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.

The two EPA proposals – the first one mandated by the 2016 reforms and the second one more optional – address the following:

CBI Review Plan Proposed Rule:  TSCA required EPA to “reset” the TSCA Inventory to identify those chemicals that are “active” in U.S. commerce.  EPA’s “Inventory Notification” rule implementing the reset called on companies to identify any chemicals on the Inventory they made or processed over the past 10 years.  While it took EPA far longer to do than called for under the law, EPA has identified about 41,000 active chemicals out of the roughly 85,000 chemicals on the Inventory in total.  That first rule also allowed companies to assert a claim to keep the identity of their active chemicals confidential, if they were among the roughly 18,000 Inventory chemicals that were already confidential.  As a result, confidential business information (CBI) claims were asserted seeking to continue to mask the identities of about 8,000 (20%) of the active chemicals.

TSCA requires EPA to promulgate a second rule that sets forth its plan to review each of those CBI claims over a 5-year period to determine if they warrant continued CBI protection from disclosure.  EPA proposed that “CBI Review Plan” rule in April, and EDF filed comments on the proposal yesterday.

CDR Modifications Proposed Rule:  Since 1986 EPA has periodically required companies to report certain information on a subset of chemicals they manufacture, under EPA’s so-called Chemical Data Reporting (CDR) Rule.  The last time these data were collected was in 2016 covering the period 2012-2015 and about 8,700 chemicals.  Stating that “EPA is releasing the 2016 CDR data in stages,” the agency issued a “partial release” in May 2017 that withheld substantial amounts of it, pending EPA’s review of the thousands of CBI claims companies had asserted.  Two years later, there has been no further release, though we hear more may be issued in the fall.

Meanwhile, the next reporting cycle is supposed to start next year.  In anticipation, EPA proposed substantial changes to the CDR rule in April, and EDF filed comments on the proposal yesterday.

Below are some of the main comments we provided EPA on each proposed rule.

Comments on CBI Review Plan Proposed Rule

  • EPA does not address its obligations to disclose specific chemical identities when confidentiality is withdrawn, not claimed, or not substantiated, or when EPA finds that confidentiality is not merited.
  • Failure to substantiate a claim should lead to disclosure of the specific chemical identity.
  • EPA needs to make clear that specific chemical identity for Inventory chemicals cannot be exempt from substantiation under TSCA.
  • EPA needs to accept and make clear that TSCA 14’s express statutory requirements overrule any contrary regulations in EPA’s general Freedom of Information Act (FOIA) regulations.  Information can only be withheld as CBI under TSCA if it qualifies for withholding under FOIA Exemption 4 and meets the requirements of TSCA § 14(c).  This was affirmed in the D.C. Circuit’s recent decision in EDF v. EPA.
  • The Court also made it clear that not being readily susceptible to reverse engineering is a substantive requirement for confidentiality claims, so EPA must incorporate this requirement into its review of the claims. EPA needs to provide notice that any person relying on a prior substantiation does so at the significant risk that the prior substantiation did not address all TSCA requirements.
  • EPA cannot rely on existing substantiation questions that were expressly rejected by the Court as arbitrary and capricious in EDF v. EPA.
  • EPA needs to make this rule coherent and consistent with its CDR Modifications rule.
  • EPA’s proposed exemption from substantiation for companies that completed the voluntary substantiation process in the Inventory notification rule does not hold in light of the D.C. Circuit’s decision in EDF v. EPA. As a practical matter, EPA must require such claimants to substantiate again and completely.
  • EPA also must modify the rule to provide public disclosure of the outcomes of its reviews of CBI claims. Specifically, EPA must publish its determinations and the underlying findings on the confidentiality claims as required under TSCA § 26(j).
  • EPA should stagger the substantiation process to avoid relying on stale substantiations in the later years of this review process. On an annual basis, EPA could identify in the Federal Register approximately one-fifth of specific chemical identities subject to confidentiality claims under this rule, and EPA could at that time require that all confidentiality claimants for that fifth substantiate their claims or identify their prior substantiations.  Such an approach would ensure that EPA is not relying on overly dated substantiations when reviewing claims.
  • Because claimants are asserting claims for specific chemical identity, EPA must also require claimants to provide structurally descriptive generic names required by TSCA. Many current generic names on the Inventory do not meet all of TSCA’s requirements, so EPA should clarify that it will also review generic names as part of its review of the confidentiality claims under the review plan.
  • Finally, EPA should codify its obligation under TSCA “to assign a unique identifier to each specific chemical identity for which the Administrator approves a request for protection from disclosure.”

Comments on CDR Modifications Proposed Rule

  • With respect to companies’ ability to claim, and EPA’s review of claims for, confidentiality:
    • Changes to the rule are needed to fully incorporate statutory requirements limiting CBI claims and clarifying EPA’s obligations to disclose both information that does not warrant confidential status under TSCA and its determinations on CBI claims.
    • EPA must codify the correct substantive criteria for review of confidentiality claims, which include those under amended TSCA as well as FOIA.
    • EPA must disclose information when it receives no claim or a deficient claim, or denies a confidentiality claim.
    • EDF identifies a number of changes needed to EPA’s proposed substantiation questions to ensure conformance with the law and the recent D.C. Circuit decision, as well as to better ensure EPA’s ability to review and make appropriate determinations on CBI claims.
    • EPA needs to add provisions to ensure that chemicals with confidential identities are assigned unique identifiers and appropriate generic names.
  • With respect to proposed modifications to reportable data elements under the CDR:
    • EDF generally supports EPA’s proposals but identifies changes needed to ensure optimal reporting and public access to CDR information.
    • EPA should require reporting of the percentage of production volume recycled.
    • EPA should require reporting of the percentage of a chemical’s total production volume that is in the form of a byproduct.
    • EPA should require reporting of the specific function of a chemical in imported mixtures.
    • EPA also needs to expand its reporting of information relevant to determining the nature and extent of chemicals exposures to children.
  • With respect to EPA’s proposed major expansions of exemptions for byproduct reporting:
    • EDF opposes these proposals as both overbroad and severely constraining EPA’s ability to obtain information it needs to carry out its duties under TSCA, including its chemical prioritization, risk evaluation and risk management responsibilities.
      • EPA should not provide an option to report by category for some inorganic byproducts.
      • EPA should not exempt byproducts generated through the use of pollution control equipment or boilers that generate heat or electricity on-site.
      • EPA should not continue to exempt byproducts disposed as waste.
    • EPA needs to revisit, rather than merely codify by rote, existing CDR exemptions, in light of the changes made to TSCA in 2016.


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