WASHINGTON—A new report from the Institute of Medicine and National Research Council suggests the US. Food and Drug Administration (FDA) should implement a risk-based approach to food safety 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.
The report offers FDA a blueprint for developing a risk-based model and 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. The report also calls for Congress to consider amending the Federal Food, Drug, and Cosmetic Act to explicitly provide the authority FDA needs to fulfill its food-safety mission.
"As recent illnesses traced to produce underscore, foodborne diseases cause significant suffering, so it's imperative that our food-safety system functions effectively at all levels," said committee chair Robert Wallace, professor, College of Public Health, University of Iowa. "FDA uses some risk assessment and management tactics, but the agency's approach is too often reactive and lacks a systematic focus on prevention. Our report's recommendations aim to help FDA achieve a comprehensive vision for proactively protecting against threats to the nation's food supply."
A risk-based approach would give FDA's food-safety officials the strategic vision needed to evaluate and plan for food safety concerns rather than tackling problems on a case-by-case basis, the report said. FDA has insufficient analytical expertise and infrastructure to gather, manage, and use data effectively. The agency should identify its data needs and review its policies for sharing data with other agencies and organizations.
The report also called on the federal government to establish a centralized food-safety data center outside of the regulatory agencies to collect information and conduct rapid, sophisticated assessments of food safety risks and appropriate policy interventions. The center would go a long way toward developing much-needed capacity and would reduce interagency competition for resources. It also could serve as an intermediate step toward consolidating food-safety activities within a single agency.
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. The change would build on current practices in which roughly 60 percent of inspections are already conducted by state inspectors under contract with FDA. This integration and leveraging of resources would increase the quality of inspections and eliminate duplication of effort, the committee said.
Despite the dramatic developments in food production and distribution that have occurred over the years, the main statutory provisions under which FDA carries out its food-safety responsibilities remain largely unchanged. Although various provisions give the agency broad discretion and flexibility through which it has been able to control potential problems, there are instances in which FDA lacks specific authority, which can make its actions vulnerable to court challenge. Congress should examine how the legislation could be revised to detail FDA's authorities in facility registration, preventive controls, risk-based inspection, mandatory recall, reporting of adulteration, and banning of food imports if the public's health is at risk, among other areas.
