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: OSHA stated that it agrees that workers should be able to report injuries, illnesses, and hazards free of intimidation. OSHA noted that its Field Operations Manual prescribes procedures for facilitating the free and open exchange of information, such as conducting onsite worker interviews without management present. OSHA further stated that when workers indicate interest in offsite interviews, the agency will conduct those interviews as prescribed by the Field Operations Manual. We note in our report that because inspectors inform plant management which workers they want to speak with, supervisors know the identity of workers interviewed onsite. Workers and worker advocates we spoke with expressed concerns about this. OSHA told us that inspectors interview meat and poultry workers offsite infrequently, since these interviews can be challenging and take additional time, and OSHA also may be challenged to find an acceptable venue when the employee is available. In June 2020, DOL informed us that OSHA had signed an alliance with several meat and poultry-related industry associations and that they expect this alliance to help improve overall safety and health for the industry's workers. We continue to believe that there are additional steps OSHA can take to better encourage workers to disclose sensitive concerns, and we look forward to learning how OSHA will draw upon this alliance to help take these steps.

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: OSHA stated that meat and poultry workers should have bathroom access as prescribed by the agency's regulations. They noted that if it is observed that processes indicate lack of bathroom access, or if a worker indicates there is an issue, the agency will investigate. Our report identified a mismatch between the concerns we heard from workers about lack of bathroom access and the problems reported by OSHA. We also reported that workers may not volunteer information about lack of bathroom access unless specifically asked. OSHA may choose to address this issue without routinely asking workers about bathroom access, such as by selectively querying workers based on criteria determined by the agency. In June 2020, DOL informed us that OSHA had signed a national alliance with several meat and poultry-related industry associations, and that bathroom access is one of the topics that will be addressed within this alliance, with a goal of developing educational materials. We note that this is a positive step forward, and we continue to stand by our recommendation.

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: In June 2020, DOL informed us that OSHA continues work on updating its guidance for employers on how to manage their health units to address the challenges of managing these units, and that OSHA anticipates initiating clearance of the draft updated guidance in fall 2020. We will consider closing this recommendation when this effort is complete.

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
Priority recommendation

Comments: In February 2020, OSHA reported that OSHA and FSIS drafted an updated MOU, which both parties are reviewing. The two agencies met in Summer 2019 to discuss workplace safety, collaboration between the two agencies, and the implementation of the MOU. During a series of working meetings, they discussed each aspect of the MOU, including training and coordination activities. FSIS and OSHA will continue to meet routinely and review the MOU to determine whether adjustments are needed, as appropriate. We will consider closing this recommendation when this effort is complete.

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
Priority recommendation

Comments: FSIS stated that it already has directives in place to recognize and report hazards affecting FSIS employees, and acknowledged that the MOU was designed to additionally have FSIS employees report hazards affecting plant employees due to the regular presence of its inspectors in plants. FSIS noted that in collaborating with OSHA, FSIS will need to ensure its primary mission is not compromised by undertaking activities that take time and resources away from its food safety inspection responsibilities. In January 2019, OSHA reported that it met with FSIS several times to discuss chemical exposures, referrals, and issues of jurisdiction in state plan states. FSIS subsequently shared the results from a NIOSH health hazard evaluation that was conducted, as well as the efforts to track the source of the infected birds. To fully implement this recommendation, FSIS should strengthen the MOU and develop a mechanism to regularly evaluate it would help ensure that the goals of the MOU are met; leveraging FSIS's presence in plants provides the federal government with a cost-effective opportunity to protect worker safety and health.

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: FSIS stated that the agency already has a process for sharing chemical safety information with its inspectors. However, FSIS has not provided us with evidence that it has shared the worker safety information it collects related to new chemicals, such as safety information that is specific for dilution levels and conditions of use at plants, as noted in the report. FSIS also stated that it would take certain steps to share information about approval of chemicals with other agencies such as OSHA and NIOSH, but the steps identified did not include sharing worker safety information. Incorporating worker safety information would further help enhance this information sharing. FSIS further stated that some of the information collected during its review of new chemicals may be proprietary.

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 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 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 February 2020, FDA said that the recommendation should be closed as not implemented. FDA has previously 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.

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 January 2020, 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. 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 January 2020, 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. The current AQI fee authority does not permit the U.S. Department of Agriculture to assess AQI fees on private vessels, private aircraft and commercial buses and to recover, through those fees, the costs of AQI services for the passengers on those vehicles.

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.

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: On November 16, 2017, FDA published a notification of availability for the draft guidance "Best Practices for Convening a GRAS Panel: Guidance for Industry," with a request for comments on the draft guidance by May 15, 2018. FDA indicated that the draft guidance represents FDA's current thinking on strategies to minimize the potential for conflicts of interest in companies' GRAS determinations, including assessing potential GRAS panel members for conflicts of interest. As of July 2020, FDA had not yet finalized the guidance, so we are leaving the recommendation open.

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 (2002 Farm Bill) established a national Food Safety Commission charged with making specific recommendations for drafting legislative language. Among other things, the Commission was 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 GAO Duplication, Overlap, and Fragmentation Report. As of March 2020, it remained unaddressed.