abdoo, Associate Commissioner, Global Policy and Strategy, and Susan Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition

For the first time, the U.S. Food and Drug Administration is using a mechanism known as equivalence to begin reopening markets in raw and processed molluscan shellfish that have been closed to trade between the United States and the European Union (EU) since 2010.  

FDA Acting Deputy Commissioner for Global Regulatory Operations and Policy, Mark Abdoo
Mark Abdoo

Understanding the food safety issues surrounding molluscan shellfish helps to explain the significance of the equivalence determination, and why this trade mechanism goes hand-in-hand with strong food safety protections.   

Molluscan bivalve shellfish – such as oysters, clams, mussels and roe-on and whole scallops – are considered good sources of quality protein and are eaten either raw or processed. As filter feeders, molluscs take nourishment by filtering water containing plankton and food particles through their gills, which raises the importance of the safety of the water through which they eat. The U.S. shellfish industry follows a variety of rigorous food safety steps both during and after harvest to ensure the safety of its product and the FDA has specific procedures in place to ensure compliance. 

As a leader in food safety standards, the FDA has a variety of import controls to ensure that food coming from outside of the United States is safe for American consumers. The FDA stopped accepting raw shellfish imported from EU countries in the 1980s due to public health concerns. In 2010, the EU, which uses different safety controls for several aspects of their food control system, stopped accepting U.S. exports of raw bivalve molluscan shellfish after the European Commission (EC) conducted an audit and determined that the U.S. food safety controls were different from and did not comply with comparable EU requirements. 

In an effort to resume molluscan shellfish trade, the FDA and the EC decided to independently assess each other’s food safety controls for molluscan shellfish using an approach spelled out in the Veterinary Equivalency Agreement signed by the U.S. and the EU in 1999. Article 4 of the 1995 World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures provides a mechanism for facilitating trade between member countries that use different food safety control measures to achieve at least the same level of public health protection. 

Beginning in 2010, the FDA initiated an equivalence assessment of the EU food safety system for raw molluscan shellfish to see if the food safety measures, as specifically implemented in Spain and the Netherlands, provide at least the same level of safety protection as comparable measures in the United States. Separately, the EC initiated an assessment of the U.S. system.

The FDA’s efforts culminated in a proposed equivalence determination published in the Federal Register in 2018. The proposal would initially be limited to shellfish harvested from specified growing areas in Spain and the Netherlands, which would be required to implement additional controls for raw molluscan shellfish exported to the United States. 

Photo of Susan T. Mayne, Ph.D.
Susan T. Mayne, Ph.D.

Around the same time, the EU’s food safety regulatory authority separately determined the U.S. food safety control system for raw and processed molluscan shellfish to be equivalent to the EU system and would begin by accepting shellfish from certain growing areas in Massachusetts and Washington.

In addition to the FDA announcing a final equivalence determination today, since 2018, the FDA and the EU have been working out implementation details that will open the door for trade in raw molluscan shellfish. Although Spain and the Netherlands in the EU and Massachusetts and Washington in the United States will be the first participants, arrangements have been made to use a streamlined process for expanding market access between these two trading partners.    

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 United States is 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 EU, suggesting that today’s determination will help to unlock economic opportunity by creating a path forward to new market access for U.S. exporters. At the same time, today’s final determination will ensure there is a wider selection of healthy and safe seafood options available to the American consumer from countries in Europe.