EDF Health

Selected tag(s): Significant New Use Rule (SNUR)

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 »

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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 / 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

Former chemical industry official Beck, now at Trump White House, again interferes to weaken EPA action on dangerous chemicals: This time it’s PFAS

By / Published: April 20, 2020

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

It was only in February that Reveal News’ Elizabeth Shogren exposed the Trump White House’s role in dramatically weakening the Environmental Protection Agency’s (EPA) draft risk evaluation for the solvent trichloroethylene (TCE), which is linked to fetal heart defects at low doses.  The White House’s 11th-hour intervention, led by former chemical industry official Dr. Nancy Beck, forced EPA to rely on a different health effect that would allow 500 times greater exposures to the ubiquitous toxic chemical.

There was every reason to expect this episode was not a one-off, given Beck’s other actions both while at EPA and once arriving at the White House.  Sure enough, last week Ellen Knickmeyer of the Associated Press exposed another such incident, this time involving a group of chemicals collectively known as “perfluoroalkyl and polyfluoroalkyl substances” or PFAS that are showing up as environmental contaminants all over the country.[pullquote]Beck’s first order of business was to compel her former colleagues at EPA to submit the proposed PFAS rule for White House review, which neither the Obama administration nor the Trump administration up to that point had deemed necessary.[/pullquote]

Knickmeyer reported on documents obtained by Senator Tom Carper of Delaware, ranking member of the Senate’s Environment and Public Works Committee, that detail Beck’s largely successful effort to scale back a rule EPA first proposed in 2015.  Called a Significant New Use Rule, or SNUR, it would require companies seeking to import products containing certain PFAS to notify EPA in advance, thereby allowing EPA to determine whether to allow the import and impose needed restrictions.  Sen. Carper made the documents public via a letter he sent to EPA Administrator Andrew Wheeler calling on EPA to finalize the original rule instead of the watered-down re-proposed rule EPA released for public comment in February.  Read More »

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

By / 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 »

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The Trump EPA says “precede” means “follow”

By / Published: January 10, 2020

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

[Corrections added below in bracketed italics on 1-17-20]

Last month EPA finally released its long-awaited update to its controversial 2017 New Chemicals Decision-Making Framework, which describes how EPA is conducting risk reviews of new chemicals under the Toxic Substances Control Act (TSCA).  While we are still reviewing it and will be filing comments, it is clear the new document suffers from many of the same problems as the prior version, as well as raising additional concerns.

A core problem of both documents is EPA’s illegal bifurcation of its treatment of a new chemical’s “intended” conditions of use – those proposed by the company submitting a premanufacture notification (PMN) to EPA – from the chemical’s “reasonably foreseen” conditions of use.  EPA does so despite TSCA’s clear instruction that EPA address potential risks from both categories in an integrated manner and at the same time.  EPA’s frameworks instead relegate any consideration of “reasonably foreseen” conditions of use to a separate, later process undertaken upon receipt of a separate notification submitted to EPA in response to a Significant New Use Rule (SNUR) – assuming EPA has actually promulgated a final SNUR for the chemical in question.

EPA has now used this bifurcated approach to greenlight hundreds of new chemicals for market entry – finding that they are “not likely to present an unreasonable risk” based on a review only of the chemicals’ intended conditions of use.  EDF has blogged in detail about the inadequacies of EPA’s “SNUR-only approach” and the disturbing extent of its application.

EPA has yet to provide any legal justification for its approach – how it believes the approach comports with TSCA – let alone demonstrate how it provides for protection of health and the environment despite deviating from what Congress intended EPA do under the law.

[pullquote]How on earth can EPA assert with a straight face that it is promulgating SNURs that precede its “not likely” determinations?[/pullquote]While we will have much more to say on the new framework, in the remainder of this post I want to focus on EPA’s characterization of its reliance on the SNUR-only approach.  EPA now says it has expanded that approach to two different scenarios:  One is “SNURs that Precede “Not Likely” Determinations” and the other is “SNURs that Follow “Not Likely” Determinations.”

We have examined the accuracy of EPA’s claim that the first type of SNUR precedes EPA’s “Not Likely” determination for a given new chemical.  The timing is critical here:  If there is a significant lag between EPA’s “Not Likely” determination and the issuance of a SNUR, all kinds of problems arise, which we have discussed previously.  To name two:

  • If a company engages in what EPA plans to deem a “significant new use” during the gap between the determination and at least proposal of a SNUR, then EPA cannot subject that use to the notification requirements of the SNUR because the use is “ongoing” and no longer “new.” That includes a new use engaged in by the company that got a green light for its chemical based on EPA’s review of only its intended conditions of use.
  • Such a company that wants to have the ability to engage in uses beyond those it said it initially intended would have serious incentives to seek to avoid having EPA issue the SNUR. Because SNURs are done through rulemaking, the company can urge EPA to block or modify the SNUR through the rulemaking process.  It can also apply pressure on EPA not to pursue a SNUR at all.

So is EPA being accurate when it claims that a large number of its SNURs precede EPA’s “Not Likely” determination for those same new chemicals?

The answer is a resounding no:  Read More »

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When will EPA fully explain and legally justify its reviews of new chemicals under TSCA?

By / Published: December 9, 2019

Stephanie Schwarz, J.D., is a Legal Fellow.  Richard Denison, Ph.D., is a Lead Senior Scientist.

Over two years have passed since EPA published its first, highly controversial New Chemicals Decision-Making Framework.  This document attempted to lay out major changes EPA was making, in response to relentless industry pressure, to its reviews of new chemicals entering the market.  Prior to this, EPA had been conducting reviews that largely conformed to the new requirements for these reviews that Congress included in the reforms to the Toxic Substances Control Act (TSCA) enacted in June 2016.

Among the many concerning aspects of EPA’s new approach were its herculean efforts to avoid finding a new chemical “may present an unreasonable risk” or that the information available to EPA is insufficient to permit a reasoned evaluation of the chemical.  Under reformed TSCA, either of those findings requires EPA to issue an order – as specified under section 5(e) of TSCA – that restricts the chemical, requires testing, or both in a manner sufficient to ameliorate the potential risk.

One of EPA’s new tactics was to illegally bifurcate its review of a company’s “intended” uses of the new chemical from other “reasonably foreseen” uses.  The company would get the coveted unfettered approval to enter commerce, based on an EPA review limited to its intended uses; these approvals take the form of EPA issuing a finding that the chemical is “not likely to present an unreasonable risk.”  Any review of other reasonably foreseen uses would be relegated (if it took place at all) to a later, wholly separate process that would only be triggered if EPA also promulgated a so-called “significant new use rule” (SNUR).  Under such a SNUR, a company seeking to engage in a reasonably foreseen use of the chemical EPA identified would be required to first notify EPA, who would then conduct a review of that new, now “intended,” use.

These SNURs are often referred to as “non-5(e) order SNURs” because they do not follow from EPA’s issuance of an order under section 5(e) – indeed, avoiding such orders was the whole point.  We have previously addressed the many problems – legal, policy, and scientific – with this approach; see for example, here and here.  These include:

  • the failure to assess all intended and reasonably foreseen uses of a new chemical at the same time, as required by TSCA and necessary to consider the potential for people to be subject to multiple exposures; and
  • the inability to require testing of the new chemical substance using a SNUR, which can be required through an order.

EPA held a public meeting and took public comment on its 2017 Framework at the time it was published.  But it never responded to the many comments it received criticizing its framework.  And when EPA was sued over its use of the Framework, it dodged the suit by claiming it was not using the Framework (see p. 14 here), leading to the lawsuit being withdrawn.  (Later in this post below we discuss that EPA has in fact been repeatedly using the core feature of the Framework.)

Meanwhile, hundreds of decisions made with no public framework

EPA has never made public any subsequent description of its decision-making approach or justification for it, despite the hundreds of new chemical approvals it has been cranking out ever since.  EPA has also never responded to the numerous public comments it received criticizing its framework.

Frustration over this situation led to a Congressional call for EPA to publish and then take comment on an updated description of its new chemicals review process.  Last January, EPA Administrator Andrew Wheeler made a commitment to Senator Carper to publish a revised new chemicals framework that would specify: “(i) the statutory and scientific justifications for the approaches described, (ii) the policies and procedures EPA is using/plans to use in its PMN reviews, and (iii) its responses to public comments received,” and to provide opportunity for public comment on the revised framework.

Last month EPA announced that it will hold a “Public Meeting on [the] TSCA New Chemicals Program,” which is to take place tomorrow, December 10.  However, while the agenda includes a speaker who will provide an “overview” of what EPA is now calling its “working approach,” EPA’s announcement indicated it would not release any actual document before the public meeting; instead, it will do so “by the end of the year.”  And while the meeting agenda provides for “public feedback” at the end of the meeting, the lack of any document to respond to will surely limit the ability of the public to provide meaningful input.

Absent such a public document, the rest of this post will provide our best understanding of how EPA has been reviewing new chemicals over the last two years, based on our scrutiny of each such decision.  Read More »

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