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 to...
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...
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...
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 non-risk...
TSCA/FIFRA/TRI EPA Releases Final Guidance For New Pesticide Applications And Registration Review Activities That Require Endangered Species Act Reviews: On September 14, 2023, the U.S. Environmental Protection Agency (EPA) announced the release of final guidance to improve the efficiency of EPA’s Endangered Species Act (ESA) analyses for new pesticide active ingredient applications and active ingredients undergoing registration review. EPA states this guidance fulfills requirements outlined...
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 FDA...
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 a...
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 potentially...
Sustainable chemistry is critical to the global economy and making the world a better place. Increasingly chemical and product innovators, businesses, and others are more discerning in selecting and using raw materials based on new criteria heavily influenced by sustainability factors. Businesses are increasingly finding value in waste as a feedstock, reducing hazardous chemicals in manufacturing processes, designing chemicals to be greener, and being more efficient in using energy, water, 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...
August 2, 2023
Environmental Regulation in Practice 2023: New Challenges and Priorities, August 2, 2023, via webinar
The Practising Law Institute presents Environmental Regulation in Practice 2023, analyzing current regulations including proposed amendments and judicial challenges concerning toxic chemicals, e-commerce, and public project developments, among other critical developments. Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), will present.
August 1, 2023
Product Stewardship Practices for Effective Supply Chain Interaction, August 1, 2023 via webinar
This webinar explored current and proposed international regulations and restrictions in developed and emerging legislation and provided examples informing and proactively promoting product stewardship practices and regulatory compliance in supply chains. Watch now. https://vimeo.com/850914224?share=copy Topics Covered: Promoting Supply Chain Interaction through Effective Product Stewardship Practices Strategic Alliances Best Practices Supply Chain and Downstream Users Supply Chain...
Chemical Watch presents "TSCA Fundamentals," a two day course providing in-depth training on the very latest TSCA regulatory and policy developments, their impact and how to anticipate their requirements, comply with the law and remain commercially competitive. Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®) and Catherine M Croke, DBA, Director of Product Stewardship and Regulatory Affairs, B&C, will present.
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...
July 3, 2023
Lynn L. Bergeson, “Expanding PFAS liability in the US,” Financier Worldwide, July 2023.
Few words inspire the panic that ‘polyfluoroalkyl substance (PFAS)’ does. Companies producing, processing, distributing and using (whether knowingly or not) these substances must be aware of expanding legal liability and take steps now to minimise risk. This article outlines key US per- and PFAS developments, the legal and commercial implications of these developments, and measures stakeholders should consider taking to limit liability.
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...
On 20 April the US EPA announced a proposed rule under section 6(a) of the Toxic Substances Control Act (TSCA) that would prohibit most uses of methylene chloride and require a workplace chemical protection program (WCPP) for non-prohibited uses. This article will outline the key elements of the EPA’s proposal and discuss the likely impact on industry. This article also looks at what this portends for the agency's future rulemaking activities on chemical substances undergoing...
On June 20, 2023, the U.S. Environmental Protection Agency (EPA) proposed significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 18 chemicals that were the subject of premanufacture notices (PMN) and are also subject to an order issued by EPA pursuant to TSCA. 88 Fed. Reg. 39804. The SNURs would require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a...
The U.S. Environmental Protection Agency (EPA) proposed on June 16, 2023, to ban most uses of perchloroethylene (PCE). 88 Fed. Reg. 39652. According to EPA’s June 8, 2023, press release, the proposed rule “would protect people from these risks by banning all consumer uses while allowing for many industrial/commercial uses to continue only where strict workplace controls could be implemented, including uses related to national security, aviation and other critical infrastructure,...