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...
TSCA/FIFRA/TRI EPA Seeks Public Comment On Whether To Limit The Scope Of The Treated Article Exemption: The U.S. Environmental Protection Agency (EPA) published an advanced notice of proposed rulemaking (ANPRM) on October 12, 2023, soliciting public comment and suggestions on specific issues related to seed treated with conventional pesticides (treated seed) and paint treated with conventional or antimicrobial pesticides (treated paint). 88 Fed. Reg. 70625. According to the ANPRM, EPA is...
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 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...