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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.
These factors might include economic considerations, the controllability of risk, and the population affected.
The committee recognizes that such multidimensional comparisons are a highly challenging endeavor.
This means focusing government effort on the greatest risks and the greatest opportunities to reduce risk, wherever they may arise.
It means adopting the interventions—presumably some combination of research, regulation, and education that will yield the greatest reduction in illness. 7) These previous documents go beyond the scope of traditional technical risk assessment by introducing such terms as “risk-based resource allocation” and “relative risk and benefit.” In its deliberations, the committee recognized the need to address risk analysis in the broader context of regu- latory decision-making processes and risk governance (see, for example, IRGC, 2005, 2009) to manage food safety.
The term “risk-based” implies the existence of an underlying science base; however, it goes a step beyond to encompass use of the tools of risk and decision analysis to create systems that optimize the ability to prevent and control foodborne illness and improve public health.
This chapter focuses on how this type of risk-based system might be constructed and implemented to enable the FDA to deal more effectively with food safety problems. [It] require[s] identification of the greatest public health needs through surveillance and risk analysis.These reports have emphasized the importance of using the best available science to understand foodborne illness, including the identification of causative agents (chemicals, toxins, and microbes) and transmission pathways and the development of appropriate surveillance systems.As the science base has developed, attention over the last decade has increasingly turned to its application within a risk-based framework, with the ultimate goal of improving public health.Thus, both the relative risks and benefits must be considered in allocating resources. 93) If the primary objective of the food safety system is to reduce the burden of disease, success requires risk-based resource allocation.The food safety system must make the best possible use of its resources to reduce the disease burden.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.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).More proactive activities might involve conducting research to address crucial unknowns, undertaking formalized quantitative risk assessment, identifying candidate mitigation strategies to prevent repeat incidents, and ensuring the implementation of those strategies.Critical to both long- and short-term initiatives are improvements in cooperation with partners (see Chapters 4 and 7); efficient data collection, sharing, and analysis (Chapter 5); and communication with the public (Chapter 9).