EDF Health

EPA seriously underestimates its costs under TSCA and lowballs industry fees as a result

Richard Denison, Ph.D.is a Lead Senior Scientist.  Stephanie Schwarz, J.D., is a Legal Fellow.

Yesterday EDF filed extensive comments on the Environmental Protection Agency’s (EPA) proposal for the last of the so-called “framework rules” called for under the 2016 amendments to the Toxic Substances Control Act (TSCA).  This rule, once finalized, will establish the “user fees” Congress authorized EPA to collect from chemical manufacturers and processors to help defray EPA's costs for implementing TSCA.

The 2016 Lautenberg Act amendments to TSCA greatly expanded both EPA authorities and responsibilities under TSCA.  These extended to chemical testing; conducting risk reviews of new chemicals and prioritizing and conducting risk evaluations of existing chemicals; managing potential or identified risks of both new and existing chemicals; collecting, reviewing and providing access to chemical information; and reviewing confidential business information (CBI) claims asserted by companies when submitting information to EPA.

To determine the level of user fees, EPA is first required to determine its full costs to exercise these authorities and carry out these responsibilities.  Fees are then to be set so as to recoup 25% of those costs or $25 million annually, whichever is lower.  Separate fees are to be collected to cover EPA’s costs to conduct risk evaluations of chemicals companies request, apart from risk evaluations EPA initiates.

So it is vital that EPA fully and as accurately as possible account for its costs, and that it set fees that meet the intent and letter of the law.

Unfortunately, EPA’s proposed rule falls far short of the mark.  EPA has severely underestimated its baseline program costs, both by omitting costs for some relevant activities altogether and by understating the extent or actual cost of other activities.  In some cases EPA set fees at a low level based only on industry’s request that it do so or by invoking factors that are not consistent with the law.  In the proposal and supporting documents, EPA has provided scant detail or conflicting information on how it calculated many of its costs, making it difficult or impossible for stakeholders to know whether EPA’s estimates are at all accurate.

As a result of these flaws, EPA has set some fees at levels below those required by TSCA and the resulting funds will not be sufficient to recoup the costs TSCA authorized EPA to defray through user fees.

This post will highlight some of the many concerns and questions we discuss in detail in the comments we have submitted.   Read More »

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Methylene chloride in paint strippers: A ban is the only health-protective path forward

Lindsay McCormick is a Project Manager and Richard Denison, Ph.D.is a Lead Senior Scientist.

Last week, EPA signaled it will advance a delayed rule regulating consumer and worker use of methylene chloride-based paint strippers.  Numerous details of EPA’s announcement remain to be filled in, and we caution EPA to avoid approaches short of the ban that was proposed.

The record for EPA’s proposed ban is clear:  Allowing such products to stay on the market based on reliance on such factors as increased labeling, protective equipment, or training requirements simply will not protect the public’s or workers’ health.

Sadly, the companies that make the chemical and paint strippers containing it are already seeking to resurrect those old arguments.   Read More »

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New EPA Science Regulation: A Trojan Horse that Hurts Public Health

By Dr. Ananya Roy, Sc.D. & Dr. Elena Craft, Ph.D

Last week, embattled EPA Administrator Scott Pruitt rushed to propose a new rule that may prevent EPA from using certain scientific studies in its decisions. He was in such a rush that he didn’t even wait for the White House Office of Management and Budget to complete its review of the proposal before releasing it. The rule was published yesterday in the Federal Register, marking the start of a 30 day public comment period.

Though touted as a measure for transparency, the proposed policy includes a carefully worded loophole[1] that would enable politically driven decisions on what science is used to support critical safety standards. It would hamper public health protections by allowing the agency’s political leadership to select studies that benefit its agenda and ignore those that don’t, opening the door to industry interests and secrecy.

Our colleague Richard Denison explained in a blog post last week how this policy might be used to decimate toxic chemicals safeguards at EPA. Here, we focus on what this deeply destructive proposal would mean for clean air and health.

Read More »

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Scott Pruitt seeks to cook the books on EPA risk assessment science

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

EPA Administrator Scott Pruitt unveiled his “secret science” initiative yesterday at a press conference to which no press were invited.  While EPA has yet to post the proposed rule or otherwise make it available to the public, it was made available by others.  The main thrust of the proposal is actually considerably different and, at least initially, more targeted, than advertised by Pruitt in recent weeks and by the House of Representatives Science Committee’s Chairman Lamar Smith (R-TX), who authored the secret science legislation on which Pruitt’s proposal was to be based and appeared with Pruitt yesterday.

Yesterday both men stuck to their earlier talking points about the need to make sure all information EPA relies on is reproducible and fully publicly available, and never mentioned the change in the focus of the proposal.  I suspect both of them would have been hard pressed to describe the actual main focus of the proposal, which is now this:

When promulgating significant regulatory actions, the Agency shall ensure that dose response data and models underlying pivotal regulatory science are publicly available in a manner sufficient for independent validation.  (p. 23, emphases in original)

But I am sure Dr. Nancy Beck, chemical industry toxicologist turned top political appointee in EPA’s toxics office, could in a heartbeat.

I would describe the new approach, while no less dangerous, as a laser-guided missile in comparison to the carpet-bombing approach taken by the House legislation and earlier iterations of the EPA proposal.   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 »

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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 »

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