OT: Congress examining role of chemical industry in regulatoin

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Studies on Chemical In Plastics Questioned

Congress Examines Role Of Industry in Regulation

By Lyndsey Layton

Washington Post Staff Writer

Sunday, April 27, 2008; A01

Despite more than 100 published studies by government scientists and

university laboratories that have raised health concerns about a

chemical compound that is central to the multibillion-dollar

plastics industry, the Food and Drug Administration has deemed it

safe largely because of two studies, both funded by an industry

trade group.

The agency says it has relied on research backed by the American

Plastics Council because it had input on its design, monitored its

progress and reviewed the raw data.

The compound, bisphenol A (BPA), has been linked to breast and

prostate cancer, behavioral disorders and reproductive health

problems in laboratory animals.

As evidence mounts about the risks of using BPA in baby bottles and

other products, some experts and industry critics contend that

chemical manufacturers have exerted influence over federal

regulators to keep a possibly unsafe product on the market.

Congressional Democrats have begun investigating any industry

influence in regulating BPA.

" Tobacco figured this out, and essentially it's the same model, "

said s, who was a federal regulator in the Clinton

administration. " If you fight the science, you're able to postpone

regulation and victim compensation, as well. As in this case,

eventually the science becomes overwhelming. But if you can get five

or 10 years of avoiding pollution control or production of

chemicals, you've greatly increased your product. "

Cheeseman, deputy director of the FDA's office of food

additive safety, said the agency is not biased toward industry.

" The fact is, it's industry's responsibility to demonstrate the

safety of their products, " he said. " The fact that industry

generated data to support the safety I don't think is an unusual

thing. "

The FDA's position on the compound was called into question earlier

this month when a National Institutes of Health panel issued a draft

report linking BPA to health concerns. Since then, Canadian

regulators have banned BPA in baby products, and Sen. E.

Schumer (D-N.Y.) has introduced a bill to prohibit some uses of the

compound. Ten states, including California and land, are

weighing their own restrictions.

U.S. manufacturers produce 7 billion pounds of BPA annually, and

business worldwide has been growing about 4 percent a year, driven

by rising demand in Asia. A U.S. government ban on BPA would affect

thousands of businesses and perhaps billions of dollars in profit

for its largest manufacturers.

As part of his investigation, Rep. D. Dingell (D-Mich.),

chairman of the House Energy and Commerce Committee, wants to

examine the role played by the Weinberg Group, a Washington firm

that employs scientists, lawyers and public relations specialists to

defend products from legal and regulatory action. The firm has

worked on Agent Orange, tobacco and Teflon, among other products

linked to health hazards, and congressional investigators say it was

hired by Sunoco, a BPA manufacturer.

Dingell has asked the Weinberg Group for all records related to its

work in connection with BPA, including studies it has funded and

payments made to experts. He cited a letter written by a company

vice president in 2003 as Weinberg managed opposition in a long-

running regulatory battle over a compound in Teflon. The strategy

would be to discourage " governmental agencies, the plaintiffs' bar

and misguided environmental groups from pursuing this matter any

further, " the letter said.

In a statement, Dingell said, " The tactics apparently employed by

the Weinberg Group raise serious questions about whether science is

for sale at these consulting groups, and the effect this faulty

science might have on the public health. "

Weinberg, the firm's chief executive, declined to be

interviewed. But in a brief written statement, he said the company

will cooperate with Dingell's investigation.

" The analyses we conduct are rigorous and adhere to established

principles of scientific integrity, " the statement said. " We believe

it is in the public interest for all scientific research to be

subject to scrutiny and the views of all affected parties to be

heard. "

Scientists first flagged possible health risks of BPA more than a

decade ago. From 1997 to 2005, 116 studies of the compound were

published, many of them focused on its effects in low doses. Of

those funded by government, 90 percent showed a health effect linked

to BPA. None of the industry-funded studies found an effect; all of

them said BPA is safe.

There is a clear bias in studies funded by industry, said s,

who now runs the Project on Scientific Knowledge and Public Policy

at Washington University and wrote the book " Doubt is Their

Product, " which details how various industries have used science to

stave off regulation.

" This is a great example of the funding effect, " he said. " It's not

so much because scientists are shaving the truth, but they ask

questions in a way to give them the answers they want. "

Sharon Kneiss, vice president of products divisions for the American

Chemistry Council, said in a conference call with reporters two

weeks ago that industry research is unassailable. " We make it a

policy to supply government agencies with data, and we have done it

in the case of BPA, " she said. " We supplied studies following the

highest levels of quality in terms of their study. We stand behind

the quality of the studies. "

The FDA and the Environmental Protection Agency both regulate BPA.

Because the compound is most readily absorbed through food and

drink, the FDA plays a critical regulatory role because it approves

the compound's use in plastic food containers, bottles, tableware

and the plastic linings of canned foods.

For much of the regulatory history of BPA, traditional toxicology

was used to assess risk to people -- researchers tried to find the

threshold amount above which BPA would cause cancer, malformation or

death.

Vogel, who holds a master's degree in public health and is

writing a doctoral dissertation at Columbia University on the

politics and scientific history of BPA, said that because practical

use of the compound was at levels much lower than the amount deemed

toxic, scientists assumed it was safe. " The idea was: Look, this

stuff is at such low levels, it really couldn't effect any harm, "

she said.

A decade ago, Frederick vom Saal, a reproductive scientist at

University of Missouri at Columbia, came up with a different

research strategy. He theorized that because BPA can mimic estrogen,

a female sex hormone, minuscule amounts introduced to fetuses or

infants could change cell structure and cause significant health

problems later in life. He found that doses 25,000 times below what

the government has labeled as safe harmed developing cells in mice.

In 1997, after he submitted his first study for publication in a

peer-reviewed scientific journal, vom Saal said he was visited by a

group of scientists including M. Waechter of Dow Chemical, a

manufacturer of BPA. According to vom Saal, Waechter began the

meeting by expressing a hope for " some mutually beneficial outcome "

if vom Saal held off on publication until a replicate study could be

performed. Vom Saal refused, and, six weeks later, sent a pointed

letter documenting the exchange to plastics industry

representatives, including Waechter, and an FDA official.

Dow declined to make Waechter available for an interview. Spokesman

Mark Walton said vom Saal misunderstood Waechter. " We categorically

reject any suggestion that what we did was in any way unethical, " he

said.

A. Clare, a lawyer with Kirkland & Ellis, representing Dow

and Waechter, said in a letter to The Washington Post that

the " mutually beneficial outcome " to which Waechter referred was

a " meaningful exchange of scientific ideas " with vom Saal, and that

Waechter had never asked vom Saal to delay or withdraw his research.

Clare also said that Waechter met with vom Saal as a representative

of a Society of Plastics Industries task force studying BPA and not

on Dow's behalf. Clare said that the SPI task force had already

submitted vom Saal's research to the EPA before the two men met to

discuss the study.

As the country's preeminent BPA researcher, vom Saal finds that his

work is regularly attacked by the chemical industry. " We were not

prepared at all for walking into a political minefield, " said vom

Saal, whose research is funded by foundations and the National

Institutes of Health.

The chemical industry, meanwhile, has funded scientists who have

served on expert review panels that advise the government about the

safety of chemical compounds.

Last year, NIH convened two panels to help it analyze BPA risks. One

panel, led by vom Saal, consisted of 38 international experts on BPA

who work for universities or governments. Last August, it found a

strong cause for health concerns, including cancer and early puberty.

The second panel included 12 scientists, none of whom had worked on

BPA. In November, it found " some concern " about neurological effects

of the compound in children but minimal concern that it would cause

cancer or early puberty. The second group relied on Sciences

International, an andria-based consulting firm, to choose and

summarize research for panel members.

The government later learned that Sciences International had done

work for Dow and BASF, two BPA manufacturers. After inquiries by

Rep. Henry A. Waxman (D-Calif.) and Sen. Barbara Boxer (D-Calif.),

the government canceled its contract with the firm and audited its

work. The panel reported " minimal " concern about the compound's

impact on reproduction and development while saying it had " some

concern " about effects on neurological development.

On April 15, the National Toxicology Program, part of NIH, issued a

draft report acknowledging " some concern " about the risk of cancer,

diabetes and other serious health problems in adults. The new report

considered dozens of studies that the earlier panel had rejected and

reviewed more than 400 studies published between April 2007 and

February.

" That was the big change -- a decision was made to consider

different sorts of studies in the evaluation, " said s, the

former federal regulator.

In response to recent findings and media reports, Cheeseman said

that FDA Commissioner C. von Eschenbach has created an agency

task force to examine BPA but that the agency maintains it

is " absolutely safe " for use in food and medical products.

Vom Saal said a flood of recent BPA studies have validated his

work. " The scientific community basically said, 'This argument is

over,' " he said. " It ended a long time ago. There's only been an

illusion of a controversy created by a well-financed public

relations outfit. The idea that the FDA tells people this is safe is

offensive. "