All Knowledge & Insights By Date

Under a November 20, 2023, final order of the U.S. Environmental Protection Agency’s (EPA) Environmental Appeals Board (EAB), Ultium Cells LLC (Ultium) and General Motors Company (GM) have entered into a consent agreement with EPA concerning alleged violations of Section 5(a)(1) of the Toxic Substances Control Act (TSCA). According to the consent agreement, the respondents voluntarily disclosed to EPA that three chemical substances were manufactured (imported) “a number of times between...

The U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued on November 15, 2023, its report on EPA’s fiscal year (FY) 2024 top management challenges. OIG states that the report “summarizes what the inspector general considers to be ‘the most serious management and performance challenges facing the agency’” for FY 2024 and briefly assesses EPA’s progress in addressing those challenges. According to OIG, the management challenges include “Safeguarding...

The U.S. Tire Manufacturers Association (USTMA) announced on November 14, 2023, that it will partner with the U.S. Geological Survey (USGS) on a research project “to assess and refine methods of evaluating potential alternatives to [N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD)] for use in tires.” As reported in our November 3, 2023, blog item, the U.S. Environmental Protection Agency (EPA) has granted a petition filed under Section 21 of the Toxic Substances Control Act (TSCA)...

The U.S. Environmental Protection Agency (EPA) proposed on October 31, 2023, to ban all uses of  trichloroethylene (TCE) after determining that it presents an unreasonable risk of injury to human health under its conditions of use as documented in EPA’s November 2020 risk evaluation (2020 TCE RE) and January 2023 revised risk determination (2023 Revised RD) pursuant to the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 74712. According to EPA’s October 23, 2023, press...

The U.S. Environmental Protection Agency (EPA) announced on October 19, 2023, a proposed rule that would amend the procedural framework rule for conducting risk evaluations under the Toxic Substances Control Act (TSCA). Published in the Federal Register on October 30, 2023, the proposed rule states that the purpose of risk evaluations under TSCA is to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without considering costs or...

The U.S. Environmental Protection Agency (EPA) announced on October 20, 2023, the release of a final rule that is intended to improve reporting on per- and polyfluoroalkyl substances (PFAS) to the Toxics Release Inventory (TRI) by eliminating an exemption that allowed facilities to avoid reporting information on PFAS when those chemicals were used in small concentrations. The final rule will add PFAS subject to reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA) and...

The American Chemistry Council (ACC) announced on September 20, 2023, that together with the Texas Chemical Council, it submitted a 60-day notice of intent to file suit for the U.S. Environmental Protection Agency’s (EPA) failure to complete manufacturer-requested risk evaluations (MRRE) for diisononyl phthalate (DINP) and diisodecyl phthalate (DIDP) under the Toxic Substances Control Act (TSCA). ACC states that EPA failed to complete the MRREs by TSCA’s mandatory deadline of three years and...

The U.S. Environmental Protection Agency (EPA) announced on October 6, 2023, that it is deploying application updates, supporting new requirements under the Toxic Substances Control Act (TSCA) Confidential Business Information (CBI) Procedural Rule, within its electronic reporting site Central Data Exchange (CDX). EPA states that the deployments will update the applications requiring CBI substantiations to be provided within the application instead of requiring substantiation documents/templates...

On August 3, 2023, the U.S. Environmental Protection Agency (EPA) announced the availability of and solicited public comment on the document entitled “White Paper: Quantitative Human Health Approach to be Applied in the Risk Evaluation for Asbestos Part 2 — Supplemental Evaluation including Legacy Uses and Associated Disposals of Asbestos” (White Paper) and related charge questions. 88 Fed. Reg. 51309. EPA states that it will be soliciting comments from expert ad hoc reviewers on the...

The Environmental Defense Fund (EDF) published a blog item on September 18, 2023, entitled “Now’s the Time — How EPA Can Use TSCA to Turn Off the PFAS Tap.” According to EDF, for both previously approved per- and polyfluoroalkyl substances (PFAS) and for new PFAS, the U.S. Environmental Protection Agency (EPA) should: EDF concludes that by using its full authority under TSCA, “EPA can ensure a future where chemicals do not compromise our health and...

Earthjustice announced on September 18, 2023, that environmental justice and health advocates have filed suit in the U.S. District Court for the District of Columbia against the U.S. Environmental Protection Agency (EPA) “for missing statutory deadlines to complete risk evaluations for 22 toxic chemicals released in high volumes in fenceline communities and found in many everyday consumer products.” Earthjustice states that “EPA initiated risk evaluations for the nearly two dozen toxic...

The U.S. Environmental Protection Agency’s (EPA) spring 2023 Unified Agenda, published on June 13, 2023, includes the following rulemakings under the Toxic Substances Control Act (TSCA) or the Toxics Release Inventory (TRI). Proposed Rule Stage Final Rule Stage...

The U.S. Environmental Protection Agency (EPA) is launching a webinar series in collaboration with the PETA Science Consortium International (PSCI), Institute for In Vitro Sciences (IIVS), and the California Department of Pesticide Regulation (CDPR). According to EPA, the quarterly series will focus on the use of new approach methodologies (NAM), or alternative methods to reduce vertebrate animal testing, for risk assessment within EPA and CDPR. The first webinar in the series will take place...

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...

The U.S. Environmental Protection Agency (EPA) announced on July 19, 2023, that it is extending the public comment period for its proposed significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) to ensure chemicals made from plastic waste-derived feedstocks are free from certain contaminants before they can be used to make transportation fuels. The SNURs would require companies to notify EPA before manufacturing or processing 18 chemicals made from plastic waste-derived...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Environmental Protection Agency (EPA) will hold a webinar on July 18, 2023, at 2:00 p.m. (EDT) on its recent final procedural rule for submitting confidential business information (CBI) under the Toxic Substances Control Act (TSCA). The final rule increases transparency, modernizes the reporting and review procedures for CBI, and aligns with the 2016 amendments to TSCA. The rule will become effective on August 7,...

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...

Bergeson & Campbell, P.C.’s (B&C®) May 17, 2023, webinar, “TOP TSCA TOPICS: PFAS, Cumulative Risk, NAMs, Risk Evaluations, CBI, and More,” is now available for on-demand viewing. During this one-hour webinar, Anna B. Lowit, Ph.D., Senior Science Advisor, the U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT); Richard E. Engler, Ph.D., Director of Chemistry, B&C; and Lynn L. Bergeson, Managing Partner, B&C, discussed...

The Organization for Economic Cooperation and Development (OECD) has published the latest edition of the Developments in Delegations on the Safety of Manufactured Nanomaterials and Advanced Materials — Tour de Table. The Tour de Table compiles information provided by delegations on the occasion of the 22nd meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in June 2022.  The Tour de Table lists U.S. developments on the human health and...

May 17, 202311:00 a.m. – 12:00 p.m. EDT REGISTER NOW The U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) has advanced groundbreaking science policy initiatives in furtherance of implementation of the Toxic Substances Control Act (TSCA). As EPA advances New Approach Methodologies (NAM), cumulative risk assessment methodologies, and systematic review procedures, chemical stakeholders must understand directionally how these initiatives are...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Environmental Protection Agency (EPA) will hold training on May 23, 2023, on Generalized Read-Across (GenRA), a publicly available tool that uses an automated approach to make reproducible read-across predictions of toxicity. EPA states that read-across “is a commonly used data gap filling technique whereby endpoint information for one substance is used to predict the same endpoint for another substance, supported by structural or...

On March 8, 2023, the U.S. Environmental Protection Agency opened a 30-day comment period on nominations for candidates to serve on the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC). According to EPA, there are currently 17 SACC members, with eight membership terms that will soon expire. Biographies for all candidates under consideration are available online. In addition, biographies for current SACC members are available on the SACC website. Comments on...

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...

Registration is now open for the “What to Expect in Chemicals Policy and Regulation and on Capitol Hill in 2023” webinar on January 31, 2023, 11:00 a.m. – 12:00 p.m. (EST). This webinar offers our best-informed judgment as to the trends and key developments chemical industry stakeholders can expect in 2023. At a political level, the Republicans’ narrow control of the U.S. House of Representatives will almost certainly invite a greater degree of oversight of U.S....

By Lynn L. Bergeson and Carla N. Hutton The U.S. Environmental Protection Agency (EPA) will hold a webinar on December 6, 2022, to provide an overview to stakeholders about its November 16, 2022, supplemental proposed rule modifying and adjusting certain aspects of the fees rule established under the Toxic Substances Control Act (TSCA). EPA states that it is publishing these changes to ensure that collected fees provide it with 25 percent of authorized TSCA costs...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Environmental Protection Agency (EPA) announced on November 10, 2022, that it is requesting nominations of prospective candidates for membership on the Science Advisory Committee on Chemicals (SACC) established under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 67898. Any interested person or organization may nominate qualified persons to be considered for appointment to the SACC. Individuals may also self-nominate. Nominations are...

By Lynn L. Bergeson and Carla N. Hutton   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...

This webinar has been rescheduled from December 7, 2022. The new and correct date and time is December 14, 2022, 12:00 p.m. – 1:00 p.m. (EST). Registration is open for the “Articles under TSCA” webinar on December 14, 2022, 12:00 p.m. – 1:00 p.m. (EST). When the Toxic Substances Control Act (TSCA) was enacted in 1976, the U.S. Environmental Protection Agency (EPA) focused its attention on chemical substances and chemical mixtures, while largely exempting the...

By Lynn L. Bergeson and Carla N. Hutton   On October 18, 2022, the U.S. Environmental Protection Agency’s (EPA) New Chemicals Program held a webinar 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. Specifically, the webinar covered examples of data (quantitative and qualitative) that are not likely to be accepted for engineering...

On October 31, 2022, the U.S. Environmental Protection Agency (EPA) proposed significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for a number of chemical substances that were the subject of premanufacture notices (PMN) and are also subject to Orders issued by EPA pursuant to TSCA. 87 Fed. Reg. 65548. The proposed SNURs include four chemical substances identified as: According to EPA, the PMNs state that the use of the substances will be...

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...

On September 29, 2022, the U.S. Environmental Protection Agency (EPA) issued final significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for certain chemical substances that were the subject of premanufacture notices (PMN), including multi-walled carbon nanotubes (MWCNT) (generic). 87 Fed. Reg. 58999. The SNUR requires persons who intend to manufacture (defined by statute to include import) or process the chemical substance identified generically as MWCNTs (PMN...

By Lynn L. Bergeson and Carla N. Hutton   On August 25, 2022, the U.S. Environmental Protection Agency (EPA) announced that registration was open for the 2022 Conference on the State of the Science on Development and Use of New Approach Methods (NAM) for Chemical Safety Testing. EPA notes that there will be limited availability in person at EPA headquarters in Washington, DC, on October 12-13, 2022, and a virtual option will also be available....

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...

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...

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,...

Bergeson & Campbell, P.C. (B&C®) is pleased to present “TSCA New Approach Methodologies,” a complimentary webinar featuring Lynn L. Bergeson, Richard E. Engler, Ph.D., James W. Cox, M.S., and Kristie Sullivan, MPH. The 2016 amendments to TSCA require EPA “to reduce and replace” vertebrate animals to the extent practicable, scientifically justified, and consistent with TSCA policies. EPA is also required to “develop a strategic plan to promote the...

By Lynn L. Bergeson On June 22, 2022, the Senate Committee on Environment and Public Works held a hearing on “Toxic Substances Control Act Amendments Implementation.” This coincides with the sixth anniversary of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) that amended TSCA. The only witness present was Michal Freedhoff, Ph.D., Assistant Administrator of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP). The recording of...

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 and Ligia Duarte Botelho, M.A. On May 12, 2022, EPA published a proposed rule relating to the assertion and maintenance of confidential business information (CBI) claims under TSCA. EPA states in its May 12, 2022, press release that the proposed rule includes new and amended requirements that, if made final, would increase transparency, modernize reporting and review procedures, and ensure consistency with the 2016 amendments to TSCA. In addition to providing...

B&C, the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health will present “TSCA Reform – Six Years Later” on June 29, 2022. This complimentary virtual conference marks the sixth TSCA Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Speakers will dive into a host of topics, including the interface of...

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...

B&C, the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health will present “TSCA Reform – Six Years Later” on June 29, 2022. This complimentary virtual conference marks the sixth TSCA Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Speakers will dive into a host of topics, including the interface of science...

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,...

The U.S. Environmental Protection Agency (EPA) filed a complaint with the Environmental Appeals Board on March 15, 2022, pursuant to Section 16(a) of the Toxic Substances Control Act (TSCA). According to the complaint, as the result of an EPA inspection of the Vorbeck Materials facility on June 20, 2019, and its follow-up actions, EPA alleges that Vorbeck has violated TSCA Section 12(b) and the Notice of Export rule requirements at 40 C.F.R. Part 707, Subpart D, thereby...

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...

By Lynn L. Bergeson and Carla N. Hutton On March 23, 2022, the U.S. Environmental Protection Agency (EPA) held a webinar on “Biofuel Premanufacture Notices: New Chemical Risk Assessment and Applications of Tools and Models.” As reported in our January 24, 2022, blog item, in January 2022, EPA announced an effort to streamline the review of new biobased or waste-derived chemicals that could displace current, higher greenhouse gas (GHG)-emitting transportation fuels. EPA states that to...

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)...