EDF Health

Selected tag(s): New chemicals

Trump’s EPA pivots yet again on reviews of new chemicals under TSCA, leaving public and worker health in the dust

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

EDF has learned from multiple sources that political appointees at the Environmental Protection Agency (EPA) are on the verge of taking yet another huge lurch away from what the 2016 reforms to the Toxic Substances Control Act (TSCA) require when EPA reviews the safety of new chemicals prior to their market entry.  A reporter at Bloomberg Environment has heard the same thing, and published an article this morning on some of the changes.

The Trump EPA apparently intends to abandon its November 2017 “New Chemicals Decision-Making Framework,” which already strayed far from the law’s requirements.  That approach would have allowed EPA staff to limit their review of a new chemical only to the intended uses identified by its manufacturer, despite the law’s clear mandate that EPA consider known or reasonably foreseen, as well as intended, uses when conducting its review.  Under the framework, where EPA had concerns about reasonably foreseen but not intended uses – rather than issue an order as required by the law – EPA would take two other steps:  make a “not likely to present an unreasonable risk” determination for the chemical, clearing it to enter commerce; and issue a Significant New Use Rule (SNUR), which could trigger a separate, future review on any subsequently intended use, wholly divorced from the initial review.

Initially, EPA staff indicated the “not likely” finding would be made only once a final SNUR had been promulgated.  That then slipped to have issuance of the finding coincide with the proposal of the SNUR.  That then slipped further to allow the finding to be issued based on EPA’s mere intent to develop a SNUR.

Now, however, the Trump EPA plans to decouple completely its ability to issue a “not likely” finding from any dependency at all on promulgation of a SNUR.  How then, you might well ask, would EPA consider reasonably foreseen uses of a new chemical?  The short answer is, it won’t.   Read More »

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

Testing analysis for TSCA new chemicals embraced by EPA’s Beck has serious omissions

Richard Denison, Ph.D.is a Lead Senior Scientist.  Ryan O’Connell, EDF High Meadows Fellow, and Stephanie Schwarz, EDF Legal Fellow, assisted in the research informing this post.

[UPDATED 5-15-18:  See clarifications and a correction added in brackets below.]

As noted in a previous blog post, EDF recently filed a request for an extension of the public comment period on EPA’s draft Alternative Testing Methods Strategic Plan under the Toxic Substances Control Act (TSCA).  This was due to the lack of public access to documents that Dr. Nancy Beck had prominently alluded to, without identifying, at EPA’s April 10, 2018, public meeting on the draft plan.  EDF requested a 30-day extension starting once the documents were placed in the docket for the draft plan.

On April 27, EPA provided a 15-day extension after placing the documents in question into the docket.  It turns out the documents (a letter and an attached spreadsheet) are from two animal welfare organizations, People for the Ethical Treatment of Animals (PETA) and Physicians Committee for Responsible Medicine (PCRM).  They are not, were not submitted as, and apparently were not intended to be, comments on the draft plan, however; rather, they raise the groups’ concerns over the increase in testing of new chemicals under the new TSCA, based on an analysis they said indicates EPA more frequently included testing provisions when issuing consent orders for new chemicals after passage of the new law than it did before.

Given that the documents PETA and PCRM submitted were not comments on the draft plan and were not submitted in that context, it is all the more curious why Dr. Beck so prominently noted and expressed such enthusiasm for them at the EPA public meeting held about the draft plan – especially because it appears she did so before EPA had conducted any serious review of the documents, which as you’ll see below, is a big problem.

I suspect Dr. Beck’s interest in the PETA/PCRM letter and analysis has little to do with sparing laboratory animals and much more to do with her seeing the documents as providing a useful pretext for her concerted efforts to avoid imposing testing requirements on new chemicals – a clear priority for her previous employer, the American Chemistry Council (ACC).  Industry has incentives to avoid testing due to its costs and the risks that testing may reveal a chemical presents significant risks to health or the environment.

Now that we’ve had a chance to review the PETA/PCRM documents, I want to use this post to highlight two things:

  • First, the PETA/PCRM analysis erroneously understated the extent of testing EPA required prior to the passage of the Lautenberg Act, because it failed to count any of the testing requirements for two-thirds of the new chemicals it examined for which EPA issued consent orders in 2015 and 2016.
  • Additional context is required when assessing the extent of testing of new chemicals EPA was mandating under the new TSCA, which was not provided in the PETA/PCRM analysis.

Read More »

Posted in EPA, Health Policy, TSCA Reform / Also tagged , | Read 2 Responses

EPA practices are hindering transparency and public confidence in TSCA’s new chemicals program

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

This is our final post in a series spurred by our review of 69 public files for new chemicals we received from EPA’s Docket Center.  For most of these chemicals, EPA made a determination that they are “not likely to present unreasonable risk” under the Toxic Substances Control Act (TSCA), which greenlights their entry into commercial production.

In our previous post we demonstrated EPA is not complying with a number of provisions under TSCA that require the agency to make public the premanufacture notices (PMNs), notices of commencement (NOCs), and information that is submitted with them.  In this post we look further into how, through these failures and others, EPA has impeded meaningful transparency in the new chemicals program.

As originally enacted in 1976, TSCA recognized the value of public access to information, like health and safety information (see, e.g., TSCA § 14(b)).  Even in EPA’s original (1983) regulations establishing the new chemicals review program, EPA recognized that “[p]ublic participation cannot be effective unless meaningful information is made available to the interested persons” (see here p. 21737).  Among the many flaws of the original TSCA, however, was the law’s inability to ensure EPA delivered the promised transparency when it came to both information EPA receives and the agency’s decisions on new chemicals.

The amendments to TSCA in 2016 were meant, in part, to expand public access to information about both chemicals and agency decisions, and in doing so increase public confidence.  For instance, under § 26, EPA must now make available to the public “all notices, determinations, findings, rules, consent agreements, and orders.”  And under § 5, EPA must now make an affirmative determination on new chemicals, which under § 26 must be made public.  These changes, in addition to the original TSCA provisions, clearly envision a robust program under which the public is able to readily access non-confidential information on new chemicals and information on EPA’s decisions about them.  

Coupled with the policy changes EPA has made, the concerns we raise here make clear that EPA under this Administration intends to weaken a new chemicals program that Congress sought to strengthen through TSCA reform – and hide as much of it from public view as possible.

As implemented, however, a number of features of the new chemicals program severely hamper the ability of the public to understand EPA’s decision-making or engage in the new chemicals program.  In addition to the failings we have discussed in previous posts in this series, this post will address several others:

  • the convoluted and fragmented public information “system” EPA has created for PMNs;
  • the failure of EPA to provide access to agency-generated health and safety information on PMN substances; and
  • EPA’s failure to publish Notices of Commencement (NOCs) and EPA’s determinations on confidentiality claims for specific chemical identity in those NOCs.

Read More »

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

EPA is keeping the public in the dark on premanufacture notices for new chemicals under TSCA

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

This is the third in a series of blog posts based on our frustrating, and frustrated, efforts to get information on premanufacture notifications (PMNs) for new chemicals under the Toxic Substances Control Act (TSCA).  The saga began when we requested from the EPA Docket Center the public files on 69 new chemicals, most of which EPA had determined were “not likely to present an unreasonable risk” under the TSCA, as amended in 2016 by the Lautenberg Act.  This series of posts analyzes and describes what we did, and did not, get from the Docket Center, to which EPA staff pointed us when we raised the fact that such files are not available on EPA’s website or at www.regulations.gov, despite EPA regulations requiring they be.

TSCA and EPA’s regulations contain a number of provisions that, if reliably implemented, would give the public better access to, or at least a better understanding of, the information EPA receives on new chemicals.  This includes mandates that EPA:

  • publish in the Federal Register EPA’s receipt of new chemical PMNs (TSCA § 5(d)(2));
  • make all PMNs and Significant New Use Notices (SNUNs) publicly available (TSCA § 5(d)(1));
  • make all information submitted with the notices available to the public (TSCA § 5(b)(3) and 40 C.F.R. § 720.95); and
  • make the public files electronically available (40 C.F.R. §§ 700.17(b)(1), 720.95).

EPA has repeatedly committed to increasing the transparency of its new chemicals program.  Unfortunately, our review of the PMN files we received has revealed massive gaps and inconsistencies in the information EPA does provide to the public, and all too often we are finding that EPA has entirely failed to comply with the law and its own regulations.  These failings are on top of efforts by the agency to actively hide information on new chemicals that it had made public for decades.

This post will focus on failings of EPA’s new chemicals program when it comes to transparency and compliance with TSCA and its own regulations with respect to the PMNs EPA receives for new chemicals.  These failings make it virtually impossible for the public to gain any understanding of, or play any meaningful role in, EPA’s review of new chemicals under TSCA.   Read More »

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

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.

Part 1               Part 2               Part 3               Part 4

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 »

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