By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program will hold a webinar on Wednesday, July 27, 2022, from 1:00 - 2:00 p.m. (EDT). During the webinar, EPA will provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) before taking questions from the audience. As reported in our June 27, 2022, memorandum, in June 2022, EPA announced a broad outreach effort to describe and to discuss with stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and worker exposure) provided for new chemicals submissions under the Toxic Substances Control Act (TSCA) and common issues that cause EPA to have to rework risk assessments for these submissions.
 
Registration for the July 27, 2022, webinar is open. According to EPA, subsequent webinars over the coming months will communicate its considerations in evaluating qualitative claims or quantitative data, especially when they deviate from model defaults such as those used in the Chemical Screening Tool for Exposures and Environmental Releases (ChemSTEER) and its considerations for evaluating information about sites not controlled by the submitter. EPA will release information about these webinars, including dates and instructions on how to register, as it becomes available.

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By Lynn L. Bergeson 

On February 1, 2021, the U.S. District Court for the District of Montana granted the U.S. Environmental Protection Agency’s (EPA) January 31, 2021, unopposed motion to vacate and remand its January 6, 2021, final rule on “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information” (86 Fed. Reg. 469). EDF v. EPA, No. 4:21-cv-03-BMM. On January 11, 2021, the Environmental Defense Fund (EDF), Montana Environmental Information Center (MEIC), and Citizens for Clean Energy (CCE) filed suit against EPA, claiming that the January 6, 2021, final rule was unlawful and that EPA’s decision to make the final rule effective on publication was unlawful. On January 27, 2021, the court granted summary judgment to the plaintiffs, finding that EPA did not provide good cause to exempt the final rule from the Administrative Procedure Act’s (APA) 30-day notice requirement. The court stated that “EPA’s decision to make the Final Rule immediately effective on publication was ‘arbitrary, capricious’ and ‘otherwise not in accordance with law.’” In its January 31, 2021, motion, EPA states based on the court’s conclusion that the final rule constitutes a substantive rule and that EPA “lacked authorization to promulgate the rule pursuant to its housekeeping authority.” According to EPA, where EPA lacked the authority to promulgate the final rule, “remand without vacatur would serve no useful purpose because EPA would not be able to cure that defect on remand.” EPA notes that because the final rule was in effect for less than a month, and it had not applied the rule in any circumstance while the rule was in effect, “there would be no disruptive consequences in remanding and vacating the rule.”

Prior to EPA’s motion to vacate and remand the final rule, on January 20, 2021, President Biden signed an Executive Order (EO) on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis. According to the EO, it is the policy of the Biden Administration “to listen to the science; to improve public health and protect our environment; to ensure access to clean air and water; to limit exposure to dangerous chemicals and pesticides; to hold polluters accountable, including those who disproportionately harm communities of color and low-income communities; to reduce greenhouse gas emissions; to bolster resilience to the impacts of climate change; to restore and expand our national treasures and monuments; and to prioritize both environmental justice and the creation of the well-paying union jobs necessary to deliver on these goals.” The EO directs all executive departments and agencies to review immediately and, as appropriate and consistent with applicable law, take action to address the promulgation of federal regulations and other actions during the Trump Administration that conflict with the Biden Administration’s national objectives, and to commence work immediately to confront the climate crisis. The EO calls for the heads of all agencies to review immediately “all existing regulations, orders, guidance documents, policies, and any other similar agency actions (agency actions) promulgated, issued, or adopted between January 20, 2017, and January 20, 2021, that are or may be inconsistent with, or present obstacles to,” the Biden Administration’s policy. For any identified actions, the EO directs the heads of agencies to “consider suspending, revising, or rescinding the agency actions.” In addition, for certain specified agency actions, the EO states that the head of the relevant agency “shall consider publishing for notice and comment a proposed rule suspending, revising, or rescinding the agency action within the time frame specified.” The specified agency actions include EPA’s January 6, 2021, final rule on “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information.”

As reported in our January 11, 2021, memorandum, the origin of EPA’s January 6, 2021, final rule is rooted in legislative proposals more clearly intended to challenge important regulatory requirements, particularly related to EPA’s air program. We predicted that the final rule would likely be among the first items subject to reversal or “clarifying” guidance making it consistent with previously established science policies (see Bergeson & Campbell, P.C.’s (B&C^®) Forecast 2021 memo). With Democratic control of both houses of Congress, there might also be attempts to repeal the rule via action under the Congressional Review Act (CRA) of recently promulgated regulations.

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By  Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On January 6, 2021, EPA issued in final its rule titled “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information.” The rule establishes how EPA will consider the availability of dose-response data underlying pivotal science used in its significant regulatory actions and influential scientific information. Under this rule, EPA will give greater consideration to studies where underlying dose-response data are available with sufficient independent validation. The rule also requires EPA to identify and make publicly available the science that serves as a basis for its regulatory decisions and actions at the draft stage to the extent practicable. Peer review required for pivotal science and criteria for the EPA Administrator to exempt certain studies from the rulemaking requirements are also part of the final rule. The rule became effective on January 6, 2021.

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By Lynn L. Bergeson

On March 3, 2020, EPA announced the availability of a supplemental notice of proposed rulemaking (SNPRM) to the Strengthening Transparency in Regulatory Science proposed rule. EPA notes that the SNPRM “is not a new rulemaking; rather, it provides clarifications on certain terms and aspects of the 2018 proposed rule.” The SNPRM:

• Proposes that the scope of the rulemaking applies to influential scientific information, as well as significant regulatory decisions;

• Defines and clarifies that the proposed rule applies to data and models underlying both pivotal science and pivotal regulatory science;

• Proposes a modified approach to the availability provisions for data and models that would underlie influential scientific information and significant regulatory decisions, as well as an alternate approach; and

• Clarifies the ability of the Administrator to grant exemptions.

EPA published the SNPRM in the Federal Register on March 18, 2020. 85 Fed. Reg. 15396. EPA states that it “is taking comment on whether to use its housekeeping authority independently or in conjunction with appropriate environmental statutory provisions as authority for taking this action.” On April 2, 2020, EPA announced that it would extend the comment period to May 18, 2020. EPA anticipates promulgating a final rule later in 2020. More information is available in our March 9, 2020, memorandum, “EPA Releases Supplemental Proposed Rule to the Proposed Rule on Strengthening Transparency in Regulatory Science.”

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By Lynn L. Bergeson

On March 3, 2020, EPA announced that a supplemental notice of the proposed rulemaking (SNPRM) titled “Strengthening Transparency in Regulatory Science” will be published in the Federal Register in the near future. While the notice would only modify EPA internal procedures, industry stakeholders are asked to comment on the proposed rule during a 30-day period after the date of publication in the Federal Register. The supplemental notice proposes the following changes to the 2018 proposed rulemaking:

• A scope that applies to influential scientific information and significant regulatory decisions;

• A modified approach to the availability provisions for data and models that would underlie influential scientific information and significant regulatory decisions as well as an alternate approach;

• Clarification on the ability of the EPA Administrator to grant exemptions; and

• Definitions and clarifications that the proposed rule applies to data and models underlying both pivotal science and pivotal regulatory science.

These proposed modifications are in response to some of the public comments received by EPA on the 2018 proposed rulemaking. Under the alternate approach to the use of data and models, EPA will also use restricted studies that are not available to the public. The proposal would apply to reviews of data, models, and studies regardless of when the data and models were generated. EPA plans to identify studies that are given greater consideration and provide a short explanation of why greater consideration was given.

EPA is seeking comment on each of the proposed changes. In particular, EPA is asking for feedback on whether this approach may improve consistency between this proposed rulemaking and certain provisions of those statutes that refer to standards for data availability.

EPA’s announcement includes a pre-publication version of the proposed supplemental rulemaking, which can be accessed here. Interested parties may wish to review Bergeson & Campbell, P.C.’s (B&C^®) March 9, 2020, memorandum on the SNPRM.

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On Wednesday, November 13, 2013, EPA Administrator Gina McCarthy testified as the sole witness before the House Committee on Science, Space, and Technology on "Strengthening Transparency and Accountability within the Environmental Protection Agency."

While the hearing was held as part of the Committee's annual oversight of EPA, it provided Committee Chair Lamar Smith (R-TX) an opportunity to question McCarthy on several concerns he reportedly had with EPA and appropriate transparency at the Agency. These included reports of EPA officials' use of outside e-mail addresses to conduct business, and questions following EPA's "insufficient" response to a subpoena last summer requesting information about the Agency's confidential health studies that form the basis for EPA regulation of greenhouse gas (GHG) emissions.

Assessments of EPA's performance during the hearing fell along party lines. Committee Democrats led by Ranking Member Eddie Bernice Johnson (D-TX) have publicly criticized Chair Smith for his criticisms of the Agency.

Administrator McCarthy's nomination was held up for several months due to concerns by the Senate Committee on Environment and Public Works Ranking Member David Vitter (D-LA) over sufficient transparency at EPA. It was allowed to go through after Administrator McCarthy pledged to bolster transparency at EPA under her leadership.
 

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