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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...
January 27, 2025
EPA Proposes Risk Management Rule to Protect Workers from Inhalation Exposure to PV29
On January 14, 2025, the U.S. Environmental Protection Agency (EPA) issued a proposed rule to address the unreasonable risk of injury to human health presented by Color Index (C.I.) Pigment Violet 29 (PV29) under its conditions of use (COU) as documented in EPA’s January 2021 risk evaluation and September 2022 revised risk determination. 90 Fed. Reg. 3107. The proposed rule states that the Toxic Substances Control Act (TSCA) requires that EPA address by rule any...
January 17, 2025
EPA Releases Final Risk Evaluation for DINP, Finding Unreasonable Risk of Injury to Human Health When Workers Are Exposed under Four COUs
On January 14, 2025, the U.S. Environmental Protection Agency (EPA) released the final risk evaluation for diisononyl phthalate (DINP) conducted under the Toxic Substances Control Act (TSCA). EPA states that it has determined that DINP presents an unreasonable risk of injury to human health because workers could be exposed to high concentrations of DINP in mist when spraying adhesive, sealant, paint, and coating products that contain DINP. According to EPA, DINP can cause developmental toxicity...
The U.S. Environmental Protection Agency (EPA) announced on January 13, 2025, that it signed a long-awaited memorandum of understanding (MOU) with the Occupational Safety and Health Administration (OSHA) formalizing coordination on EPA’s work to assess and manage existing chemicals under Section 6 of the Toxic Substances Control Act (TSCA). According to EPA’s press release, “EPA and OSHA anticipate that better coordination under this MOU will result in improved workplace health and safety...
January 13, 2025
EPA Issues Final Risk Management Rules for Trichloroethylene, Perchloroethylene, and Carbon Tetrachloride
The U.S. Environmental Protection Agency (EPA) released final risk management rules under the Toxic Substances Control Act (TSCA) for trichloroethylene (TCE) and perchloroethylene (PCE) on December 9, 2024, and for carbon tetrachloride (CTC) on December 11, 2024. EPA states that all uses of TCE will be banned over time, with “the vast majority of identified risks eliminated within one year,” and safer alternatives readily available for the majority of uses. The PCE rule will ban...
Bergeson & Campbell, P.C. (B&C®), its global consulting affiliate The Acta Group (Acta®), and consortia management affiliate B&C® Consortia Management, L.L.C. (BCCM) are pleased to share with you our 2025 Forecast. For all the reasons you might imagine, our seasoned team was especially challenged this year in speculating on what to expect in 2025 regarding global industrial, agricultural, and biocidal chemical regulatory and policy initiatives. Given the European Parliamentary...
On December 20, 2024, the Maine Department of Environmental Protection (MDEP) published a proposed rule regarding products containing intentionally added per- and polyfluoroalkyl substances (PFAS). The rule would establish criteria for currently unavoidable uses (CUU) of intentionally added PFAS in products and implement sales prohibitions and notification requirements for products containing intentionally added PFAS but determined to be a CUU. MDEP will hold a public hearing on January 16,...
December 23, 2024
EPA Requires Submission of Health and Safety Studies for 16 Chemicals Being Considered for Risk Evaluation under TSCA
On December 13, 2024, the U.S. Environmental Protection Agency (EPA) published a final Health and Safety Reporting Rule under the Toxic Substances Control Act (TSCA) to require manufacturers (including importers) of 16 chemical substances to submit copies and lists of certain unpublished health and safety studies to EPA. 89 Fed. Reg. 100756. The rule applies to manufacturers in the North American Industrial Classification System (NAICS) codes for chemical manufacturing (NAICS code 325) and...
On December 6, 2024, the California Office of Environmental Health Hazard Assessment (OEHHA) issued a notice stating that the Office of Administrative Law (OAL) approved changes to the Proposition 65 (Prop 65) Article 6 “clear and reasonable warnings” regulations for “short-form” warnings (Notice). The changes adopted are to the proposed regulations that OEHHA issued on October 27, 2023. The history of these amendments, dating back to January 2021, are set forth in our memoranda...
December 12, 2024
EPA Begins Public Consultation on Interim Framework for Advancing Consideration of Cumulative Impacts
On November 21, 2024, the U.S. Environmental Protection Agency (EPA) released a draft Interim Framework for Advancing Consideration of Cumulative Impacts (Interim Framework). 89 Fed. Reg. 92125. According to EPA, the Interim Framework provides a shared reference point for EPA programs and regions as they determine when and how to analyze and consider cumulative impacts. EPA states that Agency programs will incorporate the Interim Framework “into their processes and programs, as appropriate,...
On December 5, 2024, the Senate Environment and Public Works (EPW) Subcommittee on Chemical Safety, Waste Management, Environmental Justice, and Regulatory Oversight held a hearing on “Examining the Public Health Impacts of PFAS Exposures.” The Subcommittee heard from the following witnesses (written testimony is not available at this time): A transcript of the hearing is available online. Schaider testified that there needs to be a comprehensive strategy to address all per- and...
December 10, 2024
EPA Releases Final Supplement to the Risk Evaluation and Revised Unreasonable Risk Determination for 1,4-Dioxane
On November 13, 2024, the U.S. Environmental Protection Agency (EPA) announced the release of its final supplement to the risk evaluation and revised unreasonable risk determination for 1,4-dioxane under the Toxic Substances Control Act (TSCA). 89 Fed. Reg. 89993. EPA states in the Federal Register notice that it “used the best available science to prepare this final supplement to the risk evaluation and has determined that 1,4-dioxane poses unreasonable risk to human health.” EPA notes...
On November 21, 2024, the U.S. Environmental Protection Agency (EPA) announced the release of the National Strategy to Prevent Plastic Pollution: Part Three of a Series on Building a Circular Economy for All. According to EPA, together with EPA’s “National Recycling Strategy” and the “National Strategy for Reducing Food Loss and Waste and Recycling Organics,” the “National Strategy to Prevent Plastic Pollution” presents opportunities for voluntary and regulatory actions by...
On November 18, 2024, the Minnesota Pollution Control Agency (MPCA) requested comments on planned rules governing reporting and fees paid by manufacturers upon submission of required information about products containing per- and polyfluoroalkyl substances (PFAS). MPCA notes that “[a]t this stage, we do not have a draft rule; we want your feedback to inform us about the ideas described under the Subject of Rules section.” Instead, the purpose of the current request for comments (RFC)...
On August 1, 2023, Earthjustice filed a petition under Section 21 of the Toxic Substances Control Act (TSCA) asking the U.S. Environmental Protection Agency (EPA) to establish regulations prohibiting the manufacturing, processing, use, and distribution of the chemical N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD) for and in tires. Earthjustice filed the petition on behalf of the Yurok Tribe, the Port Gamble S’Klallam Tribe, and the Puyallup Tribe of Indians, and EPA granted the...
On October 31, 2024, U.S. Environmental Protection Agency (EPA) Administrator Michael S. Regan signed a final rule revising the regulations for decabromodiphenyl ether (decaBDE) and phenol, isopropylated phosphate (3:1) (PIP (3:1)), two of the five persistent, bioaccumulative, and toxic (PBT) chemicals addressed in final rules issued under the Toxic Substances Control Act (TSCA) in January 2021. According to the pre-publication version of the final rule (which is only available on EPA’s...
On October 9, 2024, the U.S. Environmental Protection Agency (EPA) announced that it has issued its fifth Toxic Substances Control Act (TSCA) test order requiring testing on per- and polyfluoroalkyl substances (PFAS) under its National PFAS Testing Strategy. The order requires Innovative Chemical Technologies, The Chemours Company, Daikin America, Inc., Sumitomo Corporation of Americas, and E.I. Du Pont de Nemours and Company to conduct and submit testing on...
The U.S. Environmental Protection Agency (EPA) proposed on October 8, 2024, to add 16 individual per- and polyfluoroalkyl substances (PFAS) and 15 PFAS categories representing more than 100 individual PFAS to the Toxics Release Inventory (TRI) list of toxic chemicals subject to reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA) to comply with the National Defense Authorization Act for Fiscal Year 2020 (NDAA). 89 Fed. Reg. 81776....
On October 5, 2024, Canada released three significant documents that move it closer to implementing the 2023 amendments to the Canadian Environmental Protection Act, 1999 (CEPA). The 2023 legislation, Strengthening Environmental Protection for a Healthier Canada Act (Bill S-5), requires that decisions made under CEPA respect the right to a healthy environment. Canada has released a draft implementation framework setting out how the Minister of the Environment and the Minister of Health (the...
October 9, 2024
EPA Seeks Public Comment on Manufacture of Certain PFAS during Fluorination of HDPE and Other Plastic Containers
On September 30, 2024, the U.S. Environmental Protection Agency (EPA) requested public comment on the manufacture of certain per- and polyfluoroalkyl substances (PFAS), including perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA), and perfluorodecanoic acid (PFDA), during the fluorination of high-density polyethylene (HDPE) and other plastic containers to inform regulations as appropriate under the Toxic Substances Control Act (TSCA). 89 Fed. Reg. 79581. EPA notes that this request for...
On September 26, 2024, the U.S. Environmental Protection Agency (EPA) released the final risk evaluation for Tris(2-chloroethyl) phosphate (TCEP), a flame retardant and plasticizer. 89 Fed. Reg. 78868. EPA states that it determined that TCEP poses an unreasonable risk of injury to human health and the environment. According to EPA’s September 23, 2024, press release, TCEP “has the potential to cause kidney cancer, damage the nervous system and kidneys, and harm fertility.” EPA notes that...
The White House Office of Science and Technology Policy (OSTP) announced on September 3, 2024, the release of its Per- and Polyfluoroalkyl Substances (PFAS) Federal Research and Development Strategic Plan (Strategic Plan). Prepared by the Joint Subcommittee on Environment, Innovation, and Public Health PFAS Strategy Team (PFAS ST) of the National Science and Technology Council, the Strategic Plan provides a federal strategy and implementation plan for addressing the strategic areas identified in...
The U.S. Environmental Protection Agency (EPA) announced on August 8, 2024, the availability of the final updated Safer Choice and Design for the Environment (DfE) Standard (the Standard). 89 Fed. Reg. 64915. According to EPA, the update includes a name change to the title of the Standard, a revision to the packaging criteria, a new certification for cleaning service providers, a new provision allowing for preterm partnership termination under exceptional circumstances, and the addition of...
The U.S. Environmental Protection Agency (EPA) issued a proposed rule on August 8, 2024, to address the unreasonable risk of injury to human health presented by 1-bromopropane (1-BP) under its conditions of use (COU) as documented in EPA’s August 2020 Risk Evaluation for 1-BP and the December 2022 Revised Risk Determination for 1-BP prepared under the Toxic Substances Control Act (TSCA). 89 Fed. Reg. 65066. To address the identified unreasonable risk, EPA proposes requirements to,...
The Maine Department of Environmental Protection (MDEP) announced on August 5, 2024, that its Per- and Polyfluoroalkyl Substances (PFAS) in Products Program has developed new concept draft language to implement the recently amended Title 38, Section 1614, the section addressing PFAS in products. MDEP has made the concept draft language available for an informal outreach process until August 30, 2024. After the informal outreach process, MDEP plans to proceed with rulemaking in fall 2024....
On July 10, 2024, the U.S. Environmental Protection Agency (EPA) published a compliance guide for its final methylene chloride risk management rule issued under the Toxic Substances Control Act (TSCA). According to EPA, the compliance guide will help industry, workers, and other interested stakeholders understand and comply with the new regulations to prevent injuries, long-term illnesses, and deaths. EPA also announced that in June 2024, it released a fact sheet on the rule containing...
July 29, 2024
EPA Begins 90-Day Comment Period on Proposed High-Priority Substance Designations for Five Chemicals
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...
Perfluoroalkyl and polyfluoroalkyl substances (PFAS) are attracting global legal, regulatory, commercial, and litigation attention as no other “emerging contaminant” has. Companies producing, processing, distributing, and/or using these substances must be aware of global legal and scientific developments and take steps now to minimize legal, regulatory, and commercial risk. Bergeson & Campbell, P.C. (B&C®) and its global consulting affiliate The Acta Group (Acta®) have prepared...
On July 1, 2024, the U.S. Environmental Protection Agency (EPA) announced the release of the draft risk evaluation for 1,1-dichloroethane (1,1-DCE) and the draft human health hazard assessment supporting the draft risk evaluation for 1,2-dichloroethane (1,2-DCE, also known as ethylene dichloride) prepared under the Toxic Substances Control Act (TSCA). EPA states that it “preliminarily determined 1,1-dichloroethane poses unreasonable risk to human health (of workers) and the environment.”...
July 16, 2024
EPA Grants TSCA Section 21 Petition Seeking Section 6 Rule Prohibiting Three PFAS Found in Fluorinated Plastic Containers
The U.S. Environmental Protection Agency (EPA) announced on July 11, 2024, that it granted a petition filed under Section 21 of the Toxic Substances Control Act (TSCA) requesting that EPA establish regulations under TSCA Section 6 prohibiting the manufacturing, processing, use, distribution in commerce, and disposal of three per- and polyfluoroalkyl substances (PFAS) formed during the fluorination of plastic containers. EPA “will promptly commence an appropriate proceeding under TSCA Section...
On June 26, 2024, Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University (GWU) Milken Institute School of Public Health presented “TSCA Reform — Eight Years Later.” This hybrid conference marked the eighth Toxic Substances Control Act (TSCA) Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act)...
On June 14, 2024, the California Office of Environmental Health Hazard Assessment (OEHHA) issued a notice proposing additional changes to its Proposition 65 (Prop 65) Article 6 “clear and reasonable warnings” regulations for “short-form” warnings (Notice). The changes proposed now are to the proposed regulations that OEHHA issued on October 27, 2023. The history of these amendments, dating back to January 2021, are set forth in our memorandum available here. Written comments on the...
June 21, 2024
EPA’s Proposed NMP Risk Management Rule Includes Requirements to Protect Workers and Consumers
On June 14, 2024, the U.S. Environmental Protection Agency (EPA) issued a proposed rule under Section 6(a) of the Toxic Substances Control Act (TSCA) that would protect workers and consumers from exposure to N-methylpyrrolidone (NMP). 89 Fed. Reg. 51134. To address the identified unreasonable risk, EPA proposes to: prohibit the manufacture (including import), processing, distribution in commerce, and use of NMP in several occupational conditions of use (COU); require worker protections through...
June 20, 2024
California Court Grants Injunction to Stop Prop 65 Warnings for Titanium Dioxide in Cosmetic and Personal Care Products
On June 12, 2024, the U.S. District Court for the Eastern District of California (District Court) issued an Order granting a preliminary injunction brought by the Personal Care Products Council (PCPC), which alleged that the California Office of Environmental Health Hazard Assessment’s (OEHHA) requirement for warnings under Proposition 65 (Prop 65) related to titanium dioxide in cosmetics and personal care products violated the First Amendment. The Personal Care Products Council v. Bonta, No....
The U.S. Occupational Safety and Health Administration (OSHA) issued a final rule on May 20, 2024, that amends the Hazard Communication Standard (HCS) to conform to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS), primarily Revision 7 (Rev 7), address issues that arose during the implementation of the 2012 update to the HCS, and provide better alignment with other U.S. agencies and international trading partners while enhancing the effectiveness of the standard....
May 24, 2024
EPA Releases Draft Risk Evaluation Documents for DIDP and DINP for Public Comment and Peer Review
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...
Registration is now open for “TSCA Reform — Eight Years Later,” the June 26, 2024, day-long conference sponsored by Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health. The conference focuses on Toxic Substances Control Act (TSCA) implementation challenges and accomplishments since the enactment in 2016 of the Frank R. Lautenberg Chemical Safety for the 21st Century Act...
On April 30, 2024, the House Appropriations Subcommittee for Interior, Environment, and Related Agencies held a hearing on the fiscal year (FY) 2025 budget request for the U.S. Environmental Protection Agency (EPA). The Senate Appropriations Subcommittee for the Interior, Environment, and Related Agencies held a separate hearing on EPA’s FY 2025 budget request on May 1, 2024, and the Senate Committee on Environment and Public Works held its own hearing on May 8, 2024. On...
On May 8, 2024, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) held a webinar on “Reducing PFAS in Products: Progress and Challenges.” The webinar was the third in EPA’s series on “Pollution Prevention in Action.” Jennie Romer, EPA Deputy Assistant Administrator for Pollution Prevention, hosts webinars featuring businesses, Pollution Prevention grantees, and other experts about innovations and successes in implementing...
May 17, 2024
EPA Bans Most Uses of Methylene Chloride, Requires Stronger Worker Safety Requirements for Remaining Industrial Uses
The U.S. Environmental Protection Agency (EPA) issued on May 8, 2024, a final rule to address unreasonable risks of injury to health EPA identified caused by methylene chloride under its conditions of use (COU). 89 Fed. Reg. 39254. According to EPA, the final rule will prevent serious illness and death associated with uncontrolled exposures to methylene chloride by preventing consumer access methylene chloride and by restricting the industrial and commercial use of methylene chloride while...
On May 8, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) released a plan to update, streamline, and clarify their regulations and oversight mechanisms for products of biotechnology. The Coordinated Framework for the Regulation of Biotechnology: Plan for Regulatory Reform under the Coordinated Framework for the Regulation of Biotechnology (the Plan) provides a roadmap for actions the agencies will take,...
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 April 26, 2024, the U.S. Environmental Protection Agency (EPA) requested comment on proposed consent decrees that would address lawsuits filed by the Community In-Power and Development Association Inc. (CIDA), Learning Disabilities Association of America, Louisiana Environmental Action Network, Sierra Club, and Texas Environmental Justice Advocacy Services (CIDA Plaintiffs) in the U.S. District Court for the District of Columbia on September 18, 2023, CIDA v. EPA, Case No. 1:23-cv-02715 (the...
The U.S. Environmental Protection Agency (EPA) issued on April 26, 2024, the final National Primary Drinking Water Regulation (NPDWR) for six per- and polyfluoroalkyl substances (PFAS). 89 Fed. Reg. 32532. The NPDWR establishes Maximum Contaminant Levels (MCL) for six PFAS in drinking water: perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), perfluorohexane sulfonic acid (PFHxS), perfluorononanoic acid (PFNA), and hexafluoropropylene oxide dimer acid (HFPO-DA) as contaminants...
The U.S. Environmental Protection Agency (EPA) announced on April 9, 2024, the release of an updated “Interim Guidance on the Destruction and Disposal of Perfluoroalkyl and Polyfluoroalkyl Substances and Materials Containing Perfluoroalkyl and Polyfluoroalkyl Substances.” According to EPA, the updated guidance “reflects the latest, best available science to provide information that managers of [per- and polyfluoroalkyl substances (PFAS)] wastes can use to evaluate the most appropriate...
April 29, 2024
EPA Issues Asbestos Part 2 Draft Risk Evaluation, Preliminarily Determines That Asbestos Poses Unreasonable Risk to Human Health
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...
April 26, 2024
EC Communication Defines Principles on Limiting Most Harmful Chemicals to Essential Uses
On April 22, 2024, the European Commission (EC) announced that it adopted a “Communication from the Commission: Guiding criteria and principles for the essential use concept in EU legislation dealing with chemicals.” The press release states that “[t]he overall aim of this concept is to achieve higher regulatory efficiency and predictability for authorities, investors and industry for a faster phase-out of the most harmful substances in non-essential uses, while allowing more time for the...
April 23, 2024
EPA Designates PFOA and PFOS as CERCLA Hazardous Substances, Releases CERCLA Enforcement Discretion Policy
On April 19, 2024, the U.S. Environmental Protection Agency (EPA) announced a final rule that will designate perfluorooctanoic acid (PFOA), perfluorooctanesulfonic acid (PFOS), and their salts and structural isomers as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). EPA states that under the rule, entities are required to report immediately releases of PFOA and PFOS that meet or exceed the reportable quantity (RQ) of one pound within...
The U.S. Environmental Protection Agency (EPA) announced on March 25, 2024, that it has issued the fourth Toxic Substances Control Act (TSCA) test order requiring testing on per- and polyfluoroalkyl substances (PFAS) under its National PFAS Testing Strategy. According to EPA, the action requires the 3M Company (3M) and Wacker Chemical Corporation (Wacker) to conduct and submit testing on the physical-chemical properties of 2-(N-Methylperfluoro-1-octanesulfonamido)ethanol (NMeFOSE) (Chemical...
April 9, 2024
FDA Reports That No Asbestos Was Detected in Its 2023 Testing of Talc-Containing Cosmetic Products
The U.S. Food and Drug Administration (FDA) announced on April 5, 2024, the results of its 2023 sampling assignment, testing talc-containing cosmetic products for the presence of asbestos. The testing was conducted using Polarized Light Microscopy (PLM) and Transmission Electron Microscopy (TEM). FDA states that “[a]sbestos was not detected in any of the 50 samples tested in 2023.” FDA states that it selected and purchased cosmetic products, and then it blinded and transferred the samples...