EDF Health

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

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.

Posted in EPA, Health Policy, Health Science, Regulation, TSCA Reform / Tagged , , | Comments are closed

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

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 EPA, 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

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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While harder to discern, another EPA risk evaluation severely understates risk, this time for methylene chloride

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

When EPA released the draft of its risk evaluation for methylene chloride at the end of last month, some were surprised that EPA had identified numerous unreasonable risks presented under a variety of the chemical’s conditions of use.

In an earlier post, EDF provided some context, noting how dangerous the chemical is and raising initial concerns that EPA was once again excluding known uses and exposures, making unsupported assumptions, and applying inappropriate risk benchmarks that were once again leading it to significantly understate the actual risks posed by methylene chloride.

Four weeks later, EDF has confirmed these concerns in spades.  Last night we filed 84 pages of comments on the draft risk evaluation, for consideration by EPA’s Scientific Advisory Committee on Chemicals (SACC), which will meet next week to peer review the draft.

EDF’s deep dive into the draft demonstrates that EPA has employed a host of unwarranted and unsupported assumptions and methodological approaches that lead it to either avoid identifying unreasonable risk when it should have, or to understate the extent and magnitude of the unreasonable risks it did identify.  Below we summarize some of the major concerns, which are addressed in detail in our comments.  Read More »

Posted in EPA, Health Policy, Health Science, Regulation, TSCA Reform, Worker Safety / Tagged , , | Comments are closed

EPA’s scientific peer reviewers don’t mince words in blasting its 1,4-dioxane and HBCD risk evaluations

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

Late Friday is getting to be a popular time for the toxics office at the Environmental Protection Agency (EPA) to publicly release the peer review reports of its Scientific Advisory Committee on Chemicals (SACC).

As EPA did for the Committee’s peer review report on the agency’s first draft risk evaluation under the Toxic Substances Control Act (TSCA), EPA quietly posted sometime quite late last Friday the SACC’s reports on the next two chemicals:  the likely carcinogenic solvent 1,4-dioxane and the developmentally toxic flame retardant hexabromocyclododecane (HBCD).

Even a quick read of the Executive Summaries of those reports amply illustrates why EPA sought to bury them.  I’ll focus here on 1,4-dioxane.

The SACC did note that the content and organization of this draft risk evaluation was “much improved” over the first one for Pigment Violet 29.  So much for the good news; things went downhill from there for EPA.  Read More »

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Next TSCA chemical peer reviews and draft risk evaluations to be delayed. You’ll never guess why.

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

We’re hearing that EPA has cancelled the next meeting of its Scientific Advisory Committee on Chemicals (SACC), which was scheduled for October 21-25.  The SACC is conducting peer reviews of EPA’s draft risk evaluations of the first 10 chemicals to undergo safety reviews under the Toxic Substances Control Act (TSCA).

Word is that the panel was to use its October meeting to peer-review the draft risk evaluations for methylene chloride and N-methylpyrrolidone (NMP).  But release of those drafts has been delayed, leaving insufficient time for the SACC to review them before the meeting.

We’re also hearing why release of the drafts has fallen behind.  The drafts were on track for release late last month, but apparently were blocked based on objections about at least the draft risk evaluation for methylene chloride.  The objections were lodged by Dr. Nancy Beck.  Read More »

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