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A Big Regulatory Tool-Box for a Small Technology

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Abstract

There is little doubt that the development and commercialisation of nanotechnologies is challenging traditional state-based regulatory regimes. Yet governments currently appear to be taking a non-interventionist approach to directly regulating this emerging technology. This paper argues that a large regulatory toolbox is available for governing this small technology and that as nanotechnologies evolve, many regulatory advances are likely to occur outside of government. It notes the scientific uncertainties facing us as we contemplate nanotechnology regulatory matters and then examines the notion of regulation itself, suggesting new ways to frame our understanding of both regulation and the regulatory tools relevant to nanotechnologies. By drawing upon three different conceptual lenses of regulation, the paper articulates a wide range of potential regulatory tools at hand. It also focuses particularly on the ways various tools are currently being used or perhaps may be employed in the future. The strengths and weaknesses characterising these tools is examined as well as the different actors involved. The paper concludes that we will increasingly face debate over what is likely to work most effectively in regulating nano technologies, the legitimacy of these different potential approaches, and the speed at which these different regimes may be employed.

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Notes

  1. See also van Calster [107], in which the author refers to an in-house review by the European Commission on the suitability of existing regulatory frameworks within the EU for nanotechnology. This report was made public in June 2008.

  2. There are many ways of viewing regulation. The three lenses adopted in this paper [5, 37, 68], could be supplemented by several other lenses. These include for example Baldwin and Cave [6] (who defined eight regulatory strategies: command and control, self regulation, incentives, market harnessing controls such as competition laws, franchising, contracting and tradeable permits, disclosure, direct action, rights and liabilities laws, and public compensation and social insurance); and Morgan and Yeung [71] who suggested six regulatory tools: command (legal rules), competition (economic instruments), consensus (cooperation, contracts, partnerships and self regulation), communication (social norms, disclosure, advertising), code (architecture, techno regulation), and hybridisation (such as responsive regulation). Another common regulatory lens often applied is the distinction between the regimes of command and control, self regulation, enforced self regulation, co-regulation, market-based controls and disclosure regimes.

  3. Whilst the original use by Hood [51] of this ‘regulation inside government’ category seemed to strictly refer to internal regulatory mechanisms, the use in the current paper of this category has been broadened to include all activities undertaken through government which aim to shape behaviour towards broadly identified outcomes.

  4. See for instance, EPA Grant Number: R832527-Chemical Fate, Biopersistance, and Toxicology of Inhaled Metal Oxide Nanoscale Materials (http://cfpub.epa.gov/ncer_abstracts/index.cfm/fuseaction/display.abstractDetail/abstract/7855/report/0), EPA Grant Number: R832842-Acute and Developmental Toxicity of Metal Oxide Nanoparticles to Fish and Frogs (http://cfpub.epa.gov/ncer_abstracts/index.cfm/fuseaction/display.abstractDetail/abstract/7897/report/0), EPA Grant Number: R832635-Assessment of the Environmental Impacts of Nanotechnology on Organisms and Ecosystems (http://cfpub.epa.gov/ncer_abstracts/index.cfm/fuseaction/display.abstractDetail/abstract/7915/report/0)

  5. See NSF Award Number: 0436366-Reverse Engineering Cellular Pathways from Human Cells Exposed to Nanomaterials-Development of Novel Risk Assessment Methods (http://www.nsf.gov/awardsearch/showAward.do?AwardNumber=0436366), EPA Grant Number: R830910- Implications of Nanomaterials Manufacture and Use: Development of a Methodology for Screening Sustainability (http://cfpub.epa.gov/ncer_abstracts/index.cfm/fuseaction/display.abstractDetail/abstract/6156/report/0), and EPA Grant Number: R8333327-Title: Methodology Development for Manufactured Nanomaterial Bioaccumulation Test ( http://cfpub.epa.gov/ncer_abstracts/index.cfm/fuseaction/display.abstractDetail/abstract/8405 )

References

  1. Aalders M, Wilthagen T (1997) Moving beyond command-and-control: reflexivity in the regulation of occupational safety and health and the environment. Law Policy 19(4):415–443

    Article  Google Scholar 

  2. Aitken R, Creely K, Tran C (2004) Nanoparticles: an occupational hygiene review. Institute of Occupational Medicine for the Health and Safety Executive, Edinburgh

    Google Scholar 

  3. Anderson EL, Hattis D (1999) When and how can you specify a probability distribution when you don’t have much. Risk Anal 19(1):47–68

    Google Scholar 

  4. Australian Greens Party NSW (2007) Press release: nanotech the new asbestos, greens call for moratorium. The Greens, Sydney

    Google Scholar 

  5. Ayres I, Braithwaite J (1992) Responsive regulation: transcending the deregulation debate. Oxford University Press, New York

    Google Scholar 

  6. Baldwin R, Cave M (1999) Understanding regulation: theory, strategy and practice. Oxford University Press, Oxford

    Google Scholar 

  7. BASF (2004) Code of conduct for nanotechnology. BASF, Ludwigshafen

    Google Scholar 

  8. Berkeley City Council (2006) Agenda-Berkeley City Council Meeting, 5 December. Berkeley City Council, Berkeley

    Google Scholar 

  9. Birch S (2004) Mercedes makes a scratch hit. Automot Eng, February, 108–109

  10. Black J (2002) Critical reflections on regulation. Aust J Leg Philos 27:1–36

    Google Scholar 

  11. Bowman D, Hodge G (2007) A small matter of regulation: an international review of nanotechnology regulation. Columbia Sci Technol Law Rev 8:1–36

    Google Scholar 

  12. Bowman D, Hodge G (2007) Nanotechnology and public interest dialogue: some comparative observations. Bull Sci Technol Soc 27(2):118–132

    Article  Google Scholar 

  13. Bowman D, Hodge G (2008) ‘Governing’ nanotechnology without government? Sci Public Policy, August

  14. Braithwaite, J (1982) Enforced self-regulation: a new strategy for corporate crime control. Michigan Law Review 80(7):1466–1507

    Article  Google Scholar 

  15. Braithwaite J (1993) Responsive regulation for Australia. Business regulation and Australia’s future. In P. N. Grabosky and J. Braithwaite. Canberra, Australian Institute of Criminology, pp 81–96

  16. Chaudhry Q et al (2006) Final report: a scoping study to identify gaps in environmental regulation for the products and applications of nanotechnologies. Defra, London

    Google Scholar 

  17. Civil Society-Labor Coalition (2007) An open letter to the international nanotechnology community at large-Civil Society-Labor Coalition rejects fundamentally flawed DuPont-ED proposed framework, urges all parties to reject the public relations campaign. CSLC, Washington, DC

    Google Scholar 

  18. Cobb MD, Macoubrie J (2004) Public perceptions about nanotechnology: risks, benefits and trust. J Nanopart Res 6(4):395–405

    Article  Google Scholar 

  19. Commonwealth Scientific and Industrial Research Organisation (2003) Media release-nanohouse brings nanotechnology home. CSIRO and University of Technology Sydney, Sydney

    Google Scholar 

  20. ‘Consumer Coalition’ (2007) Principles for the oversight of nanotechnologies and nanomaterials. A broad coalition of civil society, public interest, environmental and labor organizations. Washington, DC

  21. Davies JC (2006) Managing the effects of nanotechnology. Woodrow Wilson Project on Emerging Nanotechnologies, Washington, DC

    Google Scholar 

  22. Davies JC (2007) EPA and nanotechnology: oversight for the 21st Century. Woodrow Wilson Project on Emerging Nanotechnologies, Washington, DC

    Google Scholar 

  23. Department of Industry and Resources, Western Australian Government (2004) News: invisible zinc cream has arrived. http://www.innovation.wa.gov.au/Innovation/News/2004/02/invisiblezincW. Cited 21 October 2007

  24. Department of Industry Tourism and Resources (2006) Request for tender–requirement: review of possible impacts of nanotechnology on Australia’s regulatory framework. Australian Government, Canberra

    Google Scholar 

  25. Donaldson K et al (2004) Nanotoxicology. Occup Environ Med 61:727–728

    Article  Google Scholar 

  26. Dreher KL (2004) Toxicological highlight: health and environmental impact of nanotechnology: toxicological assessment of manufactured nanoparticles. Toxicol Sci 77(1):3–5

    Article  Google Scholar 

  27. Drexler K, Peterson C, Pergamit G (2003) Unbounding the future: the nanotechnology revolution. Quill Books, New York

    Google Scholar 

  28. Environmental Defense and DuPont (2007) Nano risk framework. Environmental Defense, New York

    Google Scholar 

  29. ETC Group (2002) No small matter! Nanotech particles penetrate living cells and accumulate in animal organs-communiqué Issue # 76. ETC Group, Ottawa

    Google Scholar 

  30. ETC Group (2003) No small matter II: the case for a global moratorium size matters!. ETC Group, Ottawa

    Google Scholar 

  31. ETC Group (2004) Nanotech news in living colour: an update on white papers, red flags, green goo, grey goo (and red herrings)-Communiqué Issue # 85. ETC Group, Ottawa

    Google Scholar 

  32. European Commission (ed) (2004) Nanotechnologies: a preliminary risk analysis on the basis of a workshop organized in Brussels on 1–2 March 2004 by the Health and Consumer Protection Directorate General of the European Commission (mapping out nano risks). European Commission, Brussels

  33. European Commission (2006) EU nanotechnology research: safety keeping pace with innovation. European Commission, Brussels

    Google Scholar 

  34. European Commission (2008) European Commission adopts code of conduct for responsible nanosciences and nanotechnologies research. European Commission, Brussels

    Google Scholar 

  35. Federal Ministry of Education and Research (2006) nanoTruck–Project. http://www.nanotruck.net/en/frameset_aktuell.htm. Cited 31 August 2007

  36. Feynman R (1959, December) There’s plenty of room at the bottom. California Institute of Technology, California

    Google Scholar 

  37. Freiberg A (2006) The tools of government. Paper presented to the Australasian Compliance Institute, Melbourne, April

  38. Freidrichs (2007) Risk classification made easy: the NanoSUREä control banding scheme. Presentation to the Nano-EXPO Conference & Exhibition, Nottingham, May

  39. Friends of the Earth (2006) Nanomaterials, sunscreens and cosmetics: small ingredients, big risks. Friends of the Earth Australia and Friends of the Earth United States, Sydney

    Google Scholar 

  40. Friends of the Earth (2008) Nanotechnology in food and agriculture. Friends of the Earth Australia, Melbourne

    Google Scholar 

  41. Food and Drug Administration (2007) Nanotechnology-a report of the U.S. food and drug administration nanotechnology task force. FDA, Washington DC

    Google Scholar 

  42. Fuhr M et al (2006) Legal appraisal of nanotechnology: existing legal frameworks, the need for regulation and regulative options at a European and national level. Society for Institutional Analysis, Darmstadt

    Google Scholar 

  43. Gaskell G et al (2006) Europeans and biotechnology in 2005: patterns and trends. 2006, a report to the European Commission’s Directorate-General for Research. European Commission, London

    Google Scholar 

  44. Gilardi F, Jordana J, Levi-Faur D (2006) Regulation in the age of globalization: the diffusion of regulatory agencies across Europe and Latin America. In Graeme Hodge (ed), Privatization and Market Development: Global Movements in Public Policy Ideas. Cheltenham, Edward Elgar, pp.127–147

  45. Gunningham N, Rees J (1997) Industry self-regulation: an institutional perspective. Law Policy 19(4):363–414

    Article  Google Scholar 

  46. Health and Safety Executive (2006) Review of the adequacy of current regulatory regimes to secure effective regulation of nanoparticles created by nanotechnology: the regulations covered by HSE. HSE, London

    Google Scholar 

  47. Hepeng J (2005) Chinese government increases funding for nanotechnology. China Daily, Beijing. http://www.nanochina.cn/english/index.php?option=content&task=view&id=475&Itemid=183. Cited 26 August2007

  48. Hodge GA (2007) The regulation of urban services in OECD countries: an overview of water, waste management and public transport. Presentation to the OECD Group on Regulatory Policy, Paris

  49. Hodge G, Bowman D, Ludlow K (2007) Introduction: big question for small technologies. In: Hodge G, Bowman D, Ludlow K (eds) New global regulatory frontiers in regulation: the age of nanotechnology. Edward Elgar, Cheltenham, pp 3–26

    Google Scholar 

  50. Hoet PH, Bruske-Hohlfeld I, Salata O (2004) Review: nanoparticles – known and unknown health effects. Journal of Nanobiotechnology 2(12):1–15

    Google Scholar 

  51. Hood C (1999) Regulation inside government: waste-watchers, quality police, and sleaze-busters. Oxford University Press, Oxford

    Google Scholar 

  52. International Centre for Technology Assessment (2006) Citizen petition to the United States food and drug administration. CTA, Washington, DC

    Google Scholar 

  53. Jasanoff S (2005) Designs on nature: science and democracy in Europe and the United States. Princeton, Princeton University Press

    Google Scholar 

  54. Kandlikar M et al (2007) Health risk assessment for nanoparticles: a case for using expert judgement. J Nanopart Res 9:137–156

    Article  Google Scholar 

  55. Kimbrell GA (2006) Nanomaterial consumer products and FDA regulation: regulatory challenges and necessary amendments. Nanotechnol Law Bus 3(3):329–338

    Google Scholar 

  56. Lam C-W et al (2004) Pulmonary toxicity of single-wall carbon nanotubes in mice 7 and 90 days after intratracheal instillation. Toxicol Sci 77:126–134

    Article  Google Scholar 

  57. Little G (2004) BSE and the regulation of risk. Mod Law Rev 64(5):730–756

    Article  Google Scholar 

  58. Ludlow K (2007) One size fits all? Australian regulation of nanoparticle exposure in the workplace. J Legal Issues Med 15:136–152

    Google Scholar 

  59. Lux Research Inc (2005) Nanotechnology: where does the US stand. Lux Research, New York

    Google Scholar 

  60. Lux Research Inc (2006) The nanotech report, 4th edn. Lux Research, New York

    Google Scholar 

  61. Market Attitudes Research Services (2004) Short report: Australian community opinion towards nanotechnology and the commercialisation of scientific research. Report commissioned by the Department of Industry, Tourism and Resources, Canberra

  62. Maynard AD (2006) Nanotechnology: a research strategy for addressing risk. Woodrow Wilson Project on Emerging Technologies, Washington, DC

    Google Scholar 

  63. Maynard AD (2007) Nanotechnology: the next big thing, or much ado about nothing. Annu Occup Hyg 51(1):1–12

    Article  Google Scholar 

  64. Maynard AD, Kuempel ED (2005) Airborne nanostructured particles and occupational health. J Nanopart Res 7:587–614

    Article  Google Scholar 

  65. Medina C et al (2007) Review: nanoparticles: pharamcological and toxicological significance. Br J Pharmacol 150:552–558

    Article  Google Scholar 

  66. Mee W et al (2004) Nanotechnology: the Bendigo workshop. CSIRO Minerals, Melbourne

    Google Scholar 

  67. Miles J (2007) Metrology and standards for nanotechnology. In: Hodge G, Bowman D, Ludlow K (eds) New global regulatory frontiers in regulation: the age of nanotechnology. Edward Elgar, Cheltenham, pp 333–352

    Google Scholar 

  68. Minogue M (2006) Apples and oranges: comparing international experiences in regulatory reform. In: Minogue M, Carinov L (eds) Regulatory governance in developing countries. Edward Elgar, Cheltenham, pp 61–81

    Google Scholar 

  69. Monica JC, Heintz ME, Lewis PT (2007) The perils of pre-emptive regulation. Nature Nanotechnol 2:68–70

    Article  Google Scholar 

  70. Moran A (1995) Tools of environmental policy: market instruments versus command-and-control. In: Eckersley R (ed) Markets, the state and the environment: towards integration. Macmillan Education, South Melbourne

    Google Scholar 

  71. Morgan B, Yeung K (2007) An Introduction to law and regulation: text and materials. Cambridge University Press, Cambridge

    Google Scholar 

  72. Nanowerk News (2007) European Union increases research efforts on nanotechnology risks. http://www.nanowerk.com/news/newsid=1450.php. Cited 30 August 2007

  73. National Nanotechnology Initiative (2007) NNI-Funding. 2007. http://www.nano.gov/html/about/funding.html. Cited 26 August 2007

  74. Nel A et al (2006) Toxic potential of materials at the nanolevel. Science 311:622–627

    Article  Google Scholar 

  75. Oberdörster G et al (2005) Review: principles for characterizing the potential human health effects from exposure to nanomaterials: elements of a screening strategy. Part Fibre Toxicol 2(8):1–35

    Google Scholar 

  76. Oberdörster G, Oberdörster E, Oberdörster J (2005) Nanotoxicology: an emerging discipline evolving from studies of ultrafine particles. Environ Health Perspect 113(7):823–839

    Article  Google Scholar 

  77. Oberdorster G, Stone V, Donaldson K (2007) Toxicology of nanoparticles: a historical perspective. Nanotoxicology 1(1):2–25

    Article  Google Scholar 

  78. Powell MC, Kanarek MS (2006) Nanomaterial health effects-part 1: background and current knowledge. Wisc Med J 105(2):16–20

    Google Scholar 

  79. Powell MC, Kanarek MS (2006) Nanomaterial health effects-part 2: uncertainties and recommendations for the future. Wisc Med J 105(3):18–23

    Google Scholar 

  80. Ratner MA, Ratner D (2003) Nanotechnology: a gentle introduction to the next big idea. Prentice Hall, New York

    Google Scholar 

  81. Renn O, Roco MC (2006) Nanotechnology and the need for risk governance. J Nanopart Res 8:153–191

    Article  Google Scholar 

  82. Responsible Nano Code (2007) Responsible Nanotechnologies Code consultation draft – 17 September 2007. Responsible Nano Code, London

    Google Scholar 

  83. Roco MC (2005) International perspectives on government nanotechnology funding in 2005. J Nanopart Res 7:707–712

    Article  Google Scholar 

  84. Roco MC, Bainbridge WS (eds) (2001) Societal Implications of nanoscience and nanotechnology. Springer, New York

  85. Royal Society, Insight Investment and Nanotechnology Industries Assocation (2007) Responsible Nanotechnologies Code consultation draft – 17 September 2007. Founding Partners, London

    Google Scholar 

  86. Royal Society and Royal Academy of Engineering (2004) Nanoscience and nanotechnologies: opportunities and uncertainties. RS-RAE, London

    Google Scholar 

  87. Scientific Committee on Emerging and Newly Identified Health Risks (2006) Opinion on the appropriateness of existing methodologies to assess the potential risks associated with engineered and adventitious products of nanotechnologies. European Commission, Brussels

    Google Scholar 

  88. Seaton A et al (1995) Particulate air pollution and acute health effects. Lancet 345:176–178

    Article  Google Scholar 

  89. Sheetz T et al (2005) Nanotechnology: awareness and societal concerns. Technol Soc 27:329–345

    Article  Google Scholar 

  90. Sinclair D (1997) Self-regulation versus command and control? Beyond false dichotomies. Law Policy 19(4):529–559

    Article  Google Scholar 

  91. Smallman M, Nieman A (2006) Small talk-discussing nanotechnologies. Small Talk, London

    Google Scholar 

  92. Soil Association (2008) Soil Association first organisation in the world to ban nanoparticles-potentially toxic beauty products that get right under your skin. http://www.soilassociation.org/web/sa/saweb.nsf/89d058cc4dbeb16d80256a73005a2866/42308d944a3088a6802573d100351790!OpenDocument. Cited 29 February 2008

  93. Sparrow M (2000) The regulatory craft: controlling risks, solving problems, and managing compliance. The Brookings Institution, Washington, DC

    Google Scholar 

  94. Stuart C (2005) Making labor safety a priority and a profit. Small Times, November/December, 32–33

  95. Su TT (2006) Taiwan NanoMark System Initiative and EHS Programs. Presentation to the Asian Workshop on International Collaboration on Nanotechnology Environmental Health & Safety, Tokyo

  96. Sweet L, Strohm B (2006) Nanotechnology-life-cycle risk management. Hum Ecol Risk Assess 12(3):528–551

    Article  Google Scholar 

  97. Swiss Federal Office for the Environment and Swiss Federal Office of Public Health (2007) Risk assessment and-management of engineered nanoparticles. Federal Office for the Environment, Bern

    Google Scholar 

  98. Swiss Re (2004) Nanotechnology: small matter, many unknowns. Swiss Re, Geneva

    Google Scholar 

  99. Taylor MR (2006) Regulating the products of nanotechnology: does FDA have the tools it needs. Woodrow Wilson Project on Emerging Nanotechnologies, Washington, DC

    Google Scholar 

  100. Teeguarden JG et al (2007) Particokinetics in vitro: dosimetry considerations for in vitro nanoparticle toxicity assessments. Toxicol Sci 95(2):300–312

    Article  Google Scholar 

  101. Thomas K, Sayre P (2005) Research strategies for safety evaluation of nanomaterials, part I: evaluating the human health implications of exposure to nanoscale materials. Toxicol Sci 87(2):316–321

    Article  Google Scholar 

  102. Thomas J (2006) An introduction to nanotechnology: the next small big thing. Development 49(4):39–46

    Article  Google Scholar 

  103. Tolstoshev A (2006) Nanotechnology: assessing the environmental risks for Australia. Earth Policy Centre, Melbourne

    Google Scholar 

  104. Tran CL et al (2000) Inhalation of poorly soluble particles. II. Influence of particle surface area of on inflammation and clearance. Inhal Toxicol 12(12):1113–1126

    Article  Google Scholar 

  105. Uldrich J, Newberry D (2003) The next big thing is really small: how nanotechnology will change the future of your business. Random House, New York

    Google Scholar 

  106. Utting P (2005) Rethinking business regulation-from self-regulation to social control. United Nations Research Institute for Social Development, Geneva

    Google Scholar 

  107. van Calster G (2006) Governance structures for nanotechnology regulation in the European Union. Eur Law Repor 36:10953–10957

    Google Scholar 

  108. Vogel D (2006) The private regulation of global corporate conduct, in centre for responsible business working paper series. Department of Political Science, University of California, Berkeley, Berkeley, CA

    Google Scholar 

  109. Wardak A (2003) Nanotechnology & regulation: a case study using the Toxic Substance Control Act (TSCA). Foresight Institute and Woodrow Wilson Project on Emerging Nanotechnologies, Washington, DC

    Google Scholar 

  110. Warheit DB et al (2003) Comparative pulmonary toxicity assessment of single wall carbon nanotubes in rates. Toxicol Sci 77:117–125

    Article  Google Scholar 

  111. Webb K, Morrison A (1996) The legal aspects of voluntary codes. Exploring voluntary codes in the marketplace symposium, Ottawa

  112. Weisner MR et al (2006) Assessing the risks of manufactured nanomaterials. Environ Sci Technol 15:4337–4345

    Google Scholar 

  113. Woodrow Wilson Project on Emerging Nanotechnologies (2006) Report findings based on a national survey of adults. Woodrow Wilson International Centre for Scholars Project on Emerging Nanotechnologies, Washington, DC

    Google Scholar 

  114. Woodrow Wilson Project on Emerging Nanotechnologies (2007) A Nanotechnology consumer product inventory. http://www.nanotechproject.org/index.php?id=44&action=view. Cited 13 September 2007

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  1. Monash Centre for Regulatory Studies, Faculty of Law, Monash University, Wellington Road, Clayton, Victoria, 3800, Australia

    Diana M. Bowman & Graeme A. Hodge

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Bowman, D.M., Hodge, G.A. A Big Regulatory Tool-Box for a Small Technology. Nanoethics 2, 193–207 (2008). https://doi.org/10.1007/s11569-008-0038-7

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