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Highlights

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.

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Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Food and Drug Administration 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.
Closed - Implemented
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).
Food and Drug Administration 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.
Closed - Implemented
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.
Food and Drug Administration 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.
Closed - Implemented
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.
Food and Drug Administration 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.
Closed - Implemented
In January 2011, Congress enacted the FDA Food Safety Modernization Act, which requires, among other things, that the Secretary of Health and Human Services 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. In November 2015, FDA finalized a rule establishing safety standards for produce farms. According to FDA, this rule aims to help produce farmers take steps to prevent problems before they occur.
Food and Drug Administration 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.
Closed - Implemented
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.
Food and Drug Administration 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.
Closed - Implemented
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.
Food and Drug Administration 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.
Closed - Not Implemented
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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