EDF Health

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As originally enacted in 1976, TSCA recognized the value of public access to information, like health and safety information (see, e.g., TSCA § 14(b)).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 »

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EDF requests extension of comment period on TSCA Alternative Testing Strategic Plan due to key document missing from docket

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

Last night EDF submitted a request to the Environmental Protection Agency (EPA) to extend the public comment period on its draft Alternative Testing Methods Strategic Plan under the Toxic Substances Control Act (TSCA).

EPA held a public meeting about the draft Strategic Plan on April 10, 2018.  At that meeting, Dr. Nancy Beck prominently highlighted an analysis that EPA had received from a stakeholder that she described as robust and extensive, and her description of the analysis suggested that it has or could significantly influence EPA’s consideration of the issues raised by the draft Strategic Plan.  When asked if EPA would make this analysis available to the public, an EPA official stated that it would be made available.  But the analysis has not yet been published to the docket.  The due date for comments on the draft Plan is a week from today, April 26, 2018.

Given the emphasis Dr. Beck placed on the analysis and the apparently extensive nature of it, EDF believes the public should be provided access to the document and ample time to review, and if desired, comment on it.  Hence we have requested that:

1)  EPA publish a copy of the relevant analysis to the docket for the draft Strategic Plan.

2)  EPA extend the public comment period by 30 days after it publishes the relevant analysis in the docket.

Because the deadline is impending, EDF requested that EPA respond to this request within three business days, i.e., by Monday, April 23.

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EDF comments fault EPA for deviating from the law in proposal for states and health professionals’ CBI access

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

One of the key reforms to the Toxic Substances Control Act (TSCA) made by 2016’s Lautenberg Act was the expansion of who can access confidential business information (CBI) submitted by companies to EPA.  The old law largely limited access to federal government employees and contractors.  Congress recognized the enormous value such information could provide to officials at other levels of government and to health providers and environmental officials treating or responding to chemical releases and exposures.  It therefore mandated that EPA expand CBI access, subject to certain conditions specified in the law.

In March, a full 21 months after passage of the Lautenberg Act, EPA finally issued draft guidance documents setting forth how it intends to meet the law’s mandate to expand access to CBI.  Unfortunately, as has been the case with so many other aspects of TSCA implementation under the Trump administration, EPA got a lot of things wrong in its draft guidance documents.

Yesterday, EDF filed extensive comments raising our concerns over these serious deviations from the law and providing our recommendations for fixing them.   Read More »

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Pruitt’s EPA plans to systematically deconstruct the expanded authority a bipartisan Congress gave it less than two years ago

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

EDF has learned from sources across the Environmental Protection Agency (EPA) that its political appointees are taking steps to systematically dismantle the agency’s ability to conduct broad risk reviews of chemicals and effectively address identified risks under the Toxic Substances Control Act (TSCA).

The assault is taking the form of methodically excising from the scopes of the agency’s chemical reviews any uses of, or exposures to, chemicals that fall under TSCA’s jurisdiction, if those uses or exposures also touch on the jurisdiction of another office at EPA or another Federal agency.

The Pruitt EPA’s attempt to atomize the evaluation of chemical risks has one purpose:  to make it far less likely that risks needing to be controlled will be identified.  If each activity that leads to a chemical exposure is looked at in isolation, it will be far more likely that such activity will be deemed safe.

Under the Lautenberg Act’s 2016 amendments to TSCA, Congress directed EPA to identify the first 10 chemicals to undergo risk evaluations; EPA did so in December 2016.  After the transition to the new Administration, EPA scrambled to produce documents that set forth the “scopes” of those evaluations in order to meet the law’s deadline of June 2017; EPA acknowledged, however, that its scope documents were rushed and incomplete, and promised to update them in the form of so-called “problem formulations” that would be issued within six months.  Those documents are now months late.

We now are learning why:  Political appointees at EPA are engaged in an intra-agency process intended to dramatically narrow the scopes of those first 10 reviews.  They are seeking to shed from those reviews any use of or exposure to a chemical that touches on another office’s jurisdiction, apparently regardless of whether or what action has been or can or will be taken by that office to identify, assess or address the relevant potential risks of that chemical.  Reports indicate that leadership in some offices are welcoming this move, while others are resisting it.   Read More »

Posted in EPA, Health Policy, Health Science, Industry Influence, TSCA Reform / 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 »

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How TSCA implementation could be derailed by Pruitt’s planned directive forcing EPA to ignore science

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

Several of us at EDF listened in last Friday to a webinar hosted by a committee of the American Bar Association that featured Dr. Nancy Beck, Deputy Assistant Administrator in the office of the Environmental Protection Agency (EPA) that administers the Toxic Substances Control Act (TSCA).

Dr. Beck was asked during the Q&A whether EPA was actively working on drafting risk evaluations for the first 10 chemicals TSCA required EPA to identify, even though their long-awaited “problem formulations” have not yet been made available to the public for comment.  Dr. Beck replied that, indeed, the agency was hard at work on the risk evaluations, noting that there are “thousands of studies” agency staff have identified relevant to those 10 chemicals that need to be reviewed.

What struck me about that comment, which in and of itself is not at all surprising, is that it was made just a week after news broke that Dr. Beck's boss, EPA Administrator Scott Pruitt, plans to direct agency staff to reject large numbers of scientific studies from consideration in policy making at the agency.   Read More »

Posted in EPA, Health Policy, Health Science, Industry Influence, TSCA Reform / Comments are closed