EDF Health

What the heck is going on with EPA’s risk evaluation fees under TSCA?

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

What a mess.  That’s the best that can be said from the outside about the process EPA has followed to decide which companies are to pay fees to help defray the agency’s costs of conducting risk evaluations for the next 20 chemicals under the Toxic Substances Control Act (TSCA).

EPA’s steps to endanger its ability to collect the fees under TSCA that Congress mandated border on self-sabotage.

These fees were set forth in EPA’s final TSCA fees rule issued in October 2018.  The total fee assigned to each of the next 20 chemicals for which risk evaluations are now underway was set at $1.35 million.  That fee is to be paid by manufacturers (including importers) of a chemical.  TSCA provided EPA with authority to charge processors of these chemicals a fee as well, but the agency opted to exclude processors from such fees in its final rule (see p. 52,696).  EPA also opted not to charge fees to cover any of the costs it incurred for the first 10 risk evaluations (see p. 52,708 of the fees rule), although it had authority to do so.

Last week EPA issued what it calls its “interim final list” of companies obligated to pay fees to cover the costs of the next 20 risk evaluations.  The list is dramatically scaled-back from the agency’s earlier list, and it is impossible for the public to understand the basis for the changes.  That is in no small part due to the convoluted, opaque, and legally suspect process EPA has followed.  Read More »

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Under the Trump EPA, no risk to workers is too high to impede a new chemical’s unfettered entry into the market

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

The Trump EPA’s understating of the risks to workers posed by both existing and new chemicals under the Toxic Substances Control Act (TSCA) has been a frequent topic for this blog.  This disturbing, illegal policy continues unabated and, if anything, has accelerated and expanded to outright dismissal of worker health concerns.

The Trump EPA’s blatant shirking of its clear responsibilities under TSCA to identify and mitigate the serious risks that chemicals present to workers – who are on the front lines of chemical exposures – surely constitutes one of its most egregious failings.

In its reviews of new chemicals, EPA now frequently identifies serious risks to workers that exceed its own risk benchmarks, often many times over.  How great are the exceedances EPA finds and ignores?  Our examination of recent cases, described below, reveals exceedances as high as 25,000-fold.  In other words, EPA has found and then dismissed worker exposures to new chemicals at levels as much as 25,000 times higher than it deems acceptable. That is not a typo:  In a very recent case EPA found a dermal risk of reproductive effects to workers that exceeded its own benchmark by a factor of 25,000.

Any reasonable new chemical review that identified excess risk would then impose conditions blocking or conditioning the market entry of these chemicals in a manner sufficient to mitigate the identified risks.  Indeed, that is exactly what TSCA requires EPA to do.

Instead, the Trump EPA over and over again clears these chemicals entirely, ignoring its own risk findings to assert that the chemicals are “not likely to present unreasonable risk.”  This has now been done for hundreds of new chemicals EPA has reviewed in the past two years.

To illustrate what EPA is doing, we examined the 29 new chemicals EPA found “not likely to present unreasonable risk” (“not likely” determinations) since the beginning of June of this year.  Read More »

Also posted in EPA, Health Policy, Regulation, TSCA Reform, Worker Safety / Tagged | Read 2 Responses

EPA flouts the law, science, and its obligation to protect public health yet again: The 1-bromopropane final risk evaluation

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

Today, the Trump EPA released its second final risk evaluation and determination under the reformed TSCA, for the carcinogenic solvent, 1-bromopropane (1-BP).

EPA has once again ignored expert scientific input it received from its own advisors.

As was the case with the final document for methylene chloride – which has already been challenged in court (see here and here) – EPA has doubled down on the illegal, unscientific, and un-health protective approach it has taken in all of its draft risk evaluations for the first 10 chemicals reviewed under TSCA.

EDF will be closely examining this final document, but it is already apparent that EPA continues to grossly and systematically underestimate the exposures to and risks of 1-BP to the general public, workers and the environment.

Below are four examples of the flaws; each was raised by EPA’s own Science Advisory Committee on Chemicals (SACC) in its peer review as serious deficiencies – expert scientific input that EPA has simply chosen to ignore in finalizing the document:  Read More »

Also posted in EPA, Health Policy, Health Science, Public Health, Regulation, TSCA Reform, Worker Safety / Tagged , | Read 1 Response

Greasing the skids: The Trump EPA is green-lighting dozens of new PFAS under TSCA

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

Under an obscure and opaque – and increasingly used – exemption that EPA provides under the Toxic Substances Control Act (TSCA), EPA has been quietly approving companies’ requests to introduce new poly- and per-fluorinated substances (PFAS) onto the market.  And it seems to be ramping up.

Under this EPA the “low-volume exemption” (LVE) application process is proving to be very smooth sailing for getting new PFAS onto the market.

PFAS is a class of chemicals that are showing up as environmental contaminants all over the country.  They are linked to large and growing list of adverse effects on human health.  These concerns have led to increased scrutiny about EPA’s actions to allow new PFAS to enter commerce.  EDF and others have raised concerns about a number of premanufacture notices (PMNs) companies have filed seeking approval to introduce new PFAS into commerce (see here and here); the PMN process is the standard way in which companies are to notify EPA of their intent to start manufacturing a new chemical.

But EPA has created other pathways to quickly get a chemical on the market, whereby companies can apply for an exemption from the PMN process.  As documented in this post, we have identified a whole lot of PFAS coming into EPA’s new chemicals program through exemptions, and most of them are getting quickly approved.  Worse yet, this side process is highly insulated from public scrutiny.  Read More »

Also posted in EPA, Health Policy, Health Science, PFAS, Regulation, TSCA Reform / Tagged | Comments are closed

A PSA for the Trump EPA: The chemical industry isn’t your “client” for the new chemicals program

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

[UPDATES ADDED 8-6-20: See insertions of bracketed italicized text below.]

So much for the Trump EPA’s constantly ballyhooed commitment to transparency under TSCA.

I blogged a few short weeks ago about just how brazen EPA officials have become in aligning themselves with the chemical industry when it comes to the agency’s review of companies’ requests to commercialize new chemicals under the Toxic Substances Control Act (TSCA).

Yet it just keeps getting worse.  Read More »

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5 ways we’re holding the Trump Administration accountable on the TSCA 4-year anniversary

It’s been four years since Congress passed legislation overhauling our chemical safety system to better protect American families. In the time since that bipartisan achievement, the Trump administration has worked to systematically undermine the law and weaken chemical safety.

But we’re not sitting idly by, and we have the law on our side. This year, on the anniversary of the legislation’s passage, we’re highlighting some of the victories we’ve had and ways we’re fighting back to demand EPA protect the American people from harmful chemicals.

1. Winning important legal cases to hold EPA to the letter of the law

Last year, in response to a challenge from EDF, a federal court delivered a strong rebuke to the Trump EPA’s efforts to undermine the public’s right to know about the chemicals in our homes, schools, and workplaces. The ruling on our lawsuit means that companies can’t hide, and EPA must make public, more information about chemicals in use today.

And a ruling last year in a different case – brought by health, labor and environmental groups, including EDF – has already increased pressure on EPA to stop ignoring known sources of exposure to chemicals when assessing their risks. Conducting the comprehensive risk reviews that the law requires is critical to protecting health, especially for vulnerable populations, like children, pregnant women, and fenceline communities.

Read More »

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