A report issued last week by the Institute of Medicine (IOM) and the National Research Council (at the request of Congress) concludes that the FDA is not well equipped to handle potential problems with the food supply.  “Enhancing Food Safety: The Role of the Food and Drug Administration” notes that food-borne illnesses cause more than 300,000 hospitalizations and 5,000 deaths in the U.S each year. Food-borne diseases are caused by a variety of bacteria—such as Escherichia coli or Salmonella—viruses, parasites, or chemical residues.

The severity of these diseases and the frequency with which they occur spurred this evaluation of how well the current food safety system protects the public’s health. While food safety is regulated by several agencies, the FDA oversees approximately 80 percent of the U.S. food supply, including all produce, seafood, and cheeses. Some food safety experts and some in the media have criticized the FDA’s food safety system and questioned whether it properly safeguards Americans from food-borne diseases. Congress asked the IOM to examine the possible gaps in the current food safety system under the purview of the FDA and to identify the tools needed to improve food safety.

Readers know that many of these food issues have led to litigation.

The IOM determined that the 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. Most notably, the IOM recommends that Congress take legislative action to provide the FDA with the authority it needs to fulfill its food safety mission. Americans will continue to suffer from food-borne illnesses unless the FDA reevaluates and reworks its approach to food safety management, claims the report.

The FDA, which sponsored the report, responded that through the President’s Food Safety Working Group, which includes all agencies involved in food safety, it feels it is making significant progress to ensure government agencies are working seamlessly to protect the American public. But the IOM concludes that in order for the FDA to better ensure food safety, legislative and organizational changes may be necessary. Most notably, it says, Congress should consider taking legislative action to provide the FDA with the additional authority it needs to fulfill its food safety mission. Within the FDA, authority over field activities should shift from its Office of Regulatory Affairs to its Office of Foods. Such a change will ensure that responsibility lies with well-trained personnel with specialized expertise in food safety and risk-based principles of food safety management, says the IOM.

Recognizing that organizational reform will pose challenges, the report recommends that the federal government move toward the establishment of a single food safety agency to unify the efforts of all agencies and departments with major responsibility for safety of the U.S. food supply. The committee recommends establishing a centralized, risk-based analysis and data management center in order to improve efficiency and work toward a safer food supply. This center would 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 needs to support the risk-based system are met.

With regard to legislative changes, Senator Harkin (D-Iowa), head of the Health, Education, Labor and Pension Committee is trying to bring legislation overhauling the food safety system to the Senate floor later this month. He is pushing S. 510, the Food and Drug Administration
Food Modernization Act , which is co-sponsored by Sens. Dick Durbin (D-Ill.), and Judd Gregg (R-N.H.), among others.  The  bill would give the FDA new authority to track, detect, and halt contaminated food coming from either domestic or foreign suppliers. Food-handling facilities would be required to share additional information with the FDA. Inspections would be more frequent and industry would nee to construct risk-based preventive control plans. The FDA would also get new recall authority.

The House passed its own version of food safety legislation in July, 2009, as we noted.