WASHINGTON, D.C. – U.S. Senators Susan Collins and Angus King and Representatives Chellie Pingree and Bruce Poliquin sent a letter today to the Commissioner of the U.S. Food and Drug Administration (FDA), Robert Califf, M.D., urging the FDA to outline a plan ensuring that all states wishing to export shellfish to the 28-member European Union (EU) are able to do so as the shellfish trade between the U.S. and the EU resumes. Currently, only two states are being audited by the EU to determine whether its products are suitable for export to the EU.

The FDA is carrying out an equivalency determination process to resolve a seven-year impasse that has restricted shellfish trade between the U.S. and the EU. Under this process, the U.S. and the EU conduct reciprocal reviews and audits of shellfish protection programs to ensure that the standards of the importing body are being met. The Maine congressional delegation expressed concern that limiting audits of shellfish protection programs to those in only two states will disadvantage shellfish dealers in other states, including those in Maine, wishing to explore new export opportunities.

“The equivalency determination currently being developed by the FDA should have included all states that meet the additional requirements for export to the EU, including Maine,” wrote Senators Collins and King and Representatives Pingree and Poliquin in their letter.  “We are troubled that Maine has been left out of the equivalency determination process given its strong record on ensuring shellfish safety.”

In 2014, Maine became the first—and only—state to adopt the high pressure liquid chromatography (HPLC) biotoxin monitoring method, which can quantify levels of Paralytic Shellfish Poisoning (PSP) with a high level of accuracy. This methodology is used exclusively by many shellfish producing countries in the EU.  This advanced biotoxins monitoring program makes Maine well-positioned to meet the EU’s requirements.

Senators Collins and King and Representatives Pingree and Poliquin’s letter to Commissioner Califf is available HERE; the full text is below.

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April 18, 2016

The Honorable Robert Califf, M.D.

Commissioner

U.S. Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD  20993

Dear Commissioner Califf:

We understand the Food and Drug Administration (FDA) is undertaking efforts to end a seven-year impasse that has restricted trade of shellfish between the U.S. and the European Union (EU).  The opportunity to reinstate this trade through an equivalency determination is significant and welcomed, but at the same time, we are concerned that the EU intends to limit the opportunities for trade to only two states at the outset, which will put Maine shellfish dealers at a disadvantage as the shellfish trade between the U.S. and the EU resumes.  Therefore, we urge you to ensure that a clear path for the inclusion of all U.S. states compliant with the National Shellfish Sanitation Program be defined, so that all U.S. states wishing to explore this export opportunity are able to do so.

The equivalency determination currently being developed by the FDA should have included all states that meet the additional requirements for export to the EU, including Maine.  In 2014, Maine became the first – and only – state to adopt the high pressure liquid chromatography (HPLC) biotoxin monitoring method, which can quantify levels of Paralytic Shellfish Poisoning (PSP) with a high level of accuracy.  Moreover, it is the methodology used exclusively by many shellfish producing countries in the EU, such as Portugal, Ireland, Norway, France, and the United Kingdom.  By transitioning to HPLC, Maine also has the unique ability to measure for other marine biotoxins of concern.  Because Maine is the only state to use this advanced biotoxins monitoring program, it is well-positioned to meet the EU requirements. We are troubled that Maine has been left out of the equivalency determination process given its strong record on ensuring shellfish safety.

Limiting the equivalency determination process to only two states would disadvantage shellfish dealers in other states wishing to explore export opportunities.  It is critical to Maine shell-fishermen that the FDA provides a detailed plan outlining a clear path for adding more states to this program.  We also ask that the agency consult with its counterparts in the EU regarding this plan and reply to us in detail with what steps the EU has agreed to take.

We appreciate your consideration of our request.  If you have any questions, please contact us or have your staff contact Patricia Aho of Senator Collins’ office at (207) 622-8414, Kimber Colton of Representative Pingree’s office at (202) 225-6116, Peter Benoit of Senator King’s office at (202) 224-3874, or Michael Sinacore of Representative Poliquin’s office at (202) 226-1119.  We look forward to hearing from you.

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