Summary

The United States faces challenges to ensuring food safety.

First, imported food makes up a substantial and growing portion of the U.S. food supply, with 60% of fresh fruits and vegetables and 80% of seafood coming from across our borders. In recent years, there has been an increase in reported outbreaks of foodborne illness associated with both domestic and imported produce.

Second, we are increasingly eating foods that are consumed raw and that have often been associated with foodborne illness outbreaks, including leafy greens such as spinach.

Finally, shifting demographics means that more of the U.S. population is, and increasingly will be, susceptible to foodborne illnesses. The risk of severe and life-threatening conditions caused by foodborne illnesses is higher for older adults, young children, pregnant women, and immune-compromised individuals.

In January 2007 GAO designated federal oversight of food safety as a high-risk area needing urgent attention and transformation because of the federal government's fragmented oversight of food safety. The Food and Drug Administration (FDA) is responsible for ensuring the safety of roughly 80% of the U.S. food supply—virtually all domestic and imported foods except for meat, poultry, and processed egg products—valued at a total of $466 billion annually, as of June 2008.

In 2007 the FDA Science Board, an advisory board to the agency, reported that science at FDA suffers from serious deficiencies. In addition, our prior reviews of FDA's food safety programs have identified gaps in scientific information, limiting FDA's ability to oversee food labeling, fresh produce, and dietary supplements. Further, as part of our recent review on the effectiveness of the strategic planning and management efforts of FDA, 67% of FDA managers report ed, in response to a GAO survey, that updated scientific technologies or other tools would greatly help them to contribute to FDA's goals and responsibilities; however, only 36% of managers reported that FDA was making great progress in keeping pace with scientific advances.

In written comments responding to our survey, some managers stressed the need to increase and stabilize funding, recruit and retain top scientists, and make decisions on the basis of scientific evidence. In this context, you asked us to examine ways in which FDA may use science to more effectively support its regulatory work and to inform the public about food content and safety.

This report focuses primarily on FDA's (1) progress in addressing selected recommendations identified by the Science Board; (2) incorporation of scientific and risk analysis into its oversight of the accuracy of food labeling, fresh produce, and the safety of dietary supplements; and (3) a new computer screening tool that may imp rove its efforts to screen imports using a risk-based approach.

FDA has begun to address selected Science Board recommendations. For example, FDA reported in May 2008 that it created the Office of Chief Scientist and, in May 2009, it added more responsibilities to the office to signal a new emphasis on regulatory science. According to the Acting Chief Scientist, his office plans to identify major scientific cross-cutting opportunities across FDA and to collaborate with other government agencies. However, gaps in scientific information have hampered FDA's oversight of food labeling, fresh produce, and dietary supplements. In addition, FDA's new computer tool—PREDICT—is designed to improve its risk-based import screening efforts by analyzing food shipments using criteria that include a product's inherent food safety risk and the importer's violative history, among other things, to estimate each ship ment's risk. FDA has developed a draft performance measurement plan for evaluating the effectiveness of this risk-based approach.