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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...

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,...

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...

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...

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...

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...

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...

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;...

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...

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...