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. 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. 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. 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. 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.

Summary: 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. 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.