EDF Health

Getting chemical safety back on track 5 years after TSCA reform

By EDF Blogs / Published: June 22, 2021

Five years ago, President Obama signed into law the Lautenberg Chemical Safety for the 21st Century Act, which overhauled the country’s chemical safety law to better protect people from toxic chemicals.

In a welcome change to the dismal Toxic Substances Control Act (TSCA) reform anniversaries during the Trump administration, this year we are able to highlight some signs of progress we have seen from the Biden EPA that are getting chemical safety back on track.

Though significant challenges remain and lots of work lies ahead to repair the damage done by the former administration and advance a broader vision of health protection for everyone, here are five ways the Biden administration has started to turn things around on chemical safety:

1. Naming leaders committed to scientific integrity and public health protection

With Michael Regan at the helm of EPA, the agency is already miles ahead of where it stood in the last administration. The critical position for overseeing TSCA implementation at EPA is the leader of the Office of Chemical Safety and Pollution Prevention. Fortunately, a chemist with deep experience on TSCA and other chemical issues from her time on Capitol Hill, Dr. Michal Freedhoff, has been confirmed for the role.

Both Regan and Freedhoff have made strong statements supporting a return to scientific integrity and transparency – which are critical needs to building back trust. Dr. Freedhoff specifically cited how the Trump White House forced EPA scientists to weaken their assessment of the dangerous chemical trichloroethylene, an egregious example of political interference in science-based decision-making.

Read More »

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

By Richard Denison / 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 »

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

By Richard Denison / 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 »

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At all costs: Failings of Trump EPA’s proposed TSCA fee rule

By Lindsay McCormick / Published: April 7, 2021

Lindsay McCormick, Program Manager and Richard Denison, Ph.D., Lead Senior Scientist

When Congress reformed the Toxic Substances Control Act (TSCA) in 2016, it authorized EPA to require companies to pay fees to help defray the agency’s costs of administering this extensive new law.  EPA finalized the first “fee rule” in 2018 to establish the payment framework.  Under TSCA, EPA is to adjust the fees every three years both to account for inflation and to ensure it is recouping the authorized portion of agency costs to implement the law.

Therefore, developing an accurate estimate of the agency’s costs to implement TSCA is critical.  Not only does this provide the baseline by which to establish industry fees (as EPA is to set the fees so as to recoup 25% of its program costs), but it should serve as a north star to identify the true resource needs to lawfully implement TSCA.

Recent reports by the Government Accountability Office and EPA’s Office of Inspector General found that EPA’s ability to assess and manage chemicals regressed over recent years due to lack of workforce or workload planning to ensure the agency can carry out its duties.  Both reports recognize the greatly increased scope of work under amended TSCA, and EPA’s failure to translate that into additional staff and resource needs.  Establishing a robust, accurate budget for administering TSCA is the first step to rectifying this problem.

Despite the alarm bells rung by these two watchdogs, the Trump EPA’s proposed revised fee rule seems to have lost sight of Congress’ purpose in expanding EPA’s fee authority.  The proposed rule invokes a new purpose entirely divorced from TSCA: to reduce asserted burdens on industry – without regard to the impacts that will have on EPA’s ability to implement the law or on ensuring health and environmental protection from chemical exposures.  As a result, EPA underestimated its costs and proposed fees such that, if finalized, would push an undue portion of its costs onto the taxpayer.

Below we summarize the major concerns about the fee rule proposal that we detailed in our comments submitted to the agency late last month. Read More »

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Re-visioning TSCA: Address the cumulative impacts of chemical exposures

By Richard Denison / Published: April 1, 2021

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

Part 4 of a 4-part series – see Part 1, Part 2, and Part 3 here

This series of blog posts is looking ahead toward opportunities to advance a more robust and holistic vision for implementing the Toxic Substances Control Act (TSCA) as reformed in 2016.

We discussed in the preceding installments of this series the importance of ensuring that combined exposures to a chemical from multiple sources and the greater exposures and susceptibilities of certain groups are accounted for.  But it is critical to also recognize that many other factors influence the impacts chemical exposures have on our health.  This final installment in our series will discuss how TSCA can and should take into account all of these factors – that is, account for cumulative impacts.

Read More »

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