staff located at headquarters, more than 85 percent of ORA staff work in 5 regional offices, 20 district offices, 13 laboratories, and more than 150 resident posts and border stations. In a presentation to the committee, the FDA clarified that ORA’s work to foster compliance is often done in partnership not only with the FDA centers but also with industry. During an outbreak, for example, ORA field investigators work closely with the affected center, conduct investigations, and decide on courses of action (Kraemer, 2009; Wagner, 2009). In addition to its inspectional and enforcement activities, ORA hosts an online university that offers required basic courses and specialized training, such as seafood certification for federal investigators. Numerous courses, both web- and classroom-based, are also available to state investigators; however, the FDA has no requirement for state investigators to take them. The training covers such areas as retail establishments, food protection, milk, shellfish, manufactured foods, feed and veterinary medicine, investigation response, incident command systems, rapid response teams, and on-farm investigations (Solomon, 2009).
Prior reports have evaluated the adequacy and efficiency of U.S. food inspections and determined that inspections are insufficient, the basis for determining which facilities to inspect is poor (GAO, 2004; HHS, 2010), and there is a critical need to leverage resources to provide for a more efficient system (GAO, 2005a,b). Testimony offered to the U.S. Congress on numerous occasions has also spoken to this concern. An inefficient inspection process results in public health risks that could be avoided with appropriate inspection (for example, inspection of peanut facilities should have prevented the recent outbreak associated with contaminated peanuts). This chapter presents an analysis of the inspection process and explains the committee’s conclusion that the process is inefficient for reasons that range from the cultural to the organizational. It should be noted that a full evaluation of the efficiency of the food safety inspection process cannot be conducted in isolation from similar processes performed by other government agencies, such as the U.S. Department of Agriculture and the National Oceanic and Atmospheric Administration (see Table 2-1 in Chapter 2). In accordance with its statement of task, however (see Chapter 1), the committee evaluated only the FDA’s inspectional activities and refers to the inspectional activities of others only to the extent that they could contribute to improving the efficiency of inspections performed by the FDA. In this chapter, then, the committee offers recommendations for enhancing oversight of the food production system by improving the efficiency of the FDA’s inspections and leveraging its inspectional resources. The committee comments as well on the FDA’s potential use of third-party inspections (also discussed in Chapter 4).