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FDAs Failure Urges It to Reassess Its Policies

U.S. officials are considering an overhaul in the process used to inspect and regulate imported food and it domestic production .

Last fall, grocers and shoppers were in a panic during an outbreak of E. coli-related illness linked to contaminated bagged spinach. Nationwide there were 204 illnesses, 104 serious enough to require hospitalization, and three deaths.

The FDA concluded it could not definitively determine how the E. coli contaminated the soil. It is consistent with a pattern of lackadaisical protection of consumers that was seen seen in the Vioxx scandal, the controversy surrounding the Avandia diabetes pill and the contamination of imported pet food.

California farmers have instituted voluntary changes in growing and processing practices to better protect their products from such contamination.

Over a decade, food imports have tripled, while the FDA budget has increased marginally. As a result the number of inspectors has dwindled and as little as one per cent of imported shipments are now subject to official checks.

The FDA is exploring ways to overhaul how it inspects and regulates imported food. It is considering, among other actions, using risk analysis to try to pinpoint shipments that might pose hazards.

Risk based inspections could reduce the time shipments but the proposals could require importers and manufacturers to provide more information to officials.

The focus of the proposals is to move the FDA towards shipments that pose the greatest risk to food safety.

To enable the proposed system to work efficiently, countries and private businesses -- including foreign manufacturers, importers and U.S. manufacturers using imported ingredients -- might be required to provide the FDA with more information about the production, packaging and transportation of imported foods and how food is processed and handled. This information will then be collected into a d atabase for inspectors to assess.

The shift is to be more proactive, to put more focus on prevention, said David Acheson, the FDA's assistant commissioner for food protection, who is working closely with FDA Commissioner Andrew Von Eschenbach on a new plan to improve safety of both imported and domestic food.

Michael Doyle, director of University of Georgia's Center for Food Safety, said it would be "a major step forward" if the agency adopts the risk-management approach and converts to up-to-date screening and testing technologies, as originally proposed in the 2002 plan. "It sounds like the strategic plan is what's needed for the evolving situation that we see with the rapid increase in food imports," he said. "The longer the FDA waits to reorganize itself in addressing the issue of the day, the more difficult it will be for the agency to catch up to the problems of the future.

The FDA's moves come as Congress and the Bush administration are debating how to improve the safety of both imported and domestically produced food, amid the importation of contaminated pet food and tainted toothpaste from China. Earlier this year, the FDA, in the wake of last year's E. coli contamination of spinach, recommended tough regulations on the U.S. fresh-produce industry but was rebuffed by its parent agency, the Department of Health and Human Services. Now, under fire for not moving aggressively enough to protect the food supply, the administration seems to be more amenable to taking steps to beef up safety.


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