Industry Questions Data Quality, Objectivity Of EPA’s TCE Assessment


Date: May 11, 2010 -


An aerospace industry official is urging an expert peer review panel considering EPA’s latest draft 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 Data Quality Act (DQA), particularly its requirement of objectivity.


Pat Casano, an attorney with the General Electric Co., argued at a May 10 public comment period that EPA’s assessment is not objective in its consideration of TCE’s risks, which she called “the most important requirement” of the DQA.


“The DQA requires [EPA and other federal agencies to provide data that is] unbiased in presentation and in substance,” Casano said. “It 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.


Her argument was reiterated by other industry representatives who spoke before the Science Advisory Board peer review panel. The panel is meeting May 10-12 in Washington, DC to review the assessment of the common solvent, which has been more than 10 years in the making.


Casano’s call for the peer review to follow the DQA is the latest call for EPA risk assessments to follow the law’s requirements. The Office of Management & Budget (OMB) is also calling for EPA to follow data quality requirements in comments on EPA’s draft assessment of dichloromethane (see related story).


When completed, EPA’s draft assessment of TCE will replace the 1987 Integrated Risk Information System (IRIS) cancer assessment of TCE. EPA and state governments routinely use the IRIS database to set regulatory limits.


EPA withdrew the cancer portion of the IRIS publication for TCE in 1989. A 2001 draft, which is significantly stricter than the 1992 assessment, was shelved under pressure from the Defense Department (DoD) and National Aeronautic and Space Administration, while the National Academy of Sciences reviewed key aspects of the assessment.


The latest draft, however, does not substantially change the cancer assessment from EPA’s 2001 draft, nor its reference dose, the amount EPA considers safe to ingest daily based on non-cancer effects. The reference concentration, or the amount EPA considers safe to inhale daily based on non-cancer effects, that EPA proposes is eight times more strict than the one proposed in the 2001 draft (Risk Policy Report, Nov. 10).


Casano argued that while those who are critiquing the assessment -- industry and other agencies -- have a stake in the outcome of the assessment, she argued that EPA does too. Other agencies, Casano acknowledged, can be regulated entities responsible for clean up as well as industry. But, she said, “every organization has an objective. So does EPA. That’s why we need independent peer review.”


Casano urged the review panel to consider the other agencies’ comments on the TCE draft assessment, and “actually address the agency comments and why changes [to EPA’s draft] are or are not warranted.”


The request has also been made by the Pentagon, a DoD source says. The request is among concerns that other agencies have about their role in the IRIS development process, after changes Administrator Lisa Jackson implemented last May. Among those are recommendations from OMB that EPA ensure its documents are DQA-compliant and that peer review panels ensure that their reports are also DQA-compliant. -- Maria Hegstad






Source: Risk Policy Report via

Date: May 11, 2010

Issue: Vol. 17, No. 19

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