International Handbook on Regulating Nanotechnologies
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International Handbook on Regulating Nanotechnologies

Edited by Graeme A. Hodge, Diana M. Bowman and Andrew D. Maynard

As scientists and technologists discover how to engineer matter at the nanoscale in increasingly sophisticated ways, conventional approaches to ensuring safe use are being brought into question. Nanotechnologies are challenging traditional regulatory regimes; but they are also prompting new thinking on developing and using emerging technologies safely. In this Handbook, leading international authors from industry, government, non-governmental organisations and academia examine the complex and often controversial regulatory challenges presented by nanotechnologies. Across several disciplinary boundaries, they explore how the future regulatory landscape may evolve. From the Europe Union to the United States, workplaces to personal products, and statutory instruments through to softer approaches, it is clear that considerable vigilance will be needed in governing these powerful and novel technologies. To succeed, society will need new thinking, new partnerships and new mechanisms to balance the benefits of these technologies against their possible downsides. Anything less will prompt cries of illegitimacy and potentially compromise a promising new realm of technology innovation.
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Chapter 21: The Role of Risk Management Frameworks and Certification Bodies

Thorsten Weidl, Gerhard Klein and Rolf Zöllner


Thorsten Weidl, Gerhard Klein and Rolf Zöllner 21.1 INTRODUCTION An increasing number of products with claimed or actual nano-properties are being launched on the market. Irrespective of whether these properties are highlighted in advertising or hushed up for marketing reasons, the fundamental question is whether and to what extent such products and their production processes can or should be certified. The discussion surrounding this topic also reflects the underlying assessment of nanotechnology risks. ‘The role of risk management and its certification for nanotechnology as a European certification organization views it’ could have also been an appropriate title for this chapter. The authors are responsible for developing services in nanotechnology at TÜV SÜD, which is one of the world’s leading technical consultant and certification bodies, with a German and European focus. Their responsibilities include the risk management system CENARIOS® as well as developing a certification standard for product certification. They provide an objective overview and admittedly give a particular perspective on the subject risk management framework and certification not every reader will agree with. Indeed, the sometimes provocative statements reflect the point of view of a European certification organization and member of standardization committees whose genuine duty is not only to influence decision-making in this direction but also associates reflections and attitudes. To address these issues, this chapter first takes a closer look at the concept of certification and the motivation to become certified. The key modules of risk management in nanotechnology are explained on the basis of...

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