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Posted on July 19, 2022 by Lynn L. Bergeson
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.
Posted on February 01, 2021 by Lynn L. Bergeson
By Lynn L. Bergeson and Carla N. Hutton
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 Joe 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.
Posted on September 15, 2020 by Lynn L. Bergeson
By Lynn L. Bergeson and Carla N. Hutton
On September 14, 2020, the U.S. Environmental Protection Agency (EPA) released a pre-publication version of a final rule establishing the procedures and requirements for how EPA will manage the issuance of guidance documents consistent with Executive Order (EO) 13891, “Promoting the Rule of Law Through Improved Agency Guidance Documents.” The final regulation provides a definition of guidance document for the purposes of this rule, establishes general requirements and procedures for certain guidance documents issued by EPA, and incorporates additional requirements for guidance documents determined to be significant guidance. EPA notes that the regulation, consistent with the EO, also provides procedures for the public to petition for the modification or withdrawal of active guidance documents as defined by the rule or to petition for the reinstatement of a rescinded guidance document. EPA states that the regulation is intended to increase the transparency of its guidance practices and improve the process used to manage its guidance documents. The final rule will be effective 30 days after publication in the Federal Register. More information will be available in a forthcoming memorandum that will be posted on our website.
Posted on April 06, 2020 by Lynn L. Bergeson
By Lynn L. Bergeson and Carla N. Hutton
On March 3, 2020, the U.S. Environmental Protection Agency (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.”
Posted on August 08, 2017 by Lynn L. Bergeson
By Lynn L. Bergeson and Margaret R. Graham
On August 7, 2017, the U.S. Environmental Protection Agency (EPA) issued a press release stating that it has eliminated the new chemical backlog of over 600 chemicals: “[t]he current caseload is back at the baseline and now in line with the typical active workload.” The press release also announces improvements to new chemical safety reviews, which include operating principles, improvement of EPA’s Toxic Substances Control Act (TSCA) new chemicals program, and further transparency, as detailed below.
EPA states it is committing to the following operating principles in its review of new chemicals:
- Where the intended uses in premanufacture notices (PMN) or other TSCA Section 5 notices (such as low volume exemption (LVE) requests) raise risk concerns, EPA will work with submitters, and, if the submitters submit timely amended PMNs addressing those concerns, EPA will generally make determinations based on those amended submissions.
- Where EPA has concerns with reasonably foreseen uses, but not with the intended uses as described in a PMN or LVE application, as a general matter, those concerns can be addressed through significant new use rules.
- As described in the risk evaluation rule released on June 22, 2017, identification of reasonably foreseen conditions of use will be fact-specific. It is reasonable to foresee a condition of use, for example, where facts suggest the activity is not only possible, but, over time under proper conditions, probable.
- The purpose of testing in a Section 5 order is to reduce uncertainty in regard to risk. Specifically, it is to address risk concerns that gave rise to a finding of “may present unreasonable risk” or another Section 5 finding other than “not likely to present unreasonable risk.” In addition, consistent with the statute, any request for testing by EPA will be structured to reduce and replace animal testing as appropriate.
EPA states it will continue to improve of its TSCA new chemicals program in the following ways:
- Redeploying staff to increase the number of Full-Time Equivalent (FTE) staff working on new chemicals;
- Initiating a LEAN exercise (via EPA’s new time-saving and cost-effective tools) to streamline work processes around new chemicals review; and
- Institutionalizing a voluntary pre-submission consultation process so that submitters have a clear understanding of what information will be most useful for EPA’s review of their new chemical submission, and of what they can expect from EPA during the review process. While such engagement prior to submission is an additional up-front time and resource commitment by submitters and EPA, it should more than pay for itself with faster, better-informed EPA reviews.
EPA states it needs to be more transparent in how it makes decisions on new chemicals under TSCA, and will be instituting the following to implement that goal:
- In Fall 2017, EPA’s Office of Pollution Prevention and Toxics (OPPT) intends to release, for public comment and stakeholder engagement, draft documents that will provide the public with more certainty and clarity regarding how EPA makes new chemical determinations and what external information will help facilitate these determinations;
- EPA will facilitate a public dialogue on its goal of continued improvement in the new chemicals review program; and
- EPA will continue posting weekly web updates of program statistics, so that manufacturers and the public can determine the disposition of cases as quickly as possible.