FROM A GLOBAL PERSPECTIVE
By Anne Kirchner and Ritu Nalubola
October 7, 2020
For the first time, FDA has used 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. Getting there took several years and involved scientific, policy, legal, and trade experts in FDA’s Office of Global Policy and Strategy (OGPS), the Office of the Chief Counsel and the Center for Food Safety and Applied Nutrition (CFSAN), with input from the Office of the U.S. Trade Representative.
Molluscan bivalve shellfish – such as oysters, clams, mussels and roe-on and whole scallops – are filter feeders, taking 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 and processed 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 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 United States and the EU in 1999. That agreement reaffirmed Article 4 of one of the foundational agreements establishing the World Trade Organization (WTO) in 1995, the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS). Article 4 of the SPS Agreement provides a mechanism for facilitating trade between countries that use different food safety control measures to achieve the same level of public health protection.
Technical experts in CFSAN’s Division of Seafood Safety conducted an assessment of the EU system and, initially, reached a tentative positive determination on two of the Member States after those Member States had agreed to implement additional safety controls. This technical assessment took several years and culminated in a proposed equivalence determination published in the Federal Register in 2018. FDA proposed to find equivalent raw molluscan shellfish harvested from specified growing areas in Spain and the Netherlands where additional controls were implemented for the U.S. market. Establishments interested in shipping raw product to the United States also would have to be listed by FDA on the Interstate Certified Shellfish Shippers List.
Around the time of FDA’s proposed determination, the EU’s food safety regulatory authority separately determined the U.S. food safety control system for raw molluscan shellfish to be equivalent to the EU system, beginning with accepting shellfish from certain growing areas in Massachusetts and Washington.
In addition, since 2018, FDA and the EC have been working to set up an implementation process for assessing additional EU Member States and U.S. States. OGPS’s Office of Trade, Mutual Recognition, and International Arrangements (OTMRIA) and the Europe Office (EO) joined these efforts to lead negotiations with the EU. Their efforts resulted in an Administrative Arrangement signed by FDA and the EU’s food safety regulatory authority, DG SANTE, that specifies a streamlined process for allowing exports from additional U.S. States participating in the National Shellfish Sanitation Program, and for recognizing additional EU Member States seeking to export to the United States under equivalence. That was signed at the end of July 2020. The FDA’s final equivalence determination was published in the Federal Register on Sept. 24, the agency’s first-ever final equivalence determination.
While negotiating the Administrative Arrangement for raw molluscan shellfish, OGPS also led negotiations with the EC to design an expedited equivalence assessment of the U.S. national food safety controls for processed shellfish. Using this mechanism, the EC planned to reach a final determination in a total of 12 months. The EC has made significant progress on this assessment, which they expected to conclude in mid-2021, but the timeframes had to be adjusted due to the global pandemic. A positive determination would open the EU market to processed shellfish on a nationwide-basis from all 50 States.
These and other understandings, memorialized in the Administrative Arrangement and related documents signed by the FDA and EC, provide the framework for important work still to be done. In the coming weeks, both FDA and DG SANTE will be taking the final operational steps necessary to start trade under the equivalence determinations. CFSAN’s Division of Seafood Safety will be holding webinars for States and U.S. industry interested in shipping to the EU and both agencies will be standing up electronic systems for this process and producing lists of firms eligible to export to the other.
Federal Register Notice: Food and Drug Administration Equivalence Determination Regarding Implementation by Spain and the Netherlands of the European Union System of Food Safety Control Measures for Raw Bivalve Molluscan Shellfish with Additional Controls.
Anne Kirchner, J.D., is a senior advisor in the OGPS Office of Trade, Mutual Recognition, and International Arrangements.
Ritu Nalubola, Ph.D., is director of the Europe Office in OGPS’ Office of Global Operations.