Summary: In recent years, both domestic and imported produce have been linked to reported outbreaks of foodborne illness. Contamination in produce is of particular concern because produce is often consumed raw. The Food and Drug Administration (FDA) has primary responsibility for ensuring the safety of both domestic and imported fresh produce. GAO was asked to examine (1) the resources FDA has spent on fresh produce safety and how it has allocated those resources, (2) the effectiveness of FDA's actions to oversee fresh produce safety, and (3) the extent to which FDA's planned actions to enhance fresh produce oversight address identified challenges. For this review, GAO analyzed FDA spending data and estimates and FDA activities data, reviewed FDA plans, and interviewed FDA officials and others.
While FDA has considered fresh produce safety a priority for many years, resource constraints and other work--including counterterrorism efforts and unplanned events such as foodborne illness outbreaks--have caused FDA to delay key produce safety activities. FDA has no formal program devoted exclusively to fresh produce and has not consistently and reliably tracked its fresh produce spending. Based on FDA estimates, FDA spent at least $20 million and 130 staff years on fresh produce in fiscal year 2007--or about 3 percent of its food safety dollars and 4 percent of its food safety staff years. In addition, FDA had few staff dedicated solely to fresh produce safety. Moreover, FDA acknowledged that it has not yet been able to conduct certain fresh produce work crucial to understanding the incidence of contamination of produce by pathogens such as E. coli O157:H7 or Salmonella, because it has lacked the resources to either fund its extramural research grant program or perform some critical research internally. Finally, FDA delayed issuing final fresh-cut produce guidance at least 6 years because it had to shift staff to counterterrorism and outbreak investigation work. FDA has provided limited oversight of domestic and imported fresh produce. For example, while FDA has issued guidance for industry on recommended practices for reducing the risk of contamination during the processing of fresh-cut produce, it has not issued regulations requiring firms to take action to prevent contamination, even though some industry groups would like it to do so. FDA's intervention efforts have also been limited. Specifically, domestic fresh produce firms were inspected infrequently. Furthermore, FDA examined less than 1 percent of the 7.6 million fresh produce lines imported from fiscal years 2002 through 2007. Finally, FDA has improved some elements of its emergency response by, for example, partnering with California on outbreak investigations. However, it faces challenges in tracing an outbreak involving fresh produce back to its source because produce is highly perishable and may no longer be available for testing. Also, when product is available, it may be unlabeled or mixed in packages containing products from multiple sources. FDA has proposed changes through its Food Protection Plan that could significantly enhance its fresh produce oversight. However, the agency is still in the planning stages for several enhancements and has not provided specific information on strategies and resources, making it difficult to assess the likelihood of success. To help prevent contamination, FDA plans to update its existing guidance on good agricultural practices and regulations on current good manufacturing practice for food, and has identified a need for explicit authority to issue preventive safety regulations for high-risk foods and enhanced access to records. To enhance intervention efforts, FDA plans to use more rigorous risk-based criteria to target domestic firm inspections and is testing a new import screening software tool. To improve response efforts, FDA is examining best practices for tracing contaminated foods to their source.
