All Knowledge & Insights By Date

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rule requiring manufacturers (including importers) of 16 chemical substances to submit copies and lists of certain unpublished health and safety studies to EPA. 89 Fed.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) 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...

On March 28, 2024, the U.S. Environmental Protection Agency (EPA) issued a final rule under the Toxic Substances Control Act (TSCA) to address to the extent necessary the unreasonable risk of injury to health presented by chrysotile asbestos based on the risks posed by certain conditions of use (COU). 89 Fed. Reg. 21970. According to the final rule, the injuries to human health include mesothelioma and lung, ovarian, and laryngeal cancers resulting from chronic inhalation exposure to chrysotile...

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...

On March 13, 2024, the U.S. Environmental Protection Agency (EPA) published notice of a proposed settlement agreement to address a petition for writ of mandamus filed by the Ecology Center, the Center for Environmental Health, United Parents Against Lead & Other Environmental Hazards, and the Sierra Club in the United States Court of Appeals for the Ninth Circuit (Ecology Center v. EPA, No. 23-70158 (9th Cir.)). 89 Fed. Reg. 18408. The petitioners filed a petition for writ of mandamus on...

SAVE THE DATETSCA Reform – 8 Years LaterJune 26, 2024, 8:00 a.m. - 5:30 p.m. (EDT)George Washington University Milken Institute School of Public Health, Washington, D.C., and via livestream Save the date to join Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health for a day-long conference reflecting on the challenges and accomplishments since the implementation of the 2016 Lautenberg...

The U.S. Environmental Protection Agency (EPA) announced on March 6, 2024, a settlement requiring Haifa North America, Inc. (Haifa) to pay a civil penalty of $664,267 “for violations of chemical data reporting regulations under the Toxic Substances Control Act (TSCA).” EPA states that it alleged that Haifa failed to submit a data report required under TSCA for 32 chemical substances that Haifa had imported between 2016 and 2019. According to EPA, Haifa imports “various chemicals for...

On February 29, 2024, the U.S. Environmental Protection Agency (EPA) requested public nominations of scientific and technical experts for service as ad hoc reviewers assisting the Science Advisory Committee on Chemicals (SACC) with the peer review of the Agency’s evaluation of the risks from di-isodecyl phthalate (DIDP) and di-isononyl phthalate (DINP) being conducted to inform risk management decisions under the Toxic Substances Control Act (TSCA). 89 Fed. Reg. 14836. EPA states that it is...

The U.S. Environmental Protection Agency (EPA) announced on February 28, 2024, that it is seeking public comment on the candidates under consideration for selection as ad hoc peer reviewers to assist the Science Advisory Committee on Chemicals (SACC) with its peer review of the Agency’s evaluation of the risks from formaldehyde being conducted to inform risk management decisions under the Toxic Substances Control Act (TSCA). 89 Fed. Reg. 14648. The SACC peer review will take place during a...

The Environmental Defense Fund (EDF) published a blog item on February 22, 2024, announcing its Chemical Exposure Action Map, a tool “designed to spur the Environmental Protection Agency (EPA) to transform the assessment of risks posed by toxic chemicals in our communities.” EDF states that the map focuses on multiple high-priority chemicals, highlighting the potential for cumulative risks. EDF notes that when conducting risk assessments under the Toxic Substances Control Act (TSCA), EPA...

On February 21, 2024, comments by Lynn L. Bergeson and Richard E. Engler, Ph.D. were featured in Chemical Watch’s article on a recently published update to the Toxic Substances Control Act (TSCA) fees rule. Richard Engler, director of chemistry with law firm Bergeson & Campbell, said he expects a surge, but is uncertain if there will be an overall increase in submissions or just an accelerated timeline for companies looking to get their notices in before the fee increase. The former...

The U.S. Environmental Protection Agency (EPA) announced on February 20, 2024, that it has released the latest Toxic Substances Control Act (TSCA) Inventory. According to EPA, “[t]his biannual update to the public TSCA Inventory is part of EPA’s regular posting of non-confidential TSCA Inventory data.” EPA plans the next regular update of the Inventory for summer 2024. EPA states that the TSCA Inventory contains 86,741 chemicals of which 42,293 are active in U.S commerce. EPA notes that...

The U.S. Environmental Protection Agency (EPA) announced on February 16, 2024, that, in collaboration with the PETA Science Consortium International (PSCI), the Institute for In Vitro Sciences (IIVS), and the California Department of Pesticide Regulation (CDPR) on Wednesday, February 21, 2024, at 11:00 a.m. (EST) for a webinar on the use of new approach methodologies (NAM) or alternative methods to testing on vertebrate animals for chemical risk assessments. The presenters for the webinar,...

The U.S. Environmental Protection Agency (EPA) published a final rule on February 16, 2024, amending the Toxic Substances Control Act (TSCA) regulations for polymers manufactured under the terms of the polymer exemption by extending the submission deadline for reporting. 89 Fed. Reg. 12248. EPA notes that the regulations require that manufacturers (includes importers) of polymers manufactured under the terms of the exemption submit a report of manufacture or import by January 31 of the year...

On February 14, 2024, comments by Lynn L. Bergeson and Richard E. Engler, Ph.D. were featured in Chemical Watch’s article on the U.S. Environmental Protection Agency’s (EPA) planned Toxic Substances Control Act (TSCA) test orders. Richard Engler, director of chemistry with Bergeson & Campbell, said the test order forecast in the final fees rule is "much more reasonable" than what the agency outlined in 2022.  Lynn Bergeson, the law firm’s managing partner, agreed. "EPA...

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 February 8, 2024, the Environmental Protection Agency (EPA) announced its final amendments to the 2018 final rule that established fees for the administration of the Toxic Substances Control Act (TSCA). The final rule includes changes to the fee amounts and EPA’s total costs for administering TSCA; exemptions for entities subject to the EPA-initiated risk evaluation fees; exemptions for test rule fee activities; modifications to the self-identification and reporting requirements of...

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 23rd meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in June 2023. The Tour de Table lists U.S. developments on the human health and environmental safety of nanomaterials....

The U.S. Environmental Protection Agency (EPA) announced on January 31, 2024, a 30-day public comment period on candidates currently under consideration for membership on the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC). This public comment period follows a November 2023 call for nominations of scientific experts to be considered for appointment to the SACC. EPA notes that there are currently 18 SACC members, with eight membership terms that will soon...

On January 31, 2024, the U.S. Environmental Protection Agency (EPA) announced that it will hold a webinar on February 20, 2024, at 1:00 - 4:00 p.m. (EST) on the five chemicals currently undergoing prioritization under the Toxic Substances Control Act (TSCA). EPA states that the webinar is open to all, “but EPA is particularly interested in learning more about how these chemicals are used and how people could potentially be exposed at different points in a chemical’s lifecycle. EPA is also...

Download transcript. This week I discuss with my colleague, Dr. Richard E. Engler, Director of Chemistry for B&C and The Acta Group, our consulting affiliate, what to expect in 2024 regarding TSCA developments. Rich is a leading voice on all things TSCA, especially new chemicals, and a widely sought after thought leader on the U.S. Environmental Protection Agency’s (EPA) implementation of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg), Congress’ 2016...

The U.S. Environmental Protection Agency (EPA) announced on January 24, 2024, that it is extending the review period for confidential business information (CBI) claims for specific identity of all active chemical substances listed on the confidential portion of the Toxic Substances Control Act (TSCA) Inventory submitted to EPA under TSCA. 89 Fed. Reg. 4605. EPA states that it “has determined that an extension of the statutory review period for the review of CBI claims under TSCA are necessary...

The Senate Environment and Public Works Committee held a hearing on January 24, 2024, on “Oversight of Toxic Substances Control Act (TSCA) Amendments Implementation.” Michal Freedhoff, Ph.D., Assistant Administrator (AA) of the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) was the Committee’s sole witness. Committee Chair Tom Carper (D-DE) and Ranking Member Shelley Moore Capito (R-WV) provided opening statements. On the whole, no...

Bergeson & Campbell, P.C.’s (B&C®) January 23, 2024, webinar, “What to Expect in Chemicals Policy and Regulation and on Capitol Hill in 2024,” is now available for on-demand viewing. During this one-hour webinar Lynn L. Bergeson, Managing Partner, B&C; James V. Aidala, Senior Government Affairs Consultant, B&C; and Richard E. Engler, Ph.D., Director of Chemistry, B&C participated in a lively, timely, and focused discussion on the state of play and how they...

The Senate Committee on Environment and Public Works is scheduled to hold a hearing on January 24, 2024, on “Oversight of Toxic Substances Control Act Amendments Implementation.” The only scheduled witness is Michal Freedhoff, Ph.D., Assistant Administrator of the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP). The Committee held a similar hearing on June 22, 2022, the sixth anniversary of the enactment of the Frank R. Lautenberg...

As reported in our December 5, 2023, memorandum, the U.S. Environmental Protection Agency (EPA) proposed updates to the Safer Choice Standard on November 14, 2023, that include a name change to the Safer Choice and Design for the Environment (DfE) Standard (Standard), an update to the packaging criteria, the addition of a Safer Choice certification for cleaning service providers, a provision allowing for preterm partnership termination under exceptional circumstances, and the addition of several...

The U.S. Environmental Protection Agency (EPA) announced on January 9, 2024, the automatic addition of seven per- and polyfluoroalkyl substances (PFAS) to the list of chemicals covered by the Toxics Release Inventory (TRI). For TRI Reporting Year 2024 (reporting forms due by July 1, 2025), reporting is required for these seven additional PFAS, bringing the total PFAS subject to TRI reporting to 196. The Fiscal Year (FY) 2020 National Defense Authorization Act (NDAA) includes a provision that...

On January 4, 2024, the Washington Department of Ecology (WDOE) submitted a petition to the U.S. Environmental Protection Agency (EPA) under Section 21 of the Toxic Substances Control Act (TSCA) seeking a rulemaking to eliminate the current allowances for polychlorinated biphenyls (PCB) in consumer products. WDOE states that its research found that when PCBs are found in consumer products, “they are byproducts known to be associated with pigments, paints, or inks used in the manufacturing...

On January 11, 2024, the U.S. Environmental Protection Agency (EPA) issued a final significant new use rule (SNUR) to prevent companies from starting or resuming the manufacture (including import) or processing of 329 per- and polyfluoroalkyl substances (PFAS) that are designated as inactive on the Toxic Substances Control Act (TSCA) Chemical Substance Inventory. 89 Fed. Reg. 1822. The final rule notes that persons subject to the final SNUR are required to notify EPA at least 90 days before...

The U.S. Environmental Protection Agency (EPA) will hold a webinar on January 25, 2024, on its October 2023 per- and polyfluoroalkyl substances (PFAS) reporting rule under Section 8(a)(7) of the Toxic Substances Control Act (TSCA). The rule is a statutory requirement under the fiscal year (FY) 2020 National Defense Authorization Act that requires all manufacturers (including importers) of PFAS and PFAS-containing articles in any year since 2011 to report information related to chemical identity,...

The U.S. Environmental Protection Agency (EPA) will hold a webinar on January 18, 2024, from 2:00 p.m. to 4:00 p.m. (EST) for an informational webinar to preview the 2024 Chemical Data Reporting (CDR) tool and learn how to sign up for and participate in the testing period before the tool is formally launched. Under the CDR rule, manufacturers (including importers) of chemicals listed on the Toxic Substances Control Act (TSCA) Inventory that meet specific production volume thresholds, generally...

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...

The U.S. Environmental Protection Agency (EPA) announced on December 18, 2023, that it is beginning the process to prioritize five additional toxic chemicals for risk evaluation under the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 87423. The chemicals are acetaldehyde, acrylonitrile, benzenamine, 4,4’-methylene bis(2-chloroaniline) (MBOCA), and vinyl chloride. EPA seeks relevant information, including but not limited to, the chemical substance’s hazard and exposure potential; the...

No discussion of energy issues would be complete without some mention of the utility of used plastic as a feedstock in the production of fuels, energy and building block chemicals. In spring 2023, the US Environmental Protection Agency (EPA) released its Draft National Strategy to Prevent Plastic Pollution (Strategy) to identify voluntary actions to prevent plastic waste. Plastics recycling, including both mechanical and ‘advanced’, is core to achieving improved post-use plastics materials...

On December 6, 2023, a group of Republican Representatives sent a letter to U.S. Environmental Protection Agency (EPA) Administrator Michael S. Regan regarding EPA’s risk evaluation of existing chemicals under the Toxic Substances Control Act (TSCA). According to the letter, the Representatives are “concerned that the EPA is using TSCA section 6 in a way that both subverts and supplants the statutory responsibilities of the Occupational Safety and Health Administration (OSHA).” The letter...

The U.S. Environmental Protection Agency (EPA) announced on December 1, 2023, that it issued orders to Inhance Technologies LLC directing it not to produce per- and polyfluroakyl substances (PFAS), “chemicals that are created in the production of its fluorinated high-density polyethylene [high-density polyethylene (HDPE)] plastic containers.” EPA states that in December 2022, Inhance submitted significant new use notices (SNUN) for nine long-chain PFAS. According to EPA, “[u]pon review of...

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 release, TCE is...

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 non-risk...

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: 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...