Summary
About half of the seafood imported into the US 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’ 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 provides inspection services on request. In 2009, these agencies signed a memorandum of understanding to enhance seafood oversight and leverage inspection resources. GAO was asked to assess the extent to which FDA’s program is able to ensure the safety of seafood imports against residues from unapproved drugs and 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. 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 US 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.