This section discusses the federal oversight of food safety, past reviews of the federal food safety oversight system, and the status of federal efforts to address criteria for removing oversight of food safety from our High-Risk List. Of the 16 federal agencies that collectively administer at least 30 federal laws governing food safety and quality, FDA and FSIS have primary responsibility for food safety oversight. Table 1 summarizes the food safety responsibilities of all 16 agencies. As we said earlier, for more than 4 decades, we have reported on the fragmented nature of federal food safety oversight. For example, in our past work, we described how FDA is generally responsible for ensuring that eggs in their shells (referred to as shell eggs) are safe, wholesome, and properly labeled; FSIS is responsible for the safety of eggs processed into egg products; USDA’s Agricultural Marketing Service (AMS) sets quality and grade standards for shell eggs, such as Grade A; USDA’s Animal and Plant Health Inspection Service (APHIS) manages the program that helps ensure laying hens are free from Salmonella at birth; and FDA oversees the safety of the feed that hens eat. In addition, we reported that FDA has primary responsibility for regulating manufacturers of frozen cheese pizzas, FSIS has primary responsibility for regulating manufacturers of frozen pizzas with meat, and multiple additional federal agencies play roles in regulating the components of either type of pizza. Similarly, we have noted that FSIS inspects manufacturers of packaged open-face meat or poultry sandwiches (i.e., those with one slice of bread), but FDA inspects manufacturers of packaged closed-face meat or poultry sandwiches (i.e., those with two slices of bread). However, establishments producing closed-faced meat or poultry sandwiches intended for export to Canada can be inspected for Hazard Analysis and Critical Control Point (HACCP) compliance by FSIS under a voluntary inspection program, and samples collected by FSIS will be tested for certain pathogens by AMS. In an August 1998 report, the National Academies concluded that the fragmented federal food safety oversight system was not well-equipped to meet emerging challenges. In response to the academies’ report, the President established a Council on Food Safety later that year and charged it with developing a comprehensive strategic plan for federal food safety activities, among other things. The council’s Food Safety Strategic Plan, released on January 19, 2001, recognized the need for a comprehensive food safety statute and concluded that the organizational structure of the food safety system makes it more difficult to achieve future improvements in efficiency, efficacy, and allocation of resources based on risk. In October 2001, we recommended that USDA, HHS, and the Assistant to the President for Science and Technology, as joint chairs of the President’s Council on Food Safety, reconvene the council, which had disbanded earlier that year, to facilitate interagency coordination on food safety regulation and programs. In our prior work, we have also identified options for reducing fragmentation and overlap in food safety oversight, including alternative organizational structures. These options include establishing a single food safety agency, a food safety inspection agency, a data collection and risk analysis center, and a coordination mechanism led by a central chair. We also suggested that Congress might wish to assess the need for comprehensive, uniform, risk-based food safety legislation or to amend FDA’s and USDA’s existing authorities. (For descriptions of selected options, see app. II.) When we added the federal oversight of food safety to our list of high-risk areas in January 2007, we found that a challenge for the 21st century was to find a way for federal agencies with food safety responsibilities to integrate the myriad food safety programs and strategically manage their portfolios to promote the safety and integrity of the nation’s food supply. We noted that we had detailed problems with the fragmented federal food safety oversight system and had found that the system had caused inconsistent oversight, ineffective coordination, and inefficient use of resources. We stated that Congress and the executive branch could and should create the environment needed to look across the activities of individual programs within specific agencies and toward the goals that the federal government is trying to achieve. To that end, in the January 2007 High-Risk Update, we reported that we had recommended that a mechanism be put in place to facilitate interagency coordination on food safety regulations and programs. We also suggested that Congress and the executive branch work together to develop a government-wide performance plan for food safety. A number of actions have been taken since we added federal oversight of food safety to our High-Risk List in 2007. In March 2009, the President established the Food Safety Working Group (FSWG) to coordinate federal efforts and develop goals to make food safer. In January 2011, the FDA Food Safety Modernization Act (FSMA) was enacted, representing the largest expansion and overhaul of U.S. food safety authorities since the 1930s. Also in January 2011, the statutory framework for performance management in the federal government, originally set out in the Government Performance and Results Act of 1993 (GPRA), was updated by the GPRA Modernization Act of 2010 (GPRAMA). GPRAMA adds new requirements for addressing crosscutting efforts in federal strategic and performance planning that help drive collaboration and address fragmentation. For example, GPRAMA requires agencies’ strategic plans and performance plans to contain a description of how the agencies are working with other agencies to achieve their goals and objectives. GPRAMA requirements apply at the departmental or agency level, not to organizational components. In March 2011, we recommended that OMB, in consultation with the federal agencies having food safety responsibilities, develop an annually updated government-wide performance plan for food safety. We stated that a performance plan offers a framework to help ensure agencies’ goals are complementary and mutually reinforcing and to help provide a comprehensive picture of the federal government’s performance on food safety. Furthermore, we stated that such a plan could assist decision makers in balancing trade-offs and comparing performance when resource allocation and restructuring decisions are made. In December 2014, because OMB had not taken action to develop a government-wide performance plan for food safety and the FSWG was no longer meeting, we suggested matters for Congress to consider, including (1) 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 and (2) formalizing the FSWG through statute to help ensure sustained leadership across food safety agencies over time. Congress has not taken action. We found that FDA and FSIS were involved in numerous mechanisms to facilitate interagency coordination on food safety; however, the mechanisms focused on specific issues and none provided for broad- based, centralized collaboration. As of September 2016, federal oversight of food safety remained on our High-Risk List. Table 2 shows nine selected collaborative mechanisms involving FDA and FSIS, as reported in December 2014. We have identified five criteria, all of which must be fully met for an area to be removed from our High-Risk List. In our February 2015 High-Risk Update, we found that for federal oversight of food safety, three of the criteria had been partially met, and two had not been met (see table 3). Our assessment of whether the criteria were met focused largely on efforts Congress and the executive branch had made toward developing a government-wide performance plan for food safety and establishing a centralized mechanism for broad-based collaboration, such as the FSWG. In our February 2015 High-Risk Update, we noted that, with the enactment of GPRAMA in January 2011, Congress and the executive branch demonstrated leadership commitment to improving collaboration across the federal government. We also noted that HHS and USDA had taken steps toward our December 2014 recommendation to implement GPRAMA’s crosscutting requirements for their food safety efforts but could more fully address crosscutting food safety efforts in their individual strategic and performance planning documents and thereby provide building blocks toward implementing our March 2011 recommendation that OMB develop a government-wide performance plan on food safety. However, as of February 2015, OMB had not taken action on our recommendation to develop such a plan. In addition, we noted that the President had demonstrated leadership commitment and progress by establishing the FSWG to coordinate federal efforts and develop goals to make food safer. However, as of February 2015, the working group was no longer meeting, and nothing had taken its place. Federal food safety agencies also have the capacity to participate in a centralized, collaborative mechanism on food safety—like the FSWG—but congressional action would be required to formalize such a mechanism through statute. HHS and USDA have taken some actions since 2014 to address fragmentation in the federal food safety oversight system, and OMB has focused on implementing FSMA, but USDA’s and OMB’s actions have not fully addressed our two recommendations for government-wide planning. Since 2014, HHS and USDA have continued and expanded collaboration on specific food safety issues, and HHS has updated its strategic plan to address interagency coordination on food safety. OMB has focused its efforts on working with agencies to facilitate implementation of FSMA. The facilitation, collaboration, and updates are positive steps, but USDA’s and OMB’s actions do not fully address our two recommendations for government-wide planning. The two agencies with primary responsibility for food safety within HHS and USDA—FDA and FSIS, respectively—continue to use the nine collaborative mechanisms that we reported on in December 2014, all of which focus on specific issues. For example, FDA and FSIS continue to collaborate with CDC through the Interagency Food Safety Analytics Collaboration to improve estimates of the most common sources of foodborne illnesses. According to CDC’s website, the three agencies teamed up to create this collaboration. Its goal is to improve coordination of federal food safety analytic efforts and address crosscutting priorities for food safety data collection, analysis, and use. FSIS and FDA also serve as the co-lead organizations for the food safety topic area under Healthy People 2020, a national health promotion and disease prevention initiative that provides 10-year national objectives for improving the health of all Americans and includes 42 topic areas. The food safety topic area has six objectives related to the goal of reducing foodborne illnesses in the United States, such as reducing infections caused by key pathogens transmitted commonly through food and increasing the proportion of consumers who follow key food safety practices. According to USDA officials, Healthy People 2020 informs their agency goals and their work with CDC and FDA. In addition, over the past 2 years, FDA and FSIS have developed one new collaborative mechanism, according to FDA and FSIS officials. The mechanism, called the Interagency Collaboration on Genomics and Food Safety (Gen-FS), also includes CDC and the National Institutes of Health (NIH). Gen-FS focuses on sequencing the complete DNA of pathogens for surveillance, detection and investigation of outbreaks, and antibiotic resistance for pathogens causing intestinal illnesses transmitted by food and other routes, according to FSIS officials. The Gen-FS steering committee meets monthly to discuss harmonization of training, laboratory methodologies, and data access and analysis, according to FDA officials. Furthermore, FDA officials said that implementing FSMA has been the agency’s major food safety focus over the past 2 years, and FDA is partnering with nongovernmental stakeholders, state and local governments, and federal agencies to ensure FSMA’s successful implementation. Under FSMA, FDA is responsible for more than 50 regulations, guidelines, and studies. This includes seven foundational rules. Table 4 provides additional information on the foundational rules. For example, FDA issued the final FSMA rule on produce, one of the foundational FSMA rules, in November 2015. The rule establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. To develop the rule, which went into effect on January 26, 2016, FDA officials said they worked directly with farmers, which required a significant amount of collaboration with USDA and the states. In addition, these officials said they worked with the Environmental Protection Agency (EPA) on water quality and safety aspects of the produce rule, with the Department of Homeland Security on the intentional adulteration rule, and with the Department of Transportation on the sanitary transportation rule. Furthermore, in May 2016, we found that FDA had taken numerous steps to ensure meaningful and timely input from nonfederal officials during development of the FSMA-mandated rules on produce, human food, and animal food but did not fully meet its tribal consultation responsibilities. OMB staff told us that their main food safety-related focus since 2014 has been on meeting with agencies to oversee FSMA implementation. OMB staff stated that they meet with FDA and FSIS officials via conference calls on a regular basis to discuss the implementation of FSMA, as well as the agencies’ budgets, regulations, and food safety issues more broadly. These meetings occur at times separately and at times with both FDA and FSIS officials present, according to OMB staff. These staff also said that they work on an agency-specific basis, helping agencies develop agency-specific performance plans, talking to agencies about how to improve performance, and working with agencies to collaborate on FSMA implementation. In December 2014, we found that HHS and USDA did not fully address crosscutting food safety efforts in their individual strategic and performance planning documents and that doing so could help provide a comprehensive picture of the federal government’s performance on food safety. We recommended that both HHS and USDA more fully describe how they are working with other agencies to achieve food-safety-related goals in their strategic and performance planning documents, as required by GPRAMA, and the agencies agreed with our recommendation. Since then, in taking steps to update its strategic and performance planning documents to better address crosscutting food safety efforts, HHS implemented our recommendation. Specifically, 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. Among other things, HHS described its collaboration with USDA, EPA, and others through collaborative mechanisms such as the National Antimicrobial Resistance Monitoring System, the Partnership for Food Protection (PFP), and the Food Emergency Response Network. However, USDA has not fully implemented our recommendation, although it has taken some steps toward doing so. 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. In its fiscal year 2017- 2021 strategic plan, it included a list of collaborations, and the draft fiscal year 2017 annual plan includes a section on enhancing collaboration with partners. In addition, FSIS officials told us that FSIS is partnering with CDC, FDA, and NIH on the HHS agency priority goal to reduce foodborne illness caused by Listeria. The priority goal includes (1) sequencing the complete DNA of Listeria strains to improve the detection and investigation of Listeria outbreaks and (2) FDA and FSIS jointly reporting on their activities to reduce Listeria at various points across the food supply chain. USDA plans to include information on interagency collaboration in its next strategic plan, according to USDA officials. As noted above, HHS’s and USDA’s efforts since 2014 are positive steps toward government-wide planning, but OMB has not addressed our recommendation for a government-wide plan for the federal food safety oversight system. Without an annually updated government-wide performance plan for food safety that includes results-oriented goals, performance measures, and a discussion of strategies and resources, which we recommended to OMB in March 2011, Congress, program managers, and other decision makers are hampered in their ability to identify agencies and programs addressing similar missions and to set priorities, allocate resources, and restructure federal efforts, as needed, to achieve long-term goals. Also, without such a plan, federal food safety efforts are not clear and transparent to the public. OMB staff told us that they were not aware of any current plans to develop a government-wide performance plan for food safety. OMB staff said that OMB works on an agency-specific basis, providing input on agencies’ performance plans and offering suggestions on how to improve performance. However, agencies’ individual performance plans alone do not provide the integrated perspective on federal food safety performance necessary to guide congressional and executive-branch decision making and inform the public about what federal agencies are doing to ensure food safety. A government-wide performance plan would provide a coordinated action plan for food safety and a plan for monitoring and measuring agencies’ activities. We continue to believe that a government- wide plan is important for federal food safety oversight efforts. Food safety and government performance experts identified the development and implementation of a national strategy for food safety as a first step toward improving the federal food safety oversight system. Experts identified examples of negative effects that continue to occur as a result of fragmentation in the federal food safety oversight system. These experts agreed that there is a compelling need to develop a national strategy to provide a framework for strengthening that system and addressing fragmentation and described five key elements that should be included in such a strategy. Developing a national strategy for food safety oversight could also provide a framework for addressing our March 2011 recommendation for a government-wide plan, our December 2014 matters for Congress to consider for leadership and planning, and criteria for removing federal food safety oversight from the High-Risk List. During the 2-day meeting we hosted with the assistance of the National Academies, food safety and government performance experts cited examples of the negative effects that continue to occur as a result of fragmentation in the federal food safety oversight system. These examples further illustrate negative effects we have highlighted in our past work, including our 2015 High-Risk Update. For example, experts noted that FDA and FSIS have different statutory authorities. One expert noted that the two agencies’ statutory authorities result in two fundamentally different approaches to inspections. FDA’s authority requires a risk-based approach, in which inspection rates vary depending on the level of risk associated with a food product. FSIS’s authority, in contrast, directs the agency to examine the carcasses and parts of covered animal species and all processed food products before they enter the food supply. Because of these differences, an expert raised questions about the proper allocation of resources based on risk. Commenting on the food safety system more broadly, several experts noted that the allocation of resources is not necessarily connected to the risk of foodborne illness. For example, one expert noted that at the federal level, FSIS and FDA receive close to the same amount of funding for food safety oversight but that FSIS is responsible for the safety of 20 percent of the food supply, and FDA is responsible for ensuring the safety of 80 percent of it. Furthermore, because FSIS must meet continuous inspection requirements, it may be allocating too many resources to inspecting low-risk food processing facilities that produce foods that do not pose substantial threats to public health, according to another expert. For example, the expert highlighted the differences in resource allocation by comparing inspection rates at facilities producing cheese and pepperoni pizzas. A production line at the facility producing cheese pizza, which is regulated by FDA, may be inspected once every 5 years. On the other hand, a production line producing pepperoni pizza, which is regulated by FSIS, is inspected daily. The expert said the risk of foodborne pathogens related to both types of pizza is low because the pizzas are cooked. While raw meat is a high-risk food, meat that is thoroughly cooked, such as pepperoni on pizza, does not pose the same level of risk because the process of cooking eliminates existing pathogens. The 19 experts attending our 2-day meeting agreed that there is a compelling need to develop a national strategy to provide a framework for strengthening the federal food safety oversight system and addressing fragmentation. The experts identified and described five key elements that should be included in a national strategy for food safety oversight. These five key elements follow. Purpose: The starting point for developing a national strategy includes defining the problem, developing a mission statement, and identifying goals. Leadership: The national strategy should establish sustained leadership to achieve progress in food safety oversight. The leadership should reside at the highest level of the administration and needs to have authority to implement the national strategy and be accountable for its progress. The strategy also needs to identify roles and responsibilities for implementing the national strategy and involve all stakeholders, including federal, tribal, state, and local government agencies; industry; consumer groups; academia; and key congressional committees. Resources: The national strategy should identify staffing and funding requirements and the sources of funding for implementing the strategy. Monitoring: The national strategy should establish milestones that specify time frames, baselines, and metrics to monitor progress. The national strategy should be sufficiently flexible to incorporate changes identified through monitoring and evaluation of progress. Actions: In addition to long-term actions, the national strategy should include short-term actions, such as improving training for food safety officials, to gain traction on improving the food safety system. Actions should focus on preventing, rather than reacting to, outbreaks of foodborne illnesses. For example, several experts mentioned modifying the statutes that FSIS implements, such as the Federal Meat Inspection Act and the Poultry Improvement Act, to align the authorities of USDA with the Federal Food, Drug, and Cosmetic Act, as amended by FSMA, which outlines FDA’s responsibilities. This could help ensure a consistent approach across food commodities. See appendix III for a list of actions identified by the experts that could be considered for inclusion in a national strategy for food safety oversight. The experts’ call for a national strategy for food safety oversight is consistent with our past work on national strategies. We found that complex interagency and intergovernmental efforts, which could include food safety, can benefit from developing a national strategy and establishing a focal point with sufficient time, responsibility, authority and resources to lead the effort. For example, in August 2007, we reported on another area involving significant coordination and collaboration across all levels of government, as well as the private sector: preparing for and responding to an influenza pandemic. We found that, as part of its efforts to address the potential threat of an influenza pandemic, the executive branch had developed a National Strategy for Pandemic Influenza and an associated implementation plan and had started working toward completing the plan’s action items. In February 2004, we reported that national strategies themselves are not endpoints, but rather, starting points, and, as with any strategic planning effort, implementation is the key. The five key elements of a national strategy identified by the experts are also consistent with characteristics we have identified as desirable in a national strategy. In our February 2004 report, we found that national strategies are not required, either by executive or legislative mandate, to address a single, consistent set of characteristics. However, on the basis of a review of numerous sources, we identified six desirable characteristics to aid responsible parties in further developing and implementing national strategies. Table 5 lists and describes the six desirable characteristics and shows how the elements of a national strategy for food safety oversight identified by experts align with the six desirable characteristics. Although the experts did not specify which entity should lead the national strategy, past efforts to develop high-level strategic planning for food safety have depended on leadership from entities within the Executive Office of the President (EOP), such as the Domestic Policy Council (DPC), the Office of Science and Technology Policy (OSTP), and OMB. For example, the President’s Council on Food Safety was co-chaired by OSTP, along with HHS and USDA, and involved staff and officials from OMB and the DPC among others. Similarly, the FSWG was led by USDA and HHS and was convened by the DPC. OMB staff and FDA officials stated that a national strategy for improving food safety could be beneficial. However, FDA officials cautioned that timing would be an important consideration given that FDA is focused on FSMA implementation. FSIS officials said that they would defer to OMB regarding questions on the potential benefit of a national strategy for food safety. OMB staff said that OMB relies on direction from the administration to determine national priorities. Entities within the EOP also play a leadership role in other ongoing strategies that require cross-agency collaboration. For example, since December 2013, OSTP and the National Security Council have led a multi-agency effort, including HHS and USDA, to develop the National Strategy for Combating Antibiotic-Resistant Bacteria, with a goal of preventing, detecting, and controlling outbreaks of antibiotic-resistant pathogens. In addition, OMB has established a cross-agency priority goal of improving science, technology, engineering, and mathematics education. Since May 2013, OSTP has taken a lead role, along with the National Science Foundation, in working with multiple agencies to implement a 5-year strategic plan. By developing a national strategy to guide the nation’s efforts to improve the federal food safety oversight system and address ongoing fragmentation, the appropriate entities within the EOP, in consultation with relevant federal agencies and other stakeholders, could provide a comprehensive framework for considering organizational changes and making resource decisions. Developing a national strategy for food safety oversight, as suggested by the experts, could provide a framework for addressing our March 2011 recommendation for a government-wide plan and our December 2014 matters for congressional consideration for leadership and government- wide planning. As we mentioned previously, we have found that complex interagency and intergovernmental efforts can benefit from developing a national strategy and establishing a focal point with sufficient time, responsibility, authority, and resources to lead the effort. The national strategy, as described by the experts and possessing the desirable characteristics described in our past work, could fulfill the intent behind our March 2011 recommendation for OMB to develop a government-wide performance plan for food safety. Such a strategy could include all of the elements of a government-wide performance plan for federal food safety oversight, such as government-wide goals and performance indicators. In addition to addressing our recommendation for a government-wide plan, to the extent that a national strategy for food safety oversight establishes sustained leadership for the issue, it could fulfill the intent behind our December 2014 matter for Congress to consider formalizing the FSWG through statute to help ensure sustained leadership across food safety agencies over time. In addition, developing and implementing a national strategy could provide a framework for addressing the five criteria for removing federal food safety oversight from our High-Risk List. As discussed previously, experts agreed that a national strategy should include sustained leadership, which could address the criterion for leadership commitment. In addition, the national strategy, by including information on resource requirements, actions, and milestones and metrics to monitor progress, could also meet our criteria for capacity, an action plan, and monitoring, respectively. Finally, depending on its contents, a national strategy could demonstrate progress in implementing corrective measures, the final criterion for removing federal food safety oversight from our High-Risk List. Since 2014, the primary federal agencies responsible for ensuring a safe food supply—FDA and FSIS—have taken actions to address fragmentation in the federal food safety oversight system. However, food safety and government performance experts who participated in the meeting we convened cited examples of the negative effects that continue to occur as a result of fragmentation in the federal food safety oversight system and generally agreed that there is a need for a national food safety strategy. These examples further illustrate negative effects that we have highlighted in our past work. The experts identified five key elements that should be included in such a strategy: stating the purpose, establishing sustained leadership, identifying resource requirements, monitoring progress, and including actions for gaining traction. These elements are consistent with characteristics that we have identified as desirable in a national strategy. By developing a national strategy to guide the nation’s efforts to improve the federal food safety oversight system and address ongoing fragmentation, the appropriate entities within the EOP, in consultation with relevant federal agencies and other stakeholders, could provide a comprehensive framework for considering organizational changes and making resource decisions. Experts identified the following stakeholders as key contributors to a national strategy for food safety: federal, tribal, state, and local government agencies; industry; consumer groups; academia; and key congressional committees. Such a national strategy also could provide a framework for addressing our recommendation for a government-wide plan, our matters for Congress to consider for leadership and planning, and criteria for removing federal food safety oversight from our High-Risk List. To guide the nation’s efforts to improve the federal food safety oversight system and address ongoing fragmentation, we recommend that the appropriate entities within the EOP, 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. We provided a draft of this report to HHS, USDA, OMB, and DPC for their review and comment. In written comments, HHS did not comment on our recommendation to the EOP. USDA disagreed with the need for a national strategy but cited factors to consider should changes be proposed. USDA also discussed several points related to the report’s findings. HHS’s and USDA’s written comments are reproduced in appendixes IV and V, respectively. In addition, HHS and USDA provided technical corrections, which we incorporated as appropriate. Also, according to an e-mail from the Special Assistant to the President of the EOP, OMB and DPC did not have comments on the draft report. To guide the nation’s efforts to improve the federal food safety oversight system and address ongoing fragmentation, we recommended that the appropriate entities within the EOP, in consultation with relevant federal agencies and other stakeholders, develop a national strategy that states the purpose of the strategy, established high-level sustained leadership, identifies resource requirements, monitors progress, and identifies short- and long-term actions to improve the food safety oversight system. USDA stated that it is not yet convinced that developing and implementing a national strategy would result in significantly different outcomes in protecting public health by preventing foodborne illness with its partners. However, USDA also noted that, should major changes to the federal food safety system be proposed, it is imperative that they are data-driven, well-designed, collaborative, and ultimately, continue to enable the United States to have the safest food supply in the world. Even with USDA’s reservations, we continue to believe that a national strategy would provide a comprehensive framework for considering organizational changes and resource decisions to improve the federal food safety oversight system. USDA made a number of other comments related to the report’s findings. First, USDA stated the report does not appear to explain or acknowledge the depth and breadth of key federal agency efforts and activities to work together within the bounds of existing statutory authorities, particularly across FSIS, FDA, CDC, and other federal food safety partners. In addition, USDA said that the report appears to significantly underestimate the complexity of modifying statutes that FSIS and FDA currently implement with the intent of better alignment. Related to acknowledging the depth and breadth of key federal efforts and activities, in our December 2014 report, we identified and described numerous collaborative mechanisms involving FDA and FSIS to highlight these positive efforts, and for this report, we requested information on any additional collaborative mechanisms developed since 2014, which we included. However, we found and continue to believe that these mechanisms focus on specific issues and do not provide for broad-based, centralized collaboration that would allow FDA, FSIS, and other agencies to look across their individual food safety programs and determine how they all contribute to federal food safety goals. Related to underestimating the complexity of modifying statutes that FSIS and FDA currently implement, we discuss modifying statutes as an example of the numerous actions that experts identified could be considered for inclusion in a national strategy for food safety oversight. We envision that ultimately it will be up to the stakeholders participating in such a strategy to decide which actions to pursue. Second, USDA stated that FSIS continues to strongly disagree with the draft report in that it undervalues and diminishes the many collaborative mechanisms that are in place among FSIS and FDA, as well as with CDC and other federal and non-federal food safety and public health partners. In addition, FSIS said that the characterizations of all collaborations as “narrow” and “specific,” and the implication that broad-based collaboration does not occur through FSIS’s deeply integrated engagement, is inaccurate. Further, USDA stated that the implication that the collaborations are not well-targeted or sufficient appears to reflect a lack of understanding of how agencies with food safety/public health responsibilities operate in sync with each other. USDA also stated that FSIS’s activities with FDA, CDC, and other food safety partners are strategic, highly outcome- and mission-driven, and fully address the GPRAMA crosscutting requirements for federal strategic and performance planning that help drive collaboration and address fragmentation. USDA stated that it is important to note that we did not present or provide any evidence for any area where sufficient collaboration does not occur. As we said earlier, we found and continue to believe that these collaborative mechanisms focus on specific issues and do not provide for broad-based, centralized collaboration that would allow FDA, FSIS, and other agencies to look across their individual food safety programs and determine how they all contribute to federal food safety goals. Third, USDA stated that it appreciated that our report attempts to recognize new collaborations since 2014; however, it does not include three of four new collaborations on which FSIS provided testimonial or written information to us—the HHS agency priority goal for foodborne Listeria monocytogenes illnesses interagency effort, PFP, and the One Health Initiative. Related to the HHS agency priority goal, in the report, we stated that FSIS officials told us that FSIS is partnering with CDC, FDA, and NIH on the HHS agency priority goal to reduce foodborne illness caused by Listeria. PFP and the One Health Initiative were established prior to 2014; however, in the report, we did discuss PFP in the context of presenting examples of collaborative mechanisms involving FDA and FSIS that we reported on in December 2014 and collaborative mechanisms described by HHS in its updated strategic plan. Fourth, USDA stated that our report indicates that USDA has not fully implemented our prior recommendation to address crosscutting food safety efforts in its strategic and performance planning documents, because USDA, at the department level, did not alter its just-published fiscal year 2014-2018 strategic plan to mention food safety collaboration across USDA’s large, broad, multi-agency portfolio. USDA stated that FSIS believes our continued focus on USDA not editing and reissuing its departmental strategic plan to include such reference to be misplaced. Further, USDA stated that food safety collaboration is addressed in the USDA fiscal year 2014-2018 strategic plan’s key food safety illness indicator, which directly reflects FSIS’s broad, long-standing collaborative activity with FDA and CDC associated with Healthy People, and in FSIS’s fiscal year 2011-2016 and fiscal year 2017-2021 strategic plans. In our December 2014 report, we stated that GPRAMA requires agencies to include in their strategic plan a description of how they are working with other agencies to achieve their goals and objectives. In addition, we stated that GPRAMA does not apply to organizational components of agencies. Instead, agencies are expected to work with their components to implement GPRAMA requirements in a manner that is most useful to the whole organization. In December 2014, we found several relevant crosscutting efforts that were not identified in USDA’s fiscal year 2014- 2018 strategic plan, and recommended that USDA more fully describe in its strategic and performance planning documents how it is working with other agencies to achieve its food-safety-related goals and objectives. In December 2014, USDA concurred with our recommendation, and USDA plans to include information on interagency collaboration in its next strategic plan, according to USDA officials. Fifth, USDA stated that it is concerned about the implication that many of the possible actions to include in a national strategy do not require congressional approval and can be taken by executive branch agencies without such approval; USDA stated that they cannot. In addition, USDA stated that while the recommendation for executive action is quite general, the specifics, as outlined in appendix III of our report, appear far too prescriptive for us to typically recommend, and place disproportionate value on expert opinion rather than on data-driven analysis. Further, USDA stated that we appear to place importance on expert opinions, including citing many statements that were factually incorrect or misrepresented in a prior draft, and some of whose testimonial statements we removed. This included statements that implicitly supported assertions that FDA’s statutory authorities could be appropriate to apply to the products that FSIS regulates. USDA stated that no data, study, or evidence supports this approach as being more protective of public health and prevention of foodborne illness. USDA also stated that it continues to be concerned about our selective and dominant use of expert opinion studies to support its findings. In addition, USDA stated that we cite certain prior studies and panels from 1998, 2001, and more recently, yet other studies, such as one in 2002 by a White House- established Policy Coordinating Committee, concluded that the goals of the Administration were better advanced through enhanced interagency coordination rather than through, for example, the development of legislation to create a single food safety agency. Related to USDA’s concerns about the actions listed in appendix III requiring congressional approval and appearing too prescriptive, the purpose of the appendix was to present a list of actions identified by the experts that could be considered for inclusion in a national strategy for food safety. As we stated earlier, we envision that ultimately it will be up to the stakeholders participating in such a strategy to decide which actions to pursue. Related to USDA’s concern about the apparent importance we place on expert opinions and our use of expert opinion studies to support our findings, we selected food safety and government performance experts on the basis of the relevance of their knowledge; their prominence in the public discourse on food safety issues; and their diversity of experience working in food safety, such as through prior experience working at senior levels for FDA, CDC, or USDA or current experience working for the food industry. We took steps to confirm the accuracy of information the experts provided before including it in our final product. Related to USDA’s concern about the development of legislation to create a single food safety agency, we discuss this option in an appendix in which we list a number of options we have identified in our past work to improve the federal food safety oversight. Sixth, USDA stated that in prior reports, we have written that programs are put on the High-Risk List because of their vulnerabilities to fraud, waste, abuse, or mismanagement, or are most in need of transformation to address economy, efficiency, or effectiveness challenges. Given this standard, USDA said that it continues to assert that food safety should no longer be listed as high risk. We have identified five criteria, all of which must be fully met for an area to be removed from our High-Risk List. In our February 2015 High-Risk Update, we found that for federal oversight of food safety, three of the criteria had been partially met, and two had not been met. Our assessment of whether the criteria were met focused largely on efforts Congress and the executive branch had made toward developing a government-wide performance plan for food safety and establishing a centralized mechanism for broad-based collaboration, such as the FSWG. However, we found that USDA’s and OMB’s actions since 2014 have not fully addressed the need for government-wide planning. In addition, we acknowledge that congressional action would be required to formalize in statute a centralized, collaborative mechanism on food safety, like the FSWG; however, federal food safety agencies do have the capacity to participate in such a mechanism. We believe that a national strategy for food safety could provide a framework for addressing the five criteria for removing federal food safety oversight from our High-Risk List. As agreed with your offices, unless you publicly announce the contents of this report earlier, we plan no further distribution until 30 days from the report date. At that time, we will send copies to the appropriate congressional committees; the Secretary of Health and Human Services; the Secretary of Agriculture; the Director, Office of Management and Budget; and other interested parties. In addition, the report will be available at no charge on the GAO website at http://www.gao.gov. If you or your staff members have any questions regarding this report, please contact me at (202) 512-3841 or morriss@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. Key contributors to this report are listed in appendix VI. On June 9 and 10, 2016, with the assistance of the National Academies of Sciences, Engineering, and Medicine, we convened a 2-day meeting of food safety and government performance experts to discuss fragmentation in the U.S. federal food safety oversight system and suggest actions to improve that system. Table 6 lists the experts who participated in the meeting, along with their affiliations. We selected food safety and government performance experts on the basis of the relevance of their knowledge; their prominence in the public discourse on food safety issues; and their diversity of experience working in food safety, such as through prior experience working on food safety at senior levels in the federal government as well as through current work in food-related industries, nongovernmental research organizations, state agencies, foreign food safety agencies, academia, and advocacy groups. In our previous work, we have identified several options to improve the federal food safety oversight system. These options include establishing a coordination mechanism led by a central chair, a food safety inspection agency, a data collection and risk analysis center, and a single food safety agency and are described in table 7. During the 2-day meeting we convened with the assistance of the National Academies of Sciences, Engineering, and Medicine, experts identified a number of actions to consider including in a national strategy to improve food safety oversight. At least 10 of the 19 experts agreed that each of these actions described in table 8 could be appropriate to consider for inclusion in a national strategy, but not all of the experts agreed that every identified action should be considered. We are not endorsing any of these actions. These actions were identified by experts for consideration. In addition to the contact named above, Anne K. Johnson (Assistant Director), Kevin Bray, Candace Carpenter, Stephen Cleary, Michelle Duren, Ellen Fried, Kirsten Lauber, Benjamin T. Licht, Marya Link, Rekha Vaitla, Walter Vance, and Sarah Veale made key contributions to this report.

Summary: Although the U.S. food supply is generally considered safe, foodborne illness remains a common, costly, yet largely preventable public health problem. The safety and quality of food involves 16 federal agencies. For more than 4 decades, GAO has reported on the fragmented federal food safety oversight system. Because of potential risks to the economy and to public health and safety, food safety has remained on GAO's list of high-risk areas since 2007. GAO was asked to examine efforts toward and options for addressing fragmentation in the federal food safety oversight system. This report (1) describes the actions HHS, USDA, and OMB have taken since 2014 to address fragmentation and evaluates the extent to which these agencies have addressed two prior GAO recommendations for government-wide planning and (2) assesses actions that food safety and other experts suggest are needed to improve the federal food safety oversight system. GAO convened an expert meeting, reviewed agency documents, and interviewed agency officials. Since 2014, the Department of Health and Human Services' (HHS) Food and Drug Administration (FDA) and the U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS), the federal agencies with primary responsibility for food safety oversight, have taken some actions to address fragmentation in the federal food safety oversight system, and HHS has updated its strategic plan to address interagency coordination on food safety. However, USDA has not yet fully implemented GAO's December 2014 recommendation that it describe interagency collaboration on food safety in its strategic and performance planning documents. In addition, the Office of Management and Budget (OMB) has not addressed GAO's March 2011 recommendation to develop a government-wide plan for the federal food safety oversight system. At a 2-day meeting GAO hosted in June 2016, 19 food safety and other experts agreed that there is a compelling need to develop a national strategy to address ongoing fragmentation and improve the federal food safety oversight system. This is consistent with a prior GAO finding that complex interagency and intergovernmental efforts can benefit from developing a national strategy. The experts identified the following key elements of such a strategy: Purpose: The starting point for a national strategy includes defining the problem, developing a mission statement, and identifying goals. Leadership: The national strategy should establish sustained leadership at the highest level of the administration with authority to implement the strategy and be accountable for its progress. The strategy also needs to identify roles and responsibilities and involve all stakeholders. Resources: The national strategy should identify staffing and funding requirements and the sources of funding for its implementation. Monitoring: The national strategy should establish milestones that specify time frames, baselines, and metrics to monitor progress. The strategy should be sufficiently flexible to incorporate changes identified through monitoring and evaluation of progress. Actions: In addition to long-term actions, the national strategy should include short-term actions to gain traction in improving the food safety system. Actions should focus on preventing, rather than reacting to, outbreaks of foodborne illnesses. These elements are consistent with characteristics GAO has previously identified as desirable in national strategies. Past efforts to develop high-level strategic planning for food safety have depended on leadership from the Executive Office of the President (EOP). By developing a national strategy to guide the federal food safety oversight system and address ongoing fragmentation, the EOP, in consultation with relevant federal agencies and other stakeholders, could provide a framework for making organizational and resource decisions. Among other things, such a strategy also could provide a framework for addressing GAO's recommendation for a government-wide plan and for removing food safety oversight from GAO's High-Risk List. GAO recommends that the appropriate entities within the EOP, in consultation with stakeholders, develop a national strategy to guide the federal food safety oversight system and address ongoing fragmentation. HHS, OMB, and the Domestic Policy Council did not comment on the recommendation. USDA disagreed with the need for a national strategy but cited factors to consider should changes be proposed. GAO believes the recommendation should be implemented.