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International Handbook on Regulating Nanotechnologies
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.
More Information
Critical Acclaim
Contributors
Contents
More Information
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.
This Handbook draws on contributions from leading nanotechnology regulation scholars around the globe. It goes beyond articulating how certain nanotechnologies are currently regulated and the significance of existing regulatory gaps, to assessing how the future regulatory landscape may evolve. As well as considering potential legislative responses that could be employed by governments, the Handbook examines a range of other options available to stakeholders. The Handbook employs new and innovative lenses through which to view these regulatory challenges and by adopting an in-depth, systematic and whole-of-life-approach, synergistically combines contributions from many countries, many fields and many disciplines. Informative and insightful, it presents thought-provoking and stimulating perspectives on the coming nano-age and on how we as citizens will govern its future.
This Handbook draws on contributions from leading nanotechnology regulation scholars around the globe. It goes beyond articulating how certain nanotechnologies are currently regulated and the significance of existing regulatory gaps, to assessing how the future regulatory landscape may evolve. As well as considering potential legislative responses that could be employed by governments, the Handbook examines a range of other options available to stakeholders. The Handbook employs new and innovative lenses through which to view these regulatory challenges and by adopting an in-depth, systematic and whole-of-life-approach, synergistically combines contributions from many countries, many fields and many disciplines. Informative and insightful, it presents thought-provoking and stimulating perspectives on the coming nano-age and on how we as citizens will govern its future.
Critical Acclaim
‘. . . this Handbook is an essential tool and guide to better comprehend nanotechnologies, and should be read by the full range of people involved in its development and governance. . . This is an important and timely publication, essential for all engaged in developing policy to manage this innovative, transformative and revolutionary technology.’
– Anna George, Prometheus
‘The Handbook’s 26 chapters do a remarkable job of capturing the last decade of commentary and policy perspective regarding nano-related environmental health and safety regulatory issues, along with providing some fresh perspectives on where its future might be headed. It is an invaluable primer for those wanting to hear about the issue from some of the most authoritative voices in the area.’
– John C. Monica, Jr., Porter Wright Morris & Arthur LLP
– Anna George, Prometheus
‘The Handbook’s 26 chapters do a remarkable job of capturing the last decade of commentary and policy perspective regarding nano-related environmental health and safety regulatory issues, along with providing some fresh perspectives on where its future might be headed. It is an invaluable primer for those wanting to hear about the issue from some of the most authoritative voices in the area.’
– John C. Monica, Jr., Porter Wright Morris & Arthur LLP
Contributors
Contributors: K.W. Abbott, R.J. Aitken, J. Altmann, P. Binks, H. Bouwmeester, D.M. Bowman, J. Bradley, L.K. Breggin, R. Brownsword, Q. Chaudhry, J.C. Davies, T.K. Epprecht, R. Falkner, R.S. Gaspar, A. Gergely, A. Grobe, R.F. Hertel, G.A. Hodge, M. Holman, N. Jaspers, A.D. Jones, G. Klein, K. Ludlow, G.N. Mandel, G.E. Marchant, A.D. Maynard, C. Meili, J. Miles, G. Miller, A. Nordmann, J. Pendergrass, S.A.K. Peters, R. Porter, O. Renn, G. Scrinis, V. Stone, D.J. Sylvester, O. Tassinari, C. Toumey, G. van Calster, T. Weidl, M. Widmer, D. Williams, R. Zöllner
Contents
Contents:
PART I: CONCEPTS AND FOUNDATIONS
1. Introduction: The Regulatory Challenges for Nanotechnologies
Graeme A. Hodge, Diana M. Bowman and Andrew D. Maynard
2. Philosophy of Technoscience in the Regime of Vigilance
Alfred Nordmann
3. Tracing and Disputing the Story of Nanotechnology
Chris Toumey
4. The Age of Regulatory Governance and Nanotechnologies
Roger Brownsword
PART II: FRAMEWORKS FOR REGULATING NANOTECHNOLOGIES
5. Nanotechnology Captured
John Miles
6. The Scientific Basis for Regulating Nanotechnologies
David Williams
7. The Current Risk Assessment Paradigm in Relation to the Regulation of Nanotechnologies
Qasim Chaudhry, Hans Bouwmeester and Rolf F. Hertel
8. Regulating Risk: The Bigger Picture
Karinne Ludlow and Peter Binks
9. Producing Safety or Managing Risks? How Regulatory Paradigms Affect Insurability
Thomas K. Epprecht
PART III: CASE STUDIES IN REGULATING NANOTECHNOLOGIES AND NANO-PRODUCTS
10. The Evolving Nanotechnology Environmental, Health, and Safety Landscape: A Business Perspective
Oliver Tassinari, Jurron Bradley and Michael Holman
11. Regulation of Carbon Nanotubes and Other High Aspect Ratio Nanoparticles: Approaching this Challenge from the Perspective of Asbestos
Robert J. Aitken, Sheona A.K. Peters, Alan D. Jones and Vicki Stone
12. Approaching the Nanoregulation Problem in Chemicals Legislation in the EU and US
Markus Widmer and Christoph Meili
13. A Good Foundation? Regulatory Oversight of Nanotechnologies Using Cosmetics as a Case Study
Geert van Calster and Diana M. Bowman
14. Therapeutic Products: Regulating Drugs and Medical Devices
Rogério Sá Gaspar
15. Regulatory Perspectives on Nanotechnologies in Foods and Food Contact Materials
Anna Gergely, Qasim Chaudhry and Diana M. Bowman
16. Regulation of Nanoscale Materials under Media-specific Environmental Laws
Linda K. Breggin and John Pendergrass
17. Military Applications: Special Conditions for Regulation
Jürgen Altmann
18. Regulating Nanotechnology through Intellectual Property Rights
Gregory N. Mandel
PART IV: THE FUTURE REGULATORY LANDSCAPE
19. The Role of NGOs in Governing Nanotechnologies: Challenging the ‘Benefits versus Risks’ Framing of Nanotech Innovation
Georgia Miller and Gyorgy Scrinis
20. Voluntary Measures in Nanotechnology Risk Governance: The Difficulty of Holding the Wolf by the Ears
Christoph Meili and Markus Widmer
21. The Role of Risk Management Frameworks and Certification Bodies
Thorsten Weidl, Gerhard Klein and Rolf Zöllner
22. Risk Governance in the Field of Nanotechnologies: Core Challenges of an Integrative Approach
Ortwin Renn and Antje Grobe
23. International Coordination and Cooperation: The Next Agenda in Nanomaterials Regulation
Robert Falkner, Linda K. Breggin, Nico Jaspers, John Pendergrass and Read Porter
24. Transnational Regulation of Nanotechnology: Reality or Romanticism?
Kenneth W. Abbott, Douglas J. Sylvester and Gary E. Marchant
25. From Novel Materials to Next Generation Nanotechnology: A New Approach to Regulating the Products of Nanotechnology
J. Clarence Davies
PART V: CONCLUSION
26. Conclusions: Triggers, Gaps, Risks and Trust
Andrew D. Maynard, Diana M. Bowman and Graeme A. Hodge
Index
PART I: CONCEPTS AND FOUNDATIONS
1. Introduction: The Regulatory Challenges for Nanotechnologies
Graeme A. Hodge, Diana M. Bowman and Andrew D. Maynard
2. Philosophy of Technoscience in the Regime of Vigilance
Alfred Nordmann
3. Tracing and Disputing the Story of Nanotechnology
Chris Toumey
4. The Age of Regulatory Governance and Nanotechnologies
Roger Brownsword
PART II: FRAMEWORKS FOR REGULATING NANOTECHNOLOGIES
5. Nanotechnology Captured
John Miles
6. The Scientific Basis for Regulating Nanotechnologies
David Williams
7. The Current Risk Assessment Paradigm in Relation to the Regulation of Nanotechnologies
Qasim Chaudhry, Hans Bouwmeester and Rolf F. Hertel
8. Regulating Risk: The Bigger Picture
Karinne Ludlow and Peter Binks
9. Producing Safety or Managing Risks? How Regulatory Paradigms Affect Insurability
Thomas K. Epprecht
PART III: CASE STUDIES IN REGULATING NANOTECHNOLOGIES AND NANO-PRODUCTS
10. The Evolving Nanotechnology Environmental, Health, and Safety Landscape: A Business Perspective
Oliver Tassinari, Jurron Bradley and Michael Holman
11. Regulation of Carbon Nanotubes and Other High Aspect Ratio Nanoparticles: Approaching this Challenge from the Perspective of Asbestos
Robert J. Aitken, Sheona A.K. Peters, Alan D. Jones and Vicki Stone
12. Approaching the Nanoregulation Problem in Chemicals Legislation in the EU and US
Markus Widmer and Christoph Meili
13. A Good Foundation? Regulatory Oversight of Nanotechnologies Using Cosmetics as a Case Study
Geert van Calster and Diana M. Bowman
14. Therapeutic Products: Regulating Drugs and Medical Devices
Rogério Sá Gaspar
15. Regulatory Perspectives on Nanotechnologies in Foods and Food Contact Materials
Anna Gergely, Qasim Chaudhry and Diana M. Bowman
16. Regulation of Nanoscale Materials under Media-specific Environmental Laws
Linda K. Breggin and John Pendergrass
17. Military Applications: Special Conditions for Regulation
Jürgen Altmann
18. Regulating Nanotechnology through Intellectual Property Rights
Gregory N. Mandel
PART IV: THE FUTURE REGULATORY LANDSCAPE
19. The Role of NGOs in Governing Nanotechnologies: Challenging the ‘Benefits versus Risks’ Framing of Nanotech Innovation
Georgia Miller and Gyorgy Scrinis
20. Voluntary Measures in Nanotechnology Risk Governance: The Difficulty of Holding the Wolf by the Ears
Christoph Meili and Markus Widmer
21. The Role of Risk Management Frameworks and Certification Bodies
Thorsten Weidl, Gerhard Klein and Rolf Zöllner
22. Risk Governance in the Field of Nanotechnologies: Core Challenges of an Integrative Approach
Ortwin Renn and Antje Grobe
23. International Coordination and Cooperation: The Next Agenda in Nanomaterials Regulation
Robert Falkner, Linda K. Breggin, Nico Jaspers, John Pendergrass and Read Porter
24. Transnational Regulation of Nanotechnology: Reality or Romanticism?
Kenneth W. Abbott, Douglas J. Sylvester and Gary E. Marchant
25. From Novel Materials to Next Generation Nanotechnology: A New Approach to Regulating the Products of Nanotechnology
J. Clarence Davies
PART V: CONCLUSION
26. Conclusions: Triggers, Gaps, Risks and Trust
Andrew D. Maynard, Diana M. Bowman and Graeme A. Hodge
Index
