BPA Ruling Flawed, Panel Says
FDA Ignored Scientific Evidence of Harm, Report Finds
Wednesday, October 29, 2008; Page A13
The Food and Drug Administration ignored scientific evidence and used flawed methods when it determined that a chemical widely used in baby bottles and in the lining of cans is not harmful, a scientific advisory panel has found.
In a highly critical report to be released today, the panel of scientists from government and academia said the FDA did not take into consideration scores of studies that have linked bisphenol A (BPA) to prostate cancer, diabetes and other health problems in animals when it completed a draft risk assessment of the chemical last month. The panel said the FDA didn't use enough infant formula samples and didn't adequately account for variations among the samples.
Taking those studies into consideration, the panel concluded, the FDA's margin of safety is "inadequate". The panel is part of the Science Board, a committee of advisers to the FDA commissioner, and was set up to review the FDA's risk assessment of BPA.
Many of the studies that the panel said the FDA ignored were reviewed by the National Toxicology Program, which concluded in September that it had "some concern" that BPA can affect brain and behavioral development in infants and small children.
Officials at FDA, which regulates the chemical's use in plastic food containers, bottles, tableware and the plastic linings of food cans, accepted some of the criticism in the report.
"FDA agrees that due to the uncertainties raised in some studies relating to the potential effects of low doses of bisphenol-A that additional research would be valuable," said spokeswoman Judy Leon. The agency has commissioned new research on BPA.
The report adds fuel to the debate over whether to ban the use of BPA, which is used to harden plastic, particularly in baby bottles and cans of liquid formula. Infants are considered more vulnerable to the health effects of many chemicals.
"The current levels of exposure are not safe," said Sarah Janssen, a reproductive biologist with the Natural Resources Defense Council, an environmental advocacy group. "We should get rid of it in food containers."
The American Chemistry Council, a trade group that represents BPA manufacturers, said its members would comply with whatever the FDA decides to do.
"If the agency determines that existing margins of safety are insufficient in infant applications, 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," ACC spokeswoman Tiffany Harrington said.
Retailers have already begun selling BPA-free baby bottles in response to consumer concerns. This month, Canada banned its use in baby bottles.
House Committee on Energy and Commerce Chairman John D. Dingell (D-Mich.) and Rep. Bart Stupak (D-Mich.), as well as several state attorneys general, have called on formula-makers to remove BPA from their products.
The report likely will be fodder for critics of FDA who have accused the agency of relying too heavily on industry-funded studies. But it is likely to put to rest charges by environmental groups and public health advocates that the panel's chairman, Martin Philbert, co-director of the University of Michigan's Risk Science Center, was influenced by grants that his center received from Dow Chemical, a major BPA manufacturer. Dow gave the center $15 million for research on dioxin.
The center also received $5 million from Charles Gelman, a retired businessman who has been vocal in his support for BPA. Philbert has said that those donations did not influence his work or the center's.