The Food and Drug Administration (FDA) is responsible for ensuring the safety of roughly 80 percent of the U.S. food supply, including $417 billion worth of domestic food and $49 billion in imported food annually. The recent outbreaks of E. coli in spinach, Salmonella in peanut butter, and contamination in pet food highlight the risks posed by the accidental contamination of FDA-regulated food products. Changing demographics and consumption patterns underscore the urgency for effective food safety oversight. In response to these challenges, in November 2007, FDA and others released plans that discuss the oversight of food safety. FDA's Food Protection Plan sets a framework for food safety oversight. In addition, FDA's Science Board released FDA Science and Mission at Risk, which concluded that FDA does not have the capacity to ensure the safety of the nation's food supply. This testimony focuses on (1) federal oversight of food safety as a high-risk area that needs a governmentwide reexamination, (2) FDA's opportunities to better leverage its resources, (3) FDA's Food Protection Plan, and (4) tools that can help agencies to address management challenges. To address these issues, GAO interviewed FDA officials; evaluated the Food Protection Plan using a GAO guide for assessing agencies' performance plans; and reviewed pertinent statutes and reports. GAO also analyzed data on FDA inspections and resources.

FDA is one of 15 agencies that collectively administer at least 30 laws related to food safety. This fragmentation is the key reason GAO added the federal oversight of food safety to its High-Risk Series in January 2007 and called for a governmentwide reexamination of the food safety system. We have reported on problems with this system--including inconsistent oversight, ineffective coordination, and inefficient use of resources. FDA has opportunities to better leverage its resources. Efficient use of resources is particularly important at FDA because we found that its food safety workload has increased in the past decade, while its food safety staff and funding have not kept pace. GAO has recommended that FDA establish equivalence agreements with other countries to shift some oversight responsibility to foreign governments, explore the potential for certifying third party inspections, and consider accrediting private laboratories to inspect seafood, among other actions. We also reported that FDA and the U.S. Department of Agriculture (USDA) conduct similar inspections at 1,451 facilities that produce foods regulated by both agencies. To reduce overlaps, we recommended that, if cost-effective, FDA enter into an agreement to commission USDA inspectors at such facilities. FDA incorporated some of these recommendations in its Food Protection Plan. FDA's Food Protection Plan also proposes some positive first steps intended to enhance its oversight of food safety. Specifically, FDA requests authority to order food safety recalls and issue additional preventive controls for high-risk foods, both of which GAO has previously recommended. However, more specific information about its strategies and the resources FDA needs to implement the plan would facilitate congressional oversight. FDA officials acknowledge that implementing the Food Protection Plan will require additional resources. Without a clear description of resources and strategies, it will be difficult for Congress to assess the likelihood of the plan's success in achieving its intended results. The Science Board cites numerous management challenges that have contributed to FDA's inability to fulfill its mission, including a lack of a coherent structure and vision, insufficient capacity in risk assessment, and inadequate human capital recruitment and retention. In light of these challenges, GAO has identified through other work some tools that can help agencies improve their performance over time. For example, a Chief Operating Officer/Chief Management Officer can help an agency address longstanding management problems that are undermining its ability to accomplish its mission and achieve results. In addition, a well-designed commission can produce specific practical recommendations that Congress can enact. Critical success factors that can help ensure a commission's success include a statutory basis with adequate authority, a clear purpose and timeframe, leadership support, an open process, a balanced membership, accountability, and resources.

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