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 7: The Current Risk Assessment Paradigm in Relation to the Regulation of Nanotechnologies

Qasim Chaudhry, Hans Bouwmeester and Rolf F. Hertel


Qasim Chaudhry, Hans Bouwmeester and Rolf F. Hertel 7.1 INTRODUCTION It has been suggested for some time that manipulating properties of materials at a small size scale may open up new opportunities for development of new functionalities (Feynman, 1959). The recent advent of nanotechnology has provided a systematic approach to the study and use of material properties in the size range close to the molecular level. Understanding the properties of materials at nanoscale provides opportunities for ‘finetuning’ of certain properties, as well as development of novel functionalities for specific applications. Due to the cross-cutting and enabling nature, applications of nanotechnology already span a vast range of industrial and consumer sectors. Of particular interest in this regard are engineered nanomaterials (ENMs) that are manufactured specifically to achieve a certain property or a composition. In many products and applications, ENMs are incorporated in fixed, bound or embedded forms, such as plastic materials for packaging. Other applications, such as certain cosmetics and personal care products, may contain free engineered nanoparticles (ENPs).1 The fundamental drivers at the heart of most nanotechnology applications are their potential to enable a reduction in the use of chemical substances, and development of novel functionalities. Because of the very large surface to mass ratio (also termed as aspect ratio), a relatively small amount of an ENM may provide a level of functionality that would otherwise need a much greater amount of the conventional bulk2 equivalent. The very small size of ENMs may also offer further benefits. For example,...

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