Food Safety

FDA needs risk-based approach to food safety

This report says FDA has limited resources and pursues a piecemeal approach to gathering and using information on food safety risks.


FDA’s abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks, says a new report entitled Enhancing Food Safety: The Role of the Food and Drug Administration, from the Institute of Medicine and National Research Council.

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 the greatest potential for contamination and other problems exists, 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, says the study.  

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, it’s imperative that our food safety system functions effectively at all levels,” says Committee Chair Robert Wallace, professor, College of Public Health, 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,” he says.

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.  Although it is not the sole organization overseeing food safety-the US Department of Agriculture handles meat, poultry and egg products; state and local agencies share in conducting food production facility inspections, surveillance and investigations of outbreaks. Recent outbreaks of foodborne illness led to a congressional request for a review of gaps in FDA’s food safety system.

FDA has been criticized for not adequately monitoring and inspecting food suppliers and distributors and not taking a proactive approach to food safety overall. However, given 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 tackle problems on a case-by-case basis, says the report. 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 organizations, says the report.

For more information, visit the Institute of Medicine’s Web site.

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