The U.S. Food and Drug Administration is hampered in its ability to safeguard much of the nation's food supply by "impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks," according to a recent report issued jointly by the Institute of Medicine and the National Research Council.
For FDA to better address the nation's food safety problems, the report urges the agency to implement a risk-based approach in which data and expertise are marshaled to pinpoint where along the production, distribution and handling chains there is the greatest potential for contamination and other problems. "The agency would then be able to direct appropriate amounts of its resources and attention to those high-risk areas and increase the chances of catching problems before they turn into widespread outbreaks," says the report.
This approach sounds much like the Hazard Analysis Critical Control Point (HACCP) approach that both FDA and USDA require of many food processors. HACCP is a systematic preventive approach to food safety that addresses physical, chemical, and biological hazards as a means of prevention rather than finished product inspection.
HACCP is used in the food industry to identify potential food safety hazards, so that key actions, known as critical control points, can be taken to reduce or eliminate the risk of the hazards. HACCP is used at all stages of food production and preparation processes. Meat HACCP systems are regulated by USDA, while seafood and juice are regulated by FDA.
The IOM /NRC report offers FDA a blueprint for developing a risk-based model. It also outlines several organizational steps the agency should take to improve the efficiency of its many food safety activities, such as increasing coordination with state and other federal agencies that share responsibility for protecting the nation's food supply. In addition, the report says Congress should consider amending the Federal Food, Drug, and Cosmetic Act to explicitly provide the authority FDA needs to fulfill its food safety mission.
FDA is responsible for ensuring the safety of approximately 80 percent of the nation's food supply, including seafood, dairy products, and fruits and vegetables.
The agency has been criticized for not adequately monitoring and inspecting food suppliers and distributors and for not taking a proactive approach to food safety overall. However, given that FDA is responsible for more than 150,000 food facilities, more than 1 million restaurants and other retail food establishments, and more than 2 million farms, as well as millions of tonnes of imports, it lacks the resources to sufficiently monitor the entire food supply, the report notes.
To enhance its efficiency, FDA should explore alternative approaches to regulating food safety, such as delegating food facility inspections to the states, the report says. FDA should establish national standards for the intensity and frequency of these facility reviews and help states and local municipalities bring their safety programs up to those standards. Once all programs are standardized, FDA should train and certify state inspectors with the goal of turning over the majority of inspections to them under the agency's supervision. "This change would build on current practices in which roughly 60 percent of inspections are already conducted by state inspectors under contract with FDA," the report says. "This integration and leveraging of resources would increase the quality of inspections and eliminate duplication of effort," the report adds.
The report was requested by Congress and sponsored by FDA. The National Academy of Sciences, National Academy of Engineering, Institute of Medicine , and National Research Council make up the National Academies. They are private, nonprofit institutions that provide science, technology, and health policy advice under a congressional charter. The report is available online atthis Web site.
