EDF Health

Loosening industry’s grip on EPA’s new chemicals program

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

[I delivered a shorter version of these comments at the September 22, 2021 webinar titled “Hair on Fire and Yes Packages! How the Biden Administration Can Reverse the Chemical Industry’s Undue Influence,” cosponsored by Public Employees for Environmental Responsibility (PEER), NH Safe Water Alliance, and EDF.  A recording of the webinar will shortly be available here.  The webinar, second in a series, follows on EPA whistleblower disclosures first appearing in a complaint filed by PEER that are detailed in a series of articles by Sharon Lerner in The Intercept.]

The insularity of the New Chemicals Program – where staff only interact with industry and there is no real engagement with other stakeholders – spawns and perpetuates these industry-friendly and un-health-protective policies.

I have closely tracked the Environmental Protection Agency’s New Chemicals Program for many years.  Reluctantly, I have come to the conclusion that the program does not serve the agency’s mission and the public interest, but rather the interests of the chemical industry.  Despite the major reforms Congress made to the program in 2016 when it overhauled the Toxic Substances Control Act, the New Chemicals Program is so badly broken that nothing less than a total reset can fix the problems.

Revelations emerging through responses Environmental Defense Fund finally received to a FOIA request we made two years ago, and through the disclosures of courageous whistleblowers who did or still work in the New Chemicals Program, confirm what I have long suspected, looking in from the outside.  The program:

  • uses practices that allow the chemical industry to easily access and hold sway over EPA reviews and decisions on the chemicals they seek to bring to market;
  • has developed a deeply embedded culture of secrecy that blocks public scrutiny and accountability;
  • employs policies – often unwritten – that undermine Congress’ major reforms to the law and reflect only industry viewpoints; and
  • operates through a management system and managers, some still in place, that regularly prioritize industry’s demands for quick decisions that allow their new chemicals onto the market with no restrictions, over reliance on the best science and protection of public and worker health.

Many of the worst abuses coming to light took place during the Trump administration, and it is tempting to believe the change in administrations has fixed the problems.  It has not.  The damaging practices, culture, policies and management systems predate the last administration and laid the foundation for the abuses.  Highly problematic decisions continue to be made even in recent weeks.

I am encouraged by recent statements and actions of Dr. Michal Freedhoff, Assistant Administrator of the EPA office that oversees TSCA implementation.  They clearly are moves in the right direction.  But it is essential that the deep-rooted, systemic nature of the problem be forthrightly acknowledged and forcefully addressed.

Let me provide some examples of each of the problems I just noted.  Read More »

Also posted in EPA, Health Policy, Health Science, PFAS, Public Health, Regulation, TSCA Reform, Worker Safety / Tagged , | Comments are closed

Whistleblower revelations about EPA TSCA new chemical reviews

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
cosponso
red 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 1: A post-mortem on the Trump EPA’s assault on TSCA’s new chemicals program

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

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

With last week’s announcement by EPA that it intends to reverse two of the most damaging policy changes the Trump EPA made to EPA’s reviews of new chemicals under the Toxic Substances Control Act (TSCA), there is hope that going forward EPA’s reviews will once again conform to TSCA’s requirements and better protect workers, consumers, the public and the environment.

Predictably, the chemical industry and its phalanx of law firms – who demanded and embraced the Trump EPA’s policy reversals – have been howling loudly, doing their best impressions of Chicken Little.  They predict huge backlogs and economic calamity of all sorts, including an end to American innovation, and their lawyers are already threatening legal action – a clever way to drum up business, no doubt.

The fact is that EPA spends scarce resources reviewing hundreds of new chemicals every year that their manufacturers are not serious about – and often not in any hurry about – commercializing.  And industry then uses any delays in those reviews to argue that the review process is too rigorous and demand that it be scaled back.

But facts are stubborn things.

In this first post I’ll look at a few reasons why the industry’s new round of fear-mongering is not based in fact.  And in a second post I’ll look at the decisions on new chemicals made under the Trump EPA to shed more light on the real reason why industry is upset:  It just may have lost the inside track that yielded such high dividends in the form of flawed approvals of hundreds of new chemicals.  Or, as one prominent industry attorney bluntly said recently in a related context, “the good days are over, quite frankly.”  Read More »

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Trump EPA, ACC and industry law firms colluded to weaken EPA new chemical safety reviews

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

Records obtained through FOIA reveal extensive Trump EPA-industry collusion in a key area of TSCA implementation.

You know how sometimes you know something is going on behind closed doors, but you just can’t prove it?  Well, this isn’t one of those cases.

Read More »

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EDF statement: Trump EPA’s withdrawal of proposed bans on dangerous uses of three chemicals is shameful

Decision epitomizes administration’s disdain for public health protection

(Washington, DC – January 14, 2021) Tomorrow, the Trump EPA will announce the formal withdrawal of proposed bans on high-risk uses of the dangerous chemicals methylene chloride, trichloroethylene, and N-methylpyrrolidone. By taking this action, the Trump EPA seeks to prevent the new administration from finalizing any of these bans without starting the process over.

“It appears that blocking these bans and denying crucial protections to workers and consumers for four years was not enough for the Trump EPA. This shameful move that epitomizes the Trump EPA’s concerted attacks on public health is a transparent attempt to further constrain the incoming administration. It is yet another stain on Mr. Wheeler’s dismal record,” said Dr. Richard Denison, Lead Senior Scientist, EDF Health. “We are counting down the days until the EPA’s decisions, once again, reflect its mission to protect health and the environment.”

Background:

Read More »

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A tale of two public comment extension requests: How they fared under the Trump EPA

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

In recent weeks EPA has issued for public comment significant modifications to its draft risk evaluations under the Toxic Substances Control Act for two chemicals:  Pigment Violet 29 (PV29) and 1,4-dioxane.  Because EPA initially provided relatively brief comment periods on the modifications, both were subject to requests for extensions of the comment period.

The table below tells the story of how these two requests fared under the Trump EPA.  Read More »

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