Recommendation: 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)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: FDA partially agreed with our recommendation. According to FDA, the agency is working on a plan to explore the viability of reaching cooperative arrangements with foreign regulatory bodies concerning imported aqua-cultured seafood. In exploring such arrangements, FDA stated that it will seek to explore a means by which the agency can leverage foreign regulatory bodies' seafood safety programs to provide additional oversight for seafood destined for the United States. According to FDA, such arrangements would be negotiated depending on the country's specific situation. We will continue to monitor FDA's specific efforts to implement this recommendation.

Recommendation: 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)

Agency: Department of Agriculture: Food Safety and Inspection Service
Status: Open

Comments: As of December 2019, FSIS had not yet acted on this recommendation. According to FSIS officials, the agency made a request to the USDA Office of General Counsel for their opinion on the legality of the recommendation. FSIS is waiting for OGC's response to that request. FSIS maintains that the information submitted by foreign countries as part of the equivalence determination that outlines their chemical residue monitoring plans and the review by the FSIS equivalence staff to ensure these countries employ an equivalent level of public health protection as that of the US already addresses this recommendation. We will continue to monitor how FSIS addresses this recommendation.

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)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open
Priority recommendation

Comments: 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 2019, FSIS and FDA were using the same method for measuring and confirming these two unapproved drugs. In August 2020, FDA told GAO that the agencies convene quarterly to discuss emerging and ongoing research needs in laboratory method development and the establishment of drug residue limits in seafood. We commend FDA and FSIS for taking these steps to share information on testing methods. However, GAO found that the agencies continue to use different multi-residue testing methods that look for different numbers of drugs--99 for FSIS and 40 for FDA--which results in the agencies using different maximum residue levels for some drugs. FDA's method can detect drugs that FSIS's does not and can detect some drugs at lower levels. FSIS's multi-residue method can detect 59 more drugs than FDA's method. The agencies do not have any plans to work on a multi-residue method both agencies can use.

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)

Agency: Department of Agriculture: Food Safety and Inspection Service
Status: Open
Priority recommendation

Comments: According to FSIS officials in May 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. FSIS officials indicated that FSIS 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 currently 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.

Recommendation: The Commissioner of CBP should identify and collect additional performance information on the impact of the ISF rule data, such as the identification of shipments containing contraband, to better evaluate the effectiveness of the ISF program.

Agency: Department of Homeland Security: United States Customs and Border Protection
Status: Open

Comments: In March 2018, the CBP liaison informed GAO that offices within CBP are collaborating on a plan to assess additional performance metrics to evaluate the effectiveness of the ISF program. On June 13, 2018, the CBP liaison stated that CBP staff continue to work on additional performance metrics to evaluate the effectiveness of the ISF program and noted, in particular, are analyzing data to: (1) identify the number of unmanifested containers and determine how/if they were mitigated before arrival; (2) determine the number of times C-TPAT companies were identified and given targeting benefits, but did not receive the same treatment based on manifest information; and (3) identify the number of times potential terrorism matches were made against an ISF entities vs. the number of times not matched using the same manifest data. In March 2019, the CBP liaison stated that the new estimated completed date for this recommendation is the end of 2019. This recommendation will remain open until CBP's planned actions are completed and meet the intent of GAO's recommendation. In late February 2020, CBP liaison staff informed GAO that they are continuing to work on this recommendation, which they expect to complete by March 31, 2020.

Recommendation: To strengthen CBP's trade enforcement efforts, the Commissioner of CBP should direct the Office of Trade to include performance targets, when applicable, in addition to performance measures in its Priority Trade Issue strategic and annual plans.

Agency: Department of Homeland Security: United States Customs and Border Protection
Status: Open

Comments: As of August 2019, the seven FY 2019 Priority Trade Issue (PTI) annual plans prepared by CBP's Office of Trade all included performance measures with performance targets, but some plans did not include baselines to measure it's trade enforcement efforts against. The Office of Trade reported that it was in the process of finalizing its FY2020 annual plans, which should be available in December 2019. In addition, the Office of Trade reported that it no longer develops a single strategic plan covering all of its PTIs and only prepares the PTI annual plans.

Recommendation: To strengthen CBP's trade enforcement efforts, the Commissioner of CBP should direct the Office of Trade and the Office of Field Operations to develop a long-term hiring plan that articulates how CBP will reach its staffing targets for trade positions set in the Homeland Security Act and the agency's resource optimization model.

Agency: Department of Homeland Security: United States Customs and Border Protection
Status: Open

Comments: As of June 2019, CBP stated that both the Office of Trade (OT) and Office of Field Operations (OFO) continue to take steps to address hiring gaps which include evaluating approaches to hiring and evaluating and selecting candidates for its various trade positions. For example, OT had developed a recruitment strategy for hiring regulatory auditors. OT reported that it has brought regulatory auditors onboard as a result of its strategy but experienced attrition and challenges in attaining its staffing target for this position. OT and OFO did not provide recruitment strategies for the other trade positions. OFO's Human Capital Division, along with assistance from OT and other CBP components, reported finalizing a long-term hiring plan to meet and maintain the congressional floor for certain trade and revenue positions, including those for import specialists, by the end of fiscal year 2020.

Recommendation: To help ensure the safety of food imported into the United States, the Commissioner of Food and Drugs should complete an analysis to determine the annual number of foreign food inspections that is sufficient to ensure comparable safety of imported and domestic food. If the inspection numbers from that evaluation are different from the inspection targets mandated in FSMA, FDA should report the results to Congress and recommend appropriate legislative changes.

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open
Priority recommendation

Comments: On March 25, 2020, GAO staff met with FDA officials to discuss the status of the recommendation. FDA officials said that they cannot meet the number of foreign inspections required under FSMA due to capacity constraints, and FDA's current strategy for the safety of imported food relies on a "cumulative oversight" approach involving multiple programs (including the Third-Party Certification Program, the Foreign Supplier Verification Program, the Voluntary Qualified Importer Program, and systems recognition), in addition to foreign inspections. FDA officials said that it could be a number of years before these programs are fully implemented and that FDA will provide GAO with more specific status updates on the implementation and monitoring of each of these programs in future responses to this recommendation. Because FDA is still implementing their cumulative oversight approach and has not reported the number of foreign inspections required to ensure imported food safety, the recommendation remains open.

Recommendation: To provide more efficient, consistent, and effective federal oversight of the nation's food supply, Congress should consider commissioning the National Academy of Sciences or a blue ribbon panel to conduct a detailed analysis of alternative organizational food safety structures and report the results of such an analysis to Congress.

Agency: Congress
Status: Open

Comments: The 2002 Farm Security and Rural Investment Act (2002 Farm Bill) established a national Food Safety Commission charged with making specific recommendations for drafting legislative language. Among other things, the Commission was to make recommendations on how to improve the food safety system, create a harmonized, central framework for managing federal food safety programs, and enhance the effectiveness of federal food safety resources. However, as of January 2017, as far as current staff can ascertain, the Commission was never formed, and no recommendations were ever produced. Thus, although Congress acted to create a food safety commission through legislation, the substance of our matter--recommendations for analyzing alternative food safety structures--was not implemented. GAO subsequently made the same matter for congressional consideration in several later products, and the matter also appeared in the annual GAO Duplication, Overlap, and Fragmentation Report. As of March 2020, it remained unaddressed.