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Standardisation in the Field of Nanotechnology: Some Issues of Legitimacy

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Abstract

Nanotechnology will allegedly have a revolutionary impact in a wide range of fields, but has also created novel concerns about health, safety and the environment (HSE). Nanotechnology regulation has nevertheless lagged behind nanotechnology development. In 2004 the International Organization for Standardization established a technical committee for producing nanotechnology standards for terminology, measurements, HSE issues and product specifications. These standards are meant to play a role in nanotechnology development, as well as in national and international nanotechnology regulation, and will therefore have consequences for consumers, workers and the environment. This paper gives an overview of the work in the technical committee on nanotechnology and discusses some challenges with regard to legitimacy in such work. The paper focuses particularly on stakeholder involvement and the potential problems of scientific robustness when standardising in such early stages of the scientific development. The intention of the paper is to raise some important issues rather than to draw strong conclusions. However, the paper will be concluded with some suggestions for improving legitimacy in the TC 229 and a call for increased public awareness about standardisation in the field of nanotechnology.

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Notes

  1. ELSA stands for ethical, legal and social aspects (of Emerging Technologies).

  2. In addition they share technological advances and good management practice, disseminate innovation, safeguard consumers and users, and make life simpler by providing solutions to common problems. See http://www.iso.org/iso/about/discover-iso_what-standards-do.htm. Accessed 21 January 2011.

  3. A full member country is an ISO member country with an established national standardisation body. See http://www.iso.org/iso/about/iso_members.htm. Accessed 21 January 2011.

  4. http://www.iso.org/iso/about/discover-iso_the-iso-brand.htm. Accessed 22 January 2010.

  5. ‘Liaison membership provides a way for international and broadly based regional organizations to participate in and be informed about the development of standards, and thus to ensure wider acceptance of the final result and to ensure coordination of parallel standardization activities in different bodies’ (ISO 2008c: 19).

  6. No longer operative.

  7. http://www.iso.org/iso/iso_technical_committee?commid=381983.Accessed 14 Oct 2010.

  8. From http://en.wikipedia.org/wiki/Legitimacy_(political). Accessed April 2010.

  9. For accounting and ISO 9000, cf. Tamm Hallström (2004); for accounting, cf. e.g., Johnson and Solomon (1984); for ISO 26000, cf. e.g., Ruwet (2009) and Hahn and Weidtmann (2010); for ICT, cf. Werle and Iversen (2006); for ISO 14001, cf. Raines (2003).

  10. For a critical discussion of how voluntary such voluntary standards in fact are, see Tamm Hallström (2004).

  11. See e.g., ISO/IEC/GEN 2001.

  12. There are few participants from developing countries, perhaps because they do not have nanotechnology research and industry. However, also developing countries will import nanoproducts and will experience the potential consequences in the same way as more developed countries, so that participation is therefore relevant for such countries as well.

  13. See for instance ISO’ strategic plan for 2011–2015 ‘Solutions to Global Challenges’, where it is stressed that ISO contributes to all three dimensions of sustainable development: economic, environmental and social. http://www.iso.org/iso/iso_strategic_plan_2011-2015.pdf. Accessed 02 February 2011.

  14. http://www.iso.org/iso/resources/resources_consumers.htm. Accessed 20 January 2011.

  15. From their webpage http://inni.pacinst.org/inni/. Accessed 2 April 2010.

  16. http://www.ecostandard.org/. Accessed 15 January 2010.

  17. They also illustrate the point that the broader the participation, the harder and slower the process.

  18. As Werle and Iversen say: ‘Technical standards are never purely technical’ (2006: 23).

  19. It should be noted that TC 229 uses a somewhat open-ended definition that takes this into account. In the technical specification on terminology and definitions for nano-objects, they define the nanoscale as the size range approximately from 1 to 100 nm (ISO/TS 27687).

  20. As long as there is no other regulation in place addressing this size range.

  21. The alternative is to vote ‘abstain’.

  22. These measures would be labelled as throughput measures in our model, but Werle and Iversen do not use this concept.

  23. Please note that it was beyond the scope of the project to critically assess the adequacy of TC 229’s treatment of uncertainty.

  24. For an account of the relation between the precautionary principle and stakeholder involvement cf. e.g., Stirling et al. (2006).

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Acknowledgments

I would like to thank the Research Council of Norway’s programme ‘Ethical, Legal and Social Aspects of Biotechnology, Nanotechnology and Neurotechnology’ for funding the project. I would also like to thank Standards Norway for their cooperation in the project. Finally, I will thank the informants in TC 229 and the participants in the project workshop, as well as the anonymous reviewers.

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Correspondence to Ellen-Marie Forsberg.

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Forsberg, EM. Standardisation in the Field of Nanotechnology: Some Issues of Legitimacy. Sci Eng Ethics 18, 719–739 (2012). https://doi.org/10.1007/s11948-011-9268-0

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