On November 24, 2021, the U.S. Environmental Protection Agency (EPA) proposed significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for a number of chemical substances that were the subject of premanufacture notices (PMN) and are also subject to Orders issued by EPA pursuant to TSCA. 86 Fed. Reg. 66993. The proposed SNURs include one for a chemical substance identified generically as multi-walled carbon nanotubes (PMN P-20-72). According to EPA, the PMN states that the generic (non-confidential) use of the substance will be as an additive used to impart specific physiochemical properties to finished articles. According to EPA, it identified concerns for lung effects (lung overload and lung carcinogenicity) if respirable, poorly soluble particulates and fibers are inhaled, as well as concerns for eye irritation and systemic effects. EPA notes that based on the presence of a confidential residual, it also identified concerns for acute neurotoxicity, dermal and respiratory sensitization, mutagenicity, and carcinogenicity. EPA issued the Order on September 29, 2020, 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 or the environment. To protect against these risks, the Order requires:
- 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 particulate respirator with N-100, P-100, or R-100 cartridges with an assigned protection factor (APF) of at least 50 where there is a potential for inhalation exposure;
- No domestic manufacture of the PMN substance (e., import only);
- No exceedance of the confidential annual importation volume listed in the Order;
- No importation of the PMN substance other than as confidentially described in the PMN and allowed in the Order;
- No importation of the PMN substance such that the maximum weight percentage of the confidential impurity exceeds the confidential percentage identified in the Order;
- No processing or use of the PMN substance other than for the confidential use allowed in the Order;
- Disposal of the PMN substance and any waste streams from processing and use containing the PMN substance by incineration or landfill only;
- No release of the PMN substance directly to air;
- No processing or use of the PMN substance in application methods that generate a dust, mist, spray, vapor, or aerosol unless such application method occurs in an enclosed process;
- Establishment of a hazard communication program, including human health precautionary statements on each label and in the safety data sheet (SDS); and
- No release of the PMN substance to water.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures. The proposed SNUR requires persons who intend to manufacture (defined by statute to include import) or process the chemical substances for an activity that is proposed as a significant new use to notify EPA at least 90 days before commencing that activity. Comments on the proposed SNUR are due December 27, 2021.