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Seafood Safety: FDA Needs to Improve Oversight of Imported Seafood and Better Leverage Limited Resources

GAO-11-286 Published: Apr 14, 2011. Publicly Released: May 16, 2011.
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About half of the seafood imported into the U.S. comes from farmed fish (aquaculture). Fish grown in confined aquacultured areas can have bacterial infections, which may require farmers to use drugs like antibiotics. The residues of some drugs can cause cancer and antibiotic resistance. The Department of Health and Human Services' (HHS) Food and Drug Administration (FDA) is charged with ensuring the safety of seafood against residues from unapproved drugs, and the Department of Commerce's National Marine Fisheries Service (NMFS) provides inspection services on request. In 2009, these agencies signed a memorandum of understanding (MOU) to enhance seafood oversight and leverage inspection resources. GAO was asked to assess the extent to which (1) FDA's program is able to ensure the safety of seafood imports against residues from unapproved drugs and (2) FDA and NMFS have implemented the 2009 MOU. GAO reviewed data and documents from each agency and interviewed agency officials and other key stakeholders.

FDA's oversight program to ensure the safety of imported seafood from residues of unapproved drugs is limited, especially as compared with the European Union (EU). FDA's program is generally limited to enforcing the Hazard Analysis and Critical Control Point--the internationally recognized food safety management system--by conducting inspections of foreign seafood processors and importers each year. These inspections involve FDA inspectors reviewing records to ensure the processors and importers considered significant hazards, including those resulting from drug residues if the seafood they receive are from fish farms. The inspectors generally do not visit the farms to evaluate drug use or the capabilities, competence, and quality control of laboratories that analyze the seafood. In addition, FDA has conducted foreign country assessments in five countries to gather information about those countries' aquaculture programs. However, these assessments have been limited by FDA's lack of procedures, criteria, and standards. In contrast, the EU reviews foreign government structures, food safety legislation, the foreign country's fish farm inspection program, and visits farms to ensure that imported seafood products come from countries with seafood safety systems equivalent to that of the EU. In addition, the scope of FDA's sampling program, which supplements its oversight program, is limited. Specifically, the sampling program does not generally test for drugs that some countries and the EU have approved for use in aquaculture. Consequently, seafood containing residues of drugs not approved for use in the United States may be entering U.S. commerce. Further, FDA's sampling program is ineffectively implemented. For example, for fiscal years 2006 through 2009, FDA missed its assignment plan goal for collecting import samples by about 30 percent. In addition, in fiscal year 2009, FDA tested about 0.1 percent of all imported seafood products for drug residues. Moreover, FDA's reliance on 7 of its 13 laboratories to conduct all its aquaculture drug residue testing raises questions about the agency's use of resources. FDA and NMFS have made limited progress in implementing their 2009 MOU. The agencies have developed procedures for certain MOU activities, such as notifying NMFS of pending FDA regulatory actions. However, because FDA believes NMFS inspectors need training to conduct inspections according to FDA standards, it has not utilized NMFS' inspection resources or results in a systematic manner. Better leveraging available resources is critical, especially in places like China, where FDA has inspected 1.5 percent of Chinese seafood processing facilities in the last 6 years. GAO recommends that FDA study the feasibility of adopting practices used by other entities to better ensure the safety of imported seafood, enhance its import sampling program, and develop a strategic approach for enhancing collaboration with NMFS and better leveraging resources. HHS neither agreed nor disagreed with GAO's recommendations but cited actions in process or planned that are generally responsive to them.


Recommendations for Executive Action

Agency Affected Recommendation Status
Department of Health and Human Services To better ensure the safety of seafood imports, the Secretary of Health and Human Services should direct the Commissioner of FDA to study the feasibility of adopting other practices used by other entities, such as requiring foreign countries that want to export seafood to the United States to develop a national residues monitoring plan to control the use of aquaculture drugs, to more efficiently ensure the safety of imported seafood and report its findings to the Secretary.
Closed – Not Implemented
According to FDA, the agency has developed and implemented a program that evaluates and recognizes foreign food safety programs as providing food safety assurances that are comparable to FDA?s food safety program. The agency is also offering training that is intended primarily for foreign producers on FDA requirements and recommendations for drug use in aquaculture. To date, FDA systems recognition program has been conducted with New Zealand and Canada. Although Canada is one of the top 5 seafood exporters to the U.S., FDA does not have a similar situation with the other top 5 countries including numbers one and two, that make up almost 40 percent of the seafood imports. In addition, FDA's focus on providing training to foreign seafood producers misses opportunities with foreign regulators to create a more robust seafood safety program with standardized requirements for the major seafood exporting countries.
Department of Health and Human Services To better ensure the safety of seafood imports, the Secretary of Health and Human Services should direct the Commissioner of FDA to develop a more comprehensive import sampling program for seafood by more effectively using its laboratory resources and taking into account the imported seafood sampling programs of other entities and countries.
Closed – Not Implemented
According to FDA, the agency has developed a number of new methodologies for analyzing residues of unapproved antibiotics and antifungal agents in imported aquaculture products. These methods are either already implemented in the program or are in the process of being implemented. In addition, under the FDA Food Safety Modernization Act (FSMA), FDA is developing a proposed rule on laboratory accreditation and the use of analytical results from accredited laboratories. FDA laboratories are also conducting performance evaluations of commercially available rapid, high-throughput screening methods. The FSMA requirement for establishing a laboratory accreditation program for domestic and foreign laboratories could greatly enhance the current sampling program if appropriately developed and implemented. Since this effort could address the issue of limited FDA resources, it is important to this recommendation that FDA's laboratory accreditation program be developed and implemented. It is however unclear when and how this rule will be implemented, and a complete determination of how FDA has addressed this recommendation would not be possible until this implementation has occurred.
Department of Health and Human Services To better ensure the safety of seafood imports, the Secretary of Health and Human Services should direct the Commissioner of FDA to develop a strategic approach with specific time frames for enhancing collaborative efforts with NMFS and better leveraging NMFS inspection resources.
Closed – Not Implemented
According to FDA, the agency stated that it would work with NMFS to develop strategic approaches for enhancing collaboration and better leveraging seafood inspection resources, including training and ultimately certifying NMFS inspectors on FDA regulatory procedures. FDA added however that due to competing higher priority activities and extremely limited resources, the agency had not yet achieved its goal of fully leveraging NMFS inspectional resources. According to NMFS, there is no written and standard process in place to provide FDA training to NMFS inspectors. In addition, there is no standardized system for FDA to use NMFS inspection reports in order to reduce FDA's inspection workload and not have both agencies inspect the same domestic and foreign seafood processing facilities. Without this standardization, FDA cannot fully leverage the inspection resources of another US agency that specializes in seafood oversight. We are therefore unable to close this recommendation as implemented.

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