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Regulators Failed in Assessing BPA Risk, Panel Says (Update2)

By David Olmos

Oct. 29 (Bloomberg) -- Health regulators failed to properly assess the potential safety risks posed by the chemical bisphenol A, according to a report by a panel of U.S. independent scientific advisers.

The staff of the U.S. Food and Drug Administration failed to provide ``reasonable and appropriate scientific support'' for its finding that the public wasn't at risk from bisphenol A, or BPA, a chemical linked in some studies to diabetes and developmental changes in children, the report released today found.

The rebuke widens a dispute among U.S. government scientists over the risks posed by BPA, which has been used for decades to help stiffen plastic for baby bottles and food-storage containers. The FDA said in August that the chemical is safe at current exposure levels, prompting criticism from consumer groups and lawmakers. The finding conflicted with a separate report from the National Toxicology Program that found a risk to children.

The advisory panel's findings show ``how poorly the agency has handled its review of BPA and the significant work that lies ahead in improving the agency's performance,'' Representative Rosa DeLauro, a Connecticut Democrat, said of the FDA yesterday in an e-mailed statement.

The advisers, in their report, said the FDA staff hadn't sufficiently considered independent studies suggesting BPA isn't safe at current levels. Consumer groups and lawmakers have said the review relied too much on industry-funded research. FDA staff said the industry studies met stricter scientific guidelines.

Rejected Studies

FDA staff ``considered, but rejected for various reasons, a number of potentially relevant studies,'' a subcommittee of the agency's Science Board said in the report. The safety data the staff relied upon was ``inadequate,'' the panel said.

The FDA had asked its scientific advisers to review the staff finding that BPA posed no human health risk. The subcommittee of experts on toxicology prepared the report for the full Science Board, which is scheduled to discuss it at a public meeting Oct. 31.

In a statement released yesterday, the FDA said additional study of BPA ``would be valuable.''

``The FDA is already moving forward with planned research to address the potential low-dose effects of bisphenol A, and we will carefully evaluate the findings of these studies,'' the agency said in its statement.

An estimated 93 percent of Americans have traces of bisphenol A in their urine, according to the Centers for Disease Control and Prevention based in Atlanta. The chemical was declared ``toxic'' in April by the Canadian government, which plans to ban baby bottles made with BPA.

Product Bans

The American Chemistry Council, an industry group, says ``trace levels'' in consumer products don't pose a risk. Still, Energizer Holdings Inc.'s Playtex Infant Care unit and Thermo Fisher Scientific Inc., the maker of Nalgene sports bottles, have stopped using BPA in their new products.

The FDA, in its statement, said Canadian regulators acted ``out of an abundance of caution'' though ``Health Canada's assessment of bisphenol A on newborns and infants up to 18 months of age concludes that exposure levels are below the levels that could cause health effects.''

Animal studies reviewed by the U.S. government's National Toxicology Program this year also linked the chemical to developmental changes in fetuses and young children. The group, which is part of the Health and Human Services Department, ranked the risk level for children in the middle of a five-point scale.

Conflict of Interest

Lawmakers, including DeLauro, also have raised questions about ties between Martin Philbert, acting director of the Risk Science Center at the University of Michigan, and the chemical industry. The center received grants totaling $15 million from Dow Chemical Co., a manufacturer of BPA, DeLauro has said.

Philbert heads the advisory panel that issued the report critical of the FDA.

Randall Lutter, the FDA's deputy commissioner for policy, today issued a letter to the head of the Science Board saying ``it might be wise'' for Philbert not to vote on questions about BPA before the panel.

To contact the reporter on this story: David Olmos in San Francisco at dolmos@bloomberg.net.

Last Updated: October 29, 2008 13:54 EDT

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