EDF Health

Finally something we can (mostly) commend EPA for doing under TSCA

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

Readers of this blog will know how concerned EDF is with ensuring the public’s right to know about chemicals to which they may be exposed.  We have repeatedly sounded the alarm when EPA has taken steps to deny public access to chemical information, whether for chemicals entering the market or those already in commerce.  Even in recent months, EPA has sided with chemical companies in denying access to health and safety information on chemicals EPA is assessing under the Toxic Substances Control Act (TSCA).

So we were pleasantly surprised by a letter to an industry group that EPA posted on Friday.  Read More »

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The Trump EPA says “precede” means “follow”

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

[Corrections added below in bracketed italics on 1-17-20]

Last month EPA finally released its long-awaited update to its controversial 2017 New Chemicals Decision-Making Framework, which describes how EPA is conducting risk reviews of new chemicals under the Toxic Substances Control Act (TSCA).  While we are still reviewing it and will be filing comments, it is clear the new document suffers from many of the same problems as the prior version, as well as raising additional concerns.

A core problem of both documents is EPA’s illegal bifurcation of its treatment of a new chemical’s “intended” conditions of use – those proposed by the company submitting a premanufacture notification (PMN) to EPA – from the chemical’s “reasonably foreseen” conditions of use.  EPA does so despite TSCA’s clear instruction that EPA address potential risks from both categories in an integrated manner and at the same time.  EPA’s frameworks instead relegate any consideration of “reasonably foreseen” conditions of use to a separate, later process undertaken upon receipt of a separate notification submitted to EPA in response to a Significant New Use Rule (SNUR) – assuming EPA has actually promulgated a final SNUR for the chemical in question.

EPA has now used this bifurcated approach to greenlight hundreds of new chemicals for market entry – finding that they are “not likely to present an unreasonable risk” based on a review only of the chemicals’ intended conditions of use.  EDF has blogged in detail about the inadequacies of EPA’s “SNUR-only approach” and the disturbing extent of its application.

EPA has yet to provide any legal justification for its approach – how it believes the approach comports with TSCA – let alone demonstrate how it provides for protection of health and the environment despite deviating from what Congress intended EPA do under the law.

How on earth can EPA assert with a straight face that it is promulgating SNURs that precede its “not likely” determinations?

While we will have much more to say on the new framework, in the remainder of this post I want to focus on EPA’s characterization of its reliance on the SNUR-only approach.  EPA now says it has expanded that approach to two different scenarios:  One is “SNURs that Precede “Not Likely” Determinations” and the other is “SNURs that Follow “Not Likely” Determinations.”

We have examined the accuracy of EPA’s claim that the first type of SNUR precedes EPA’s “Not Likely” determination for a given new chemical.  The timing is critical here:  If there is a significant lag between EPA’s “Not Likely” determination and the issuance of a SNUR, all kinds of problems arise, which we have discussed previously.  To name two:

  • If a company engages in what EPA plans to deem a “significant new use” during the gap between the determination and at least proposal of a SNUR, then EPA cannot subject that use to the notification requirements of the SNUR because the use is “ongoing” and no longer “new.” That includes a new use engaged in by the company that got a green light for its chemical based on EPA’s review of only its intended conditions of use.
  • Such a company that wants to have the ability to engage in uses beyond those it said it initially intended would have serious incentives to seek to avoid having EPA issue the SNUR. Because SNURs are done through rulemaking, the company can urge EPA to block or modify the SNUR through the rulemaking process.  It can also apply pressure on EPA not to pursue a SNUR at all.

So is EPA being accurate when it claims that a large number of its SNURs precede EPA’s “Not Likely” determination for those same new chemicals?

The answer is a resounding no:  Read More »

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

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

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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