EDF Health

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

EPA still has a very long way to go on transparency under TSCA

By Richard Denison / Published: January 28, 2020

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

EPA recently held a public meeting where it unveiled its first set of confidential business information (CBI) claim “determinations.”  These came three and half years after updates to the Toxic Substances Control Act (TSCA) required EPA to review CBI claims and publicly state the basis for its decision to approve or deny each claim.  EPA also recently finally started assigning “unique identifiers” to chemicals where it approves a claim to hide the chemical’s identity from the public.  These identifiers also come very late, having been called for starting immediately under the 2016 reforms to TSCA.

EPA also recently began posting to its ChemView database premanufacturing notices (PMNs) it receives on new chemicals, as well as some of the documents it generates when reviewing new chemicals (though these are exceedingly hard to find).

These and a few other modest recent improvements are certainly better late than never.  Their slowness in arriving, however, is a stark illustration of the far greater priority the Trump EPA has given to favoring the chemical industry’s interests over the public interest.

Moreover, EDF’s examination of these recent measures reveals both how far behind EPA still is in meeting TSCA’s mandates to provide chemical information to the public, and that EPA is failing to comply with a number of those mandates.

Last Friday EDF filed comments with EPA detailing both the shortcomings in what EPA has done and what it has failed to do.  We also provided a host of recommendations for improvements to the EPA websites and databases that are critical if they are to meet the public’s right to know about chemicals and EPA’s review of them under TSCA.  This post will summarize some of the key findings detailed in our comments.  Here is a list of topics covered in our comments and, more briefly, in this post:

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

Finally something we can (mostly) commend EPA for doing under TSCA

By Richard Denison / Published: January 14, 2020

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

Readers of this blog will know how concerned EDF is with ensuring the public’s right to know about chemicals to which they may be exposed.  We have repeatedly sounded the alarm when EPA has taken steps to deny public access to chemical information, whether for chemicals entering the market or those already in commerce.  Even in recent months, EPA has sided with chemical companies in denying access to health and safety information on chemicals EPA is assessing under the Toxic Substances Control Act (TSCA).

So we were pleasantly surprised by a letter to an industry group that EPA posted on Friday.  Read More »

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

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

By Richard Denison / Published: June 25, 2019

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

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

By Richard Denison / Published: June 3, 2019

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 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

By Richard Denison / 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.

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

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

By Richard Denison / 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 »

Posted in Health policy, Industry influence, TSCA reform / Also tagged , | Read 5 Responses