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EPA Proposes SNUR for Certain Multi-Walled Carbon Nanotubes

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.

©2022 Bergeson & Campbell, P.C.National Law Review, Volume XI, Number 333

About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy process allows her to develop client-focused strategies whether...

Carla Hutto, Bergeson Campbell PC environmental law regulatory analyst,Toxic Substances Control Act law attorney
Regulatory Analyst

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client...