Report: FDA's food safety oversight role needs complete overhaul

Report: FDA's food safety oversight role needs complete overhaulMillions of Americans will continue to suffer from food poisoning each year unless the U.S. Food and Drug Administration revamps its approach to food safety management, concludes a new report by the Institute of Medicine and National Research Council.

The report, Enhancing Food Safety: The Role of the Food and Drug Administration, says the FDA's ability to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by the inefficient use of limited resources and a piecemeal approach to information gathering and use.

The report recommends the adoption of a risk-based approach -- harnessing data and expertise to pinpoint areas with the greatest potential for contamination along the food production, distribution and handling chains. Such an approach, said the committee that wrote the report, would allow the FDA to focus its attention on high-risk areas and increase the chances of eliminating problems before they turn into widespread outbreaks.

"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," committee chair Robert Wallace, professor, College of Public Health, University of Iowa, Iowa City, said in a statement. "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."

Approximately 76 million foodborne illnesses occur each year in the United States, the report noted, causing more than 300,000 hospitalizations and 5,000 deaths. Although food safety is regulated by several agencies -- the U.S. Department of Agriculture handles meat, poultry, and egg products -- the FDA oversees approximately 80% of the U.S. food supply, including all produce, seafood, and dairy products. Recent outbreaks of E. coli and salmonella resulted in a congressional request for the IOM to identify gaps in the FDA's food safety system and recommend solutions.

Besides offering the FDA a blueprint for the adoption of a risk-based system, the report calls for a number of steps necessary to improve the efficiency of the national food safety system, including:
  • Improvement of the FDA's inadequate analytical expertise and infrastructure for gathering, managing and using data by identifying its needs and reviewing its policies for sharing data with other agencies and organizations.
  • Exploration by the FDA of alternative methods of food safety regulation, such as delegating food facility inspections to the states.
  • The establishment by the federal government of 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.
  • Strengthening the FDA's authority by amending the Federal Food, Drug, and Cosmetic Act to underscore the agency's role in facility registration, preventive controls, risk-based inspection, mandatory recalls and food import bans.
Although the FDA has come under withering criticism for its failure to prevent outbreaks of food poisoning, the report notes that it simply lacks the resources to monitor the more than 150,000 food facilities, one million restaurants, two million farms and millions of tons of imports that fall under its purview. A risk-based approach, the report says, would provide the agency with the strategic vision needed to evaluate and plan for food safety hazards, rather than tackling them on a case-by-case basis.

"The FDA needs to move from a reactive to a proactive strategy," said J. Glenn Morris Jr., Director, Emerging Pathogens Institute, University of Florida, Gainesville, during a conference call. "There really needs to be a rethinking of the way the agency does business."
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