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Industry studies delay re-evaluation of plastics
Independent research warns of additive in baby bottles
BY LYNDSEY LAYTON The Washington Post

    WASHINGTON — Despite more than 100 published studies by government scientists and university laboratories that have raised health concerns about a chemical compound that is central to the multibillion-dollar plastics industry, the Food and Drug Administration has deemed it safe largely because of two studies, both funded by an industry trade group.
    The agency says it has relied on research backed by the American Plastics Council because it had input on its design, monitored its progress and reviewed the raw data.
    The compound, bisphenol A (BPA), has been linked to breast and prostate cancer, behavioral disorders and reproductive health problems in laboratory animals.
    As evidence mounts about the risks of using BPA in baby bottles and other products, some experts and industry critics contend that chemical manufacturers have exerted influence over federal regulators to keep a possibly unsafe product on the market.
    Congressional Democrats have begun investigating any industry influence in regulating BPA.
    “Tobacco figured this out, and essentially it’s the same model,” said David Michaels, who was a federal regulator in the Clinton administration. “If you fight the science, you’re able to postpone regulation and victim compensation, as well. As in this case, eventually the science becomes overwhelming. But if you can get five or 10 years of avoiding pollution control or production of chemicals, you’ve greatly increased your product.”
    Mitchell Cheeseman, deputy director of the FDA’s office of food additive safety, said the agency is not biased toward industry.
    “The fact is, it’s industry’s responsibility to demonstrate the safety of their products,” he said. “The fact that industry generated data to support the safety I don’t think is an unusual thing.”
    The FDA’s position on the compound was called into question earlier this month when a National Institutes of Health panel issued a draft report linking BPA to health concerns. Since then, Canadian regulators have banned BPA in baby products, and Sen. Charles Schumer, D-N.Y., has introduced a bill to prohibit some uses of the compound. Ten states, including California and Maryland, are weighing their own restrictions.
    U.S. manufacturers produce 7 billion pounds of BPA annually, and business worldwide has been growing about 4 percent a year, driven by rising demand in Asia. A U.S. government ban on BPA would affect thousands of businesses and perhaps billions of dollars in profit for its largest manufacturers.
DELAYING TACTICS
    As part of his investigation, Rep. John Dingell, D-Mich., chairman of the House Energy and Commerce Committee, wants to examine the role played by the Weinberg Group, a Washington firm that employs scientists, lawyers and public relations specialists to defend products from legal and regulatory action. The firm has worked on Agent Orange, tobacco and Teflon, among other products linked to health hazards, and congressional investigators say it was hired by Sunoco, a BPA manufacturer.
    Dingell has asked the Weinberg Group for all records related to its work in connection with BPA, including studies it has funded and payments made to experts. He cited a letter written by a company vice president in 2003 as Weinberg managed opposition in a longrunning regulatory battle over a compound in Teflon. The strategy would be to discourage “governmental agencies, the plaintiffs’ bar and misguided environmental groups from pursuing this matter any further,” the letter said.
    In a statement, Dingell said, “The tactics apparently employed by the Weinberg Group raise serious questions about whether science is for sale at these consulting groups, and the effect this faulty science might have on the public health.”
    Matthew Weinberg, the firm’s chief executive, declined to be interviewed. But in a brief written statement, he said the company will cooperate with Dingell’s investigation.
    “The analyses we conduct are rigorous and adhere to established principles of scientific integrity,” the statement said. “We believe it is in the public interest for all scientific research to be subject to scrutiny and the views of all affected parties to be heard.”
    Scientists first flagged possible health risks of BPA more than a decade ago. From 1997 to 2005, 116 studies of the compound were published, many of them focused on its effects in low doses. Of those funded by government, 90 percent showed a health effect linked to BPA. None of the industry-funded studies found an effect; all of them said BPA is safe.
BOUGHT SCIENCE
    There is a clear bias in studies funded by industry, said Michaels, who now runs the Project on Scientific Knowledge and Public Policy at George Washington University and who wrote the book “Doubt is Their Product,” which details how various industries have used science to stave off regulation.
    “This is a great example of the funding effect,” he said. “It’s not so much because scientists are shaving the truth, but they ask questions in a way to give them the answers they want.”
    Sharon Kneiss, vice president of products divisions for the American Chemistry Council, said in a conference call with reporters two weeks ago that industry research is unassailable. “We make it a policy to supply government agencies with data, and we have done it in the case of BPA,” she said. “We supplied studies following the highest levels of quality in terms of their study. We stand behind the quality of the studies.”
    The FDA and the Environmental Protection Agency both regulate BPA. Because the compound is most readily absorbed through food and drink, the FDA plays a critical regulatory role because it approves the compound’s use in plastic food containers and bottles, tableware and in the plastic linings of canned foods.
    For much of the regulatory history of BPA, traditional toxicology was used to assess risk to people — researchers tried to find the threshold amount above which BPA would cause cancer, malformation or death.
    Sarah Vogel, who holds a master’s degree in public health and is writing a doctoral dissertation at Columbia University on the politics and scientific history of BPA, said that because practical use of the compound was at levels much lower than the amount deemed toxic, scientists assumed it was safe. “The idea was: Look, this stuff is at such low levels, it really couldn’t effect any harm,” she said.