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The FDA's Evolving Approach to Food Safety
Institute of Medicine report sparks calls for reform
by Edward J. Johnson and Daniel R. Matlis
Editor’s Note: This article and the others in this special section (“Money for the Food Safety Mission,” and “Managing Supplier Quality,”) are based on a webinar originally presented on our website on June 9, 2010. Check out the webinar “Food Safety Legislation and Regulation: Ready or Not?” at www.foodquality.com/view/0/webcasts.html.
On June 8, the Institute of Medicine (IOM) published a report on the U.S. Food and Drug Administration’s (FDA) role in ensuring the safety of the American food supply. In response to criticism leveled by both food safety experts and the public, Congress had commissioned the IOM to examine gaps in the current food safety system and to identify the tools needed to improve food safety.
The report, Enhancing Food Safety: The Role of the Food and Drug Administration, was highly critical of the agency’s approach to food safety. The main thrust of the IOM report is that the FDA lacks a comprehensive vision for ensuring the safety of the nation’s food supply. According to the IOM, the agency has been taking a reactive approach to food safety that only addresses failures on a case-by-case basis. The report recommends that the FDA take a proactive approach, one that focuses on prevention and emphasizes surveillance and research to accomplish its goals.
That proactive approach should be a risk-based one to allow for comprehensive evaluation of the system and a systematic process for addressing and preventing problems. The risk-based approach to food safety would consist of the following components:
- strategic planning;
- public health risk ranking (ranking of hazards);
- targeted information gathering such as surveillance;
- designing an intervention plan; and
- monitoring and review.
New Personnel Required
In order to implement such a risk-based approach, the FDA will require personnel with subject matter expertise in risk management and risk analysis. The IOM recommends that the FDA hire and train to develop and expand its expertise base. Resources need to be allocated to prevention efforts based on those foods and areas posing the greatest risk to the nation’s food supply.
A critical part of the risk-based food safety program is the efficient use of data to guide decision-making. According to the IOM, the FDA currently lacks both the subject matter expertise in data analysis and the infrastructure to support analysis and collection, interpretation, management, and sharing of data. The report suggests that the FDA examine existing federal data sharing regulations to develop its own program for sharing food safety data at the federal, state, and local level. The end result should be a centralized repository of food safety data that can be accessed by state and local agencies.
The current state of food safety inspections also comes under IOM scrutiny. The lack of integration of state and federal food inspection systems can lead to duplicate efforts. The report recommends that the FDA develop inspection standards, provide them to state and local agencies, and oversee their implementation.
The IOM recommends that the FDA hire and train to develop and expand its expertise base. Resources need to be allocated to prevention efforts based on those foods and areas posing the greatest risk to the nation’s food supply.
The agency should also streamline its inspection program, making it directly accountable to the FDA’s Office of Foods, setting and implementing inspection standards, and delegating more of the actual inspections to state and local agencies. Included in this approach would be effective food safety education and risk communication. The IOM recommends that the FDA research the overall food safety knowledge of the industry and public in order to develop an effective education program.
The IOM report also targets the lack of a centralized, single agency with authority over food safety. The FDA shares an interest in food safety with other agencies:
- the Food Safety and Inspection Service, which is part of the U.S. Department of Agriculture;
- the National Marine Fisheries Service, which, as part of the National Oceanic and Atmospheric Administration, is part of the U.S. Department of Commerce;
- the Environmental Protection Agency; and
- the Centers for Disease Control and Prevention.
The IOM recommends that authority of field activities be transferred from the Office of Regulatory Affairs to the Office of Foods. The report further recommends the establishment of a single, centralized food safety agency that can unify the food safety efforts of all federal, state, and local agencies and departments.
Analysis of the 2011 FDA budget by Axendia, an analyst and strategic advisory firm, shows that the agency plans to allocate significant resources to address IOM report findings (see “Money for the Food Safety Mission").