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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) met with the Environmental Defense Fund (EDF) on August 5, 2021, to clarify concepts from the July 27, 2021, tiered data reporting (TDR) webinar. EPA’s meeting summary states that EDF representatives requested clarification on the following issues discussed during the webinar:

  • Whether EPA intends to scale back the Chemical Data Reporting (CDR) requirements with respect to the amount of information collected per chemical or to the number of chemicals reported.
    • EPA responded that the changes to CDR discussed in the webinar presentation would reduce the data collected per chemical and would not impact which chemicals were required to be reported under CDR.
  • Whether the data expected to be used to inform the identification of potential candidate chemicals for prioritization was limited to CDR.
    • EPA responded that the webinar presentation was not intended to identify all sources of information that would be used for the various steps of the overall existing chemicals process, including informing the identification of the pool of potential candidate chemicals for the prioritization process. Rather, the intent was to identify the data that would be available from either CDR or TDR for use for each step in the process.
  • Reasoning behind EPA’s decisions regarding timing of the collection tiers and selected data elements.
    • EPA responded that the specifics of what data elements would be included in which collection tiers was under development and that the Agency is interested in comments from EDF or other stakeholders to help inform the TDR proposal.
  • Whether EPA had any more details about the post-risk management stage, which was included in the webinar presentation as “TBD.”
    • EPA responded that there were no additional details at this time.

According to the meeting summary, EDF provided additional comments during the meeting, including concern about scaling back CDR; belief that data should be collected earlier in the existing chemicals process to be more useful and enable EPA to make better use of TSCA Section 4; and a request to make the reported data publicly available in a timely manner to inform public comment. EDF “also reiterated their concern with the length of the comment period following the webinar.” The meeting summary states that EPA will accept supplemental comments after August 16, 2021, that are e-mailed to Susan Sharkey (.(JavaScript must be enabled to view this email address)), but that such comments should be provided as soon as possible. EPA noted that interested parties could comment during interagency review and following the publication of the proposal.

More information on EPA’s July 27, 2021, webinar is available in our July 29, 2021, memorandum. As reported in our August 6, 2021, blog item, EPA posted a memorandum in Docket ID EPA-HQ-OPPT-2021-0436 stating that it will not extend the August 16, 2021, comment period stemming from the July 27, 2021, public webinar.


By Lynn L. Bergeson and Carla N. Hutton
As reported in our March 23, 2020, memorandum, on March 18, 2020, a coalition of non-governmental organizations (NGO) filed suit in the U.S. District Court for the District of Columbia against the U.S. Environmental Protection Agency (EPA), claiming that EPA fails to disclose information about new chemical substances under the Toxic Substances Control Act (TSCA).  Environmental Defense Fund v. Wheeler, No. 1:20-cv-762.  On July 27, 2020, the parties submitted a joint case management statement.  According to the statement, the parties agree that the case can be resolved by motions for summary judgment and that there is no need for a trial.  The parties state that they disagree about whether administrative records exist and the availability and scope of discovery, however.  Resolving these questions will implicate the timing for any discovery, the appropriate deadline for final amended pleadings, and the appropriate schedule for summary judgment briefing.  The parties note that they are currently discussing options to resolve as many of these questions as possible and that they believe successfully resolving them could reduce the number and complexity of procedural issues before the court.  In particular, according to the statement, the parties are discussing options to narrow the scope of factual and legal issues presented, which may minimize the potential for future disputes over the availability and scope of discovery.  The parties propose to submit an updated case management statement no later than August 31, 2020.


By Lynn L. Bergeson and Carla N. Hutton
The Environmental Defense Fund (EDF) published a September 16, 2019, blog item entitled “EPA’s latest move to deflect criticism of its TSCA risk evaluations: Muzzle its science advisors.”  EDF notes that it has opposed a number of recent decisions made by the U.S. Environmental Protection Agency (EPA) “that aim to limit the risks it finds when evaluating the safety of chemicals under the Toxic Substances Control Act (TSCA),” including:

  • Excluding from its analysis known human and environmental exposures to a chemical, based on the assumption that those exposures are adequately managed by other statutes;
  • Claiming without support that workers are protected by assuming universal and universally effective use of personal protective equipment throughout chemical supply chains and the adequacy of the Occupational Safety and Health Administration (OSHA) regulations that either do not apply or are out of date;
  • Arbitrarily loosening EPA’s longstanding risk standards governing when cancer incidences are deemed unacceptably high; and
  • Choosing not to exercise its enhanced authorities under TSCA to require submission of robust information on chemicals’ hazard and exposures, instead making “questionable assumptions and relying on voluntarily submitted industry data that are unrepresentative or of poor or indeterminate quality.”

EDF states that through these decisions, EPA increases the likelihood that it will either not find unreasonable risk and thereby avoid regulating the chemical, or find risks that are low enough that it can impose few restrictions.  According to EDF, in response to each of these decisions, EPA received critical comments on its draft risk evaluations from state and local governments, labor and health groups, environmental non-governmental organizations (NGO), and members of the scientific community.  EDF reports that during the first several peer reviews conducted by EPA’s Scientific Advisory Committee on Chemicals (SACC), many of the SACC members raised similar concerns.  According to EDF, EPA has directed SACC “that these issues are off-limits to the peer reviewers because they represent policy decisions that are beyond the charge given to the SACC.”  EDF states that “[t]his is beyond the pale” for the following reasons:

  1. Such issues fall squarely within SACC’s charge.  EPA’s charge questions to SACC for its most recent peer review of 1-bromopropane (1-BP) “specifically (and appropriately) call on the SACC to comment on the ‘assumptions, uncertainties and data limitations in the methodology used to assess risks from 1-BP’”;
  2. It is “absolutely” SACC’s role and responsibility to comment on the scientific consequences of EPA’s decisions that directly affect its characterization of exposure, hazard, and risk; and
  3. With respect to the adequacy of the information on which EPA relies, EPA “has recently made an additional claim to the SACC:  that EPA has no choice but to use the data it has readily at hand, however limited they are.”

EDF concludes that EPA’s direction to SACC “is but the latest in a series of moves to limit the scientific information and scientific advice that EPA can obtain and use to make decisions.”


By Lynn L. Bergeson and Carla N. Hutton
The Environmental Defense Fund (EDF) announced on June 17, 2019, a report entitled Toxic Consequences:  Trump’s attacks on chemical safety put our health at risk.  EDF notes that “[c]oncern over toxic exposures and a lack of confidence in the badly outdated chemical safety system” led to Congress passing the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) to reform the Toxic Substances Control Act (TSCA).  The bipartisan bill “finally” gave the U.S. Environmental Protection Agency (EPA) “the power to strengthen health protections for American families and the environment.”  EDF claims that the Trump Administration “is seeking to dismantle the new authorities and mandates under the law with the goal of shifting policies to serve the chemical industry’s agenda,” however.  According to EDF, EPA has taken the following actions that undermine the Lautenberg Act:

  • Approving new chemicals without regard for the law or public health;
  • Ignoring real-life exposures when evaluating risks of existing chemicals; and
  • Blocking or weakening bans of toxic chemicals.

EDF concludes that “without a drastic change to EPA’s current direction on chemical safety, we will be forced to endure the toxic consequences of its mistakes for decades to come.”

Tags: EDF, Report