EDF Health

EDF joins Opening Brief in legal challenge to EPA’s Prioritization and Risk Evaluation Rules

By EDF Blogs / Published: April 17, 2018

Late yesterday, EDF joined fourteen other Petitioners in filing an Opening Brief in our case challenging EPA’s Prioritization Rule and Risk Evaluation Rule.  The Brief was filed with the U.S. Court of Appeals for the Ninth Circuit.

Our Brief argues that the Toxic Substances Control Act (TSCA), as amended by the Lautenberg Act, requires EPA to comprehensively evaluate a chemical’s hazards and exposures arising from all of its “conditions of use,” a term defined under TSCA as encompassing the chemical’s entire lifecycle from manufacturing and processing to use and disposal.  EPA is then to make a holistic determination of whether the chemical presents an unreasonable risk of injury to human health or the environment, including to potentially exposed or susceptible subpopulations.  EPA’s Rules violate this requirement because EPA asserts unfettered discretion to exclude known or reasonably foreseen exposures and conditions of use from consideration, thereby ignoring potentially important contributors to a chemical’s overall risk.  As a result, the Rules threaten to leave the public—especially vulnerable groups like children, pregnant women, and workers—as well as the environment inadequately protected from the potential risks posed by the thousands of chemicals to which we are exposed every day.

EPA’s response brief in the case is due to the Court on July 5, 2018.  As this litigation proceeds, you can find more information – including all significant legal documents – on EDF’s website.

 

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

By / Published: April 17, 2018

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

By / Published: April 3, 2018

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.[pullquote]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.[/pullquote]

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 »

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

By / Published: April 2, 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

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

By / Published: March 29, 2018

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 »

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Too little, too fast: EDF comments raise numerous concerns with EPA’s proposal to expand use of a toxic chemical

By / Published: March 13, 2018

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

Last month EDF blogged about  our request to the Environmental Protection Agency (EPA) to extend the illegally and unreasonably short 15-day comment period it had provided on a modification EPA is proposing to make to expand the ways a toxic chemical could be used, subject to certain conditions, without triggering any requirement to first notify EPA.  Specifically, EPA is proposing to modify the Significant New Use Rule (SNUR) applicable to the chemical – which currently limits its use to metalworking fluid – to allow the chemical also to be used as an anti-corrosive agent in in oilfield operations and hydraulic fluids.

Our request  also noted that EPA had failed to provide the public with anything approaching a complete set of documents relevant to its proposal.  For example, the public docket for the proposed modified SNUR lacked even a redacted copy of the Significant New Use Notice (SNUN) that triggered EPA’s consideration of the expanded use.

EPA’s proposal to amend the SNUR noted that, while EPA was expanding the allowable uses of the chemical, it was also proposing to impose additional conditions on the use.  These conditions were necessary, EPA argued, because of “test data on the substance and on new data regarding the expected release of formaldehyde from the substance, for skin and eye irritation, neurotoxicity, mutagenicity, oncogenicity, allergic responses, and developmental toxicity.”

Yet the docket did not include copies of these health and safety studies or the test data, despite being referred to in the proposal and in other documents that are in the docket.  As a reminder, such health and safety studies and their underlying data must be made public under the Toxic Substances Control Act (TSCA).  And of course, access to them is crucial if the public is expected to comment on EPA’s proposal.

A few days before the end of the 15-day comment period, EPA did grant a 17-day extension.  It also added a copy of the SNUN to the docket.  But it failed to add any of the health and safety studies or associated data we had identified as missing.

The comment period ended yesterday, and despite the serious time constraint and information gaps, EDF filed these extensive comments last night.  In preparing our comments, however, we found that the amount of health and safety data EPA had failed to provide is even greater than we had originally thought.  And our concerns over the adequacy of EPA’s review of this new proposed use and of the conditions it proposes to include in the modified SNUR have only grown.   Read More »

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