Imported Seafood Safety: FDA and USDA Could Strengthen Efforts to Prevent Unsafe Drug Residues

GAO-17-443 Published: Sep 15, 2017. Publicly Released: Oct 02, 2017.
Jump To:
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.

Skip to Highlights
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.

Skip to Recommendations

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
FDA partially agreed with our recommendation. As of February 2022, and according to FDA, the agency has engaged with regulatory counterparts in India and Ecuador, two of the top importing countries of aqua-cultured shrimp, to pursue a mutual agreement that could include testing of shrimp for drugs of concern. FDA is also in preliminary discussions on this issue with Indonesia. We will continue to follow up on this recommendation as FDA pursues its discussions with these countries.
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
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
As of February 2022, FSIS had not acted on this recommendation. FSIS stated that it does not plan to set requirements for foreign countries' residue monitoring plans. FSIS maintains that as part of the FSIS equivalence program, a foreign country must demonstrate that it either employs the same measures as the United States, and many foreign countries take this approach, or that the measures that it employs, while different from those of the United States, provide an equivalent level of public health protection as those of this country. According to FSIS, its review of documents from the countries that export catfish to the United States show that all these countries maintain residue monitoring programs that offer equivalent levels of public health protection as the United States. We requested FSIS provide documents that include the foreign countries' residue control programs and test results, latest list of drugs FSIS tests for, a list of drugs that FSIS may require foreign countries include in their residue monitoring plan, and a list of drugs approved for use in aquaculture in the foreign countries that FSIS has approved to export catfish to the United States. We will review the documents that FSIS provides.
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
FDA agreed with this recommendation. In February 2022, FDA stated that both agencies were using the same method for measuring and confirming two unapproved drugs. In addition, FDA and FSIS have been working collaboratively, including FSIS' participation in the Aquaculture Research Working Group (ARWG) quarterly meetings. According to FDA, the testing methods each agency uses is appropriate for the types of food products each regulates. FDA uses it multi-residue method to test all seafood it regulates. FSIS uses its method to test not only catfish but also other products including poultry and bovine. For FDA to include the additional drugs in FSIS's method with no known use in aquaculture would result in FDA not using its resources efficiently. According to FDA, the use of a single common method by FSIS accounts for differences in the maximum residue levels between FSIS and FDA. FDA added that the agencies will use the ARWG to collaborate on establishing, validating, and using sharable methodologies to allow for streamlined and efficient application between agencies if there is a need for new methods. However, the agencies have not provided any analysis to identify the additional costs and inefficiencies caused by sharing a single multi-residue method that would be comprehensive and result in the same maximum residue levels. According to FDA officials, FDA and FSIS do not have any plans to work on a multi-residue method both agencies can use. To fully implement this recommendation, FDA should coordinate with FSIS on (1) the development of testing methods that both agencies can use on imported seafood, including catfish, and on (2) MRLs that will allow the agencies to consistently apply similar standards.
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
According to FSIS officials in November 2020, the agency coordinates with FDA and EPA to carry out the National Residue Program, which entails testing FSIS-regulated products, including catfish, for chemical compounds of public health concern. In June 2021, FSIS officials indicated that it will continue to use its own test methods that meet the agency's pre-defined quality assurance criteria, are applicable to the particular commodity under its jurisdiction, and fit its business model. Thus, FSIS does not have plans to work on a multi-residue method that both it and FDA can use on imported seafood, including catfish, as we have recommended. To fully implement this recommendation, FDA and USDA should coordinate on (1) the development of testing methods that both agencies can use on imported seafood, including imported catfish and on (2) maximum residue levels that will allow the agencies to consistently apply similar standards.

Full Report

GAO Contacts