Recommendation: The Acting Commissioner of CBP should better communicate to stakeholders the types of information stakeholders could collect and submit to CBP to help the agency initiate and investigate forced labor cases related to seafood and, as appropriate, other goods. (Recommendation 1)

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

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Commissioner of the Food and Drug Administration, in coordination with the Secretary of Agriculture, should more fully incorporate the seven leading practices for effective collaboration in the agencies' interagency agreement for the joint oversight of cell-cultured meat. (Recommendation 1)

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

Comments: FDA and USDA partially concurred with this recommendation. FDA stated that it concurred with the intent of incorporating the seven leading practices into the interagency agreement, and both agencies said that they are open to incorporating the practices into their development of the structure for joint oversight of cell-cultured meat. However, the agencies stated that they did not agree to revise the agreement at this time. FDA and USDA stated that the agreement is a general framework and that incorporating the leading practices would constitute an inappropriate level of detail. Instead, the agencies stated that they believe it would be most valuable to incorporate the leading practices into a more detailed joint framework or standard operating procedure they plan to issue. We appreciate the agencies' willingness to incorporate the leading practices for effective collaboration into their efforts. The March 2019 interagency agreement states that the agencies have the ability to modify it as needed and will review the agreement every 3 years to determine whether they should modify or terminate it. Therefore, the agencies are due to revisit the agreement in March 2022, if not sooner. Regarding the agencies' concern that incorporating the leading practices in the interagency agreement would add an inappropriate level of detail, we note that, as we state in our report, the existing agreement already partially incorporates each of the seven leading practices. We continue to believe that FDA and USDA should more fully incorporate the seven leading practices for effective collaboration into their interagency agreement for the joint oversight of cell-cultured meat. Developing a more detailed joint framework or standard operating procedure in accordance with the existing interagency agreement that incorporates those leading practices would meet the intent of our recommendation to improve the effectiveness of the agencies' collaboration.

Recommendation: The Secretary of Agriculture, in coordination with the Commissioner of the Food and Drug Administration, should more fully incorporate the seven leading practices for effective collaboration in the agencies' interagency agreement for the joint oversight of cell-cultured meat. (Recommendation 2)

Agency: Department of Agriculture
Status: Open

Comments: FDA and USDA partially concurred with this recommendation. FDA stated that it concurred with the intent of incorporating the seven leading practices into the interagency agreement, and both agencies said that they are open to incorporating the practices into their development of the structure for joint oversight of cell-cultured meat. However, the agencies stated that they did not agree to revise the agreement at this time. FDA and USDA stated that the agreement is a general framework and that incorporating the leading practices would constitute an inappropriate level of detail. Instead, the agencies stated that they believe it would be most valuable to incorporate the leading practices into a more detailed joint framework or standard operating procedure they plan to issue. We appreciate the agencies' willingness to incorporate the leading practices for effective collaboration into their efforts. The March 2019 interagency agreement states that the agencies have the ability to modify it as needed and will review the agreement every 3 years to determine whether they should modify or terminate it. Therefore, the agencies are due to revisit the agreement in March 2022, if not sooner. Regarding the agencies' concern that incorporating the leading practices in the interagency agreement would add an inappropriate level of detail, we note that, as we state in our report, the existing agreement already partially incorporates each of the seven leading practices. We continue to believe that FDA and USDA should more fully incorporate the seven leading practices for effective collaboration into their interagency agreement for the joint oversight of cell-cultured meat. Developing a more detailed joint framework or standard operating procedure in accordance with the existing interagency agreement that incorporates those leading practices would meet the intent of our recommendation to improve the effectiveness of the agencies' collaboration.

Recommendation: As the three cell-cultured meat working groups move forward, the Commissioner of the Food and Drug Administration, in coordination with the Secretary of Agriculture, should more fully incorporate the seven leading practices for effective collaboration, such as identifying specific outcomes and a way to monitor and evaluate progress toward outcomes. (Recommendation 3)

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

Comments: In March 2020, FDA officials agreed with this recommendation. We will follow up to determine what steps they take to implement the recommendation.

Recommendation: As the three cell-cultured meat working groups move forward, the Secretary of Agriculture, in coordination with the Commissioner of the Food and Drug Administration, should more fully incorporate the seven leading practices for effective collaboration, such as identifying specific outcomes and a way to monitor and evaluate progress toward outcomes. (Recommendation 4)

Agency: Department of Agriculture
Status: Open

Comments: In March 2020, USDA officials agreed with this recommendation. We will follow up to determine what steps they take to implement the recommendation.

Recommendation: The Commissioner of the Food and Drug Administration, in coordination with the Secretary of Agriculture, should clearly document in their interagency agreement, or other publicly available document, which agency will oversee cell-cultured seafood other than catfish. (Recommendation 5)

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

Comments: In March 2020, FDA officials agreed with this recommendation. We will follow up to determine what steps they take to implement the recommendation.

Recommendation: The Secretary of Agriculture, in coordination with the Commissioner of the Food and Drug Administration, should clearly document in their interagency agreement, or other publicly available document, which agency will oversee cell-cultured seafood other than catfish. (Recommendation 6)

Agency: Department of Agriculture
Status: Open

Comments: In March 2020, USDA officials agreed with this recommendation. We will follow up to determine what steps they take to implement the recommendation.

Recommendation: The Director of United States Citizenship and Immigration Services should work with the Assistant Secretary for the Employment and Training Administration to assess options for changing the H-2B visa program and, as warranted, implement changes or submit proposed legislative changes to Congress. DHS and DOL could consider options included in their June 2019 report to Congress and identify those that may be implemented cost effectively and without adversely affecting U.S. workers. (Recommendation 1)

Agency: Department of Homeland Security: United States Citizenship and Immigration Services
Status: Open

Comments: DHS agreed with this recommendation and noted that it plans to work further with DOL to explore options for improving the H-2B visa program and possibly develop proposals for legislative changes.

Recommendation: The Assistant Secretary for the Employment and Training Administration should work with the Director of United States Citizenship and Immigration Services to assess options for changing the H-2B visa program and, as warranted, implement changes or submit proposed legislative changes to Congress. DOL and DHS could consider options included in their June 2019 report to Congress and identify those that may be implemented cost effectively and without adversely affecting U.S. workers. (Recommendation 2)

Agency: Department of Labor: Employment and Training Administration
Status: Open

Comments: DOL agreed with this recommendation. DOL said it is prepared to work with DHS to consider options for changing the H-2B program and to provide any technical assistance that Congress may need on this issue. We will monitor the agency's progress to implement this recommendation.

Recommendation: The Director of United States Citizenship and Immigration Services should work with the Assistant Secretary for the Employment and Training Administration to assess the advantages and disadvantages of considering current economic trends in determining the appropriate number of additional H-2B visas to provide when given this authority by Congress and, as warranted, implement an approach that considers such trends. (Recommendation 3)

Agency: Department of Homeland Security: United States Citizenship and Immigration Services
Status: Open

Comments: DHS did not agree with this recommendation. DHS said it would continue to work with DOL-as it has done in prior years--if and when Congress delegates the authority to make additional H-2B visas available beyond the statutory cap to DHS. The agency also expressed its view that Congress is better positioned to determine whether and how many additional visas should be made available to meet the needs of U.S. businesses. In fiscal years 2017 through 2020, DHS was authorized to increase the number of H-2B visas beyond the statutory cap, after consulting with DOL to determine that "the needs of American businesses [could not] be satisfied...with United States workers..." In exercising this authority in prior years, DHS stated that "[t]he scope of the assessment called for by the statute [in making this determination] is quite broad, and accordingly delegates the Secretary of Homeland Security broad discretion to identify the business needs [s]he finds most relevant." In light of DHS's broad view of its authority, we continue to believe that it would be appropriate for DHS, in consultation with DOL, to assess the advantages and disadvantages of considering current economic trends in determining the appropriate number of additional H-2B visas to provide. If they determine that using such data would be warranted, the agencies would then be well positioned to implement such an approach if DHS is granted such authority in the future. Moreover, if-as DHS stated in its response to our recommendation-the agency believes that Congress is best suited to determine what increases in visa numbers may be needed to meet the needs of U.S. businesses, consistent with protecting American workers, it may wish to work with Congress to draft a legislative proposal reflecting this view.

Recommendation: The Assistant Secretary for the Employment and Training Administration should work with the Director of United States Citizenship and Immigration Services to assess the advantages and disadvantages of considering current economic trends in determining the appropriate number of additional H-2B visas to provide when given this authority by Congress and, as warranted, implement an approach that considers such trends. (Recommendation 4)

Agency: Department of Labor: Employment and Training Administration
Status: Open

Comments: DOL agreed with this recommendation. The agency plans to draw on its data on labor market and economic trends to provide technical assistance to DHS on the determination of how many additional H-2B visas to make available.

Recommendation: The Assistant Secretary for the Employment and Training Administration should take steps to target its audits of H-2B employers to employers with the highest likelihood of violating program requirements; such steps could include moving ahead with developing a system for identifying trends in H-2B employer audit outcomes. (Recommendation 5)

Agency: Department of Labor: Employment and Training Administration
Status: Open

Comments: DOL agreed with this recommendation. DOL noted that while further development of a system for tracking industry and occupational trends in H-2B employer violations is currently on hold due to budgetary constraints, when this system is available it will provide the capacity to take a risk-based approach to selecting employers for audits. We will monitor the agency's progress to implement this recommendation.

Recommendation: The NMFS Assistant Administrator for Fisheries should work with the South Atlantic and Gulf of Mexico councils, and other councils as appropriate, to develop documented processes for conducting allocation reviews. (Recommendation 1)

Agency: Department of Commerce: National Oceanic and Atmospheric Administration: National Marine Fisheries Service
Status: Open

Comments: Commerce and NOAA agreed with this recommendation and stated that NOAA's NMFS will work to implement it to the extent possible. We will continue to monitor NMFS' efforts to do so.

Recommendation: The NMFS Assistant Administrator for Fisheries should work with the South Atlantic and Gulf of Mexico councils, and other councils as appropriate, to specify how the councils will document their allocation reviews, including the basis for their allocation decisions, whether fishery management plan objectives are being met, and what factors were considered in the reviews. (Recommendation 2)

Agency: Department of Commerce: National Oceanic and Atmospheric Administration: National Marine Fisheries Service
Status: Open

Comments: Commerce and NOAA agreed with this recommendation and stated that NOAA's NMFS will work to implement it to the extent possible. We will continue to monitor NMFS' efforts to do so.

Recommendation: The Commissioner of FDA should establish a process to monitor whether the agency is meeting its audit goals and expectations for sampling and inspections to support its removal decisions for seafood import alerts. This could be done through regularly analyzing data that FDA collects, such as those in CMS, FACTS, and OASIS. (Recommendation 1)

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

Comments: FDA agreed with our recommendation. In August 2020, FDA told us that the agency is working to review and modify appropriate sections of its Regulatory Procedures Manual to better reflect the importance of foreign suppliers' corrective actions when making decisions to remove a firm from an import alert and identify higher-risk problem areas where more robust information may be needed. In addition, a checklist for import alerts and associated Compliance Management System (database) functionality are under development. According to FDA, the agency is also working to refine internal communications to better assure that firms which have recently been removed from an import alert are also considered for an inspection. Additionally, in November 2019, FDA published a Notice of Proposed Rulemaking on accreditation of laboratories that conduct food testing to support removal from import alert and other purposes. We will continue to monitor FDA's planned actions to determine if they satisfy our recommendation.

Recommendation: The Commissioner of FDA should establish a time frame for developing performance goals and measures for its imported food safety program. (Recommendation 2)

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

Comments: FDA agreed with this recommendation. In August 2020, FDA told us that the agency has published some performance metrics and plans to develop additional performance measures and outcome indicators for imported food safety, to support FDA's Strategy for the Safety of Imported Food (Strategy). In addition, after publishing these initial metrics for the Strategy, the agency will develop additional performance metrics. FDA stated that the COVID-19 situation is quite fluid and the agency is unable to project timelines for developing additional performance measures at this time. We will continue to monitor FDA's planned actions to determine if they satisfy our recommendation.

Recommendation: The Commissioner of FDA should, as the agency develops goals and measures for its imported food safety program, develop performance goals and corresponding performance measures specific to seafood import alerts. (Recommendation 3)

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

Comments: FDA agreed with this recommendation. In August 2020, FDA told us that the agency remains committed to developing additional performance goals and measures for its imported food safety program. FDA is still reviewing the Import Alert Effectiveness Program and will consider metrics, as appropriate, based on the outcome of that review. FDA stated that the COVID-19 situation is quite fluid and the agency is unable to project timelines for developing additional performance measures at this time. We will continue to monitor FDA's planned actions to determine if they satisfy our recommendation.

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.