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

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: For more than a decade, GAO has reported on the fragmented federal food safety system. In 2007, GAO added federal oversight of food safety to its list of high-risk areas because of risks to the economy and to public health and safety.
GAO conducted this work under the authority of the Comptroller General to assist Congress with its food safety oversight responsibilities. This report examines (1) HHS and USDA implementation of GPRAMA requirements for addressing crosscutting efforts in their food safety strategic and performance planning and (2) the extent to which FDA and FSIS have a centralized mechanism in place to collaborate across federal food safety programs. GAO reviewed relevant legislation and agency documentation; analyzed responses from food safety experts; and interviewed OMB staff and officials from FDA and FSIS.
section_title: What GAO Found
paragraphs: The Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA) have taken steps to implement GPRA Modernization Act of 2010 (GPRAMA) requirements but could more fully address crosscutting food safety efforts. For example, GPRAMA requires agencies to describe in their strategic and performance planning how they are working with other agencies to achieve their goals. HHS and USDA vary in the amount of detail they provide on their crosscutting food safety efforts. In addition, they do not include several relevant crosscutting efforts, such as the National Antimicrobial Resistance Monitoring System, which tracks whether foodborne bacteria are resistant to the antibiotics used to treat and prevent illness.
Fully addressing crosscutting efforts in individual strategic and performance planning documents is an important first step toward providing a comprehensive picture of federal food safety performance. However, individual agencies' documents do not provide an integrated perspective on federal food safety performance. In 2011, GAO recommended that the Office of Management and Budget (OMB), in consultation with the federal agencies having food safety responsibilities, develop a government-wide performance plan for food safety. OMB has not acted on that recommendation. 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. GAO continues to believe that a government-wide performance plan for food safety is necessary.
HHS's Food and Drug Administration (FDA) and USDA's Food Safety and Inspection Service (FSIS) have mechanisms in place to facilitate interagency coordination on food safety that focus on specific issues, but none provides for broad-based, centralized collaboration. For example, FDA and FSIS are collaborating with the Centers for Disease Control and Prevention through the Interagency Food Safety Analytics Collaboration to improve estimates of foodborne illness sources. However, this and other mechanisms do not allow FDA, FSIS, and other agencies to look across their individual programs and determine how they all contribute to federal food safety goals. Nearly all the experts GAO interviewed agreed that a centralized collaborative mechanism on food safety is important to foster effective interagency collaboration and could enhance food safety oversight. The Food Safety Working Group (FSWG) served as a centralized mechanism for broad-based food safety collaboration and resulted in a number of accomplishments, including improved coordination. However, the FSWG is no longer meeting. A prior centralized mechanism for broad-based collaboration on food safety also was not sustained. Without a centralized collaborative mechanism on food safety, there is no forum for agencies to reach agreement on a set of broad-based food safety goals and objectives. Experts suggested that a centralized collaborative mechanism on food safety--like the FSWG--could provide sustained leadership across agencies over time if it were formalized in statute. Without such formalization, centralized collaborative mechanisms on food safety may continue to be short-lived.
section_title: What GAO Recommends
paragraphs: GAO recommends that HHS and USDA build upon their efforts to implement GPRAMA requirements to fully address crosscutting food safety efforts. Congress should consider (1) directing OMB to develop a government-wide food safety performance plan and (2) formalizing the FSWG through statute to help ensure sustained leadership across food safety agencies over time. GAO provided a draft of this report for review and comment to HHS, OMB, and USDA. HHS and USDA agreed with the recommendation. HHS, OMB, and USDA provided technical comments, which GAO incorporated as appropriate.

section_title: Letter
paragraphs: According to the Centers for Disease Control and Prevention (CDC), the  U.S. food supply remains one of the safest in the world. Nevertheless,  foodborne illness is still a common, costly, yet largely preventable, public  health problem. CDC data indicate that each year, as a result of  foodborne disease, roughly 1 in 6 Americans (or 48 million people) get  sick, 128,000 are hospitalized, and 3,000 die. Two independent studies  published in 2012 estimated the cost of foodborne illness in the United  States. According to a September 2013 bulletin from the U.S. Department  of Agriculture’s (USDA) Economic Research Service, the study that used  the more conservative approach estimated the cost to be $14.1 billion per  year. Three major trends also create food safety challenges. First, a  substantial and increasing portion of the U.S. food supply is imported.  Second, consumers are eating more raw and minimally processed foods.  Third, segments of the population that are particularly susceptible to  foodborne illnesses, such as older adults and immune-compromised  individuals, are growing.
The safety and quality of the U.S. food supply is governed by a highly  complex system stemming from at least 30 laws related to food safety  that are collectively administered by 15 federal agencies. The agencies  with primary food safety oversight responsibility are USDA’s Food Safety  and Inspection Service (FSIS) and the Department of Health and Human  Services’ (HHS) Food and Drug Administration (FDA). FSIS is  responsible for the safety of meat, poultry, and processed egg products.FDA is responsible for virtually all other food. programs and policies, the existing food safety system evolved on a  piecemeal basis, typically in response to particular health threats or  economic crises.
Catfish Inspection  FDA has traditionally overseen the safety of  all seafood, including catfish, but as a result of  2008 Farm Bill provisions amending the  Federal Meat Inspection Act, regulatory  responsibility for catfish inspection will fall to  FSIS once it issues final regulations for a  mandatory catfish examination and inspection  program. We suggested that Congress  consider repealing these provisions of the  2008 Farm Bill. However, the 2014 Farm Bill  instead modified these provisions to require  the Secretary of Agriculture to enter into a  memorandum of understanding (MOU) with  the Commissioner of FDA that would ensure  that inspection of catfish conducted by FSIS  and FDA are not duplicative. We maintain that  such an MOU does not address the  fundamental problem, which is that FSIS’s  catfish program, if implemented, would result  in duplication of activities and an inefficient  use of taxpayer funds. Duplication would  result if facilities that process both catfish and  other seafood were inspected by both FSIS  and FDA.
For more than a decade, we have reported on the fragmented nature of  federal food safety oversight. In January 2007, we added the federal  oversight of food safety to our list of high-risk areas because of risks to  the economy and to public health and safety. We found that a challenge  for the twenty-first 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 stated that Congress and the  executive branch “can 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 January 2007, we recommended that a mechanism be put in  place to facilitate interagency coordination on food safety regulations and  programs. In March 2009, the President established the Food Safety  Working Group (FSWG) to coordinate federal efforts and develop goals to  make food safer.
Egg Production Oversight  The 2010 nationwide recall of more than 500  million eggs because of Salmonella  contamination also highlights fragmentation in  federal food safety oversight. Several  agencies have different roles and  responsibilities in the egg production system.  For example, FDA is generally responsible for  ensuring that eggs in their shells—referred to  as shell eggs—including eggs at farms such  as those where the outbreak occurred, are  safe, wholesome, and properly labeled. FSIS,  on the other hand, is responsible for the  safety of eggs processed into egg products. In  addition, USDA’s Agricultural Marketing  Service sets quality and grade standards for  shell eggs, such as Grade A, but does not test  the eggs for bacteria such as Salmonella.  Further, while USDA’s Animal and Plant  Health Inspection Service manages the  program that helps ensure laying hens are  free from Salmonella at birth, FDA oversees  the safety of the feed they eat.
In January 2007, we also suggested that Congress and the executive  branch work together to develop a government-wide performance plan for  food safety. In our March 2011 report on federal food safety oversight, we  recommended that the Office of Management and Budget (OMB), in  consultation with the federal agencies having food safety responsibilities,   We stated  develop a government-wide performance plan for food safety.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. Such a plan could assist decision makers in balancing trade-offs  and comparing performance when resource allocation and restructuring  decisions are made. However, according to our review of actions taken  since the 2007 and 2011 reports, no government-wide performance plan  for food safety has been developed.
Pub. L. No. 111-353, 124 Stat. 3885 (2011).
We conducted this work under the authority of the Comptroller General to  assist Congress with its oversight responsibilities for the federal food  safety system. This report examines (1) HHS and USDA implementation  of 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 FDA and USDA’s FSIS—have a centralized mechanism in place to  collaborate broadly across federal food safety regulations and programs.
To answer our first objective, we reviewed GPRAMA, relevant OMB  guidance on the implementation of GPRAMA, and our prior work on  effective implementation of GPRAMA. We also reviewed current HHS and  USDA strategic and performance plans and information about HHS and  USDA agency priority goals published on a central, government-wide  performance website required by GPRAMA and implemented by OMB as  Performance.gov. To further address our first objective, we reviewed  agency documentation related to HHS and USDA food safety goals and  objectives, including FDA and FSIS strategic plans that 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 past GAO work  and agency documentation. We also interviewed experts in food safety  knowledgeable about interagency collaboration, OMB staff, and officials  from FDA and FSIS about the status and nature of existing collaborative  mechanisms. 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. Additionally  for this 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. We also asked  them about 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 and asking them to identify other relevant experts.  We interviewed 10 experts in the first round of interviews and 12 experts  in the second round. The experts included representatives from federal  agencies, trade associations, industry, 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 questions that we used for all of the interviews  during the second round. We then conducted content analyses to assess  experts’ responses during the second round of interviews. Appendix I  presents a more detailed description of our objectives, scope, and  methodology, and appendix II lists the names and affiliations of the  experts we interviewed.
We conducted this performance audit from March 2014 to December  2014 in accordance with generally accepted government auditing  standards. Those standards require that we plan and perform the audit to  obtain sufficient, appropriate evidence to provide a reasonable basis for  our findings and conclusions based on our audit objectives. We believe  that the evidence obtained provides a reasonable basis for our findings  and conclusions based on our audit objectives.
subsections: section_title: Background
paragraphs: 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.
section_title: HHS and USDA Have Taken Steps to Implement GPRAMA Requirements but Could More Fully Address Crosscutting Food Safety Efforts
paragraphs: 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.
subsections: section_title: GPRAMA Established New Requirements for Addressing Crosscutting Efforts in Federal Strategic and Performance Planning
paragraphs: 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.
section_title: HHS and USDA Include Varying Levels of Detail About Crosscutting Food Safety Efforts in Their Strategic and Performance Planning
paragraphs: 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.
subsections: section_title: Agency Priority Goals
paragraphs: 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.
section_title: Some Crosscutting Efforts Are Not Included
paragraphs: 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.
section_title: Agency Strategic and Performance Planning Documents Do Not Provide an Integrated Perspective on Federal Food Safety Performance
paragraphs: 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.
section_title: FDA and FSIS Have Mechanisms in Place to Facilitate Interagency Coordination, but None Provides Centralized, Broad- Based Collaboration
paragraphs: 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.
subsections: section_title: Existing Collaborative Mechanisms Involving FDA and FSIS Are Focused on Specific Topics
paragraphs: 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.
section_title: Experts Agreed That a Centralized Mechanism for Broad-Based Collaboration Could Enhance Food Safety Oversight
paragraphs: 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.
subsections: section_title: Potential Benefits
paragraphs: 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.
section_title: Potential Challenges
paragraphs: 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.
section_title: Potential Characteristics
paragraphs: 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.
section_title: The FSWG Served as a Centralized Mechanism for Broad-Based Collaboration but Is No Longer Meeting
paragraphs: 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.
section_title: Conclusions
paragraphs: 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.
section_title: Recommendation for Executive Action
paragraphs: 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.
section_title: Matters for Congressional Consideration
paragraphs: 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.
section_title: Agency Comments and Our Evaluation
paragraphs: 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.
section_title: Appendix I: Objectives, Scope, and Methodology
paragraphs: 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.
section_title: Appendix II: List of Experts
paragraphs: 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.
section_title: Appendix III: Comments from the Department of Health and Human Services
section_title: Appendix IV: Comments from the U.S. Department of Agriculture
section_title: Appendix V: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: 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.