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WASHINGTON (March 16, 2021) – The American Chemistry Council (ACC) today sent a letter to the Environmental Protection Agency (EPA) responding to accusations of political interference in the agency’s risk characterization of trichloroethylene (TCE) and calling for an independent review of the health endpoint in question should EPA decide to reevaluate the decision in the final risk evaluation released in November 2020.

In the letter to EPA Acting Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff, ACC reiterated its concerns with the agency’s treatment of fetal cardiac defects (FCDs) in the TCE risk evaluation but agreed with EPA’s decision not to use the endpoint for its risk determination. ACC Senior Director Steve Risotto pointed to recent reviews by the EPA Science Advisory Committee on Chemicals (SACC) and the National Academies of Science, Engineering and Medicine which confirmed that the weight of scientific evidence does not support using the cardiac endpoint for determining risk

“If your office decides to reconsider the conclusions regarding cardiac effects, we urge you to commission an independent review panel with the appropriate expertise to ensure the transparency and objectivity of the process,” Risotto wrote.

Last November, EPA released its final risk evaluation for TCE, as mandated by the Toxic Substances Control Act (TSCA) amendments passed by Congress in 2016. Upon release, ACC stated that the agency had not gone far enough in invalidating the purported risk of cardiac effects, which is not supported by the vast majority of available research.

Complete text of the letter can be found below:

March 16, 2021

Michal Freedhoff, Ph.D.
Acting Assistant Administrator
Office of Chemical Safety and Pollution Prevention
US Environmental Protection Agency
1200 Pennsylvania Ave. NW
Washington, DC 20460

Re: TSCA Trichloroethylene Risk Evaluation

Acting Assistant Administrator Freedhoff:

In recent correspondence to Acting Administrator Nishida, Alaska Community Action on Toxics and several other groups1 requested that your office reconsider its conclusions regarding fetal heart malformations in the final Risk Evaluation for Trichloroethylene (TCE). The request is based on an allegation of political interference in a February 2020 Reveal News story.

ACC also has concerns with the Agency’s evaluation of the fetal heart malformations, and recent reviews by the Agency’s Science Advisory Committee on Chemicals (SACC) and the National Academies of Science, Engineering and Medicine (NASEM) have confirmed that the weight of scientific evidence does not support the use the cardiac endpoint as a basis for risk determination. If your office decides to reconsider the conclusions regarding cardiac effects, however, we urge you to commission an independent review panel with the appropriate expertise to ensure the transparency and objectivity of the process.

The February 26 letter from the environmental groups provides a detailed accounting of events leading up to the release of the draft Risk Evaluation in February 2020, but it neglects to discuss significant events that occurred subsequent to the release of the draft. These more recent events include the review of the draft Risk Evaluation by the SACC and the recent NASEM report on the systematic review process used for evaluating TCE and nine other priority chemicals under Section 6 of the Toxic Substances Control Act (TSCA).

Included in the list of charge questions developed by the Agency for the SACC’s review of the TCE Risk Evaluation last March was a specific request to comment on the “weight of evidence (WOE) analysis approach and conclusions for [fetal heart malformations].” In response, the majority of the 27 standing and ad hoc members of the Committee agreed that the limited evidence for heart malformations should not be used for the purposes of quantifying risks.

In its report to the Agency, the SACC identified a number of concerns with the draft Evaluation’s analysis of the health endpoint, noting that the scoring of results for cardiac effects was “overly simplistic, difficult to understand, and problematic in its value judgments and net result.”2 Importantly, the SACC recommended that the Agency “revise and expand” its justification for not using fetal heart malformations for its risk determination but did not challenge the decision to use another health endpoint.

The recent NASEM report from its review of the TSCA systematic review process was similarly critical of the WOE analysis in the TCE Risk Evaluation.3 The committee’s review included an evaluation of cardiac defects for TCE as “the only example of a WOE determination or evidence evaluation provided by the Agency.” The Committee concluded that overall confidence in the results of the TCE hazard review was “critically low” and that the review “should not be relied on to provide an accurate and comprehensive summary of the available studies.” The committee also noted that the TCE evaluation of the cardiac endpoint conflated aspects of three important systematic review elements – an evaluation of the individual studies, consideration of the body of evidence, and the level of confidence in a recommendation or determination of causation.

The NASEM committee report concluded that the lack of a documented process to explain deviations from standard practice greatly impacts the transparency of the evidence integration for heart defects. In particular, the committee noted that the use of two different methods within the evidence integration step (mathematical average, semi-qualitative grouping) is troubling and “runs completely counter” to published Agency guidance.

Like the SACC and NASEM, ACC is deeply concerned about the significant divergence from standard practice and Agency guidance evidenced by the Agency’s analysis of heart malformation data for TCE. Given the considerable irregularities in the analysis, any further review of the cardiac endpoint should be conducted by an independent group of the appropriate experts to ensure the credibility of such a review.

Sincerely,
Stephen P. Risotto
Senior Director
American Chemistry Council

 

1 Letter from Alaska Community Action on Toxics, et al. to Acting Administrator Jane Nishida, February 26, 2021.
2 TSCA Science Advisory Committee on Chemicals. Meeting Minutes and Final Report No. 2020-4 (2020). EPA-HQ-OPPT-2019-0500-0111
3
NASEM. The Use of Systematic Review in EPA’s Toxic Substances Control Act Risk Evaluations. Washington, DC. National Academies Press (2021). https://doi.org/10.17226/25952.

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