Federal Food Safety Oversight: Food Safety Working Group Is a Positive First Step but Governmentwide Planning Is Needed to Address Fragmentation
Published: 2011-03-18T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: For more than a decade, GAO has reported on the fragmented nature of federal food safety oversight and how it results in inconsistent oversight, ineffective coordination, and inefficient use of resources. In 2007, GAO added this issue to its high-risk list. In March 2009, the President established the Food Safety Working Group (FSWG) to coordinate federal efforts and establish food safety goals to make food safer. Section 21 of Public Law 111-139 mandated that GAO identify programs, agencies, offices, and initiatives with duplicative goals and activities. This review examines: (1) steps, if any, that the FSWG has taken to increase collaboration among federal food safety agencies, and (2) options we and others have identified to reduce fragmentation, overlap, and potential duplication in food safety oversight. GAO reviewed information about the FSWG and alternative organizational structures for food safety, and conducted interviews.
section_title: What GAO Found
paragraphs: Creation of the FSWG elevated food safety as a national priority, demonstrated strong commitment and top leadership support, and was designed to foster interagency collaboration on this cross-cutting issue. The FSWG includes officials from the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), the Office of Management and Budget (OMB), and other federal agencies. Through the FSWG, federal agencies have taken steps designed to increase collaboration in some areas that cross regulatory jurisdictions--in particular, improving produce safety, reducing Salmonella contamination, and developing food safety performance measures. However, the FSWG has not developed a governmentwide performance plan for food safety that provides a comprehensive picture of the federal government's food safety efforts. When GAO added food safety oversight to its high-risk list in 2007, it said that what remains to be done is to develop a governmentwide performance plan for food safety that is mission based, results oriented, and provides a cross-agency perspective. Officials from OMB, FDA, and USDA told us that the FSWG's July 2009 "key findings" represent the governmentwide plan for food safety. However, most of the goals outlined in the key findings are not results oriented and do not include performance measures. Further, the FSWG has not provided information about the resources that are needed to achieve its goals. Our prior work has identified results oriented goals and performance measures and a discussion of strategies and resources as standard elements of performance plans. GAO and other organizations have identified options to reduce fragmentation and overlap in food safety oversight in the form of alternative organizational structures, but a detailed analysis of their advantages, disadvantages, and potential implementation challenges has yet to be conducted. GAO has suggested that Congress consider commissioning the National Academy of Sciences or a blue ribbon panel to conduct a detailed analysis of alternative organizational structures for food safety. Some of the alternative organizational structures include a single food safety agency, a food safety inspection agency, a data collection and risk analysis center, and a coordination mechanism led by a central chair. GAO recognizes that reorganizing federal food safety responsibilities would be a complex process that could have short-term disruptions and transition costs. GAO and other organizations have regularly paired proposals for alternative food safety organizations with calls for comprehensive, unified, risk-based food safety legislation. New food safety legislation that was signed into law in January 2011 strengthens a major part of the food safety system; however, it does not apply to the federal food safety system as a whole or create a new risk-based food safety structure.
section_title: What GAO Recommends
paragraphs: GAO recommends that the Director of OMB, in consultation with the federal food safety agencies, develop a governmentwide performance plan for food safety that includes results oriented goals and performance measures for food safety oversight and a discussion about strategies and resources. OMB declined to comment on a draft of this report. USDA and Health and Human Services provided technical comments.

section_title: Letter
paragraphs: For more than a decade, GAO has reported on the fragmented nature of  federal food safety oversight. While the Food and Drug Administration  (FDA) and U.S. Department of Agriculture’s (USDA) Food Safety and  Inspection Service (FSIS) have primary oversight responsibilities, a total  of 15 agencies collectively administer at least 30 food-related laws. In 2007,  we added the federal oversight of food safety to our list of high-risk areas  in need of broad-based transformation to achieve greater economy,  efficiency, effectiveness, accountability, and sustainability. We also cited  the need to integrate this fragmented system as a challenge for the 21st  century.
The 2010 nationwide recall of more than 500 million eggs due to  Salmonella contamination highlights how this fragmentation persists, with  several agencies having different roles and responsibilities throughout 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 (AMS) 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.
Many of our reports have found that fragmentation in the nation’s food  safety system results in inconsistent oversight, ineffective coordination,  and inefficient use of resources. In 2005, we reported that federal agencies  spend resources on overlapping activities, including inspections of  domestic and imported foods, training, research, risk assessment,  education, and rulemaking. We recommended that federal agencies take a  number of steps to reduce overlap, leverage resources, and enhance  coordination. For example, to better use FDA’s limited inspection  resources and leverage USDA’s resources, we recommended that, if  appropriate and cost effective, the Commissioner of the FDA enter into an  agreement to commission USDA inspectors to carry out FDA’s inspection  responsibilities for food establishments that are under the jurisdiction of  both agencies. We have made several other recommendations intended to  address the fragmented federal oversight of the nation’s food supply. In  2001, we recommended that the Secretary of Agriculture, the Secretary of  Health and Human Services, and the Assistant to the President for Science  and Technology, as joint chairs, reconvene the President’s Council on  Food Safety to facilitate interagency coordination on food safety  regulation and programs. The council had disbanded earlier that year.  Positively, in March 2009, the President established the Food Safety  Working Group (FSWG), which is co-chaired by the Secretaries of  Agriculture and Health and Human Services, to coordinate federal efforts  and develop goals to make food safer. When we added food safety  oversight to our high-risk list in 2007, we said that what remains to be  done is to develop a governmentwide performance plan for food safety  that is mission based, has a results orientation, and provides a cross- agency perspective. Finally, in reports dating back to 2001 we have been  suggesting that Congress consider commissioning the National Academy  of Sciences or a blue ribbon panel to conduct a detailed analysis of  alternative organizational food safety structures and consider enacting  comprehensive food safety legislation.
New food safety legislation that was signed into law in January 2011—FDA  Food Safety Modernization Act—strengthens a major part of the food  safety system. It shifts the focus of FDA regulators from responding to  contamination to preventing it, according to FDA, and expands FDA’s  oversight authority. For example, the law directs FDA to increase the  frequency of its inspections, and allocate resources to inspect facilities  according to the facilities’ known safety risks, with high-risk facilities  being inspected the most frequently. The law also has several sections that  require interagency collaboration on food safety oversight in areas such as  inspections, seafood safety, and food imports. While the new law is a  positive development, it does not apply to the federal food safety system  as a whole. In particular, it does not address USDA’s authorities, which  remain separate and distinct from FDA’s.
A new statutory requirement mandates that GAO identify federal  programs, agencies, offices, and initiatives with duplicative goals and  activities within departments and governmentwide. Under that mandate,  this review examines: (1) steps, if any, that the FSWG has taken to  increase collaboration among federal food safety agencies, and (2) options  we and others have identified to reduce fragmentation, overlap, and  potential duplication in food safety oversight. To complete our work we  reviewed food safety reports and legislation, and interviewed officials  from USDA, FDA, and the Office of Management and Budget (OMB). We  also collected and analyzed information about the FSWG, its activities, and  its governmentwide plan for food safety, as well as alternative  organizational structures for food safety. More detailed information about  our scope and methodology appears in appendix I. We conducted this  performance audit from July 2010 to March 2011 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: 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 agencies. The two primary food safety  agencies are USDA and FDA. USDA is responsible for the safety of meat,  poultry, processed egg products, and, as soon as recently proposed  regulations are finalized, catfish. FDA is responsible for virtually all other  food, including seafood. In fiscal year 2009, budget obligations for FDA’s  Foods Program were $685 million and budget obligations for FSIS were  approximately $975 million. Federal food safety activities include  inspecting domestic food-processing facilities and imported food at ports  of entry, visiting foreign countries or firms to inspect and evaluate foreign  food safety systems, analyzing samples collected at food-processing  facilities to identify possible contamination, rulemaking and standard  setting, and developing guidance for industry, among other things.  Appendix II summarizes the federal agencies’ food safety responsibilities  and main authorizing statutes. The federal food safety system is  supplemented by the states, which may have their own statutes,  regulations, and agencies for regulating and inspecting the safety and  quality of food products.
The existing food safety system, like many other federal programs and  policies, evolved piecemeal, typically in response to particular health  threats or economic crises. Existing statutes give agencies different  regulatory and enforcement authorities for different food products. For  example, the 2008 Farm Bill gave USDA responsibility for inspecting  catfish, but left general responsibility for seafood safety with FDA, making  the system more fragmented. According to USDA officials, USDA  estimates it will spend no more than $5 million in fiscal year 2011 and did  not request funding for fiscal year 2012 for its catfish inspection program.
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 food-borne  illnesses, such as older adults and immune-compromised individuals, are  growing.
section_title: The FSWG Has Taken Steps Designed to Improve Collaboration among Federal Agencies but Has Not Developed a Comprehensive Governmentwide Performance Plan for Food Safety
paragraphs: Creation of the FSWG by the President in March 2009 elevated food safety  as a national priority, demonstrated strong commitment and top  leadership support, and was designed to foster interagency collaboration  on this crosscutting issue. However, the FSWG has not developed a  governmentwide performance plan that provides a comprehensive picture  of the federal government’s food safety efforts. The FSWG is co-chaired by  the Secretaries of Health and Human Services and Agriculture. It also  includes officials from FDA, FSIS, the Centers for Disease Control and  Prevention (CDC), the Environmental Protection Agency, the Department  of Homeland Security, the Department of Commerce, the Department of  State, and several offices in the Executive Office of the President,  including OMB. Both FDA and FSIS have created executive positions to  focus agency efforts on food safety, and officials from both agencies told  us that the FSWG has increased interagency collaboration. However, while  creating the FSWG is a positive first step, we have reported that the  continuity of food safety coordination efforts can be hampered by changes  in executive branch leadership. As a presidentially appointed working  group, the FSWG’s future is uncertain, and the experience of the former  President’s Council on Food Safety, which disbanded less than 3 years  after it was created, illustrates that this type of approach can be short  lived.
Nevertheless, through the FSWG, federal agencies have taken steps  designed to increase collaboration in some areas that cross regulatory  jurisdictions––in particular, improving produce safety, reducing  Salmonella contamination, and developing food safety performance  measures.
Produce safety. Preventing contamination of fresh produce is an FSWG  priority. In 2009, FDA issued draft guidance for industry on produce safety  to minimize food safety hazards and contamination of leafy greens,  tomatoes, and melons. FDA has also publicly announced that it is  developing a proposed regulation setting enforceable standards for fresh  produce safety at farms and packing houses, and FDA and AMS officials  told us the agencies are collaborating on the rulemaking process, as AMS  establishes quality and condition standards the food industry can  voluntarily adopt for marketing purposes through marketing agreements.  Specifically, an AMS employee who USDA describes as having extensive  experience working with the produce industry for over 20 years has been  temporarily assigned to work as a Senior Policy Analyst in FDA’s Office of  Foods from October 2009 to March 2011 to help develop the regulation.  The AMS employee told us she is providing FDA with information about  practices on farms and in packing houses that FDA officials are using to  inform their rulemaking. She is also helping FDA leverage existing AMS- industry relationships to conduct outreach to farms and packing houses  before the produce safety regulation goes into effect. In addition, AMS has  publicly announced that it is developing a proposed national marketing  agreement for leafy greens that will include food safety standards. The  purpose of the proposed marketing agreement is to enhance the quality of  fresh leafy green vegetable products through the application of good  agricultural and handling practices, and to improve consumer confidence,  among other things. Based on our review of Federal Register documents  and interviews with AMS and FDA officials, we found that AMS is  coordinating with FDA to ensure that the standards in the proposed  marketing agreement are consistent with the standards FDA is setting in  the produce safety regulation.
Salmonella contamination. According to FSIS, FDA, and OMB officials,  FSIS and FDA worked together to establish complementary performance  goals under the High Priority Performance Goal initiative—a White House  management initiative—for reducing illness caused by Salmonella. FSIS  officials told us that staff from FSIS and FDA communicated on a regular  basis to coordinate efforts to develop their respective agencies’ goals, as  they are closely intertwined. Salmonella contamination can occur in  poultry and egg products, which are under FSIS’s regulatory jurisdiction,  and shell eggs, which are primarily under FDA’s jurisdiction. Both  agencies set goals to reduce illness from Salmonella within their own  areas of egg safety jurisdiction by the end of 2011. According to the FSIS  officials, FSIS and FDA coordinated on ensuring that the goals  complemented one another, utilized the same datasets, and covered the  same time period so that the agencies measure their progress consistently.  FSIS’s goal is to reduce the rate of illness due to Salmonella in FSIS- regulated products to 5.3 cases per 100,000 people by 2011, a reduction of  approximately 22,600 illnesses below the current baseline with an  associated cost reduction of $404 million. FDA’s goal is a 10 percent  decrease by 2011 over the 2007-2009 average baseline rate of Salmonella  Enteritidis illness in the population. The agencies have taken additional  actions to address Salmonella. Specifically, in May 2010, FSIS announced  new performance standards that poultry establishments must meet for  Salmonella and released a compliance guide for industry. In July 2009,  FDA issued a final rule requiring shell egg producers to implement  measures to prevent Salmonella Enteritidis from contaminating eggs and,  in August 2010, issued draft guidance for producers on implementing the  rule.
Food safety performance measures. FSWG members have proposed 21  performance measures for assessing the federal government’s progress  toward meeting its crosscutting food safety goals. For example, to assess  progress in preventing harm to consumers from unsafe food, one of the  performance measures the FSWG is proposing is to track the prevalence  of selected foodborne hazards in key commodity groups. As a next step,  FSIS and FDA are beginning to set quantitative targets for the measures.  For example, one of FSIS’s proposed quantitative targets is to reduce the  prevalence of Salmonella Enteritidis in FSIS prepasteurized egg products  from 14.12 percent (the fiscal year 2009 baseline) to 12.71 percent by fiscal  year 2015. FDA is developing its own quantitative targets. FSWG and  agency documents show that both agencies, with support from CDC, are  coordinating to pilot-test a framework for developing the quantitative  targets for Salmonella Enteritidis that covers multiple agencies’ oversight  jurisdictions. FSIS officials told us this framework could identify data gaps  and help target areas where more attention is needed. An FDA official told  us that the agencies plan to use this framework to assess progress toward  other food safety goals, but could not estimate when the agencies will  finish developing a complete set of quantitative targets for the food safety  performance measures.
In addition, we found that federal food safety agencies are taking actions  in two other areas. First, FDA is leading an effort involving other federal  agencies including CDC, USDA, and the Department of Homeland  Security, to increase the inspection, laboratory, and outbreak-response  capacities of state and local food safety agencies. FDA issued a draft paper  describing its vision and established working groups of federal, state, and  local government representatives to address issues such as national  standards for food regulatory programs and standardized laboratory  practices and procedures, among others. It has also hosted two national  meetings that were attended by public health and food safety officials  from federal, state, local, and territorial government agencies. Second, in  February 2011, federal food safety agencies established a Multi-Agency  Coordination group intended to improve the response to outbreaks of  foodborne illness, an FSWG priority. According to agency documents, the  group will be used to coordinate the response of federal agencies, and  state, local, and tribal governments, in managing large-scale foodborne  illness outbreaks, prioritizing the allocation of critical resources, and  making policy decisions. It is co-chaired by USDA and the Department of  Health and Human Services and participating federal agencies include  FDA, CDC, FSIS, AMS, the Food and Nutrition Service, the Animal and  Plant Health Inspection Service, the Foreign Agricultural Service, the  Environmental Protection Agency, and the Departments of Homeland  Security, State, and Justice.
However, while the FSWG has taken steps to increase interagency  collaboration on food safety, it has not developed a governmentwide  performance plan that provides a comprehensive picture of the federal  government’s food safety efforts. When we added food safety oversight to  our high-risk list in 2007, we said that what remains to be done is to  develop a governmentwide performance plan for food safety that is  mission based, results oriented, and provides a cross-agency perspective.  We also said this plan could be used to help decision makers balance  trade-offs and compare performance when resource allocation and  restructuring decisions are made. Officials from OMB, FDA, and USDA  told us the FSWG’s July 2009 “key findings” represent the governmentwide  plan for food safety. The key findings identify the FSWG’s three core  principles for improving the safety of the U.S. food supply—prioritizing  prevention, strengthening surveillance and enforcement, and improving  response and recovery—and outline a number of goals and actions the  agencies are taking, or plan to take, to improve food safety. The key  findings are mission based and offer a cross-agency perspective. For  example, both FSIS and FDA are contributing to goals for reducing illness  from Salmonella and E. coli, and multiple federal agencies are  contributing to goals for improving the response to outbreaks of  foodborne illness.
Some of the goals are results oriented, such as FSIS’s goal to have 90  percent of poultry establishments meeting its new standards to reduce  Salmonella in turkeys and poultry by the end of 2010, and FDA’s goal to  reduce foodborne illness from shell eggs by approximately 60 percent by  issuing a final rule to control Salmonella during egg production. However,  most of the goals are not results oriented and do not include performance  measures, focusing instead on specific actions the agencies plan to take in  the near term. For example, to reduce illness from E. coli, FSIS’s goal is to  issue improved instructions to its workforce and increase its sampling. It  is not clear the extent to which these one-time actions will help reduce  illness from E. coli.
Further, it is not clear how the key findings align with the 21 performance  measures for food safety proposed by the FSWG. Our prior work has  identified results oriented goals and performance measures as standard  elements of performance plans. Because the FSWG’s key findings  generally lack results oriented goals and performance measures, they do  not provide a concrete statement of the federal government’s expected  performance for food safety that can be used for subsequent comparison  with its actual performance. Identifying performance gaps can help  decision makers target scarce resources. In addition, the key findings do  not include information about the resources that are needed to achieve the  FSWG’s goals. A discussion of the strategies and resources needed to  achieve annual goals is also a standard element of performance plans. The  key findings also do not address the entire food supply; for example none  of the goals specifically addresses food imports, which represent 60  percent of fresh fruits and vegetables and 80 percent of seafood.
Although performance plans are to be updated on an annual basis, OMB  officials told us there are currently no plans to update the key findings,  which were issued in 2009. Those officials also told us that, instead, the  intent was to integrate the FSWG’s planning into the agencies’ budgeting  processes, which include developing performance goals. While individual  agency documents provide important and useful information, they do not  provide a broader and more integrated picture of food safety oversight  throughout the federal government. Without a governmentwide  performance plan for food safety, decision makers do not have a  comprehensive picture of the federal government’s performance on this  crosscutting issue. Further, performance plans provide an opportunity for  agencies to identify factors that influence the accomplishment of their  goals and discuss the strategies they plan to take to leverage or mitigate  the influence such factors can have on achieving results. For example, a  governmentwide plan for food safety could recognize that the federal  agencies’ food safety oversight authorities differ and recognize and  address other external factors, such as the actions of state and local  governments, which influence the accomplishment of federal food safety  goals.
Recent legislation reinforces the need for and importance of  governmentwide planning. The GPRA Modernization Act of 2010, which  updates the requirements for strategic plans and performance plans, also  recognizes the importance of governmentwide planning on crosscutting  issues. In addition, the recently enacted FDA Food Safety Modernization  Act calls for coordination among federal agencies. Specifically, the Act  directs the Secretary of Health and Human Services to improve  coordination and cooperation with the Secretaries of Agriculture and  Homeland Security to target food inspection resources and to submit  annual reports to Congress describing those efforts and providing other  information about FDA’s inspections. The Act also requires the Secretaries  of Health and Human Services and Agriculture, in consultation with the  Secretary of Homeland Security, to prepare a National Agriculture and  Food Defense Strategy. It also requires the Secretary of Health and Human  Services, in coordination with the Secretaries of Agriculture and  Homeland Security, to submit a comprehensive report to Congress that  identifies programs and practices that are intended to promote the safety  and security of the food supply and prevent foodborne outbreaks. The  information provided in those reports could help inform a  governmentwide performance plan for food safety. Moreover, we have  reported that establishing mutually reinforcing or joint strategies is a key  practice that can help enhance and sustain interagency collaboration  among federal agencies. Such strategies help in aligning the collaborating  agencies’ activities, core processes, and resources to accomplish a  common outcome. In this current fiscal environment, we and others have  called for agencies to leverage scarce resources for food safety and other  issues.
Our past work on other interagency planning may provide models for  governmentwide planning on food safety. While FDA and USDA have  collaborated on setting food safety goals for Healthy People—a  multiagency initiative to improve public health—they are long-term goals,  set every 10 years, and are not linked to resources. We have reported on  interagency planning for sharing health resources for military service  members and veterans and managing wildland fires.
Health resource sharing. The Department of Veterans Affairs (VA) and  Department of Defense (DOD) collaborate to use federal health resources,  such as space in medical facilities, under the Veterans Administration and  Department of Defense Health Resources Sharing and Emergency  Operations Act. In addition, the VA/DOD Joint Executive Council develops  a joint strategic plan to shape, focus, and prioritize the coordination and  sharing efforts, as directed by Congress and recommended by a  presidential task force. The council has developed a new joint strategic  plan each year since 2003, which is included in the council’s annual report  to the VA and DOD Secretaries on the status of implementing its  collaboration and sharing activities. We reported that, according to DOD,  the joint strategic plan outlines actionable objectives, assigns  accountability, and establishes performance targets.
Wildland fire management. Five federal agencies that share responsibility  for wildland fire management—the Forest Service at USDA and the  Bureau of Indian Affairs, Bureau of Land Management, Fish and Wildlife  Service, and National Park Service at the Department of Interior—have  long coordinated their fire suppression efforts. The intergovernmental  Wildland Fire Leadership Council, which was recommended by GAO and  established by the Secretaries of Agriculture and the Interior in 2002, seeks  to support implementation of federal fire management policy by  coordinating agency policies and providing strategic direction. In reports  dating back to 1999, we have recommended that the agencies develop a  cohesive strategy that identifies options and funding for preventing and  responding to fires. At the direction of Congress, the council began  developing a cohesive wildland fire management strategy in 2010 that is  required to address fire suppression, prevention, and resource allocation  issues.
section_title: We and Others Have Identified Options to Reduce Fragmentation and Overlap in Food Safety Oversight, but They Have Not Been Analyzed in Detail
paragraphs: We, the National Academy of Sciences, the Produce Safety Project, and the  former President’s Council on Food Safety have identified options to  reduce fragmentation and overlap in food safety oversight in the form of  alternative organizational structures (see app. III), but a detailed analysis  of their advantages and disadvantages and the potential challenges that  could arise if they are implemented has yet to be conducted. In 2001, we  first suggested that Congress consider commissioning the National  Academy of Sciences or a blue ribbon panel to conduct a detailed analysis  of alternative organizational structures for food safety and reiterated the  suggestion over the years, most recently in the 2011 high-risk list update.
Some of the alternative organizational structures that we and others have  identified include:    Single food safety agency. All aspects of food safety at the federal level  could be consolidated into a single food safety agency, either housed  within an existing agency or established as an independent entity. This  consolidation would bring oversight of all foods under a single  administrator and consolidate tasks that are currently dispersed throughout multiple federal agencies, such as inspections, risk  assessment, standard setting, research, and surveillance.
Food safety inspection agency. Food safety inspection activities, but not  other activities such as surveillance, could be consolidated under USDA or  FDA. As we reported in the past, any new inspection system should  employ a unified risk-based approach, which would require Congress to  modify the current legislative structure.
Data collection and risk analysis center. Data collection and risk analysis  could be consolidated into a single center that would disseminate the  results of its analyses to the food safety agencies. For example, this center  could consolidate food safety surveillance data collected from a variety of  sources and analyze it at the national level to support risk-based decision  making. While the center would be independent from the regulatory  agencies to give its analyses scientific credibility, it would also consult  with the agencies to understand their needs, but would not preempt any  agency’s authority to develop its own food safety management approach.
Coordination mechanism. Centralized, executive leadership could be  provided for the existing organizational structure using a coordination  mechanism with representatives from the agencies, similar to the FSWG.  However, unlike the FSWG, the coordination mechanism would be led by  a central chair who would be appointed by the President and have control  over resources.
While a detailed analysis of the alternatives has not been conducted,  organizations have offered some preliminary observations on some of  their benefits. For example, in its strategic plan, the former President’s  Council on Food Safety stated that consolidation could eliminate  duplication and fragmentation, create a centralized leadership, clarify lines  of authority, and facilitate priority setting and resource allocation based  on risk. Similarly, in its 2010 report Enhancing Food Safety: The Role of  the Food and Drug Administration, the National Academy of Sciences  concluded that the core federal food safety responsibilities should reside  within a single entity having a unified administrative structure, clear  mandate, dedicated budget, and full responsibility for oversight of the  entire food supply. In its report, the National Academy of Sciences also  stated that centralizing data collection and risk analysis would eliminate  the need for each agency to develop its own comprehensive expertise in  risk and decision analysis; promote communication, collaboration, and  data sharing among federal agencies; and could be a first step toward  accomplishing the more challenging goal of consolidating all federal food  safety activities into a single agency.
We recognize that reorganizing federal food safety responsibilities would  be a complex process. Further, our work on other agency mergers and  transformations indicates that reorganizing food safety could have short- term disruptions and transition costs. We reported that a merger or  transformation is a substantial commitment that could take years before it  is completed, and therefore must be carefully and closely managed. In  particular, the experience of major private sector mergers and acquisitions  has been that productivity and effectiveness actually decline initially, in  part because attention is concentrated on critical and immediate  integration issues and diverted from longer-term mission issues. Our work  on seven other countries’ experiences between 1997 and 2004 in  consolidating their food safety systems found that while the extent to  which those countries consolidated their food systems varied  considerably, they faced similar challenges in deciding whether to place  the new agency within the existing health or agriculture agency or  establish it as a stand-alone agency and in determining what  responsibilities the new agency would have. We also reported that the  countries experienced benefits, such as improved public confidence in  their food safety systems. In addition, each country modified its existing  legal framework to give legal authority and responsibility to the new food  safety agency. Some European Union (EU) countries were further  prompted to consolidate in order to comply with new EU food safety  legislation that became effective, in large part, in January 2006. The EU  adopted comprehensive food safety legislation in 2004 intended to create a  single, transparent set of food safety rules applicable to both animal and  nonanimal products.
We and other organizations have regularly paired proposals for alternative  food safety organizations with calls for comprehensive, unified, risk-based  food safety legislation. Existing statutes give agencies different regulatory  and enforcement authorities, and we have reported that legislation  governing the agencies’ authorities, jurisdictions, and inspection  frequencies is not the product of strategic design as to how to protect  public health. In May 2004, we reported that a critical step in designing  and implementing a risk-based food safety system is identifying the most  important food safety problems across the entire food system from a  public health perspective and concluded that comprehensive, uniform, and  risk-based food safety legislation is needed to provide the foundation for  this approach. The National Academy of Sciences also concluded that to  create a science-based food safety system current laws must be revised,  and recommended that Congress change federal statutes so that  inspection, enforcement, and research efforts can be based on risks to  public health. While the new food safety law strengthens a major part of  the food safety system and expands FDA’s oversight authority, it does not  apply to the federal food safety system as a whole or create a new risk- based food safety structure. In February 2011, we reiterated our  suggestion for comprehensive, unified, risk-based food safety legislation.
section_title: Conclusions
paragraphs: We are encouraged by the executive branch’s attention to food safety  through the FSWG and its initial efforts designed to improve interagency  collaboration on this very important crosscutting issue. However, food  safety remains fragmented and much work remains to be done on several  of the FSWG initiatives. Further, the collaboration that has begun under  the FSWG may be short lived, putting some of the longer-term efforts, such  as developing results-oriented food safety goals and measures, at risk of  not being completed. Because food safety oversight faces ongoing  challenges, it is important that this issue be given sustained attention; as  we have previously reported, the continuity of food safety coordination  efforts can be hampered when executive branch leadership changes. Thus,  it is critical that the primary food safety agencies engage in  comprehensive, governmentwide planning to increase interagency  collaboration under the current system. Such a plan, paired with  comprehensive risk-based food safety legislation and a detailed analysis of  alternative organizational structures for food safety oversight, could be an  important tool for addressing fragmentation in federal food safety  oversight. However, without an annually updated governmentwide  performance plan for food safety that contains results-oriented goals and  performance measures and a discussion of strategies and resources used  by the agencies with food safety responsibilities, decision makers do not  have a comprehensive picture of the federal government’s performance on  this crosscutting issue. Further, without such information, decision  makers may be hampered in their efforts to make key resource allocation  and restructuring decisions.
section_title: Recommendation for Executive Action
paragraphs: In order to improve collaboration among federal agencies on food safety  oversight and provide an integrated perspective on this crosscutting issue  we are making the following recommendation.
The Director of the Office of Management and Budget, in consultation with  the federal agencies that have food safety responsibilities, should develop  a governmentwide performance plan for food safety. The performance  plan should include results-oriented goals and performance measures for  food safety oversight throughout the federal government, as well as a  discussion about strategies and resources. It should be updated on an  annual basis.
section_title: Agency Comments
paragraphs: We provided USDA, the Department of Health and Human Services, and  OMB with drafts of this report for review. OMB declined to comment on  the draft report. USDA and Health and Human Services provided technical  comments, which we incorporated as appropriate.
We are sending copies of this report to the appropriate congressional  committees, the Secretary of Agriculture, Director of the Office of  Management and Budget, Commissioner of the Food and Drug  Administration, and other interested parties. The report also is available at  no charge on the GAO website at http://www.gao.gov.
If you or your staffs have any questions about this report, please contact  me at (202) 512-3841 or shamesl@gao.gov. Contact points for our Offices  of Congressional Relations and Public Affairs may be found on the last  page of this report. GAO staff who made key contributions to this report  are listed in appendix IV.
section_title: Appendix I: Scope and Methodology
paragraphs: A new statutory requirement mandates that GAO identify programs,  agencies, offices, and initiatives with duplicative goals and activities  within departments and governmentwide. Under that mandate this review  examines: (1) steps, if any, that the Food Safety Working Group (FSWG)  has taken to increase collaboration among federal food safety agencies,  and (2) options we and others have identified to reduce fragmentation,  overlap, and potential duplication in food safety oversight.
To complete our work we reviewed food safety reports and legislation,  and interviewed officials from the Department of Agriculture (USDA), the  Food and Drug Administration (FDA), and the Office of Management and  Budget (OMB). To address the first question we also collected and  analyzed information about the FSWG, its activities, and its plan for food  safety. We also collected documentation about the FSWG’s activities from  the agencies, the Federal Register, and budget documents. We assessed  the FSWG’s “key findings,” which FSWG officials told us represent the  governmentwide plan for food safety, against GAO’s criteria for  performance plans. To identify options for reducing fragmentation,  overlap, and potential duplication, we identified alternative organizational  structures for food safety by reviewing reports by GAO, the National  Academy of Sciences, the Produce Safety Project, and the former  President’s Council on Food Safety. We also reviewed reports by GAO  about federal agency and private sector mergers and organizational  transformations. We did not independently verify the foreign laws  discussed in this report.
We conducted this performance audit from July 2010 to March 2011 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.
section_title: Appendix II: Federal Agencies with Food Safety Responsibilities
paragraphs: G & CoopveOAee A.
Responsible for: Ensuring tht the ntion’ dometic nd imported  commercisupply of met, poltry, egg prodct, nd ctfi safe,  wholeome, nd correctly labeled nd pckged, nd for enforcing the  Hne Method of Saughter Act of 1978, as mended. Reponle for  providing volntry fee-for-ervice inpection for exotic nd other edile  nim.
Main authorizing statutes: Poltry Prodct Inpection Act, Pub. L. No.  85-172, 71 St. 441 (1957) (codified as mended t 21 U.S.C. ss.  451-472); Federl Met Inpection Act, ch. 2907, 34 St. 1256, 1260  (1907) (codified as mended t 21 U.S.C. ss. 601-695); Egg Prodct  Inpection Act, Pub. L. No. 91-597, 84 St. 1620 (1970) (codified as  mended t 21 U.S.C. ss. 1031-1056). See o, Hne Method of  Saughter Act of 1978, Pub. L. No. 95-445, 92 St. 1069 (codified as  mended t 7 U.S.C. ss. 1902, 1904, 21 U.S.C. ss. 603, 610, 620); Federl  Anti-Tmpering Act, Pub. L. No. 98-127, . 2. 97 St. 831, 831 (1983)  (codified as mended t 18 U.S.C. . 1365); Agricltl Mrketing Act of  1946, ch. 966, tit. II, . 203, 60 St. 1087, 1087 (codified as mended t 7  U.S.C. . 1622). See o NtionSchool Lnch Act, ch. 281, 60 St. 230  (1946) (codified as mended t 42 U.S.C. ss. 1751-1770), as mended y  Child Ntrition nd WIC Reauthoriztion Act of 2004, Pub. L. No. 108-265,  . 118, 118 St. 729, 752 (codified as mended t 42 U.S.C. . 1762(h)).
Responsible for: Preventing the introdction or dissemintion of plnt  pe. Reponle for preventing the introdction or dissemintion of  livetock pe or dias.
Main authorizing statutes: Agricltl Bioterrorim Act of 2002, Pub. L.
No. 107-188, tit. II, subtit. B, 116 St. 647 (codified as mended t 7  U.S.C. . 8401); Animl Helth Protection Act, Pub. L. No. 107-171, tit. X,  116 St. 494 (2002) (codified as mended t 7 U.S.C. ss. 8301-8322);  Plnt Protection Act, Pub. L. No. 106-224, tit. IV, 114 St. 438 (2000)  (codified as mended t 7 U.S.C. ss. 7701-7721).
Responsible for: Eablihing quality ndrd, inpection procedre,  rketing of grin nd other relted prodct.
Main authorizing statutes: United Ste Grin Sndrd Act, ch. 313,  St. 482 (1916) (codified as mended t 7 U.S.C. ss. 71-87k).
G & CoopveOAee A.
Responsible for: Eablihing quality nd condition ndrd for, mong  other thing, diry, frit nd vegetable, livetock.
Main authorizing statutes: Agricltl Mrketing Act of 1946, ch. 966, tit.
II, 60 St. 1087 (codified as mended t 7 U.S.C. ss. 1621-1638d). See  o e.g., Periable Agricltl Commoditie Act, 1930, ch. 436, 46 St.  531 (codified as mended t 7 U.S.C. . 499- 499); FederSeed Act,  Ch. 615, 53 St. 1275 (1939) (codified as mended t 7 U.S.C. ss.  1551-1611).
Ntrition, Food Safety,  nd Quality food supply i safe nd ecre nd tht food meet foreign nd dometic  regtory reqirement.
Main authorizing statutes: 7 U.S.C. ss. 1622, 2204, 3101, 3121, 3318,  ; o e.g., 7 U.S.C. ss. 136i-2, 391, 7654.
Responsible for: Providing ly of the economic issu ffecting the  safety of the U.S. food supply.
Main authorizing statutes: 7 U.S.C. ss. 1622, 2204, 3101, 3121, 3318,  ; o e.g., 7 U.S.C. ss. 136i-2, 391, 7654.
Responsible for: Providing titicl d, inclding gricltl chemicusage d, relted to the safety of the food supply.
Main authorizing statutes: 7 U.S.C. ss. 1622, 2204, 3101, 3121, 3318,  ; o e.g., 7 U.S.C. ss. 136i-2, 391, 7654.
Ntionl Integrted  Food Safety Rerch  Inititive niverity tem nd other prtner orgniztion tht demontrte n  integrted pproch to olving prolem in pplied food safety rerch,  edtion, or extenion.
Main authorizing statutes: 7 U.S.C. ss. 361-361i, 3121, 3151, 3155,  3318, 3319, 6971(f); o e.g., 7 U.S.C. ss. 450i, 3902.
Responsible for: Ensuring thll dometic nd imported food,  exclding mend poltry prodct, re safe, wholeome, sanitry, nd  properly labeled.
G & CoopveOAee A.
Responsibilities and main authorizing statutes   Act of 1994, Pub. L. No. 103-417, 108 St. 4325; Food nd DrModerniztion Act of 1997, Pub. L. No. 105-115, 111 St. 2296; Public  Helth Secrity nd Bioterrorim Prepredness nd Repone Act of  2002, Pub. L. No. 107-188, tit. III, 116 St. 594; Sanitry Food  Trporttion Act of 2005, Pub. L. No. 109-59, tit. VII, . 7202, 119 St.  1891, 1911; FDA Food Safety Moderniztion Act. Pub. L. No. 111-353, 124  St. 3885 (2011). See o, Act of Feuary 15, 1927 (Federl Import Milk  Act), ch. 155, 44 St. 1101 (codified as Amended t 21 U.S.C. 141-149);  Fir Pckging nd Labeling Act, Pub. L. No. 89-755, 80 St. 1296 (1966)  (codified as mended t 15 U.S.C. ss. 1451-1461); Federl Anti-Tmpering  Act, Pub. L. No. 98-127, . 2. 97 St. 831, 831 (1983) (codified as  mended t 18 U.S.C. . 1365); Peticide Monitoring Improvement Act of  1988, Pub. L. No. 100-418, . 4702, 102 St. 1411, 1412 (codified as  mended t 21 U.S.C. . 1401).
Responsible for: Preventing the trmission, dissemintion, nd preof foodorne illness to protect the public helth.
Main authorizing statutes: Public Helth Service Act, ch. 373, 58 St.  682 (1944) (codified as mended t 42 U.S.C. ss. 201-300bbb). food for safety nd quality    Responsible for: Providing volntry, fee-for-ervice exmintion of     Main authorizing statutes: Agricltl Mrketing Act of 1946, ch. 966, tit.
II, . 203, 205, 60 St. 1087, 1087 (codified as mended t 7 U.S.C. ss.  1622, 1624). See o Act of My 25, 1900 (Lcey Act), ch. 553, 31 St.  187 (codified as mended in prt t 16 U.S.C. . 3371).
Polltion Prevention nd  Toxin; Peticide  Progrm; Safe Drinking  Wter tht preent nreasonable rk of injry to helth or the environment.  Reponle for issuing regtion to eablih, modify, or revoke  tolernce for peticide chemicl reid. Reponle for etting ntionl  drinking wter ndrd of quality nd consulting with FDA efore FDA  promlgte regtion for ndrd of quality for ottled wter.
Main authorizing statutes: Toxic Subsnce Control Act, Pub. L. No.  94-469, 90 St. 2003 (1976) (codified as mended t 15 U.S.C. ss.  2601-2697) Federl Inecticide, Fngicide, nd Rodenticide Act, ch. 125,  61 St. 163 (1947) (codified as mended t 7 U.S.C. ss. 136-136y), as  mended y the Food Quality Protection Act of 1996, Pub. L. No. 104-170,  110 St. 1489; 21 U.S.C. . 346, Safe Drinking Wter Act of 1974, Pub. L.  No. 93-523, 88 St. 1660 (codified as mended t 21 U.S.C. . 349 nd 42  U.S.C. ss. 300f throgh 300j-26).
G & CoopveOAee A.
Responsibilities and main authorizing statutes    Responsible for: Regting, enforcing, nd issuing permit for the  prodction, labeling, nd ditribution of lcoholic everge.
Main authorizing statutes: Federl Alcohol Adminitrtion Act, ch. 814,  St. 977 (1935) (codified as mended t 27 U.S.C. ss. 201-219).
Responsible for: Inpecting import, inclding food prodct, plnt, nd  live nim, for complince with U.S. lnd assting ll federgencie in enforcing their regtion t the order.
Main authorizing statutes: Triff Act of 1930, 19 U.S.C. ss. 1202-1654.
See o Homelnd Secrity Act of 2002, Pub. L. No. 107-296, . 421, 116  St. 2135, 2182.
Responsible for: Enforcing prohiition int fdvertiing for,  mong other thing, food prodct.
Main authorizing statutes: Federl Trde Commission Act, ch. 311, 38  St. 717 (1914) (codified as mended t 15 U.S.C. ss. 41-58).
The 200 Farm Bill amended the Federal Meat Inspection Act to give USDA responsibility for the  inspection of catfish. The amendments specified that they would not apply until USDA issues final  regulations implementing them, a process that was not yet complete as of February 2011.
section_title: Appendix III: Reports Identifying Options for Alternative Organizational Structures for Food Safety Oversight
paragraphs: GAO, Food Safety and Security: Fundamental Changes Needed to Ensure  Safe Food. GAO-02-47T. Washington, D.C.: October 10, 2001.
Institute of Medicine and National Research Council, Enhancing Food  Safety: The Role of the Food and Drug Administration. The National  Academies Press. Washington, D.C.: 2010.
Institute of Medicine and National Research Council, Ensuring Safe Food:  From Production To Consumption. The National Academies Press.  Washington, D.C.: 1998.
President’s Council on Food Safety, Food Safety Strategic Plan.  Washington, D.C.: January 19, 2001.
Batz, Michael and J. Glenn Morris, Jr., Building the Science Foundation of  a Modern Food Safety System: Lessons From Denmark, The Netherlands,  and The United Kingdom on Creating a More Coordinated and  Integrated Approach to Food Safety Information. A report for the  Produce Safety Project. Washington, D.C.: May 10, 2010.
section_title: Appendix IV: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: In addition to the contact named above, José Alfredo Gómez (Assistant  Director), Annamarie Lopata (Analyst-in-Charge), Kevin Bray, Diana  Goody, Tesfaye Negash, Alison O’Neill, and Katherine Raheb made key  contributions to this report.
section_title: Related GAO Products
paragraphs: Opportunities to Reduce Potential Duplication in Government  Programs, Save Tax Dollars, and Enhance Revenue. GAO-11-318SP.  Washington, D.C.: March 1, 2011.
High-Risk Series: An Update. GAO-11-278. Washington, D.C.: February  2011.
Live Animal Imports: Agencies Need Better Collaboration to Reduce the  Risk of Animal-Related Diseases. GAO-11-9. Washington, D.C.: November  8, 2010.
Food Safety: Agencies Need to Address Gaps in Enforcement and  Collaboration to Enhance Safety of Imported Food. GAO-09-873.  Washington, D.C.: September 15, 2009.
Seafood Fraud: FDA Program Changes and Better Collaboration among  Key Federal Agencies Could Improve Detection and Prevention.  GAO-09-258. Washington, D.C.: February 19, 2009.
Food Safety: Selected Countries’ Systems Can Offer Insights into  Ensuring Import Safety and Responding to Foodborne Illness.  GAO-08-794. Washington, D.C.: June 10, 2008.
Oversight Of Food Safety Activities: Federal Agencies Should Pursue  Opportunities to Reduce Overlap and Better Leverage Resources.  GAO-05-213. Washington, D.C.: March 30, 2005.
Food Safety and Security: Fundamental Changes Needed to Ensure Safe  Food. GAO-02-47T. Washington, D.C.: October 10, 2001.
Agency Performance Plans: Examples of Practices That Can Improve  Usefulness to Decisionmakers. GAO/GGD/AIMD-99-69. Washington, D.C.:  February 26, 1999.
Agencies’ Annual Performance Plans Under The Results Act: An  Assessment Guide to Facilitate Congressional Decisionmaking.  GAO/GGD/AIMD-10.1.18. Washington, D.C.: February 1998.
Managing For Results: Using the Results Act to Address Mission  Fragmentation and Program Overlap. GAO/AIMD-97-146. Washington,  DC: August 29, 1997.