According to data from the NOAA’s  National Marine Fisheries Service, the United States imported about 4.2  billion pounds, or more than 80 percent, of its seafood in 2002, as shown in  the figure. FDA’s Imported Seafood Safety Program Shows Some Improvement, but Deficiencies Persist

Since our January 2001 report, FDA has made improvements to three of the  four approaches it uses for ensuring the safety of imported seafood— importer inspections, foreign inspections, and port-of-entry inspections. FDA has not implemented either of the recommendations we made in our  2001 report regarding establishing equivalence agreements with exporting  countries or communicating deficiencies found during inspections to FDA’s  port-of-entry personnel. Additionally, FDA continues to experience long  delays in issuing warning letters or detaining imported seafood at U.S.  ports of entry after investigators find serious deficiencies. As we reported in 2001, in the absence of equivalence agreements, U.S.  seafood importers are required to maintain written product specifications  and take at least one of six affirmative steps to document foreign firms’  compliance with U.S. requirements. Most FDA Regulatory Actions Are Not Timely

To ensure that FDA takes prompt regulatory action when its investigators  find food safety violations during importer and foreign firm visits, we  recommended in our 2001 report that FDA communicate deficiencies to  port-of-entry personnel so that they can examine potentially contaminated  imported seafood before it can enter the United States. However, FDA took an  average of 157 calendar days to issue these warning letters. Finally, we  found that FDA does not prioritize enforcement actions when violations  that pose the most serious public health risk occur or have an automated  system for tracking the time involved in documenting, reviewing, and  processing enforcement actions. Options Are Available for Enhancing FDA’s Imported Seafood Safety Program, but They Present Challenges

Several options could help FDA overcome some of the problems we  identified with its current regulatory approach for ensuring the safety of  imported seafood. To strengthen FDA’s current imported seafood program and ensure the  safety of seafood consumed in the United States, the Commissioner of FDA  should take the following five actions:  make it a priority to establish equivalence or other similar types of  agreements with seafood-exporting countries, starting first with  countries that have high-quality food safety systems;  develop and implement a system to track the time involved in  documenting, reviewing, and processing regulatory and enforcement  actions, such as issuing warning letters and detaining unsafe products,  so that FDA can identify the reasons for the delays and take actions to  address them;  give priority to taking enforcement actions when violations that pose  the most serious public health risk occur;  consider the costs and benefits of implementing an accreditation  program for private laboratories; and   explore the potential of implementing a certification program for third- party inspectors, which would involve reviewing FDA’s legal authorities  and considering the costs and benefits, including developing and  implementing the standards, controls, and oversight necessary to  provide FDA with reasonable assurance that third-party inspectors are  qualified and independent. FDA also said that  establishing these agreements is extraordinarily resource intensive. FDA also raised some concerns about inferences that could be drawn from  the report. In addition, we interviewed and/or received documents from the National  Oceanic and Atmospheric Administration’s (NOAA) National Marine  Fisheries Service, Seafood Inspection Program, and National Sea Grant  Program. However, the scope of this review did not include exploring whether  Agriculture could make inspection or other resources available to augment  FDA’s seafood inspection program. Panelists specifically  discussed these changes, including (1) a shift in focus from inspecting  foreign countries’ entire food safety systems for equivalence to inspecting  more foreign firms for HACCP compliance, (2) a slight increase in the  number of port-of-entry examinations and laboratory testing of imported  seafood, and (3) an increase in testing for aquaculture drug residues. Panelists stated that such agreements should not imply that FDA must  find a foreign government’s seafood safety system “equal” to that of the  U.S. system. GAO Comments

1. However, we continue to believe, as  supported by our panel of nationally recognized food safety experts,  that equivalence agreements or less comprehensive alternatives, such  as compliance agreements or memorandums of understanding  represent a more effective long-term approach for ensuring the safety  of imported seafood and would allow FDA to leverage its staff  resources by shifting some of its regulatory burden to exporting  countries. Also see comment 1.
Why GAO Did This Study

More than 80 percent of the seafood that Americans consume is imported. The Food and Drug Administration (FDA) is responsible for ensuring that imported seafood is safe and produced under sanitation and safety systems comparable to those of the United States. Since GAO reported in 2001 that FDA's seafood inspection program did not sufficiently protect consumers, additional concerns have arisen about imported seafood containing banned substances, such as certain antibiotics. In this review, GAO was asked to evaluate (1) FDA's progress in implementing the recommendations in the 2001 report and (2) other options to enhance FDA's oversight.

What GAO Found

Since GAO's January 2001 report, FDA's imported seafood safety program has shown some improvement. FDA inspects more foreign firms, and its inspections show that more U.S. seafood importers are complying with its requirements. FDA also slightly increased the number of seafood products it tests at U.S. ports of entry to just over 1 percent. However, FDA still has not established equivalence agreements with seafood exporting countries as GAO recommended in its 2001 report. Equivalence agreements that commit U.S. trading partners to maintain comparable food safety systems are an efficient way to ensure imported seafood safety. Unlike the U.S. Department of Agriculture, FDA is not legally required to certify that countries exporting food products to the United States have equivalent food safety systems. According to a panel of nationally recognized experts that GAO convened to address this and other issues, establishing these types of agreements would shift some of FDA's burden for ensuring seafood safety to foreign governments. This shift, in turn, would allow FDA to focus its limited resources on seafood products from countries with less advanced food safety systems. FDA also made little progress regarding the recommendation GAO made in 2001 that FDA communicate to U.S. port-of-entry personnel serious deficiencies identified during inspections so that potentially contaminated imported seafood is examined before it enters the United States. GAO found that FDA continues to experience long delays between finding deficiencies and taking action. For example, GAO's review of foreign firm inspection records found that it took an average of 348 days for FDA to alert port-ofentry personnel about serious safety problems identified at six foreign firms. Moreover, GAO found that FDA does not prioritize enforcement actions when violations that pose the most serious public health risk occur or have an automated system to track the time involved in documenting, reviewing, and processing enforcement actions. FDA officials acknowledged some of the problems that GAO identified regarding FDA's current imported seafood inspection program, but they also raised concerns about limited inspection resources and competing priorities, such as the recent need to implement provisions of the Bioterrorism Act of 2002. GAO identified several options that FDA could consider to augment its resources and enhance its current program, including (1) commissioning seafood inspectors from the National Oceanic and Atmospheric Administration's (NOAA) Seafood Inspection Program, (2) using state regulatory laboratories and/or private laboratories to augment FDA's testing of imported seafood, and (3) developing a program to use third-party inspectors to augment its program.