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Highlights

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.

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Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Department of Health and Human Services 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.
Closed - Not Implemented
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.
Food and Drug Administration 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.
Closed - Not Implemented
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.
Food and Drug Administration 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.
Closed - Implemented
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.
Food and Drug Administration 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.
Closed - Not Implemented
FDA has not yet taken action on this recommendation.
Food and Drug Administration 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.
Closed - Not Implemented
FDA is studying this recommendation but as of July 28, 2008, had not taken action to implement it.
Food and Drug Administration 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.
Closed - Implemented
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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