EDF Health

Selected tag(s): New chemicals

EPA’s Significant New Use Rules under TSCA must reflect its policy goals

By Lauren Ellis / Published: January 6, 2022

Lauren Ellis, Research Analyst, Environmental Health 

We recently submitted comments to the Environmental Protection Agency (EPA) on a subset of proposed Significant New Use Rules (SNURs) published by the New Chemicals program under the Toxic Substances Control Act (TSCA). We commend EPA for issuing these proposed SNURs. Our review of some of the SNURs, however, raised concerns about chemical releases to the environment, risks to consumers, and the absence of worker protections. We believe EPA can address many of these concerns by following through on its stated policy goals. 

For all the chemicals in this batch, EPA had previously issued “consent orders” – which impose restrictions on a new chemical – because the agency found at the time of their initial review for market entry that the chemical substances may present an unreasonable risk to health or the environment. We strongly support EPA’s use of SNURs to follow up on consent orders it issues, as a consent order only applies to the original company that submitted a premanufacture notice (PMN) to EPA to domestically manufacture or import a new chemical. 

A SNUR is a separate action that requires any company seeking to engage in a “significant new use” identified in the SNUR to notify EPA at least 90 days before beginning that use, triggering EPA’s review of the potential new use. For new chemicals that received orders, a SNUR can conform to the order – meaning it mirrors the conditions in the consent order for the chemical – or it can apply more broadly to activities or uses that are beyond the scope of the consent order. Either way, SNURs enable the agency to review potentially risky uses prior to their commencement. 

In our comments, we call for four major changes to a subset of the proposed SNURs: 

Read More »

Posted in TSCA reform / Also tagged , , , | Comments are closed

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

By / Published: September 22, 2021

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 »

Posted in Health policy, Health science, Industry influence, Public health, Regulation, TSCA reform, Worker safety / Also tagged , , | Authors: / Comments are closed

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 »

Posted in Health policy, Industry influence, TSCA reform, Worker safety / Also tagged , , | Read 3 Responses

Reversing the last administration’s TSCA new chemicals policies needs to be a priority for this one

By / Published: May 4, 2021

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

Reprinted by permission from The Environmental Forum®, May/June 2021. MAY/ JUNE 2021 | 55
Copyright © 2021, Environmental Law Institute®, Washington, D.C. www.eli.org.

[NOTE:  This post is my contribution to a debate on TSCA implementation published by ELI.  I wrote this piece, which ELI titled “Reversing New Chemicals Program a Priority,” in late March.]

As with so much else these past four years, implementation of the 2016 reforms to the Toxic Substances Control Act was not normal.

Despite bipartisan support for TSCA’s overhaul and the chemical industry’s acknowledgment that it needed a stronger federal system to restore public confidence in its products, this progress evaporated virtually overnight with the ascendance of the most anti-environmental and anti-public health administration in our lifetimes.

Nowhere was this more apparent than in the Trump EPA’s systematic undermining of the new TSCA’s enhancements of safety reviews for the hundreds of new chemicals entering commerce each year. The chemical industry, its army of law firms, and its political plants inside EPA went for broke.  Read More »

Posted in Health policy, TSCA reform / Also tagged | Comments are closed

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 »

Posted in Health policy, TSCA reform, Worker safety / Also tagged , , | Authors: / Comments are closed

The damage done, Part 1: A post-mortem on the Trump EPA’s assault on TSCA’s new chemicals program

By / Published: April 8, 2021

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 »

Posted in Health policy, Industry influence, TSCA reform / Also tagged , | Authors: / Comments are closed