FDA's conclusion that chemical is safe is flawed ... USA TODAY Oct 28, 2008

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http://www.usatoday.com/news/washington/2008-10-28-1336525240_x.htm FDA's conclusion

that chemical is safe is flawed By

Alonso-Zaldivar, Associated Press Writer

USA TODAY Oct 28, 2008

WASHINGTON — The Food and Drug Administration's assurances that a controversial

chemical is safe for use in food containers are badly flawed, an independent

panel of scientific advisers concluded in a report released Tuesday. The chemical, known as

bisphenol A, is used to make plastic for food packaging, baby bottles and other

consumer and medical goods. Environmental groups want to ban BPA in products

for infants because of concerns that it can interfere with their development.

But the FDA recently said there is no harm from the low doses of BPA that

babies, children and most adults get by eating foods from containers made with

the chemical. Asked by the agency to review

that conclusion, a panel of outside advisers delivered what amounts to a

scientific rebuke. "The margins of

safety defined by FDA as 'adequate' are, in fact, inadequate," said the

report, a copy of which was provided to The Associated Press. The advisers

found that the FDA had not considered all available, credible scientific

evidence, and urged the agency to essentially go back to the lab. The report came as a

welcome surprise to environmentalists and their supporters in Congress. Citing

some of the advisers ties to industry, critics had initially questioned the

objectivity of the panel. "Despite the

concerns about their objectivity, (the panel) agreed with the many independent

scientists that questioned FDA's initial assessment on BPA," said Rep.

DeLauro, D-Conn., who chairs a committee that oversees the agency's

budget. The report "is reinforcing the position that the FDA should

restart the BPA evaluation process." The report will be

discussed at a meeting of the FDA's science board Friday, but what it will mean

for consumers was not immediately clear. With the advisers saying more studies

are needed, the FDA is unlikely to move quickly to restrict the use of BPA.

Concerned consumers, however, can reduce their exposure by avoiding plastic

containers imprinted with the recycling number 7, as many of these contain BPA. "The panel was very

clear, but we don't know if the FDA is going to listen," said consumer

activist Zuckerman, president of the

National Research Center for Women &

Families. "If they do, it could be a couple of years before they do

anything. The FDA's assessment should have been done right the first time. Now

it's going to have to be redone." The FDA had no immediate

comment on the advisers' report, but administration officials said it shows the

agency is open to second opinions, even critical ones. The worries about BPA

come from the fact that it can mimic the effects of estrogen, a powerful

hormone. While the kidneys of mature children and grown-ups quickly eliminate

the chemical from their bodies, newborns and infants may retain it for longer

periods. Babies can be exposed to BPA through infant formula packaged in

containers made with the chemical. The advisers' report

faulted the FDA for relying on relatively narrow studies in rats to reach its

conclusion that low doses of BPA are safe. Instead, it urged the agency to take

into account a much broader range of scientific literature, including a recent

study that raised suspicions about a link to heart problems in adults. The FDA's approach

"creates a false sense of security" and "overlooks a range of

potentially serious findings," the report said. The advisers also

concluded that FDA scientists' margin of safety for BPA was off, too generous

by factor of 10 times or more. The chemical industry

urged the FDA to expedite a final scientific verdict on BPA. "If the agency

determines that existing margins of safety are insufficient in infant

(products), 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 American Chemistry Council said in a

statement.