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...
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...
April 5, 2024
EPA Proposes to Require Submission of Health and Safety Studies for 16 Chemicals Being Considered for TSCA Risk Evaluation
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....
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...
On March 21, 2024, the U.S. Court of Appeals for the Fifth Circuit vacated the U.S. Environmental Protection Agency’s (EPA) December 2023 orders prohibiting Inhance Technologies, L.L.C. (Inhance) from manufacturing or processing per- and polyfluoroalkyl substances (PFAS) during its fluorination process. The court notes that in March 2022, EPA “charged for the first time” that Inhance’s fluorination process was subject to the significant new use rule (SNUR) regarding long-chain...
March 21, 2024
EPA Issues Draft Risk Evaluation for Formaldehyde, Preliminarily Finds That Formaldehyde Poses Unreasonable Risk to Human Health
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 February 15, 2024, the U.S. Environmental Protection Agency (EPA) announced the release of a new methodology for detecting 32 per- and polyfluoroalkyl substances (PFAS) in high-density polyethylene (HDPE) containers. According to EPA, the method can accurately identify PFAS contamination at levels as low as 0.002 parts per billion (ppb) (or 2 parts per trillion (ppt)). EPA states that in releasing this method to the public, it “is enabling the industries that utilize HDPE containers,...
March 5, 2024
EPA Amends Risk Management Program Requirements to Protect At-Risk Communities from Chemical Accidents
On March 1, 2024, the U.S. Environmental Protection Agency (EPA) released its “Safer Communities by Chemical Accident Prevention Rule” (SCCAP Rule), amending the Risk Management Program (RMP) “to further protect vulnerable communities from chemical accidents, especially those living near facilities in industry sectors with high accident rates.” The rule implements sweeping amendments to the RMP. It reflects the culmination of three public hearings, many comments on EPA’s proposed rule...
February 16, 2024
EPA Extends Submission Deadline for Polymer Exemption Reports and Accompanying Claims
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 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...
February 5, 2024
EPA Proposes to Modify the Definition of Hazardous Waste and Add Multiple PFAS as Hazardous Constituents
The U.S. Environmental Protection Agency (EPA) announced on February 1, 2024, two proposed rules that will add to its comprehensive approach to tackling per- and polyfluoroalkyl substances (PFAS) pollution and the commercial bottom line for hundreds of businesses facing costs for cleanup. The first proposed rule would modify the definition of hazardous waste as it applies to cleanups at permitted hazardous waste facilities. EPA states that this modification “would assure that EPA’s...
On January 24, 2024, the U.S. Environmental Protection Agency (EPA) began a 30-day public comment period on the draft updates to its Scientific Integrity Policy (Policy). 89 Fed. Reg. 4606. EPA states that in accordance with the requirements of the 2021 Presidential Memorandum on Restoring Trust in Government Through Scientific Integrity and Evidence-based Policymaking, it is revising its Policy. The updated Policy will adopt a new federal definition of scientific integrity and “meaningfully...
On January 25, 2024, the U.S. Environmental Protection Agency (EPA) held a webinar on EPA’s Toxic Substances Control Act (TSCA) Section 8(a)(7) rule on the reporting and recordkeeping requirements for per- and polyfluoroalkyl substances (PFAS). During the webinar, EPA provided an overview of the rule’s requirements. EPA also answered questions from webinar participants and stated that it is preparing a frequently asked questions (FAQ) document that it intends to circulate in early summer...
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...
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...
Click here for a PDF brochure of the memorandum Bergeson & Campbell, P.C. (B&C®) and its global consulting affiliate The Acta Group (Acta®) and consortia management affiliate B&C® Consortia Management, L.L.C. (BCCM) are delighted to share with you our Forecast 2024. This carefully curated document represents our seasoned team’s collective take on what to expect regarding global industrial, agricultural, and biocidal chemical initiatives in the New Year. Given the global state of...
December 28, 2023
EPA Begins TSCA Prioritization Process for Five Chemicals, Requires Reporting on MBOCA
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...
December 21, 2023
EPA Proposes to Determine That TCEP, as a Whole Chemical Substance, Presents Unreasonable Risk to Human Health and the Environment
On December 15, 2023, the U.S. Environmental Protection Agency (EPA) announced the availability of and solicited public comment on its draft risk evaluation for tris(2-chloroethyl) phosphate (TCEP) and related draft charge questions. 88 Fed. Reg. 86894. EPA states on its website that it reviewed the exposures and hazards of TCEP uses and made risk findings on TCEP. EPA considered relevant risk-related factors, including, but not limited to: the hazards and exposure, magnitude of risk, exposed...
The U.S. Environmental Protection Agency (EPA) announced proposed updates to the Safer Choice Standard on November 13, 2023. According to the November 14, 2023, notice, the proposed changes 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...
On November 24, 2023, the U.S. Environmental Protection Agency (EPA) published a proposed rule that will amend 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. 88 Fed. Reg. 82287. In the proposed rule, EPA states that after receiving additional comments following the...
On November 7, 2023, the Ninth Circuit affirmed the District Court for the Eastern District of California’s (District Court) June 22, 2020, decision granting summary judgment in favor of Plaintiffs. The Ninth Circuit entered a permanent injunction enjoining the California Attorney General from enforcing Proposition 65’s (Prop 65) carcinogen warning requirement for the herbicide glyphosate. National Ass’n of Wheat Growers et al. v. Bonta (Opinion).The Ninth Circuit found that requiring the...