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    Subject Term: "Food inspection"

    13 publications with a total of 29 open recommendations including 2 priority recommendations
    Director: Steve Morris
    Phone: (202) 512-3841

    5 open recommendations
    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: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Administrator of FSIS should ensure that agency staff doing an on-site audit in another country for an equivalence determination visit at least a sample of farms whose catfish are exported to the United States to determine the conditions under which the catfish are being raised, including the drugs being used. (Recommendation 2)

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

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

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Steve D. Morris
    Phone: (202) 512-3841

    1 open recommendations
    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 February 2017, the agency had not acted on our recommendation.
    Director: Thomas Melito
    Phone: (202) 512-9601

    2 open recommendations
    Recommendation: To strengthen USAID's monitoring and evaluation of cash transfer and food voucher projects and help ensure improved program oversight of these projects, the USAID Administrator should take steps to ensure that final reports submitted for cash transfer and food voucher projects comply with USAID's minimum data requirements.

    Agency: United States Agency for International Development
    Status: Open

    Comments: In June 2017, USAID said it had entered into an institutional support contract in December 2016 to address this recommendation. Support staff under this contract will be responsible for assisting each geographic team to ensure that implementing partners adhere to existing award processes and procedures, including compliance with reporting on minimum data requirements. USAID noted that the revised target completion date is 9/30/2017.
    Recommendation: To strengthen USAID's monitoring and evaluation of cash transfer and food voucher projects and help ensure improved program oversight of these projects, the USAID Administrator should strengthen the indicators USAID uses to measure the timeliness, cost-effectiveness, and appropriateness of Emergency Food Security Program cash transfer and food voucher projects.

    Agency: United States Agency for International Development
    Status: Open

    Comments: In June 2017, USAID stated that it released an updated Annual Program Statement for Emergency Food Assistance Programs in December 2016, which addresses this recommendation. As implementation provides data to support a closure request, USAID anticipates completing this recommendation in Fiscal Year 2017. The revised target completion date is 9/30/2017.
    Director: Steve Morris
    Phone: (202) 512-3841

    1 open recommendations
    Recommendation: To further enhance FDA's PREDICT tool and its ability to ensure the safety of imported food, the Secretary of Health and Human Services should direct the Commissioner of FDA to document the process for identifying the type of open source data to collect, obtaining such data, and determining how PREDICT is to use the data.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of February 2017, GAO was awaiting action by the agency to implement this recommendation.
    Director: John Neumann
    Phone: (202) 512-3841

    1 open recommendations
    including 1 priority recommendation
    Recommendation: To improve the ability of the federal veterinarian workforce to carry out its activities, and to prepare for an emergency involving a large-scale animal disease outbreak, the Secretary of Agriculture should direct the Administrator of the Animal and Plant Health Inspection Service to assess the veterinarian workforce needs under possible scenarios for an emergency response to a large-scale animal disease outbreak. Building on the Talent Management Advisory Council's (TMAC) efforts to determine the veterinarian workforce needed to respond to an animal disease outbreak, the assessment should include the number and types of veterinarians needed, the sources required to have a sufficient workforce to respond, and the training needed to carry out their roles.

    Agency: Department of Agriculture
    Status: Open
    Priority recommendation

    Comments: USDA provided information in April 2017 on steps taken to partially address this recommendation. According to USDA, the agency uses its experiences with real-world animal disease outbreaks, such as recent outbreaks of highly pathogenic avian influenza, to assess its veterinarian workforce needs. To fully implement this recommendation, APHIS needs to develop an estimate of the number of veterinarians necessary to respond to large-scale animal disease outbreaks, such as a nationwide foot-and-mouth disease outbreak in livestock.
    Director: J. Alfredo Gómez
    Phone: (202) 512-3841

    1 open recommendations
    including 1 priority 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: 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.
    Director: John Neumann
    Phone: (202) 512-3841

    9 open recommendations
    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

    Comments: In February 2015, FDA posted a report summarizing the results of its Fiscal Year 2012 Pesticide Monitoring Program. The report identified which pesticides the agency tested for in FY 2012. However, the report did not identify which pesticides with EPA-established tolerances were not tested for, nor did it discuss the potential effect of not testing for those pesticides. As of December 2016, FDA had not provided an updated status for this recommendation. It plans to provide a status update in early calendar year 2017.
    Recommendation: To gather and report reliable, nationally representative data on pesticide residue violations, the Secretary of Health and Human Services should direct the Commissioner of FDA to design and implement a statistically valid sampling methodology that would enable the agency, within existing resources, to gather nationally representative pesticide residue incidence and level data for both domestically produced and imported foods, or justify statistically the use of a nonprobability method that can measure the estimation error. In designing either approach, FDA should consider the extent to which the benefits exceed the costs.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In February 2015, FDA issued a report summarizing the results of its pesticide monitoring program for Fiscal Year 2012. This report followed by about 4 months the issuance of our report, GAO-15-38, in October 2014. The FDA report stated that the sampling methodology used in FY 2012 was not statistically based. However, in light of our recommendation that FDA design and implement a statistically valid sampling methodology, the agency could have used its February 2015 report to announce its plan to develop such a methodology for use in the future, but it did not do so. As of December 2016, FDA had not provided an updated status for this recommendation. It plans to provide a status update in early calendar year 2017.
    Recommendation: To gather and report reliable, nationally representative data on pesticide residue violations, the Secretary of Health and Human Services should direct the Commissioner of FDA to report the nationally representative incidence and level data in its annual pesticide monitoring reports, including disclosing the limits of its chosen sampling methodology.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of December 2016, FDA had not provided an updated status for this recommendation. It plans to provide a status update in early calendar year 2017.
    Recommendation: To evaluate and refine its targeted pesticide compliance and enforcement monitoring program, the Secretary of Health and Human Services should direct the Commissioner of FDA to use the incidence and level data to assess the effectiveness of FDA's targeted pesticide compliance and enforcement monitoring program, including its use of the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting targeting tool for imported foods, by comparing the rate of violations detected through the program to the overall rate of pesticide residue violations within the domestic and imported food supplies.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of December 2016, FDA had not provided an updated status for this recommendation. It plans to provide a status update in early calendar year 2017.
    Recommendation: To evaluate and refine its targeted pesticide compliance and enforcement monitoring program, the Secretary of Health and Human Services should direct the Commissioner of FDA to identify any types of domestic and imported foods that are at high risk for pesticide residue tolerance violations to improve the ability of its targeted pesticide compliance and enforcement monitoring program to consistently identify food likely to have violations.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of December 2016, FDA had not provided an updated status for this recommendation. It plans to provide a status update in early calendar year 2017.
    Recommendation: To better inform the public about the frequency and scope of pesticide tolerance violations, the Secretary of Agriculture should direct the FSIS Administrator 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 National Residue Program and the potential effect of not testing for those pesticides.

    Agency: Department of Agriculture
    Status: Open

    Comments: In March 2015, FSIS issued its Fiscal Year 2015 Residue Sampling Plan for the National Residue Program for Meat, Poultry, and Egg Products. The sampling plan contained information on the pesticides that FSIS would include in its residue testing program. However, the sampling plan did not identify pesticides with EPA-established tolerances that FSIS did not plan to include in its testing program. In December 2015, FSIS issued its Fiscal Year 2014 Residue Sample Results for its national residue program. The agency's report on its results did not identify pesticides with EPA-established tolerances that were not included in its testing program, nor did it report on the potential effect of not testing for those pesticides. In June 2016, FSIS issued its sampling plan for Fiscal Year 2016. The sampling plan contained information on the pesticides that FSIS would include in its residue testing program. However, the sampling plan did not identify pesticides with EPA-established tolerances that FSIS did not plan to include in its testing program. The FSIS sampling results for Fiscal Year 2015 were not available as of December 2016.
    Recommendation: To better meet federal standards and best practices for statistical surveys, the Secretary of Agriculture should direct the AMS Administrator to provide better documentation of the survey methods used in its Pesticide Data Program in the program's annual reports by providing more complete information on the sampling methodology the agency uses, such as how it identifies and selects states, food distribution centers, and commodities for pesticide residue testing, and include measures of sampling error for reported estimates.

    Agency: Department of Agriculture
    Status: Open

    Comments: The Agricultural Marketing Service published its 2015 Pesticide Data Program annual report in November 2016. As with earlier reports, this report does not provide sufficient documentation of the survey methods used in the program. In particular, the report does not provide complete information on the sampling methodology the agency used, such as how it identified and selected states, food distribution centers, and commodities for pesticide residue testing. Further, it does not include measures of sampling error for reported estimates.
    Recommendation: To better meet federal standards and best practices for statistical surveys, the Secretary of Agriculture should direct the AMS Administrator to provide better documentation of the survey methods used in its Pesticide Data Program in the program's annual reports by reporting on the extent to which its survey covers commodities in the U.S. food supply and any limitations associated with its survey methodology.

    Agency: Department of Agriculture
    Status: Open

    Comments: The Agricultural Marketing Service published its 2015 Pesticide Data Program annual report in November 2016. This report has a new section titled Sampling Limitations. In that section, the agency acknowledges that the total number of distribution centers and terminal markets within the participating states is difficult to establish because existing sites may go out of business or merge and new sites may open during the course of the year. Despite this limitation, the agency concludes that the sites selected in the program are representative of all sites in these states. However, the agency has not provided sufficient documentation in the report to support the claim that its data are representative of conditions across the country for commodities in the U.S. food supply.
    Recommendation: To better meet federal standards and best practices for statistical surveys, the Secretary of Agriculture should direct the AMS Administrator to provide better documentation of the survey methods used in its Pesticide Data Program in the program's annual reports by describing methods users should employ to analyze the data, including obtaining margins of error for making generalizeable estimates of pesticide residues in commodities.

    Agency: Department of Agriculture
    Status: Open

    Comments: The Agricultural Marketing Service published its 2015 Pesticide Data Program annual report in November 2016. This report does not describe methods users should employ to analyze the data, including obtaining margins of error for making generalizeable estimates of pesticide residues in commodities.
    Director: Gomez, Jose A
    Phone: (202) 512-3841

    2 open recommendations
    Recommendation: To enhance FDA's ability to use AERs and to oversee dietary supplement products, the Secretary of the Department of Health and Human Services should direct the Commissioner of FDA to incorporate a mechanism to collect information on when AERs are used to support and inform consumer protection actions (i.e., surveillance, advisory, and regulatory actions).

    Agency: Department of Health and Human Services
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will update this information.
    Recommendation: To enhance FDA's ability to use AERs and to oversee dietary supplement products, the Secretary of the Department of Health and Human Services should direct the Commissioner of FDA to establish a time frame for issuing final guidance for the draft (1) New Dietary Ingredient (NDI) guidance and (2) guidance clarifying whether a liquid product may be labeled and marketed as a dietary supplement or as a conventional food with added ingredients.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: Although FDA issued final guidance for distinguishing liquid dietary supplements from beverages in January 2014, it has not yet issued final guidance on new dietary ingredients (NDI). Once FDA completes the NDI guidance, we can close the recommendation.
    Director: Irving, Susan J
    Phone: (202) 512-6806

    2 open recommendations
    Recommendation: In light of declining discretionary budgets, to reduce or eliminate the reliance of the AQI program on taxpayer funding, Congress should consider allowing USDA to set AQI fees to recover the aggregate estimated costs of AQI services--thereby allowing the Secretary of Agriculture to set fee rates to recover the full costs of the AQI program.

    Agency: Congress
    Status: Open

    Comments: As of March 2017, Congress had not passed legislation to give the Secretary of Agriculture authority to set fee rates to fully recover the aggregate costs of agricultural quarantine inspection (AQI) services, as GAO suggested in March 2013. In the 114th Congress, the Savings, Accountability, Value, and Efficiency Act of 2015 was introduced in the House and referred to the committees of jurisdiction. The act would require the Secretary of Agriculture to (1) study whether the amount of AQI fees collected cover the aggregate costs of AQI services, and (2) report to Congress the results of the study and any recommendations for ensuring that fees covered costs. The act would not authorize the Secretary of Agriculture to set fee rates to recover the full costs of the AQI program. The current AQI fee authority does not permit the U.S. Department of Agriculture to set AQI fees to recover the aggregate estimated costs of AQI services. Authorizing the Secretary of Agriculture to set fee rates to recover the full costs of the AQI program would save the federal government money by reducing the program's reliance on U.S. Customs and Border Protection's annual Salaries and Expenses appropriation.
    Recommendation: Congress should consider amending USDA's authorization to assess AQI fees on bus companies, private vessels, and private aircraft and include in those fees the costs of AQI services for the passengers on those buses, private vessels, and private aircraft.

    Agency: Congress
    Status: Open

    Comments: As of March 2017, Congress had not passed legislation to give the Secretary of Agriculture authority to assess agricultural quarantine inspection (AQI) fees on private vessels, private aircraft, and commercial buses and include in those fees the costs of AQI services for the passengers on those vehicles. In the 114th Congress, the Savings, Accountability, Value, and Efficiency Act of 2015 was introduced in the House and referred to the committees of jurisdiction. The act would require the Secretary of Agriculture to (1) study whether the amount of AQI fees collected cover the aggregate costs of AQI services, and (2) report to Congress the results of the study and any recommendations for ensuring that fees covered costs. The current AQI fee authority does not permit the U.S. Department of Agriculture to assess AQI fees on private vessels, private aircraft and commerical buses and to recover, through those fees, the costs of AQI services for the passengers on those vehicles.
    Director: Crosse, Marcia G
    Phone: (202)512-3407

    1 open recommendations
    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 August 2017, FDA reported that it remains committed to strengthening its efforts and systematically monitoring and evaluating the overseas offices' contributions to the agency's mission and objectives. FDA also stated that it is making significant progress in several areas by enhancing strategic planning and analysis, refining the Office of International Program's (OIP) performance metrics, and designing a monitoring and evaluation plan. For example, FDA stated it has developed a framework with refined performance metrics to distinguish and assess the distinct contribution of OIP and its foreign offices towards program objectives and broader agency goals. FDA said that the performance metrics will track and monitor the quantity, quality, and timeliness of activity outputs and intermediate outcomes resulting from OIP's work. The measures have been standardized and defined, and will be further disaggregated to enable various levels of analyses, including distinguishing the unique efforts by foreign offices and product type. According to FDA, it plans to roll out its performance framework, related metrics, and monitoring and evaluation processes in fiscal year 2018. FDA said it anticipates that its performance measures, enhanced monitoring, and increased sharing of best practices across foreign offices and FDA headquarters will facilitate tracking of performance, allow greater accountability, and provide a foundation for continuous improvement. GAO will continue to monitor FDA's progress.
    Director: Shames, Lisa R
    Phone: (202) 512-2649

    2 open recommendations
    Recommendation: To better ensure FDA's oversight of the safety of GRAS substances, the Commissioner of FDA should develop a strategy to minimize the potential for conflicts of interest in companies' GRAS determinations, including taking steps such as issuing guidance for companies on conflict of interest and requiring information in GRAS notices regarding expert panelists' independence.

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

    Comments: In September 2014, FDA indicated that guidance on potential conflicts of interest for experts participating on GRAS panels is a priority for the agency. In its Final Rule on Substances Generally Recognized as Safe (81 FR 54959), issued Aug. 17, 2016, FDA stated that it had decided to issue guidance regarding conflicts of interest and that it would announce the availability of a draft guidance document through a notice in the Federal Register. As of December 2016, FDA had not yet issued this draft guidance.
    Recommendation: To better ensure FDA's oversight of the safety of GRAS substances, the Commissioner of FDA should develop a strategy to monitor the appropriateness of companies' GRAS determinations through random audits or some other means, including issuing guidance on how to document GRAS determinations.

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

    Comments: On Aug. 17, 2016, FDA published a final rule on Substances Generally Recognized as Safe (GRAS) (81 FR 54959). This final rule includes a section titled "Guidance on Documenting Conclusions of GRAS Status," which states that FDA is "issuing a guidance" for companies on how to document their GRAS determinations. It is not clear from the rule the time frame for issuing this guidance, whether it will be issued in draft first for comment, and whether it will part of the guidance on conflicts of interest that FDA also plans to issue at a later date, as noted elsewhere in the rule. As of December 2016, FDA had not issued this guidance.
    Director: Gomez, Jose A
    Phone: (202)512-2649

    1 open recommendations
    Recommendation: To enhance FDA's oversight of dietary supplements and foods with added dietary ingredients, and to better enable FDA to meet its responsibility to regulate dietary supplements that contain new dietary ingredients, the Secretary of the Department of Health and Human Services should direct the Commissioner of FDA to issue guidance to clarify when an ingredient is considered a new dietary ingredient, the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing ingredient identity.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In July 2011, FDA published draft guidance for industry on new dietary ingredient notifications and related issues. This draft guidance includes information on when a dietary ingredient is considered new, evidence of safety, and methods for ingredient identity. We are waiting for the draft guidance to become final to close the recommendation.
    Director: Dyckman, Lawrence J
    Phone: (202)512-9692

    1 open recommendations
    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 established a national Food Safety Commission charged with making specific recommendations for drafting legislative language. Among other things, the Commission is 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 DOF report. As of January 2017, no action had been taken. Therefore, in January 2017, we reopened this matter.