EDF Health

Whistleblower revelations about EPA TSCA new chemical reviews

By / Published: July 29, 2021

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

[I delivered these comments at the July 28, 2021 webinar titled “Toxic Chemicals, Whistleblowers, and the Need for Reform at EPA”
cosponsored by Public Employees for Environmental Responsibility (PEER), NY PIRG, and EDF.  [A recording of the webinar is available here.]  The webinar followed on whistleblower disclosures in a complaint filed by PEER and the first in what will be a series of articles by Sharon Lerner in The Intercept detailing the allegations.]

I have long described the EPA new chemicals program as a “black box.”  For decades, it has operated almost entirely out of public view, in multiple respects:

  • Excessive confidentiality claims and withholding of information from the public have been standard operating procedures.
  • A purely bilateral mode of operating developed, where the only parties in the room are EPA and the chemical industry.
  • The inability of the public to access information and meaningfully participate has severely limited public input and scrutiny.
  • As a result, a highly insular, almost secretive program culture arose over time, one where EPA has often viewed its only stakeholders to be the companies seeking quick approval of their new chemicals.
  • In sum, private interests trumped public interests.

TSCA reform sought to address key problems

The 2016 amendments to TSCA significantly overhauled the new chemicals provisions of the then-40-year-old law, seeking to rebalance those interests to some extent:

  • EPA for the first time is required to make a safety finding for each new chemical and explain the scientific basis for its finding.
  • Lack of sufficient information in and of itself is grounds for restricting a chemical and/or requiring testing. Before, unless EPA had enough data to show potential risk, it simply dropped the chemical from further review and allowed it onto the market.
  • Companies’ ability to simply assert their submissions are confidential has been reined in in several ways.

To be sure, the amendments did not address all of the program’s problems.  For example, despite the fact that the vast majority of new chemicals lack basic safety data, requiring companies to provide a minimum set of information – as many other countries do for new chemicals – was a bridge too far in the face of massive industry opposition.  The revelations indicate this is still a big problem:  Despite TSCA’s mandate that EPA restrict or require testing of chemicals lacking sufficient information, that has not been happening.  EPA still excessively relies on estimating a new chemical’s potential risks using models and extrapolations of data from other chemicals – approaches that have serious limitations, introduce large uncertainties, and are themselves a black box.

Enter the Trump EPA – the damage done

Immediately after the 2016 reforms, there were signs that EPA was starting down a better path.  But under the last Administration that progress was quickly reversed and the worst features of the pre-reform program came roaring back.  Indeed, where the program ended up was worse than before TSCA reform.  Clearly, the new revelations vividly show that – and how far we have to go, both in implementing the reforms and in changing the disturbing culture that still pervades the program.  What strikes me about the whistleblowers’ allegations is that they all cut in industry’s favor, removing or downplaying risks the scientists had flagged.  This argues against these simply being cases of scientific disagreement and points to a systemic problem.  Read More »

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The damage done, Part 2: A post-mortem on the Trump EPA’s assault on TSCA’s new chemicals program

By / Published: April 9, 2021

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

Part 2 of a 2-part series (see Part 1 here)

Last week’s announcement by EPA about improvements it is making to EPA’s reviews of new chemicals under the Toxic Substances Control Act (TSCA) indicated it will begin by reversing two of the most damaging policy changes the Trump EPA made to the program:

Under the Trump EPA policies being reversed, at least 425 new chemicals were granted unfettered market access despite potential risks or insufficient information.

  • EPA will cease avoiding issuance of the binding orders TSCA requires to address potential risk or insufficient information:
    “EPA will stop issuing determinations of ‘not likely to present an unreasonable risk’ based on the existence of proposed SNURs [Significant New Use Rules]. Rather than excluding reasonably foreseen conditions of use from EPA’s review of a new substance by means of a SNUR, Congress anticipated that EPA would review all conditions of use when making determinations on new chemicals and, where appropriate, issue orders to address potential risks. Going forward, when EPA’s review leads to a conclusion that one or more uses may present an unreasonable risk, or when EPA lacks the information needed to make a safety finding, the agency will issue an order to address those potential risks.”
  • EPA will cease assuming workers are adequately protected from chemical exposures absent binding requirements on employers:
    “EPA now intends to ensure necessary protections for workers identified in its review of new chemicals through regulatory means. Where EPA identifies a potential unreasonable risk to workers that could be addressed with appropriate personal protective equipment (PPE) and hazard communication, EPA will no longer assume that workers are adequately protected under OSHA’s worker protection standards and updated Safety Data Sheets (SDS). Instead, EPA will identify the absence of worker safeguards as “reasonably foreseen” conditions of use, and mandate necessary protections through a TSCA section 5(e) order, as appropriate.”

If you want the details on what was wrong with these policies – legally, scientifically, and health-wise – see EDF’s comments submitted to the agency last year and a summary of them here.

It’s no accident that these two policies were prioritized for reversal.  As I discuss below, each had massive adverse impact on the rigor and outcome of EPA’s reviews of new chemicals.  The result was that the Trump EPA allowed many hundreds of new chemicals to enter commerce under no or insufficient conditions.  It did this by:  1) illegally restricting its review to only the intended uses of a new chemical selected by its maker, hence failing to follow TSCA’s mandate to identify and assess reasonably foreseen uses of the chemicals; and 2) dismissing significant risks to workers that its own reviews identified, despite TSCA’s heightened mandate to protect workers.  Read More »

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Haste makes waste: The Trump EPA’s 1,4-dioxane supplement may be its shoddiest TSCA work yet

By / Published: December 11, 2020

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

Yesterday EDF submitted comments on a supplement to EPA’s 1,4-dioxane risk evaluation under the Toxic Substances Control Act (TSCA), which the agency issued a scant three weeks ago.

This solvent is a likely human carcinogen that contaminates drinking water nationwide and is present in millions of consumer products.[pullquote]What EPA left out of its analysis swallows what it included.[/pullquote]

The supplement expands the scope of EPA’s ongoing risk evaluation of 1,4-dioxane.  It now includes certain water exposures and certain exposures of consumers to products in which the chemical is present as a contaminant (more technically, a “byproduct”).

EPA rushed the public comment period, providing only 20 days and refusing requests from at least 14 organizations for an extension.  The agency also cut out another vital step in the process – peer review –in violation of its own rules for how risk evaluations are to be conducted.

But that wasn’t the only thing EPA rushed.  The Supplement itself was an 11th-hour affair, done mainly to appease a hypocritical demand from the formulated chemical products industry.

The haste with which it was assembled badly shows.  The additional exposures EPA examined are so narrowly constructed as to omit major, and potentially the largest, sources of exposure and risk people face from the presence of 1,4-dioxane in water and products.

And what EPA left out of its analysis swallows what it included.  Read More »

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Under the Trump EPA, no risk to workers is too high to impede a new chemical’s unfettered entry into the market

By / Published: August 27, 2020

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

The Trump EPA’s understating of the risks to workers posed by both existing and new chemicals under the Toxic Substances Control Act (TSCA) has been a frequent topic for this blog.  This disturbing, illegal policy continues unabated and, if anything, has accelerated and expanded to outright dismissal of worker health concerns.[pullquote]The Trump EPA’s blatant shirking of its clear responsibilities under TSCA to identify and mitigate the serious risks that chemicals present to workers – who are on the front lines of chemical exposures – surely constitutes one of its most egregious failings.[/pullquote]

In its reviews of new chemicals, EPA now frequently identifies serious risks to workers that exceed its own risk benchmarks, often many times over.  How great are the exceedances EPA finds and ignores?  Our examination of recent cases, described below, reveals exceedances as high as 25,000-fold.  In other words, EPA has found and then dismissed worker exposures to new chemicals at levels as much as 25,000 times higher than it deems acceptable. That is not a typo:  In a very recent case EPA found a dermal risk of reproductive effects to workers that exceeded its own benchmark by a factor of 25,000.

Any reasonable new chemical review that identified excess risk would then impose conditions blocking or conditioning the market entry of these chemicals in a manner sufficient to mitigate the identified risks.  Indeed, that is exactly what TSCA requires EPA to do.

Instead, the Trump EPA over and over again clears these chemicals entirely, ignoring its own risk findings to assert that the chemicals are “not likely to present unreasonable risk.”  This has now been done for hundreds of new chemicals EPA has reviewed in the past two years.

To illustrate what EPA is doing, we examined the 29 new chemicals EPA found “not likely to present unreasonable risk” (“not likely” determinations) since the beginning of June of this year.  Read More »

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EPA flouts the law, science, and its obligation to protect public health yet again: The 1-bromopropane final risk evaluation

By / Published: August 11, 2020

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

Today, the Trump EPA released its second final risk evaluation and determination under the reformed TSCA, for the carcinogenic solvent, 1-bromopropane (1-BP). [pullquote]EPA has once again ignored expert scientific input it received from its own advisors.[/pullquote]

As was the case with the final document for methylene chloride – which has already been challenged in court (see here and here) – EPA has doubled down on the illegal, unscientific, and un-health protective approach it has taken in all of its draft risk evaluations for the first 10 chemicals reviewed under TSCA.

EDF will be closely examining this final document, but it is already apparent that EPA continues to grossly and systematically underestimate the exposures to and risks of 1-BP to the general public, workers and the environment.

Below are four examples of the flaws; each was raised by EPA’s own Science Advisory Committee on Chemicals (SACC) in its peer review as serious deficiencies – expert scientific input that EPA has simply chosen to ignore in finalizing the document:  Read More »

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“Illegal, unscientific, and un-health protective”: Summing up EPA’s final methylene chloride risk evaluation

By / Published: June 19, 2020

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

Today, the Trump EPA released its first final risk evaluation and determination under the reformed Toxic Substances Control Act (TSCA), for the carcinogenic and acutely lethal chemical methylene chloride.

Sadly, despite EPA’s rush to issue this document as the 4th anniversary of TSCA reform on June 22 approaches, EPA doubled down on the illegal, unscientific, and un-health protective approach it has taken in all of its draft risk evaluations for the first 10 chemicals reviewed under TSCA.

EDF will be closely examining this final document, but it is already apparent that EPA has grossly and systematically underestimated the exposures to and risks of methylene chloride.  Read More »

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