EDF Health

Selected tag(s): Pigment Violet 29 (PV29)

The Trump EPA’s first TSCA risk evaluation is an epic fail

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

Yesterday Environmental Defense Fund (EDF) filed more than 100 pages of comments on a 40-page draft risk evaluation the Trump Administration’s Environmental Protection Agency (EPA) has prepared for Pigment Violet 29 (PV29).  PV29 is the first of 10 chemicals undergoing risk evaluations under the Toxic Substances Control Act (TSCA).  Our comments were so much longer than the EPA document we were commenting on because there was far more to say about what information EPA failed to obtain, make available or consider than what EPA included in its draft.

The essence of our lengthy comments can be boiled down to a single sentence, however:  EPA has utterly failed to demonstrate that PV29 does not present unreasonable risk of injury to health or the environment.

For folks who want somewhat more detail than this, our comments start with a 4-page Executive Summary that capsulizes the many serious deficiencies we identified in EPA’s draft.  I’ll provide some highlights in this post.   Read More »

Posted in EPA, Health Policy, Health Science, Industry Influence, Regulation, TSCA Reform / Also tagged | Comments are closed

Correction: The Trump EPA’s first TSCA risk evaluation is a skyscraper of cards, not just a house

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

We blogged before the holiday break about how EPA used a single, unverified and conflicted estimate of worker exposure to build a whole house of cards and then used it to conclude that Pigment Violet 29 (or PV29) poses no risk to human health.

But upon further consideration, we need to issue a correction:  It’s not a house, it’s a veritable skyscraper of cards EPA has constructed.  That’s because EPA took its highly suspect worker exposure level and combined it with a hazard value EPA erroneously asserts demonstrates minimal hazard, in violation of its own and other authoritative guidance.   Read More »

Posted in EPA, Health Policy, Regulation, TSCA Reform / Also tagged | Read 1 Response

The Trump EPA’s first risk evaluation under the new TSCA is a house of cards

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

I’ve been blogging about the deep problems surrounding the first draft risk evaluation the Trump Administration’s Environmental Protection Agency (EPA) has released under the recently amended Toxic Substances Control Act (TSCA).  This risk evaluation, which is now out for public comment, is on a chemical commonly called Pigment Violet 29, or PV29.  Among the many problems that immediately jumped out as we began our review of this draft evaluation are EPA’s reliance on clearly inadequate health and environmental hazard data to conclude the chemical is safe, as well as EPA’s illegal withholding from the public of the little hazard information it does have.

I suppose if you start with almost no reliable data on a chemical, are dead set against using your enhanced authorities to get any more data, and are hell-bent on finding the chemical is safe, this is how you might choose to conduct a risk evaluation.

This post will look at the other half of the risk equation, exposure.  EPA has even less information on exposures to PV29 than it does on hazard.  EPA has no actual data on the levels of PV29 released to or present in air, soil, sediment, surface water, people, other organisms, workplaces or products containing or made from the chemical.  It lacks any data from, and hasn’t used its authorities to require, monitoring in workplaces or any environmental media.

So what does EPA have?   Read More »

Posted in EPA, Health Policy, Health Science, Industry Influence, Regulation, TSCA Reform / Also tagged | Comments are closed

Exhibit PV29: Why this EPA can’t be trusted to forthrightly assess chemical risks under TSCA

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

I blogged last week about the Environmental Protection Agency’s (EPA) illegal and hypocritical decision to deny the public access to health and safety studies conducted on the first chemical to undergo a risk evaluation under the reformed Toxic Substances Control Act (TSCA).  In its draft risk evaluation, now out for public comment, EPA relied on these secret studies to assert that the chemical, commonly known as Pigment Violet 29, or PV29, is safe, so EPA’s denial of public access matters a great deal.

EPA asserts that these studies are entitled to protection as confidential business information (CBI) under TSCA, when in fact TSCA explicitly does not extend CBI protection to such studies.  The only health and environmental information on this chemical that is public are brief summaries of those studies that were prepared by the companies that make the chemical, and were submitted to the European Chemicals Agency (ECHA) when the chemical was registered under the European Union’s REACH Regulation.  (EPA erroneously states that the studies were “summarized by ECHA.”  This is simply not the case:  Registrants, not ECHA, develop the summaries that are then made available in the registration “dossiers” for REACH chemicals.)

As we review EPA’s draft risk evaluation for PV29, we are finding that EPA’s assertions cannot be trusted even about what these summaries state are the findings of the underlying studies.  I’ll discuss one such case in this post.   Read More »

Posted in EPA, EU REACH, Health Policy, Health Science, TSCA Reform / Also tagged , | Comments are closed

The Trump EPA’s latest TSCA gift to the chemical industry is illegal and the height of hypocrisy

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

‘Tis the season for giving, but it’s not quite keeping in the spirit to have our Environmental Protection Agency (EPA) pile on giveaways to the chemical industry.  The latest one I’ll discuss in this post is not only in direct violation of the Toxic Substances Control Act (TSCA); it exposes this EPA’s two-facedness when it comes to making public the information EPA relies on in making regulatory decisions that affect our health and our environment.

EPA’s failure to make health and safety studies available to the public is blatantly illegal and a slap in the face to the 2016 bipartisan reforms to TSCA that sought to increase public access to information on chemical risks.

First some background.  It has been a long time since EPA has proposed a rule to require testing to determine the hazards of a chemical; the last time was way back in 2011.  (That proposed rule was never finalized.  And despite Congress’ major expansion of EPA’s authority to require testing when reforming TSCA in 2016, EPA has steadfastly refused to even consider use of that new authority.)

The American Chemistry Council (ACC) filed comments opposing the 2011 proposed rule.  As I blogged about at the time, ACC insisted that, instead of calling on its members to provide the health and safety data sought through the proposed rule, EPA should seek to get it from the European Chemicals Agency (ECHA). ACC asserted that ECHA likely had already received the requested data under the European Union’s (EU) REACH Regulation.  I noted that’s not as easy as it sounds, because the chemical industry itself has thrown up major roadblocks to such inter-governmental data sharing.  But here’s the rub:  ACC further argued that, should EPA succeed in obtaining the health and safety data submitted to ECHA, EPA could and should deny public access to those data – despite the fact that TSCA clearly prohibits EPA from withholding health and safety studies.  ACC added that the public should make do with mere summaries of the studies, summaries that were prepared by the companies making the subject chemicals.

At the time, EPA was having none of this.  It indicated that if necessary it could use, and was considering using, its subpoena authority under section 11(c) of TSCA to get the studies from the companies that had submitted them to ECHA; see pages 16-17 of this 2013 report from the Government Accountability Office (GAO).

That was then.  Now, with a former ACC senior official essentially running the TSCA office at EPA, the agency is virtually following ACC’s script.   Read More »

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