Fast Facts

Ninety percent of the seafood eaten in the United States is imported, and about half of that is raised on fish farms. Farmers may treat fish with antibiotics and other drugs because these fish can be susceptible to infections. Misuse of drugs can leave residues in seafood that cause health problems for consumers.

We looked at how the two agencies charged with ensuring seafood safety protect against unsafe drug residues, and made five recommendations to strengthen their efforts. For example, agencies could require foreign governments to do more testing for these drug residues.

Major Exporters of Popular Seafood to the United States in 2015

Figure showing countries that export the most shrimp, salmon, tilapia and catfish to United States.

Figure showing countries that export the most shrimp, salmon, tilapia and catfish to United States.

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Highlights

What GAO Found

To help ensure the safety of imported seafood from unsafe drug residues, the Food and Drug Administration (FDA) generally depends on the actions of foreign processors and U.S. importers. FDA requires processors and importers to follow its Hazard Analysis and Critical Control Point (HACCP) regulations to identify hazards and the critical control points where the hazards, such as pathogen contamination, are likely to occur and take corrective action. FDA also performs a limited number of (1) inspections of processors and importers each year to ensure HACCP compliance, and (2) tests of imported seafood for contaminants, including unsafe drug residues. FDA could strengthen its efforts to ensure the safety of imported seafood from unsafe drug residues by pursuing agreements with other countries requiring that they test seafood exported to the United States for unsafe drug residues. Under an agency plan, FDA is to coordinate with other countries to increase their capabilities related to the safety of food exported to the United States and better leverage their resources. FDA has used country agreements with respect to pathogen hazards in molluscan shellfish intended for export to the United States. According to FDA officials, it might be worthwhile for the agency to pursue agreements with some countries, but FDA would have to carefully consider a number of factors in determining which countries would be appropriate, which it has not yet done.

In assuming responsibility for inspecting imported catfish, the U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) provided foreign countries and others a transition period—March 1, 2016, through September 1, 2017—before full implementation of its catfish inspection program. Following the transition, countries seeking to continue exporting catfish to the United States are to request equivalence determinations by providing documentation showing that their catfish safety inspection systems are equivalent to the U.S. system. FSIS could strengthen its efforts to ensure the safety of imported catfish. The Agricultural Act of 2014 directs FSIS, in part, to consider the conditions under which catfish are raised, domestically and abroad, but FSIS has not made farm visits a routine part of an equivalence determination. It is not clear how FSIS could consider the conditions under which imported catfish are raised consistent with the act without visiting farms. In addition, during this determination, the agency will already have its inspectors in the foreign country for an on-site audit. FSIS officials generally visit government offices, commercial food processing facilities, and food testing laboratories in a foreign country. Without visiting a sample of farms whose catfish are exported to the United States, FSIS may be missing an opportunity to consider the conditions under which catfish are being raised.

FDA and FSIS took steps to accomplish the transfer of catfish oversight from FDA to FSIS, as called for in the 2014 memorandum of understanding (MOU) that both agencies signed. However, they generally have not coordinated on drug residue testing methods, resulting, in some cases, in differences in drug residue levels used to determine if seafood is unsafe—specifically for unapproved drugs—as called for in the 1984 MOU. Without this coordination, the agencies do not have reasonable assurance that they are consistently protecting consumers from unsafe drug residues.

Why GAO Did This Study

Most seafood consumed in the United States is imported, and about half of it is raised on fish farms. Because farmed seafood is raised in confined areas and susceptible to infections, farmers may use drugs like antibiotics. The use of unapproved drugs or the misuse of approved drugs may result in unsafe residues in seafood that can cause cancer or allergic reactions, according to FDA, which is charged with ensuring the safety of most seafood. Beginning in April 2016, FSIS became responsible for ensuring the safety of imported catfish.

This report examines (1) how FDA helps ensure the safety of imported seafood from unsafe drug residues and ways the agency could strengthen its efforts; (2) how FSIS helps ensure the safety of imported catfish from unsafe drug residues and ways the agency could strengthen its efforts; and (3) the extent to which FDA and FSIS coordinate their oversight efforts. GAO reviewed information from each agency and interviewed agency officials and other key stakeholders.

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Recommendations

GAO is making five recommendations, including that FDA pursue agreements with other countries to test seafood exported to the United States and that FSIS visit a sample of fish farms as part of foreign country on-site audits; and that FDA and FSIS coordinate in developing testing methods and corresponding residue levels for imported seafood. FDA agreed with or partially agreed with two; FSIS partially agreed with two and stated it already addresses a third. GAO disagrees and believes the recommendations should be implemented.

Recommendations for Executive Action

Agency Affected Recommendation Status
Food and Drug Administration The Commissioner of FDA should pursue formal agreements with countries exporting seafood to the United States that commit these countries to test for drugs of concern to FDA and the corresponding maximum residue levels (MRLs) that FDA established for these drugs. (Recommendation 1)
Open

Recommendation status is Open.

FDA partially agreed with our recommendation. On February 25, 2019, FDA published a Strategy for the Safety of Imported Food. One overarching goal of FDA's Strategy is that food offered for import meet U.S. food safety requirements. To accomplish that goal, FDA has identified an objective of leveraging the oversight efforts of regulatory counterparts. As part of that objective, it states that "FDA may enter arrangements with foreign regulatory authorities to conduct specific oversight and offer certain verifications (e.g., pre-export testing) to provide assurances of the safety of certain exported products." However, as of August 2019, FDA had not provided any information on agency plans to specifically implement this objective and has not entered into a formal agreement with a foreign government to test for drugs of concern to FDA and the corresponding maximum residue levels (MRLs) that FDA established for these drugs. We will continue to monitor FDA's specific efforts to implement this recommendation.
Food Safety and Inspection Service The Administrator of FSIS should ensure that agency staff doing an on-site audit in another country for an equivalence determination visit at least a sample of farms whose catfish are exported to the United States to determine the conditions under which the catfish are being raised, including the drugs being used. (Recommendation 2)
Closed - Implemented

Recommendation status is Closed - Implemented.

During the 2018 on-site equivalence determination visits to China, Thailand, and Vietnam, FSIS staff visited farms in each country. FSIS updated its methodology for determining how many and which specific foreign sites FSIS visits during equivalence audits. This methodology now includes visits to aquaculture farms and ponds. According to FSIS, the agency will implement this updated methodology during the audit planning process.
Food Safety and Inspection Service The Administrator of FSIS should require as part of an equivalence determination that countries exporting catfish to the United States include in their residue monitoring plans the drugs of concern to FSIS and the corresponding maximum residue levels. (Recommendation 3)
Open

Recommendation status is Open.

As of April 2019, FSIS had not yet acted on this recommendation. GAO will meet with FSIS officials in late September 2019 to get information on the status of this recommendation.
Food and Drug Administration
Priority Rec.
This is a priority recommendation.
The Commissioner of FDA should coordinate and communicate with FSIS in developing drug residue testing methods and corresponding maximum residue levels for imported seafood that may also be applicable to imported catfish. (Recommendation 4)
Open

Recommendation status is Open.

FDA agreed with this recommendation. According to FDA officials, the agency shared its testing methods for two drugs with FSIS and as of as of April 17, 2019, FSIS and FDA were using the same method for measuring and confirming these two unapproved drugs. In addition, FDA makes recommendations to FSIS on maximum residue levels for drug residues, but FDA understands that the maximum residues levels applied depend on the method and the instrumentation used. FDA officials stated that these differences in method and instrumentation can lead to several orders of magnitude differences in maximum residue levels between the two agencies. According to FDA officials, the agencies share information on validated and reproducible residue detection methods and best practices regarding instrumentation. However, as of August 2019, FDA and FSIS continued to use different multi-residue testing methods that look for different numbers of drugs--61 for FSIS and 28 for FDA--and results in different maximum residue levels for some drugs that the agencies use to determine if imported seafood is unsafe. We will continue to monitor the agencies' efforts to implement this recommendation.
Food Safety and Inspection Service
Priority Rec.
This is a priority recommendation.
The Administrator of FSIS should coordinate and communicate with FDA in developing drug residue testing methods and corresponding maximum residue levels for imported catfish that may also be applicable to other imported seafood. (Recommendation 5)
Open

Recommendation status is Open.

According to FSIS officials, the agency plans to use FDA's testing methods for two drugs. FSIS coordinates with FDA and other agencies on which drugs should be included in testing methods and they communicate about the results of its sampling plans. However, as of April 2019, FSIS officials stated that they have no plans for further coordination with FDA on method development or maximum residue levels. In addition, FSIS and FDA continue to use different multi-residue testing methods that look for different numbers of drugs-61 for FSIS and 28 for FDA-and results in different maximum residue levels for some drugs that the agencies use to determine if imported seafood is unsafe. GAO will meet with FSIS officials in late September 2019 to get information on the status of this recommendation.

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