EDF Health

Selected tag(s): Confidential Business Information (CBI)

EDF files comments on two EPA proposals affecting EPA’s and the public’s access to chemical information under TSCA

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

Yesterday Environmental Defense Fund (EDF) filed comments on two EPA proposals (here and here) that will have major impacts on what chemical information EPA obtains and the public has access to.  While EPA risk evaluations and risk management actions (such as they are) often garner the lion’s share of stakeholder attention, the 2016 amendments to the Toxic Substances Control Act (TSCA) also made sweeping changes to EPA’s authority and duty to obtain better information on chemical uses, hazards and exposures, and to rein in rampant industry claims aimed at keeping much of that information hidden from public view.

As readers of this blog know, the extent of chemical information available to the agency and disclosed to the public has been a major point of controversy under the Trump EPA.  Three years after passage of the reforms to TSCA, EPA has yet to use its expanded information authorities even once, despite major data gaps for the chemicals it is prioritizing and evaluating.  In some cases, EPA has asked companies to voluntarily submit information without any safeguards against selective reporting.  EPA has then sought to deny public access even to submitted health and safety studies, arguing they are confidential despite TSCA’s clear prohibition on protecting such information from public disclosure; see here and here.

So EPA proposals that directly affect both what information is submitted to EPA and public access to it warrant serious scrutiny.  I’ll describe both proposals below, but as a preview I first want to highlight some of the key themes detailed in EDF’s comments:

  • EPA continues to resist acknowledging that the 2016 TSCA reforms changed the substantive standard governing confidentiality by imposing new requirements on top of those EPA has relied on in the past in regulations it promulgated pursuant to the Freedom of Information Act (FOIA). In both proposals, EPA must acknowledge the change and incorporate all of the law’s new requirements, which Congress enacted to place new limits on what information is eligible for protection from public disclosure.
  • In one of its proposals, EPA has proposed welcome changes that appear intended to make EPA’s review of confidentiality claims more efficient, by clarifying what companies can and cannot claim as confidential and what substantiation they need to provide to support their claims. However, it falls short of that goal and omits several key provisions that must be incorporated when the proposal is finalized.
  • The other proposal is far less robust and would continue to rely on obsolete regulatory provisions that do not reflect the law’s new requirements. As a result, it is also wholly inconsistent with the first proposal even with respect to the analogous procedures for claim assertion, substantiation and EPA review.
  • In the name of burden reduction, EPA has proposed to continue existing exemptions from chemical information reporting, and to add major new exemptions. If finalized, these exemptions will negatively impact EPA’s access to information on chemicals’ conditions of use, releases and potential exposures that it needs to carry out its duties under reformed TSCA.  The consequences of EPA’s failure to obtain robust information on chemicals it is reviewing were amply demonstrated in critical comments ($) the agency received at last week’s meeting of EPA’s Scientific Advisory Committee on Chemicals (SACC) held to peer review EPA’s first draft risk evaluation under TSCA.

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The Trump EPA is illegally denying requests for public files on new chemicals

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

For some time now, Environmental Defense Fund (EDF) has been requesting “public files” of new chemical notices the Environmental Protection Agency (EPA) receives under the Toxic Substances Control Act (TSCA).  The process is kludge-y to say the least.  We have to email our request to EPA’s Docket Center, and, typically, several weeks later the staff there copy the files that staff in the TSCA office have given them in response to our request onto a CD-ROM and snail-mail it to us.

This, despite the fact that EPA’s own regulations (see here and here) state unequivocally that EPA is to promptly make new chemicals’ premanufacture notifications (PMNs) and associated documents broadly available to the general public by posting them to electronic dockets.  One regulation states: “All information submitted with a notice, including any health and safety study and other supporting documentation, will become part of the public file for that notice, unless such materials are claimed confidential.”  The other regulation states that public files are to be made available in the electronic docket posted at http://www.regulations.gov.

We have blogged extensively about how, even once we receive the public files, they are rife with wholesale omissions, illegal redactions and myriad other problems.

After two years of our repeated requests to EPA to comply with its own regulations, it appears EPA may be taking a first step to try do so:  EPA recently announced (via email, but not anywhere on its website that we can find) that it will start posting PMNs and associated documents it receives in the future to its ChemView database, within 45 days of their receipt.  While this could be a welcome development, it does nothing to remedy EPA’s failure to provide access to the thousands of PMNs it has received in the past.  And it remains to be seen what EPA actually will and won’t be posting.

We’ll be watching closely to see when and what EPA actually makes available.  Part of the need for vigilance comes from a disturbing response we’ve been receiving from EPA’s Docket Center to some recent requests for new chemical public files:   Read More »

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

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

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

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

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.

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 »

Posted in EPA, Health Policy, Industry Influence, TSCA Reform / Also tagged | Read 3 Responses

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

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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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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