EDF Health

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

A tale of two public comment extension requests: How they fared under the Trump EPA

By / Published: December 10, 2020

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

In recent weeks EPA has issued for public comment significant modifications to its draft risk evaluations under the Toxic Substances Control Act for two chemicals:  Pigment Violet 29 (PV29) and 1,4-dioxane.  Because EPA initially provided relatively brief comment periods on the modifications, both were subject to requests for extensions of the comment period.

The table below tells the story of how these two requests fared under the Trump EPA.  Read More »

Posted in Health policy, Industry influence, TSCA reform / Also tagged , | Comments are closed

Peer reviewers confirm EPA has failed to show Pigment Violet 29 doesn’t present unreasonable risk

By / Published: September 23, 2019

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

Late on Friday, EPA quietly posted the final peer review report of the Scientific Advisory Committee on Chemicals (SACC) for pigment violet 29, the first chemical for which EPA issued a draft risk evaluation under the Toxic Substances Control Act (TSCA) as amended in 2016.

No wonder EPA posted it late Friday with no announcement.  The peer reviewers’ report confirms what EDF and others have been saying since release of the draft:  EPA has fallen far short of supporting its sweeping conclusion that the chemical does not present unreasonable risk, including to vulnerable subpopulations.  The report also faults EPA’s use of systematic review, and reiterates that EPA needs to submit its method to the National Academy of Sciences for review.  Read More »

Posted in Health policy, Health science, Regulation, TSCA reform / Also tagged , | Comments are closed

Round 2 on PV29 reveals even deeper flaws in EPA’s TSCA risk evaluation of the chemical

By / Published: May 20, 2019

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

On Friday, Environmental Defense Fund (EDF) submitted a new set of extensive comments to the Environmental Protection Agency (EPA) in response to its March release of additional information on Pigment Violet 29 (PV29), the first chemical to undergo a risk evaluation under the Toxic Substances Control Act (TSCA) following the law’s amendment in 2016.

After EDF and others criticized both the dearth of health and environmental data on PV29, and EPA’s illegal withholding of those data, EPA released some additional information and opened a new comment period in mid-April.  In releasing the new information, EPA was quick to judgment, asserting that “[t]he release of these studies does not change the Agency’s proposed ‘no unreasonable risk’ determination as concluded in the draft risk evaluation published in November.”

EDF’s 100 pages of comments in Round 1 enumerated the myriad ways EPA has failed to demonstrate that PV29 does not present unreasonable risk.  Unfortunately, if anything, Round 2 has only deepened our concerns over the inadequacy of EPA’s risk evaluation.   Read More »

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EPA says PV29 is perfectly safe. The EU, citing concerns and a dearth of data, begs to differ.

By / Published: May 7, 2019

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

In contrast to the Environmental Protection Agency’s (EPA) asserted clean bill of health for Pigment Violet 29 (PV29) in its draft risk evaluation, authorities under the European Union’s REACH program have formally declared the chemical to be a suspected persistent, bioaccumulative and toxic (PBT) substance and a suspected very persistent and very bioaccumulative (vPvB) substance.  Either designation, if confirmed, would classify PV29 as a substance of very high concern (SVHC) under the EU’s REACH Regulation.

In EDF’s earlier comments on EPA’s draft risk evaluation, we noted that PV29 had been proposed to be so listed under REACH and to undergo a full substance evaluation in 2021.  Since we filed those comments, the European Chemicals Agency (ECHA) has published an update to its Community Rolling Action Plan (CoRAP) that now formally designates PV29 as a “suspected PBT/vPvB” that will be subject to a full substance evaluation.  The listing is accompanied by a “justification document” for PV29’s designation.

The justification document, prepared by the Belgian Competent Authority (BE CA) under REACH and endorsed by REACH authorities, echoes many of the concerns about PV29 and EPA’s draft risk evaluation that EDF had raised in our earlier comments.   Read More »

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Industry deletions in PV29 study summaries should raise alarm bells on both sides of the Atlantic

By / Published: May 2, 2019

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

[pullquote]The intentional alteration of industry study summaries under REACH that I report here should raise major alarms on both sides of the Atlantic and illustrates why public access to full studies on chemicals to which we are or may be exposed must be paramount.[/pullquote]Well, I certainly wasn’t expecting to find this when I started working on EDF’s comments on supplemental materials the Environmental Protection Agency (EPA) recently made available on Pigment Violet 29 (PV29), the first of 10 chemicals undergoing risk evaluations under the amended Toxic Substances Control Act (TSCA).  What I discovered – almost by chance – strongly reinforces EDF’s and others’ view that the public’s ability to independently assess and trust EPA chemical assessments falls flat without access to full and unredacted copies of the health and safety information EPA cites in support of its risk evaluation.   Read More »

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EDF statement in advance of House hearing on failure by the Trump EPA to protect workers from toxic chemicals

By / Published: March 12, 2019

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

Tomorrow, the House Energy and Commerce Committee’s Subcommittee on the Environment and Climate Change will hold an oversight hearing on “Mismanaging Chemical Risks: EPA’s Failure to Protect Workers.” In advance of the hearing, Environmental Defense Fund lead senior scientist, Dr. Richard Denison, made the following statement:

“Under the Trump Administration, every aspect of EPA’s implementation of the Toxic Substances Control Act (TSCA) — our recently reformed chemical safety law — has gone off the rails. The Trump EPA has abdicated its authority and responsibility under the law to address risks to workers. Among the ways EPA has shirked these duties are the following:

  • Clearing new chemicals despite risks to workers. EPA has approved new chemicals for unfettered market access even where the agency has identified significant risks to workers or has indicated it has insufficient information to determine risks to workers. EPA has done so for many dozens of chemicals.
  • Abandoning worker protections from methylene chloride. EPA is poised to finalize a ban of methylene chloride-based paint strippers far narrower than the one it proposed over two years ago. While consumer uses will be banned, EPA will not limit commercial uses, leaving workers, who are most at risk from these products, unprotected.
  • Ignoring worker safety in chemical risk evaluations under TSCA. In the only draft risk evaluation of a chemical issued to date, EPA relied exclusively on a single undocumented workplace air concentration value, provided through a private personal communication by a conflicted industry source, as the basis to conclude that workers across the supply chain for this chemical face no significant exposure to the chemical.

“Oversight of this EPA’s reckless approach to worker protection under existing law is long overdue.  We applaud the subcommittee for holding this hearing. This EPA is putting the public’s health – especially worker’s health — at risk by systematically weakening and undermining chemical safety: the agency must be held accountable.”

 

 

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