EDF Health

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 »

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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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Peer reviewers confirm EPA has failed to show Pigment Violet 29 doesn’t present unreasonable risk

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

Late on Friday, EPA quietly posted the final peer review report of the Scientific Advisory Committee on Chemicals (SACC) for pigment violet 29, the first chemical for which EPA issued a draft risk evaluation under the Toxic Substances Control Act (TSCA) as amended in 2016.

No wonder EPA posted it late Friday with no announcement.  The peer reviewers’ report confirms what EDF and others have been saying since release of the draft:  EPA has fallen far short of supporting its sweeping conclusion that the chemical does not present unreasonable risk, including to vulnerable subpopulations.  The report also faults EPA’s use of systematic review, and reiterates that EPA needs to submit its method to the National Academy of Sciences for review.  Read More »

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EPA’s latest move to deflect criticism of its TSCA risk evaluations: Muzzle its science advisors

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

Readers of this blog know that Environmental Defense Fund (EDF) has voiced strong opposition to a number of decisions made by the Environmental Protection Agency (EPA) that aim to limit the risks it finds when evaluating the safety of chemicals under the Toxic Substances Control Act (TSCA).

These decisions include:

  • excluding from its analysis known human and environmental exposures to a chemical, based on unwarranted assumptions that those exposures are adequately managed by other statutes;
  • claiming without support that workers are protected by assuming universal and universally effective use of personal protective equipment throughout chemical supply chains and the adequacy of OSHA regulations that either don’t apply or are decades out of date;
  • arbitrarily loosening EPA’s longstanding risk standards governing when cancer incidences are deemed unacceptably high; and
  • choosing not to exercise its enhanced authorities under TSCA to require submission of robust information on chemicals’ hazard and exposures, resorting instead to questionable assumptions and relying on voluntarily submitted industry data that are unrepresentative or of poor or indeterminate quality.

Through these decisions, EPA increases the likelihood that it will either not find unreasonable risk and thereby avoid regulating the chemical, or if that can’t be accomplished, find risks that are low enough that it can impose few restrictions, thereby burdening industry as little as possible.

In response to each of these decisions, EPA has received dozens of highly critical comments on its draft risk evaluations from state and local governments, labor and health groups, environmental NGOs and members of the scientific community.  And in the first several peer reviews conducted by its Scientific Advisory Committee on Chemicals (SACC), many of the scientists voiced quite similar concerns during the committee’s public meetings (as of yet, final peer review reports have not been issued).

Rather than address the problems, EPA has adopted a new tactic to stifle the criticism, one that is quite chilling (literally and figuratively):  It is telling the SACC that these issues are off-limits to the peer reviewers because they represent policy decisions that are beyond the charge given to the SACC.  This is beyond the pale, for several reasons.  Read More »

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