The U.S. Food and Drug Administration (FDA) should 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, a new report by the Institute of Medicine and National Research Council says.
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, said the committee that wrote the report.
Blueprint for a risk-based model
The report offers FDA a blueprint for developing a risk-based model. It also outlines several organisational 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% of the nation's food supply, including seafood, dairy products, and fruits and vegetables. Although it is not the sole organisation overseeing food safety recent outbreaks of foodborne illness led to a congressional request for a review of gaps in FDA's food safety system.
The agency has been criticised 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 tons of imports, it lacks the resources to sufficiently monitor the entire food supply, the committee noted.
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 says. Without good information, agency officials cannot identify where its resources are needed most or determine which policy interventions are most effective. 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 organisations.
Centralised food safety data center requested
The federal government should establish a centralised 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. This center would go a long way toward developing much-needed capacity and would reduce interagency competition for resources, the committee said. It could also serve as an intermediate step toward consolidating food safety activities within a single agency, which many individuals and organisations have called.
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 standardised, 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. This integration and leveraging of resources would increase the quality of inspections and eliminate duplication of effort, the committee said.
A brief summary of the report can be found here
Source: Institute of Medicine and National Research Council