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

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 (e.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 (i.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.

©2023 Bergeson & Campbell, P.C.National Law Review, Volume XI, Number 50

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...