WP: BPA Ruling Flawed, Panel Says

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BPA Ruling Flawed, Panel Says

FDA Ignored Scientific Evidence of Harm, Report Finds

By Annys Shin

Washington Post Staff Writer

Wednesday, October 29, 2008; A13

The Food and Drug Administration ignored scientific evidence and used

flawed methods when it determined that a chemical widely used in baby

bottles and in the lining of cans is not harmful, a scientific

advisory panel has found.

In a highly critical report to be released today, the panel of

scientists from government and academia said the FDA did not take

into consideration scores of studies that have linked bisphenol A

(BPA) to prostate cancer, diabetes and other health problems in

animals when it completed a draft risk assessment of the chemical

last month. The panel said the FDA didn't use enough infant formula

samples and didn't adequately account for variations among the

samples.

Taking those studies into consideration, the panel concluded, the

FDA's margin of safety is " inadequate " . The panel is part of the

Science Board, a committee of advisers to the FDA commissioner, and

was set up to review the FDA's risk assessment of BPA.

Many of the studies that the panel said the FDA ignored were reviewed

by the National Toxicology Program, which concluded in September that

it had " some concern " that BPA can affect brain and behavioral

development in infants and small children.

Officials at FDA, which regulates the chemical's use in plastic food

containers, bottles, tableware and the plastic linings of food cans,

accepted some of the criticism in the report.

" FDA agrees that due to the uncertainties raised in some studies

relating to the potential effects of low doses of bisphenol-A that

additional research would be valuable, " said spokeswoman Judy Leon.

The agency has commissioned new research on BPA.

The report adds fuel to the debate over whether to ban the use of

BPA, which is used to harden plastic, particularly in baby bottles

and cans of liquid formula. Infants are considered more vulnerable to

the health effects of many chemicals.

" The current levels of exposure are not safe, " said Janssen, a

reproductive biologist with the Natural Resources Defense Council, an

environmental advocacy group. " We should get rid of it in food

containers. "

The American Chemistry Council, a trade group that represents BPA

manufacturers, said its members would comply with whatever the FDA

decides to do.

" 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, " ACC spokeswoman Harrington said.

Retailers have already begun selling BPA-free baby bottles in

response to consumer concerns. This month, Canada banned its use in

baby bottles.

House Committee on Energy and Commerce Chairman D. Dingell (D-

Mich.) and Rep. Bart Stupak (D-Mich.), as well as several state

attorneys general, have called on formula-makers to remove BPA from

their products.

The report likely will be fodder for critics of FDA who have accused

the agency of relying too heavily on industry-funded studies. But it

is likely to put to rest charges by environmental groups and public

health advocates that the panel's chairman, Philbert, co-

director of the University of Michigan's Risk Science Center, was

influenced by grants that his center received from Dow Chemical, a

major BPA manufacturer. Dow gave the center $15 million for research

on dioxin.

The center also received $5 million from Gelman, a retired

businessman who has been vocal in his support for BPA. Philbert has

said that those donations did not influence his work or the center's.