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 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 Administrator of the EPA should develop a program management plan that includes a schedule of the actions EPA will take and the resources and funding it needs to establish and implement the Columbia River Basin Restoration Program, including formation of the associated Columbia River Basin Restoration Working Group, and submit this plan to the appropriate congressional authorizing committees as part of the fiscal year 2020 budget process. (Recommendation 1).

Agency: Environmental Protection Agency
Status: Open

Comments: EPA reconvened the Columbia River Toxics Reduction Working Group. As of May 2019, EPA officials told us they are working on the development of a program management plan to identify the actions and timeline for implementing the Columbia River Basin Restoration Program. In July 2019, EPA released a status update entitled, "2019 Status Update: Columbia River Basin Toxics Reduction" that provides a summary of the working group's major accomplishments since 2010, as well as priority efforts for future work. In September 2019, EPA announced the availability of $900,000 in grants to reduce toxics throughout the Columbia River Basin for the Clean Water Act Section 123 Columbia River Basin Restoration Grant Program for fiscal year 2019 through fiscal year 2020. As of October 2020, we have not received additional information from EPA regarding this recommendation. We will update the recommendation's status when we do.

Recommendation: The Director of OMB should develop and provide guidance on the types of projects and activities that agencies involved in the protection and restoration of the Columbia River Basin should include in their reports, as well as the processes they should follow in compiling the related budget and spending information. (Recommendation 2).

Agency: Executive Office of the President: Office of Management and Budget
Status: Open

Comments: As of April 2020, OMB staff did not provide an update. When we receive an update, we will provide information on actions taken.

Recommendation: To help NMFS and the Councils incorporate climate information into the fisheries management process and better manage climate-related risks, the Secretary of Commerce should direct NOAA's Assistant Administrator for Fisheries to, in finalizing the regional action plans for implementing the NOAA Fisheries Climate Science Strategy, (1) incorporate the key attributes associated with successful performance measures in the final performance measures developed for the plans and (2) assess whether agency-wide performance measures may be needed to determine the extent to which the objectives of the Strategy overall are being achieved, and develop such measures, as appropriate, that incorporate the key attributes of successful performance measures.

Agency: Department of Commerce
Status: Open

Comments: The Department of Commerce and NOAA agreed with this recommendation. In October 2019, NOAA provided GAO with a written update on actions taken in response to this recommendation, including the development of agency-wide metrics for the NOAA Fisheries Climate Science Strategy. In September 2020, NOAA informed GAO that it plans to update the performance metrics for the regional action plans to include our key attributes in 2021. We will continue to monitor NOAA's progress on this effort and will review the updated performance metrics to assess the extent to which the agency has addressed our recommendation.