FDA’s Program to Ensure the Safety of Imported Seafood from Residues of Unapproved Drugs Is Limited, Especially as Compared with the EU

FDA’s program to ensure the safety of imported seafood from residues of  unapproved drugs is limited, because the agency’s primary oversight  program generally involves reviews of documents at individual foreign  processing facilities and importers for HACCP compliance. In contrast, the  EU reviews foreign government structures, food safety legislation, and the  foreign country’s fish farm inspection program to ensure imported seafood  products come from countries with seafood safety systems equivalent to  that of the EU. These inspections  involve reviewing the processors’ HACCP plans and other records to  ensure the processors have considered drug residues as a hazard that is  reasonably likely to occur if the seafood products it receives are from fish  farms. In general, as part of foreign HACCP inspections, FDA inspectors  do not visit fish farms to evaluate drug use or controls. In addition to FDA’s HACCP inspections, the agency conducts foreign  country assessments to gather information about other countries’  aquaculture programs including the country’s competent authority and  regulatory infrastructure. However, according to FDA  officials, the agency does not have any written operating procedures or  any criteria or standards that it uses for these assessments to evaluate a  country’s regulatory infrastructure; farms; or the capabilities, competence,  and quality controls of foreign laboratories. FDA has  conducted such foreign country assessments in five countries: Chile,  China, India, Indonesia, and Vietnam. Thus,  FDA does not generally test for drugs that some countries and the EU have  approved for use in aquaculture. In addition, FDA does not effectively implement its limited sampling  program. Thus, in fiscal year 2009, the seafood samples FDA reported  it collected for drug residue testing amounted to 0.1 percent of all the  seafood products imported into the United States. For example,  while some other countries have increased their laboratory capabilities  through programs to accredit commercial laboratories, FDA relies on 7 of  its 13 laboratories to conduct all of its aquaculture drug residue testing. FDA and NMFS Have Made Limited Progress to Implement the 2009 MOU, and FDA Has Not Leveraged NMFS Inspection Resources

FDA and NMFS have made limited progress in implementing the 2009  MOU, resulting in a lack of systematic collaboration between the agencies. FDA has inspected 41 of 2,744 (or 1.5 percent) Chinese  seafood processing facilities in the last 6 years. Recommendations for Executive Action

To better ensure the safety of seafood imports, we recommend that the  Secretary of Health and Human Services direct the Commissioner of FDA  to take the following three actions:    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;   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; and   develop a strategic approach with specific time frames for enhancing  collaborative efforts with NMFS and better leveraging NMFS inspection  resources. On March 23, 2011, we received written  comments from HHS, which are reproduced in appendix IV; HHS neither  agreed nor disagreed with the findings and recommendations in the report. The Department of Commerce’s National Marine Fisheries  Service (NMFS) provides voluntary fee-for-service inspections to ensure  compliance with FDA’s Hazard Analysis and Critical Control Point  (HACCP) regulations, among other things. To assess the extent to which  FDA ensures the safety of seafood imports against residues from  unapproved drugs, we analyzed information on FDA’s oversight  mechanism for seafood imports—importer and foreign country processing  facilities inspections—and its seafood import sampling program. We analyzed fiscal years  2006 through 2009 data on FDA’s import sampling program’s test results to  determine the magnitude and scope of the program. 1.
Why GAO Did This Study

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.

What GAO Found

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.

What GAO Recommends

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.