Memoranda

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...

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...

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...

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rule requiring manufacturers (including importers) of 16 chemical substances to submit copies and lists of certain unpublished health and safety studies to EPA. 89 Fed.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

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,...

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...

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 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...

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...

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...

On October 27, 2023, the California Office of Environmental Health Hazard Assessment (OEHHA) issued a notice proposing changes to its Proposition 65 (Prop 65) Article 6 “clear and reasonable warnings” regulations for “short-form” warnings (Notice). OEHHA first proposed changes to the short-form warning requirements on January 8, 2021, with modifications proposed on December 13, 2021, and April 5, 2022. Industry was harshly critical of OEHHA’s proposal in written comments and during a...

On September 26, 2023, the U.S. Environmental Protection Agency (EPA) requested comment on a proposed framework to strengthen the assessment of antimicrobial-resistance risks associated with pesticide use. EPA, the U.S. Department of Health and Human Services (HHS), and the U.S. Department of Agriculture (USDA), under the oversight of the White House Executive Office of the President, have published a concept note. EPA states that the concept note is the first step in creating the framework...

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...

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...

On September 15, 2023, the U.S. Food and Drug Administration (FDA) announced that it is seeking comment on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067). The submission portal and paper forms are part of FDA’s implementation of the new registration and listing requirements mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). FDA has provided screenshots of the draft electronic system, draft Form...

On September 28, 2023, the U.S. Environmental Protection Agency (EPA) released a long-overdue final rule under Section 8(a)(7) of the Toxic Substances Control Act (TSCA) regarding reporting and recordkeeping requirements for per- and polyfluoroalkyl substances (PFAS). As discussed below, the final rule is not what many of us expected, nor wanted. EPA states that the reporting rule is a statutory requirement under the fiscal year (FY) 2020 National Defense Authorization Act (NDAA) that requires...

The U.S. Environmental Protection Agency (EPA) announced on September 27, 2023, that the U.S. Department of Justice (DOJ), on behalf of EPA, filed a complaint against eBay Inc. (eBay) “for unlawfully selling, offering for sale, causing the sale of, and distributing hundreds of thousands of products” in violation of the Clean Air Act (CAA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the Toxic Substances Control Act (TSCA). According to EPA, the complaint seeks...

The U.S. Consumer Product Safety Commission (CPSC) published a request for information (RFI) on per- and polyfluoroalkyl substances (PFAS) used in commerce or potentially used in consumer products, potential exposures associated with the use of PFAS in consumer products, and potential human health effects associated with exposures to PFAS from their use in consumer products. 88 Fed. Reg. 64890. CPSC also announced the availability of a contractor report with a focus on PFAS that are...

On August 3, 2023, the Joint Subcommittee on Environment, Innovation, and Public Health Sustainable Chemistry Strategy Team (Sustainable Chemistry ST) of the National Science and Technology Council (NSTC) published a report entitled Sustainable Chemistry Report: Framing the Federal Landscape. As reported in our January 19, 2021, memorandum, the fiscal year (FY) 2021 National Defense Authorization Act (NDAA) included the text of the bipartisan Sustainable Chemistry Research and...

The U.S. Environmental Protection Agency (EPA) announced on August 15, 2023, that it issued the third Toxic Substances Control Act (TSCA) test order requiring testing on per- and polyfluoroalkyl substances (PFAS) under EPA’s National PFAS Testing Strategy. EPA has ordered the Chemours Company FC LLC, E. I. du Pont de Nemours and Company, and 3M Company to conduct and submit testing on 2,3,3,3-Tetrafluoro-2-(heptafluoropropoxy)propanoyl fluoride (HFPO-DAF), “a substance used as...

The U.S. Environmental Protection Agency (EPA) announced on August 15, 2023, that it issued the third Toxic Substances Control Act (TSCA) test order requiring testing on per- and polyfluoroalkyl substances (PFAS) under EPA’s National PFAS Testing Strategy. EPA has ordered the Chemours Company FC LLC, E. I. du Pont de Nemours and Company, and 3M Company to conduct and submit testing on 2,3,3,3-Tetrafluoro-2-(heptafluoropropoxy)propanoyl fluoride (HFPO-DAF), “a substance used as...

On July 27, 2023, the United Nations (UN) published an electronic version of the tenth revision (Rev 10) of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) available for free for consultation purposes. The amendments to the ninth revision of the GHS (Rev 9) include the classification procedure for desensitized explosives (Chapter 2.17); the use of non-animal testing methods for classification of health hazards, in particular: skin corrosion/irritation...

Health Canada has begun a consultation on a proposal to introduce new requirements for consumer chemical products under the Canada Consumer Product Safety Act (CCPSA). Health Canada states that many substances found in consumer chemical products, like household cleaning products, have been linked to human health hazards of concern (HHHOC) such as carcinogens, mutagens, and reproductive toxicants. The proposed new requirements include the introduction of classification criteria for...

The U.S. Food and Drug Administration (FDA) issued draft guidance for industry on the registration and listing of cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) on August 7, 2023. The draft guidance provides details on the submissions process, including the information required and who is responsible for the submission. FDA is accepting comments until September 7, 2023. In addition, FDA seeks applications from interested parties to...

On August 2, 2023, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) released a report entitled The EPA Lacks Complete Guidance for the New Chemicals Program to Ensure Consistency and Transparency in Decisions. According to OIG, EPA’s New Chemicals Division (NCD) “lacks assurance that the new chemicals review process operates as intended and achieves its objective to protect human health and the environment.” OIG made four recommendations, including...

Canada published a notice in the Canada Gazette on June 24, 2023, announcing that it is collecting information on 850 substances for the purpose of prioritization, risk assessment, and risk management. Canada is gathering information from Canadian manufacturers, importers, and users on the commercial status, facility information (for example, releases), and uses of these substances in Canada, pursuant to Section 71 of the Canadian Environmental Protection Act (CEPA)....

On July 10, 2023, the U.S. Environmental Protection Agency (EPA) announced the availability of the draft supplement to the risk evaluation for 1,4-dioxane for public comment and peer review. 88 Fed. Reg. 43562. EPA states in its July 7, 2023, press release that the draft supplement to the 2020 risk evaluation considers air and water exposure pathways that were excluded from the earlier risk evaluation and exposure to 1,4-dioxane generated as a byproduct. The draft...

On July 25, 2023, the U.S. Environmental Protection Agency announced an opportunity for public input on the potential expansion of the Safer Choice and Design for the Environment (DfE) programs’ certification to new product categories. EPA notes in its July 27, 2023, Federal Register notice that Safer Choice “helps consumers, businesses, and purchasers find products that perform and contain ingredients that are safer for human health and the environment.” 88 Fed....

On July 17, 2023, the U.S. Environmental Protection Agency (EPA) announced that it will propose to ban uses of carbon tetrachloride (CTC) that have been phased out and establish a workplace chemical protection program (WCPP) for uses not prohibited to address the unreasonable risk to human health. EPA states in the prepublication version of the proposed rule that it determined that CTC presents an unreasonable risk of injury to health due to cancer from chronic inhalation and...

On July 3, 2023, the Brazil Association of Technical Standards (ABNT) adopted the amendment to the standard for classifying and labeling chemicals according to NBR 14725. The “new” NBR 14725:2023 merges the four-part standard into one, and adopts the 7th revised edition of the United Nations (UN) Globally Harmonized System of Classification and Labeling of Chemicals (GHS). These revisions enter into force on July 4, 2025. The following four parts consolidated into NBR 1475:2023...

The U.S. Environmental Protection Agency (EPA) announced on June 29, 2023, a new framework (the Framework) for addressing new per- and polyfluoroalkyl substances (PFAS) and new uses of existing PFAS. The Framework outlines EPA’s planned approach when reviewing new PFAS and new uses of PFAS to ensure that, before these chemicals are allowed to enter into commerce, EPA will undertake an extensive evaluation to ensure they pose no harm to human health and the environment....

On July 5, 2023, the Pipeline and Hazardous Materials Safety Administration (PHMSA) published an advance notice of proposed rulemaking (ANPRM) to solicit stakeholder feedback on initiatives PHMSA is considering that may modernize the Hazardous Materials Regulations (HMR) and improve efficiencies while maintaining or improving a current high level of safety. 88 Fed. Reg. 43016. To engage fully with stakeholders, the ANPRM solicits comments and input on questions related to 46 distinct topics...

On July 6, 2023, the U.S. Environmental Protection Agency (EPA) announced a final rule under Section 8(a) of the Toxic Substances Control Act (TSCA) that will require reporting and recordkeeping requirements for asbestos. The pre-publication version of the final rule states that EPA will require certain persons who manufactured (including imported) or processed asbestos and asbestos-containing articles, including as an impurity, in the four years prior to the date of...

The U.S. Environmental Protection Agency (EPA) announced on June 16, 2023, a 60-day public comment period on the draft Guidelines for Cumulative Risk Assessment Planning and Problem Formulation (draft CRA Guidelines). 88 Fed. Reg. 39424. According to EPA, the draft CRA Guidelines describe steps for the planning and problem formulation of CRAs and offer guidelines for when CRAs could be appropriate. Planning defines both the process for conducting the risk assessment and its...

On June 29, 2023, Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health presented “TSCA Reform — Seven Years Later.” This virtual conference marked the seventh 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) and...

On June 22, 2023, the U.S. Environmental Protection Agency (EPA) published proposed significant new use rules (SNUR) for three flame retardants, tris(2-chloroethyl) phosphate (TCEP), 4,4′-(1-methylethylidene)bis[2,6-dibromophenol], also known as “tetrabromobisphenol A” (TBBPA), and triphenyl phosphate (TPP), which are all undergoing risk evaluations under the Toxic Substances Control Act. 88 Fed. Reg. 40728. EPA states that the proposed significant new uses are manufacture (including...

Bill S-5, Strengthening Environmental Protection for a Healthier Canada Act (the Act), received Royal Assent on June 13, 2023. According to Environment and Climate Change Canada’s (ECCC) Backgrounder, the Act modernizes the Canadian Environmental Protection Act, 1999 (CEPA) and represents the first set of comprehensive amendments to CEPA since it was enacted over 20 years ago. It also makes related amendments to the Food and Drugs Act. The Act was initially introduced in the...