cine, has drawn attention and resources away from FDA’s ability to develop the science base and infrastructure needed to efficiently support innovation in the food industry, provide effective routine surveillance, and conduct emergency outbreak investigation activities to protect the food supply. FDA’s inability to keep up with scientific advances means that American lives are at risk.8 [Emphasis added.]

In part, this state of affairs reflects deficits in both the number and the expertise of FDA’s scientific workforce: “[D]espite the significant increase in workload during the past two decades, in 2007 the number of appropriated personnel remained essentially the same—resulting in major gaps of scientific expertise in key areas…. The turnover rate in FDA science staff in key scientific areas is twice that of other government agencies” (FDA Subcommittee on Science and Technology, 2007). In fact, in the past three years, one-fifth of the science staff and 600 inspectors have left FDA’s Center for Food Safety and Applied Nutrition (TFAH, 2008).

Within the department, the organization of food safety responsibilities and information technology infrastructure is inadequate (FDA Subcommittee on Science and Technology, 2007). There are three separately managed components of FDA with major food safety responsibilities—the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and the Office of Regulatory Affairs, which oversees FDA’s field force and controls the majority of the agency’s food safety resources. FDA has established an assistant commissioner for foods “to provide advice and counsel to the Commissioner on strategic and substantive food safety and food defense matters” (FDA, 2007a). However, there is no FDA official whose full-time job is food safety and who has line and budget authority over the three food safety operating components. Moreover, monitoring any food-related outbreaks that occur—the


The Subcommittee on Science and Technology concluded that “science at the FDA is in a precarious position: the Agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” The report indicates that the science base of the entire agency is lacking, not just in the area of food safety, and is in need of reinforcement (FDA Subcommittee on Science and Technology, 2007). A discussion earlier in this chapter calls for a strengthened science base for HHS, including FDA.

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