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    Results:

    Subject Term: "Food safety"

    19 publications with a total of 48 open recommendations including 2 priority recommendations
    Director: Cindy Brown Barnes
    Phone: (202) 512-7215

    7 open recommendations
    Recommendation: The Assistant Secretary of Labor for Occupational Safety and Health should take additional steps to encourage workers to disclose sensitive concerns during OSHA inspections of meat and poultry plants; for example, by considering additional off-site interviews or exploring other options to obtain information anonymously. (Recommendation 1)

    Agency: Department of Labor: Occupational Safety and Health 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 Assistant Secretary of Labor for Occupational Safety and Health should gather more information, such as by asking workers during meat and poultry plant inspections, to determine the extent to which bathroom access is a problem and how to address any identified issues. (Recommendation 2)

    Agency: Department of Labor: Occupational Safety and Health 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 Assistant Secretary of Labor for Occupational Safety and Health should update its guidance for employers on how to manage their health units to address the challenges of managing these units. (Recommendation 3)

    Agency: Department of Labor: Occupational Safety and Health 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 Assistant Secretary of Labor for Occupational Safety and Health should work with FSIS to assess the implementation of the MOU and make any needed changes to ensure improved collaboration; and set specific timeframes for periodic evaluations of the MOU. (Recommendation 4)

    Agency: Department of Labor: Occupational Safety and Health 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 FSIS Administrator should work with OSHA to assess the implementation of the MOU and make any needed changes to ensure improved collaboration; and set specific timeframes for periodic evaluations of the MOU. (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.
    Recommendation: The FSIS Administrator should develop a process to regularly share the worker safety information it collects during its review of new chemicals with FSIS inspectors, plant management, OSHA, and the Centers for Disease Control and Prevention's National Institute for Occupational Safety and Health (NIOSH). (Recommendation 6)

    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 Director of NIOSH should consider including in the agency's research agenda a proposal for examining the extent of peracetic acid's use in combination with other chemicals in meat and poultry plants, and any safety and health hazards these combinations may pose to workers. (Recommendation 7)

    Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention: National Institute for Occupational Safety and Health
    Status: Open

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

    6 open recommendations
    Recommendation: The Secretary of Health and Human Services should direct the Commissioner of FDA to develop a process, which may include time frames, to establish appropriate durations of use on labels of all medically important antibiotics used in food animals.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS neither agreed nor disagreed with this recommendation, and as of July 2017, we await action from FDA.
    Recommendation: The Secretary of Health and Human Services should direct the Commissioner of FDA to establish steps to increase veterinary oversight of medically important antibiotics administered in routes other than feed and water, such as injections and tablets.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS neither agreed nor disagreed with this recommendation, and as of July 2017, we await action from FDA.
    Recommendation: The Secretary of Health and Human Services should direct the Commissioner of FDA to develop performance measures and targets for actions to manage the use of antibiotics such as revising the veterinary feed directive and developing guidance documents on judicious use.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS neither agreed nor disagreed with this recommendation, and as of July 2017, we await action from FDA.
    Recommendation: The Secretary of Agriculture should direct the Administrator of APHIS to develop performance measures and targets for collecting farm-specific data on antibiotic use in food animals.

    Agency: Department of Agriculture
    Status: Open

    Comments: USDA agreed with this recommendation. In July 2017, the Animal and Plant Health Inspection Service stated that it will develop performance measures and targets for collecting farm-specific data on antibiotic use in farm animals and antibiotic resistant bacteria by September 30, 2017.
    Recommendation: The Secretary of Agriculture should direct the Administrator of APHIS to develop performance measures and targets for collecting farm-specific data on antibiotic-resistant bacteria in food animals.

    Agency: Department of Agriculture
    Status: Open

    Comments: USDA agreed with this recommendation. In July 2017, the Animal and Plant Health Inspection Service stated that it will develop performance measures and targets for laboratory monitoring for antibiotic resistance of pathogens by September 30, 2017.
    Recommendation: The Secretary of Agriculture should direct the Administrator of APHIS and the Administrator of the Food Safety and Inspection Service to work with the Director of CDC to develop a framework for deciding when on-farm investigations are warranted during outbreaks.

    Agency: Department of Agriculture
    Status: Open

    Comments: USDA agreed with this recommendation. In July 2017, USDA's Animal and Plant Health Inspection Service agreed to work with USDA's Food Safety and Inspection Service and HHS' Centers for Disease Control and Prevention to develop an additional decision matrix by December 31, 2017 for use to determine when on-farm antimicrobial resistance investigative activities are warranted.
    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: 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: Steve D. Morris
    Phone: (202) 512-3841

    3 open recommendations
    Recommendation: To improve USDA's ability to oversee GE crops, the Secretary of Agriculture should direct the Administrator of the Animal and Plant Health Inspection Service (APHIS) to develop a timeline, with milestones and interim steps, for updating its existing regulations to cover GE crops developed with alternative technologies that either do not use plant pests or use plant pests but do not result in plant pest deoxyribonucleic acid in the crop developed.

    Agency: Department of Agriculture
    Status: Open

    Comments: In its August 2016 Statement of Action on our report, USDA notes that it has a timeline, but the department did not provide documentation of this timeline. The Statement of Action also indicates that USDA planned to update its biotechnology regulations and publish a proposed rule in the summer of 2016. As of December 2016, the proposed rule had not yet been published.
    Recommendation: To improve USDA's ability to better understand the economic impacts of unintended mixing of GE and other crops, the Secretary of Agriculture should direct the Administrator of the National Agricultural Statistics Service (NASS) to work with all relevant USDA stakeholders, including APHIS and the Organic Working Group, to determine what additional information should be sought in future organic surveys, such as the costs of reshipping and re-storing shipments rejected because of unintended GE presence, as well as the costs associated with finding new buyers for such shipments.

    Agency: Department of Agriculture
    Status: Open

    Comments: In its August 2016 Statement of Action on our report, USDA did not provide any new information on actions it has taken, if any, to implement this recommendation. For example, there is no indication whether stakeholders internal to the department have continued to meet to discuss the 2014 Organic Survey results and how to move forward with future survey questions to obtain additional data, such as data needed to better understand the economic impacts of unintended mixing with GE crops.
    Recommendation: To improve USDA's ability to better understand the economic impacts of unintended mixing of GE and other crops, the Secretary of Agriculture should direct the Administrator of NASS to include producers, growing identity-preserved crops, in addition to organic producers in USDA's survey efforts.

    Agency: Department of Agriculture
    Status: Open

    Comments: In its August 2016 Statement of Action on our report, USDA did not provide any new information on actions it has taken, if any, to implement this recommendation. We continue to believe that USDA should survey producers growing identity-preserved crops regarding their potential economic losses from unintended GE presence, as is being done for organic producers. As we previously reported, U.S. acreage planted to identity-preserved crops is significantly greater than that planted to organic crops; yet, little is known about the economic costs to identity-preserved farmers of unintended mixing.
    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: Morris, Steve D
    Phone: (202) 512-3841

    3 open recommendations
    including 1 priority recommendation
    Recommendation: To help ensure that their food safety goals are complementary and strategies are mutually reinforcing, the Secretary of Agriculture and the Secretary of Health and Human Services should continue to build upon their efforts to implement GPRAMA requirements to address crosscutting food safety efforts, including by more fully describing in their strategic and performance planning documents how they are working with other agencies to achieve their food safety-related goals and objectives.

    Agency: Department of Agriculture
    Status: Open
    Priority recommendation

    Comments: USDA and HHS agreed with our recommendation that they continue to build upon their efforts to implement GPRAMA requirements to address crosscutting food safety efforts. In response to the recommendation, HHS took steps to update its strategic and performance planning documents to better address crosscutting food safety efforts. For example, in February 2015, HHS updated its strategic plan to more fully describe how it is working with other agencies to achieve its food safety-related goals and objectives. As a result, we closed the recommendation to HHS as implemented. In its written comments on our report, USDA said that the Department was working to achieve the GPRAMA requirement for interagency collaboration and continues to work with HHS to align its strategic and performance planning to achieve their mutual food safety goals and efforts. As of March 2017, USDA had not fully implemented our recommendation, although the Department's Food Safety and Inspection Service (FSIS) had taken some steps that could contribute toward full implementation. For example, FSIS included more information on crosscutting food safety efforts in its fiscal year 2017-2021 strategic plan and in its draft fiscal year 2017 annual plan than it did in its prior strategic and annual plans. Such information could be included in USDA's next strategic plan. According to USDA officials, the Department plans to include more information on interagency collaboration in its next strategic plan, to be issued in February 2018. As USDA and its component agencies work to develop the Department's new strategic plan, attention should be given to fully addressing crosscutting food safety efforts in it and in USDA's associated performance planning documents. Once USDA's new strategic plan has been released, we will evaluate whether the recommendation has been implemented. We continue to believe that implementing the recommendation is an important step toward addressing fragmentation in federal oversight of food safety.
    Recommendation: Because challenges associated with the fragmented federal food safety system are long-standing, decision makers do not have an integrated perspective on federal food safety performance, and centralized mechanisms for broad-based collaboration have not been sustained, Congress should consider directing OMB to develop a government-wide performance plan for food safety that includes results oriented goals and performance measures and a discussion of strategies and resources.

    Agency: Congress
    Status: Open

    Comments: As of March 2017, Congress had not acted on this matter.
    Recommendation: Because challenges associated with the fragmented federal food safety system are long-standing, decision makers do not have an integrated perspective on federal food safety performance, and centralized mechanisms for broad-based collaboration have not been sustained, Congress should consider formalizing the FSWG through statute to help ensure sustained leadership across food safety agencies over time.

    Agency: Congress
    Status: Open

    Comments: As of March 2017, Congress had not acted on this matter.
    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: J. Alfredo Gómez
    Phone: (202) 512-3841

    1 open recommendations
    Recommendation: To help ensure that FSIS efforts protect human health by reducing Salmonella and Campylobacter contamination in FSIS-regulated poultry products, in future revisions of the compliance guidelines on controlling Salmonella and Campylobacter, the Secretary of Agriculture should direct the Administrator of FSIS to ensure the inclusion of information on the effectiveness of each recommended farm practice to reduce these pathogens in live poultry.

    Agency: Department of Agriculture
    Status: Open

    Comments: In December 2015, USDA's Food Safety and Inspection Service released the draft revised compliance guideline to assist poultry establishments in controlling Salmonella and Campylobacter in raw poultry. The draft guideline included information on the effectiveness of each recommended farm practice to reduce Salmonella and Campylobacter in live poultry. FSIS announced the availability of and requested comment on the revised compliance guideline in a December 2015 Federal Register Notice. FSIS officials told us that they anticipate finalizing the draft guideline in fiscal year 2017 and the guideline states that while the document is draft, establishments are encouraged to incorporate information in the guideline in their decision-making process. As of April 2017, FSIS had not finalized the guideline.
    Director: Mihm, J Christopher
    Phone: (202) 512-6806

    1 open recommendations
    Recommendation: To improve implementation of GPRAMA and help address pressing governance issues, given the common, long-standing difficulties agencies continue to face in measuring the performance of various types of federal programs and activities--contracts, direct services, grants, regulations, research and development, and tax expenditures--the Director of OMB should work with the PIC to develop a detailed approach to examine these difficulties across agencies, including identifying and sharing any promising practices from agencies that have overcome difficulties in measuring the performance of these program types. This approach should include goals, planned actions, and deliverables along with specific time frames for their completion, as well as the identification of the parties responsible for each action and deliverable.

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

    Comments: As of August 2017, OMB and the PIC have taken some limited actions to address this recommendation. According to information provided by staff from OMB and the PIC in June 2015, they had taken some initial steps to address this recommendation in a few areas, such as acquisition management (contracts). In addition, the PIC formed a working group on performance measurement that, in part, is focusing on how to develop appropriate performance measures. However, OMB and the PIC have not yet developed a comprehensive and detailed approach to address these issues as recommended in our report. OMB staff told us in August 2017 that efforts related to the future implementation of the Program Management Improvement Accountability Act could help address this recommendation. We will continue to monitor progress.
    Director: Gomez, Jose A
    Phone: (202) 512-3841

    1 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.
    Director: Cackley, Alicia P
    Phone: (202) 512-8678

    2 open recommendations
    Recommendation: To improve the awareness, use, and usefulness of SaferProducts.gov, the CPSC should establish and incorporate metrics to assess efforts to increase awareness and use of SaferProducts.gov.

    Agency: Consumer Product Safety Commission
    Status: Open

    Comments: The Commission states that it measures overall awareness of SaferProducts.gov in a manner similar to the manner in which it measures the awareness of CPSC.gov: by the number of visits to the website. The Commission states that website visits is a reasonable proxy measure of overall awareness that is cost-effective to collect. According to the Commission, in fiscal year 2014, SaferProducts.gov had 2.4 million visits and 863,000 visitors, where visits are the number of sessions the site was hit and visitors are the count of unique IP addresses who came to the site. The Commission had previously indicated that it planned to include three questions on SaferProducts.gov in a National Awareness Survey designed to determine overall awareness of CPSC on a national level. While the Commission administered the survey, it did not include questions related to SaferProducts.gov. As of March 2017, the Commission has not taken specific steps to measure the overall awareness of SaferProducts.gov.
    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 had begun making usability improvements to SaferProducts.gov by improving the search functionality and improving the user experience of submitting incident reports. The Commission planned to include a tagline to its website to increase users' understanding of the site's purpose--either "Report. Search. Protect." or "Report. Search. Be Empowered." by March 2017. However, as of April 2017, SaferProducts.gov does not include a tagline. The Commission also has not made any other website improvements in this regard, nor have staff undertaken user experience studies to assess users' understanding of the site.
    Director: Shames, Lisa R
    Phone: (202) 512-3841

    1 open recommendations
    Recommendation: To strengthen FDA's process for ordering recalls, the Secretary of Health and Human Services should direct the Commissioner of FDA to document FDA's process for ordering food recalls in regulations or industry guidance to include information on how the agency will weigh evidence on whether a recall is necessary.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In May 2015, FDA published a notice in the Federal Register announcing that draft guidance for industry on mandatory food recalls was available for public comment. According to FDA officials, a review of public comments has been completed and finalization of the guidance is pending. We will continue to monitor FDA's efforts to finalize this guidance. (As of February 2017, we continue to await agency action.)
    Director: Shames, Lisa R
    Phone:

    1 open recommendations
    Recommendation: To enhance the effectiveness of the food safety system for catfish and avoid duplication of effort and cost, Congress should consider repealing provisions of the Farm Bill that assigned USDA responsibility for examining and inspecting catfish and for creating a catfish inspection program.

    Agency: Congress
    Status: Open

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