EDF Health

Selected tag(s): New chemicals

The Trump EPA says “precede” means “follow”

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.

How on earth can EPA assert with a straight face that it is promulgating SNURs that precede its “not likely” determinations?

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?

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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No, Bergeson & Campbell, the public’s right to know about new chemicals is not a distraction or waste of resources

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

Earlier this month, EDF and other NGOs filed a notice of intent (NOI) to sue the Environmental Protection Agency for violations of the Toxic Substances Control Act and its own regulations that deny the public timely access to information on chemicals companies seek to bring onto the market.

Members of the public have a right to know about chemicals entering the market because they may well be exposed to them.  And they have a right to know about and meaningfully participate in EPA’s review of the safety of those chemicals because such transparency, accountability, and public participation are fundamental to good government, as well as being required by the law.

This week the industry law firm Bergeson & Campbell (B&C) offered a commentary on the NOI, lamenting it as “hugely distracting and draw[ing] resources and [EPA] management’s attention away from other priorities.”  Note that B&C represents many companies that submit new chemicals to EPA for review under TSCA and has been a central actor in the chemical industry’s efforts to weaken those reviews.

In its commentary, B&C acknowledges that the NOI has identified real legal violations committed by EPA, and that these violations result in the public having less information about the agency’s new chemicals program.  But B&C asserts that the violations don’t really matter because they have been going on for a long time, not just under this administration.  While that is true in some cases, the argument ignores the two elephants in the room.  Read More »

Posted in EPA, Health Policy, Industry Influence, Regulation, TSCA Reform / Tagged | Comments are closed

Trump EPA caves again to industry demands on new chemicals, and workers pay the price

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

Isocyanates are nasty chemicals, including when they are left over as residuals after manufacturing other chemicals.  Here are the kinds of risks they pose, according to the National Institute for Occupational Safety and Health (NIOSH):

Isocyanates are powerful irritants to the mucous membranes of the eyes and gastrointestinal and respiratory tracts.  Direct skin contact can also cause marked inflammation.  Isocyanates can also sensitize workers, making them subject to severe asthma attacks if they are exposed again. There is evidence that both respiratory and dermal exposures can lead to sensitization.  Death from severe asthma in some sensitized subjects has been reported.

In prior reviews of new chemicals under the Toxic Substances Control Act, EPA has repeatedly indicated that “[i]socyanate exposure has been identified as the leading attributable cause of work-related asthma, and prevalence in the exposed workforce has been estimated at 1-20 percent.”

Both NIOSH and EPA have raised even greater concern over activities involving spray application of chemicals containing isocyanates.  In 2006, NIOSH issued a rare alert calling for workers to undergo medical surveillance and wear high-efficiency respirators and gloves when engaged in such activities.

Even in the recent past, when reviewing new chemicals containing isocyanate residuals, EPA has typically (1) issued a consent order subjecting the company submitting the chemical for review to multiple conditions in order to limit workplace inhalation exposures to the residuals, and (2) followed up with a Significant New Use Rule (SNUR) that extends those conditions to other companies, requiring them to notify EPA prior to engaging in any activity that exceeds those workplace limits.  And the only case since TSCA was amended in 2016 where EPA found a new chemical “presents an unreasonable risk” – as opposed to the more common, lower-bar finding that it “may present an unreasonable risk” – involved residual isocyanates present after manufacture of two new chemicals.

In such cases EPA has imposed some combination of three types of conditions on manufacture of such chemicals:  prohibitions on activities that could generate inhalable forms of the chemical and result in inhalation exposures; strict requirements for the use of high-efficiency respirators and gloves; and a strict limit on the amount of isocyanate residuals allowed to be present in the new chemical, typically in the range of 0.1% to 0.2%.

So it is quite disturbing to see how EPA has dealt with the most recent such new chemical for which EPA has issued its final decision – which requires that companies employ NONE of these protections.  Read More »

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The Trump EPA is illegally denying requests for public files on new chemicals

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

For some time now, Environmental Defense Fund (EDF) has been requesting “public files” of new chemical notices the Environmental Protection Agency (EPA) receives under the Toxic Substances Control Act (TSCA).  The process is kludge-y to say the least.  We have to email our request to EPA’s Docket Center, and, typically, several weeks later the staff there copy the files that staff in the TSCA office have given them in response to our request onto a CD-ROM and snail-mail it to us.

This, despite the fact that EPA’s own regulations (see here and here) state unequivocally that EPA is to promptly make new chemicals’ premanufacture notifications (PMNs) and associated documents broadly available to the general public by posting them to electronic dockets.  One regulation states: “All information submitted with a notice, including any health and safety study and other supporting documentation, will become part of the public file for that notice, unless such materials are claimed confidential.”  The other regulation states that public files are to be made available in the electronic docket posted at http://www.regulations.gov.

We have blogged extensively about how, even once we receive the public files, they are rife with wholesale omissions, illegal redactions and myriad other problems.

After two years of our repeated requests to EPA to comply with its own regulations, it appears EPA may be taking a first step to try do so:  EPA recently announced (via email, but not anywhere on its website that we can find) that it will start posting PMNs and associated documents it receives in the future to its ChemView database, within 45 days of their receipt.  While this could be a welcome development, it does nothing to remedy EPA’s failure to provide access to the thousands of PMNs it has received in the past.  And it remains to be seen what EPA actually will and won’t be posting.

We’ll be watching closely to see when and what EPA actually makes available.  Part of the need for vigilance comes from a disturbing response we’ve been receiving from EPA’s Docket Center to some recent requests for new chemical public files:   Read More »

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Company safety data sheets on new chemicals frequently lack the worker protections EPA claims they include

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

Readers of this blog know how concerned EDF is over the Trump EPA’s approval of many dozens of new chemicals based on its mere “expectation” that workers across supply chains will always employ personal protective equipment (PPE) just because it is recommended in the manufacturer’s non-binding safety data sheet (SDS).

How much farther under the bus will the Trump EPA throw American workers?

The typical course has been for EPA to identify risks to workers from a new chemical it is reviewing under the Toxic Substances Control Act (TSCA), but then – instead of issuing an order imposing binding conditions on the chemical’s entry onto the market, as TSCA requires – to find that the chemical is “not likely to present an unreasonable risk” and impose no conditions whatsoever on its manufacturer.  This sleight of hand is pulled off by EPA stating that it:

expects employers will require and workers will use appropriate personal protective equipment (PPE) … consistent with the Safety Data Sheet prepared by the new chemical submitter, in a manner adequate to protect them.

We have detailed earlier the myriad ways in which this approach strays from the law, is bad policy and won’t protect workers.  But here’s yet another gaping problem:  When we are able to look at the actual SDSs – that is, when EPA has made them available and when they are not totally redacted – we are frequently finding that the specific PPE that EPA claims to be specified in the SDSs – and that EPA asserts is sufficient to protect all workers handling the chemical – is not in the SDSs.   Read More »

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