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February 19, 2021

OECD Publishes Developments on the Safety of Manufactured Nanomaterials in Tour de Table

Lynn L. Bergeson Carla N. Hutton

The Organization for Economic Cooperation and Development (OECD) has published the latest edition of the Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour de Table.  The Tour de Table compiles information provided by delegations on the occasion of the 20th meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in September 2020.  Below are highlights from the Tour de Table:

  • Canada: Canada is developing a nanomaterial regulatory risk assessment framework to outline approaches and key considerations (g., unique properties of nanomaterials).  The framework will inform the assessment of manufactured nanomaterials under the Canadian Environmental Protection Act, 1999 (CEPA), including existing nanomaterials in commerce in Canada, and new nanomaterials notified prior to being manufactured or imported into Canada.  It will provide guidance to regulators on the assessment of nanomaterials for their risk to the environment and human health.  According to the Tour de Table, Canada will share a draft risk assessment framework with partners of the OECD WPMN for peer-review.
  • United States: The U.S. Environmental Protection Agency (EPA) completed review of low volume exemptions for two graphene oxide substances, a metal oxide substance, and a carbon nanotube.  EPA allowed the exemptions under conditions that limit human and environmental exposures to prevent unreasonable risks.  Additionally, EPA reviewed and completed six pre-manufacture notices (PMN) for nanoscale materials, including one carbon nanotube and six quantum dots.  These new chemical substances were regulated with consent orders owing to limited available data on nanomaterials; these consent orders limit uses and human and environmental exposure to prevent unreasonable risks.

Between November 2018 and August 2020, EPA received notification of ten nanoscale substances that met reporting criteria pursuant to its authority under Section 8(a) of the Toxic Substances Control Act (TSCA), bringing the total number of notifications to 77.  Reporting criteria exempt nanoscale chemical substances already reported as new chemicals under TSCA and those nanoscale chemical substances that do not have unique or novel properties.  Most reporting was for metals or metal oxides.

Since January 2005, EPA has received and reviewed more than 230 new chemical notices for nanoscale materials under TSCA, including fullerenes, quantum dots, and carbon nanotubes.  EPA has issued consent orders and significant new use rules (SNUR) regulating new chemical submissions of these nanoscale materials permitting manufacture under limited conditions.

  • European Union (EU): Amendments to Annex II of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to address nanomaterials took effect on January 1, 2020.  By January 1, 2020, the European Chemicals Agency (ECHA) had received 86 unique submissions for 34 substances covering nanomaterials.  ECHA had received a further 37 unique submissions by May 31, 2020 (e., by the deadline for submissions to the Tour de Table), resulting in a total of 54 substances covering nanoforms for which registration dossiers have been submitted following the updated REACH requirements.  Up-to-date information on the nanomaterials registered under REACH, as well as information on nanomaterials notified to different EU nanomaterial inventories, can be found on the EU Observatory for Nanomaterials (EUON) website.