Food Safety:

FDA's Imported Seafood Safety Program Shows Some Progress, but Further Improvements Are Needed

GAO-04-246: Published: Jan 30, 2004. Publicly Released: Mar 3, 2004.

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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.

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.

Status Legend:

More Info
  • Review Pending-GAO has not yet assessed implementation status.
  • Open-Actions to satisfy the intent of the recommendation have not been taken or are being planned, or actions that partially satisfy the intent of the recommendation have been taken.
  • Closed-implemented-Actions that satisfy the intent of the recommendation have been taken.
  • Closed-not implemented-While the intent of the recommendation has not been satisfied, time or circumstances have rendered the recommendation invalid.
    • Review Pending
    • Open
    • Closed - implemented
    • Closed - not implemented

    Recommendations for Executive Action

    Recommendation: To strengthen FDA's current imported seafood program and ensure the safety of seafood consumed in the United States, the Commissioner of FDA should consider the costs and benefits of implementing an accreditation program for private laboratories.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Not Implemented

    Comments: FDA is studying this recommendation but as of July 28, 2008, had not taken action to implement it.

    Recommendation: To strengthen FDA's current imported seafood program and ensure the safety of seafood consumed in the United States, the Commissioner of FDA should give priority to taking enforcement actions when violations that pose the most serious public health risk occur.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Not Implemented

    Comments: FDA has not yet taken action on this recommendation.

    Recommendation: To strengthen FDA's current imported seafood program and ensure the safety of seafood consumed in the United States, the Commissioner of FDA should 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.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Implemented

    Comments: FDA implemented a Compliance Management System (CMS) to process and track the time associated with regulatory and enforcement actions (including actions for seafood), such as warning letters, seizures, and injunctions. The system facilities document exchange, storage, and access, and interacts with other FDA core Information Technology applications.

    Recommendation: To strengthen FDA's current imported seafood program and ensure the safety of seafood consumed in the United States, the Commissioner of FDA should 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.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Not Implemented

    Comments: FDA has not yet taken action on this recommendation. In response to this recommendation, FDA, in May 2008, noted that they were working with Vietnam on an exchange of letters that would facilitate the utilization of Vietnam's analysis of aqua-cultured fish for veterinary drug residues to assist FDA in entry review decision making. The effort is intended to result in a pilot program where this information can be integrated into the entry review process.

    Recommendation: To more efficiently and effectively monitor the safety of imported seafood, the Secretary of Health and Human Services should direct the Commissioner of FDA to work toward developing a memorandum of understanding with NOAA that leverages NOAA's Seafood Inspection Program's resources. The memorandum of understanding should address mutually agreeable protocols and training programs that are necessary to begin using NOAA employees to provide various services. Those services could include inspections of foreign firms, importer inspections, port-of-entry examinations and sample collections, and laboratory analyses.

    Agency Affected: Department of Health and Human Services

    Status: Closed - Not Implemented

    Comments: FDA reports that they have taken some action, but GAO has determined that the recommendation is not yet fully implemented. FDA agrees that it is important to explore if there are additional cooperative activities that can help the agency better leverage Department of Commerce NOAA/NMFS Seafood Inspection Program resources to more efficiently and effectively protect the public health. FDA's initial legal review has determined that under certain circumstances, they can use the authority under 21 U.S.C. 372(a)(2) to commission inspectors for the Department of Commerce/NMFS to conduct examinations and inspections because, like FDA, the Department of Commerce/NMFS is authorized by legislation to inspect seafood facilities. Now that they have completed the initial legal review and developed procedures for commissioning, they will enter into more formal discussions to explore the potential for commissioning NMFS inspectors. FDA has a working group which is charged with reassessing and modifying as necessary to best integrate the activities of the two agencies with respect to inspection of seafood facilities. The MOU review will include an effort to determine whether commissioning NMFS inspectors could permit NMFS to provide more service to the industry, increase the value of being inspected to the industry, and assist FDA in meeting its public health responsibilities.

    Recommendation: To strengthen FDA's current imported seafood program and ensure the safety of seafood consumed in the United States, the Commissioner of FDA should explore the potential of implementing a certification program for thirdparty 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.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Implemented

    Comments: In the Federal Register of April 2, 2008, FDA issued a notice requesting comments on the use of third-party certification programs for foods and animal feeds. On July 8, 2008, HHS Secretary Mike Leavitt announced two groundbreaking programs designed to enhance the safety of food and medical products exported to the United States. One of these initiatives is a third-party certification pilot program involving aquacultured (farm-raised) shrimp. HHS/FDA is seeking the participation of certification bodies that currently certify foreign processors of aquacultured shrimp for compliance with the FDA's seafood regulations. The project is designed to help HHS/FDA learn how to evaluate third-party certification programs and implement them in the field -- a key part of leveraging the additional resources of the private sector and other regulators.

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