EDF Health

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.[pullquote]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.[/pullquote]

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.

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EDF submits comments on Oregon’s proposed rules for lead testing in child care centers

Lindsay McCormick, Project Manager and Tom Neltner, J.D.Chemicals Policy Director

EDF recently submitted comments to the Oregon Department of Education’s Early Learning Division regarding the state’s proposed rules for lead testing for water in licensed and regulated child care centers.

Children are particularly vulnerable to lead exposure: even very low blood lead levels can impair normal brain development, contribute to learning and behavioral problems and lower IQs.

While national attention on lead in drinking water has spurred action to address lead in schools, fewer states have addressed lead in water in child care settings – even though these centers serve children at their most vulnerable ages.

Read More »

Posted in Drinking water, Health policy, Lead, Public health / 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.

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

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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The growing crisis over PFCs: A clear example of the need for EPA’s IRIS Program

Jennifer McPartland, Ph.D., is a Senior Scientist with the Health Program.

As I blogged about earlier, the FY2018 Interior, Environment and Related Agencies bill posted in November by the Senate Appropriations committee majority would eliminate EPA’s Integrated Risk Information System (IRIS) program. Located within the research arm of EPA, this non-regulatory program produces top-tier chemical hazard assessments used not only by multiple regulatory offices within EPA, but also by other federal agencies, regions, and states. IRIS chemical assessments, and the scientists that develop them, are relied on to support a broad range of core environmental decisions from setting clean-up levels at contaminated sites to evaluating health risks of chemicals in commerce and setting standards to ensure clean air and drinking water.

The widespread contamination of drinking water with perfluorinated compounds (PFCs)—chemicals that stick around in the environment for years and years—is a timely example of just how critical scientists within IRIS and related EPA research programs are. Across the country, governments are grappling with how to manage contamination from well-known toxic PFCs, like PFOA and PFOS, while simultaneously trying to understand potential health risks from a plethora of other less well-studied PFCs like GenX.

So what’s the job of EPA IRIS in a situation like this? Read More »

Posted in Drinking water, Health science / Tagged , | Comments are closed