EDF Health

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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EDF tells EPA it must modify its proposed CBI Claim Review Rule to comply with recent D.C. Circuit decision

By / Published: May 3, 2019

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

Yesterday Environmental Defense Fund (EDF) sent a letter to the Assistant Administrator of EPA’s Office of Chemical Safety and Pollution Prevention in follow-up to last month’s decision by the D.C. Circuit Court of Appeals in EDF’s challenge to EPA’s Inventory Notification Rule (EDF v. EPA, 17-1201).

The letter identifies “immediate, time-sensitive implications [of the decision] for EPA’s ongoing rulemaking for” EPA’s proposed Confidential Business Information (CBI) Claim Review Rule, which is currently undergoing public comment.  EDF noted that, in addition to addressing problems the Court identified in EPA’s regulations promulgated pursuant to its Inventory Notification Rule, EPA will need to modify the current proposed rule to ensure it is consistent with the Court’s Opinion, and accept comments on the modified proposal.

This is because the proposed rule explicitly references and applies regulatory provisions that the Court found were unlawful.  Specifically, the Court found that EPA’s CBI claim substantiation questions were flawed because they failed to inquire into “a chemical identity’s susceptibility to reverse engineering” and “effectively excised a statutorily required criterion from the substantiation process.”  Hence, to align the proposed rule with the Court’s ruling and the representations that EPA made to the Court in its briefing and at argument, EPA will need to revise the substantiation questions and the substantive standard that EPA plans to use when reviewing claims under the CBI Claim Review Rule.

EDFs letter also notes that the proposed rule allows persons to rely on the voluntary substantiations they submitted as part of the Inventory notification process.  But the Court’s Opinion establishes that these substantiations are inadequate because they fail to address a chemical’s susceptibility to reverse engineering, and EPA will need to modify the proposed rule to require companies to provide substantiations that address this statutory factor for confidentiality claims.

See EDF’s letter for more details.

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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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D.C. Circuit Affirms Public’s Right to Know about Chemicals in Use under Reformed Law

By / Published: April 26, 2019

Court strongly rebukes Trump EPA’s unlawful attempts to scale back transparency requirements

(April 26, 2019 – Washington, D.C.) Today, the U.S. Court of Appeals for the D.C. Circuit delivered a strong rebuke to the Trump Environmental Protection Agency’s (EPA) implementation of the nation’s chemical safety law, protecting key aspects of the public’s right to know about the toxic chemicals in our homes, schools, and workplaces.

The Court agreed with EDF that EPA had failed to require companies to show that the identities of their chemicals cannot be reverse-engineered in order to claim them confidential under the Toxic Substances Control Act (TSCA).

The Court remanded the rule back to EPA to require that companies make this showing to claim confidentiality.  The Court also affirmed that other key TSCA requirements apply to confidentiality claims despite EPA’s failure to include them in its regulations.

“This decision is a significant win for public disclosure and a strong affirmation by the Court of the public’s right to know about the chemicals to which we all are or may be exposed. The Court ruled that EPA must require companies to provide real substantiation for their claims for confidentiality – and that EPA had failed to do so in the rule we challenged,” said Robert Stockman, Senior Attorney at Environmental Defense Fund.  “EPA will now have to require significantly more evidence from companies before they can conceal the identities of chemicals they make and sell.  As a result, fewer such claims will be allowed and workers, consumers and the public will gain access to more information about those chemicals.”

In the case, EDF v. EPA (D.C. Cir. 17-1201), EDF aimed to ensure that EPA upholds the requirements set forth in the reformed Toxic Substances Control Act (TSCA) to maximize transparency and public knowledge about which chemicals are currently in use by narrowing the grounds for asserting confidentiality claims and requiring more scrutiny of them.  The Court affirmed that these requirements apply despite EPA’s failure to incorporate them into its regulation.

“A key goal of the reformed chemical safety law is to make more information public about the chemicals we’re exposed to at home, in our workplaces and schools, and through our environment.” said Dr. Richard Denison, Lead Senior Scientist at Environmental Defense Fund. “While the Trump EPA has taken every opportunity to skirt its responsibility and conceal information that the public has a right to know, the Court’s decision today affirms that the law trumps those efforts.”

On some issues, the Court gave deference to EPA in interpreting the law as it did:  EPA’s decision to delay assigning “unique identifiers” to certain chemicals with confidential chemical identities; and its decision to exempt chemicals made only for export from the law’s Inventory notification requirement.  Finally, the Court unfortunately ruled that EPA could in its discretion allow any manufacturer or processor to make a claim for the confidentiality of a chemical, regardless of whether that company had previously made such a claim.  While EDF does not agree with the Court’s characterization of our position, the Court cited the Chevron standard that provides agencies with considerable deference.

For more background on the decision, see the bullets below.  For more information on this and other lawsuits challenging EPA’s implementation of TSCA, see: https://www.edf.org/health/tsca-case-resources. Read More »

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PART 3: Busting more industry-perpetrated myths about new chemicals and worker protection under TSCA

By / Published: April 3, 2019

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

Part 1          Part 2         Part 3

I have been blogging in the last few weeks about myths the chemical industry is perpetrating about the adequacy and legality of the Environmental Protection Agency’s (EPA) recent reviews of the risks that chemicals just entering the market may present to workers.  In this post, I address another such myth that, unfortunately, EPA has swallowed hook, line, and sinker.  This myth was laid out by one of the industry witnesses at the March 13 House Energy & Commerce Committee hearing on EPA’s failures to protect workers from chemical risks.[pullquote]One wonders when EPA will start doing what Congress told it to do, first in 1976 and then again, with renewed vigor in 2016:  Protect workers under TSCA – using TSCA’s authorities to meet TSCA’s health standard, not OSHA’s.[/pullquote]

I’ll get to this third myth in a moment.  But let me first try to crystallize what is at stake in this debate.  While the Toxic Substances Control Act (TSCA) has always given EPA authority to regulate workplace risks, the 2016 amendments to TSCA strengthened EPA’s authority and mandate to protect workers.  TSCA now expressly identifies workers as a “potentially exposed or susceptible subpopulation.”  See the definition of that term in paragraph 12 here.  TSCA then requires EPA to identify and assess potential risks to such subpopulations when reviewing both new and existing chemicals.  Finally, it requires EPA to use its TSCA authorities to impose restrictions on any chemical found to present an “unreasonable risk” – which is TSCA’s health standard – to any such subpopulation.

In a word, TSCA requires EPA to protect workers under TSCA – using TSCA’s authorities to meet TSCA’s health standard, not OSHA’s.

Both before and after the 2016 TSCA amendments, the chemical industry has sought to compel or convince EPA not to regulate workplaces under TSCA, and instead to defer to OSHA.  Industry wants this because OSHA’s authority and capacity are severely limited and its legal requirements for regulating toxic substances (“health standards” in OSHA parlance) allow vastly greater risks to workers than do TSCA’s (see my previous post).

Sadly, under the Trump EPA, industry is getting its wish.  At industry’s urging, EPA is acting in a manner that is wholly contrary to TSCA – and is less health-protective than even under TSCA before the 2016 reforms.

Now let’s get back to more myth-busting.   Read More »

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