Ahead of the Bell: FDA meeting on bisphenol

FDA meets to review safety of bisphenol A, controversial plastic used in baby bottles

Associated Press, Matthew Perrone
Published September 16, 2008

WASHINGTON (AP) -- Government experts are scheduled to meet Tuesday to discuss the safety of bisphenol A, a widely used chemical at the center of a debate among scientists, parents, politicians and corporations. The Food and Drug Administration has asked its panel of science experts to weigh in on whether the plastic hardening chemical poses a risk to children and infants. Bisphenol has been used in baby bottles and the lining of canned food for over 50 years, but recent studies in animals suggest it can disrupt hormones and cause developmental problems in the brain. At the behest of scientists and consumer advocates, federal regulators have been reviewing the chemical, but with little agreement about its risks. The FDA last month issued a preliminary report saying the trace amounts of bisphenol found in food packaging are not dangerous. But two weeks ago the government's National Toxicology Program -- which is made up of scientists from several agencies -- concluded bisphenol poses "some risk" to infants and children. While nearly all scientists agree more studies are needed on bisphenol's effects, responsibility for regulating how it is used in food packaging ultimately rests with the FDA -- a fact that worries some groups. "It puts us in a pretty distressing position because the FDA is supposed to regulate this stuff and they're not," said Renee Sharp, an analyst with the Environmental Working Group. "As consumers, we're stuck." Sharp's group, a consumer advocacy organization, is one of more than a dozen scheduled to speak Tuesday. Most of the groups want the U.S. to follow the example of Canada, which is moving to ban bisphenol. Heading off similar restrictions in the U.S. is a top priority for the American Chemistry Council, which has boosted its lobbying budget to battle proposals unfriendly to chemical makers. In the first half of this year the group spent $2.2 million on lobbying, nearly double what it spent in the same period last year. Results of the lobbying boost have been mixed. Last month, President Bush signed a law that restricts the use of chemicals called phthalates in toys. The chemistry council had argued for the safety of the plastic-softening chemicals. Members of the council, which include Dow Chemical and Bayer, manufacture about 6 billion pounds of bisphenol in the U.S. each year. The chemical industry has endorsed the FDA's opinion that bisphenol is safe, saying it is based on the most rigorous studies available. But more than a dozen outside scientists and consumer safety proponents criticized the FDA report, complaining it was based on older studies conducted by chemical makers. These scientists say the National Toxicology Program's findings are more accurate because they considered dozens of animal studies which suggest bisphenol can interfere with hormones. Researchers like Frederick vom Saal, of the University of Missouri, argue that chemicals with hormonal properties like bisphenol have more of an effect at minuscule doses. That theory is not shared by many toxicologists, who test chemicals for safety at high levels and then assume smaller doses pose less of a risk. Vom Saal is one of seven scientists who will serve on the FDA's outside panel, which also includes representatives from the American Chemistry Council, the federal National Institutes of Health and universities. The FDA's final conclusions on bisphenol will also impact makers of baby formula like Abbott Laboratories and PBM Nutritionals. Rep. John Dingell, D-Mich., who chairs the House Energy and Commerce Committee, has asked the companies to remove the chemical from their packaging. None have done so, though several said they are in the process of seeking alternatives.