Federal Food Safety Oversight: Additional Actions Needed to Improve Planning and Collaboration
Released: 2014-12-18T00:00:00

Letter

Background

Of the 15 federal agencies involved in food safety oversight, FDA and FSIS have primary oversight responsibility. Table 1 summarizes the food safety responsibilities of all 15 agencies.

U.S. food safety oversight is not the only federal effort that involves multiple agencies. Many federal government initiatives require the coordinated efforts of more than one federal agency, level of government, or sector. Nevertheless, agencies face a range of challenges and barriers when they attempt to work collaboratively. The need for improved interagency collaboration has been highlighted throughout our work over many years. Our reports over the past 4 years identified more than 90 areas where opportunities exist for executive branch agencies or Congress to reduce fragmentation, overlap, and duplication. We found that resolving many of these issues require better collaboration among agencies. In addition, collaboration and improved working relationships across agencies are fundamental to addressing many of the issues that we have designated as high risk due to their vulnerability to fraud, waste, abuse, and mismanagement, or because they are most in need of transformation.

Furthermore, for almost 2 decades, we have reported on agencies’ missed opportunities for improved collaboration through effective implementation of GPRA. In our June 1997 assessment of the status of GPRA implementation government-wide, we found that agencies faced challenges addressing crosscutting issues, which led to fragmentation In 2004—more than 10 years after GPRA’s enactment— and overlap. we found that there still was an inadequate focus on addressing issues that cut across federal agencies.GPRA’s enactment, our work continues to demonstrate that the needed collaboration is not sufficiently widespread.

Now, more than 20 years since Both Congress and the executive branch have recognized the need for improved collaboration across the federal government. In January 2011, GPRAMA amended provisions of GPRA to add new requirements for addressing crosscutting efforts in federal strategic and performance planning that help drive collaboration, among other things.

HHS and USDA Have Taken Steps to Implement GPRAMA Requirements but Could More Fully Address Crosscutting Food Safety Efforts

Our review of HHS and USDA strategic and performance planning showed that both agencies have taken steps to implement GPRAMA’s crosscutting requirements for their food safety efforts. However, the agencies do not fully address crosscutting food safety efforts in their strategic and performance planning. HHS and USDA vary in the amount of detail they provide on their crosscutting food safety efforts in their individual strategic and performance planning documents. Fully addressing crosscutting efforts in strategic and performance planning documents is important in helping to provide a comprehensive picture of the federal government’s performance on food safety.

GPRAMA Established New Requirements for Addressing Crosscutting Efforts in Federal Strategic and Performance Planning

GPRAMA established a new framework for a more coordinated, crosscutting, and integrated approach to focus on results and improve government performance. The new GPRAMA framework could also help to ensure that agencies’ goals are complementary, that strategies are mutually reinforcing, and that common performance measures are used, as appropriate. It added new requirements for addressing crosscutting efforts in federal strategic and performance planning, including the following:

Agency strategic goals and objectives. 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.

Agency performance goals. GPRAMA requires agencies to include in their performance plan a description of (1) the organizations, program activities, regulations, policies, and other activities that contribute to each performance goal, both within and external to the agency and (2) a description of how the agency is working with other agencies to achieve its performance goals.

Agency priority goals. Certain agencies—including HHS and USDA—are required to develop a limited number of agency priority goals every 2 years. These goals are to reflect the highest priorities of each agency and be informed by input from both federal and nonfederal stakeholders. According to OMB guidance, in developing their priority goals, agencies are to consider several criteria, including areas where cross-component or cross-agency coordination is needed to improve outcomes. Agencies are also required to conduct quarterly performance reviews. In these reviews, agencies are required to coordinate with relevant personnel within and outside the agency who contribute to the goal’s accomplishment and assess whether organizations, program activities, regulations, policies, and other activities are contributing as planned. In addition, agencies are required to make information about each priority goal available on OMB’s Performance.gov website on a quarterly basis, including a description of (1) the organizations, program activities, regulations, policies, and other activities that contribute to each goal, both within and external to the agency; (2) how the agency is working with other agencies to achieve the goal; and (3) whether relevant organizations, program activities, regulations, policies, and other activities are contributing as planned.

Our reporting on GPRAMA’s implementation has found that the executive branch needs to more fully use the GPRAMA framework to address pressing federal governance challenges, including crosscutting issues. We have found that effective GPRAMA implementation could play an important role in clarifying desired outcomes, in addressing program performance that spans multiple organizations, and in facilitating future actions to reduce, address, or better manage unnecessary duplication, overlap, and fragmentation.

HHS and USDA Include Varying Levels of Detail About Crosscutting Food Safety Efforts in Their Strategic and Performance Planning

HHS and USDA strategic and performance planning documents include a number of goals and objectives related to food safety.2.) (See figs. 1 and In HHS’s current performance plan, HHS lists three performance goals related to food safety, including its priority goal on Salmonella reduction. (See fig. 1.) HHS identifies FDA as an internal contributor to these goals but does not discuss any work with other agencies to achieve the goals.

Agency Priority Goals

GPRAMA Requirement Agencies shall identify agency priority goals from among the performance goals of the agency. Agencies shall identify on Performance.gov federal organizations, program activities, regulations, policies, and other activities—both internal and external to the agency—that contribute to each of their priority goals and to describe whether they are contributing as planned. Agencies shall also describe on Performance.gov how they are working with other agencies to achieve each of their priority goals.

HHS and USDA have each identified one priority goal related to food safety, both focusing on a different aspect of Salmonella reduction.figs. 1 and 2.) On Performance.gov, HHS and USDA identify internal contributors to these goals and include some details on the external agencies they are collaborating with and the nature of the collaboration. Specifically, USDA discusses work being carried out internally by FSIS, and HHS discusses work being carried out internally by FDA and CDC, in partnership with IFSAC. Additionally, HHS identifies FSIS as an external contributor, and USDA identifies FDA and CDC as external contributors. However, HHS does not specify what FSIS is doing to contribute to HHS’s goal. USDA does provide an example of actions by CDC and FDA, but the example occurred in the past and is not a current effort to achieve (See the goal. Specifically, USDA states that FSIS worked with FDA and CDC on the development of HHS’s agency priority goal. Both agencies identify FoodNet—a collaborative program led by CDC and involving FDA, FSIS, and 10 state health departments—as the source of the data used to measure progress toward the goals. In addition, USDA states that its goal aligns with illness reductions identified in the Healthy People 2020 initiative.

Some Crosscutting Efforts Are Not Included

Our review found several relevant crosscutting efforts that are not identified in HHS and USDA strategic and performance planning documents. For example, FDA and FSIS officials both told us that they colead the National Antimicrobial Resistance Monitoring System, which tracks whether foodborne and other bacteria are resistant to the antibiotics used to treat and prevent the spread of illness. In addition, FDA and FSIS officials told us about their involvement with the Food Emergency Response Network, which integrates the nation’s food-testing laboratories at the federal, state, and local levels to better respond to emergencies involving biological, chemical, or radiological contamination of food. The network’s steering committee is cochaired by senior executives from FDA and FSIS, and its members include numerous federal and state partners. However, neither of these efforts is discussed in HHS and USDA strategic or performance plans or on Performance.gov. Furthermore, HHS and USDA have various interagency agreements in place with other food safety agencies, including the Environmental Protection Agency, aimed at assisting one another in carrying out their food safety oversight responsibilities. Moreover, in its strategic and performance planning documents, USDA discusses several collaborative mechanisms, such as IFORC and IRAC, in relation to its food safety goals and objectives. IFORC and IRAC also include HHS agencies; however, in its strategic and performance planning documents, HHS does not mention these efforts in relation to its food safety goals and objectives. Similarly, HHS discusses some collaborative mechanisms, such as PFP and Presidential Policy Directive 8 (PPD-8),USDA agencies, but USDA does not discuss them.

By not fully addressing crosscutting program efforts in their strategic and performance planning documents, HHS and USDA miss important opportunities to help ensure that their food safety goals are complementary, and strategies are mutually reinforcing. In addition, they miss opportunities to highlight their crosscutting efforts and provide greater confidence that they are working in concert with others to achieve common outcomes in a way that conserves scarce resources and enhances the overall effectiveness of the federal effort. FDA and FSIS officials told us they recognize that more could be done to implement GPRAMA crosscutting requirements.

Agency Strategic and Performance Planning Documents Do Not Provide an Integrated Perspective on Federal Food Safety Performance

Fully addressing crosscutting food safety efforts in individual strategic and performance planning documents is an important first step toward providing a comprehensive picture of the federal government’s performance in overseeing food safety. However, the agency-by-agency focus of individual planning documents alone does 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. Those individual documents could, however, provide building blocks toward the next, more challenging task of developing a single, government-wide performance plan for food safety. As we previously recommended to OMB in March 2011, this plan should include results- oriented goals and performance measures and a discussion of strategies and resources.develop such a plan. The passage of GPRAMA in January 2011 further highlights the need for crosscutting strategic and performance planning for issues that involve multiple federal agencies and could provide the initial steps toward a government-wide performance plan for food safety. Without a government-wide performance plan for food safety, Congress, program managers, and other decision makers are hampered in their ability to identify agencies and programs addressing similar missions and However, OMB has not taken action in almost 4 years to to set priorities, allocate resources, and restructure federal efforts, as needed, to achieve long-term goals. In addition, without such a plan, federal food safety efforts are not clear and transparent to the public. Currently, to understand what its government is doing to ensure the safety of the food supply, Congress, program managers, other decision makers, and the public must access and attempt to make sense of and reconcile individual documents across the 15 federal food safety federal agencies. OMB staff said that OMB could work with agencies to develop a government-wide plan performance plan for food safety, but that the Administration previously worked through the FSWG to coordinate major federal food safety activities and, most recently, through implementation of FSMA. However, as discussed above, a government-wide performance plan for food safety goes beyond coordination of agency activities to provide an integrated perspective of federal food safety performance.

Based on our prior work, we believe that, to be most effective, a government-wide plan must be more than a compilation of agency-level plans. It should build on agency-level documents but provide value that exceeds the sum of its parts. A central and distinguishing feature should be a clear and direct discussion of government-wide goals and objectives, which can be used to help provide critical horizontal and vertical linkages across and within individual agencies. Horizontally, it can be used to integrate and foster synergies among food safety agencies. Vertically, it can be used to provide a framework within which individual agencies can align their food safety goals that would cascade down to individual employees. Another distinguishing feature is that the plan should be organized in terms of broad goals and objectives rather than in a sequential, agency-by-agency format. Presenting information in an agency-by-agency manner is appropriate to emphasize agency accountability but tends to inadequately reflect the relative contributions of various agencies and strategies to the overarching goals and objectives, and it reduces opportunities to compare and assess interactions.

FDA and FSIS officials told us they recognize that a government-wide performance plan for food safety could be beneficial in providing clarity and transparency to the public regarding federal food safety efforts. They also said, however, that developing such a plan would be difficult, because statutes mandate that the agencies oversee different food products, often with different associated health risks, and using different approaches. The way one agency approaches its mandate may not be appropriate for another agency, they said, so a government-wide performance plan may be unrealistic. We acknowledge that there are challenges associated with the different statutory authorities and jurisdictions of the agencies with food safety responsibilities. However, if each agency is focused on a different aspect of food safety oversight, there is a risk that no entity will take the necessary broader view toward ensuring the safety of the overall food supply. For example, a major trend creating food safety challenges is the substantial and increasing portion of the U.S. food supply that is imported. HHS and USDA both conduct work focused on ensuring the safety of imported food and could articulate, in a government-wide performance plan, a common goal and mutually reinforcing strategies to do so, in addition to common performance measures, as appropriate, to track the nation’s overall progress. Our prior reports have identified other areas of food safety that cut across different agencies—such as recall communication, seafood safety, seafood fraud, inspection of food production facilities, oversight of genetically engineered crops, and defense of food and agriculture against terrorist attacks and natural disasters—which could form the basis of common goals and objectives articulated in a government-wide performance plan. We have found that when agencies do not have a compelling rationale, such as legislation, directives, or their perceptions of the benefits from collaboration, it is difficult to overcome differences in missions and priorities and to define and articulate a common outcome that is consistent with their respective agency missions. However, through their strategic and performance planning documents, HHS and USDA have already recognized that their food safety efforts are interconnected by, for example, including statements about their joint efforts to enhance food safety. In this regard, they have already highlighted a common goal: ensuring food safety.

FDA and FSIS Have Mechanisms in Place to Facilitate Interagency Coordination, but None Provides Centralized, Broad- Based Collaboration

Our analysis identified numerous collaborative mechanisms involving FDA and FSIS, but 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. Experts we interviewed agreed that a centralized collaborative mechanism on food safety is important to foster effective interagency collaboration and could enhance food safety oversight. The FSWG served as a centralized mechanism for broad-based collaboration on food safety and resulted in a number of accomplishments, such as improved interagency coordination. However, our review indicated that the FSWG is no longer meeting.

Existing Collaborative Mechanisms Involving FDA and FSIS Are Focused on Specific Topics

Our analysis identified numerous collaborative mechanisms involving FDA and FSIS. For example, FDA and FSIS are collaborating with CDC through IFSAC to improve estimates of the most common sources of foodborne illnesses. However, these mechanisms are focused 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. See table 3 for selected collaborative mechanisms involving FDA and FSIS.

FDA and FSIS also participate in many interagency agreements focusing on a variety of topics, ranging from the sharing of biological materials to collaboration on foodborne illness response. In addition, FSMA includes numerous provisions requiring interagency collaboration; however, these too focus on specific topics and do not provide for centralized, broad- based collaboration across food safety regulations and programs. FDA and FSIS leaders also told us they collaborate on an informal basis. For example, they see one another at conferences and other events and contact one another on an “as needed” basis, according to a senior FSIS official.

Experts Agreed That a Centralized Mechanism for Broad-Based Collaboration Could Enhance Food Safety Oversight

Nearly all—10 of the 12—experts in food safety we interviewed agreed that a centralized collaborative mechanism on food safety is important to foster effective interagency collaboration and could enhance food safety oversight. The experts identified several potential benefits, challenges, and characteristics of having such a mechanism. Appendix II lists the names and affiliations of the experts we interviewed.

Potential Benefits

The experts cited several potential benefits of a centralized, collaborative mechanism for food safety oversight. For example, nearly all of them told us that a centralized mechanism could foster coordination, collaboration, and communication among key food safety agencies and leaders; increase visibility for food safety as an important issue within the executive branch; and build relationships and establish trust. All of the experts agreed that such a mechanism could enhance the sharing of knowledge and strategy and the use of best practices among federal agencies responsible for food safety. For example, one expert said such a mechanism could provide a forum for the regular sharing of best practices among the agencies. According to several of the experts, it could also help the agencies to look strategically and prospectively toward addressing emerging food safety issues. Specifically, several of the experts told us that a new centralized mechanism could help move the food safety agencies from a typically reactive approach—such as actions prompted by foodborne illness outbreaks—to a more proactive one. Some experts stated that, without such a mechanism, federal food safety agencies do not have a forum for conversations on broad food safety issues. One expert noted that, without a centralized collaborative mechanism on food safety, it is difficult for the agencies to work out their differences and articulate a uniform policy to enhance food safety.

Potential Challenges

All of the experts we interviewed acknowledged that there could be challenges in implementing a centralized mechanism for interagency collaboration on food safety. For example, nearly all of the experts agreed that unless the mechanism could hold members accountable, it would be less likely that recommendations would be acted upon. In addition, nearly all of the experts said that the agencies’ different agendas could pose a challenge. For example, FDA and FSIS approach their food safety work differently because of the laws that they must comply with, so finding common ground can be difficult, according to one expert. A further challenge, according to most experts, is that a centralized collaborative mechanism would require leadership and energy from already busy agency officials. For example, one expert told us that the agencies are focused on carrying out their individual mandates, leaving little time and resources for additional responsibilities. However, some former FSWG members told us the FSWG met infrequently—once every 3 to 6 months on average.

Potential Characteristics

The experts discussed potential characteristics of a centralized collaborative mechanism for food safety, including formalization, accountability, the frequency of meetings, and membership composition. Several of these characteristics are consistent with our prior work on key features and issues to consider when implementing collaborative mechanisms.

Key Considerations for Implementing Interagency Collaborative Mechanisms Our prior reporting has found that, although collaborative mechanisms differ in complexity and scope, they all benefit from certain key features, which raise issues to consider when implementing these mechanisms.

Outcomes and Accountability: Have short-term and long-term outcomes been clearly defined? Is there a way to track and monitor their progress?

Bridging Organizational Cultures: What sustained over the long-term? If leadership is shared, have roles and responsibilities been clearly identified and agreed upon? experts also told us that doing so would provide for a long lasting, effective collaboration that would also have visibility within the government. However, several experts acknowledged that enactment of a statute to formalize a collaborative mechanism would present the most challenges in terms of time and effort. Some experts said that an interagency agreement could work as a means to set up the mechanism and would likely be the easiest and most immediate option. However, most of the experts also told us that interagency agreements can be weak and may not provide the most sustainable or effective way to formalize such a group. Some other experts said a presidential directive would be the best way to formalize the mechanism because it would bring high- level visibility to such a group. On the other hand, most experts expressed concern that, if established by a presidential directive, the mechanism may not survive a change in administrations. We have found that lack of continuity is a frequent issue with collaborative mechanisms that are tied to the Executive Office of the President, particularly when administrations change.

Have participating agencies clarified roles and responsibilities? participants been included? Do they have the ability to commit resources for their agency? mechanism be funded and staffed? Have online collaboration tools been developed?

Written Guidance and Agreements: If appropriate, have participating agencies documented their agreement regarding how they will be collaborating? Have they developed ways to continually update and monitor these agreements?

Nearly all of the experts agreed that a centralized mechanism should be held accountable for its results and suggested several options for achieving accountability. For example, most said the mechanism could establish goals that member agencies would be publicly accountable for meeting. Several experts also said the mechanism should periodically report to Congress and the public; for example, one expert said that would provide accountability. Some others said holding public meetings would be helpful to get stakeholders’ views and to provide information to the public on the mechanism’s activities. We have also found that outcomes and accountability are key features of any collaborative mechanism.

Nearly all of the experts we interviewed emphasized the importance of regular meetings. Most told us that it would be important to have meetings quarterly. As one expert explained, such a frequency would help to establish momentum for the mechanism. Some suggested it could be helpful to hold more frequent meetings initially, to get the mechanism off the ground. Some experts who were members of the FSWG told us that the FSWG met more frequently early on and less frequently over time. Several experts also suggested the possibility of a two-tier structure, with high-level officials meeting less frequently and another group of subject matter experts and additional staff meeting more frequently. Our prior work has highlighted the importance of in-person meetings to build relationships and trust.

The experts expressed a range of views on the membership composition of a centralized collaborative mechanism on food safety. Several experts agreed that nongovernmental stakeholders, including consumer groups and industry associations, should be included in some way, for example, by getting stakeholder input during public meetings or through an advisory committee. However, most of the experts said stakeholders should not be official members of the mechanism because having only government officials as members would allow for more candid discussions and facilitate decision making. Half of the experts thought it would be important to include White House officials, such as those from OMB, in the mechanism’s membership; the other half either disagreed or had no opinion on whether White House officials should be included. Some experts said White House involvement could help to elevate food safety issues and raise visibility of the group. Several others, however, told us that White House officials could potentially politicize the process. Nearly all of the experts told us that a new centralized mechanism should be led by a designated chair or an executive director; most of the experts also agreed the mechanism should have dedicated staff. Having staff or a designated chair could help to institutionalize the group, but some experts also pointed out that any independent staffing of the group would likely require funding. One expert suggested that the White House appoint a chair for up to 5 years to help to ensure the sustainability of the mechanism. We have found that including all relevant participants is an important feature of a collaborative mechanism.

The FSWG Served as a Centralized Mechanism for Broad-Based Collaboration but Is No Longer Meeting

The FSWG served as a centralized mechanism for broad-based collaboration on food safety, but our review found that the group is no longer meeting. According to the FSWG’s December 2011 Progress Report, the FSWG was a central coordinating mechanism for the federal government’s food safety activities. The report said its mission was to strengthen federal efforts and develop short-term and long-term strategies to improve food safety. The Secretaries of HHS and USDA jointly cochaired the working group, which included several other partner agencies. In addition, the White House Domestic Policy Council convened the group. However, FDA and FSIS officials told us that the FSWG is no longer meeting because, they believe, it served its purpose of improving interagency coordination. The last item posted under “recent actions” on the FSWG’s website is its December 2011 Progress Report. FDA officials said they thought the FSWG’s last meeting was in April 2011, but they could not provide an exact date.

OMB staff and FDA and FSIS officials told us that the FSWG provided numerous benefits to the federal food safety system. For example, they told us that the FSWG was instrumental in helping to achieve legislative reform of food safety laws through enactment of FSMA. In addition, they told us that the FSWG helped to establish strong working relationships between agency officials, which continue to this day and which foster effective formal and informal collaboration. Moreover, they said that the FSWG provided the operational direction for work that has been done by the agencies subsequently. For example, FDA officials told us that the FSWG led to the creation of IFSAC as a means of strengthening collaboration across FDA, FSIS, and CDC in estimating the sources of foodborne illness. According to FDA officials, prior to IFSAC the agencies used different estimation approaches, with little coordination or information sharing, which made it difficult to obtain accurate estimates. FSIS officials told us that, through IFSAC, the agencies are now developing attribution estimates and methods to be used jointly in setting performance standards and developing risk assessments, economic analyses, and policies, among other things. In addition, according to a notice published by FSIS in the Federal Register, FSIS developed new performance standards for two pathogens—Salmonella and Campylobacter—in response to the work of the FSWG. In March 2011, we found that through the FSWG federal agencies took steps designed to increase collaboration in areas that cross regulatory jurisdictions—in particular, improving produce safety, reducing Salmonella contamination, and developing food safety performance measures.Salmonella, for example, FSIS officials told us that staff from FSIS and FDA communicated on a regular basis to coordinate efforts to develop their respective agencies’ priority goals on Salmonella reduction, as they are closely intertwined.

As shown in figure 3, when it was functioning, the FSWG also held public meetings, issued a report on “key findings” identifying its core principles and a number of goals and actions it was taking, or planning to take, to improve food safety, and released progress reports documenting its accomplishments.

According to senior FDA and FSIS officials and OMB staff, the FSWG is no longer needed, given the existence of other collaborative mechanisms, both formal and informal. However, as already noted, the existing mechanisms are focused on specific issues and do not allow for centralized, broad-based collaboration across federal food safety regulations and programs. For example, none provides a forum for food safety agencies to reach agreement on a set of broad-based food safety goals and objectives. Moreover, we have previously found that informal coordination mechanisms that rely on relationships between individual officials can end once the officials leave government or move to a different position. Agency officials also said there is little time for high- level officials to meet in a group like the FSWG, given competing demands. However, some former FSWG members told us the FSWG met infrequently—once every 3 to 6 months on average.

Some agency officials acknowledged the value of having a centralized collaborative mechanism for food safety. For example, a senior FSIS official told us that reconvening the FSWG would be beneficial because it could help to ensure program transparency and produce results. A senior FDA official also told us that there would be value to a having a group like the FSWG in place, because it could help to foster relationships.

An FDA official estimated that the FSWG has not met for at least 3 years; an OMB staff member confirmed that the group no longer meets and that there are no plans to meet in the future. However, the OMB staff member told us the FSWG could be reconvened if there was a need to do so, but there is not currently a need for the group. FSIS officials told us there is currently no centralized collaborative mechanism to discuss food safety issues. Agencies still refer to the FSWG in current documents as if it is an active entity. For example, HHS states in its current strategic plan that it works with multiple partners to ensure the safety of food, including the FSWG. In addition, HHS’s current performance plan links to FDA’s plan for addressing our high-risk designation for food safety, which cites improving interagency coordination through the FSWG as one of five key steps to address our high-risk designation. Moreover, the FSWG website is still active, but no new activities have been recorded since December 2011.

In 2011, we reported that the creation of the FSWG was a positive step because it made food safety a national priority, demonstrated strong commitment and top leadership support (one of five criteria that must be met for GAO to remove a high-risk designation), and was designed to foster interagency collaboration on the crosscutting issue of food safety. However, we also expressed concern at the time about the group’s future, given the history of the short-lived President’s Council on Food Safety, which was created in 1998. It served as a coordinating mechanism encompassing all aspects of federal food safety programs, but it was disbanded in 2001 after a change in administrations. We recommended in 2001 that the President’s Council on Food Safety be reconvened, but that did not happen. Instead, 8 years later, the FSWG was convened, but it stopped meeting after an estimated 2 years. Our prior reports have also identified other cases where leadership of an interagency collaborative mechanism changed, and the mechanism either disappeared or became less useful. In 2012, we found that transitions and inconsistent leadership can weaken the effectiveness of any collaborative mechanism; in that report, we said that lack of continuity is a frequent issue with presidential advisers or mechanisms that are tied to the Executive Office of the President, particularly when administrations change. In addition, all of the experts on food safety we interviewed agreed that a collaborative mechanism on food safety should be formalized to help ensure sustained leadership over time. Without formalizing a centralized collaborative mechanism for food safety, such as in statute, they may continue to be short-lived.

Conclusions

HHS and USDA have both taken steps to implement GPRAMA’s crosscutting requirements for their food safety efforts. However, the agencies do not fully address crosscutting food safety efforts in their strategic and performance planning documents. GPRAMA requires agencies to describe how they are working with other agencies to achieve their goals and objectives, among other things, but the agencies vary in the amount of detail they provide on such efforts. In addition, they do not include several relevant crosscutting efforts in either agency’s strategic and performance planning documents. Fully addressing crosscutting food safety efforts in individual strategic and performance planning documents is an important first step toward providing a comprehensive picture of federal food safety performance. Nevertheless, the agency-by-agency focus of individual documents alone does not provide an integrated perspective on federal food safety performance. In March 2011, we recommended that OMB, in consultation with the federal agencies having food safety responsibilities, develop a government-wide performance plan for food safety. OMB has not taken action in almost 4 years to develop such a plan. GPRAMA further highlights the need for crosscutting strategic and performance planning for issues that involve multiple federal agencies and could provide the initial steps toward a government-wide performance plan for food safety. Without such a plan, 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. In addition, without such a plan, federal food safety efforts are not clear and transparent to the public. As we have previously recommended, a government-wide performance plan should include results-oriented goals and performance measures and a discussion of strategies and resources.

In addition, although a number of collaborative mechanisms on food safety involving FDA and FSIS exist, they are focused on specific issues and do not provide for broad-based, centralized collaboration. All of the experts on food safety we interviewed agreed that a centralized mechanism for broad-based collaboration could enhance the sharing of knowledge and strategy and the use of best practices among federal agencies responsible for food safety. We previously recommended that a centralized mechanism should be in place to facilitate interagency coordination across food safety regulations and programs. The FSWG, created by the Administration in March 2009, served as a centralized mechanism for broad-based collaboration on food safety, but the group is no longer meeting. The President’s Council on Food Safety, a previous centralized mechanism for broad-based collaboration, was also short- lived. Challenges associated with the fragmented federal food safety system are long-standing, and centralized mechanisms for broad-based collaboration have not been sustained. Experts on food safety suggested that a centralized collaborative mechanism on food safety—like the FSWG—could provide sustained leadership across food safety agencies over time if it were formalized in statute. Without such formalization, centralized collaborative mechanisms for food safety may continue to be short-lived.

Recommendation for Executive Action

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

Matters for Congressional Consideration

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, and formalizing the FSWG through statute to help ensure sustained leadership across food safety agencies over time.

Agency Comments and Our Evaluation

We provided a draft of this report for review and comment to the Secretary of Health and Human Services, the Director of the Office of Management and Budget, and the Secretary of Agriculture. HHS and USDA each provided written comments, which are presented in appendixes III and IV. In their written comments, HHS and USDA agreed with our recommendation that they continue to build upon their efforts to implement GPRAMA requirements to address crosscutting food safety efforts. HHS, OMB, and USDA also provided technical comments, which we incorporated as appropriate.

We are sending copies of this report to the appropriate congressional committees, the Director of the Office of Management and Budget, the Secretary of Agriculture, the Secretary of Health and Human Services, and other interested parties. In addition, the report is available at no charge on the GAO website at http://www.gao.gov.

If you or your staff have any questions about 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 V.

Appendix I: Objectives, Scope, and Methodology

Our review provides information on: (1) Department of Health and Human Services (HHS) and U.S. Department of Agriculture (USDA) implementation of GPRA Modernization Act of 2010 (GPRAMA) requirements for addressing crosscutting efforts in their food safety strategic and performance planning, and (2) the extent to which the two agencies primarily responsible for federal food safety oversight—HHS’s Food and Drug Administration (FDA) and USDA’s Food Safety and Inspection Service (FSIS)—have a centralized mechanism in place to collaborate broadly across federal food safety regulations and programs.

To answer our first objective, we identified requirements for addressing crosscutting efforts in federal strategic and performance planning by reviewing GPRAMA and relevant guidance from the Office of Management and Budget (OMB) on the implementation of GPRAMA. We also reviewed our past and recent work on effective implementation of the act. Next, we reviewed current HHS and USDA strategic plans (for fiscal years 2014 through 2018), current HHS and USDA performance plans (for fiscal year 2015), and information about HHS and USDA priority goals published on the government website Performance.gov in September 2014. We analyzed this information to determine which HHS and USDA goals and objectives apply to food safety and the extent to which HHS and USDA discuss crosscutting efforts in relation to these goals and objectives through implementation of relevant GPRAMA provisions. In addition to the act’s requirements, our assessment was informed by OMB guidance applying the act and our past work on how to effectively implement the act. To further address our first objective, we reviewed agency documentation related to the goals and objectives, including FDA and FSIS strategic plans (for fiscal years 2011 through 2015 and 2011 through 2016, respectively), which are to support HHS and USDA goals and objectives, respectively. We also interviewed OMB staff and officials from HHS and USDA regarding federal food safety strategic and performance planning and crosscutting efforts.

To address our second objective, we identified existing collaborative mechanisms involving FDA and FSIS through reviews of our past work and of agency documentation and through interviews with experts in food safety knowledgeable about interagency collaboration and interviews with OMB staff and officials from FDA and FSIS. In doing so, we also analyzed relevant documentation—including memorandums of understanding (MOUs), charters and public websites—to gather information on current collaborations between FDA and FSIS. We analyzed the scope of the existing collaborative mechanisms identified throughout the course of our review to determine whether they were broad-based or focused on specific topics. We also reviewed our past and recent work on key features and issues to consider when implementing collaborative mechanisms. To further address our second objective, we reviewed agency documentation related to Food Safety Working Group (FSWG) activities, including information posted on the FSWG website. We also interviewed OMB staff and FDA and FSIS officials regarding the FSWG, as well as former members of the FSWG who were part of our expert outreach, described below.

For our second objective, we conducted a two-stage interview process with experts in food safety knowledgeable about interagency collaboration to obtain their views on existing collaborative mechanisms and on the potential benefits, challenges, and characteristics of a new centralized collaborative mechanism for food safety. We identified these experts through a snowball sampling approach, starting with recommendations from internal GAO experts in food safety, contacting those external experts during our first round of interviews and asking them to identify other relevant experts. For the second round of interviews, we prioritized former members of the FSWG, and those closely associated with the FSWG, for inclusion, as well as other food safety experts knowledgeable about interagency collaboration on food safety. We interviewed 10 experts in the first round of interviews and 12 experts in the second round. The experts included representatives from federal agencies, industry or trade associations, and public interest groups, as well as former federal officials who had been members of the FSWG. Based on our analysis of responses provided during the first round of expert interviews, we developed a set of closed-ended and open-ended questions which we administered during the second round of interviews. We then conducted content analyses to assess experts’ responses during the second round of interviews. Appendix II lists the names and affiliations of the experts we interviewed.

Appendix II: List of Experts

Appendix II: List of Experts Affiliation Founder and CEO, The Acheson Group Former Chief Medical Officer, U.S. Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS)

Former Assistant and Associate Commissioner for Foods, FDA Senior Lobbyist, Food and Water Watch Executive Director, Association of Food and Drug Officials Stanley Morrison Professor of Law, Stanford University Law School Former White House Special Assistant to the President for Justice and Regulatory Policy Senior Policy and Science Advisor, National Association of State Departments of Agriculture Director of the Safe Food Project and Manager of the Safe Food Project, respectively, The Pew Charitable Trusts Senior Vice President, Strategic Planning, Science and Technology, Western Growers Senior Advisor, Food Safety, Deloitte & Touche LLP Former Under Secretary for Food Safety, USDA Senior Policy Advisor, Sidley Austin LLP Former Counselor for Science and Public Health to Secretary Sebelius, Department of Health and Human Services Specialist in Agricultural Policy, Congressional Research Service Senior Food Safety Risk Analyst, RTI International Former CEO and Director of Research, Center for Foodborne Illness Research and Prevention Former Senior Advisor for Rural Affairs, White House Domestic Policy Council Former Senior Advisor to Secretary Vilsack, USDA Partner, Squire Patton Boggs (US) LLP Global Registration Manager, DuPont Pioneer Former Chief of Staff to Under Secretary for Food Safety, USDA Food Safety Director, Center for Science in the Public Interest Director, Food Policy Institute, Consumer Federation of America Former President’s Food Safety Working Group member.

Appendix III: Comments from the Department of Health and Human Services

Appendix IV: Comments from the U.S. Department of Agriculture

Appendix V: GAO Contact and Staff Acknowledgments

GAO Contact

Staff Acknowledgments

In addition to the individual named above, Anne K. Johnson (Assistant Director), Cheryl Arvidson, Kevin Bray, Rebecca Makar, Kristiana Moore, Steven Putansu, Emmy Rhine Paule, Dan Royer, Kiki Theodoropoulos, and Sarah Veale made key contributions to this report.