EDF Health

This EPA has a blatant double standard when it comes to transparency on new chemicals under TSCA

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

I’ve blogged extensively over the past year about the Trump EPA’s moves to dismantle health-protective reviews of new chemicals under the Toxic Substances Control Act (TSCA).  A remarkable feature of those moves is that they have been cast as an effort to improve transparency in the new chemicals review process.

A year ago when Scott Pruitt unveiled his intent to institute “Improvements to New Chemical Safety Reviews,” he cast it as necessary to increase the program’s transparency, using the word no fewer than five times in the press release.  When EPA released its “Points to Consider” guidance to aid companies in expediting getting their new chemicals through the review process, EPA touted it as a move to “improve transparency with the public.”

In fact, it seems that whenever the agency has acted to assist companies under the new chemicals program, it’s all about transparency.  But as for the public?  EPA has actually denied the public access to information it has a right to, and has taken steps to hide information from the public that it used to make available.   Read More »

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PART 2: EPA rams through its reckless review scheme for new chemicals under TSCA, your health be damned

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

Part 1               Part 2               Part 3

I blogged last week about how political appointees at EPA are starting to clear new chemicals to enter commerce based on a new – apparently unwritten and certainly not public – review process that ignores the law and will put the health of the public, workers and the environment at greater risk than even under the weak reviews conducted before Congress’ 2016 overhaul of the Toxic Substances Control Act (TSCA).

In this post I’ll start to take a deeper look at the specific fragrance chemical that is the subject of EPA’s first decision under the new scheme:

Oxirane, 2-methyl-, polymer with oxirane, bis[2-[(1-oxo-2-propen-1-yl)amino]propyl] ether
CAS 1792208-65-1

Recall that, even as it declared the chemical safe, EPA noted its “potential for the following human health hazards: irritation, mutagenicity, developmental/ reproductive toxicity, neurotoxicity, and carcinogenicity.”  I’ll explore those hazard concerns more in a subsequent blog post.  Here, let’s consider use of and exposure to the chemical.

Here’s the thing:  None of the parameters of the intended use is binding.  They can be deviated from at any time without consequence.

With its decision, EPA has allowed this chemical to enter the market without any conditions whatsoever placed on how or how much of it can be produced or used or by whom.  This is in fact the aim of the new scheme and, barring another change in course, we can now expect this outcome for the great majority of new chemicals EPA reviews.  It will be achieved by EPA routinely making determinations that the chemicals are “not likely to present an unreasonable risk.”   Read More »

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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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EDF Calls on EPA to Withdraw Censored Science Proposal

Experts for Environmental Defense Fund (EDF) called on the Environmental Protection Agency (EPA) today to withdraw the “censored science” proposal – a proposed rule that would bar the agency from considering some of our most important public health studies in making decisions about vital protections for human health and the environment.

EPA held an all-day public hearing on its proposal at its Washington, D.C. headquarters today. EDF Senior Health Scientist Jennifer McPartland was among the more than 100 Americans who were expected to testify.

“EPA’s proposed rule represents a total disregard for the agency’s core mission: protection of human health and the environment,” said McPartland in her testimony. “If finalized the rule will erode critical public health protections, and with them, the scientific integrity and public trust of the agency.”

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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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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