EDF Health

Selected tag(s): New chemicals

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.

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.

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

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.

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.

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 »

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

Is there no limit to industry’s overreach and hubris when it comes to new chemicals under TSCA?

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

We’ve already blogged about how changes the agency is making to its reviews of new chemicals under the Toxic Substances Control Act (TSCA) are illegal as well as bad policy.  But an industry letter and attachment added last week to EPA’s new chemicals docket shows the chemical industry isn’t done yet in seeking to eviscerate the program.

The letter and position statement were submitted to Jeffery Morris, Director of EPA’s Office of Pollution Prevention and Toxics (OPPT) by something called the TSCA New Chemicals Coalition (NCC).

They raise a multitude of red flags.

The NCC is a creation of the industry law firm Bergeson & Campbell (B&C). The letter to Morris describes NCC as “a group of representatives from over 20 companies that have come together to identify new chemical notification issues under the amended Toxic Substances Control Act (TSCA) and to work collaboratively with you and your team to address them.”

First red flag:  Nowhere are the 20+ companies identified, not in the letter or associated position statement, nor on B&C’s web pages for NCC.  Such secrecy always sets off an alarm when it comes to the chemical industry’s history of forming misleading front groups and coalitions.  Why don’t the companies want their identities known?

Second red flag:  The NCC letter and position statement claim that “OSHA has in place an extensive regulatory scheme, as well as enforcement mechanisms, governing chemical exposure in the workplace” and refers to the “robust nature of the existing OSHA regulatory program” and its “overarching and comprehensive requirements” that apply in the workplace.  Now, anyone outside of industry readily acknowledges that OSHA’s ability to adequately address workplace exposures has been decimated over time – through sustained industry efforts on many fronts, including mounting legal challenges to OSHA’s authority and successfully pressing for reduction after reduction in its budget and staffing.  Those attacks continue today, and if anything have accelerated under the Trump Administration.

Why then, you may wonder, is NCC writing to the director of EPA’s TSCA office to tout OSHA’s sweeping authority over workplace chemical exposures?  By now you may be getting a sense of where this is headed … .   Read More »

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

EDF comments at EPA’s public meeting on new chemical reviews question the credibility and legality of recent changes

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

EPA held a public meeting today to present information on major changes it is making to its review of new chemicals under last year’s reforms made to the Toxic Substances Control Act (TSCA) by the Lautenberg Act.

EPA provided brief opportunities for stakeholders to provide comments.  Two of us from EDF – I, and my colleague Robert Stockman, Senior Attorney – gave oral comments at the meeting.  We are providing those comments here in written form.

Through these actions, many clearly contrary to the law, EPA is returning the new chemicals program to its dark ages under the old TSCA, making it again into a black box within which EPA acts as if its only stakeholder is the chemical industry.

My comments are available here.

Robert Stockman’s comments are available here.

As the comments make clear, EDF believes the changes EPA is making and discussed today are both contrary to the requirements of the new TSCA and represent a retreat from the credible, transparent and accountable new chemicals program Congress sought to establish under the new law.

As I noted in my comments:  “Through these actions, many clearly contrary to the law, EPA is returning the new chemicals program to its dark ages under the old TSCA, making it again into a black box within which EPA acts as if its only stakeholder is the chemical industry.”

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Too little, too late: Why SNURs alone are not a sufficient alternative to consent orders for new chemicals

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

The Environmental Protection Agency (EPA) is in the process of making some major changes to its policies and practices governing new chemical reviews.  This post discusses one of the most troubling ones.  

The SNUR-only approach EPA is now deploying differs dramatically from and provides far less risk protection than would result from it simply doing what the law requires:  using orders, with SNURs as backup.

As I have previously described, last year’s Lautenberg Act made extensive changes to section 5 of the Toxic Substances Control Act (TSCA), which governs the review of new chemicals prior to their manufacture and use.  Among these changes is a requirement that EPA must evaluate potential risks, and mitigate potential unreasonable risks, of a new chemical under its “conditions of use,” which the new law defines to include “reasonably foreseen” circumstances of production, processing, distribution, use or disposal, as well as those intended by the company submitting notice of the new chemical to EPA.  If EPA identifies potential risk or significant exposure or lacks sufficient information on a new chemical, it must issue an order prohibiting or limiting the conditions of use of the chemical in order to mitigate any unreasonable risk.

After passage of the Lautenberg Act until recently, and in keeping with the new law, if EPA’s review identified risk concerns relating to conditions of use beyond those strictly identified by a company submitting a new chemical notice to EPA, the agency made a “may present an unreasonable risk” finding and pursued development of a consent order with the company sufficient to ameliorate those concerns.  (While EPA has authority to issue unilateral orders, it typically negotiates with the company to arrive at a consent order that both parties sign.)

Now EPA is indicating it will instead make a “not likely to present an unreasonable risk” finding for the intended conditions of use, and says it can address any concerns over reasonably foreseen uses without issuing an order by developing only a significant new use rule (SNUR).  This “SNUR-only approach” is inconsistent with the law, a matter I won’t discuss further here.  However, it also raises a host of policy concerns, some of which I lay out in this post.

The SNUR-only approach EPA is now deploying differs dramatically from and provides far less risk protection than would result from it simply doing what the law requires:  using orders, with SNURs as backup.

There are ample reasons why Congress called on EPA to use orders to address concerns and then use SNURs as backup:  Orders (including consent orders) and SNURs are not created equal.  This post discusses 12 key differences, with respect to:

(Spoiler alert:  Deep dive ahead. Let me apologize to and warn readers in advance that this post gets rather into the weeds, as the issues are complicated and the details are important.)   Read More »

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