The Organisation for Economic Co-operation and Development (OECD) has published the Developments in Delegations on the Safety of Manufactured Nanomaterials and Advanced Materials between July 2023 and June 2024 — Tour de Table (Tour de Table). The Tour de Table lists U.S. developments on the human health and environmental safety of nanomaterials. Risk assessment decisions, including the type of nanomaterials assessed, testing recommended, and outcomes of the assessment include:
- The U.S. Environmental Protection Agency (EPA) completed review of three low volume exemptions (LVE) that included a graphene material, an indium phosphide zinc sulfide quantum dot, and a graphene oxide material. Two of the LVEs were denied, and one is pending review.
- According to the Tour de Table, EPA has under review 14 premanufacture notices (PMN), 12 of which are for multi-walled carbon nanotubes and two of which are for silica materials. The Tour de Table states that EPA is still reviewing these 14 chemical substances for potential risks to human health and the environment. EPA is also reviewing one significant new use notice (SNUN) for a single-walled carbon nanotube.
The Tour de Table includes the following information regarding risk management approaches in the United States:
- Between June 2023 and May 2024, EPA received notification of two nanoscale substances based on metal oxides that met reporting criteria pursuant to its authority under the Toxic Substances Control Act (TSCA) Section 8(a), bringing the total number of notifications to 89. Reporting criteria exempted nanoscale chemical substances already reported as new chemicals under TSCA and those nanoscale chemical substances that did not have unique or novel properties. According to the Tour de Table, most reporting was for metals or metal oxides.
- Since January 2005, EPA has received and reviewed almost 300 PMNs for nanoscale materials under TSCA, including fullerenes and carbon nano-onions, quantum dots, semiconducting nanoparticles, and carbon nanotubes. EPA has issued consent orders and significant new use rules (SNUR) permitting manufacture under limited conditions. A manufacturer or processor wishing to engage in a designated significant new use identified in a SNUR must submit a SNUN to EPA at least 90 days before engaging in the new use. The Tour de Table notes that because of confidential business information (CBI) claims by submitters, EPA may not be allowed to reveal to the public the chemical substance as a nanoscale material in every new chemical SNUR it issues for nanoscale materials. EPA will continue to issue SNURs and consent orders for new chemical nanoscale materials in the coming year.
- Because of limited data to assess nanomaterials, the consent orders and SNURS contain requirements to limit exposure to workers through the use of personal protective equipment (PPE), limit environmental exposure by not allowing releases to surface waters or direct releases to air, and limit the specific applications/uses to those described in the PMN.
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