April 9, 2024

FDA Reports That No Asbestos Was Detected in Its 2023 Testing of Talc-Containing Cosmetic Products

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...
April 5, 2024

EPA Proposes to Require Submission of Health and Safety Studies for 16 Chemicals Being Considered for TSCA Risk Evaluation

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rule requiring manufacturers (including importers) of 16 chemical substances to submit copies and lists of certain unpublished health and safety studies to EPA. 89 Fed.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....
March 28, 2024

EPA Bans Ongoing Uses of Asbestos

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...
March 25, 2024

Appellate Court Vacates EPA’s TSCA Section 5 Orders Prohibiting Inhance from Manufacturing or Processing PFAS during Its Fluorination Process

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...
March 25, 2024

PFAS – What to Know Now, and What to Expect

Perfluoroalkyl and polyfluoroalkyl substances (PFAS) are attracting global legal, regulatory, commercial, and litigation attention as no other “emerging contaminant” has. Companies producing, processing, distributing, and/or using these substances must be aware of global legal and scientific developments and take steps now to minimize legal, regulatory, and commercial risk. Bergeson & Campbell, P.C. (B&C®) and its global consulting affiliate The Acta Group (Acta®) have prepared...
March 21, 2024

EPA Issues Draft Risk Evaluation for Formaldehyde, Preliminarily Finds That Formaldehyde Poses Unreasonable Risk to Human Health

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...
March 7, 2024

EPA Releases New Methodology to Detect Low Levels of PFAS in HDPE Containers

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,...
March 5, 2024

EPA Amends Risk Management Program Requirements to Protect At-Risk Communities from Chemical Accidents

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...
February 16, 2024

EPA Extends Submission Deadline for Polymer Exemption Reports and Accompanying Claims

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...
February 14, 2024

EPA Releases Final TSCA Fees Rule

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...