A government report claiming that bisphenol A is safe was written largely by the plastics industry and others with a financial stake in the controversial chemical, the Journal Sentinel found.

Although the Food and Drug Administration will not reveal who prepared its draft, the agency's own documents show that the work was done primarily by those with the most to gain by downplaying concerns about the safety of the chemical.

That includes Stephen Hentges, executive director of the American Chemistry Council's group on bisphenol A, who commissioned a review of all studies of the neurotoxicity of bisphenol A and submitted it to the FDA. The FDA then used that report as the foundation for its evaluation of the chemical on neural and behavioral development. The American Chemistry Council is a trade group representing chemical manufacturers.

The FDA's draft, released in August, found no cause for worry about bisphenol A, which is found in thousands of household products, including baby bottles, infant formula containers and the lining of aluminum cans.

That finding is at odds with the conclusions of the FDA's own advisers from the National Toxicology Program. The NTP announced in September that the chemical is of some concern for effects on the development of the prostate gland and brain, and for behavioral effects in fetuses, infants and children. The NTP also found some concern for the neurodevelopment of young children, infants and fetuses.

Last week, the government of Canada declared that bisphenol A is a toxin and is banning its use in baby bottles and other products used by children.

The FDA draft finding no harm is under review by a subcommittee, which will decide if the conclusions need to be amended. That assessment is expected to be released any day and will be presented Oct. 31 in Washington

The Journal Sentinel reported earlier this month that subcommittee chairman Martin Philbert is founder and co-director of an institute that received $5 million from a retired medical supply manufacturer who said he considered bisphenol A "perfectly safe." The donor, Charles Gelman, told the newspaper that he has expressed his views to Philbert in several conversations.

Philbert at first denied ever having been contacted by Gelman about bisphenol A. He now says that he is aware of Gelman's views but is not influenced by them.

Congressional inquiry

A congressional committee launched an investigation into the connection, citing the newspaper report.

Those same congressional investigators are now looking into other possible conflicts of interest. They are scrutinizing the role that ICF, a consulting firm whose clients include the American Chemistry Council and the American Petroleum Institute, had in preparing the FDA draft.

Neither ICF nor the FDA would say what role the consulting firm had in the agency's review of the chemical. But the newspaper found reports issued to the FDA by the consulting firm from 2000 to 2007. Those reports included reviews of government and industry studies on the effects of bisphenol A on animal health.

The task force used ICF's reviews in its draft.

ICF spokesman Douglas Beck declined to comment on his company's involvement in the study of bisphenol A..

FDA spokesman Michael Herndon is referring all questions about the draft to congressional investigators.

The House Committee on Energy and Commerce and its subcommittee on Oversight and Investigation has asked FDA Commissioner Andrew von Eschenbach to appear for an interview by committee staff to explain the agency's decision-making relating to bisphenol A.

"Specifically, why industry-funded studies provide the basis of your regulatory decisions and why the totality of the science around the chemical continues to be ignored by your science-based agency," the committee letter said.

Investigators want transcripts of all communication between ICF and the FDA by Wednesday.

Poring over evidence

The newspaper reviewed the body of evidence that the task force considered. It found memos with entire sections blacked out, reviews commissioned by the American Plastics Council, an arm of the American Chemistry Council, and reviews completed by consulting firms with clients who havefinancial interests in the sale of bisphenol A.

Many of these reviews of individual studies are at odds with the NTP's reviews of the same studies.

For example, one study funded by the National Institutes of Health and the Department of Defense looked at the effects of bisphenol A on prostate development in rats.

The FDA called it "severely limited," in contrast to the NTP's review, which labeled it of "high utility."

Another government-funded study, which also looked at the effects of the chemical on the prostate, again was considered of "high utility" by the NTP for its evaluation, and it was deemed "very limited" by the FDA.

Much of the science that the task force considered was 20 years old or older, including a study commissioned in 1976.

The older studies are not as sensitive as modern tests. They used high doses of the chemical and did not consider the unique effects on the endocrine system.

Bisphenol A was developed in 1891 as a synthetic estrogen.

It came into widespread use in the 1950s when scientists realized it could be used to make polycarbonate plastic and some epoxy resins to line food and beverage cans.

The chemical is used in a host of products from dental sealants and eyeglasses to CDs and water bottles. Bisphenol A has been detected in the urine of 93% of Americans tested.

Sales of the chemical reached $6 billion worldwide in 2007.

Last year, the Journal Sentinel reviewed 258 research papers on bisphenol A and found that a large majority showed the chemical was harmful to lab animals. Those that didn't find harm overwhelmingly were paid for by the chemical industry. The newspaper also found that the government was basing its safety recommendations for bisphenol A on outdated studies performed more than two decades ago.

Columbia University professor David Rosner, who researches the relationship of industry and government regulators of toxic substances, has compared the controversy over bisphenol A to tobacco and asbestos.

"It makes sense that we have a process that is not tainted by corruption," he said. "This looks tainted."

A plastics industry spokeswoman defended the role of Hentges and others in shaping the FDA's task force draft. Hentges was out of the country on Wednesday and not available for comment.

Tiffany Harrington, spokeswoman for the American Chemistry Council, said Hentges was acting appropriately in his capacity as an advocate for the plastics industry.

"We are a stakeholder just like anyone else," Harrington said. "It's part of the process."