Improving the FDA Seafood Oversight Program

Jun 01, 2011   

On April 14, 2011, the U.S. Government Accountability Office (GAO) reported that the U.S. Food and Drug Administrations (FDA) seafood oversight program, which ensures the safety of all imported seafood, is “limited” and needs improvement. In response to the GAO report, Congresswoman Rosa DeLauro (D-CT) announced her support for increased funding and better oversight for seafood to protect the public. DeLauro demanded that we “ensure that the FDA has the additional resources needed to be successful at their mission in ensuring the safety of these products and the protection of the American public.”

Currently, 80 percent of all seafood consumed in the U.S. is imported, and half of all imported seafood is farm-raised. However, due to the high rates of infection associated with raising fish in farms, farmers find it necessary to treat their fish with drugs, such as antibiotics and antifungal agents, which creates a potential risk of drug residue for consumers.

Concerned with the safety and increasing quantities of imported seafood, DeLauro emphasized that “only one in every ten imported fish, shellfish, shrimp, or other seafood is tested for drug residues when it enters our country.” The FDA tests for residue of 16 unapproved drugs, in comparison to the European Union (EU) which tests for residue of as many as 50 drugs. The GAO recommended that the FDA should study the feasibility of adopting other practices, such as developing a national residues monitoring plan to control the use of aquaculture drugs to ensure the safety of imported seafood.

The GAO also found that sampling of imported seafood was inadequate. The FDA collects approximately 0.1 percent of imports for sampling, a very limited number. The EU samples as much as 4 percent of seafood imports. The GAO proposed that the FDA develop a more comprehensive import sampling program effectively using its laboratory resources. Currently, the FDA only utilizes 7 of 13 available laboratories for seafood drug residue testing. Additionally, the GAO found that the FDA should take into account the imported seafood sampling programs of other entities and countries.

The GAO further discussed that FDA inspectors do not typically visit foreign aquaculture farms to evaluate drug use or the capabilities, competence, and quality control of laboratories that analyze the seafood. In China, the FDA has only inspected 1.5 percent of seafood processing facilities in the last 6 years. The GAO noted that the FDAs assessment is limited by the lack of procedures, criteria, and standards. In contrast, the EUs inspection includes a review of the government structure, food safety legislation, and the foreign countrys own inspection program. The GAO recommended developing a strategic approach with specific time frames to enhance the current inspection program.

Fuerst Ittleman will continue to monitor the FDA for implementation of changes to the seafood oversight program. For more information, contact us at