Review panel finds FDA’s study of BPA risks flawed

WASHINGTON – 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 take into account variations among the samples.

Taking those studies into consideration, the panel concluded, the FDA’s margin of safety is “inadequate” and it recommended that the agency redo its risk assessment. The panel is part of the Science Board, a committee of advisers to the FDA commissioner. It 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 the FDA, which regulates the chemical’s use in plastic food containers, bottles, tableware and the plastic linings of food cans, declined to comment Tuesday night.

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.

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