//About 3,7 million tons of Bisphenol A are produced every year worldwide. BPA has been used in babies' drinks bottles and teats in addition to food packaging. The largest producers are Sunoco, Dow, Bayer, Hexion and GE. Bayer has a 25% market share in the US.//
Oct. 22, 2008, Milwaukee Journal Sentinel
Plastics industry behind FDA research on bisphenol A, study finds
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.
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 have financial 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." By SUSANNE RUST and MEG KISSINGER
New York Times, October 30, 2008
Panel Faults FDA on Stance That Chemical in Plastic Is Safe
A scientific panel has issued a blistering report against the Food and Drug Administration, saying it ignored important evidence in reassuring consumers about the safety of the controversial chemical bisphenol-A.
The panel, in a report issued this week, did not draw any conclusions about the safety of the chemical, known as BPA. But it criticized the drug agency as ignoring crucial studies and using what it said were flawed methods in reaching its conclusions.
The agencys evaluation of BPA “creates a false sense of security and “overlooks a wide range of potentially serious findings, the report said.
In a statement, the agency said that the report “raised important questions and that more study was needed, but it did not back away from its claim that the chemical was safe. It will review the report on Friday.
BPA is widely used to make hard, clear plastic water bottles and baby bottles, and it is found in the lining of nearly every soft drink and canned food product. The chemical appears to have estrogen-like effects, and in animal studies it appears to accelerate puberty and pose a cancer risk.
While most worries about BPA focus on children, some reports suggest BPA may interfere with chemotherapy, and in adults the chemical has been tied to higher risk for heart disease and diabetes. The drug agency has said the levels of BPA to which children and adults are exposed do not pose a meaningful risk.
This fall, the agency asked an independent panel of scientific advisers to review its conclusions on BPA. The seven-member panel includes environmental health, toxicology and statistics experts from three major universities, the Environmental Protection Agency and the Centers for Disease Control and Prevention.
These are among the concerns raised by the panel:
The F.D.A. assessment does not have an adequate number of infant-formula samples and relies too heavily on averages, rather than accounting for variability in the samples.
The agency excluded several important animal studies that raised questions about the safety of BPA.
New research on BPA in adult humans and animals was published after the F.D.A.s draft report and should be included.
The margins of safety for BPA exposure used by the agency are “inadequate.
In its statement, the agency said consumers should know that “based on all available evidence, the present consensus among regulatory agencies in the United States, Canada, Europe and Japan is that current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and babies. By TARA PARKER-POPE
Milwaukee Journal Sentinel Posted: Jun. 3, 2009
House panel wants new review of BPA safety
Congressmen ask FDA to assess closeness to chemical industry
By Meg Kissinger and Susanne Rust of the Journal Sentinel
A congressional committee is investigating whether the Food and Drug Administration gave undue influence to chemical makers after several recent reports in the Journal Sentinel revealed how government regulators relied heavily on industry lobbyists when considering the safety of the controversial chemical bisphenol A.
Henry Waxman (D-Calif.), chairman of the House Committee on Energy and Commerce, and Bart Stupak (D-Mich.), chairman of the Subcommittee on Oversight and Investigations, wrote FDA Commissioner Margaret Hamburg on Tuesday, asking the agency to examine its relationship with industry groups. They also want the FDA to reconsider its assessment that the chemical is safe.
FDA spokesman Michael Herndon said Tuesday that the agency is expected to release a new decision on the chemical within "weeks, not months."
Also on Tuesday, the California Senate voted to ban BPA from food and drink containers designed for children ages 3 and younger. The bill moves to the state Assembly for a vote.
The federal investigation comes after the Journal Sentinel revealed Saturday that lobbyists met last week at an exclusive club in Washington to hammer out a public relations strategy to sell the benefits of BPA to the American public, including "befriending people that are able to manipulate the legislative process."
The group also discussed hiring a pregnant woman as a spokeswoman for the chemical, referring to such a person as the "holy grail" for the public-relations campaign.
That story followed earlier reports in the Journal Sentinel that showed how industry lobbyists wrote large sections of the FDA opinion, released last September. The FDA's opinion was based on two studies, both paid for by industry. Those studies since have been assailed by an international consortium of scientists as "incomplete and unreliable," the newspaper reported in April.
Last month, the Journal Sentinel reported that e-mails obtained through the Freedom of Information Act showed that the FDA relied on chemical industry lobbyists to examine BPA's risks. The agency also counted on lobbyists to track legislation and even to monitor press coverage.
In one instance, an FDA official sought information from the chemical lobby to discredit a study that found the chemical caused miscarriages, even before FDA scientists had a chance to scrutinize the study.
"These new press accounts raise serious questions about the extent to which FDA relied on industry for independent scientific advice," Waxman and Stupak wrote.
The North American Metal Packaging Alliance, the lobby group for food packagers, has hired a crisis consultant firm.
The congressmen have written to John Rost, the association's chairman, demanding that he furnish them with all copies of documents and communications, including talking points, minutes, summaries, memorandums, media statements, e-mails and drafts. They also want a list of all those who attended last week's meeting.
Rost said Tuesday that he was too busy to talk to reporters.
However, the association posted a press release Saturday on its Web site defending its tactics.
"Should it come as a surprise that our industry seeks to defend the legitimate scientific process that has concluded BPA is safe to use in food contact applications?" the press release reads. "Should it be viewed as a scandal that the accumulated frustration of the industry leads to consideration of alternative means of communication? We think not."
BPA, found in the urine of 93% of Americans tested, has been linked to heart disease, cancers of the breast and prostate, heart disease and hyperactivity. Used to make hard, clear plastic, it leaches into food. The FDA ruled last September that the chemical is safe.
News of the lobbying efforts to manipulate the legislative process drew a sharp response from Rep. Edward J. Markey (D-Mass.), who introduced a bill in the House last March to ban BPA in all food and drink packaging.
"Instead of spending money to manipulate the legislative process through fear tactics or slick PR campaigns, I suggest these companies ramp up their research and development, ensuring that only safe alternatives to this dangerous substance are used in food and beverage containers," Markey said. "No matter how they package it, BPA is a toxic substance linked to cancer and heart disease."