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).Clearly, short- and long-term responsibilities coexist as the FDA seeks to both manage and prevent foodborne illness.
In the area of food safety, a process is needed for allocating resources based on public health data and information.
Risk managers must consider a wide variety of factors in their decision-making process, including the needs and values of a diverse set of stakeholders, which may diverge even with respect to public health.
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.
However, the lack of such a systematic approach to risk-based decision making causes problems, from a decrease in public trust to unintended consequences in the marketplace, the environment, and society.
In addition, the lack of such an approach may make a regulatory agency more vulnerable to political influences.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 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.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.As described in Chapter 2, the responsibilities of the U. Food and Drug Administration’s (FDA’s) new Office of Foods include providing executive leadership and management to all FDA food-related programs; directing the development of integrated strategies, plans, policies, and budgets to build the FDA’s food-related scientific and regulatory capacities and programs, including the recruitment and training of key personnel and the development of information systems (FDA, 2009); and exercising direct line authority over the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM).Its responsibilities include both short-term decision making in direct response to a food crisis and longer-term initiatives focused on sustained, continued improvement in food safety and public health.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 (IOM/NRC, 1998) and is also addressed by other reports of the IOM/NRC (IOM/NRC, 2003), the U. Government Accountability Office (GAO) (GAO, 2004a,b,c, 2005, 2007, 2008, 2009a,b), consumer groups (Consumers Union, 2008; Tucker-Foreman, 2009), and Congress (Becker, 2008, 2009; Brougher and Becker, 2008).