WASHINGTON — A study published by the Institute of Medicine and conducted by its Food and Nutrition Board as well as the National Research Council recommends the Food and Drug Administration (F.D.A.) shift away from its current “reactive” efforts to ensuring food safety to one that is more proactive and focused on a risk-based approach. The study, titled “Enhancing food safety: The role of the Food and Drug Administration,” recommends that the F.D.A. increase its use of data to facilitate decision making and integrate efforts with state and local public health authorities in an effort to improve inspection efforts. The I.O.M. also called upon Congress to create a single food safety agency to further improve food safety.
The report was developed at the request of Congress in an effort to assess the gaps in the current food safety system under the purview of the F.D.A. and to identify the tools needed to improve food safety.
“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, professor, College of Public Health, University of Iowa, Iowa City. “F.D.A. 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 F.D.A. achieve a comprehensive vision for proactively protecting against threats to the nation's food supply.”
Gaps within the F.D.A.’s food safety programs and highlighted in the I.O.M. report include a lack of overall vision, the limited use of data to assess industry performance, and a lack of integration with regard to inspection activities at the federal, state and local levels.
“The agency should use a risk-based approach to evaluate food safety problems rather than its current reactive approach to food safety — which only addresses problems on a case-by-case basis and may fail to account for all the factors involved in making decision,” the report said. “A risk-based approach allows decision makers to evaluate the system in a comprehensive way and to follow a systematic process for addressing and preventing problems.”
The report’s authors said a current shortcoming within the F.D.A. relates to the use of data, which drives the risk-based decision-making approach.
“Currently, the F.D.A. has limited analytical expertise and lacks the infrastructure to collect, analyze, interpret, manage and share data, thus precluding the F.D.A. from using data to support decision making,” said the report. “It is critical that the F.D.A. evaluate its food safety data needs, including surveillance, behavioral, economic, food production and other data on a risk approach.”
The I.O.M. also recommended that the F.D.A. explore alternative approaches to inspection.
“Since a number of food safety inspections already are conducted at the state and local levels, the committee recommends that, once their food safety programs and activities meet federal standards, the F.D.A. conduct fewer inspections and instead delegate them to state and localities,” the study said.
Finally, with the long-term goal of creating a single food safety agency, the I.O.M. recommended the creation of a risk-based analysis and data management center in order to improve efficiency and work toward a safer food supply.
“This center should include staff and support resources necessary to conduct rapid and sophisticated assessments of short- and long-term food safety risks and to ensure that the comprehensive data needed to support the risk-based system are met,” the study said. “This type of center will bring the F.D.A. closer to establishing a single food safety agency.”
Pamela G. Bailey, president and chief executive officer of the Grocery Manufacturers Association, said the G.M.A. fully supports the report’s recommendation that the U.S. Food and Drug Administration should implement a risk-based approach to food safety.
“By providing the F.D.A. with the resources and authorities the agency needs to help make prevention the focus of our food safety strategies, combined with increased industry resources and vigilance, we can greatly enhance the safety of our food safety system,” Ms. Bailey said. “Industry and government both have unique and important roles when it comes to food safety. Currently the F.D.A. Food Safety Modernization Act of 2009 is before the United States Senate. Like the I.O.M. report — and the House of Representative’s bipartisan food safety bill passed last summer — the Senate bill calls for the greater use of risk-based approaches and preventative strategies in the protection of our food supply and will provide the F.D.A. with the resources and authorities the agency needs to strengthen and modernize our nation’s food safety system. We strongly urge the Senate to vote on this important, bipartisan bill as quickly as possible.”