EDF Health

EPA’s new chemical review process: A thought experiment

Two metal gears meshing. The one on the top says "process." The one on the bottom says "optimization."

Note: This is the last in our 6-part series of blogs on EPA’s proposed changes to its new chemical review process. See below under Go Deeper for links to the other blogs in the series.

In our previous blogs in this multipart series, we have focused on some of the major changes we believe EPA needs to make in its review process for new chemicals—and how EPA could propose regulations to make those reviews safer.

In this post, we want to walk you through why EPA must set rules that protect us from all the ways that a chemical is likely to be used. Read More »

Posted in Chemical regulation, Congress, Cumulative risk assessment, Risk assessment, Risk evaluation, Rules/Regulations, TSCA / Authors: / Comments are closed

Industry is scapegoating EPA for new chemical review delays

What’s Happening?

The chemical industry has an extensive—and ongoing—history of complaining about how long it takes EPA to do new chemical safety reviews.

The irony is that industry is the very player causing the delays in EPA’s review process. Clear data indicate that chemical manufacturers are primarily responsible for the length of EPA’s reviews and the backlog of cases.

Illustration of a goat looking anxious as 6 fingers point at it from outside the frame

Why It Matters

One of EPA’s vital roles is to assess the safety of new chemicals before they enter the market.

Industry’s outcry about a backlog serves as a smokescreen to pressure EPA into swiftly approving new chemicals even when they may not be safe. This would put us all at risk, particularly those who are more susceptible or maybe more highly exposed, such as children, pregnant people, and people who live and work in fenceline communities.

Read More »

Posted in Chemical regulation, Industry influence / Tagged , , , , | Authors: / Comments are closed

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

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

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 »

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

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

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