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OECD Tour de Table Highlights International Developments on the Safety of Manufactured Nanomaterials

On September 27, 2017, the Organization for Economic Cooperation and Development (OECD) published a corrected version of the Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour De Table, which covers developments on the safety of manufactured nanomaterials that were provided by OECD delegations from March to August 2017.  It summarizes relevant information on activities related to manufactured nanomaterials, as well as other activities on nanotechnologies at the international level.  The reported activities include:

  • The French National Institute for Industrial Environment and Risks (INERIS) “has developed some preliminary guidance values on human toxicity (inhalation, ingestion) as well as for ecotoxicity for the case of [titanium dioxide] at the nanoform.”

  • Germany’s Federal Institute for Occupational Safety and Health (BAuA) and Federal Institute for Risk Assessment (BfR) have “decided on including investigations on nanofibers with special emphasis on fiber rigidity in their research program. The focus shall be on characterization, exposure assessment and inhalation toxicology.”

  • Korea’s Ministry of Environment (MOE) has added nanomaterials to the list for hazard evaluation prescribed in the Act on Registration and Evaluation, etc. of Chemical Substances (K-REACH):

    • Risk assessment decisions, including the type of: (a) nanomaterials assessed; (b) testing recommended; and (c) outcomes of the assessment;

    • Development related to exposure measurement and exposure mitigation;

    • Risk management approaches;

    • Any updates, including proposals or modifications to previous regulatory decisions; and/or

    • New regulatory challenge(s) with respect to any action for nanomaterials.

Based on the policy and research infrastructures developed from the first National Nano-Safety Master Plan (2012-2016) at interministerial levels (including MOE and the Ministries of Trade, Industry, and Energy, and Food and Drug Safety), the Korean government will establish the goal, vision, and implementation plan of the second Master Plan (2017-2021), and intended to make an official announcement by the first half of 2017.  MOE plans to introduce an effective safety management system of nanomaterials and nanoproducts distributed during the second period.  The secondary plan will include assessing the hazards of nanomaterials, and evaluating and managing safety assessments of nanomaterials in nanoproducts.

  • The European Commission (EC) intends to propose the adoption of possible revised Annexes to the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation addressing nanomaterials in the beginning of 2018, “with further transition arrangement regarding full application.”

©2020 Bergeson & Campbell, P.C.National Law Review, Volume VII, Number 271
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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...

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Carla Hutton, Bergeson Campbell PC, global regulatory attorney, public health activists lawyer, metals industry legal counsel, Toxic Substances Control Act law
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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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