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(TSCA) to require manufacturers (including importers) of 16 chemical substances to submit copies and lists of certain unpublished health and safety studies to EPA. 89 Fed.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

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 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...

Bergeson & Campbell, P.C. (B&C®) is pleased to announce publication of the 2024 edition of Guide to the Toxic Substances Control Act (TSCA), LexisNexis (Guide to TSCA), the first under the editorial direction of the TSCA team at Bergeson & Campbell, P.C. Guide to TSCA is the definitive comprehensive treatise on TSCA, written for lawyers, regulatory affairs specialists, and commercial and business people who need to understand the details of this...

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). The final rule is complicated, and the compliance guide is a useful document for stakeholders to consider reading. ...

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, among other...

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...

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 standard of judicial review for most critical TSCA determinations under section 19 is “substantial evidence in the record taken as a whole”. This is a tough standard, considerably more rigorous than the Administrative Procedure Act (APA) standard under section 706, where agency action will be set aside if it is “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” The recent Loper...

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.”...

On 28 March, the Environmental Protection Agency (EPA) issued its long-awaited first final risk management rule under the Toxic Substances Control Acta (TSCA), banning the import and eventual use of chrysotile asbestos. This is the only form of asbestos known to be used in the US. You may be thinking now that because your company does not import or use asbestos, this does not affect you. You should care about it because the EPA’s approach to the risk management of chrysotile asbestos has much...

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...

The US Environmental Protection Agency (EPA) recently issued final risk management rules under the Toxic Substances Control Act (TSCA) banning certain uses of two chemicals: chrysotile asbestos and methylene chloride. The identity of these two chemicals is less important than the process by which the EPA concluded that the banned uses of these chemicals pose unreasonable risks to human health and the environment, and the nature and intrusiveness of the workplace and other restrictions the EPA...

The U.S. Environmental Protection Agency (EPA) issued on May 8, 2024, a final rule under the Toxic Substances Control Act (TSCA) to address the unreasonable risk of injury to health presented by methylene chloride under its conditions of use (COU). To no one’s surprise, the EPA banned most uses of the chemical. However, surprisingly, the EPA also adopted a de minimis threshold to account for impurities and the unintended presence of methylene chloride. The final rule goes into effect July 8,...

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...

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 also...

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...

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...

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 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...

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...

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 90 days before...

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...

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...