EPA Proposes New Rules for Graphene Nanoplatelets Under TSCA

The U.S. Environmental Protection Agency (EPA) has proposed significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances, including graphene nanoplatelets (generic), that are subject to premanufacture notices (PMNs) and a Microbial Commercial Activity Notice (MCAN). This proposal, detailed in the Federal Register (89 Fed. Reg. 67368), introduces new requirements for manufacturers and processors of these substances.

Key Provisions of the Proposed SNURs

Under the proposed SNURs, individuals intending to manufacture (including import) or process any of the specified chemical substances must notify the EPA at least 90 days before commencing such activities. The manufacture or processing for any significant new use as outlined by the SNUR cannot begin until the EPA has reviewed the notification, made a determination, and taken necessary actions based on that determination. Comments on the proposal are due by September 19, 2024.

Concerns and Restrictions for Graphene Nanoplatelets

The PMN for graphene nanoplatelets (generic) indicates that the substance will be used as an additive in paint coatings. However, the EPA has identified potential concerns related to lung and systemic effects based on comparisons with similar chemical substances. Consequently, the EPA issued an Order under TSCA Sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), which imposes the following restrictions:

- No domestic manufacture of the substance, allowing only importation in solution form.
- No processing that results in inhalation exposure.
- Processing or use limited to liquid formulations.
- Use restricted to confidential applications and concentrations specified in the Order.
- Prohibition on releasing the substance or any waste containing it into U.S. waters.
- Mandatory use of personal protective equipment (PPE) to prevent dermal exposure.
- Required use of a NIOSH-certified respirator with an assigned protection factor of at least 50 for potential inhalation exposure.
- Establishment of a hazard communication program, including precautionary statements on labels and in safety data sheets (SDS).

Implications and Potential Modifications

The proposed SNUR would designate the absence of these protective measures as a significant new use. The EPA suggests that certain information, such as specific target organ toxicity, pulmonary effects, sediment toxicity, and aquatic toxicity testing results, could be useful for those seeking to modify the Order or submit a significant new use notice (SNUN). Although the Order does not mandate these tests, the restrictions will remain in effect until the Order is modified or revoked by the EPA based on new information.