Clearly, short- and long-term responsibilities coexist as the FDA seeks to both manage and prevent foodborne illness. As noted earlier, the FDA has often been criticized as responding reactively to food problems. Sometimes, this type of action is necessary; the FDA has no choice but to react when a problem manifests itself. However, greater proactive efforts by the FDA would enhance food safety. This chapter presents a conceptual approach for the prioritization of activities and allocation of resources to support both short- and long-term FDA responsibilities for food safety. Accordingly, the chapter lays out the foundation for a proactive, risk-based food safety system. Succeeding chapters describe elements of such a system that are dependent on the success of the approach presented here. For instance, application of a risk-based approach at all levels of regulation is a prerequisite for harmonization of federal, state, and local food safety programs (Chapter 7). Similarly, effective cooperation and communication with diverse stakeholders will require that all levels of the FDA embrace a proactive, risk-based approach to food safety management and facilitate its implementation (Chapter 9).
The committee did not conduct a comprehensive review of the details of all the risk-based activities of the FDA, such as the models utilized or factors considered in making individual decisions. The committee was provided with general information with regard to the FDA’s risk-based activities and describes its understanding of those activities in this chapter. In this discussion, the committee uses concrete examples of those activities and identifies gaps with respect to the extent to which they adhere to the attributes and steps of the recommended approach. Although the committee concluded that those activities would have been enhanced by the use of a more extensive risk-based approach, in this and subsequent chapters the committee also recognizes that the FDA will face challenges in this regard. The committee identified challenges and courses of action to overcome them, for example, in hiring the appropriate personnel and coordinating data collection and sharing (Chapter 5), reorganizing the agency’s food safety research portfolio (Chapter 6), integrating FDA programs with those of state and local governments (Chapter 7), carrying out risk communication and education (Chapter 9), and addressing organizational problems (Chapter 11).
There is consensus that food safety programs and any approach to food safety reform must be both science- and risk-based. This view was first articulated in the 1998 Institute of Medicine (IOM)/National Research Council (NRC) report Ensuring Safe Food: From Production to Consumption (IOM/NRC, 1998) and is also addressed by other reports of the IOM/NRC (IOM/NRC, 2003), the U.S. Government Accountability Office (GAO) (GAO, 2004a,b,c, 2005, 2007, 2008, 2009a,b), consumer groups (Consumers Union, 2008; Tucker-Foreman, 2009), and Congress (Becker,