Federal Oversight of Food Safety: High-Risk Designation Can Bring Needed Attention to Fragmented System
Published: 2007-02-08T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: Each year, about 76 million people contract a foodborne illness in the United States; about 325,000 require hospitalization; and about 5,000 die. While the recent E. coli outbreaks highlighted the risks posed by accidental contamination, the attacks of September 11, 2001, heightened awareness that the food supply could also be vulnerable to deliberate contamination. This testimony focuses on the (1) role that GAO's high-risk series can play in raising the priority and visibility of the need to transform federal oversight of food safety, (2) fragmented nature of federal oversight of food safety, and (3) need to address federal oversight of food safety as a 21st century challenge. This work is based on previously issued reports.
section_title: What GAO Found
paragraphs: GAO's high-risk series is intended to raise the priority and visibility of government programs that are in need of broad-based transformation to achieve greater economy, efficiency, effectiveness, accountability, and sustainability. In January 2007, as part of our regular update of this series for each new Congress, GAO designated the federal oversight of food safety as a high-risk area for the first time. While this nation enjoys a plentiful and varied food supply that is generally considered to be safe, the federal oversight of food safety is fragmented, with 15 agencies collectively administering at least 30 laws related to food safety. The two primary agencies are the U.S. Department of Agriculture (USDA), which is responsible for the safety of meat, poultry, and processed egg products, and the Food and Drug Administration (FDA), which is responsible for other food. In many previous reports, GAO found that this fragmented system has caused inconsistent oversight, ineffective coordination, and inefficient use of resources. For example, existing statutes give agencies different regulatory and enforcement authorities. Under current law, thousands of USDA inspectors must examine all slaughtered carcasses and visit all processing facilities at least once during each operating day. However, federal law does not mandate the frequency of inspection for foods that are under FDA's jurisdiction. Food recalls are generally voluntary. While USDA and FDA provide guidance to companies for carrying out voluntary recalls, they do not know how promptly and completely companies carry out recalls and do not promptly verify that recalls have reached the entire distribution chain. In addition, they use procedures that may not be effective to alert consumers to a recall. Federal agencies are spending resources on overlapping food safety activities. USDA and FDA both inspect shipments of imported food at 18 U.S. ports of entry but do not share inspection resources at these ports. Integrating the fragmented federal food safety system is a significant challenge for the 21st century, particularly in light of the nation's current deficit and growing structural fiscal imbalance. To help Congress review and reconsider the base of federal spending, GAO framed illustrative questions for decision makers to consider in 21st Century Challenges: Reexamining the Base of the Federal Government. Among these questions are how agencies can integrate and share accountability for their activities on crosscutting issues and how they can adopt more innovative methods to contribute to the achievement of national outcomes. While framing these questions, GAO specifically cited the myriad of food safety programs managed across several federal agencies.

section_title: Letter
paragraphs: I am pleased to be here today to discuss the designation of federal  oversight of food safety as a high-risk area in the January 2007 update to  our High-Risk Series. Let me state at the outset that this nation enjoys a  plentiful and varied food supply that is generally considered to be safe.  However, each year, about 76 million people contract a foodborne illness  in the United States; about 325,000 require hospitalization; and about 5,000  die, according to the Centers for Disease Control and Prevention. In  addition, as we have repeatedly reported, our fragmented food safety  system has resulted in inconsistent oversight, ineffective coordination, and  inefficient use of resources. With 15 agencies collectively administering at  least 30 laws related to food safety, the patchwork nature of the federal  food safety oversight system calls into question whether the government  can more efficiently and effectively protect our nation’s food supply. As a  result, we added the federal oversight of food safety to our list of programs  needing urgent attention and transformation in order to ensure that our  national government functions in the most economical, efficient, and  effective manner possible.
Our high-risk status reports are provided at the start of each new Congress  to help in setting congressional oversight agendas and to help in raising  the priority and visibility of government programs needing transformation.  These reports also help Congress and the executive branch carry out their  responsibilities while improving the government’s performance and  enhancing its accountability for the benefit of the American people. In this  regard, I recently provided congressional leadership with a set of  recommendations based on GAO’s work, including work on some areas  we have designated as high risk, for its consideration in developing the  oversight agenda of the 110th Congress. Together, the high-risk update  and the recommendations for oversight can help congressional decision  makers focus on the programmatic challenges facing the nation.
Because of your continuing interest in the effective use of food safety  resources, I will focus on three key points: (1) the role of GAO’s High-Risk  Series in raising the priority and visibility of the need to transform federal  oversight of food safety, (2) the fragmented nature of federal oversight of  food safety, and (3) the need to address federal oversight of food safety as  a 21st century challenge. My testimony is based on published GAO  products that were developed in accordance with generally accepted  government auditing standards. Appendix I includes highlights of selected  reports.
subsections: section_title: GAO’s High-Risk Series Raises the Priority and Visibility of the Need to Transform Federal Oversight of Food Safety
paragraphs: Overall, our High-Risk Series has served to identify and help resolve  serious government weaknesses in areas that involve substantial resources  and provide critical services to the public. Since we began reporting on  high-risk areas, the government has taken high-risk problems seriously  and has made long-needed progress toward correcting them. With that in  mind, we designated the federal oversight of food safety as a high-risk area  to raise the priority and visibility of the need to transform the federal  government’s oversight system.
Since 1990, GAO has reported on government operations that we identified  as high risk and has periodically reported on the status of progress to  address high-risk areas and updated our high-risk list. Historically, high- risk areas have been so designated because of traditional vulnerabilities  related to their greater susceptibility to fraud, waste, abuse, and  mismanagement. As our high-risk program has evolved, we have  increasingly used the high-risk designation to draw attention to areas  needing broad-based transformations to achieve greater economy,  efficiency, effectiveness, accountability, and sustainability of selected key  government programs and operations.
In determining whether a government program or operation is high risk,  we consider whether it has national significance or a management  function that is key to performance and accountability. Further, we  consider qualitative factors, such as whether the risk  involves public health or safety, service delivery, national security,  national defense, economic growth, or privacy or citizens’ rights; or    could result in significantly impaired service, program failure, injury or  loss of life, or significantly reduced economy, efficiency, or  effectiveness.
Clearly, these factors weighed heavily into our deliberations to place the  federal oversight of food safety on our high-risk list.
We remove a high-risk designation when legislative and agency actions,  including those in response to our recommendations, result in significant  and sustainable progress toward resolving a high-risk problem. Key  determinants include a demonstrated strong commitment to and top  leadership support for addressing problems, the capacity to do so, a  corrective action plan, and demonstrated progress in implementing  corrective measures. The sustained attention and commitment by  Congress and agencies to resolve serious, long-standing high-risk  problems have paid off; because of sufficient progress, we were able to  remove the high-risk designation from 18 areas—more than half of our  original list. As we have with areas previously removed from the high-risk  list, we will continue to monitor these programs, as appropriate, to ensure  that the improvements we have noted are sustained.
For areas that remain on our high-risk list for 2007, there has been  important—but varying levels of—progress. Top administration officials  have expressed their commitment to ensuring that high-risk areas receive  adequate attention and oversight. The Office of Management and Budget  (OMB) has led an initiative to prompt agencies to develop detailed action  plans for each area on our high-risk list. These plans are intended to  identify specific goals and milestones that address and reduce the risks we  identified within each high-risk area. Further, OMB has encouraged  agencies to consult with us regarding the problems our past work has  identified and the many recommendations for corrective actions we have  made. While progress on developing and implementing plans has been  mixed, concerted efforts by agencies and ongoing attention by OMB are  critical.
In addition to the programs that remain on the list, we recently designated  three new areas as high risk, including the need to transform federal  oversight of food safety. For these recently added areas, along with those  remaining on the list, we expect that continued perseverance will  ultimately yield significant benefits. To begin to address the weaknesses in  federal oversight of food safety, executive agencies can start by  implementing our recommendations intended to improve the problems we  previously identified. Further, continued congressional oversight,  including today’s hearing, and additional legislative action will also be key  to achieving progress, particularly in addressing challenges in the broad- based transformation needed to promote the safety and integrity of the  nation’s food supply.
section_title: Fragmented Federal Oversight of Food Safety Led to High- Risk Designation
paragraphs: For several years, we have reported on issues that suggest that food safety  could be designated as a high-risk area because of the need to transform  the federal oversight framework to reduce risks to public health as well as  the economy. Specifically, the patchwork nature of the federal food  oversight system calls into question whether the government can plan  more strategically to inspect food production processes, identify and react  more quickly to outbreaks of contaminated food, and focus on promoting  the safety and the integrity of the nation’s food supply. This challenge is  even more urgent since the terrorist attacks of September 11, 2001,  heightened awareness of agriculture’s vulnerabilities to terrorism, such as  the deliberate contamination of food or the introduction of disease to  livestock, poultry, and crops.
An accidental or deliberate contamination of food or the introduction of  disease to livestock, poultry, and crops could undermine consumer  confidence in the government’s ability to ensure the safety of the U.S. food  supply and have severe economic consequences. Agriculture, as the  largest industry and employer in the United States, generates more than $1  trillion in economic activity annually, or about 13 percent of the gross  domestic product. The value of U.S. agricultural exports exceeded $68  billion in fiscal year 2006. An introduction of a highly infectious foreign  animal disease, such as avian influenza or foot-and-mouth disease, would  cause severe economic disruption, including substantial losses from halted  exports. Similarly, food contamination, such as the recent E. coli  outbreaks, can harm local economies. For example, industry  representatives estimate losses from the recent California spinach E. coli  outbreak to range from $37 million to $74 million.
While 15 agencies collectively administer at least 30 laws related to food  safety, the two primary agencies are the U.S. Department of Agriculture  (USDA), which is responsible for the safety of meat, poultry, and  processed egg products, and the Food and Drug Administration (FDA),  which is responsible for virtually all other foods. Among other agencies  with responsibilities related to food safety, the National Marine Fisheries  Service (NMFS) in the Department of Commerce conducts voluntary, fee- for-service inspections of seafood safety and quality; the Environmental  Protection Agency (EPA) regulates the use of pesticides and maximum  allowable residue levels on food commodities and animal feed; and the  Department of Homeland Security (DHS) is responsible for coordinating  agencies’ food security activities.
The food safety system is further complicated by the subtle differences in  food products that dictate which agency regulates a product as well as the  frequency with which inspections occur. For example, how a packaged  ham and cheese sandwich is regulated depends on how the sandwich is  presented. USDA inspects manufacturers of packaged open-face meat or  poultry sandwiches (e.g., those with one slice of bread), but FDA inspects  manufacturers of packaged closed-face meat or poultry sandwiches (e.g.,  those with two slices of bread). Although there are no differences in the  risks posed by these products, USDA inspects wholesale manufacturers of  open-face sandwiches sold in interstate commerce daily, while FDA  inspects manufacturers of closed-face sandwiches an average of once  every 5 years.
This federal regulatory system for food safety, like many other federal  programs and policies, evolved piecemeal, typically in response to  particular health threats or economic crises. During the past 30 years, we  have detailed problems with the current fragmented federal food safety  system and reported that the system has caused inconsistent oversight,  ineffective coordination, and inefficient use of resources. Our most recent  work demonstrates that these challenges persist.  Specifically:    Existing statutes give agencies different regulatory and enforcement  authorities. For example, food products under FDA’s jurisdiction may  be marketed without the agency’s prior approval. On the other hand,  food products under USDA’s jurisdiction must generally be inspected  and approved as meeting federal standards before being sold to the  public. Under current law, thousands of USDA inspectors maintain  continuous inspection at slaughter facilities and examine all  slaughtered meat and poultry carcasses. They also visit each  processing facility at least once during each operating day. For foods  under FDA’s jurisdiction, however, federal law does not mandate the  frequency of inspections.
Federal agencies are spending resources on overlapping food safety  activities. USDA and FDA both inspect shipments of imported food at  18 U.S. ports of entry. However, these two agencies do not share  inspection resources at these ports. For example, USDA officials told  us that all USDA-import inspectors are assigned to, and located at,  USDA-approved import inspection facilities and some of these facilities  handle and store FDA-regulated products. USDA has no jurisdiction  over these FDA-regulated products. Although USDA maintains a daily  presence at these facilities, the FDA-regulated products may remain at  the facilities for some time awaiting FDA inspection. In fiscal year  2003, USDA spent almost $16 million on imported food inspections,  and FDA spent more than $115 million.
Food recalls are voluntary, and federal agencies responsible for food  safety have no authority to compel companies to carry out recalls— with the exception of FDA’s authority to require a recall for infant  formula. USDA and FDA provide guidance to companies for carrying  out voluntary recalls. We reported that USDA and FDA can do a better  job in carrying out their food recall programs so they can quickly  remove potentially unsafe food from the marketplace. These agencies  do not know how promptly and completely companies are carrying out  recalls, do not promptly verify that recalls have reached all segments of  the distribution chain, and use procedures that may not be effective to  alert consumers to a recall.
The terrorist attacks of September 11, 2001, have heightened concerns  about agriculture’s vulnerability to terrorism. The Homeland Security  Act of 2002 assigned DHS the lead coordination responsibility for  protecting the nation against terrorist attacks, including agroterrorism.  Subsequent presidential directives further define agencies’ specific  roles in protecting agriculture and the food system against terrorist  attacks. We reported that in carrying out these new responsibilities,  agencies have taken steps to better manage the risks of agroterrorism,  including developing national plans and adopting standard protocols.  However, we also found several management problems that can reduce  the effectiveness of the agencies’ routine efforts to protect against  agroterrorism. For example, there are weaknesses in the flow of  critical information among key stakeholders and shortcomings in  DHS’s coordination of federal working groups and research efforts.
More than 80 percent of the seafood that Americans consume is  imported. We reported in 2001 that FDA’s seafood inspection program  did not sufficiently protect consumers. For example, FDA tested about  1 percent of imported seafood products. We subsequently found that  FDA’s program has improved: More foreign firms are inspected, and  inspections show that more U.S. seafood importers are complying with  its requirements. Given FDA officials’ concerns about limited  inspection resources, we also identified options, such as using  personnel in the National Oceanic and Atmospheric Administration’s  (NOAA) Seafood Inspection Program to augment FDA’s inspection  capacity or state regulatory laboratories for analyzing imported  seafood. FDA agreed with these options.
In fiscal year 2003, four agencies—USDA, FDA, EPA, and NMFS— spent a total of $1.7 billion on food safety-related activities. USDA and  FDA together were responsible for nearly 90 percent of federal  expenditures for food safety. However, these expenditures were not  based on the volume of foods regulated by the agencies or consumed  by the public. The majority of federal expenditures for food safety  inspection were directed toward USDA’s programs for ensuring the  safety of meat, poultry, and egg products; however, USDA is  responsible for regulating only about 20 percent of the food supply. In  contrast, FDA, which is responsible for regulating about 80 percent of  the food supply, accounted for only about 24 percent of expenditures.
section_title: Federal Oversight of Food Safety Should Be Addressed as a 21st Century Challenge
paragraphs: We have cited the need to integrate the fragmented federal food safety  system as a significant challenge for the 21st century, to be addressed in  light of the nation’s current deficit and growing structural fiscal  imbalance. The traditional incremental approaches to budgeting will need  to give way to more fundamental reexamination of the base of  government. While prompted by fiscal necessity, such a reexamination can  serve the vital function of updating programs to meet present and future  challenges within current and expected resource levels. To help Congress  review and reconsider the base of federal spending, we framed illustrative  questions for decision makers to consider. While these questions can apply  to other areas needing broad-based transformation, we specifically cited  the myriad of food safety programs managed across several federal  agencies.  Among these questions are the following:    How can agencies partner or integrate their activities in new ways,  especially with each other, on crosscutting issues, share accountability  for crosscutting outcomes, and evaluate their individual and  organizational contributions to these outcomes?
How can agencies more strategically manage their portfolio of tools  and adopt more innovative methods to contribute to the achievement  of national outcomes?
Integration can create synergy and economies of scale and can provide  more focused and efficient efforts to protect the nation’s food supply.   Further, to respond to the nation’s pressing fiscal challenges, agencies may  have to explore new ways to achieve their missions. We have identified  such opportunities. For example, as I already mentioned, USDA and FDA  spend resources on overlapping food safety activities, and we have made  recommendations designed to reduce this overlap. Similarly, regarding  FDA’s seafood inspection program, we have discussed options for FDA to  use personnel at NOAA to augment FDA’s inspection capacity.
Many of our recommendations to agencies to promote the safety and  integrity of the nation’s food supply have been acted upon. Nevertheless,  as we discuss in the 2007 High-Risk Series, a fundamental reexamination  of the federal food safety system is warranted. Such a reexamination  would need to address criticisms that have been raised about USDA’s dual  mission as both a promoter of agricultural and food products and an  overseer of their safety. Taken as a whole, our work indicates 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, we have recommended, among other things, that Congress  enact comprehensive, uniform, and risk-based food safety legislation and  commission the National Academy of Sciences or a blue ribbon panel to  conduct a detailed analysis of alternative organizational food safety  structures. We also recommended that the executive branch reconvene  the President’s Council on Food Safety to facilitate interagency  coordination on food safety regulation and programs.
These actions can begin to address the fragmentation in the federal  oversight of food safety. Going forward, to build a sustained focus on the  safety and the integrity of the nation’s food supply, Congress and the  executive branch can integrate various expectations for food safety with  congressional oversight and through agencies’ strategic planning  processes. The development of a governmentwide performance plan that  is mission-based, is results-oriented, and provides a cross-agency  perspective offers a framework to help ensure agencies’ goals are  complementary and mutually reinforcing. Further, this plan can help  decision makers balance trade-offs and compare performance when  resource allocation and restructuring decisions are made.
As I have discussed, GAO designated the federal oversight of food safety  as a high-risk area that is in need of a broad-based transformation to  achieve greater economy, efficiency, effectiveness, accountability, and  sustainability. The high-risk designation raises the priority and visibility of  this necessary transformation and thus can bring needed attention to  address the weaknesses caused by a fragmented system. GAO stands  ready to provide professional, objective, fact-based, and nonpartisan  information and thereby assist Congress as it faces tough choices on how  to fundamentally reexamine and transform the government. Lasting  solutions to high-risk problems offer the potential to save billions of  dollars, dramatically improve service to the American public, strengthen  public confidence and trust in the performance and accountability of our  national government, and ensure the ability of government to deliver on its  promises.
Madam Chairwoman, this concludes my prepared statement. I would be  pleased to respond to any questions that you or other Members of the  Subcommittee may have.
section_title: Contact and Staff Acknowledgments
paragraphs: Contact points for our Offices of Congressional Relations and Public  Affairs may be found on the last page of this statement. For further  information about this testimony, please contact Lisa Shames, Acting  Director, Natural Resources and Environment at (202) 512-3841 or  ShamesL@gao.gov. Key contributors to this statement were Erin  Lansburgh, Bart Fischer, Alison O’Neill, and Beverly Peterson.
section_title: Related GAO Products
paragraphs: Homeland Security: Management and Coordination Problems Increase the  Vulnerability of U.S. Agriculture to Foreign Pests and Disease. GAO-06-644.  Washington, D.C.: May 19, 2006.
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: Experiences of Seven Countries in Consolidating Their Food  Safety Systems. GAO-05-212. Washington, D.C.: February 22, 2005.
Food Safety: USDA and FDA Need to Better Ensure Prompt and Complete  Recalls of Potentially Unsafe Food. GAO-05-51. Washington, D.C.: October 6,  2004.
Antibiotic Resistance: Federal Agencies Need to Better Focus Efforts to  Address Risk to Humans from Antibiotic Use in Animals. GAO-04-490.  Washington, D.C.: April 22, 2004.
School Meal Program: Few Instances of Foodborne Outbreaks Reported, but  Opportunities Exist to Enhance Outbreak Data and Food Safety Practices.  GAO-03-530. Washington, D.C.: May 9, 2003.
Food-Processing Security: Voluntary Efforts Are Under Way, but Federal  Agencies Cannot Fully Assess Their Implementation. GAO-03-342.  Washington, D.C.: February 14, 2003.
Meat and Poultry: Better USDA Oversight and Enforcement of Safety Rules  Needed to Reduce Risk of Foodborne Illnesses. GAO-02-902. Washington, D.C.:  August 30, 2002.
Genetically Modified Foods: Experts View Regimen of Safety Tests as  Adequate, but FDA’s Evaluation Process Could Be Enhanced. GAO-02-566.  Washington, D.C.: May 23, 2002.
Food Safety: Improvements Needed in Overseeing the Safety of Dietary  Supplements and “Functional Foods.” GAO/RCED-00-156. Washington, D.C.:  July 11, 2000. his is a work of the U.S. government and is not subject to copyright protection in the  United States. It may be reproduced and distributed in its entirety without further  permission from GAO. However, because this work may contain copyrighted images or  other material, permission from the copyright holder may be necessary if you wish to  reproduce this material separately.