	Federal Oversight of Food Safety Is a High- Risk Area that Needs a Governmentwide Reexamination

While part of today’s hearing focuses specifically on FDA’s responsibilities  for the oversight of food safety, it is important to note that FDA is one of  15 federal agencies that collectively administer at least 30 laws related to  food safety. This fragmentation is a key reason we designated federal  oversight of food safety as a high-risk area. While we have reported on problems with the federal food safety system— including inconsistent oversight, ineffective coordination, and inefficient  use of resources—most noteworthy for today’s hearing is that federal  expenditures for the oversight of food safety have not been commensurate  with the volume of foods regulated by the agencies or consumed by the  public. FDA Has Opportunities to Better Leverage its Resources

In response to the nation’s fiscal challenges, agencies may have to explore  new approaches to achieve their missions, and we have identified options  for FDA to better leverage its resources. Efficient use of resources is  particularly important at FDA because, while its food safety workload has  increased in the past decade, resources have not kept pace. Some of these options are presented in FDA’s Food Protection  Plan. We recommended that FDA:    Make it a priority to establish equivalence agreements with other  countries. Such agreements would shift some of FDA’s oversight burden to  foreign governments. Explore the potential for certifying third-party inspectors. Consider accrediting private laboratories to test seafood. A portion of these activities included overlapping  and even duplicative inspections of 1,451 domestic food-processing  facilities that produce foods regulated by both agencies. We recommended that, if cost effective,  FDA enter into an agreement to commission USDA inspectors at jointly  regulated facilities. We found that both FDA and USDA maintain inspectors  at 18 U.S. ports of entry to inspect imported food. FDA’s Food Protection Plan Proposes Some Positive First Steps, but Additional Information on the Plan’s Strategies and Resources would Facilitate Congressional Oversight

FDA’s Food Protection Plan proposes several positive first steps that are  intended to enhance food safety oversight, including requesting several  authorities recommended by GAO, but more specific information about its  strategies and the resources needed to implement the plan would facilitate  congressional oversight. Specifically, the plan requests authority for FDA to:    Order food recalls. Issue additional preventive controls for high-risk foods. While FDA officials have acknowledged that implementing the Food  Protection Plan will require additional resources, FDA has not provided  specific information on the resources it anticipates the agency will need to  implement this plan. Similarly,  the Food Protection Plan does not discuss the strategies it needs in the  upcoming years to implement this plan. 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. Tools that Agencies Can Use to Address Management Challenges

The Science Board cites numerous management challenges that have  contributed to FDA’s inability to fulfill its mission, such as 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, we have identified through other work some tools that  can help agencies improve their performance, which may also be relevant  to FDA. For example, we reported on the use of a Chief Operating Officer  (COO)/Chief Management Officer (CMO) as one way to address  longstanding management problems that are undermining agencies’  abilities to accomplish their missions and achieve results. Another tool that can help federal agencies address their management  challenges is a well-designed commission that can produce specific  practical recommendations that Congress can enact. Based on our recent analysis of several commissions, there are  several critical success factors that can be applied to ensure a  commission’s success including:  A statutory basis with adequate authority. A clear purpose and timeframe. Key leadership support. An open and transparent process. A balanced and capable membership. Food safety concerns not only continue but will likely become more  urgent in view of changing demographics and consumption patterns. Thus its ability to carry out  those responsibilities is necessary to help ensure the safety of the nation’s  food supply in the most efficient, effective, accountable, and sustainable  way.
Why GAO Did This Study

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.

What GAO Found

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.