EDF Health

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

By / Published: November 27, 2019

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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The Court’s TSCA decision is a much bigger win for public health than first meets the eye

By EDF Blogs / Published: November 15, 2019

Robert Stockman is a Senior Attorney.  Richard Denison, Ph.D., is a Lead Senior Scientist.

Yesterday the Ninth Circuit Court of Appeals ruled in a landmark case involving a challenge to EPA’s so-called “framework rules” that lay out how it will implement core provisions of the Toxic Substances Control Act (TSCA) as amended in 2016 by the Lautenberg Act.

An array of health, labor and environmental groups, EDF among them, (see full list of petitioners below) had challenged EPA’s Risk Evaluation Rule and Prioritization Rule on the grounds that they deviated in significant ways from amended TSCA’s requirements.

We clearly won on a major issue in the litigation, but a careful reading of the Court’s opinion shows that we effectively won on another key issue even though the court ruled against us.  And several of the court’s other rulings either suggest it agrees with, or outright affirms, our view of TSCA’s core requirements.  On those remaining issues, the Court specifically did not foreclose any of our arguments, making it clear that they could be presented in legal challenges we bring to EPA decisions in risk evaluations and determinations for individual chemicals.

Read on for our analysis.  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

By / Published: November 4, 2019

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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EPA’s just-released methylene chloride draft risk evaluation: Some important context

By / Published: October 29, 2019

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

After more than a month’s delay, EPA today released its draft risk evaluation for methylene chloride.  Running to 725 pages (not counting more than a dozen supplemental files), it will take some time to digest.  But here are some initial observations that provide context for those of you who will be looking closer.

First, methylene chloride is a very nasty chemical.  It has killed a lot of people.  It causes cancer.  Short- and long-term exposure to it is tied to liver effects, immune system effects, nervous system effects, and reproductive/developmental effects.

So it shouldn’t be surprising that EPA’s draft – even coming from an administration not known to be overly worried about the risks of chemicals – has found that most industrial, commercial and consumer uses of methylene chloride present unreasonable risks.

For example, EPA found that workers using methylene chloride-based paint strippers face high risks.  Of course, we knew that already:  EPA identified those risks more than five years ago, and proposed to ban those uses.  This EPA decided it had to do it all over again – which means that thousands of workers have continued to be unnecessarily exposed to this deadly chemical.  And it will be even more years before we get back to where we were before EPA took its mulligan.

So the good news is that EPA seems to be acknowledging that methylene chloride presents high enough risks to warrant regulation under the Toxic Substances Control Act (TSCA).

The bad news is that EPA is dramatically underestimating the magnitude of methylene chloride’s risks – by pulling the same tricks it has for other chemicals among the first 10 it is evaluating under TSCA:

  • EPA once again ignores all exposures and risks to the general population by falsely assuming those exposures and risks are eliminated by actions it has taken or could take under other laws. That means ignoring over 4 million pounds of methylene chloride annually released to air, water and land.  See this backgrounder for the details and why this EPA assumption about methylene chloride is deeply flawed.
  • EPA once again grossly understates risks to workers:
    • EPA assumes that workers will always wear fully effective personal protective equipment (respirators and gloves) to make many of the risks it identifies go away – and to grossly understate the magnitude of the unreasonable risks it does find.
    • EPA once again finds a cancer risk to workers unreasonable only if it exceeds a level of 1 in 10,000 – which is 100 times higher a risk than warrants regulation under TSCA to protect workers and other vulnerable subpopulations.
    • For occupational non-users (ONUs), EPA has once again failed to identify unreasonable risks for the most highly exposed, and hence most vulnerable, workers unless it finds that the majority of workers also face unreasonable risks.

These are just a few initial observations based on our reading of EPA’s opus so far.

So while it’s somewhat encouraging that this new draft risk evaluation has found many more risks than previous drafts, we can already tell the draft falls far short of adequately describing the risks presented by methylene chloride.

Stay tuned.

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

By / Published: October 2, 2019

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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