Issue Date: April 14, 2008
EPA Science Investigated
The chemical industry's ability to determine how science is used to shape the national debate over product safety is being investigated by a key House committee.
"Our committee intends to determine what influence the chemical industry yields over the scientific community and whether that influence is proper," said Rep. John D. Dingell (D-Mich.), chairman of the House Energy & Commerce Committee, in a statement releasing an April 2 letter to the American Chemistry Council (ACC). The letter seeks a long list of documents from the U.S. chemical industry's primary lobbying arm.
In mid-March, Dingell's committee also asked the Environmental Protection Agency for related documents and raised similar concerns that agency science is biased in the chemical industry's favor. Both requests demand the information within two weeks from the dates of the letters.
The genesis of the congressional investigations is ACC's successful demand that EPA retroactively remove the views of the chairwoman who had overseen a peer review assessment on a family of flame retardants. The agency struck the chairwoman's views after the report had been published. The investigation, however, goes beyond this apparent influencing of EPA.
Among the requested data from ACC are "all records of payments and communications" between former American Chemical Society president William F. Carroll and ACC. Carroll served as ACS president in 2005 and, as a member of the three-year presidential succession, was a member of the society's board of directors in 2004–06.
The Energy & Commerce Committee is particularly concerned about "cross-pollination" between Carroll's role as the head of a society of chemical professionals while at the same time serving as a chief industry proponent for the vinyl industry, a committee staff member says.
Carroll has worked for Occidental Chemical continuously for nearly 30 years and is currently the company's vice president for chlorovinyl issues. He was identified in the House committee letter as an executive with the Vinyl Institute, an industry group allied with ACC. But Carroll strongly denies this: "I was never an executive with the institute. Our company is a member, but I have never worked for them," he says.
Carroll has had a long relationship with ACC, however, and was acting managing director of ACC's chlorine division for six months in 2006. And in 1994???96, he was a staff member of the Chlorine Chemistry Council, an ACC subsidiary. Carroll says he was never on the payroll of ACC or the chlorine council.
The committee is also seeking information on nine scientists with industry contacts who served on EPA review panels, as well as information on a law office and a public relations firm.
Additionally, the committee is exploring industry and science ties through information it is seeking about ACC's relationship to the International Society for Regulatory Toxicology & Pharmacology and its journal, Regulatory Toxicology & Pharmacology, which is owned and published by Elsevier. The society, the committee staff member says, is funded by several corporations and associations, including ACC.
Environmental and public health advocates have been critical of the journal. Jennifer Sass, a toxicologist with the Natural Resources Defense Council, says that in studies the journal publishes, previously reported toxic or adverse health effects from chemical exposure are downplayed, dismissed, or simply not mentioned. The journal includes mainly mathematical models and meta analyses of other published studies, she adds, and its editorial board includes attorneys who represent corporations.
Dingell asked ACC for records of any payments to journal officials, but Gio B. Gori, editor of the journal, tells C&EN he has never received money from ACC and is paid for his editing work by Elsevier. "I don't know why they're investigating us," he says. "We have nothing to hide."
At the heart of the investigation is Deborah C. Rice, a former EPA scientist and currently a toxicologist with the state of Maine, who chaired an EPA external peer review panel set up to conduct a toxicological review of polybrominated diphenyl ethers (PBDEs). The review of this group of flame retardants began in 2002. The European Union and several U.S. states have banned penta-BDE and octa-BDE. The main BDE found in commerce in the U.S. is deca-BDE, which is incorporated into plastics in the housings of television sets and other electric and electronic equipment, as well as upholstery for furniture and other items.
The peer review panel examined EPA's draft assessment of BDEs, which includes agency expert judgments on how much exposure to each BDE is safe. These judgments can have far-ranging regulatory effects.
EPA places its peer-reviewed judgments on safe doses of chemicals and the scientific justification behind them in a database called the Integrated Risk Information System, which is available on the Web. EPA, other federal agencies, state environmental departments, and even regulators in foreign countries rely on the database. For instance, they often depend on the database's safe daily dose numbers to decide how much cleanup a polluter must do at a contaminated site.
Rice is a world-class toxicologist, according to several toxicologists interviewed by C&EN, some of whom are associated with EPA and did not wish to comment publicly. She was a toxicologist with Health Canada and the U.S. EPA's National Center for Environmental Assessment, which is conducting the PBDE review.
Rice declined to comment to C&EN, as did EPA officials.
Rice was selected for the peer review panel in 2006 and was one of five reviewers. The panel met in February 2007 and issued its assessment in mid-March, when EPA posted the report on its website.
On May 3, 2007, ACC wrote to George M. Gray, EPA assistant administrator for R&D, complaining about "the appearance that [the] peer review panel's leadership might lack the impartiality and objectivity necessary to conduct a fair and impartial review of the data." Rice, the letter says, had testified before the Maine State Legislature on behalf of a state agency, the Center for Disease Control & Prevention, where she works. There, she advocated a phaseout of deca-BDE.
Rice simply conveyed the policy position of her employer to state lawmakers, says Sonya Lunder, senior analyst with the Environmental Working Group, a nonprofit advocacy and research organization.
In a Jan. 8, 2008, letter to ACC, Gray announced that the agency had removed all of Rice's comments from the final peer review report. The agency had redacted her comments from the report and reposted it to the website.
In his Jan. 8 letter, Gray said his letter was a follow-up to a June 15, 2007, meeting with ACC to discuss Rice's involvement. Gray wrote in his letter that EPA made the changes because "one of the panel members had a potential conflict of interest."
At ACC's urging, Gray said he had also reviewed initial and final comments of other panel reviewers to determine if the chairwoman had influenced their views. His review found "minor additions" from reviewers but provided no evidence that Rice had "significantly influenced the other panelists."
Rice "has no conflict of interest that I'm aware of," says Merrill Goozner, director of the Integrity in Science project at the watchdog group Center for Science in the Public Interest. Under federal laws and policies for advisory panels, conflicts of interest have to do with advisers' potential financial gain or loss from their recommendations.
Goozner's group and environmental organizations regularly write letters to EPA contending that external peer reviewers have financial conflicts of interest. "ACC has every right to write a letter to EPA, just like we do," he tells C&EN. It is the agency's job, Goozner says, to investigate the situation and determine if a reviewer indeed has a conflict.
EPA, however, "made the wrong decision" in Rice's case, Goozner says.
"Apparently, EPA didn't want to hear from this person because industry disagreed with her conclusions," says David Michaels, a professor of environmental and occupational health at George Washington University.
Michaels, former Department of Energy assistant secretary for environment, safety, and health, says the removal of Rice from the panel is consistent with other actions the Bush Administration has taken to stack advisory groups with scientists favorable to its views and to silence opponents.
Lunder and other scientists interviewed by C&EN warn of the chilling effect Gray's actions may have on other scientists asked to take part in peer reviews. They note that Rice had already been vetted and selected by EPA and the contractor that put together the panel.
"Peer reviewers should be free to say whatever they think," Lunder says, "and to have retroactive retaliation by removing your name sends a message that if you say something unpopular or out of line with EPA, your views may get dropped. It challenges the whole principle of review by an unbiased panel without fear of retribution."
In a statement released earlier this month, ACC said its "strong support for science" and "an independent peer review process" led it to raise concerns with EPA about Rice's membership on the PBDE panel. "We believe EPA acted appropriately and consistently with the rules governing membership in scientific review panels," the industry group said.
"ACC will work with the Energy & Commerce Committee to provide it with the requested materials pertaining to this matter," the statement said.
The final toxicological human health assessment of PBDE is expected this month. It is now being examined by the White House's Office of Management & Budget, according to EPA officials. An official familiar with the draft said Rice's toxicological studies are cited in the assessment although her views on the draft had been struck.
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