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Scientists: FDA's Assertion of BPA Unreliable And Incomplete

Posted by Chrissie Cole
Tuesday, April 14, 2009 9:45 AM EST
Category: Major Medical
Tags: FDA and Prescription Drugs, Protecting Your Family, BPA, Toxic Substances, Bisphenol-A, Environmental Health, Dangerous Products, Children's Health, Plasticizers


IMAGE SOURCE: Wikimedia Commons / chemical structure of bisphenol-A / Calvero

The U.S. Food and Drug Administration’s (FDA) case that the chemical bisphenol-A (BPA) is safe, has been rejected as incomplete and unreliable by an international consortium of industry, academic and government scientists.

The group met in Germany last month and is planning to release a consensus statement in the coming weeks. The meeting was held behind closed doors, but McClatchy Newspapers has been able to interview many of the scientists in attendance and has viewed several working versions of the agreement.

Two studies the FDA has used as its foundation to declare the chemical is safe, were called into question by the group which calls for a broader look BPA than what the FDA has provided.

According to scientists that attended the meeting, Rochelle Tyl, the author of the two studies, conceded that there were errors and inconsistencies in the 2008 report which were paid for by the American Chemistry Council, a BPA-makers trade association.

Laura Vandenberg, one of several scientists from around that world that attended the conference said, “It clearly undeniable that BPA is dangerous.”

“The FDA’s standard for safety is reasonable certainty. It is no longer reasonable to say BPA is safe.”

Also called into question by the group, are the European Safety Authority’s assessment of BPA. The authority, which also relies on Tyl’s studies, sets policy for all countries within the European Union.

The scientists’ consensus statement will challenge claims made by industry spokesmen who have been citing the FDA and European assessments as proof that BPA is safe.

Tyl declined an interview, but answered questions via e-mail. She told McClatchy that her studies did not claim BPA is safe. They were not structured to cover all facets of the BPA’s effects. They simply show no effects of the reproductive system of rats that were exposed to low doses of the chemical, she said.

The March conference was intended to reassess BPA safety for German regulators. The agreements made there are being closely monitored worldwide by those with a stake in the future of the chemical including BPA-makers, regulators and advocates who consider the chemical to be unsafe.

The group agreed that the scope of both studies by Tyl were too limited to be considered bench marks and failed to consider serious dangers posed by the chemical. They include effects on behavior and brain development as well as the prostate. Those problems were identified in the National Toxicology Program report that was published last year.

FDA administrators plan to address those issues more closely now.

Bisphenol A is compound that hardens plastic and is used in thousands of everyday consumer items including the lining of food cans, food containers, DVD cases, shower curtains, and baby bottles.

BPA, is a known estrogen disruptor, meaning it can mimic the hormonal activity in animals and humans. Several billion pounds are produced every year and it’s been found in the urine of an estimated 93 percent of Americans. #

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