It's the official legislative reason that the EPA's 2001 upgraded toxicity assessment for TCE was withdrawn. You remember this assessment, don't you? It's the one in which the EPA most recently determined that TCE is highly likely to cause cancer in humans. Well, Industry basically told the EPA in response to its draft, "We think your assessment lacks scientific integrity.*" Based on this complaint in an official request under the Data Quality Act, the EPA acquiesced and pulled its report.

So what is this Data Quality Act ?

According to this fine PDF summary from ENVIRON International Corporation (aka the ENVIRON Health Sciences Institute), the act requires the EPA (and all federal agencies) to:

1. Issue data quality guidelines ensuring and maximizing the quality, objectivity, utility and integrity of information (including statistical information) disseminated by the agency;

2. Establish administrative mechanisms allowing affected persons to seek and obtain correction of information maintained and disseminated by the agency that does not comply with the data quality guidelines; and

3. Periodically report on the number and nature of complaints received by the agency regarding the accuracy of information disseminated by the agency, and how such complaints were handled by the agency.

Those are the basic provisions of the act. The rationale behind them is explained:

As stated in the Data Quality Guidelines, there are many existing agency statues, regulations (for example, data quality requirements set forth under the Safe Drinking Water Act), and scientific practices that USEPA employs to implement these guidelines, including both internal quality management systems and external peer review. Further, USEPA believes that if data are subjected to formal, independent, external peer review, the information may generally be presumed to be of acceptable objectivity. However, this presumption of objectivity is rebuttable.

Therefore, the most significant aspect of the Data Quality Act is the provision of a mechanism that enables the public to seek and obtain, where appropriate, correction of disseminated information that does not comply with the Data Quality Guidelines.

OK, so here's what that actually means:

Persons believing that information being disseminated by USEPA does not meet the requirements of the Data Quality Act may submit a Request for Correction (RFC) to USEPA. The RFC should include (1) an explanation of how the information does not comply with USEPA or OMB guidelines, (2) a recommendation for corrective action, and (3) an explanation of how the alleged error affects or how a correction would benefit the petitioner.

In developing an RFC, the following issues should be considered: Is the information accurate, reliable and unbiased? For example, (1) was the best available science employed in accordance with sound and objective scientific practices, including, when available, peer reviewed science and supporting studies, and (2) were data collected by accepted or best available methods?

And finally, here's how it was generally applied to TCE:

One particular example of a potential source for an RFC is USEPA’s current use of human health toxicity data presented in the August 2001 external review draft of the Trichloroethylene (TCE) Health Risk Synthesis and Characterization report (Cogliano 2001). Specifically, senior staff of ENVIRON International Corporation who were intimately involved with underlying studies used by USEPA in the TCE risk assessment have identified this risk assessment as fundamentally flawed due in part to inappropriate use of risk estimates based on studies that are inadequate for quantitative purposes. Further, the risk assessment fails to address the issue of carcinogenicity by inhalation which is critical for estimating vapor inhalation risks which often drive site risk assessments. The key bases for challenging the TCE risk assessment under the Data Quality Act are detailed in ENVIRON’s Evaluation of the Conformance of the EPA Draft Trichloroethylene Health Risk Assessment to the Data Quality Act of 2001 (2002).

We're trying to get ahold of the full ENVIRON evaluation mentioned in this last line so we can report how this was specifically applied to TCE. If anybody knows where we can find it faster, please let us know.

For more on the Data Quality Act, see this Washington Post article, Data Quality Law is Nemesis of Regulation (warning: free registration required)


*Because don't we all first think of Industry when we think of the notions integrity and protecting public health?