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.