EDF Health

Selected tag(s): Lautenberg Act

No justification: Substantiations for rampant new chemical CBI claims are deficient or lacking altogether

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

We recently started a series of blog posts describing what we did, and did not, get from the EPA Docket Center when we requested the public files on about 70 new chemicals, most of which EPA had determined were “not likely to present an unreasonable risk” under the Toxic Substances Control Act (TSCA), as amended in 2016 by the Lautenberg Act.  To continue our series, we address in this post EPA’s pervasive failure to require companies to adequately substantiate Confidential Business Information (CBI) claims, and its own apparent failure to review such claims, despite clear requirements to do so under § 14 of TSCA. 

Twenty months after passage of the Lautenberg Act, we simply must ask:  When will EPA start carrying out its new responsibilities on CBI claims – which includes compelling companies to comply with the law?

First, to provide some context, let us address a question we were asked based on our first post: whether the PMN situation we are describing is any worse now than it was pre-Lautenberg Act.  We suspect it is not necessarily worse.  However, the purpose of the reforms to CBI in the Lautenberg Act was to fix these problems, by requiring substantiation and EPA review of most CBI claims, including those asserted in premanufacture notifications (PMNs) submitted for new chemicals.  By and large it appears this is simply not happening, 20 months after the law passed and those provisions took effect.

Few of the PMN public files we received included any substantiations, despite massive assertions of CBI claims that require substantiation; instead, companies simply redacted the information.  In addition, nearly all of those submissions that do include a substantiation document are wholly inadequate, routinely claiming information as CBI that is not eligible for nondisclosure or failing to provide justification for information that may be eligible.  The violations are so egregious that they indicate EPA is failing to conduct even a cursory review of the claims and redactions.   Read More »

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EDF requests extension of illegally and unreasonably short comment period on proposed rule with incomplete docket

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

Environmental Defense Fund (EDF) today submitted a request to the Environmental Protection Agency (EPA) to extend the mere 15-day period EPA has provided for public comments on a proposed modification to a Significant New Use Rule (SNUR).  The proposed SNUR modification was published in the Federal Register just last Thursday (February 8), and stated that comments must be received by February 23.

EPA must comply with its own requirements and provide electronic access to a public file containing all relevant documents prior to commencing at a minimum a 30-day comment period on this proposed rule.

EPA’s own regulations require EPA to provide the public with at least 30 days to comment on SNURs, see 40 CFR 721.160(c)(4) and 721.170(d)(4), making EPA’s 15-day comment period illegally short.

EDF requested that EPA provide at least 30 days for public comment – with that period to commence only after a complete public docket of relevant materials is made available by EPA.  As our request details, the docket EPA has provided for this proposed SNUR is woefully incomplete, missing even basic documents that preclude the public from being able to provide meaningful comments on the proposal.   Read More »

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ACC doubles down on its revisionist history of the Lautenberg Act’s reforms to new chemical reviews under TSCA

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

Last August, Scott Pruitt announced that the Environmental Protection Agency (EPA) would reverse course in its conduct of risk reviews of new chemicals under the reforms made in 2016 to the Toxic Substances Control Act (TSCA) by the Lautenberg Act.  The changes will effectively return the program to its pre-Lautenberg state – under which few chemicals were subject to any conditions and even fewer to any testing requirements – or make it even weaker.

In December, despite indicating it had already made the changes Pruitt had previewed, EPA held a public meeting and accepted public comments on the changes.  EDF filed extensive written comments, as did many other stakeholders.

Undeterred by the facts, ACC persists in its wishful thinking that the law’s provisions on new chemicals are meant to maintain the status quo and that this is what stakeholders wanted.

Among them was, of course, the American Chemistry Council (ACC).  While I won’t describe those comments at any length here, ACC’s primary thesis was that the Lautenberg Act made no significant changes to the new chemicals provisions of TSCA, and that this was in keeping with the wishes of Congress and an acknowledgment that the program has always worked just fine.

If this thesis sounds familiar, it should:  ACC has basically echoed this talking point ever since the Lautenberg Act was signed into law nearly 20 months ago.  In seeking to support its case, one of the most outlandish of ACC’s arguments is this one:  ACC asserts that it was the TSCA reform bill passed by the House of Representatives in June 2015 that “led to” the final bill that became the new law, and that because the 2015 House bill made no changes at all to the new chemicals section of TSCA, that is evidence that this was what Congress intended.

In fact, at least with respect to new chemicals, it was the Senate bill – which made extensive changes to the new chemicals section of TSCA – that was reflected in the final bill that became law.  Indeed, Congress expressly rejected the House bill’s decision not to touch these provisions, by instead adopting virtually all of the changes made to these provisions by the Senate bill.

Nonetheless, undeterred by these facts, ACC persists in its wishful thinking that the law’s provisions on new chemicals are meant to maintain the status quo and that this is what stakeholders wanted.

This new round of public comments on the law’s effect on new chemical reviews under TSCA played out almost exactly a year after the first round in December 2016-January 2017.  In that earlier round, ACC also insisted that Congress intended no significant change to those reviews.  In response, EDF included in our comments 23 pages of statements from both members of Congress and stakeholders. The statements demonstrate both that the law was intended to and did make major changes to new chemical reviews under TSCA, and that many stakeholders had emphasized the need for those changes.

Given ACC’s continued state of denial and perpetuation of its revisionist history of this issue, I feel compelled to include the content of those 23 pages here.  Here you go:   Read More »

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EDF files comments on EPA’s approaches to the process under TSCA formerly known as pre-prioritization

Lindsay McCormick, is a Project Manager.

Last week, EDF filed detailed comments to the Environmental Protection Agency (EPA) on the approaches it has presented for identifying potential candidates for prioritization under TSCA.

EDF believes the purpose of prioritization is to provide an orderly, transparent process for EPA to use in working its way through the huge backlog of chemicals needing risk reviews and to provide an accountable means by which EPA decides which chemicals need full risk evaluations and which have ample information at the time of the prioritization decision indicating they can be set aside absent new information.  Our comments argue for a simple process for identifying potential candidates for prioritization that:

  • is not overly formalized or regimented;
  • ensures sufficient information is available or will be developed in a timely manner to inform prioritization, and subsequently risk evaluations, through robust and early use of EPA’s section 4, 8 and 11 information-generation and information-gathering authorities;
  • proceeds at an incremental pace to build trust and gain experience, and preserve balance between high- and low-priority designations; and
  • allows EPA to routinely meet deadlines for making priority designations and completing risk evaluations on high-priority substances.

In light of these objectives, EDF recommends using an augmented TSCA Work Plan approach to identify potential high-priority candidates. The earlier methodology would need to be updated to incorporate statutory requirements not previously included – or not sufficiently addressed (e.g., exposure to children) – and to integrate new information.

We also believe EPA could use the Safer Choice Ingredient List (SCIL) as a starting point for identifying a comparable number of low-priority candidates.  However, EDF does not believe that the presence of a chemical on the SCIL list alone is at all sufficient for designating it as low-priority.  Rather, the SCIL list may help EPA identify a select number of candidates, which would need to undergo a much more robust evaluation to determine whether they meet the strict statutory requirements for low-priority designations.

For additional detail, check out our full comments.

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

EPA’s appalling failure to provide public access to public data on TSCA new chemicals

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

At last month’s public meeting held by EPA to discuss changes it is making to its new chemical review program, the issue of public access to information about those chemicals and EPA’s review of them featured prominently.  This post describes EDF’s recent exasperating attempt to gain access to information that the Toxic Substances Control Act (TSCA) and EPA’s own regulations require be made public.

We blogged recently about how EPA is now hiding its tracks when it comes to the outcomes of its initial reviews of new chemicals.  This post details another way in which EPA is cutting the public out of the new chemicals review process.

EDF has repeatedly informed EPA that the agency’s regulations (see here and here) require EPA to promptly make 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.

Despite the clear requirements for electronic access, EPA acknowledged at its December 6 meeting that it has not provided such access.  It then stated that “[s]anitized PMNs and their attachments can be requested directly from the EPA Docket Center.”  So we decided to try getting these materials by that route.

On December 13, 2017, EDF sent a letter to the EPA Docket Center requesting electronic versions of the sanitized Pre-Manufacturing Notices (PMNs), any health and safety studies, and any other supporting documentation associated with each chemical substance for which, between the law’s passage on June 22, 2016, and the date of our request, EPA had made a finding:

  • under § 5(g), in accordance with § 5(a)(3)(C), that the new chemical substance is “not likely to present an unreasonable risk of injury to health or the environment;” or
  • in accordance with §§ 5(a)(3)(A) and 5(f), that the new chemical substance “presents an unreasonable risk of injury to health or environment.”

We received a CD from the docket center two weeks later, on December 26, 2017. The CD contained file folders for 67 PMNs; a week later we requested additional file folders for two PMNs that received “not likely” findings around the time of our first request, and subsequently received a second CD.

We have been reviewing these materials.  This post is the first in a series that will describe what we got – and didn’t get.   Read More »

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EDF files extensive comments challenging EPA’s changes to new chemical reviews under TSCA

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

This weekend EDF submitted detailed comments to the Environmental Protection Agency (EPA) on its implementation of changes to the New Chemicals Review Program, as well as comments responding to the agency’s draft New Chemicals Decision‐Making Framework.

After the passage of the Lautenberg Act in June 2016, EPA started out on a sound footing in implementing the major changes to Section 5 of the Toxic Substances Control Act (TSCA), correctly subjecting more new chemicals to conditions or testing requirements through issuance of consent orders.  It also took successful steps to address a temporary backlog that was largely due to the fact that these changes to TSCA took immediate effect.

Beginning in August of last year, however, using the already eliminated backlog as an excuse, the new political leadership at EPA signaled its intent to reverse course and effectively return the program to its pre-Lautenberg state – under which few chemicals were subject to any conditions and even fewer to any testing requirements, despite the fact that the great majority of new chemicals reviewed by EPA lack any health or environmental safety data.

EPA convened a meeting in early December of last year to present its New Chemicals Decision‐Making Framework implementing these changes.  The agency noted it was already using the Framework, despite also accepting comments on it.

EDF’s comments raise a host of legal, policy, scientific, good government and transparency objections to EPA’s new approach.  I won’t attempt to summarize the 42 pages of our comments here, many aspects of which we have raised through this blog over the past many months.

We hope EPA reconsiders its rash change of course and opts to comply with the law.

 

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