December 27, 2023

EPA Begins TSCA Prioritization Process for Five Chemicals, Requires Reporting on MBOCA

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...
December 21, 2023

EPA Proposes to Determine That TCEP, as a Whole Chemical Substance, Presents Unreasonable Risk to Human Health and the Environment

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...
December 5, 2023

EPA Proposes Updates Intended to Strengthen the Safer Choice Standard

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...
November 27, 2023

EPA Proposes to Amend PBT Rules for decaBDE and PIP (3:1)

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...
November 14, 2023

Ninth Circuit Finds Glyphosate Prop 65 Warning Unconstitutional

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...
November 6, 2023

EPA Extends the Comment Period on the Proposed Framework to Assess the Risk to the Effectiveness of Human and Animal Drugs Posed by Certain Antibacterial or Antifungal Pesticides

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...
November 3, 2023

EPA Proposes to Ban TCE

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...
November 2, 2023

OEHHA Re-proposes Significant Changes to Short-Form Warning Option

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...
October 30, 2023

EPA Proposes to Amend TSCA Risk Evaluation Framework Rule

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...