On August 20, 2024, the U.S. Environmental Protection Agency (EPA) proposed significant new use rules (SNUR) ) under the Toxic Substances Control Act (TSCA) for 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 a TSCA Order. 89 Fed. Reg. 67368. The SNURs would require persons who intend to manufacture (defined by statute to include import) or process any of the chemical substances for an activity that is proposed as a significant new use by the rule 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. Comments are due September 19, 2024.

According to EPA, the PMN for graphene nanoplatelets (generic) states that the generic (non-confidential) use will be as an additive for paint coatings. EPA states that based on comparison to analogous chemical substances, it has identified concerns for lung effects and systemic effects. EPA issued the Order under TSCA Sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• No manufacture of the PMN substance other than by import into the United States in the form of a solution (i.e., no domestic manufacture);
• No processing of the PMN substance in any manner that results in inhalation exposure;
• No processing or use of the PMN substance other than in a liquid formulation;
• No use of the PMN substance other than for the confidential use listed in the Order;
• No use of the PMN substance in an application method where the concentration of the PMN substance in the formulation exceeds the confidential concentration listed in the Order;
• No release of the PMN substance, or any waste stream containing the PMN substance, into waters of the United States;
• Use of personal protective equipment (PPE) where there is a potential for dermal exposure;
• Use of a National Institute for Occupational Safety and Health (NIOSH)-certified combination particulate and gas/vapor respirator with an assigned protection factor (APF) of at least 50 where there is a potential for inhalation exposure; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the safety data sheet (SDS).

The proposed SNUR would designate as a significant new use the absence of these protective measures. EPA states that it has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a significant new use notice (SNUN) for a significant new use that will be designated by the SNUR. According to EPA, the results of specific target organ toxicity, pulmonary effects, sediment toxicity, and aquatic toxicity testing “may be potentially useful to characterize the health and environmental effects of the PMN substance.” EPA notes that although the Order does not require these tests, “the Order’s restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.”