Food Safety:

Improvements Needed in FDA Oversight of Fresh Produce

GAO-08-1047: Published: Sep 26, 2008. Publicly Released: Sep 26, 2008.

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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.

Status Legend:

More Info
  • Review Pending-GAO has not yet assessed implementation status.
  • Open-Actions to satisfy the intent of the recommendation have not been taken or are being planned, or actions that partially satisfy the intent of the recommendation have been taken.
  • Closed-implemented-Actions that satisfy the intent of the recommendation have been taken.
  • Closed-not implemented-While the intent of the recommendation has not been satisfied, time or circumstances have rendered the recommendation invalid.
    • Review Pending
    • Open
    • Closed - implemented
    • Closed - not implemented

    Recommendations for Executive Action

    Recommendation: To enhance FDA's oversight of fresh produce safety, Commissioner of FDA should see that the agency develop a plan for identifying research priorities and facilitating research related to fresh produce.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Implemented

    Comments: In its August 2011 update on implementation of GAO recommendations, FDA stated that the creation of a science and research plan at the agency's Center for Food Safety and Applied Nutrition responded to this recommendation. FDA provided GAO with a copy of this plan, which states that the agency has prioritized research, and that the primary research in its first strategic objective, to better control and prepare for hazards, focuses on, among other things, commodities most susceptible to hazards (including fresh produce).

    Recommendation: To enhance FDA's oversight of fresh produce safety, Commissioner of FDA should see that the agency identify approaches for obtaining testing and other information from industry members to inform its research agenda.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Implemented

    Comments: In its 2012 update on implementation of recommendations from GAO-08-1047, FDA provided information on the following two identified methods. 1) Data on pathogen incidence to inform agency risk assessments and research priorities: FDA officials told us that the agency's Center for Food Safety and Applied Nutrition is collaborating with industry member Earthbound Farm, and that the two entities will share information using a Research Collaboration Agreement, in effect as of November 29, 2011. 2) Data from industry to test FDA's risk assessment model for produce safety: FDA officials told us the agency established collaboration with academic partners that will allow collection of data from industry to test FDA's quantitative predictive risk assessment model for produce safety. According to a press release on the collaboration, the goal of the research is to provide scientific knowledge/data and analysis for the development of good agricultural/horticultural metrics for fresh produce.

    Recommendation: To enhance FDA's oversight of fresh produce safety, Commissioner of FDA should see that the agency update its good agricultural practices guidance for fresh produce to incorporate new knowledge about safe growing practices.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Implemented

    Comments: FDA agreed with this recommendation and in July 2009, the agency released three separate guidance documents, tailored to the following fresh produce commodities: tomatoes, melons, and leafy greens. FDA stated that the guidance documents are intended to assist both domestic and foreign firms by recommending practices to minimize microbial food safety hazards throughout the supply chain. FDA encouraged each firm to assess the recommendations in their guidance documents, and then tailor food safety practices to their particular operations.

    Recommendation: To enhance FDA's oversight of fresh produce safety, Commissioner of FDA should see that the agency update its current good manufacturing practice regulations for food to incorporate new knowledge about the food industry and safe manufacturing, processing, and holding practices.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Open

    Comments: Since we issued our report, Congress enacted the FDA Food Safety Modernization Act (FSMA) in January 2011, which includes a provision that would address this recommendation. Specifically, it requires, among other things, that the Secretary of Health and Human Services publish a notice of proposed rulemaking to establish science-based minimum standards for the safe production and harvesting of fresh produce, which must include elements related to growing, harvesting, sorting, packing, and storage operations. Following GAO's 2008 recommendations and the 2011 enactment of FSMA, FDA drafted a rule outlining new requirements for produce safety, which is under review at the Office of Management and Budget before being released for public comment. FDA has indicated that development of these new standards responds to this recommendation.

    Recommendation: To enhance FDA's authority to oversee fresh produce, the Commissioner of FDA should seek authority from the Congress to make explicit FDA's authority to adopt preventive controls for high-risk foods.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Implemented

    Comments: On January 4, 2011, Congress enacted the Food Safety Modernization Act, requiring under Section 103 that (1) food facilities conduct hazard analyses and identify and implement preventive controls, and (2) FDA establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls.

    Recommendation: To enhance FDA's authority to oversee fresh produce, the Commissioner of FDA should seek authority from the Congress to provide FDA enhanced access to firm records during food-related emergencies.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Implemented

    Comments: Since we issued our report, FDA indicated it continued to provide assistance to the Congress on the Food Safety Modernization Act (FSMA), which includes a provision that addresses our recommendation. On January 4, 2011, Congress enacted FSMA, enhancing FDA's access to records beyond records relating to the specific food of concern to records relating to any other article of food that the agency reasonably believes is likely to be affected in a similar manner.

    Recommendation: To foster transparency and accountability, the Commissioner of FDA should provide specific information to the Congress and to the public on the strategies and resources for implementing the Food Protection Plan.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Not Implemented

    Comments: FDA agreed with the need for transparency and accountability in implementing the Food Protection Plan. In 2010, FDA officials told GAO that work to implement GAO's recommendation was taking place via the newly-created Food Safety Working Group chaired by the Secretaries of Health and Human Services and the Department of Agriculture, and provided information on strategies used by the working group, but no information on resources. In 2011, FDA officials told GAO that the Food Safety Modernization Act (FSMA) sets out timelines for implementation of a produce safety regulation and guidance document, and that the President's 2012 budget request included $10.6 million to support produce safety efforts. In 2012, FDA officials told GAO that the agency's public Web site provided information on implementation of FSMA. While this information improves transparency, it does not fully implement the recommendation in that it does not provide information on resources used to implement activities of the Food Safety Working Group or FSMA.

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