Regulating the invisible: interaction between the EU and Norway in managing nano-risks

Abstract

Over the last decade, the need for governance of human health and environmental safety risks of nanotechnology (NT) has received increased attention at international, national and EU levels. There were early calls for increased funding of independent research, risk analysis and voluntary or mandatory regulation, but currently overall regulatory efforts have not materialised. One possible explanation is that research has revealed little need to regulate environmental and health safety risks of NT. Alternatively, there is a gap between politics and governance and the evolving state of knowledge. Such a gap can be caused by various factors including change in interests, saliency and organisation. Organisational challenges related to the science–policy interface at national, international and the EU can affect how new knowledge is channelled into decision-making processes. Decrease in public saliency is another possibility. Finally, opposition to regulation among affected producers may have increased and in turn stalled regulation through lobbying. The two explanations are analysed in a multi-level governance context. Norway is chosen as an interesting case: Highly profiled as a frontrunner i.a. in regulating gene technology, but currently awaiting regulations in the EU due to the European Economic Area agreement.

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Notes

  1. 1.

    To promote responsible technological development, the Government will facilitate an increase in the proportion of publicly funded R&D efforts in this field accounted for by HSE and ELSA research to a level which is among the leading internationally. (HSE: health, safety and environment, and ELSA: ethical, legal and social aspects) (White Paper 2012: 55).

  2. 2.

    The Norwegian Pollution Control Authority was renamed the Norwegian Climate and Pollution Agency in 2010, and then changed its name to the Norwegian Environment Authority in 2013.

  3. 3.

    This is in line with the EU Classification, Labelling and Packaging (CLP) Regulation.

  4. 4.

    List provided by the NEA to the authors, 26 April 2016.

  5. 5.

    In 2011, the EU adopted the following definition of nanomaterial (2011/696/EU): ‘A …material containing particles …for 50% or more…is in the size range of 1–100 nm’. In specific cases (health, environment, safety, competitiveness) the 50% criterion may be replaced by a threshold between 1 and 50%.

  6. 6.

    RRI aims to create space for reflection for those involved in R&D in new technologies; RRI literature has evolved within the EU (Schomberg 2012; Owen et al. 2013). However, limited attention has been given to vested economic interests or indeed any kind of power in the RRI literature, which is recognised as a dilemma for RRI (Owen et al. 2013: p. 33).

  7. 7.

    Out of a total of roughly€ 2.6 million, about one-fifth (€0.5 mill) was applied to fund independent ELSA projects that focused on potential risks of NT. The subsequent NANOMAT/NANO2021 programme is much larger (approx. € 55 million) and is divided into support for industrial, commercial projects and participatory research grants (responsible research and innovation, RRI) for risk analysis and methodology. The RRI part has received one-fifteenth of this total, with about €3.5 mill. for environmental testing.

  8. 8.

    Confirmed in interview RCN, October 2016.

  9. 9.

    Gold and silver alter their properties at the nano-level, with silver acquiring antibacterial traits and gold changing from one of the most inert to a highly reactive material. Aluminium turns explosive, carbon nanotubes are extremely strong, and silicon becomes a conductor rather than an insulator.

  10. 10.

    However, this definition would include much of traditional chemistry and physics, without capturing how the utility of nanotechnology lies in its transformation of properties of known elements. Nanotechnology spans a wide range of technologies and sciences, including medicine, material science, biotechnology, physics and chemistry and is applied in a great variety of sectors, all aiming to manufacture nanomaterials at the nanoscale.

  11. 11.

    This includes ELSA (2002–2006, since 2008 linked to NANOMAT) and NANOMAT (2002–2011)/NANO2021 (2012–2021). http://www.forskningsradet.no/prognett-nano2021/Prosjektarkiv/1253969916290.

    http://www.forskningsradet.no/prognett-elsa/Programme_description/1224698247089 (Accessed 9 April 2016.).

  12. 12.

    Interviews, Norwegian Institute of Bioeconomy Research (NIBIO), November 2015 and RCN, October 2016.

  13. 13.

    These examples and the conclusion were given in separate interviews, first on 10 November 2015 with two senior advisors in the Norwegian Environment Agency, then on 19 November 2015, with a senior researcher at Norwegian Institute of Bioeconomy Research (NIBIO).

  14. 14.

    Interview, NEA, November 2016.

  15. 15.

    Interviewees in GenØk, NBT, NIPH and NICR also stressed this.

  16. 16.

    Interviews, GenØk, October 2016 and NIBIO, November 2015.

  17. 17.

    Interview, GenØk, October 2016.

  18. 18.

    Interview RCN, October 2016.

  19. 19.

    Interview, NEA, November 2016.

  20. 20.

    This view was confirmed in interviews, GenØk, October 2016, and Norwegian Institute of Public Health, October 2016.

  21. 21.

    Data on file with authors.

  22. 22.

    As pointed out by Strandbakken et al. (2009; referred to in Rosness 2010: 45), attention to NT in Norway has included how NT may be applied to combat environmental problems (reduced and cleaner emissions). This could go some way towards explaining why Norwegian NGOs have not been very critical to NT.

  23. 23.

    Interview, NEA, November 2016.

  24. 24.

    https://www.euractiv.com/section/innovation-industry/news/industry-ngos-at-odds-over-nanotech-regulation/. Accessed 27 November 2016.

  25. 25.

    The study found a lack of use of adequate personal protective equipment (PPE) and lack of adequate safety data sheets with information on nanomaterials (Aune 2015).

  26. 26.

    The nanomaterials most frequently employed in Norwegian businesses are carbon black, carbon nanotubes, fibres and threads, polymers, titan dioxide and gold (Aune 2015: 55 and 75). 70% of the 102 businesses that handled carbon nanotubes were found to be only marginally aware of potential health effects, with less than a quarter of the workforce using personal protective equipment when handling these materials (ibid.: 100).

  27. 27.

    Interview, NEA, November 2016.

  28. 28.

    http://www.forskningsradet.no/prognett-nanomat/Nyheter/Forbrukerrettigheter_knyttet_til_nanoprodukter/1253953602454&lang=no (accessed 11 November 2016). Confirmed in interview with senior researcher Norwegian Institute for Consumer Research, 22nd November 2016. See also: http://hcwh-newsletter.ecn.cz/article.shtml?x=2084060 Accessed 27th November 2016.

  29. 29.

    The reason may be linked to the new EU definition of nanomaterials in 2011.

  30. 30.

    http://www.ianano.org/Site/About/Lloyd%20Tran-Interview-Research%20Media.pdf.

  31. 31.

    Interview, NEA, November 2016.

  32. 32.

    http://www.cefic.org/nanomaterials.

  33. 33.

    Letter from the Norwegian Ministry of the Environment to the European Commission, European Parliament, Council of European Union, 23 April 2012: Effective regulation of nanomaterials—comments by Norway.

    Norway Ministry of Environment (2012) Effective regulation of nanomaterials- comment from Norway. Ministry of Environment. http://www.eu-norge.org/PageFiles/606326/Innspill_nanomaterialer_23april2012.pdf [Accessed: 17 June 2013].

  34. 34.

    Interview, NEA, November 2016.

  35. 35.

    Interview, NEA, November 2016.

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Affiliations

Authors

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Correspondence to G. Kristin Rosendal.

Interviewees

Interviewees

Two senior advisors, Norwegian Environmental Agency (NEA), November 2016

Senior researcher, GenØk – Centre for Biosafety, October 2016

Senior researcher, Norwegian Institute of Bioeconomy Research (NIBIO), November 2015

Senior advisor, Research Council of Norway (RCN), October 2016

Senior researcher, Norwegian Institute of Public Health (NIPH), October 2016

Senior researcher, Norwegian Institute for Consumer Research (NICR), November 2016

Senior advisor, Norwegian Board of Technology (NBT), June 2015.

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Andresen, S., Rosendal, G.K. & Skjærseth, J.B. Regulating the invisible: interaction between the EU and Norway in managing nano-risks. Int Environ Agreements 18, 513–528 (2018). https://doi.org/10.1007/s10784-018-9401-5

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Keywords

  • Nanotechnology
  • Governance
  • Science–policy
  • Organisation
  • Management design