Courtesy of USA TODAY
The Food and Drug Administration is reconsidering the safety of a hormone-like chemical, bisphenol A, or BPA, commonly found in baby bottles and infant formula cans.
FDA Commissioner Andrew von Eschenbach launched the review after the National Toxicology Program's April 15 report suggesting that BPA may alter human development. Days later, Canada declared the chemical toxic and proposed banning it.
The FDA isn't recommending people stop using BPA, says Laura Tarantino, director of the FDA's Office of Food Additive Safety. But the agency will take another look at the safety of baby bottles, formula cans and other products made with BPA, which has been shown to leach into food. Depending on their findings, she says, the agency could require changes in the way these products are made or the amount of BPA that's allowed to be used.
The review is being welcomed both by industry and environmentalists.
Rep. John Dingell and Rep. Bart Stupak, Michigan Democrats and leaders of the energy and commerce committee, have been investigating the FDA's handling of BPA. They called for a new safety check after the toxicology program's report, which expressed "some concern" that low levels of BPA cause changes in behavior and the brain, prostate gland, breast and the age at which girls enter puberty.
Scientists don't have much evidence about how BPA affects people. But environmental organizations such as the Environmental Working Group note that 100 studies have found harmful effects in animals at very low levels. Many researchers are concerned that BPA, which acts like the female hormone estrogen, causes profound effects on animals in low doses, especially during pregnancy and infancy. Researchers from the Centers for Disease Control and Prevention have found BPA in 95% of Americans tested.
Dingell and Stupak say the FDA ignored that research last July when the agency determined that BPA is safe in the amounts to which Americans are now exposed. In a letter to Dingell and Stupak, the FDA says it based its conclusions on two reports funded by the American Plastics Council, an industry group.
"There is a wealth of scientific information available about the safety and health effects of Bisphenol A, yet FDA seems to have relied exclusively on two industry funded studies, one of which has not even been made available to the public for review," Dingell said in a statement. "This raises serious concerns about whether the science FDA relied on to approve the use of bisphenol A was bought and paid for by industry."
Dingell says he plans to watch the FDA closely during the new review.
Tarantino says the FDA has always considered all of the evidence about BPA. When setting a safe exposure level, though, the FDA drew on the industry studies because they were large and designed to answer specific questions about how much BPA is safe to consume, she says.
In its new review, the FDA will include the toxicology program report, the Canadian study and other recent publications, Tarantino says.
Rep. Henry Waxman (D-Calif.), who also has been investigating the safety of BPA, praised the toxicology program for bringing the chemical's risks to light.
"The FDA needs to act quickly and undertake a thorough review so that the public — and especially infants — are protected," Waxman said in a statement.
Sarah Janssen, science fellow at the Natural Resources Defense Council, an environmental group, says the FDA should let the public know who attends its meetings and which scientific studies are included.
The American Chemistry Council, an industry group, says the FDA should clear up the fear and confusion about BPA, which it says has been safely used for decades. A new FDA statement, the council says, will "help explain the extensive scientific review that has already been conducted."
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