An Overhauled and Better-Funded FDA Should Adopt Risk-Based Approach

With literally millions of locations to police — and that’s just domestically —the FDA lacks the resources to sufficiently monitor the entire food supply.

Nevertheless, Congress should overhaul the agency and provide it with the authority and funds it needs to fulfill its food safety mission, according to a report by the Institute of Medicine (IOM) and National Research Council.

"The FDA’s ability to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by inefficient use of its resources and a piecemeal approach to gathering and using information on risks," says the report, which was publicized in early June. Congress asked 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," according to IOM.

The report says FDA lacks a comprehensive vision for food safety and should take a risk-based approach in order to properly protect the nation’s food. In addition, the FDA should provide standards for food inspection so that states and the federal government follow the same rigorous methods for inspections, surveillance and outbreak investigations.

"To more proactively tackle food safety problems, 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," the report 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.

The 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.

"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, who also is professor in the College of Public Health at University of Iowa, Iowa City. "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."

In addition to applauding the report, Consumers Union urged the Senate to immediately schedule a vote on S.510, the Food Safety Modernization Act, which has been sitting on the Senate general legislative calendar since December.

While FDA is not alone in policing food safety, it is responsible for about 80 percent of the nation's food supply, including seafood, dairy products and fruits and vegetables (USDA handles meat, poultry, and egg products). State and local agencies share in conducting food production facility inspections, surveillance and investigations of outbreaks.

However, the report notes, 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.

More on the report, "Enhancing Food Safety: The Role of the Food and Drug Administration" is available at www.iom.edu.

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