Food safety experts and the public have criticized the FDA’s food safety system and questioned whether it properly safeguards Americans from foodborne
diseases. Thus, Congress asked the Institute of Medicine (IOM) to examine the gaps in the current food safety system under the purview of the FDA and to identify the tools needed to improve food safety. Although the FDA recently created the Office of Foods to oversee and coordinate all food policy efforts within the agency, the FDA’s approach to food safety continues to be reactive, lacking a systematic focus on prevention. The IOM committee’s report, Enhancing Food Safety: The Role of the Food and Drug Administration, suggests that the FDA lacks a comprehensive vision for food safety and says it should change its approach in order to properly protect the nation’s food.
Loosely translated, the Institute of Medicine’s consensus report finds that the FDA simply cannot protect this country’s food supply in the modern world, and that the approach needs to change before things get worse . . . or just stay the same. Some of the IOM’s specific findings and suggestions:
1. The agency should use a risk-based approach to evaluate food safety problems rather than its current reactive approach to food safety.
2. The FDA should define the roles of all responsible parties, including suppliers, farmers, retailers, consumers, and government agencies among others. The FDA also should develop a comprehensive, transparent strategy for choosing the level and intensity of policy interventions, which can range from setting standards to educating the public.
3. The FDA has limited analytical expertise and lacks the infrastructure to collect, analyze, interpret, manage, and share data, thus precluding the FDA from using data to support decision making. It is critical that the FDA evaluate its food safety data needs including surveillance, behavioral, economic, food production, and other data based on a risk approach. The FDA reports that sharing data among government agencies is difficult; therefore, the committee recommends that the FDA review the data sharing statutes and policies and develop plans to improve the sharing of data in a timelier manner by all federal, state, and local food safety agencies.
4. Food safety activities, such as inspections, surveillance, and outbreak investigations, are divided between the states and the federal government. The states are responsible for foods produced or sold within their borders and the federal government shares jurisdiction with the state and local governments for food transferred across state borders. However,these systems are not well integrated; a more integrated system would minimize duplication of food safety activities by leveraging the efforts of the state and local governments. In an effort to normalize and integrate food safety practices across the nation, the FDA should provide
standards to states and localities and oversee their implementation.
5. The FDA’s Office of Foods needs direct authority over the inspectors who work in the field, to minimize substantial delays in policy implementation that affect how inspections are conducted. Also, to increase efficiency, the FDA should streamline inspections to ensure that the amount of time and rigor used to inspect a facility is based on risks to the public’s health and should set minimum standards for the frequency and intensity of the inspections of all facilities. Since a number of food safety inspections already are conducted at the state and local levels, the committee recommends that, once their food safety programs and activities meet federal standards, the FDA conduct fewer inspections and instead delegate them to the states and localities. A small group of inspectors should remain within the FDA to audit inspections, provide specialty expertise, develop training material for inspectors, and conduct inspections in situations of special need.
6. In order for the FDA to better ensure food safety, legislative and organizational
changes are necessary. Most notably, Congress should consider taking legislative action to provide the FDA with the authority it needs to fulfill its food safety mission. Within the FDA, authority over field activities should shift from its Office of Regulatory Affairs to its Office of Foods. Such a change will ensure that responsibility lies with well-trained personnel with specialized expertise in food safety and risk-based principles of food safety management.