GAO’s recommendations database contains report recommendations that still need to be addressed.
GAO’s priority recommendations are those that we believe warrant priority attention.
We sent letters to the heads of key departments and agencies, urging them to continue focusing on these issues.
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As of February 9, 2020, there are 4958 open recommendations, of which 422 are priority recommendations. Recommendations remain open until they are designated as Closed-implemented or Closed-not implemented.
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Recommendation: The Chair of the Board of Governors of the Federal Reserve System should engage in collaborative discussions with other relevant financial regulators in a group that includes all relevant stakeholders and has defined agency roles and outcomes to address issues related to consumers' use of account aggregation services. (Recommendation 6)
Agency: Federal Reserve System: Board of Governors Status: Open Priority recommendation
Comments: In a May 2018 letter, the Chair of the Federal Reserve Board noted that the Federal Reserve recognizes the importance of working together to determine how best to encourage socially beneficial innovation in the marketplace, while ensuring that consumers' interests are protected. The letter noted that the Federal Reserve staff have been meeting with other regulators and industry participants. The Chair states that the Federal Reserve will continue to facilitate and engage in collaborative discussions with other relevant financial regulators in these and other settings to help market participants address the important issues surrounding reimbursement for consumers who use financial account aggregators and experience unauthorized transactions. In October 2018, Federal Reserve staff advised us that issues related to data aggregation were discussed at a June 28, 2018 meeting of the Fintech Interagency Discussion Group, which includes OCC, the Federal Reserve, the Federal Deposit Insurance Corporation, the National Credit Union Administration, and the Bureau of Consumer Financial Protection. They noted they are monitoring private sector efforts related to resolving data aggregation issues and that they expect to hold additional discussions among the regulator about these issues in the future. In March 2019, the agency noted that it continues to collaborate on this issue. We plan to follow up with Federal Reserve staff to obtain updates on these efforts in the future.
Recommendation: The Chairman of the Federal Deposit Insurance Corporation should engage in collaborative discussions with other relevant financial regulators in a group that includes all relevant stakeholders and has defined agency roles and outcomes to address issues related to consumers' use of account aggregation services. (Recommendation 7)
Agency: Federal Deposit Insurance Corporation Status: Open Priority recommendation
Comments: In November 2018, FDIC staff confirmed that they have engaged in collaborative discussions with other relevant financial regulators regarding issues related to consumers' use of account aggregation services and associated liability issues. We followed up in April 2019 and they confirmed that their collaboration had yet to produce outcomes that would satisfy the recommendation.
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. Among other things, the agency has developed 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 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 needs to develop intermediate outcomes to link with final outcomes and intends to address this step in fiscal year 2019.
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: In January 2015, we recommended that the Commissioner of FDA complete an analysis to determine the annual number of foreign food inspections that is sufficient to ensure comparable safety of imported and domestic food. Additionally, if the inspection numbers from that analysis are different from the inspection targets mandated in the FDA Food Safety Modernization Act (FSMA), FDA should report the results to Congress and recommend appropriate legislative changes. At the time of our report, FDA was not keeping pace with FSMA's mandate to increase inspections each year from 2011 through 2016. In April 2017, FDA indicated that that it does not anticipate going significantly beyond 1,200 foreign food facilities inspections per year, based on the amount of additional funding needed to meet the foreign inspection requirement of FSMA. However, FDA has not conducted an analysis to determine whether the increased number of inspections mandated by FSMA or the lower number of inspections it is currently conducting is sufficient to ensure comparable safety of imported and domestic food. FDA noted that, in January 2017, it began an analysis to define and describe the global inventory of human and animal food firms and examine the application of regulatory oversight tools across the inventory. According to FDA, the analysis will help it assess the annual number of foreign food facility inspections as part of an overall risk-based allocation of resources for ensuring that imported foods are produced in a manner the meets applicable U.S. safety standards. We continue to believe that FDA should complete such an analysis and report the results to Congress. In August 2018, agency officials indicated that FDA is undertaking a larger review of its approach to overseeing the safety of imported food and will be drafting a new strategy. As part of this effort, they will determine the annual number of foreign food inspections that is sufficient to ensure comparable safety of imported and domestic food. They were not able to provide a date as to when they expect to complete the analysis, but they indicated that it may take more than a year to finalize their study. As of August 2019, FDA is making progress toward achieving the recommendation. Specifically, FDA has conducted an analysis of the global inventory of foreign and domestic facilities. They stated that the correct number of inspections is related to the amount of "cumulative oversight" applied to foreign facilities. Cumulative oversight includes new authorities given to them under FSMA, including inspections of importers, audits conducted under the accredited third party certification program, FDA's voluntary qualified import program, and systems recognition (oversight of food facilities by foreign authorities that have been comprehensively assessed to deliver FDA-comparable food safety outcomes). According to FDA, the information they get through this cumulative oversight will inform the annual number of inspections needed. FDA also indicated that they are investigating the potential to develop an integrated modeling framework to support risk-based allocation decisions related to strategic global oversight of human and animal food facilities and firms. This part of the effort is still in process. For GAO to close the recommendation, FDA will still need to determine (using the methods they described) a target number of foreign facilities to inspect.
Recommendation: To better inform users of the annual monitoring report about the frequency and scope of pesticide tolerance violations, the Secretary of Health and Human Services should direct the Commissioner of FDA to disclose in the agency's annual pesticide monitoring program report which pesticides with EPA-established tolerances the agency did not test for in its pesticide monitoring program and the potential effect of not testing for those pesticides.
Agency: Department of Health and Human Services Status: Open Priority recommendation
Comments: In July 2019, FDA said that the recommendation should be closed as not implemented. FDA said that it remained concerned that the disclosure of pesticides for which FDA does not test would enable users to more easily circumvent the pesticide monitoring program, which could jeopardize public health and, at a minimum, would undermine FDA's law enforcement efforts. In addition, FDA said that it discloses in its annual reports all pesticides tested for within the reports' annual scope as required by the Pesticide Monitoring Improvements Act of 1988. FDA's annual reports also clarify that not all pesticides for which EPA has established tolerances were analyzed. FDA said that the Pesticide Monitoring Improvements Act of 1988 does not specifically direct the agency to report information on untested pesticides with EPA-established tolerances. We continue to believe that disclosing the pesticides that are not included in FDA's testing program would be consistent with OMB best practices for reporting limitations relevant to analyzing and interpreting results from a data collection effort. In particular, we continue to believe that FDA should be more transparent about the potential effect of not testing for all pesticides for which EPA has established tolerances. We also note that the Department of Agriculture's Food Safety and Inspection Service implemented a similar recommendation to disclose information about its pesticide monitoring program. As a result, we are keeping this recommendation open.