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OECD Tour de Table Includes Information on International Developments Regarding Nanomaterials

By Lynn L. Bergeson & Carla N. Hutton on June 9, 2023
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The Organization for Cooperation and Development (OECD) has published the latest edition of the Developments in Delegations on the Safety of Manufactured Nanomaterials and Advanced Materials — Tour de Table. The Tour de Table compiles information provided by delegations on the occasion of the 22nd meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in June 2022. Below are highlights on international developments from the Tour de Table:

  • Canada is developing a nanomaterial regulatory risk assessment framework to 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. The framework discusses the nanomaterial-specific considerations for risk assessment, such as the key physical and chemical properties specific for nanomaterial identification and used for grouping or classifying nanomaterials for information gathering; the data considerations used in a nanomaterial risk assessment, such as test data or modeling; and the behavior of nanomaterials throughout the lifecycle of the nanomaterial and characterizing those potential effects on human health and the environment. As reported in our June 21, 2022, blog item, the draft was published on June 17, 2022, for a 60-day public comment period.
  • The Netherlands volunteered to initiate pilot inspections on registrations of nanomaterials under the European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. The main aim is to determine whether EU-wide enforcement action should be put in place to address the low level of information updates in dossiers for substances in nanoforms. The European Chemicals Agency (ECHA) will provide support with the REACH Competent Authority in the Netherlands. Based on a list provided by ECHA, companies will be selected to gain insight in the type of information companies use in their considerations to register the substances with nanoforms or not. With the project, the inspectors aim to build up knowledge and expertise on the (low number of) registrations of nanomaterials. According to the Tour de Table, France also showed interest in performing such pilot inspections. Depending on the results of the experiences in these pilot inspections, the ECHA Forum may discuss potential further action related to nanomaterials at a later stage.
  • In the EU, compliance check processes addressing REACH registrations of three substances in nanoform are ongoing. Under the Cosmetic Products Regulation (CPR), a targeted revision of the regulation is taking place and is planned to address nanomaterials. Within the food sector, the European Food Safety Authority (EFSA) is implementing nano guidance documents published in 2021; the activity is mostly focused on novel foods and food and feed additives. According to the Tour de Table, in most cases, there is a need to request additional information from applicants to ensure that nanoscale considerations are addressed according to the new guidance. EFSA organized a 2021 stakeholder event to facilitate the implementation of these new challenges; presentations and recordings are available online.
  • Malaysia launched a National Nano Product and Technology Roadmap on April 13, 2022, to support Malaysia’s National Nanotechnology Policy and Strategy 2021-2030 (DSNN). The nano ecosystem has been mapped towards these jumpstart sectors: energy; environment; food and agriculture; medical and well-being; healthcare; and electronics and devices.
Photo of Lynn L. Bergeson Lynn L. Bergeson

Owner of Bergeson & Campbell, P.C. (B&C®), 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…

Owner of Bergeson & Campbell, P.C. (B&C®), 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 advocating before Congress, the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), or other governance and standard-setting bodies.

Ms. Bergeson counsels corporations, trade associations, and business consortia on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters pertinent to conventional, biobased, and nanoscale chemicals, particularly with respect to TSCA, FIFRA, Food Quality Protection Act (FQPA), REACH and REACH-like programs, and Occupational Safety and Health Administration (OSHA) matters.

She served as chair of the American Bar Association Section of Environment, Energy, and Resources, and has served in many Section leadership positions. She has served on the Board of Directors of the Environmental Law Institute, the NanoBusiness Commercialization Association, and the Product Stewardship Society, among other business and law organizations, and lectures and writes frequently on legal, regulatory, and science policy issues. Ms. Bergeson is also President of The Acta Group (Acta®), B&C’s scientific and regulatory consulting arm, which assists chemical and product manufacturers in marketing and sustaining their products globally, and President of B&C Consortia Management, L.L.C., which helps the chemical industry leverage resources and maximize impact by forming consortia to achieve shared research, testing, regulatory, and access goals.

According to the Chambers USA Guide: “The universally highly regarded Lynn Bergeson of Bergeson & Campbell, P.C. has developed an enviable reputation in chemical and pesticide regulatory work, with particular expertise in nanotechnology. ‘She is probably the premier pesticide lawyer in DC,’ notes one impressed commentator. Peers predict that she is set to become ‘one of the most important lawyers in America.'”

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Photo of Carla N. Hutton Carla N. Hutton

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…

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 initiatives. These tasks have proven invaluable to many clients, keeping them aware and abreast of developing issues so that they can respond in kind and prepare for the future of their business.

Ms. Hutton brings a wealth of experience and judgment to her work in federal, state, and international chemical regulatory and legislative issues, including green chemistry, nanotechnology, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), Proposition 65, and the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program.

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  • Posted in:
    Environmental and Climate
  • Blog:
    Nano and Other Emerging Chemical Technologies Blog
  • Organization:
    Bergeson & Campbell, PC

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