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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...
October 12, 2023
FDA Seeks Comment on Cosmetics Direct and Forms Regarding Registration of Cosmetic Product Facility and Cosmetic Product Listing
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...
September 28, 2023
EPA and DOJ Claim eBay Unlawfully Sold Pesticides, Banned Chemical Products, and Devices That Defeat Pollution Controls on Motor Vehicles
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...
August 17, 2023
Health Canada Begins Consultation on Proposed New Requirements for Consumer Chemical Products under the CCPSA
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...
August 7, 2023
OIG Reports that EPA “Lacks Complete Guidance for the New Chemicals Program to Ensure Consistency and Transparency in Decisions”
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)....
July 31, 2023
Draft Supplement to Risk Evaluation and Draft Revised TSCA Risk Determination for 1,4-Dioxane for Public Comment
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...
July 27, 2023
EPA Will Accept Comment on Potential Expansion of Safer Choice and DfE Programs, Announces August 29, 2023, Webinar
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....
July 26, 2023
EPA Will Propose to Ban Uses of CTC That Have Been Phased Out and Establish WCPP for Uses Not Prohibited
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...