EDF Health

EPA refuses to extend TCE comment deadline, ignoring requests from Congress, health groups

By Joanna Slaney / Published: April 28, 2020

Joanna Slaney, Legislative Director and Lindsay McCormick, Program Manager. 

Yesterday, in the midst of the COVID-19 national emergency, the Environmental Protection Agency (EPA) closed the comment period on an extremely flawed draft risk evaluation on the toxic chemical, trichloroethylene (TCE).

Due to the many scientific and legal concerns raised by the draft risk evaluation, and its significance for any future regulation of TCE, the draft needs thorough and careful review from experts, the public, and other affected stakeholders. However, EPA refused to delay the deadline for the draft risk evaluation’s comment period, despite the growing hardships and major disruptions resulting from the current COVID-19 crisis.  EPA now seems intent on racing to the finish line with its flawed evaluation, ignoring multiple requests to ensure the document is fully vetted:

  • Congress: In two separate letters from the House and Senate, Members of Congress raised concerns with EPA moving forward with various rulemakings and scientific reviews without sufficient opportunity for expert and public input in light of the pandemic – explicitly referencing the TCE draft risk evaluation as a prime example.
  • Health groups: Health organizations whose staff and members are on the front lines of the pandemic requested that EPA extend the public comment period until after the national emergency is lifted due to severe capacity constraints. EPA did not respond.
  • Impacted communities: In early March, nearly 300 people from communities grappling with TCE contamination asked EPA to hold a public meeting to allow them “to ask questions of the agency and engage in critical dialogue.” EPA denied the request.

Read More »

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Peer reviewers of EPA’s TCE report must affirm that the key risk is fetal heart damage

By / Published: April 1, 2020

Richard Denison, Ph.D., is a Lead Senior Scientist.

Last week, the EPA Science Advisory Committee on Chemicals (SACC) conducted a virtual peer review meeting for the Agency’s draft risk evaluation of trichloroethylene (TCE). As expected, there was substantial discussion on the appropriateness of EPA’s decision to make risk determinations based on immune endpoints rather than fetal cardiac malformations (FCMs). Unfortunately, the review panel lacked anyone with specific expertise in cardiac development.

During the meeting, many of the peer review panelists signaled an initial inclination toward supporting EPA’s decision to use immune endpoints for risk determinations. However, panel members also noted with serious concern the recent investigations that have uncovered political influence exerted on EPA that led it to base the risk determinations in the draft risk evaluation on immune endpoints instead of FCMs.

Stepping back from the specifics of the discussions last week, it is important to understand the longstanding basis and support for EPA’s reliance on FCMs, the unprecedented nature of EPA’s decision to now move away from it, and the adverse implications of the decision for EPA’s ability to adequately manage the risks of TCE to all relevant subpopulations.

This decision is a major departure from thoroughly peer-reviewed science, fails to protect the most sensitive populations as mandated by TSCA, and deviates dramatically from existing Agency guidance. These concerns, discussed at length in EDF’s comments in the TCE Docket, are briefly summarized below:  Read More »

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EPA’s draft risk evaluation of trichloroethylene contains major scientific flaws that understate the chemical’s risk and demand robust review

By / Published: March 19, 2020

Richard Denison, Ph.D., is a Lead Senior Scientist.

Yesterday Environmental Defense Fund (EDF) filed comments on the Environmental Protection Agency’s draft risk evaluation for the highly toxic chemical trichloroethylene, or TCE.

This draft, readers will recall, is the document that the Trump White House forced EPA to dramatically weaken just prior to public release, as reported in detail by Elizabeth Shogren of Reveal News.

It is also the document that EPA seems intent on subjecting to a rushed peer review next week in a 4-day virtual meeting of the Scientific Advisory Committee on Chemicals (SACC) – despite numerous reasons why, in the midst of the current COVID-19 public health crisis, such a meeting simply will not provide the robust scientific review that this draft warrants.  EDF has urged EPA to postpone the SACC review so that it can be done under circumstances that are conducive to a proper review and fair to SACC members and stakeholders who would like to participate.

EDF submitted comments yesterday in order to meet the very tight deadline EPA set for comments if they are to be considered by the SACC.  Our comments raise numerous scientific deficiencies in EPA’s draft.  These flaws arise from a host of unwarranted and unsupported assumptions and methodological approaches that systematically lead EPA to understate the risks posed by this chemical to pregnant women, infants and children; to workers; to consumers; to the public; and to the environment.

Exposure to TCE is ubiquitous, coming from ambient and indoor air, vapor intrusion from contaminated sites, groundwater and drinking water wells, and food – yet EPA’s draft ignores or downplays each of these exposure sources and pathways.

It is vital that the current public health crisis caused by COVID-19 not be allowed to compromise the quality and integrity of scientific assessments of other critical public health risks we face.

Below I summarize some of the major concerns in EPA’s draft that we address in detail in our comments.  Read More »

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EPA needs to postpone next week’s peer review of its draft risk evaluation of trichloroethylene

By / Published: March 16, 2020

Richard Denison, Ph.D., is a Lead Senior Scientist.

As we all deal with an emerging major health crisis, it is critical that the quality of ongoing work on other issues vital to protecting public health is not sacrificed or compromised as a result.  Given this, we strongly urge EPA to postpone next week’s peer review of its draft risk evaluation of trichloroethylene.

A few short weeks ago, EPA issued a draft risk evaluation for a highly toxic chemical, trichloroethylene or TCE.  The draft is many hundreds of pages long (thousands of pages counting supplemental files).  EPA also scheduled the peer review by the Scientific Advisory Committee on Chemicals (SACC) for next week, March 24-27.

Even before the COVID-19 crisis, the time frame EPA provided for getting meaningful expert review of this important document was already questionable.  Now it is simply untenable.

As of now, EPA intends to proceed with the meeting as a virtual meeting.  While traveling to a meeting next week should of course be off the table, proceeding with a virtual meeting at this point is asking far too much of SACC members and their families and will clearly lead to a severely compromised peer review.  Consider, for example:

  • SACC members who are dealing with their own and their families’ health and well-being, are now being asked to spend dozens of hours over 4 days next week trying to participate in the virtual meeting. We all know how hard that is to do under normal circumstances.  It is unrealistic and unfair to expect it under our current circumstances.
  • Some SACC members are themselves members of the public health community that are responding to the COVID-19 crisis.
  • Many or most SACC members are faculty at colleges and universities, and hence are likely already grappling as part of their day jobs with a shift to online teaching.
  • SACC members are being expected to have found the time in these recent chaotic days to have read these massive documents, draft initial comments and be prepared to discuss all of this next week.
  • Stakeholders are preparing comments for the SACC’s consideration, which are due this Wednesday. SACC members are expected to review these materials on top of everything else.
  • Stakeholders from health and labor groups who have been participating in the risk evaluation process by providing comments to the SACC as well as EPA are presently consumed with addressing COVID-19 issues facing their members and constituents.

As we are learning in real time during this unfolding health crisis, ensuring there is sound expert input into public health decisions is absolutely essential.  We cannot let the current crisis result in a weakening of the quality and credibility of scientific input on other important public health issues.

EPA needs to promptly postpone the SACC peer review of TCE and reschedule it at a time and in a manner that respects the critical role the SACC plays.

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EPA’s draft risk evaluation of carbon tetrachloride is riddled with unsupported exclusions and assumptions

By / Published: February 21, 2020

Richard Denison, Ph.D., is a Lead Senior Scientist.

Next week, the Scientific Advisory Committee on Chemicals (SACC), established under the Toxic Substances Control Act (TSCA) to peer-review EPA’s draft chemical risk evaluations, will meet to review the latest of those drafts, for the likely human carcinogen carbon tetrachloride.

As with other recent draft risk evaluations, EPA has been scheduling the SACC meetings in the middle of rather than following the public comment period.  This means the public has at best a few weeks to digest these huge documents and draft and submit comments in order to have them be part of the record that the SACC is allowed to take into consideration in its peer review.

However, we have learned that EPA is now further constraining the SACC’s schedule, requesting that the panel members come to the peer review meeting with their comments already drafted, and then delivering their final report within 60 days rather than the 90 days previously provided.  These developments further jam both the public and the SACC in their efforts to ensure EPAs work is subject to a robust peer review.

Whatever the reasons for EPA making these changes, EDF decided to expedite our initial comments to seek to ensure they could be considered.  We submitted comments last week, a full week before the February 19 deadline, to ensure the SACC received and had sufficient time to review them in advance of the peer review meeting.

We deemed this critical because of the glaring gaps and flaws in EPA’s draft that lead it yet again to drastically understate the risks of this chemical.  These include the same problems that have plagued the draft risk evaluations for other chemicals, as well as new ones.  Read More »

Posted in Health policy, Health science, Industry influence, Regulation, TSCA reform, Worker safety / Tagged , , , | Comments are closed

More words minced this time, but EPA’s science advisors raise serious concerns with its draft risk evaluation of 1-bromopropane

By / Published: December 16, 2019

Richard Denison, Ph.D., is a Lead Senior Scientist.

The peer review report by the Scientific Advisory Committee on Chemicals (SACC) on EPA’s draft risk evaluation of 1-bromopropane (1-BP) has been released.  This carcinogenic solvent is one of the first 10 chemicals undergoing risk evaluation under the amended Toxic Substances Control Act (TSCA), and the new SACC report covers the fourth of EPA’s draft risk evaluations (DREs) to be peer-reviewed.  We’ve blogged earlier about the SACC’s reports on EPA’s draft risk evaluations for 1,4-dioxane and HBCD and Pigment Violet 29.

At first blush, the new report reads less harshly than the last one, and the SACC notes clear improvements in the content and organization of the 1-BP draft over earlier ones.  But even the Executive Summary raises quite scathing criticisms that go to the heart of whether EPA has developed sufficient data to support its risk determinations for this chemical.  Here is a telling excerpt (p. 17, emphases added):

Overall, the Committee concurred that even though data provided in the DRE underestimated risk, these data did support the finding of unreasonable risk to consumers and occupational conditions, including occupational non-users. Conversely, inadequate data were presented for a robust risk characterization for the environmental assessment, and the information provided did not support the conclusion of “no unreasonable risk to the environment.”

These conclusions mirror those drawn by EDF in the comments we submitted to EPA on the 1-BP DRE.

Themes sounded by the SACC in its earlier peer reviews came up again here.  Read More »

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