EDF Health

EPA’s new Collaborative Research Program – A step toward improving new chemical reviews under TSCA

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: May 16, 2022

Maria Doa, Ph.D., Senior Director, Chemicals Policy; Lauren Ellis, MPH, Research Analyst; and Lariah Edwards, Ph.D., Post-Doctoral Fellow 

The Environmental Defense Fund (EDF) recently filed comments on EPA’s Toxic Substances Control Act (TSCA) Collaborative Research Program to Support New Chemical Reviews (Collaborative Research Program). The Collaborative Research Program is a multi-year scientific partnership between the agency’s Office of Pollution Prevention and Toxics (OPPT) and Office of Research and Development (ORD) aimed at modernizing the methods, approaches, and tools used to evaluate new chemicals under TSCA.  

We strongly support OPPT’s collaboration with ORD, which has a breadth of scientific expertise across EPA’s different research programs. As such, ORD will help OPPT implement the best available science in its new chemical assessments, which should ultimately prevent risky chemicals from entering the marketplace. We urge OPPT to use this opportunity – and ORD’s expertise – to improve and expand its consideration of new chemical impacts to frontline communities, the risks new chemicals may pose throughout their entire life cycle, as well as cumulative risks from chemicals that may cause similar health effects. 

Below we outline the five proposed research areas for new chemicals under the Collaborative Research Program and our comments on each. All five can have an important impact on EPA’s new chemical assessments and consequently on EPA’s determination on whether a new chemical is expected to present an unreasonable risk.  Read More »

Posted in New approach methods (NAMs), TSCA reform / Tagged , , | Authors: / Comments are closed

Whistleblower revelations about EPA TSCA new chemical reviews

By Richard Denison / 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 / Tagged , , , | Read 3 Responses

The Trump EPA’s “Working Approach” to new chemical reviews is only working for the chemical industry

By Richard Denison / Published: February 20, 2020

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

On Tuesday EDF filed detailed comments on the Environmental Protection Agency’s (EPA) “Working Approach to Making New Chemical Determinations under TSCA.”

The document is a major disappointment, to say the least.  The Trump EPA has worked very hard to render this long-awaited update of its approach to reviewing new chemicals under TSCA an empty exercise.  Despite Administrator Wheeler’s promises in January 2019 to the contrary:

  • EPA has still failed to provide any legal or scientific justification for its Working Approach.
  • EPA provided no actual response to the many detailed comments it received on its 2017 framework, instead issuing a 1.5-page document that dismisses many of the comments merely as having “stemmed from a misunderstanding of the Agency’s intent.”
  • EPA held a public meeting – but did so without first providing the Working Approach to stakeholders; EPA then limited their comments at the meeting to 2-3 minutes each and ended the meeting well ahead of schedule.
  • EPA’s new framework ignores the earlier comments it received, retaining all of the core flaws of the 2017 Framework and in fact doubling down on several of them.

Most remarkably, EPA seems to want to make clear that the Working Approach is hardly worth the paper on which it is written.  Read More »

Posted in Health policy, Industry influence, Regulation, TSCA reform / Tagged , , , | Comments are closed

Six Senators key to TSCA reform question EPA’s new chemical reviews in letter to Wheeler

By Richard Denison / Published: July 24, 2018

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

In a letter sent today to the Environmental Protection Agency’s Acting Administrator Andrew Wheeler, six Senators who were instrumental to achieving the 2016 Lautenberg Act’s reforms to the Toxic Substances Control Act (TSCA) raised “serious concern” about further weakening changes EPA is poised to make in its review of new chemicals.

EDF had blogged about the changes last week.

The Senators’ letter includes a “request that your staff brief our offices about the planned changes prior to moving to implement them.”

The letter was signed by Senators Tom Udall, Tom Carper, Sheldon Whitehouse, Ed Markey, Cory Booker, and Jeff Merkley.

The Senators noted that “While in the months after passage EPA began to implement these provisions in a manner we believe was faithful to both the letter and spirit of the law, beginning in the middle of last year EPA signaled it would change course by narrowing the scope of its new chemical reviews and the requisite risk determinations in a manner that deviated from the statute.”

EDF has for many months raised concerns over the steady effort by Trump Administration political appointees at EPA to undermine the provisions of the Lautenberg Act intended to significantly enhance EPA reviews of new chemicals prior to allowing them onto the market.  The latest moves deviate even further from the requirements of the new law and threaten public and worker health.

EDF hopes that today’s letter will help convince EPA to return to a lawful, health-protective approach to conducting reviews of new chemicals under TSCA.

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

ACC doubles down on its revisionist history of the Lautenberg Act’s reforms to new chemical reviews under TSCA

By Richard Denison / Published: February 5, 2018

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

Last August, Scott Pruitt announced that the Environmental Protection Agency (EPA) would reverse course in its conduct of risk reviews of new chemicals under the reforms made in 2016 to the Toxic Substances Control Act (TSCA) by the Lautenberg Act.  The changes will effectively return the program to its pre-Lautenberg state – under which few chemicals were subject to any conditions and even fewer to any testing requirements – or make it even weaker.

In December, despite indicating it had already made the changes Pruitt had previewed, EPA held a public meeting and accepted public comments on the changes.  EDF filed extensive written comments, as did many other stakeholders.[pullquote]Undeterred by the facts, ACC persists in its wishful thinking that the law’s provisions on new chemicals are meant to maintain the status quo and that this is what stakeholders wanted.[/pullquote]

Among them was, of course, the American Chemistry Council (ACC).  While I won’t describe those comments at any length here, ACC’s primary thesis was that the Lautenberg Act made no significant changes to the new chemicals provisions of TSCA, and that this was in keeping with the wishes of Congress and an acknowledgment that the program has always worked just fine.

If this thesis sounds familiar, it should:  ACC has basically echoed this talking point ever since the Lautenberg Act was signed into law nearly 20 months ago.  In seeking to support its case, one of the most outlandish of ACC’s arguments is this one:  ACC asserts that it was the TSCA reform bill passed by the House of Representatives in June 2015 that “led to” the final bill that became the new law, and that because the 2015 House bill made no changes at all to the new chemicals section of TSCA, that is evidence that this was what Congress intended.

In fact, at least with respect to new chemicals, it was the Senate bill – which made extensive changes to the new chemicals section of TSCA – that was reflected in the final bill that became law.  Indeed, Congress expressly rejected the House bill’s decision not to touch these provisions, by instead adopting virtually all of the changes made to these provisions by the Senate bill.

Nonetheless, undeterred by these facts, ACC persists in its wishful thinking that the law’s provisions on new chemicals are meant to maintain the status quo and that this is what stakeholders wanted.

This new round of public comments on the law’s effect on new chemical reviews under TSCA played out almost exactly a year after the first round in December 2016-January 2017.  In that earlier round, ACC also insisted that Congress intended no significant change to those reviews.  In response, EDF included in our comments 23 pages of statements from both members of Congress and stakeholders. The statements demonstrate both that the law was intended to and did make major changes to new chemical reviews under TSCA, and that many stakeholders had emphasized the need for those changes.

Given ACC’s continued state of denial and perpetuation of its revisionist history of this issue, I feel compelled to include the content of those 23 pages here.  Here you go:   Read More »

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

EDF files extensive comments challenging EPA’s changes to new chemical reviews under TSCA

By Richard Denison / Published: January 22, 2018

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

This weekend EDF submitted detailed comments to the Environmental Protection Agency (EPA) on its implementation of changes to the New Chemicals Review Program, as well as comments responding to the agency’s draft New Chemicals Decision‐Making Framework.

After the passage of the Lautenberg Act in June 2016, EPA started out on a sound footing in implementing the major changes to Section 5 of the Toxic Substances Control Act (TSCA), correctly subjecting more new chemicals to conditions or testing requirements through issuance of consent orders.  It also took successful steps to address a temporary backlog that was largely due to the fact that these changes to TSCA took immediate effect.

Beginning in August of last year, however, using the already eliminated backlog as an excuse, the new political leadership at EPA signaled its intent to reverse course and effectively return the program to its pre-Lautenberg state – under which few chemicals were subject to any conditions and even fewer to any testing requirements, despite the fact that the great majority of new chemicals reviewed by EPA lack any health or environmental safety data.

EPA convened a meeting in early December of last year to present its New Chemicals Decision‐Making Framework implementing these changes.  The agency noted it was already using the Framework, despite also accepting comments on it.

EDF’s comments raise a host of legal, policy, scientific, good government and transparency objections to EPA’s new approach.  I won’t attempt to summarize the 42 pages of our comments here, many aspects of which we have raised through this blog over the past many months.

We hope EPA reconsiders its rash change of course and opts to comply with the law.

 

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