Salmonella outbreak prompts review of US food safety.
When the US president worries aloud about the safety of his 7-year-old daughter's peanut butter sandwich, as Barack Obama did last week, it may be safe to assume that change is at last coming to the government's beleaguered food-safety system.
When he announces, in the same interview, "a complete review" of operations at the Food and Drug Administration (FDA), it may be equally reasonable to expect new things at the $2.3-billion agency responsible for ensuring the safety of most US food and drugs.
Yet no top-to-bottom review will be possible until the agency has a new leader. On 30 January, the White House announced that the appointment of the FDA commissioner was imminent; but that was before the 3 February withdrawal of Tom Daschle, Obama's nominee for secretary of health and human services, to whom the FDA commissioner reports. It is not clear whether Daschle's withdrawal will speed or slow the naming of an FDA chief.
Although roughly two-thirds of the FDA's budget goes to regulating drugs and medical devices, the agency is also responsible for ensuring the safety of 80% of US foods — and it is in food safety that Obama has run into the FDA's ongoing problems. Since September, 575 people in 43 states — half of them children — have fallen ill in an outbreak of Salmonella poisoning that originated at a peanut plant in Georgia.
The outbreak has highlighted the steady weakening of the FDA's food-safety capabilities. Between 2003 and 2008, for instance, the number of food scientists at the agency's Maryland headquarters shrank by 18% even as the number of food-borne disease outbreaks more than doubled.
Obama himself introduced legislation last year aimed at strengthening and expanding food surveillance technologies. It would also have forced the FDA, the Centers for Disease Control and Prevention in Atlanta, Georgia, and state and local public-health agencies to share data on outbreaks of food poisoning and to coordinate investigations more effectively.
At a 5 February hearing of the Senate agriculture committee, chairman Tom Harkin (Democrat, Iowa) waved a jar of Jif peanut butter, saying: "When Americans can't count on the safety of basic items that go into our children's lunch boxes, then we are in big trouble."
This "is a turning point", says Michael Taylor, a former FDA deputy commissioner for policy who is a professor of health policy at George Washington University in Washington DC. "Members on both sides of the aisle are getting that there is a system-wide problem here, that there has to be institutional change."
“There has to be institutional change. ”
Importantly, the food industry — which has lost hundreds of millions of dollars in the past two years after recalls of tainted spinach and peppers — is also at the table. Last month, ten industry groups, including the Grocery Manufacturers Association, wrote to House and Senate leaders begging them to "quickly enact food safety reforms" by giving the FDA new powers. A bill introduced on 4 February, by Representative Rosa DeLauro (Democrat, Connecticut) would consolidate the agency's food-safety functions at a new Food Safety Administration, whose chief would report directly to the secretary of health and human services.
The FDA's current lack of food-safety teeth was evident at last week's Senate hearing, at which senators grilled agency officials on the history of inspections at the Peanut Corporation of America in Blakely, Georgia. There, company tests revealed Salmonella-tainted products in 12 separate instances beginning in June 2007; the company retested and got a negative result, then shipped the products. At least eight people have died after eating peanut products that originated at the plant.
Stephen Sundlof, director of the FDA's Center for Food Safety and Applied Nutrition, clarified at the hearing that companies are under no obligation to report to the FDA when food tests turn up tainted products; that the agency has no power to require that companies recall products; and that it cannot demand the results of a company test unless it has a reasonable belief that an already-shipped product is tainted.
Although the Salmonella outbreak is the first major FDA-related issue for Obama, there will undoubtedly be more. A steady stream of reports in recent years from groups such as the Institute of Medicine, the National Academy of Sciences and the Government Accountability Office has documented the woes of an understaffed, underfunded, demoralized and scientifically deficient agency (see _Nature_ 450, 1143; 2007).
A Government Accountability Office report released last month said that the FDA has been lax in implementing stringent review procedures for some of the riskiest medical devices such as heart valves and pacemakers. And the same month, a group of nine dissident agency scientists wrote to Obama charging that their superiors had targeted them for a criminal investigation, after they complained that agency officials are putting patients at risk by approving high-risk devices that have not been proved to be safe or effective.
Whether it is the politics of devices and drugs or the public outcry over food safety, the new commissioner, once installed, will have plenty on his or her plate. Taylor says that the person will need "the skill to work within the agency well but also the strength to work with the outside world — to manage the slings and arrows that will come when you try to make change".
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