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Thursday, March 27, 2008

Industry Directed FDA Policy on Plastics Chemical

The House Energy and Commerce Committee's investigation into the use of Bisphenol-A — a chemical substance common in plastics and in the lining of food cans — continues to turn up startling information. The Food and Drug Administration (FDA) says Bisphenol-A is safe, but studies have shown the chemical is associated with a host of adverse health effects including breast and prostate cancer, according to the Environmental Working Group.

The committee wrote to FDA in January asking the agency to identify the studies it used to make its determination that Bisphenol-A does not pose a "safety concern at the current exposure level." In response, FDA identified two studies. Both studies were funded by industry and were absent the usual scientific rigor characteristic of regulatory decision making, according to The Milwaukee Journal-Sentinel.

The Journal-Sentinel has the full story:

In response to a congressional inquiry, Stephen Mason, the FDA's acting assistant commissioner for legislation, wrote in a letter that his agency's claim relied on two pivotal studies sponsored by the Society of the Plastics Industry, a subsidiary of the American Chemistry Council.

One of the studies has never been published, and therefore never subjected to peer review; the second has been heavily criticized by researchers who say the results are inconclusive because of flawed experimental methods….

According to the letter, the FDA based its claim that there is no "safety concern at the current exposure level" on its own studies, conducted in the 1990s, which indicated that people were exposed to small amounts of the chemical.

They gathered that information by testing products such as aluminum cans and baby bottles to see how much of the chemical was leaching. Then they looked to the two chemical industry studies to see if those exposure levels could cause harm.

The two studies said the chemical caused no harm to rodents at low doses.