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On March 21, 2025, the U.S. Court of Appeals for the District of Columbia Circuit heard oral argument in a case challenging the U.S. Environmental Protection Agency’s (EPA) May 3, 2024, final rule amending the procedural framework rule for conducting risk evaluations under the Toxic Substances Control Act (TSCA). United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union (USW) v. EPA, Consolidated Case No. 24-1151. If you have a...

On March 10, 2025, the U.S. Environmental Protection Agency (EPA) announced its intent to reconsider the May 3, 2024, rule amending the procedural framework rule for conducting risk evaluations under the Toxic Substances Control Act (TSCA) (2024 Risk Evaluation Framework Rule). According to EPA, it will initiate a rulemaking “that will ensure the agency can efficiently and effectively protect human health and the environment and follow the law.” As reported in our February 7, 2025,...

The U.S. Environmental Protection Agency (EPA) announced on March 11, 2025, the rescheduled meeting dates of the Science Advisory Committee on Chemicals (SACC) that had been previously scheduled for February 2025 to consider and review the draft risk evaluation for 1,3-butadiene. 90 Fed. Reg. 11737. The rescheduled preparatory meeting for the SACC to consider the scope and clarity of the revised draft charge questions for the peer review will now be held on March 25,...

The U.S. Environmental Protection Agency (EPA) announced on March 7, 2025, that it is extending the comment period on the draft risk evaluation for dicyclohexyl phthalate (DCHP) under the Toxic Substances Control Act (TSCA). EPA released the risk evaluation for DCHP on January 7, 2025, with a comment period that closed March 10, 2025. EPA states that it will soon publish a Federal Register notice extending the public comment period for an additional 60 days....

On March 5, 2025, the U.S. Environmental Protection Agency (EPA) extended the comment period on the draft scope of the risk evaluation to be conducted under the Toxic Substances Control Act (TSCA) for vinyl chloride. 90 Fed. Reg. 11315. As reported in our January 28, 2025, memorandum, under TSCA, the scope documents must include the conditions of use (COU), hazards, exposures, and the potentially exposed or susceptible subpopulations (PESS) that EPA expects to consider in...

The U.S. Environmental Protection Agency (EPA) announced on January 31, 2025, that it is extending the public comment period on the draft risk evaluation for 1,3-butadiene under the Toxic Substances Control Act (TSCA). 90 Fed. Reg. 8798. Comments that were due February 3, 2025, are now due March 5, 2025. EPA states in its announcement that to give the peer reviewers on the Science Advisory Committee on Chemicals (SACC) time to review any additional comments...

On January 16, 2025, the U.S. Environmental Protection Agency (EPA) announced the availability of and requested public comment on the draft scope of the risk evaluation to be conducted under the Toxic Substances Control Act (TSCA) for vinyl chloride. 90 Fed. Reg. 4738. EPA notes that under TSCA, the scope documents must include the conditions of use (COU), hazards, exposures, and the potentially exposed or susceptible subpopulations (PESS) that EPA expects to consider in conducting...

The U.S. Environmental Protection Agency (EPA) announced on September 3, 2024, the release of the draft risk evaluation for diisononyl phthalate (DINP) under the Toxic Substances Control Act (TSCA) for public comment. 89 Fed. Reg. 71270. EPA states in its August 30, 2024, press release that it preliminarily determined that two industrial uses and one consumer use “significantly contribute to the unreasonable risk of DINP out of the 45 uses evaluated.” EPA preliminarily determined that...

The U.S. Environmental Protection Agency (EPA) announced on July 25, 2024, that it is proposing to designate acetaldehyde, acrylonitrile, benzenamine, vinyl chloride, and 4,4-methylene bis(2-chloroaniline) (MBOCA) as high-priority substances (HPS) for risk evaluation under the Toxic Substances Control Act (TSCA). 89 Fed. Reg. 60420. EPA is providing a 90-day comment period, during which interested persons may submit comments on the proposed designations of these chemicals as HPSs for risk...

The U.S. Environmental Protection Agency (EPA) announced on May 20, 2024, the availability of and solicited public comment on the draft manufacturer-requested risk evaluation (MRRE) for di-isodecyl phthalate (DIDP) and the draft physical chemical, fate, and hazard assessments for di-isononyl phthalate (DINP) prepared under the Toxic Substances Control Act (TSCA). 89 Fed. Reg. 43847. In its May 17, 2024, press release, EPA states that it preliminarily determined that all but one of the uses of...

The U.S. Environmental Protection Agency (EPA) released a final rule on April 23, 2024, that amends the procedural framework rule for conducting risk evaluations under the Toxic Substances Control Act (TSCA). According to the final rule, published in the Federal Register on May 3, 2024, EPA reconsidered the procedural framework rule for conducting such risk evaluations and is revising certain aspects of that framework to align better with the statutory text and applicable court decisions,...

On May 3, 2024, comments by Lynn L. Bergeson were featured in Chemical Watch’s article on possible legal challenges to updated TSCA risk evaluation procedures. See – https://product.enhesa.com/1074319/publication-of-tsca-risk-evaluation-rule-starts-clock-for-parties-to-file-legal-challenge (subscription required)...

On April 16, 2024, the U.S. Environmental Protection Agency (EPA) announced the availability of and requested public comment on a draft document titled “Draft Risk Evaluation for Asbestos Part 2: Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos” (the Draft Asbestos Part 2). 89 Fed. Reg. 26878. EPA is evaluating legacy uses and associated disposals of asbestos, including chrysotile asbestos, five additional fiber types, asbestos-containing talc, and Libby...

The U.S. Environmental Protection Agency (EPA) published on March 26, 2024, a proposed rule requiring manufacturers (including importers) of 16 chemical substances to submit copies and lists of certain unpublished health and safety studies to EPA. 89 Fed. Reg. 20918. EPA identified 15 of the chemical substances as potential candidates for prioritization through a screening process based on a combination of hazard, exposure (including uses), and persistence and bioaccumulation characteristics....

The U.S. Environmental Protection Agency (EPA) announced on March 15, 2024, the availability of and solicited public comment on the 2024 draft risk evaluation for formaldehyde prepared under the Toxic Substances Control Act (TSCA). 89 Fed. Reg. 18933. EPA states that it “preliminarily finds that formaldehyde poses unreasonable risk to human health. The risk evaluation notes that these risks may not apply to everyone, everywhere and describes some of the sources of uncertainties in EPA’s...

The U.S. Environmental Protection Agency (EPA) announced on February 14, 2024, the list of ten scientific experts selected to review the 2023 draft risk evaluation for tris(2-chloroethyl) phosphate (TCEP) under the Toxic Substances Control Act (TSCA). Biographies of these experts are available in docket EPA-HQ-OPPT-2023-0265. EPA states that it will hold a virtual public meeting on March 5, 2024, to review the documents and draft charge questions being posed to the reviewers and address any...

On December 28, 2023, the U.S. Environmental Protection Agency (EPA) released comments from the letter peer review for its 2023 white paper presenting EPA’s quantitative approach for the human health risk assessment for part 2 of the Toxic Substances Control Act (TSCA) risk evaluation for asbestos. EPA notes in its December 28, 2023, press release that under the previous Administration, it narrowed the scope of the asbestos risk evaluation by reviewing only ongoing uses and...

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 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...

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...

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...

On July 7, 2023, Earthjustice, on behalf of its clients, announced that it notified the U.S. Environmental Protection Agency (EPA) of its intent to sue for missing the statutory deadlines under the Toxic Substances Control Act (TSCA) for EPA to evaluate the risks to public health posed by 22 toxic chemicals. Earthjustice states that until EPA completes the overdue risk evaluations, “some of the most dangerous and widely used chemicals on the market will remain...

On June 22, 2023, the U.S. Environmental Protection Agency (EPA) called for public nominations of scientific and technical experts to review the “2023 White Paper on the Quantitative Human Health Approach to be Applied in the Risk Evaluation for Asbestos Part 2.” 88 Fed. Reg. 40819. EPA states that it will release the white paper for public review and comment in late July 2023 and subsequently submit it for letter peer review. EPA currently anticipates selecting approximately ten...

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 U.S. Environmental Protection Agency (EPA) will hold a virtual public preparatory meeting for the Science Advisory Committee on Chemicals (SACC) members, ad hoc reviewers, and the public to comment on and ask questions regarding the scope and clarity of the draft charge questions to be used for the May 8-11, 2023, review of two draft documents related to cumulative risk assessment under the Toxic Substances Control Act (TSCA). As reported in our March 1,...

The U.S. Environmental Protection Agency (EPA) has posted the justification for its fiscal year (FY) 2024 appropriation estimates for the Committee on Appropriations (Congressional Justification (CJ)). According to the CJ, EPA’s FY 2024 budget includes $470.7 million and 1,677 full-time equivalents (FTE) for Objective 7.1, “Ensure Chemical and Pesticide Safety.” The CJ includes the following target dates for actions under the Toxic Substances Control Act...

The Senate Committee on Environment and Public Works will hold a hearing on March 22, 2023, on the proposed fiscal year (FY) 2024 budget for the U.S. Environmental Protection Agency (EPA). The only listed witness is EPA Administrator Michael Regan. As reported in our March 14, 2023, blog item, the budget requests over $12 billion in discretionary budget authority for EPA, a $1.9 billion or 19 percent increase from the FY 2023 enacted level. Highlights of the FY 2024...

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...

The U.S. Environmental Protection Agency (EPA) announced on November 30, 2020, that it is inviting small businesses, governments, and not-for-profits to participate as Small Entity Representatives (SER) to provide advice and recommendations to two Small Business Advocacy Review (SBAR) Panels.  One Panel will focus on EPA’s development of a proposed rule to address unreasonable risks identified in EPA’s recently completed Toxic Substances Control Act (TSCA) risk evaluation for...

The U.S. Environmental Protection Agency (EPA) has provided a report to Congress on its capacity to implement certain provisions of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). The report provides point-in-time estimates of EPA’s current estimated capacity and resources needed to implement the 2016 Lautenberg Act amendments to the Toxic Substances Control Act (TSCA). EPA states that it recognizes its responsibility to identify and implement...

 The U.S. Environmental Protection Agency (EPA) announced on September 8, 2020, a “broad public engagement and outreach effort” to discuss how EPA will approach the rulemaking process to address unreasonable risks found in final Toxic Substances Control Act (TSCA) chemical risk evaluations.  After issuing the first two final risk evaluations, methylene chloride and 1-bromopropane, EPA states that it “is moving into the risk management phase and is hosting a robust...

The U.S. Environmental Protection Agency (EPA) announced on September 8, 2021, the availability of the draft scope of the risk evaluation to be conducted for octamethylcyclotetra-siloxane (D4). 86 Fed. Reg. 50347. As reported in our October 7, 2020, blog item, through the American Chemistry Council’s Silicones Environmental, Health, and Safety Center, Dow Silicones Corporation, Elkem Silicones USA Corporation, Evonik Corporation, Momentive Performance Materials, Shin-Etsu Silicones of...

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: EPA asks that attendees register for the NAMs...

On August 19, 2021, the U.S. Environmental Protection Agency (EPA) announced a collaborative agreement with Unilever to explore better ways to assess chemical risks associated with consumer products. According to EPA, this agreement builds on prior cooperation between EPA and Unilever regarding New Approach Methods (NAM), “which are a promising alternative to conventional toxicity testing that are intended to reduce reliance on the use of animals.” EPA states that the collaboration...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Environmental Protection Agency (EPA) announced on August 11, 2022, that it updated the Safer Chemical Ingredients List (SCIL), “a living list of chemicals by functional-use class that EPA’s Safer Choice program has evaluated and determined meet the Safer Choice Standard.” EPA added 22 chemicals to the SCIL. EPA states that to expand the number of chemicals and functional-use categories on the SCIL, it encourages...

The U.S. Environmental Protection Agency (EPA) announced on July 21, 2022, that the meeting minutes and final report (final report) are now available for the April 19-21, 2022, Science Advisory Committee on Chemicals (SACC) virtual meeting regarding EPA’s proposed Draft Systematic Review Protocol Supporting TSCA Risk Evaluations for Chemical Substances Version 1.0 (Draft Protocol). As reported in our December 21, 2021, memorandum, EPA released the Draft...

On May 23, 2022, the Vinyl Institute, Inc. (VI) filed suit in the U.S. Court of Appeals for the District of Columbia against the U.S. Environmental Protection Agency (EPA), seeking review of EPA’s March 2022 test order for 1,1,2-trichloroethane issued under Section 4(a)(2) of the Toxic Substances Control Act (TSCA). As reported in our March 25, 2022, blog item, EPA announced on March 24, 2022, that it issued a second round of test orders under TSCA Section 4 to obtain...

As reported in our March 25, 2022, blog item, the U.S. Environmental Protection Agency (EPA) announced on March 24, 2022, that it issued a second round of test orders under Section 4 of the Toxic Substances Control Act (TSCA) to obtain additional data on eight of the next 20 chemicals undergoing risk evaluation. In April 2022, EPA issued corrections to the following test orders: EPA amended Appendix D — Order Recipient Selection. Appendix D referred...

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...

On March 28, 2022, the Biden Administration submitted to Congress President Biden’s budget for fiscal year (FY) 2023. According to the U.S. Environmental Protection Agency’s (EPA) March 28, 2022, press release, the budget makes critical investments, including:...

The U.S. Environmental Protection Agency (EPA) announced on March 24, 2022, that it has issued a second round of test orders under Section 4 of the Toxic Substances Control Act (TSCA) to obtain additional data on eight of the next 20 chemicals undergoing risk evaluation. EPA states that after reviewing reasonably available data on these chemicals, it determined additional data are needed and is using its TSCA test order authority to require companies to develop and submit...

The U.S. Environmental Protection Agency (EPA) announced on February 14, 2022, that it will reopen the comment period for its draft revision to the risk determination for the cyclic aliphatic bromide cluster (HBCD) risk evaluation issued under the Toxic Substances Control Act (TSCA). As reported in our December 29, 2021, memorandum, EPA is reconsidering two key aspects of the risk determinations for HBCD. First, EPA proposes that the appropriate approach to these determinations under TSCA and...

On February 10, 2022, the U.S. Environmental Protection Agency (EPA) extended the comment period on the draft scope of a risk evaluation under the Toxic Substances Control Act (TSCA) for Asbestos Part 2: Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos. 87 Fed. Reg. 7833. As reported in our December 30, 2021, memorandum, in the Part 2 risk evaluation, EPA will evaluate the conditions of use of asbestos (including other types of asbestos fibers in...

The U.S. Environmental Protection Agency (EPA) announced on February 7, 2022, that registration is now open for the March 15-17. 2022, meeting of the Science Advisory Committee on Chemicals (SACC) to peer review EPA’s “Draft TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities Version 1.0” (screening level methodology). As reported in our January 24, 2022, memorandum, EPA will use the screening level methodology to evaluate potential...

The U.S. Environmental Protection Agency (EPA) announced on January 13, 2022, that it is accepting public comments on candidates under consideration for selection as ad hoc peer reviewers assisting the Science Advisory Committee on Chemicals (SACC) with its review of the Draft Systematic Review Protocol Supporting TSCA Risk Evaluations for Chemical Substances. This comment period follows a previous 30-day call for nominations that ended on November 17, 2021. EPA will use comments on the...

The U.S. Environmental Protection Agency (EPA) has reopened the online dockets for 20 high-priority substances. According to the December 9, 2021, memorandum authorizing the re-opening of the dockets, EPA is re-opening these dockets to receive use, hazard, exposure, and any other information that can help inform their risk evaluations. Information must be submitted by June 9, 2022, when EPA will close the dockets. Information submitted to the docket should be identified by the...

The U.S. Environmental Protection Agency (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) is accepting public comments on candidates under consideration for selection as ad hoc reviewers assisting the Science Advisory Committee on Chemicals (SACC) with their review of the draft EPA Toxic Substances Control Act (TSCA) Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities. EPA will use the comments to assist it in selecting approximately...

The U.S. Environmental Protection Agency (EPA) announced the availability of the Draft Systematic Review Protocol Supporting TSCA Risk Evaluations for Chemical Substances (Draft Protocol) on December 20, 2021. 86 Fed. Reg. 71891. According to EPA, the Draft Protocol includes a revised generic approach for Toxic Substances Control Act (TSCA)-related approaches accounting for previous peer review comments from the Science Advisory Committee on Chemicals (SACC) reviews of risk...