On July 29, 2025, the U.S. Environmental Protection Agency (EPA) issued final significant use rules (SNUR) for certain chemical substances, including graphene nanoplatelets (generic), that were the subject of premanufacture notices (PMN) and a Microbial Commercial Activity Notice (MCAN) and are also subject to an Order issued by EPA pursuant to the Toxic Substances Control Act (TSCA). 90 Fed. Reg. 35624. The SNURs require persons who intend to manufacture (including import) or process any of the chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. EPA notes that the manufacture or processing for the significant new use may not commence until EPA has conducted a review of the required notification, made an appropriate determination regarding that notification, and taken such actions as required by that determination. The final SNURs will be effective September 29, 2025.
EPA states that the chemical substance identified generically as graphene nanoplatelets (PMN P-22-54) is subject to reporting for the significant new uses described below. EPA notes that the requirements do not apply to quantities of the substance after they have been completely reacted or cured; or embedded into a permanent solid polymer form that is not intended to undergo further processing, except mechanical processing or physical blending. The significant new uses are:
- Protection in the workplace: Requirements as specified in 40 C.F.R. Section 721.63(a)(1) and (3)-(5), (b), and (c). When determining which persons are reasonably likely to be exposed as required for Section 721.63(a)(1) and (4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of Section 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 50. For purposes of Section 721.63(b), the concentration is set at 1.0 percent.
- Hazard communication: Requirements as specified in 40 C.F.R. Section 721.72(a)-(f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of Section 721.72(e), the concentration is set at 1.0 percent. For purposes of Section 721.72(g)(1), this substance may cause specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) and the U.S. Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (HCS) may be used.
- Industrial, commercial, and consumer activities: Requirements as specified in 40 C.F.R. Section 721.80(k), (v)(3), and (x)(3). It is a significant new use to manufacture the substance other than by import into the United States in the form of a solution (i.e., no domestic manufacture). It is a significant new use to process the substance in any manner that generates inhalation exposure. It is a significant new use to use the substance in an application method where the concentration of the substance in the formulation exceeds the confidential concentration listed in the Order.
- Release to water: Requirements as specified in 40 C.F.R. Section 721.90(a)(1), (b)(1), and (c)(1).
The above provisions apply except as modified below:
- Recordkeeping: Recordkeeping requirements as specified in 40 C.F.R. Section 721.125(a)-(i) and (k) are applicable to manufacturers, importers, and processors of this substance; and
- Limitation or revocation of certain notification requirements: The provisions of Section 721.185 apply.