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UBA Report Summarizes Work to Develop New OECD Test Guideline on Dispersion Stability of Nanomaterials

In December 2017, Germany’s Federal Environment Agency (UBA) published a report entitled Clarification of methodical questions regarding the investigation of nanomaterials in the environment:  Development of a decision support tool for the investigation of nanomaterial’s environmental behaviour based on dispersion behaviour and dissolution in relation to various environmental parameters.  UBA states that for an adequate and valid interpretation of data regarding the environmental fate and behavior of nanomaterials, it is essential to describe parameters like dissolution, dispersibility, and dispersion stability.  The aim of the project was to develop a standardized test method to determine dispersibility and dispersion stability of nanomaterials in simulated environmental media as a new Organization for Economic Cooperation and Development (OECD) Test Guideline.  For this objective, both conceptual and experimental work was conducted, and an international round robin was initiated and executed to validate the proposed test setup regarding reliability and reproducibility.  According to UBA, two comprehensive expert commenting rounds of the OECD Test Guideline Program supported the refinement of the draft within this project.  The test method developed was submitted to OECD by UBA and published by OECD in October 2017 as a new “Test Guideline on dispersion stability of nanomaterials in simulated environmental media (OECD No. 318).”  The final report describes the considerations, experimental approaches, and obtained results that build the basis for the new OECD Test Guideline.  The report also contains a literature review of transformation reactions of nanomaterials in environmental media (up to 2015).

©2017 Bergeson & Campbell, P.C.

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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

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...

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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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