Recommendation: The Commissioner of the Food and Drug Administration, in coordination with the Secretary of Agriculture, should more fully incorporate the seven leading practices for effective collaboration in the agencies' interagency agreement for the joint oversight of cell-cultured meat. (Recommendation 1)

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

Comments: FDA and USDA partially concurred with this recommendation. FDA stated that it concurred with the intent of incorporating the seven leading practices into the interagency agreement, and both agencies said that they are open to incorporating the practices into their development of the structure for joint oversight of cell-cultured meat. However, the agencies stated that they did not agree to revise the agreement at this time. FDA and USDA stated that the agreement is a general framework and that incorporating the leading practices would constitute an inappropriate level of detail. Instead, the agencies stated that they believe it would be most valuable to incorporate the leading practices into a more detailed joint framework or standard operating procedure they plan to issue. We appreciate the agencies' willingness to incorporate the leading practices for effective collaboration into their efforts. The March 2019 interagency agreement states that the agencies have the ability to modify it as needed and will review the agreement every 3 years to determine whether they should modify or terminate it. Therefore, the agencies are due to revisit the agreement in March 2022, if not sooner. Regarding the agencies' concern that incorporating the leading practices in the interagency agreement would add an inappropriate level of detail, we note that, as we state in our report, the existing agreement already partially incorporates each of the seven leading practices. We continue to believe that FDA and USDA should more fully incorporate the seven leading practices for effective collaboration into their interagency agreement for the joint oversight of cell-cultured meat. Developing a more detailed joint framework or standard operating procedure in accordance with the existing interagency agreement that incorporates those leading practices would meet the intent of our recommendation to improve the effectiveness of the agencies' collaboration.

Recommendation: The Secretary of Agriculture, in coordination with the Commissioner of the Food and Drug Administration, should more fully incorporate the seven leading practices for effective collaboration in the agencies' interagency agreement for the joint oversight of cell-cultured meat. (Recommendation 2)

Agency: Department of Agriculture
Status: Open

Comments: FDA and USDA partially concurred with this recommendation. FDA stated that it concurred with the intent of incorporating the seven leading practices into the interagency agreement, and both agencies said that they are open to incorporating the practices into their development of the structure for joint oversight of cell-cultured meat. However, the agencies stated that they did not agree to revise the agreement at this time. FDA and USDA stated that the agreement is a general framework and that incorporating the leading practices would constitute an inappropriate level of detail. Instead, the agencies stated that they believe it would be most valuable to incorporate the leading practices into a more detailed joint framework or standard operating procedure they plan to issue. We appreciate the agencies' willingness to incorporate the leading practices for effective collaboration into their efforts. The March 2019 interagency agreement states that the agencies have the ability to modify it as needed and will review the agreement every 3 years to determine whether they should modify or terminate it. Therefore, the agencies are due to revisit the agreement in March 2022, if not sooner. Regarding the agencies' concern that incorporating the leading practices in the interagency agreement would add an inappropriate level of detail, we note that, as we state in our report, the existing agreement already partially incorporates each of the seven leading practices. We continue to believe that FDA and USDA should more fully incorporate the seven leading practices for effective collaboration into their interagency agreement for the joint oversight of cell-cultured meat. Developing a more detailed joint framework or standard operating procedure in accordance with the existing interagency agreement that incorporates those leading practices would meet the intent of our recommendation to improve the effectiveness of the agencies' collaboration.

Recommendation: As the three cell-cultured meat working groups move forward, the Commissioner of the Food and Drug Administration, in coordination with the Secretary of Agriculture, should more fully incorporate the seven leading practices for effective collaboration, such as identifying specific outcomes and a way to monitor and evaluate progress toward outcomes. (Recommendation 3)

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

Comments: In March 2020, FDA officials agreed with this recommendation. We will follow up to determine what steps they take to implement the recommendation.

Recommendation: As the three cell-cultured meat working groups move forward, the Secretary of Agriculture, in coordination with the Commissioner of the Food and Drug Administration, should more fully incorporate the seven leading practices for effective collaboration, such as identifying specific outcomes and a way to monitor and evaluate progress toward outcomes. (Recommendation 4)

Agency: Department of Agriculture
Status: Open

Comments: In March 2020, USDA officials agreed with this recommendation. We will follow up to determine what steps they take to implement the recommendation.

Recommendation: The Commissioner of the Food and Drug Administration, in coordination with the Secretary of Agriculture, should clearly document in their interagency agreement, or other publicly available document, which agency will oversee cell-cultured seafood other than catfish. (Recommendation 5)

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

Comments: In March 2020, FDA officials agreed with this recommendation. We will follow up to determine what steps they take to implement the recommendation.

Recommendation: The Secretary of Agriculture, in coordination with the Commissioner of the Food and Drug Administration, should clearly document in their interagency agreement, or other publicly available document, which agency will oversee cell-cultured seafood other than catfish. (Recommendation 6)

Agency: Department of Agriculture
Status: Open

Comments: In March 2020, USDA officials agreed with this recommendation. We will follow up to determine what steps they take to implement the recommendation.

Recommendation: The Secretary of Agriculture should direct Departmental Administration to work with the mission areas to develop department-level outcome-oriented performance goals and related measures for the business centers, and use them to assess the effectiveness and impact of the business center reforms. (Recommendation 1)

Agency: Department of Agriculture
Status: Open

Comments: In January 2020, USDA officials agreed with our recommendation and stated that the department is evaluating options for the development of performance metrics and inclusion of these metrics and related information as part of the regular and recurring reviews by the department's Deputy Secretary who is identified as the Chief Operating Officer.

Recommendation: The Commissioner of FDA should establish a process to monitor whether the agency is meeting its audit goals and expectations for sampling and inspections to support its removal decisions for seafood import alerts. This could be done through regularly analyzing data that FDA collects, such as those in CMS, FACTS, and OASIS. (Recommendation 1)

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

Comments: FDA agreed with our recommendation. In August 2020, FDA told us that the agency is working to review and modify appropriate sections of its Regulatory Procedures Manual to better reflect the importance of foreign suppliers' corrective actions when making decisions to remove a firm from an import alert and identify higher-risk problem areas where more robust information may be needed. In addition, a checklist for import alerts and associated Compliance Management System (database) functionality are under development. According to FDA, the agency is also working to refine internal communications to better assure that firms which have recently been removed from an import alert are also considered for an inspection. Additionally, in November 2019, FDA published a Notice of Proposed Rulemaking on accreditation of laboratories that conduct food testing to support removal from import alert and other purposes. We will continue to monitor FDA's planned actions to determine if they satisfy our recommendation.

Recommendation: The Commissioner of FDA should establish a time frame for developing performance goals and measures for its imported food safety program. (Recommendation 2)

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

Comments: FDA agreed with this recommendation. In August 2020, FDA told us that the agency has published some performance metrics and plans to develop additional performance measures and outcome indicators for imported food safety, to support FDA's Strategy for the Safety of Imported Food (Strategy). In addition, after publishing these initial metrics for the Strategy, the agency will develop additional performance metrics. FDA stated that the COVID-19 situation is quite fluid and the agency is unable to project timelines for developing additional performance measures at this time. We will continue to monitor FDA's planned actions to determine if they satisfy our recommendation.

Recommendation: The Commissioner of FDA should, as the agency develops goals and measures for its imported food safety program, develop performance goals and corresponding performance measures specific to seafood import alerts. (Recommendation 3)

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

Comments: FDA agreed with this recommendation. In August 2020, FDA told us that the agency remains committed to developing additional performance goals and measures for its imported food safety program. FDA is still reviewing the Import Alert Effectiveness Program and will consider metrics, as appropriate, based on the outcome of that review. FDA stated that the COVID-19 situation is quite fluid and the agency is unable to project timelines for developing additional performance measures at this time. We will continue to monitor FDA's planned actions to determine if they satisfy our recommendation.

Recommendation: The Secretary of Agriculture should work with the Commissioner of FDA to develop a mechanism to facilitate coordination with relevant nonfederal stakeholders, including state, local, and tribal governments, on actions related to date labels as part of their efforts to reduce food loss and waste. (Recommendation 1)

Agency: Department of Agriculture
Status: Open

Comments: USDA agreed with our recommendation and is planning actions to implement the recommendation.

Recommendation: The Commissioner of FDA should work with the Secretary of Agriculture to develop a mechanism to facilitate coordination with relevant nonfederal stakeholders, including state, local, and tribal governments, on actions related to date labels as part of their efforts to reduce food loss and waste. (Recommendation 2)

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

Comments: FDA agreed with our recommendation and is taking actions to implement the recommendation. For example, as of August 2020, FDA said it is meeting regularly with USDA and EPA to coordinate activities including to clarify and communicate information on food date labels. FDA also named a representative to the Association of Food and Drug Officials (AFDO) Food Recovery Committee. FDA is encouraging the Committee to explore how date labels on packaged foods can create a barrier to food donation and to track state legislative activities related to date labeling of food. We will update the status of this recommendation as FDA makes more progress.

Recommendation: The Administrator of EPA should work with the Commissioner of FDA and Secretary of Agriculture to incorporate leading collaboration practices as they implement their interagency FLW reduction strategic plan, to include (1) agreeing on roles and responsibilities; (2) developing mechanisms to monitor, evaluate, and report on results; (3)clearly defining short- and long-term outcomes; (4) identifying how leadership commitment will be sustained; and (5) ensuring that the relevant stakeholders have been included in the collaborative effort.(Recommendation 1)

Agency: Environmental Protection Agency
Status: Open

Comments: The agency agreed with this recommendation. As of June 2020, EPA indicated that its proposed completion date is October 2020. EPA published joint and individual agency accomplishments in each of the six priority areas listed as contributing efforts on EPA's webpage (https://www.epa.gov/sustainable-management-food/winning-reducing-food-waste-federal-interagency-strategy). In addition, EPA indicated that it is coordinating with government and other stakeholders through: (1) monthly high-level check-in calls for senior USDA and FDA officials, in which the meeting chair rotates among agencies; (2) twice a month (or as needed) staff work group meetings, led by the recently appointed USDA food loss and waste liaison, to explore potential activities aligned with the six priority areas in the interagency strategy to reduce food loss and waste; and (3) participation in quarterly meetings with relevant stakeholders, such as ReFED, the Food Waste Reduction Alliance (FWRA), and Further with Food, to coordinate efforts and learn of opportunities to collaborate on reducing food loss and waste. We will continue to follow up with the agency. When we confirm what additional actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Commissioner of FDA should work with the Administrator of EPA and Secretary of Agriculture to incorporate leading collaboration practices as they implement their interagency FLW reduction strategic plan, to include (1) agreeing on roles and responsibilities; (2) developing mechanisms to monitor, evaluate, and report on results; (3)clearly defining short- and long-term outcomes; (4) identifying how leadership commitment will be sustained; and (5) ensuring that the relevant stakeholders have been included in the collaborative effort. (Recommendation 2)

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

Comments: The agency agreed with this recommendation. As of December 2019, we are following up with the agency. When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of Agriculture should work with Administrator of EPA and Commissioner of FDA to incorporate leading collaboration practices as they implement their interagency FLW reduction strategic plan, to include (1) agreeing on roles and responsibilities; (2) developing mechanisms to monitor, evaluate, and report on results; (3)clearly defining short- and long-term outcomes; (4) identifying how leadership commitment will be sustained; and (5) ensuring that the relevant stakeholders have been included in the collaborative effort. (Recommendation 3)

Agency: Department of Agriculture
Status: Open

Comments: The agency agreed with this recommendation. As of December 2019, we are following up with the agency. When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Administrator of the Food Safety and Inspection Service (FSIS) should document the agency's process for deciding which products to consider for new pathogen standards, including the basis on which such decisions should be made. (Recommendation 1).

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

Comments: As of September 2019, FSIS is drafting a document that will outline the agency's process for deciding which products to consider for new pathogen standards, including the basis on which such decisions should be made. FSIS estimates the document will be finalized in the fourth quarter of fiscal year 2020. As of October 2020, FSIS has not completed this action.

Recommendation: The Administrator of FSIS should set time frames for determining what pathogen standards or additional policies are needed to address pathogens in beef carcasses, ground beef, pork cuts, and ground pork. (Recommendation 2).

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

Comments: In October 2019, FSIS proposed new pathogen reduction performance standards for Salmonella in raw ground beef and beef trimmings. FSIS told us the agency is developing performance standards for some pork products and plans to issue draft standards sometime in fiscal year 2020 but as of October 2020 has not completed this action.

Recommendation: The Administrator of FSIS should include available information on the effectiveness of on-farm practices to reduce the level of pathogens as it finalizes its guidelines for controlling Salmonella in hogs. (Recommendation 3).

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

Comments: As of September 2019, FSIS is revising its draft guidelines for controlling Salmonella in hogs. The agency plans to include in the guidelines available scientific information on the effectiveness of on-farm practices to reduce Salmonella. FSIS estimates it will complete its revision of the guidelines in the fourth quarter of fiscal year 2020 but as of October 2020 has not completed this action.

Recommendation: The Commissioner of FDA should develop a timeline for updating the risk assessment on arsenic in rice. (Recommendation 1)

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

Comments: As of August 2020, FDA stated that it will update the risk assessment when more scientific evidence becomes available. In the meantime, FDA noted that it will continue to monitor research in this area, including ongoing work by the National Academies of Sciences (NAS) Board on Environmental Studies and Toxicology, which is currently reviewing EPA's work on inorganic arsenic, specifically on EPA's IRIS Toxicological Assessments of Inorganic Arsenic. GAO will assess whether FDA has taken action responsive to the recommendation when additional information becomes available.

Recommendation: The Commissioner of FDA should ensure that the FVM Program develops performance measures with associated targets and time frames for all eight of FDA's food safety- and nutrition-related objectives. (Recommendation 2)

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

Comments: As of August 2020, FDA had not fully implemented our recommendation, although the agency reported taking several steps. For example, FDA stated that implementation of Food Safety Modernization Act (FSMA) based preventive controls standards is a top priority for the agency and a key component of the Foods and Veterinary Medicine Program's strategic plan, and for this reason, FSMA-related performance metrics have been prioritized. In addition, FDA reported that in September 2019, the agency published an online Food Safety Dashboard, whose purpose is to measure the progress of each of the FSMA rules, and FDA provides regular updates to the dashboard to promote transparency to the public. FDA also stated that as of June 2020, the dashboard contains measures related to Preventive Controls and Current Good Manufacturing Practice Rules and Imported Food Safety Program, and it includes data for human and animal food and, in some cases, data starting in FY 2017. FDA added that since the FSMA rules have staggered compliance dates, the measures associated with the rules are developed in phases, and over time, the Food Safety Dashboard will be populated with additional data to show more FSMA-related outcomes. However, the recommendation is not fully implemented since our recommendation included the related objectives within the Foods and Veterinary Medicine Program's strategic plan. In August 2020, FDA told us that given the agency's 2018 reorganization, FDA has aligned the performance measures and dashboard with the FSMA rules, and the current alignment covers most of the food safety objectives within the strategic plan. FDA also reported that it is reviewing the strategic plan to ensure alignment with FDA's current priorities and structure, including the recently released New Era of Smarter Food Safety Blueprint. We will follow up with FDA and provide an update in FY 2021.

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: 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: In July 2017, as part of the agency's formal comments, HHS initially neither agreed nor disagreed with the recommendation. Subsequently, in a September 2017 letter, HHS agreed with this recommendation. In July 2018, HHS stated that FDA published a notice in the Federal Register In September 2016 requesting information from the public about how to establish appropriately targeted durations of use for therapeutic products affected by Guidance for Industry #213 with no defined duration of use. According to HHS, FDA evaluated the comments received and plans to develop a strategy to address this issue. In July 2019, HHS stated that FDA published a Request for Applications on April 1, 2019 for study proposals to help establish more targeted or defined durations of use for approved medically important antimicrobial drugs used in the feed of food-producing animals. There are currently no such products approved for use in water with an undefined duration of use. According to HHS, due to significant scientific and technical challenges, FDA anticipates that this initiative will require substantial time to fully implement so the primary objective is to update product dosage regimens to better target when and for how long the drug may be used.

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: In July 2017, as part of the agency's formal comments, HHS initially neither agreed nor disagreed with the recommendation. Subsequently, in a September 2017 letter, HHS agreed with this recommendation. In July 2018, HHS stated that FDA recognizes that a limited number of medically important antimicrobial products, available in dosage forms other than feed or water (e.g., injectable), continue to be marketed as OTC products and the agency intends to work with the sponsors to put these products under veterinary oversight. In July 2019, HHS stated that FDA released a broad 5-year plan in September 2018 outlining steps to support stewardship of medically important antimicrobials in veterinary settings. As part of that plan, FDA intends to publish a draft strategy, likely in the form of draft guidance for industry, to bring all dosage forms (such as injectables and tablets) of medically important antimicrobial drugs under veterinary oversight. The draft strategy will also provide a framework, including proposed timelines, for transitioning from over-the-counter to prescription marketing status for all approved medically important antimicrobial drugs that are not yet subject to veterinary oversight. FDA plans to issue this draft strategy no later than the end of fiscal year 2019. In conjunction with issuing the draft strategy, FDA intends to publish a list of affected new animal drug applications.

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: In July 2017, as part of the agency's formal comments, HHS initially neither agreed nor disagreed with the recommendation. Subsequently, in a September 2017 letter, HHS agreed with this recommendation. In July 2018, HHS noted that FDA has taken steps to develop performance measures and targets. According to HHS, FDA issued a final rule in May 2016 revising annual reporting requirements for drug sponsors of antimicrobials sold or distributed for use in food-producing animals to obtain estimates of sales broken out by major food-producing species (i.e., cattle, swine, chickens, and turkeys). Additionally, in August 2017, FDA published a paper proposing the use of a biomass denominator to adjust annual data on the volume of antimicrobials sold or distributed for use in food-producing animals in the United States. According to HHS, this adjusted estimate will provide insight into broad shifts in the volume of antimicrobials sold for use in food-producing animals. FDA is also funding two grants for antimicrobial use data collection. These collection efforts are intended to provide part of the baseline information on antimicrobial use practices in the four major food-producing animal groups (i.e., cattle, swine, chickens, and turkeys), which is a critical element in measuring overall impact of the agency's judicious use strategy. FDA expects these data collection efforts to provide important information on methodologies to help optimize long-term strategies to collect and report such antimicrobial use data. In addition, FDA has been working in close collaboration with USDA, including providing input on recent surveys administered by USDA to collect information on antimicrobial use on farms. In July 2019, according to HHS, FDA agrees that performance measures and targets are needed to help gauge the success of antimicrobial stewardship efforts. While the agency continues to work on developing such measures and targets, FDA reported a decrease in domestic sales and distribution of all medically important antimicrobials intended for use in food-producing animals (e.g. decreased by 33 percent from 2016 through 2017). HHS noted that the reduction in sales volume is an important indicator that ongoing efforts to support antimicrobial stewardship are having a significant impact even though sales data do not necessarily reflect antimicrobial use.

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 August 2018, USDA's Animal and Plant Health Inspection Service (APHIS) stated that it is working closely with USDA's Food Safety and Inspection Service (FSIS) and HHS' Centers for Disease Control and Prevention (CDC) to develop a framework for deciding when on-farm antimicrobial resistance investigative activities are warranted. In September 2019, according to APHIS officials, the lead agencies, including APHIS, FSIS, and CDC, have agreed that it is imperative that cross sector partners from a range of animal agriculture industries be included in developing the framework that was requested in GAO's final report. A framework for making decisions regarding on-farm antimicrobial resistance investigative activities simply will not work without including industry sector partners in the development of the framework, according to APHIS officials. Due to the logistics of getting all of the cross sector partners together, APHIS is unable to schedule the next meeting in the series to develop the Pre-Harvest Framework until December 2019. APHIS anticipates that it will take the remainder of fiscal year 2020 to work through additional meetings with partners and finalize this framework.

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 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 was no indication whether stakeholders internal to the department had 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. As of September 2020, USDA did not have an update regarding the implementation of this recommendation. We will continue to follow up on USDA's efforts.

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. As of September 2020, USDA did not have an update regarding the implementation of this recommendation. We will continue to follow up on USDA's efforts.

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: 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 2020, Congress had not acted on this matter. OMB informed GAO in January 2020 that they had no plans to develop a government-wide performance plan for food safety. We continue to believe that such a plan is necessary for effective 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 formalizing the FSWG through statute to help ensure sustained leadership across food safety agencies over time.

Agency: Congress
Status: Open

Comments: As of March 2020, Congress had not acted on this matter.

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

Agency: Consumer Product Safety Commission
Status: Open

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

Recommendation: To 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.