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: To guide the nation's efforts to improve the federal food safety oversight system and address ongoing fragmentation, the appropriate entities within the EOP should, in consultation with relevant federal agencies and other stakeholders, develop a national strategy that states the purpose of the strategy, establishes high-level sustained leadership, identifies resource requirements, monitors progress, and identifies short- and long-term actions to improve the food safety oversight system.

Agency: Executive Office of the President
Status: Open

Comments: As of March 2020, the Executive Office of the President had not acted on our recommendation. In January 2020, OMB told GAO there were no plans to develop a national strategy on food safety. Instead, OMB said that the administration planned to work toward greater efficiency and interagency coordination within the framework provided by the FDA Food Safety Modernization Act.

Recommendation: To help ensure that FDA's foreign offices are able to fully meet their mission of helping to ensure the safety of imported products, as the agency continues to test performance measures and evaluate its Office of International Programs (OIP) strategic workforce plan, the Commissioner of FDA should assess the effectiveness of the foreign offices' contributions by systematically tracking information to measure whether the offices' activities specifically contribute to drug safety-related outcomes, such as inspections, import alerts, and warning letters.

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

Comments: In June and July 2018 FDA reported on its recent efforts to assess the effectiveness of the foreign offices' contributions to drug-safety related outcomes. These efforts include the development of new performance measures for these offices along with a monitoring and evaluation plan; strengthened communications and collaboration between the foreign offices and FDA program centers and its Office of Regulatory Affairs; and an assessment of the foreign offices to help set their objectives and ensure the right balance of personnel, skillsets, and resources. However, FDA still had to develop intermediate outcomes to link with final outcomes. In an August 2020 written response, the agency reported that because of a reorganization and strategic planning effort for its Office of Global Policy and Strategy, it was still revising and updating its measures and its approach to evaluating impact in 2020 to align with a five-year strategic plan completed in March 2020. The agency indicated that the recommendation should remain open, and GAO will continue to monitor the implementation of this recommendation.

Recommendation: In order to improve FDA's strategic planning for regulatory science efforts, the Secretary of Health and Human Services should direct the Commissioner of FDA to develop and document measurable goals, such as targets and time frames, for its regulatory science efforts so it can consistently assess and report on the agency's progress in regulatory science efforts.

Agency: Department of Health and Human Services
Status: Open

Comments: In September 2018, the agency described the actions of committees developed by each of the centers to oversee their regulatory science activities. In July 2019, the agency indicated that it was revisiting its strategic regulatory science priorities as part of its cyclical strategic planning process, and the centers and various offices have taken steps to address the recommendation. In an August 2020 written response, the agency reported that a committee had undertaken a review its 2011 regulatory science strategic plan that will result in the issuance of an accountability framework--an internal document outlining the type of information that FDA centers and offices will provide to the agency's Chief Scientist to demonstrate progress made in addressing relevant focus areas of regulatory science. FDA reported that its goal was to complete this work by the end of December 2020. However, FDA still needs to document steps taken by these centers to develop measurable goals, and the agency indicated that the recommendation should remain open. GAO will continue to monitor the implementation of this recommendation.

Recommendation: In order to improve FDA's strategic planning for regulatory science efforts, the Secretary of Health and Human Services should direct the Commissioner of FDA to systematically track funding of regulatory science projects across each of its priority areas.

Agency: Department of Health and Human Services
Status: Open

Comments: In September 2018 and July 2019, the agency described actions taken by each center to better track its regulatory science funding. However, FDA still needed to complete these activities and document that funds are systematically tracked across each of the priority areas. In an August 2020 written response, the agency reported that there continue to be efforts to improve tracking of funds for regulatory science projects in priority areas. Specifically, it described the development of an accountability framework-an internal document outlining the type of information that FDA centers and offices will provide to the agency's Chief Scientist to demonstrate progress made in addressing relevant focus areas of regulatory science. According to FDA, as part of the internal accountability framework, it will track regulatory science projects. FDA reported that its goal was to complete this work by the end of December 2020. The agency indicated that the recommendation should remain open, and GAO will continue to monitor the implementation of this recommendation.

Recommendation: To help ensure that FDA has relevant and timely information to support management decisions, including the critical information necessary to ensure the safety and effectiveness of drugs compounded for animals, the Secretary of Health and Human Services should direct the Commissioner of the FDA to develop policy or guidance for agency staff that specifies circumstances under which FDA will or will not enforce compounding regulations for animals and clearly define key terms.

Agency: Department of Health and Human Services
Status: Open

Comments: In November 2019, FDA released for public comment its new Draft Guidance for Industry #256 - Compounding Animal Drugs from Bulk Drug Substances. The draft guidance describes FDA's policy regarding the compounding of animal drugs from bulk drug substances including the conditions under which FDA does not intend to take enforcement action for violations of the Federal Food, Drug, and Cosmetic Act's requirements for approval, adequate directions for use, and current Good Manufacturing Practices. We will review the updated guidance when it is finalized and determine if it addresses this recommendation. In August 2020, FDA indicated that, in response to numerous requests from external stakeholders, the comment period on the draft guidance has been extended to October 2020. Once the comments have been reviewed, FDA anticipates finalizing the guidance by the end of calendar year 2021.

Recommendation: To help ensure that FDA has relevant and timely information to support management decisions, including the critical information necessary to ensure the safety and effectiveness of drugs compounded for animals, the Secretary of Health and Human Services should direct the Commissioner of the FDA to consistently document the bases for FDA's decisions about how or whether it followed up on warning letters, adverse event reports, and complaints about drug compounding for animals.

Agency: Department of Health and Human Services
Status: Open

Comments: In July 2019, FDA reported to GAO that when the Draft Guidance for Industry #256 was issued that calendar year, FDA intended to develop a risk-based compliance program to address compounding of animal drugs from bulk drug substances. As part of that compliance program, FDA reported that it intended to consistently document the basis for its decisions about what actions are taken, for example, warning letters, adverse event reports, and complaints. In August 2020, FDA reported that a working group has been formed to develop a risk-based compliance strategy, which will include a process for documenting the basis for FDA's decisions about how or whether it followed up on warning letters, adverse event reports, and complaints about drug compounding for animals. FDA anticipates implementing this strategy simultaneously with the finalization of Guidance for Industry #256, which is anticipated to occur at the end of calendar year 2021. We will follow-up with FDA regarding these actions and determine if the actions address our recommendation.

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 achieve greater efficiency and effectiveness, Congress should consider transferring the oversight of the markings of toy and imitation firearms in 15 U.S.C. 5001 from the National Institute of Standards and Technology (within the Department of Commerce) to the Consumer Product Safety Commission.

Agency: Congress
Status: Open

Comments: This matter is an action identified in GAO's annual Duplication and Cost Savings reports. No legislative action identified. The Gun Look-Alike Case Act, H.R. 3224, which was introduced on July 27, 2015, in the 114th Congress, would transfer the authority to regulate the markings of toy, look-alike, and imitation firearms in section 5001 of title 15 of the U.S. Code from NIST to CPSC, as GAO suggested in November 2014. This bill was referred to the Subcommittee on Commerce, Manufacturing, and Trade of the Committee on Energy and Commerce in the United States House of Representatives, and did not pass out of committee. This bill was not reintroduced in the 115th Congress and, as of March 2020, has not been reintroduced by the 116th Congress. Continued regulation of the marking of toy and imitation firearms by NIST rather than CPSC does not leverage each agency's expertise and therefore may not be the most efficient use of scarce federal resources.

Recommendation: To improve existing coordination of oversight for consumer product safety, Congress should consider establishing a formal comprehensive oversight mechanism for consumer product safety agencies to address crosscutting issues as well as inefficiencies related to fragmentation and overlap such as communication and coordination challenges and jurisdictional questions between agencies. Different types of formal mechanisms could include, for example, creating a memorandum of understanding to formalize relationships and agreements or establishing a task force or interagency work group. As a starting point, Congress may wish to obtain agency input on options for establishing more formal coordination.

Agency: Congress
Status: Open

Comments: This matter is an action identified in GAO's annual Duplication and Cost Savings reports. As of March 2020, no legislation was identified that would establish a collaborative mechanism to facilitate communication across the relevant agencies and to help enable them to collectively address crosscutting issues, as GAO suggested in November 2014. Some of the agencies with direct regulatory oversight responsibilities for consumer product safety reported that they continue to collaborate to address specific consumer product safety topics. However, without a formal comprehensive oversight mechanism, the agencies risk missing opportunities to better leverage resources and address challenges, including those related to fragmentation and overlap.

Recommendation: To enhance its oversight of drug shortages, particularly as the agency fine-tunes the manner in which it gathers data on shortages and transitions from its database to a more robust system, the Commissioner of FDA should conduct periodic analyses using the existing drug shortages database (and, eventually, the new drug shortages information system) to routinely and systematically assess drug shortage information, and use this information proactively to identify risk factors for potential drug shortages early, thereby potentially helping FDA to recognize trends, clarify causes, and resolve problems before drugs go into short supply.

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

Comments: In September 2018, FDA told us that it was using its drug shortage data system, the "Shortage Tracker," to summarize information reported by manufacturers as the reasons for existing shortages. The agency indicated that it was developing a model that would factor in drug shortage data, warning signs identified through social media, and other factors to help identify early indicators that may predict future shortages. In July 2019, the agency indicated it could conduct periodic analyses of the causes of drug shortages. However, FDA had not yet proactively conducted any rigorous analyses of predictors of drug shortages to help recognize trends, clarify causes, and resolve problems before drugs go into short supply. In an August 2020 written response, FDA reported that it was undertaking modeling efforts to explore the feasibility of predicting future drug shortages using machine learning approaches. FDA planned to complete the initial modeling by fall 2020, at which time it would identify next steps. The agency indicated that the recommendation should remain open, and GAO will continue to monitor the implementation of this recommendation.

Recommendation: To improve the awareness, use, and usefulness of SaferProducts.gov, the CPSC should implement cost-effective usability improvements to SaferProducts.gov, taking into account the results of any existing usability testing or any new testing CPSC may choose to conduct.

Agency: Consumer Product Safety Commission
Status: Open

Comments: The Commission has taken some steps to address this recommendation by making usability improvements to SaferProducts.gov that we identified in our consumer testing in our report. For example, in 2015, the Commission addressed issues identified with the search functionality of the website by improving the advanced search function to enable searches by injury, time period, and location. In August 2018, the Commission clarified the purpose of SaferProducts.gov by adding the tagline (brief text that gives users an immediate idea of what the site does) "Report. Search. Protect." to its website. As of August 2019, CPSC has explored further ways to improve the usability of SaferProducts.gov. Specifically, in February 2019, CPSC published a request for information from the public on how to improve SaferProducts.gov. In March 2019, CPSC held a public hearing to obtain a feedback on how the design of SaferProducts.gov and process of submitting safety reports could be improved. For example, two consumer groups recommended that CPSC further improve the website's search function to yield more relevant and streamlined results and that it be designed for better use on mobile devices. Based on this input, CPSC is in the process of developing a plan for re-designing SaferProducts.gov using modern web-design standards, which includes improving the website's layout and styling, search capabilities, and functionality on mobile devices. According to CPSC, its staff plans to explore cost-effective resources to assess usability and identify further improvements to the website, such as coordinating with the General Services Administration on the design aspects of SaferProducts.gov and using other federal best practices to inform this process. However, no such cost-effective changes have yet been made to the website. According to officials, CPSC plans to begin this re-design in 2019 or 2020 pending available future funding. Until the Commission fully addresses this recommendation, it remains open. We will continue to monitor the Commission's progress in implementing our recommendation.

Recommendation: To better enable CPSC to target unsafe consumer products, Congress may wish to amend section 29(f) of CPSA to allow CPSC greater ability to enter into information-sharing agreements with its foreign counterparts that permit reciprocal terms on disclosure of nonpublic information.

Agency: Congress
Status: Open

Comments: As of May 15, 2020, Section 29 of CPSA had not been amended since 2008. In 2013, a bill was introduced (S.1887) but not passed. That bill would have allowed "the Commission, when sharing information under the federal-state cooperation program with a foreign government agency for official law enforcement or consumer protection purposes, to authorize a foreign government agency to make that information available to another agency of the same foreign government (including a political subdivision of that foreign government that is located within the same territory or administrative area as the agency disclosing the information) if an appropriate official of the foreign government agency disclosing the information certifies (by prior agreement, memorandum of understanding with the CPSC, or other written certification) that it will establish and apply specified confidentiality restrictions under the Consumer Product Safety Act."

Recommendation: To help ensure that FDA's overseas offices are able to fully meet their mission of helping to ensure the safety of imported products, the Commissioner of FDA should ensure, as it completes its strategic planning process for the overseas offices, that it develops a set of performance goals and measures that can be used to demonstrate overseas office contributions to long-term outcomes related to the regulation of imported products and that overseas office activities are coordinated with the centers and Office of Regulatory Affairs (ORA).

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

Comments: In June and July 2018 FDA reported on its recent efforts to assess the effectiveness of the foreign offices' contributions to drug-safety related outcomes. Among other things, the agency developed new performance measures for these offices along with a monitoring and evaluation plan and conducted an assessment of the foreign offices to help set their objectives and ensure the right balance of personnel, skillsets, and resources. However, FDA still had to develop intermediate outcomes to link with final outcomes. In August 2020, the agency indicated that because of a reorganization and strategic planning effort for its Office of Global Policy and Strategy, it was still revising and updating its measures and its approach to evaluating impact in 2020 to align with a five-year strategic plan completed in March 2020. The agency indicated that the recommendation should remain open, and GAO will continue to monitor the implementation of this recommendation.