All Knowledge & Insights By Date

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: Use the Best Available Science: EDF states that EPA’s Toxic Substances Control Act (TSCA) program should rely on the scientific expertise on PFAS across the Agency, such...

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 Tiered Data Reporting to Inform Prioritization, Risk Evaluation and Risk Management under TSCA (RIN: 2070-AK62): EPA is developing a rulemaking under TSCA Sections 8(a) and (d) to establish reporting requirements based upon a chemical’s status in...

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 Century Act”...

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, 2023. EPA states that the...

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. EDTREGISTER 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 influencing...

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 information in Section 5...

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. Environmental...

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 consistent with direction in the...

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 regulation of chemicals in...

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 assessment,...

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: Multi-walled carbon nanotubes (MWCNT); closed; 4.4-12.8 nanometer (nm) diameter; bundle length...

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 EPA makes...

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. Conference topics include: Variability and...

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, EPA announced a broad outreach...

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 violating TSCA...

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)...

By Lynn L. Bergeson and Carla N. Hutton On February 23, 2022, the U.S. Environmental Protection Agency (EPA) held a webinar on requirements under the Toxic Substances Control Act (TSCA) and the premanufacture notice (PMN) process for biofuels. 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...

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...

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, February 23, 2022, from 2:00 to 3:00 p.m. (EST) to learn about requirements under the Toxic Substances Control Act (TSCA) and the premanufacture notice (PMN) process for biofuels. 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...

Bergeson & Campbell, P.C.’s (B&C®) January 26, 2022, webinar “What to Expect in Chemicals in 2022” is now available for on-demand viewing at https://attendee.gotowebinar.com/recording/864194569862780944. During the 1-hour webinar, Lynn L. Bergeson, Managing Partner, B&C; Richard E. Engler, Ph.D., Director of Chemistry, B&C; and James V. Aidala, Senior Government Affairs Consultant, B&C offered their best informed judgment as to the trends and key...

The Organization for Economic Cooperation and Development (OECD) has published the latest edition of the Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour de Table. The Tour de Table compiles information provided by delegations on developments concerning the safety of manufactured nanomaterials. It includes the following information on developments in the United States. The U.S. Environmental Protection Agency (EPA) completed review of two low volume...

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

By Lynn L. Bergeson  EPA Office of Inspector General (OIG) announced the availability of its FY 2022 oversight plan on December 14, 2021. According to OIG, the plan reflects the priority work that the OIG believes is necessary to keep EPA, the U.S. Chemical Safety and Hazard Investigation Board (CSB), and Congress fully informed about issues relating to the administration of EPA programs and operations. The planned oversight projects concerning Ensuring the Safe Use of Chemicals...