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
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
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
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
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.