EDF Health

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 »

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How Pruitt's EPA finds a dangerous chemical is safe: Ignore most exposures to it

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

The 2016 Lautenberg Act amendments to the Toxic Substances Control Act (TSCA) expanded and enhanced Congress’ vision for how the Environmental Protection Agency (EPA) should evaluate and mitigate the potential risks of chemicals.  

The industry’s interest is simple:  The fewer exposures to a chemical EPA looks at, the more likely it is to find those it does look at safe.

The original TSCA was intended to encompass the full lifecycles of chemicals, from manufacturing to use to disposal, authorizing EPA to regulate any of those activities.  It gave EPA co-authority with the Occupational Safety and Health Administration (OSHA) over chemical exposures in workplaces and with the Consumer Product Safety Commission (CPSC) over chemical exposures from consumer products.  And it provided a wide array of means by which EPA could regulate chemicals to address unreasonable risks it identified, ranging from requiring warnings to limiting the amount of a chemical that could be used in a certain way to an outright ban on all uses of a chemical.  Unfortunately, the original law also contained fatal flaws that rendered this vision unachievable in practice.

Congress finally stepped in to address those flaws through the 2016 amendments.  But the amendments also did something else:  they added several elements that further expanded what EPA was to include in addressing chemical risks.  Congress explicitly required that EPA identify and protect against risks not only to the general population, but to vulnerable subpopulations at potentially greater risk due to heightened exposure or greater susceptibility to a given exposure.  It mandated that EPA prioritize chemicals, and evaluate and regulate their risks, under the chemicals’ “conditions of use,” a term Congress defined broadly to encompass not only the full chemical lifecycle, but also all of the “intended, known, or reasonably foreseen” activities that occur at each lifecycle stage.

And Congress directed EPA to determine whether a chemical’s risks were unreasonable and warranted regulation based solely on its effects on human health or the environment, without regard to costs or other non-risk factors.  Only after EPA completed its science-based evaluation of risks and determined regulation was warranted, was EPA to consider costs and other non-risk factors, and then only in deciding how best to eliminate the unreasonable risk.  Congress also retained the provision of TSCA that relegates to the very last step any consideration of whether other authorities – be they EPA’s or other agencies’ – could be used instead of TSCA.

Each of the new elements has a strong basis in the large body of science that has emerged over the decades since TSCA first passed in 1976 that elucidates how we are exposed to chemicals, how they can affect our basic biology, and how variability in the human population mediates the potential impacts.

Any objective reading of the new law would lead one to expect, therefore, that the breadth and depth of EPA’s chemical risk evaluations would grow considerably.  And for most of the first year after passage of the new law, that was where things appeared to be heading.

Enter the Pruitt EPA.   Read More »

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Pruitt EPA Illegally and Dramatically Undermines Authority to Limit Dangerous Chemicals under Reformed Chemical Safety Law

EPA today revealed its severely flawed approach to reviewing the risks to health and the environment posed by the first 10 chemicals being evaluated under the newly reformed chemical safety law, the Toxic Substances Control Act (TSCA).  These chemicals were selected in 2016 because of their potential dangers to the health of American families, but the Pruitt EPA has chosen to ignore many sources of exposure to the chemicals and, in doing so, will severely underestimate their actual risks.

“EPA is both ignoring the law and endangering public health.  The approach it is taking – designed by an appointee who came straight from the chemical industry’s lobbying arm – ignores millions of pounds of toxic pollution,” said Dr. Richard Denison, EDF lead senior scientist.  “Pruitt’s EPA won’t examine the real extent of exposures to these chemicals – and that will put at risk the lives and health of Americans.”

An analysis by Environmental Defense Fund reveals that EPA will ignore more than 68 million pounds of seven of these 10 chemicals released to the nation’s air, water, and land every year.  Among the chemicals are known killers such as asbestos and other toxic chemicals such as trichloroethylene (TCE) that cause cancer and are linked to developmental and neurological disorders.

Download or view the above table at this link.   Read More »

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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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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 »

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