EDF Health

Selected tag(s): New chemicals

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 »

Posted in EPA, Health Policy, Industry Influence, Regulation, TSCA Reform, Worker Safety / Also tagged , | Comments are closed

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 »

Posted in EPA, Health Policy, TSCA Reform / Also tagged | Comments are closed

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 »

Posted in EPA, Health Policy, Industry Influence, Regulation, TSCA Reform, Worker Safety / Tagged | Read 1 Response

PART 3: Busting more industry-perpetrated myths about new chemicals and worker protection under TSCA

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

Part 1          Part 2         Part 3

I have been blogging in the last few weeks about myths the chemical industry is perpetrating about the adequacy and legality of the Environmental Protection Agency’s (EPA) recent reviews of the risks that chemicals just entering the market may present to workers.  In this post, I address another such myth that, unfortunately, EPA has swallowed hook, line, and sinker.  This myth was laid out by one of the industry witnesses at the March 13 House Energy & Commerce Committee hearing on EPA’s failures to protect workers from chemical risks.

One wonders when EPA will start doing what Congress told it to do, first in 1976 and then again, with renewed vigor in 2016:  Protect workers under TSCA – using TSCA’s authorities to meet TSCA’s health standard, not OSHA’s.

I’ll get to this third myth in a moment.  But let me first try to crystallize what is at stake in this debate.  While the Toxic Substances Control Act (TSCA) has always given EPA authority to regulate workplace risks, the 2016 amendments to TSCA strengthened EPA’s authority and mandate to protect workers.  TSCA now expressly identifies workers as a “potentially exposed or susceptible subpopulation.”  See the definition of that term in paragraph 12 here.  TSCA then requires EPA to identify and assess potential risks to such subpopulations when reviewing both new and existing chemicals.  Finally, it requires EPA to use its TSCA authorities to impose restrictions on any chemical found to present an “unreasonable risk” – which is TSCA’s health standard – to any such subpopulation.

In a word, TSCA requires EPA to protect workers under TSCA – using TSCA’s authorities to meet TSCA’s health standard, not OSHA’s.

Both before and after the 2016 TSCA amendments, the chemical industry has sought to compel or convince EPA not to regulate workplaces under TSCA, and instead to defer to OSHA.  Industry wants this because OSHA’s authority and capacity are severely limited and its legal requirements for regulating toxic substances (“health standards” in OSHA parlance) allow vastly greater risks to workers than do TSCA’s (see my previous post).

Sadly, under the Trump EPA, industry is getting its wish.  At industry’s urging, EPA is acting in a manner that is wholly contrary to TSCA – and is less health-protective than even under TSCA before the 2016 reforms.

Now let’s get back to more myth-busting.   Read More »

Posted in EPA, Health Policy, Industry Influence, Regulation, TSCA Reform, Uncategorized, Worker Safety / Also tagged , , | Comments are closed