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Meta-Regulation and Nanotechnologies: The Challenge of Responsibilisation Within the European Commission’s Code of Conduct for Responsible Nanosciences and Nanotechnologies Research

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Abstract

This paper focuses on the contribution of meta-regulation in responding to the regulatory needs of a field beset by significant uncertainties concerning risks, benefits and development trajectories and characterised by fast development. Meta-regulation allows regulators to address problems when they lack the resources or information needed to develop sound “discretion-limiting rules”; meta-regulators exploit the information advantages of those actors to be regulated by leveraging them into the task of regulating itself. The contribution of meta-regulation to the governance of nanotechnologies is assessed in terms of responsibilisation. Responsibilisation is regarded as a pre -requisite for regulatory actors to internalise social values (such as consumer safety and occupational health) and to ensure that these values are built into regulatory practice. In order to explore the potential of responsibilisation, the Code of Conduct for Responsible Nanosciences and Nanotechnologies Research launched by the European Commission in 2008 is evaluated. The Code is a good case of meta-regulation that aims to steer the self-regulation of nanotechnological business and research organisations. The paper concludes that, while efforts were made on the part of meta-regulators and self-regulators to contribute to responsibilisation, important opportunities for responsibilisation such as dissemination and promotion of the Code, trust-building activities, and failure to provide rewards, incentives and stakeholder guidance were not taken up. In order to foster responsibilisation within the meta-regulatory instrument of the EC Code, a number of crucial activities to be undertaken by meta-regulators are recommended.

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Notes

  1. Indeed it has been estimated that costs for toxicity testing of existing nanoparticles available in the United States will range from $249 million to $1.18 billion and the time taken to complete testing will be significant (35–43 years) [10].

  2. The “More than Moore” domain refers to a set of technologies that enable non-digital micro/nanoelectronic functions such as radio frequency (RF) communication, power control, passive components, sensors and actuators. These technologies are based on, or derive from, silicon technology but do not necessarily scale with Moore’s Law. “Beyond Moore” refers to a set of disruptive functions—from progress in nanometre-sized functions—that, in the long term, will complement or replace conventional silicon technology.

  3. Our argumentation is based on reviews of the literature, policy documents and empirical studies.

  4. With this broad view on regulatory activities, we follow Parker who maintains that meta-regulation can entail any form of regulation that regulates any other form of regulation [41]. Narrow views focus only on oversight [30] or on enforcement activities [1, 7].

  5. See, for instance, the Responsible Care programme [14].

  6. Along a continuum of forms of regulation, starting with complete discretion to acting according to self-interest (‘freedom’), and ending with command and control, to aligning to social goals (‘control’), meta-regulation can be placed in the middle (15).

  7. These studies review process-oriented regulation which includes management-based regulation and meta-regulation [23]. Process-oriented regulation involves the steering of the regulatory process. Unlike management-based regulation, meta-regulation focuses on systematic regulatory learning which seems crucial for the regulation of emerging technologies with complex uncertainties.

  8. For meta-regulation in general see [47].

  9. Other meta-regulatory instruments include voluntary reporting schemes such as the Defra programme which aim at facilitating the collection of data on the potential hazards posed by engineered nanoparticles (see [6]).

  10. Meaning, for example, is defined as follows: ‘N&N research activities should be comprehensible to the public. They should respect fundamental rights and be conducted in the interest of the well-being of individuals and society in their design, implementation, dissemination and use’ [23:6]. Innovation is described as follows: ‘Governance of N&N research activities should encourage maximum creativity, flexibility and planning ability for innovation and growth’ [23:7].

  11. Thus, for example, for the good governance of N&N research, N&N research organisations and researchers ‘should ensure that scientific data and results are duly peer-reviewed before being widely disseminated outside the scientific community in order to ensure their clarity and balanced presentation’ [23:7].

  12. The Code is also meant to provide guidelines for responsible nanoresearch to employers and all individual and civil society organisations involved or interested in nanoscience and nanotechnologies research (“all stakeholders”).

  13. Such a performance agreement, for instance, commits meta-regulators to giving particular rewards and incentives, while it commits self-regulators to information provision and certain self-regulatory activities.

  14. The use of mediators is proposed as a means of enabling more ‘genuine’ deliberation [3]. Mediators are expected to stimulate responsibilisation by translating various interests and ‘world views’ in order to facilitate communication across the different stakeholders.

  15. Recent research shows that weak forms of rewards such as public recognition call responsibilisation into question [14].

  16. The aim of the NanoCode project—funded by the European Commission’s Framework Programme 7 (FP7)—was to develop a strategic framework (the MasterPlan) aimed at guiding the further development and implementation of the Code of Conduct, in addition to the development of a practical implementation assistance tool to help stakeholders assess their performance in complying with the Code’s principles. A March 2011 Synthesis Report [24] presents the findings of the international, quantitative and qualitative NanoCode survey about the Code. The results summarised in the Synthesis Report and MasterPlan offer insight into stakeholders’ patterns of awareness, their expectations, attitudes and appraisals. In all, 304 European and international experts contributed to the NanoCode survey in the period August-October 2010. In addition, around 150 experts were involved in qualitative interviews or focus groups in the different countries between October 2010 and January 2011. All project partners contributed to identifying relevant stakeholders and prepared a catalogue of national stakeholders, in addition to participants from different national organisations. Furthermore, each partner was responsible for inviting the identified experts to participate in the electronic survey through a personal mailing procedure. Key experts were defined as persons with a role in planning, managing or funding of activities in research and development (R&D), its safety, quality of corporate responsibility or communication issues in their organisation; or a role in planning or managing of international/national/regional or sector specific regulations, guidelines, voluntary measures and policies or funding strategies. A large number of stakeholders (62 %) were involved in research (in academia, industry and public research institutions), 16 % derived from business and the rest belonged to institutions (governmental departments and agencies, R&D governing bodies, regulatory and standards agencies, etc.) and civil society (non-governmental organisations (NGOs), consumer associations, labour associations). According to the report, the results show a “surprisingly unambiguous tendency”, given the large and heterogeneous sample.

  17. The FramingNano project [53] was another FP7 project which had the objective of defining a governance framework aimed at supporting responsible development of nanoscience and nanotechnology through international multi-stakeholder dialogue amongst the scientific, industrial, non-governmental and broader public communities. A multi-step approach was taken in the FramingNano project, which included a two-stage Delphi exercise and a multi-stakeholder workshop used to collect the opinions of stakeholders. Stakeholder opinions on regulation included opinions on the EC Code.

  18. Countries were distinguished between those with relevant activities in N&N (Type A countries such as France, Switzerland, the UK, the Netherlands, Germany, etc.) and those with a quantitatively lower level of activity in N&N (Type B countries such as Italy, Spain, Czech Republic, Argentina, South Africa, etc.)

  19. See http://www.framingnano.eu/index.php?option=com_content&task=view&id=163&Itemid=84

  20. The number of stakeholders is not provided.

  21. No additional information concerning who exactly these readers are or how many is provided.

  22. http://ec.europa.eu/research/consultations/pdf/nano-consultation_en.pdf

  23. The analysis paper of results from the Consultation does not offer a definition of what might comprise a ‘valid’ answer. However, the paper notes that ‘Many answers were substantiated [own emphasis] by (existing or ad hoc) high quality papers representing a significant amount of work’ (p.1).

  24. http://ec.europa.eu/research/consultations/nano-code/results_en.pdf

  25. The disadvantages of not taking up the Code were not set out either.

  26. The report points out that the innovation principle appears to be meant to primarily address Member States who are invited to ensure that innovation is pursued to the benefit of society and individuals.

  27. The number or percentage of survey participants is not provided.

  28. In addition, the CodeMeter provides context information about important elements of the guidelines, offers hints as to how to improve compliance and enables monitoring and documentation of compliance over time.

  29. A number of options were identified in the NanoCode consultation, ranging from weak forms of incentives to stronger enforcing and monitoring mechanisms (disincentives) and encompassing the following: a positive label of Code compliance, priority in public research funding, compliance for public research funding, a whitelist/blacklist, and turning the Code into a standard for quality control. Mandatory rules for the implementation of the Code suggested by FramingNano stakeholders included verification that the code is followed by industry stakeholders in the production process, mandatory legislation requiring industry to implement a code, and the use of the code in applications for EU proposals.

  30. Soft measures included the implementation of an internet homepage, as a forum for frequently asked questions and a platform for stakeholders to exchange experiences with the implementation of the Code and the organisation of regular meetings of different stakeholders to discuss various issues regarding the implementation of the Code.

  31. See http://www.nanopodium.nl/CieMDN/content/NanoCode_Country_Report_NL_Final.pdf

  32. See also DEEPEN report (Davies et al. [16]). Davies et al. argue that filling in what responsible development means in practice is made more difficult by a lack of consensus regarding the meaning of terms such as ‘responsibility’, ‘socially acceptable’; the same may be true for the specific responsibilities of the stakeholders.

  33. Of course it may be the case that it would be premature to have such teeth in such an instrument given the lack of certainty concerning risks that still persists.

  34. See: http://www.observatorynano.eu/project/filesystem/files/ObservatoryNano_Nanotechnologies_RegulationAndStandards_2012.pdf

References

  1. Ayres I, Braithwaite J (1992) Responsive regulation: Transcending the deregulation debate. Oxford University Press, Oxford

    Google Scholar 

  2. Baldwin R, Cave M, Lodge M (2012) Understanding regulation: theory, strategy, and practice, 2nd edn. Oxford University Press, Oxford, pp 125–137

  3. Black J (2001) Proceduralising regulation part II. Curr Leg Probl 54:103

    Article  Google Scholar 

  4. Black J (2002) Critical reflections on regulation. Aust J Leg Philos 27:1–46

    Google Scholar 

  5. Bowman DM, Hodge GA (2008) A big regulatory tool-box for a small technology. NanoEthics 2:193–207

    Article  Google Scholar 

  6. Bowman DM, Ludlow K (2009) Filling the information void: using public registries as a tool in nanotechnologies regulation. J Bioeth Inq 6:25–36

    Article  Google Scholar 

  7. Braithwaite J (2003) Meta risk management and responsive regulation for tax system integrity. Law Policy 26:1–16

    Article  Google Scholar 

  8. Cherney A, O’Reilly J, Grabosky P (2006) Networks and meta-regulation: strategies aimed at governing illicit synthetic drugs. Polic Soc 16:370–385

    Article  Google Scholar 

  9. Cherney A, O’Reilly J, Grabosky P (2006) The multilateralization of policing: the case of illicit synthetic drug control. Police Pract Res 7:177–194

    Article  Google Scholar 

  10. Choi J-Y, Ramachandran G, Kanlikar M (2009) The impact of toxicity testing costs on nanomaterial regulation. Environ Sci Technol 43:3030–3034

    Article  Google Scholar 

  11. Coglianese C, Lazer D (2003) Management-based regulation: prescribing private management to achieve public goals. Law Soc Rev 37:691–730

    Article  Google Scholar 

  12. Coglianese C, Nash J (2004) The Massachusetts Toxics Use Reduction Act: design and implementation of a management-based environmental regulation, Regulatory Policy Program Report RPP-07-2004. Center for Business and Government, John F. Kennedy School of Government, Harvard University, Cambridge, MA

    Google Scholar 

  13. Coglianese C (2010) Engaging business in the regulation of nanotechnology. In: Bosso C (ed) Governing uncertainty: Environmental regulation in the age of nanotechnology. Earthscan

  14. Coglianese C, Mendelson E (2010) Meta-regulation and self-regulation. In: Cave M, Baldwin R, Lodge M (eds) The Oxford Handbook of Regulation. Oxford University Press, New York, pp 146–168

    Google Scholar 

  15. Davies C (2009) Oversight of next generation nanotechnology. Washington DC: Project on emerging nanotechnologies. http://www.nanotechproject.org/process/assets/files/7316/pen-18.pdf. Accessed September 27 2012

  16. Davies SR, Macnaghten P, Kearnes M (2009) Reconfiguring responsibility: lessons for public policy (Part 1 of the report on Deepening Debate on Nanotechnology). Durham University, Durham

    Google Scholar 

  17. Dorbeck-Jung BR (2011) Soft regulation and responsible nanotechnological development in the European Union: regulating occupational safety in the Netherlands. Eur J Law Technol 2(3):1–14

    Google Scholar 

  18. European Commission (2004) Towards a European Strategy for Nanotechnology. Commission of the European Communities, Luxembourg

    Google Scholar 

  19. Commission E (2005) Nanosciences and Nanotechnologies: An Action Plan for Europe 2005–2009. European Commission, Brussels

    Google Scholar 

  20. Commission E (2007) Towards a code of conduct for responsible nanosciences and nanotechnologies research—consultation paper. European Commission, Brussels

    Google Scholar 

  21. Commission E (2008) Commission Recommendation of 07/02/2008 on a code of conduct for responsible nanosciences and nanotechnologies research. European Commission, Brussels

    Google Scholar 

  22. Ford CL (2010) Principles-based securities regulation in the wake of the global financial crisis. McGill Law J 55:257–310

    Google Scholar 

  23. Gilad S (2010) It runs in the family: meta-regulation and its siblings. Regul Gov 4:485–506

    Article  Google Scholar 

  24. Grobe A, Kreinberger N, Funda P (2011) NanoCode WP2 Synthesis Report on Stakeholder Consultations, March 2011

  25. Gunningham N (2007) Mine safety: Law regulation Policy. Federation Press, Sydney

    Google Scholar 

  26. Gunningham N, Grabosky P, Sinclair D (1998) Smart regulation: designing environmental policy. Oxford University Press, Oxford

  27. Haines F (2009) Regulatory failures and regulatory solutions: a characteristic analysis of the aftermath of disaster. Law Soc Inq 34:31–60

    Article  Google Scholar 

  28. Handy RD, Owen R, Valsami-Jones E (2008) The ecotoxicology of nanoparticles and nanomaterials: current status, knowledge gaps, challenges and future needs. Ecotoxicology 17:315–325

    Article  Google Scholar 

  29. Hutter BM (2001) Regulation and risk: occupational health and safety on the railways. Oxford University Press, Oxford

    Google Scholar 

  30. Hutter B (2006) Risk, regulation, and management. In: Taylor-Gooby P, Zinn J (eds) Risk in social science. Oxford University Press, New York, pp 202–227

    Google Scholar 

  31. Kearnes MB, Rip A (2009) The emerging governance landscape of nanotechnology. In: Gammel S, Losch S, Nordmann A (eds) Jenseits Von Regulierung: Zum Politischen Umgang Mit Der Nanotechnologie. Akademische Verlagsgesellschaft, Berlin, pp 97–121

    Google Scholar 

  32. Kjølberg KL, Strand R (2011) Conversations about responsible nanoresearch. NanoEthics 5:99–113

    Article  Google Scholar 

  33. Lee R, Jose PD (2008) Self-interest, self-restraint and corporate responsibility for nanotechnologies: emerging dilemmas for modern managers. Tech Anal Strateg Manag 20:113–125

    Article  Google Scholar 

  34. Levi-Faur D, Comaneshter H (2007) The risks of regulation and the regulation of risks: the governance of nanotechnology. In: Hodge G, Bowman D, Ludlow K (eds) New Global Regulatory Frontiers in Regulation: The Age of Nanotechnology. Edward Elgar, Cheltenham, pp 149–165

    Google Scholar 

  35. May PJ (2007) Regulatory regimes and accountability. Regul Gov 1:8–26

    Article  Google Scholar 

  36. Morgan B (2003) The economization of politics: meta-regulation as a form of nonjudicial legality. Soc Leg Stud 12:489–523

    Article  Google Scholar 

  37. Meili C, Widmer M, Schwarzkopf S, Mantovani E, Porcari A (2011) NanoCode MasterPlan: Issues and options on the path forward with the European Commission Code of Conduct on Responsible N&N Research. http://www.nanocode.eu/files/NanoCode-MasterPlan.pdf. Accessed 29 September 2012

  38. Pariotti E (2009) Regulating nanotechnologies: towards the interplay of hard and soft law. Notizie di Politeia 25(94):29–40

    Google Scholar 

  39. Parker C (2002) The open corporation: effective self-regulation and democracy. Cambridge University Press, New York

    Google Scholar 

  40. Parker C et al (2004) Introduction. In: Parker C et al (eds) Regulating law. Oxford University Press, New York, pp 1–12

    Chapter  Google Scholar 

  41. Parker C (2007) Meta-regulation: legal accountability for corporate social responsibility? In: McBarnet D, Voiculescu A and Campbell T (eds) The new corporate accountability: corporate social responsibility and the law. Cambridge University Press, Cambridge, pp 207–241

  42. Randles S (2008) From nano-ethicswash to real-time regulation. J Ind Ecol 12(3):270–274

    Article  Google Scholar 

  43. Renton A (2006) Welcome to the world of nanofoods. The Observer. http://observer.guardian.co.uk/foodmonthly/futureoffood/story/0,,1971266,00.html. Accessed 1 October 2012

  44. Rip A (2006) Folk theories of nanotechnologists. Sci Cult 15:349–365

    Article  Google Scholar 

  45. Scott C (2003) Speaking softly without big sticks: meta-regulation and public sector audit. Law Policy 25:203–219

    Article  Google Scholar 

  46. Scott C (2012) A meta-regulatory turn? Control and learning in regulatory governance. In: Muller S, Zouridis S, Frishman M, Kistemaker L (eds) The law of the future and the future of law, vol II. Torkel Opsahl Academic Publisher, The Hague, pp 61–72

    Google Scholar 

  47. Scott C (2012) Regulating everything: from mega- to meta-regulation. Law Policy 60:61–89

    Google Scholar 

  48. Selznick P (2002) The communitarian persuasion. Johns Hopkins University Press, Baltimore, MD

    Google Scholar 

  49. Shamir R (2008) The age of responsibilization: on market-embedded morality. Econ Soc 37:1–19

    Article  Google Scholar 

  50. Thomas T, Bahadori T, Savage N, Thomas K (2009) Moving towards exposure and risk evaluation of nanomaterials: challenges and future directions. WIREs Nanomedicine Nanobiotechnol 4:426–433

    Article  Google Scholar 

  51. Von Schombeg R (2007) From the ethics of technology to the ethics of knowledge assessment. In: Goujon P et al (eds) The information society: innovation, legitimacy, ethics and democracy. Springer, Boston, pp 39–55

  52. Von Schombeg R (2010) Organising collective responsibility: on precaution, codes of conduct and understanding public debate. In: Fiedeler U, Coenen C, Davies SR, Ferrari A (eds) Understanding nanotechnology: philosophy, policy and publics. Ios Press, Amsterdam, pp 61–70

    Google Scholar 

  53. Widmer M, Meili C, Mantovani E, Porcari A (2010) The FramingNano Governance Platform: A New Integrated Approach to the Responsible Development of Nanotechnologies, February 2010. http://www.framingnano.eu/index.php?option=com_content&task=view&id=161&Itemid=84. Accessed 26 September 2012

  54. Williams T (2007) Empowerment of whom and for what? Financial literacy education and the new regulation of consumer financial services. Law Policy 29(2):226–256

    Article  Google Scholar 

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Dorbeck-Jung, B., Shelley-Egan, C. Meta-Regulation and Nanotechnologies: The Challenge of Responsibilisation Within the European Commission’s Code of Conduct for Responsible Nanosciences and Nanotechnologies Research. Nanoethics 7, 55–68 (2013). https://doi.org/10.1007/s11569-013-0172-8

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