Issue Date: October 6, 2008
EPA's Scientific Integrity Probed
DID THE ENVIRONMENTAL Protection Agency acquiesce to the chemical industry by deleting a peer reviewer's comments on a report about a substance's hazards, or was EPA protecting its scientific integrity?
This question swirls around the agency's removal of comments by Deborah Rice, a widely respected toxicologist, from a completed peer review of an EPA assessment of four polybrominated diphenyl ethers (PBDEs). It is also at the heart of a congressional investigation into scientific integrity at the agency.
PBDEs are used as flame retardants, especially in the plastic housing of computers, televisions, and other electronic equipment. According to the Agency for Toxic Substances & Disease Registry, PBDEs may cause neurobehavioral problems and adversely affect the immune system.
EPA removed Rice's comments from a completed peer-reviewed report on the four PBDEs after complaints from the American Chemistry Council, a chemical industry trade association. ACC said Rice, who chaired the five-member peer review panel, "might lack the impartiality and objectivity necessary to conduct a fair and impartial review of the data." The concern is justified, ACC argued, because Rice had testified before the Maine Legislature as state lawmakers considered a ban on one of the flame retardants under EPA review, deca-BDE. Maine has since enacted a law phasing out use of this chemical in plastic-cased electronics by 2010.
According to ACC, the agency didn't go far enough to protect the scientific process and should have jettisoned the whole peer review panel and started afresh.
But if EPA had abandoned the peer review report and convened a new one, the move would have set back completion of the agency's hazard assessment of the four PBDEs. This, in turn, would delay any new regulation of the chemicals—especially the widely used deca-BDE—that might be based on the assessment.
AS THIS CASE UNFOLDED, some Democrats in Congress, backed by environmental activists, said EPA's actions demonstrated the sway of industry over the agency. Rep. John D. Dingell (D-Mich.), chairman of the House of Representatives' Energy & Commerce Committee, in April launched an investigation that included not just the incident with Rice, but also the chemical industry's power over how science is used to shape national discussions on product safety (C&EN, April 14, page 35).
EPA has been tight-lipped about its actions in the Rice affair—until recently.
George M. Gray, EPA assistant administrator for research and development, spoke publicly for the first time about the issue at a Sept. 18 congressional hearing convened by the House Energy & Commerce Subcommittee on Oversight & Investigations. According to Gray, EPA eliminated Rice's peer review comments because of a conflict of interest or the content of her testimony to the Maine Legislature. Instead, the agency erased her comments due to Rice's failure to disclose her testimony before the state lawmakers, he said.
"The subject of her testimony is not what's important," Gray told the subcommittee. "What's important is the fact that it wasn't disclosed to us.
"Dr. Rice was asked just before the peer review panel got together, 'Have you made any public statements or taken positions on this or other subjects closely related to the chemical or topic under review?' " Gray said. Rice, who had spoken before the Maine Legislature the day before, responded with a no, according to Gray.
Rice told the congressional subcommittee that, contrary to ACC's claims, she did not testify in favor of a Maine ban on deca-BDE. Rice, a toxicologist for the Maine Center for Disease Control & Prevention, explained that her job requires her to provide expert scientific opinion to her state's Legislature. She said she spoke to Maine lawmakers about whether safer alternatives to deca-DBE existed (C&EN, Sept. 22, page 12). Rice said her comments to the Legislature on deca-BDE focused on the compound's persistence in the environment and its propensity to bioaccumulate.
In contrast, the EPA assessment that Rice helped peer review focuses on the toxicity of four PBDEs, and not on whether it can bioaccumulate or persist in the environment. The assessment derived a safe daily dose for ingestion of each of the flame retardants. Safe daily doses set by EPA are used by regulators at the agency, in states, and in other countries for decisions that range from cleanup standards to controls on production or use of a substance.
Derivation of a safe daily dose "is a very limited exercise," Rice told the congressional subcommittee. "It talks only about the hazards, it talks only about toxicity" and not other properties of a chemical, such as bioaccumulation, she noted. According to Rice, her testimony to the Maine Legislature was only about properties of deca-BDE other than its toxicity, and she said nothing about a possible safe daily dose.
"In retrospect, I probably should have said to EPA that I testified to the Maine Legislature," Rice acknowledged at the hearing. "But in my mind, the two exercises, the two topics were completely separate."
The EPA contractor that assembled the PBDE review panel of scientists from outside the agency, Gray said, "did not have the information needed to make an appropriate judgment" on whether Rice was a suitable candidate as a peer reviewer. The agency uses a contractor to assemble the panel in order to maintain a distance between the reviewers and EPA as an ethical safeguard.
Because Rice didn't follow EPA's disclosure procedure, "it was inappropriate for her comments to be part of that record," Gray said. Thus, EPA redacted them.
"If she would have disclosed, I'm guessing that the contractor would not have changed the situation" and Rice still would have been chosen for the peer review panel, Gray stated.
REP. BART STUPAK (D-Mich.), chairman of the Oversight & Investigations Subcommittee, told Gray, "I can't believe you disqualified her on this." Stupak noted that Rice's comments about EPA's draft assessment were essentially the same as the other four peer reviewers on the panel.
"It's important to have a process of integrity that people can trust," Gray responded. "We didn't want to start over" with the peer review process, which ended two months before ACC lodged its complaint, he said. By redacting Rice's comments, EPA moved the assessment forward, he continued. "It was an appropriate response," Gray argued.
But Sharon H. Kneiss, vice president of ACC's products divisions, said EPA did not go far enough. She told the subcommittee that Rice's public statements "could reasonably lead to the perception that she had clearly taken sides and was unwilling to consider other perspectives."
"The appropriate response would have been to reconstruct the entire panel," she told the subcommittee. "Instead, EPA's actions undermined the confidence that anyone, including the agency itself, can have either in the process it followed" or in the resulting determination of the safe daily dose for deca-BDE, Kneiss stated.
The debate over EPA's removal of Rice's comments continues. Gray told reporters that the agency's inspector general is scrutinizing the situation. The report from EPA's internal probe is expected to be completed in the coming days, he added. Meanwhile, an aide to the Energy & Commerce Committee tells C&EN that the investigation into the integrity of EPA's science, which includes the agency's expunging of Rice's comments, is ongoing.
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