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Global Summit on Regulatory Science Will Focus on Nanotechnology Standards and Applications

The 2016 Global Summit on Regulatory Science (GSRS) will be held September 7-9, 2016, in Bethesda, Maryland. Each GSRS meeting focuses on an area of regulatory science that would benefit from discussions aimed at identifying future research directions, and this GSRS meeting will focus on nanotechnology standards and applications, building on an October 11, 2015, GSRS workshop.  The 2015 workshop focused on physico-chemical measurements and standards relevant to nanomaterials in the “pristine state” and in complex matrices. This meeting will expand on that focus to include both physico-chemical and biological measurements and standards for specific applications, namely nanomaterial-containing drugs, medical devices, food and food contact materials, and personal care products.  The goals of the meeting are to:

  • Educate a broad group of stakeholders on the state of the art in nanotechnology science, measurement methods, and standards for regulatory applications;

  • Identify the most immediate needs in nanotechnology science, measurement methods, and standards relevant to regulatory applications; and

  • Facilitate greater coordination between stakeholders in the development of standards.

The desired outcomes of the meeting include:

  • Publication of a meeting report: Information generated by the brainstorming panel sessions will be summarized to capture and prioritize needs for new consensus-based documentary standards, guidance documents, and reference materials specifically targeted for regulatory applications of nanotechnology products.  Similarly, state-of-the-art and existing gaps in nanotechnology regulatory science will be addressed across a broad spectrum of applications.  This information will be incorporated in a publicly available report; and

  • Global consensus for a centralized website: There are a number of websites that contain information on standards, for example, the Nanotechnology Standards Database hosted by the American National Standards Institute.  A new, centralized website containing links to existing lists of international standards is needed to consolidate the information in a single location.  It could be examined whether this website can be part of the European Union’s Nanomaterials Observatory to be established and hosted by the European Chemicals Agency.

The read-ahead material is a 26-page document listing U.S. and international regulatory agency guidance documents, documents from other organizations, documentary standards, publicly available protocols, and nanoscale reference materials.

©2019 Bergeson & Campbell, P.C.

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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

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
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 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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