Memoranda

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...

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rule requiring manufacturers (including importers) of 16 chemical substances to submit copies and lists of certain unpublished health and safety studies to EPA. 89 Fed.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

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...

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...

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...

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,...

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...

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...

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...

The U.S. Environmental Protection Agency (EPA) announced on February 1, 2024, two proposed rules that will add to its comprehensive approach to tackling per- and polyfluoroalkyl substances (PFAS) pollution and the commercial bottom line for hundreds of businesses facing costs for cleanup. The first proposed rule would modify the definition of hazardous waste as it applies to cleanups at permitted hazardous waste facilities. EPA states that this modification “would assure that EPA’s...