October 30, 2008 — vol. 44, no 12
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Scientific panel: FDA came to flawed conclusion about chemical’s safety
WASHINGTON — Assurances made by the Food and Drug Administration (FDA) that a controversial chemical is safe for use in food containers are badly flawed, an independent panel of scientific advisers concluded in a report released Tuesday.The chemical, known as bisphenol A or BPA, is used to make plastic for food packaging, baby bottles and other consumer and medical goods. Environmental groups want to ban BPA in products for infants because of concerns that it can interfere with their development. But the FDA recently said there is no harm from the low doses of BPA that babies, children and most adults get by eating foods from containers made with the chemical.
Asked by the agency to review that conclusion, a panel of outside advisers delivered what amounts to a scientific rebuke.
“The margins of safety defined by FDA as ‘adequate’ are, in fact, inadequate,” said the report, a copy of which was provided to The Associated Press. The advisers found that the FDA had not considered all available, credible scientific evidence, and urged the agency to essentially go back to the lab.
The report came as a welcome surprise to environmentalists and their supporters in Congress. Citing some of the advisers ties to industry, critics had initially questioned the objectivity of the panel.
“Despite the concerns about their objectivity, [the panel] agreed with the many independent scientists that questioned FDA’s initial assessment on BPA,” said U.S. Rep. Rosa DeLauro, D-Conn., who chairs a committee that oversees the agency’s budget. The report “is reinforcing the position that the FDA should restart the BPA evaluation process.”
The report will be discussed at a meeting of the FDA’s science board Friday, but what it will mean for consumers was not immediately clear. With the advisers saying more studies are needed, the FDA is unlikely to move quickly to restrict the use of BPA. Concerned consumers, however, can reduce their exposure by avoiding plastic containers imprinted with the recycling number 7, as many of these contain BPA.
“The panel was very clear, but we don’t know if the FDA is going to listen,” said consumer activist Diana Zuckerman, president of the National Research Center for Women & Families. “If they do, it could be a couple of years before they do anything. The FDA’s assessment should have been done right the first time. Now it’s going to have to be redone.”
The FDA had no immediate comment on the advisers’ report, but administration officials said it shows the agency is open to second opinions, even critical ones.
The worries about BPA come from the fact that it can mimic the effects of estrogen, a powerful hormone. While the kidneys of mature children and grown-ups quickly eliminate the chemical from their bodies, newborns and infants may retain it for longer periods. Babies can be exposed to BPA through infant formula packaged in containers made with the chemical.
The advisers’ report faulted the FDA for relying on relatively narrow studies in rats to reach its conclusion that low doses of BPA are safe. Instead, it urged the agency to take into account a much broader range of scientific literature, including a recent study that raised suspicions about a link to heart problems in adults.
The FDA’s approach “creates a false sense of security” and “overlooks a range of potentially serious findings,” the report said.
The advisers also concluded that FDA scientists’ margin of safety for BPA was too generous by factor of 10 times or more.
The chemical industry urged the FDA to expedite a final scientific verdict on BPA.
“If the agency determines that existing margins of safety are insufficient in infant [products], our member companies that manufacture BPA will put processes in place to promptly phase out the use of materials containing BPA in baby bottles and infant formula packaging,” the American Chemistry Council said in a statement.
(Associated Press)
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Read the full report
The report filed by the scientific panel questioning the Food and Drug Administration's conclusions about the relative danger of bisphenol A can be found in its entirety on the FDA's Web site here. NOTE: The report is presented in PDF format, and Adobe Reader is required to read it. You can download the latest version here.
Milwaukee Journal Sentinel: Chemical fallout
"WARNING: The chemical bisphenol A has been known to pose severe health risks to laboratory animals. AND THE CHEMICAL IS IN YOU," the Milwaukee Journal Sentinel wrote in this Dec. 2, 2007 report. "It's in baby bottles, soda cans and 93 [percent] of us. It causes breast cancer, testicular cancer, diabetes and hyperactivity in lab animals, according to 80 [percent] of studies analyzed by the Journal Sentinel. But U.S. regulators side with the chemical-makers and say it's safe." More »
