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does not lie solely with the FDA, the focus of this report is on enhancing that agency’s food programs, specifically those devoted to food safety.

STUDY APPROACH

To conduct this study, a 13-member committee with extensive experience in FDA food programs and policies, food law and regulations, risk analysis and communication, economics, epidemiology, monitoring and surveillance, food microbiology and toxicology, feed issues, and state food programs was convened. The committee gathered information through six meetings, statements in response to specific queries to the FDA, and public documents.

As requested (Box S-1), the committee reviewed the FDA’s 2007 Food Protection Plan (FPP), a road map aligned with the agency’s strategic plan, but it also worked to identify additional tools and capacities to improve food safety. Since the publication of the FPP, organizational and leadership changes in the federal government3 have altered the U.S. food safety scene. In this new environment, the committee envisioned the FPP as a point of departure but focused its attention on providing the FDA with concrete guidance in various areas of concern, including the need to implement a risk-based food safety management system.

The committee left many of the details of the implementation of its recommendations to the FDA, especially since food safety is just one of the agency’s many responsibilities. The committee considered cost and resource issues in a general sense by drawing on the experience of members who formerly held senior leadership positions at the FDA. Because essential information was not always accessible, however, the committee lacked the full evidence base needed to address these issues in detail.

CONCLUSIONS

This section presents the committee’s main conclusions. It begins with a brief review of the FPP, which is evaluated throughout the report as appropriate. It then presents conclusions concerning the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management.

3

For example, these include a change in administration, the formation of the White House Food Safety Working Group, and the FDA’s establishment of a new Office of Foods with oversight and authority over the two FDA centers that regulate food—the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine.



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