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Austrian Academy of Sciences Publishes NanoTrust Dossier on the Safe-By-Design Concept

The Institute of Technology Assessment of the Austrian Academy of Sciences has published a NanoTrust Dossier entitled “Safe-by-Design — The Early Integration of Safety Aspects in Innovation Processes.”  The Dossier presents an overview of the concepts behind the idea of integrating health or environmental safety considerations in the design of materials, products, or processes, focusing on the nano-specific Safe-by-Design (SbD) concept.  SbD aims to take account of safety issues early on and throughout the entire product development process.  According to the Dossier, the nano-specific concepts of SbD are intended to address prevailing uncertainties about potential risks to the environment and human health at the beginning stages in the development of new nanomaterials and products.  The Dossier states that the basic assumption of the SbD concept is that risks can be reduced through the choice of materials, products, tools, and technologies, making them as safe as possible.  Particular attention is paid to the product development stage, when it is still possible to intervene to control the selection of these factors. In line with the precautionary principle, the early integration of safety in the innovation process is generally seen as desirable.  In recent years, according to the Dossier, many projects have been dedicated to the SbD concept and its practical implementation in industry.  Alongside the strengths of the concept, such as the early focus on safety-relevant issues, a number of challenges concerning practical applicability have been identified.  The Dossier notes that the voluntary nature of the use of SbD increases the users’ outlay in money and time without any visible added benefit for the enterprise.  Currently, therefore, “the nano-specific SbD concept must be considered as difficult to implement, although the effort to include safety as early as possible in the innovation process is generally very positively received.”  The Dossier includes a summary of projects at the European Union (EU) and national levels that have addressed or are addressing SbD in the nano-context.

 

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Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
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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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