WASHINGTON — The Food and Drug Administration needs an overhaul, beefed-up enforcement authority and a new focus on spotting threats to the nation's food supply before serious outbreaks occur, according to a report released Tuesday.
The report, by the National Research Council and the Institute of Medicine, says the agency is hamstrung by limited resources and gaps in research-gathering and information-sharing, all of which make it difficult for the FDA to thwart the spread of deadly food-borne illnesses.
To maximize the agency's efforts, the report recommends, the FDA should focus most of its monitoring, inspection and prevention efforts on areas of the food chain that pose the greatest risk of contamination. This "risk-based" approach would help catch potential problems in the production, distribution, handling and storage of foods before they start turning up in hospitals.
The FDA monitors the safety of about 80 percent of the U.S. food supply, including seafood, dairy products, fruits and vegetables.
It's faced withering criticism over the years for being unable to handle its responsibility to monitor and inspect more than 150,000 food facilities, more than a million restaurants, more than 2 million farms and millions of tons of imported foods.
Reported outbreaks of food-borne illness have increased in connection with domestic and foreign produce. Roughly 76 million people become sick each year in the U.S. after eating contaminated food, 325,000 are hospitalized and some 5,000 die. In 69 percent of the outbreaks that are investigated, no source of contamination is ever found, however, according to the Center for Foodborne Illness Research and Prevention, an education and advocacy organization.
The FDA lacks the scientific data and analytical expertise to identify the most problematic areas and the most effective preventative approaches. For instance, while scientists know that cattle carry E. coli that can make people ill, they aren't sure how the bacteria contaminate fresh produce or how far cattle should be kept from growing areas to safeguard crops.
The report recommends establishing a centralized food-safety information center that would collect and analyze research, inspection and testing data from state and federal agencies.
The center also would have an analytical component to assess food safety risks and recommend corrective actions, said Robert Wallace, a public health professor at the University of Iowa who chaired the committee that authored the report.
In addition, the report says that Congress should consider amending the Federal Food, Drug and Cosmetic Act to give the FDA more authority over mandatory recalls, reporting food adulteration, registering food facilities and banning imported foods that could jeopardize public health.
"As recent illnesses traced to produce underscore, food-borne diseases cause significant suffering, so it's imperative that our food safety system functions effectively at all levels," Wallace said. "FDA uses some risk assessment and management tactics, but the agency's approach is too often reactive and lacks a systematic focus on prevention."
The report, which Congress requested, also recommends that the states, which already provide some 60 percent of FDA inspections on a contract basis, get more food inspection authority. That would improve the quality of inspections and eliminate duplication, the report says.
Wallace said that more state inspections probably would require additional federal funding because state employees were more subject to budget cuts. In addition to retaining oversight of state inspectors, the report recommends that the FDA set standards for the intensity and frequency of their inspections and train and certify state inspectors.
In 2007, the Government Accountability Office declared federal food-safety oversight a "high-risk" area that required a major overhaul. In March 2009, President Barack Obama formed a Food Safety Working Group to advise him how to do so.
In July 2009, the House of Representatives passed the Food Safety Enhancement Act (H.R. 2749), which would require more inspection of food facilities, give inspectors more access to company records and require companies to register, pay certain fees and implement safety plans that protect against hazards. The bill also would require the FDA to establish minimum standards for safety plans, give the agency the authority to order product recalls and impose new requirements to trace foods' origins better.
A similar bill in the Senate, the FDA Food Safety Modernization Act, is awaiting a floor vote, but several amendments could undo support for the measure.
Sens. Jon Tester, D-Mont., and Kay Hagan, D-N.C., are co-sponsoring an amendment that would exempt small farms and food processors from many of the reporting requirements, penalties and fees in the legislation.
Judith McGeary, the executive director of the Farm and Ranch Freedom Alliance, which represents independent farmers and ranchers and which supports the amendment, said the smaller entities already were regulated at the state and local level and added that these smaller facilities have never caused a major outbreak of food-borne illness. She said the FDA should target larger interstate companies, which have been the source of previous outbreaks.
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