Scientific panel criticizes FDA report that labels bisphenol A safe ... Milwaukee Journal Sentinel Oct. 29, 2008

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"Scores of scientific studies spanning two decades have

found it to cause a host of problems in laboratory animals, including cancer,

diabetes, obesity, heart disease, reproductive failures, autism and

hyperactivity."

Panel criticizes FDA report labeling

bisphenol A safe http://www.jsonline.com/watchdog/watchdogreports/33486484.html Scientific panel criticizes FDA report that labels bisphenol A

safe By Meg Kissinger

and ne Rust

of the Milwaukee Journal Sentinel Oct. 29, 2008 The Food and Drug Administration ignored valuable studies

when it concluded last summer that bisphenol A is a safe chemical, a panel of

scientists said in a report to be released today. The panel, appointed by the FDA's Science Board to review

its task force report, called the FDA's conclusions last August inadequate and

recommended that the agency abandon its earlier findings about the safety of

the controversial chemical. Bisphenol A, developed as a synthetic estrogen, is found

in baby bottles, infant formula containers, the lining of aluminum cans and

thousands of other household products. Scores of scientific studies spanning two decades have

found it to cause a host of problems in laboratory animals, including cancer,

diabetes, obesity, heart disease, reproductive failures, autism and

hyperactivity. Other government panels, including the National

Toxicology Program, have linked bisphenol A, also known as BPA, to concerns

about neurological and prostate development in fetuses, newborns and young

children. Most significantly, the new panel report says that the

FDA's conclusion of how much bisphenol A is safe for people was too high, and

suggested the agency reduce it by a factor of at least 10. The American Chemistry Council, representing makers of

bisphenol A, immediately released a statement, saying it was ready to comply

with whatever the FDA ultimately decides is a safe level. "Once the FDA assessment is complete, the public can

be assured that ACC and its member companies will comply with FDA's

direction," said Harrington, spokeswoman for the industry group.

"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." The panel's criticism of the committee's findings was

hailed by health advocates as a victory. "We are thrilled," said Sonya Lunder, senior

analyst with the Environmental Working Group, a health advocacy group that

has done extensive testing on baby bottles and infant formula, and has

lobbied for the chemical to be removed from those products. The 17-page report, which is to be posted on the FDA Web

site today, was being closely watched by chemical makers. Sales of bisphenol

A last year topped $6 billion. The panel report comes just days before

Friday's scheduled meeting of the FDA to discuss the safety of bisphenol A. The subcommittee's chairman had come under fire in the

past few weeks for his ties to an outspoken advocate for the chemical.

Philbert, chairman of the FDA subcommittee, serves as founder and co-director

of the University of

Michigan 's

Risk Science Center . The center had

received a $5 million donation in July from Gelman, a retired medical

supply manufacturer. Gelman told the Journal Sentinel, which broke the story,

that he considered bisphenol A to be "perfectly safe" and

acknowledged that he had several conversations with Philbert about his views

on the matter. That relationship heightened concerns about the panel's

objectivity, especially given that Philbert had failed to disclose the

donation in his conflict of interest statements that he filed with the FDA

when being considered for the post. Several congressmen called for an

investigation and asked that the subcommittee hearing, scheduled for Friday,

be postponed. But Philbert's subcommittee showed no deference to

chemical makers in their report. In fact, the group took the FDA to task for having relied

on a study that looked at only 14 infant formula cans bought in the

Washington , D.C. ,

area as the basis for its estimate of what children across the country were

being exposed to. The subcommittee also charged that the FDA's statistical

methods in many areas were faulty or incomplete. They disagreed with several assumptions made by the FDA

about how parents feed and care for their children, including the assumption

that at the age of 12 months, parents will no longer feed their babies

formula. The panel also challenged the FDA's assumption that parents stop sterilizing

their baby bottles when the infant reaches 2 months of age. The subcommittee faulted the FDA for failing to look at

the effects a microwave oven could have on polycarbonate baby bottles. The FDA was wrong to base its earlier findings on only

two studies, both of which were funded by the chemical industry, Philbert's

subcommittee found. It also criticized the FDA for dismissing studies that

the NTP found of value, saying that the FDA's basis for dismissal seemed

arbitrary and inconclusive. The scientists also said that the FDA's reviews

of the studies did not seem as carefully done or thoughtful as those outlined

in the NTP's report. Frederick vom Saal, a toxicologist from the

University of

Missouri who has studied the effects

of bisphenol A for years, criticized the government for cowing to pressure

from the chemical industry. "The FDA relied on the plastic industry in telling

the American public that bisphenol A is safe," he said. "When a

regulatory agency acts as a public relations outlet for the corporations it

is supposed to be regulating, the agency should be eliminated." A Journal Sentinel investigation published last year

analyzed more than 250 scientific studies. Most of them found that bisphenol A

posed risks to laboratory animals. Those that didn't find a problem were

largely funded by the chemical industry.