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On April 25, 2025, the U.S. Environmental Protection Agency (EPA) announced the availability of new resources intended to help companies with the requirements described in EPA’s December 2024 final rule governing the review of new chemicals under the Toxic Substances Control Act (TSCA). According to EPA, the new materials “provide companies with clear instructions on how to include required data elements in the current system used for new chemical submissions while the agency works to...

U.S. Environmental Protection Agency (EPA) Administrator Lee Zeldin on February 4, 2025, announced the “Powering the Great American Comeback Initiative” (PGAC Initiative). It consists of five pillars and is intended to serve as a roadmap to guide EPA’s actions under Administrator Zeldin. The five pillars are:  Administrator Zeldin explained Pillar 3 by stating, “Any business that wants to invest in America should be able to do so without having to face years-long, uncertain, and...

In a development no one could have predicted several weeks ago, the first hearing of the 119th Congress in the House Committee on Energy and Commerce (E&C) focused on the Toxic Substances Control Act (TSCA) and amendments to TSCA that were enacted more than eight years ago. The E&C Subcommittee on Environment (the Subcommittee) hearing on January 22, 2025, “A Decade Later: Assessing the Legacy and Impact of the Frank R. Lautenberg Chemical Safety for...

The U.S. Government Accountability Office (GAO) publicly released a report entitled “New Chemicals Program: EPA Needs a Systematic Process to Better Manage and Assess Performance” on January 22, 2025. GAO states that it was asked to review the U.S. Environmental Protection Agency’s (EPA) implementation of its Toxic Substances Control Act (TSCA) New Chemicals Program. The report summarizes the perspectives of selected manufacturers on EPA’s review process and evaluates the extent to which...

President-elect Trump’s proposed (and aspirational) Department of Government Efficiency (DOGE) is the latest incarnation of a new Administration’s attempt to leave its mark on the federal government. In the November 20, 2024, Wall Street Journal, Elon Musk and Vivek Ramaswamy published an Op-ed about the DOGE effort they will lead and the three kinds of reform DOGE will pursue: regulatory recissions, administrative reductions, and cost savings. We propose that DOGE add a fourth, equally...

During the June 26, 2024, “TSCA Reform — Eight Years Later” conference, presented by Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute, (ELI), and the George Washington University Milken Institute School of Public Health, Michal Ilana Freedhoff, Ph.D., Assistant Administrator, Office of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency (EPA) provided the keynote address. During her remarks, Freedhoff announced four new initiatives...

The U.S. Environmental Protection Agency (EPA) provided notice of disclosure on April 2, 2024, to all potentially affected businesses under the Toxic Substances Control Act (TSCA) that submitted information to EPA pursuant to TSCA Section 5 that it will disclose information to the U.S. Government Accountability Office (GAO). 89 Fed. Reg 22713. According to the notice, GAO is initiating a review of EPA’s practices for managing and assessing the performance of EPA’s New Chemicals Review...

The U.S. Environmental Protection Agency (EPA) released on January 8, 2024, a decision framework for identifying eye irritation or corrosion hazards for new chemicals reviewed under the Toxic Substances Control Act (TSCA). 89 Fed. Reg. 1093. EPA states that the “New Chemicals Program Decision Framework for Hazard Identification of Eye Irritation and Corrosion” provides a decision framework for use by the Office of Pollution Prevention and Toxics (OPPT) New Chemicals Division (NCD) to...

By Lynn L. Bergeson and Carla N. Hutton On July 19, 2023, the U.S. Environmental Protection Agency (EPA) extended the comment period on proposed amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 46125. According to EPA, the amendments are “intended to align the regulatory text with the amendments to TSCA’s new chemicals review provisions contained in the [2016] Frank R. Lautenberg Chemical Safety for the 21st...

On July 19, 2023, the U.S. Environmental Protection Agency (EPA) will publish a Federal Register notice extending the comment period on proposed amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). According to EPA, the amendments are “intended to align the regulatory text with the amendments to TSCA’s new chemicals review provisions contained in the [2016] Frank R. Lautenberg Chemical Safety for the 21st Century Act”...

By Lynn L. Bergeson and Carla N. Hutton   On May 26, 2023, the U.S. Environmental Protection Agency (EPA) proposed amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 34100. According to EPA, the amendments are “intended to align the regulatory text with the amendments to TSCA’s new chemicals review provisions contained in the [2016] Frank R. Lautenberg Chemical Safety for the 21st Century Act” (Lautenberg...

April 3-5, 2023, Washington D.C. Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) are proud to be sponsors of and presenting during the 2023 GlobalChem Conference. This three-day event offers authoritative speakers, in-depth sessions, and a chance to meet and reconnect with industry peers and key government representatives. Highlights from the diverse and substantive program planned for GlobalChem attendees include: The full agenda is available...

The U.S. Environmental Protection Agency (EPA) announced on February 23, 2023, that the New Chemicals Program will hold a webinar on February 28, 2023, on EPA’s process for assessing the potential risks of new chemicals under Section 5 of the Toxic Substances Control Act (TSCA) and the types of data EPA considers in this assessment. EPA states that specifically, the upcoming webinar will cover commonly missed information in Section 5 submissions and how EPA evaluates environmental...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Environmental Protection Agency (EPA) announced on February 23, 2023, that the New Chemicals Program will hold a webinar on February 28, 2023, on EPA’s process for assessing the potential risks of new chemicals under Section 5 of the Toxic Substances Control Act (TSCA) and the types of data EPA considers in this assessment. EPA states that specifically, the upcoming webinar will cover commonly missed...

On December 15, 2022, the U.S. Environmental Protection Agency (EPA) announced a redesign and updates to the statistics web page for the New Chemicals Review Program. According to EPA, the update includes additional information and metrics on the Agency’s review of new chemicals under the Toxic Substances Control Act (TSCA), increasing transparency for the public, the regulated community, and other stakeholders. According to EPA, before TSCA was amended in 2016 by the...

By Lynn L. Bergeson and Carla N. Hutton   Under the Reports Consolidation Act of 2000, each agency’s inspector general must prepare an annual statement summarizing what the inspector general considers to be “the most serious management and performance challenges facing the agency” and to assess briefly the agency’s progress in addressing those challenges. On November 29, 2022, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released...

On November 21, 2022, the U.S. Environmental Protection Agency (EPA) announced that it has improved public access to certain reports submitted by chemical companies in ChemView, EPA’s web application for public access to non-confidential business information (non-CBI) on chemicals regulated under the Toxic Substances Control Act (TSCA), including new chemical notices and notices of substantial risk. EPA has published previously unpublished new chemical notices received under TSCA Section 5...

The U.S. Environmental Protection Agency (EPA) announced on November 4, 2022, that it will hold the first of a two-part webinar series on November 17, 2022, on EPA’s new standardized process to assess risk and apply mitigation measures, as appropriate, for mixed metal oxides (MMO), including new and modified cathode active materials (CAM). As reported in our October 11, 2022, memorandum, in October 2022, EPA announced an innovative effort intended to help make its review of new MMOs,...

The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program will host a webinar on October 18, 2022, on EPA’s process for assessing the potential risks of new chemicals under Section 5 of the Toxic Substances Control Act (TSCA) and the types of data EPA considers in this assessment. The webinar will cover examples of quantitative and qualitative data unlikely to be accepted for engineering assessment, considerations EPA makes when evaluating data, and clarifications of common...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program will host a webinar on October 18, 2022, on EPA’s process for assessing the potential risks of new chemicals under Section 5 of the Toxic Substances Control Act (TSCA) and the types of data EPA considers in this assessment. The webinar will cover examples of quantitative and qualitative data unlikely to be accepted for engineering assessment, considerations...

The U.S. Environmental Protection Agency (EPA) announced on October 11, 2022, that the Office of Research and Development’s (ORD) Board of Scientific Counselors (BOSC) will review the Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. 87 Fed. Reg. 61313. The meeting will be held October 24-25, 2022, via videoconference. Attendees must register by October 23, 2022. Comments must be received by October 23, 2022, to be considered by...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Environmental Protection Agency (EPA) announced on August 22, 2022, that as part of its commitment to re-evaluate policies and practices under the Toxic Substances Control Act (TSCA) New Chemicals Program to ensure they adhere to statutory requirements and the Biden Administration’s executive orders and directives, it has updated its policy to discontinue the use of exposure modeling thresholds when assessing the health and...

The U.S. Environmental Protection Agency (EPA) announced on August 22, 2022, that as part of its commitment to re-evaluate policies and practices under the Toxic Substances Control Act (TSCA) New Chemicals Program to ensure they adhere to statutory requirements and the Biden Administration’s executive orders and directives, it has updated its policy to discontinue the use of exposure modeling thresholds when assessing the health and environmental risks of new chemicals under TSCA. According...

By Lynn L. Bergeson and Carla N. Hutton The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program held a webinar on July 27, 2022, to provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) of new chemicals. 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...

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 The U.S. Environmental Protection Agency (EPA) announced on June 24, 2022, that it is “conducting a broad outreach effort to describe and discuss with stakeholders how the Agency evaluates data provided for new chemicals submissions and common issues that cause EPA to have to reconduct risk assessments (‘rework’) for these submissions.” According to EPA, its goal is to reduce rework of initial risk assessments for new chemicals submissions caused...

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 and Ligia Duarte Botelho, M.A. On June 2, 2022, TSCA NCC submitted comments in response to the Office of Science and Technology Policy’s (OSTP) Request for Information (RFI) related to Subtitle E of the 2021 National Defense Authorization Act (NDAA), also called the Sustainable Chemistry Research and Development Act. TSCA NCC’s comments addressed specifically: The definition of green chemistry and sustainable chemistry; Policy considerations; New...

By  Lynn L. Bergeson The U.S. Environmental Protection Agency (EPA) announced on February 25, 2022, the proposed Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. On March 10, 2022, EPA posted the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA.” The Office of Chemical Safety and Pollution Prevention (OCSPP) proposes to develop and implement a multi-year collaborative research...

The American Chemical Society’s Green Chemistry Institute® (ACS GCI) will host its 26th Annual Green Chemistry & Engineering (GC&E) Conference in Reston, VA, from June 6 to June 8, 2022. The theme for the 2022 GC&E Conference is “Thinking in Systems: Designing for Sustainable Use.” This theme will explore how green and sustainable chemistry and engineering contribute to the development and commercialization of products for sustainable use. On June 6,...

On May 27, 2022, the U.S. Environmental Protection Agency (EPA) requested nominations for technical experts to serve as special government employees (SGE) to participate in the review of the New Chemicals Collaborative Research Program with the Board of Scientific Counselors (BOSC), a federal advisory committee to EPA’s Office of Research and Development (ORD). 87 Fed. Reg. 32161. BOSC will be evaluating ORD’s draft Strategic Research Action Plans Fiscal...

By  Lynn L. Bergeson On April 20-21, 2022, EPA held a virtual public meeting to provide an overview of the TSCA New Chemicals Collaborative Research Program and give stakeholders an opportunity to provide input. As reported in our March 14, 2022, memorandum on the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA,” the Office of Chemical Safety and Pollution Prevention (OCSPP) proposes to develop and implement a...

The U.S. Environmental Protection Agency (EPA) announced on February 25, 2022, the proposed Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. 87 Fed. Reg. 10784. On March 10, 2022, EPA posted the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA.” The Office of Chemical Safety and Pollution Prevention (OCSPP) proposes to develop and implement a multi-year collaborative research...

The U.S. Environmental Protection Agency (EPA) held a virtual public meeting on April 20-21, 2022, to provide an overview of the Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program and give stakeholders an opportunity to provide input. As described in EPA’s draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA,” the Office of Chemical Safety and Pollution Prevention (OCSPP) proposes to develop and...

As reported in our February 28, 2022, blog item, on February 25, 2022, the U.S. Environmental Protection Agency (EPA) announced that it is revoking the 1980 guidelines and associated procedures for correcting the specific chemical identities of incorrectly described chemical substances submitted to EPA in 1978 using the original reporting form for inclusion on the Toxic Substances Control Act (TSCA) Inventory. 87 Fed. Reg. 10781. On March 25, 2022, the TSCA New Chemicals Coalition...

By Lynn L. Bergeson As reported in our February 25, 2022, blog item, the U.S. Environmental Protection Agency (EPA) announced on February 25, 2022, the proposed Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. 87 Fed. Reg. 10784. On March 10, 2022, EPA the posted the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA.” The Office of Chemical Safety and Pollution Prevention (OCSPP)...

The U.S. Environmental Protection Agency will hold a virtual public meeting April 20-21, 2022, to seek individual input on the proposed Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. 87 Fed. Reg. 10784. In addition, EPA announced the availability of and is soliciting public comment on the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA.” EPA states that the Office of Chemical Safety...

By Lynn L. Bergeson and Carla N. Hutton The U.S. Environmental Protection Agency will hold a virtual public meeting April 20-21, 2022, to seek individual input on the proposed Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. 87 Fed. Reg. 10784. In addition, EPA announced the availability of and is soliciting public comment on the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA.” EPA...

On January 21, 2022, the U.S. Environmental Protection Agency (EPA) announced a new effort under the Toxic Substances Control Act (TSCA) to streamline the review of new chemicals that could be used to displace current, higher greenhouse gas (GHG) emitting transportation fuels. The Office of Chemical Safety and Pollution Prevention’s (OCSPP) New Chemicals Division (NCD) has implemented a “robust, consistent, and efficient process to assess the risk and apply mitigation measures, as...

By Lynn L. Bergeson  According to an October 26, 2021, project notification memorandum, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) plans to begin fieldwork on an audit of EPA’s process for conducting reviews of new chemicals under the Toxic Substances Control Act (TSCA). The memorandum states that the audit “is self-initiated based on OIG’s oversight plan for fiscal year [(FY)] 2022 and to address complaints submitted to the OIG...

By Lynn L. Bergeson and Carla N. Hutton   According to an October 26, 2021, project notification memorandum, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) plans to begin fieldwork on an audit of EPA’s process for conducting reviews of new chemicals under the Toxic Substances Control Act (TSCA). The memorandum states that the audit “is self-initiated based on OIG’s oversight plan for fiscal year [(FY)] 2022 and to address complaints...

According to an October 26, 2021, project notification memorandum, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) plans to begin fieldwork on an audit of EPA’s process for conducting reviews of new chemicals under the Toxic Substances Control Act (TSCA). The memorandum states that the audit “is self-initiated based on OIG’s oversight plan for fiscal year [(FY)] 2022 and to address complaints submitted to the OIG Hotline.” The audit also...

The U.S. Environmental Protection Agency (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced on October 14, 2021, several actions intended to enhance scientific integrity, including establishing two internal science policy advisory councils, creating a new senior-level career position to serve as a science policy advisor to the Assistant Administrator, and making further improvements to policies and procedures. The announcement includes the following actions:...

The U.S. Environmental Protection Agency (EPA) has prepared a strategic plan for the Office of Pollution Prevention and Toxics (OPPT) for fiscal years (FY) 2021-2023. The strategic plan outlines how OPPT intends to fulfill its obligations under the Toxic Substances Control Act (TSCA), the Emergency Planning and Community Right-to-Know Act (EPCRA), the Pollution Prevention Act (PPA), and related EPA policies and procedures “in ways that value science, protect people and the environment, and...

The U.S. Environmental Protection Agency (EPA) announced on April 27, 2021, “important policy shifts in its review of new [per-and polyfluoroalkyl substances (PFAS)] before they can enter the market.”  According to EPA, although some new PFAS have been allowed to enter the market through low volume exemptions (LVE), EPA’s New Chemicals Program is implementing a new strategy for reviewing and managing LVE requests for PFAS.  EPA states that due to the scientific...

By Lynn L. Bergeson EPA announced on March 29, 2021, that it is evaluating its policies, guidance, templates, and regulations under the Toxic Substances Control Act (TSCA) new chemicals program to ensure they “adhere to statutory requirements,” the Biden-Harris Administration’s executive orders, and other directives. EPA identified several instances where its approach for making determinations and managing risks associated with new chemicals can, according to EPA, more...

On January 12, 2021, the U.S. Environmental Protection Agency (EPA) and the Occupational Safety and Health Administration (OSHA) announced a memorandum of understanding (MOU) that advances collaboration and communication on EPA’s review of new chemicals under the Toxic Substances Control Act (TSCA).  EPA states that the MOU provides a framework for coordination and communication between the two agencies on exposure to new chemicals in the workplace and will help achieve the...

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...

The 2020 GlobalChem webinar series addresses major developments in chemicals management and provides participants a chance to engage with policymakers and other key experts throughout the chemical industry value chain.  On May 13, 2020, at 12:00 p.m. (EDT), Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®), will present during the “TSCA New Chemicals” webinar.  Other presenters include Lynn Dekleva, Ph.D.,...