EDF Health

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

By Lindsay McCormick / Published: January 29, 2018

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.

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

By / Published: January 24, 2018

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

Part 1               Part 2               Part 3               Part 4

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.[pullquote]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.[/pullquote]

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

By / Published: January 22, 2018

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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Hiding its tracks: The black box of EPA’s new chemical reviews just got a whole lot blacker

By / Published: January 4, 2018

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

[UPDATED 1-8-18:  See updates below]

We have been blogging about damaging changes being made to the Environmental Protection Agency’s (EPA) new chemicals review program for some time.  Despite the reforms made in 2016 under the Lautenberg Act that were intended to significantly strengthen new chemical reviews, Scott Pruitt’s EPA has been moving since August of last year to seriously weaken the program.

Late yesterday, EPA made a change to its new chemicals website that not only reverses changes made to implement the Lautenberg Act, but actually makes the site less transparent than it has been for decades.[pullquote]EPA’s intent is now quite clear:  to prevent the public from knowing when EPA’s professional staff flagged any concern in their initial review of a new chemical.[/pullquote]

The change makes clear that the agency is now planning to cover its tracks as it weakens new chemical reviews:  EPA will now hide from the public any information about whether its initial review of a new chemical raises any concerns or warrants a more extensive review.  Is this what Scott Pruitt meant when he said he intended to bring increased “transparency” to the review program – a term he used no fewer than five times in his August news release previewing changes he was making?   Read More »

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Dourson emails show he was paid by and worked closely with ACC when providing states “advice” on chemicals made by ACC members

By / Published: December 21, 2017

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

[Use this link to see all of our posts on Dourson.]

I blogged last week about how a trove of emails recently released by the New York Times shines a light on the cozy relationship between Michael Dourson, who just withdrew his nomination to run the Environmental Protection Agency’s (EPA) toxics office, and the American Chemistry Council (ACC), the main chemical industry trade association.  [pullquote]Dourson email to ACC staffer: “We should talk while I am still able to do so directly. I am not sure what limitations I will have with outside groups.”[/pullquote]You might ask why I’m blogging again about these emails.  It’s because they provide a rare and fascinating inside look at how – and how closely – paid consultants, who often tout themselves to the public and state and federal agencies as independent and objective arbiters of sound science, work with industry.  In this post I’ll describe what the emails tell us about Dourson’s work with state governments – and point to a “Bcc” in one of those emails that raises a big red flag.   Read More »

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Systematic slowdown: EPA indefinitely delays virtually all proposed actions to restrict chemicals under TSCA

By / Published: December 20, 2017

Richard Denison, Ph.D., is a Lead Senior Scientist.  My colleague Ryan O’Connell assisted in the research described in this post.

By the time the long-awaited reforms of the Toxic Substances Control Act (TSCA) passed in June of 2016, nearly all stakeholders had come to agree that we needed a stronger federal chemical safety system, one that gave EPA more authority and more resources to act.  Only through this could public confidence in the system begin to be restored – to the benefit of both business and public health.

That was then.  A scant 18 months later, the law is being implemented by an Administration hell-bent on rolling back existing or indefinitely delaying new health protections, even those called for by large bipartisan majorities in Congress.  And the chemical industry?  So much for the influence of its better angels who supported reform.  It’s now going for broke, grabbing what it can while it can.[pullquote]Virtually every proposed action that would impose restrictions or conditions on specific chemicals has been either moved to the “long-term action” attic or simply deleted altogether.[/pullquote]

Yesterday, the New York Times and The Intercept ran stories spotlighting EPA’s decision to back-burner proposed restrictions on high-risk uses of three highly toxic chemicals – trichloroethylene (TCE), methylene chloride (MC), and N-methylpyrrolidone (NMP) – relegating them to the bureaucratic dustbin of “long-term actions.”  Not coincidentally, the chemical industry has strongly opposed all of the proposed restrictions.

But those aren’t the only proposed actions on chemicals for which this EPA has applied the brakes.  An examination of EPA’s two most recent semi-annual “unified agendas” – that trumpeted by the President last week, and the preceding one issued this past April – reveals a much broader and more disturbing pattern:  Virtually every proposed action that would impose restrictions or conditions on specific chemicals has been either moved to the “long-term action” attic or simply deleted altogether.   Read More »

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