EPA Faces Growing Calls To Subject Science To Strict Data Quality Rules

EPA is facing growing calls from industry, GOP lawmakers and the White House budget office to apply strict Data Quality Act (DQA) requirements to agency science, a push that could make it difficult for the agency to use some scientific data to justify stringent new chemical safety, cleanup and climate policy decisions.

Legal and regulatory sources say industry and Republican lawmakers could increasingly use the DQA to question agency policy decisions and regulations, particularly if they believe the Obama EPA's growing regulatory push is not firmly based on the underlying science.

The increased use of DQA is "driven by an increase in regulation. . . . More and more people are impacted" by agency rules, says a source with the Center for Regulatory Effectiveness (CRE), a think tank with industry ties that supports greater use of DQA petitions.

But the new push to force agencies to follow the DQA requirements could face hurdles as courts have so far largely rejected industry efforts to enforce the law in court, though industry sources say one recent ruling may open the door to future challenges, such as an expected challenge to EPA's assessment of arsenic risks.

Another hurdle, say public health advocates who oppose application of the law, is that the Obama administration is unlikely to enforce DQA requirements in the same way the Bush administration did. "I don't think you can conclude [the White House regulatory review office] will be actively supporting that just on the basis of what we've seen so far," a source with the Center for Progressive Reform, a think tank that supports greater environmental and human health protections. If the White House Office of Management & Budget (OMB) were to begin pushing the increased use of the DQA, it would be "such a throwback to the bad old days," the source says.

The DQA requires EPA and other federal agencies to ensure that scientific and other data used to develop policy stances are objective, reproducible and peer-reviewed. The law requires agencies to accept and respond to petitions to correct allegedly flawed data used in rulemakings and other decisions.

Environmentalists have also opposed application of the requirements, saying the petitions delay regulation and stymie agency action.

While the new push faces political and legal hurdles, many are nevertheless calling for EPA to follow the requirements. OMB recently called on EPA to follow DQA guidelines when peer reviewing chemical risk assessments for the agency's Integrated Risk Information System (IRIS) database, which could require peer reviewers to ensure that any recommendations and scientific data under consideration meets strict standards for objectivity and reproducibility (Inside EPA, May 7). The calls were included in OMB comments on the draft risk assessment for the solvent dichloromethane.

IRIS is "notorious" for "pushing the outcome" of what the science actually shows, a legal source says, pointing to the National Academy of Sciences reviews that have questioned the approaches used in EPA chemical assessments.

Industry officials have echoed those calls, urging a peer review panel considering EPA's latest draft IRIS assessment of the risks posed by the ubiquitous drinking water contaminant trichloroethylene (TCE) to consider whether the draft, and their review, are consistent with the DQA, particularly its requirement of objectivity.

"The DQA requires [EPA and other federal agencies to provide data that is] unbiased in presentation and in substance," Pat Casano, a representative of General Electric, argued at a May 10 public meeting, charging that EPA's assessment is not objective in its consideration of TCE's risks, which she called "the most important requirement" of the DQA.

Casano said that DQA "requires EPA to provide all of the evidence, especially those that don't meet its criteria" for showing associations between health effects and exposure to the examined chemical or contaminant. Instead, Casano argues, there are "simply too many examples where EPA has used the studies that support its conclusions and discounted" those that did not. She added that this is not only true for the draft assessment of TCE, but also for other recently released draft assessments, including EPA's cancer risk assessment of arsenic.

Industry is also warning that stricter EPA regulation of some chemicals is also at odds with the DQA. For example, both Dow Chemical and the American Chemistry Council argued in recent comments that EPA's proposed targets for cleaning up soil contaminated with dioxin "do not comport" with DQA guidelines. According to Dow's April 2 comments on the interim goals, "For numerous reasons, the information that constitutes the proposed action meets neither the 'objectivity' nor the 'utility' standards set forth in EPA's [DQA] implementing guidelines."

And House Republicans are reiterating past calls for EPA to apply DQA requirements to its climate risk finding, calls that EPA in the past has rejected. EPA is "violating its own rules" by relying on data from the International Panel on Climate Change that is not "clear and transparent" for the agency's climate endangerment finding, Republicans on the House Select Committee on Global Warming said in a May 6 report.

But EPA is rejecting their efforts. In a statement, an EPA spokeswoman notes that while some "corporate interest groups" have challenged its assertion that greenhouse gases threaten public health, "the agency has not yet seen anything that would justify reopening the endangerment finding." The spokeswoman maintains that EPA "undertook a comprehensive and transparent review of the soundest available science," relying on "an array of highly respected, peer-reviewed sources."

Industry sources say they are also considering new data challenges. For example, one industry source says there could be a DQA petition questioning the studies used by EPA in its recently released draft risk assessment of arsenic, based on questions about the underlying studies used in the assessment. The group is questioning why the assessment is not using studies from after 2007 in the assessment, among other issues, a source says.

Industry sources say the new challenges could be bolstered by a recent appellate court ruling -- Prime Time Int'l Co. v. Vilsack -- where the U.S. Court of Appeals for the District of Columbia Circuit backed government arguments that "the substantive [U.S. Department of Agriculture] action at issue was an 'adjudication,' and therefore specifically exempt from the [DQA] under the OMB guidelines," according to the CRE Web site. This means other agency actions that are not adjudications could potentially be challenged and invalidate the legal precedent set by the 4th Circuit in the Salt Institute & U.S. Chamber of Commerce v. Michael Leavitt ruling.

"All we can do is keep reminding [EPA and other agencies]" about DQA requirements, says one industry source, who says the issue of whether DQA petitions are judicially reviewable is not settled. "At some point -- on some point or document -- it will go to court," the source says.

Inside EPA