Analysis: Twenty-first century novel: Regulating nanotechnologies

Journal of Environmental Law

Volumn 21, Issue 3, 2009, Pages 469-482

  Lee, Robert ^a   Stokes, Elen ^a  

^a NONE

Author keywords

Chemical safety; Nanotechnology; Regulation; Risk

Indexed keywords

ENVIRONMENTAL LEGISLATION; ENVIRONMENTAL PROTECTION; NANOTECHNOLOGY; POLLUTION CONTROL; REGULATORY FRAMEWORK;

EURASIA; EUROPE; UNITED KINGDOM; WESTERN EUROPE;

EID: 70449466153     PISSN: 09528873     EISSN: 1464374X     Source Type: Journal    
DOI: 10.1093/jel/eqp028     Document Type: Review

References (64)

1. Royal Commission on Environmental Protection, 'Novel Materials in the Environment: The Case of Nanotechnology' (27th Report, RCEP, London 2008) 71: Hereafter RCEP.
2. Here, the term 'nanomaterials' is used to describe products and substances that have been deliberately engineered or enhanced using nanotechnologies. It excludes naturally occurring nanomaterials. Nanotechnologies involve the manufacture and manipulation of materials which have at least one dimension in the range 1-100 nm. A nanometre is one billionth of a metre. For more information, see British Standards Institute, Vocabulary - Nanoparticles, Publicly Available Specification 71 (BSI, London 2005).
3. RCEP 56.
4. Scott Kirsch, 'The Incredible Shrinking World? Technology and the Production of Space' (1995) 13 Environ Plan D: Soc Space 529-55.
5. Discussed below at n 39ff.
6. RCEP 62; Elen Stokes, 'Regulating Nanotechnologies: Sizing Up the Options' (2009) 29 LS 281-304.
7. RCEP 65.
8. Following the publication of the 'Better Regulation Task Force Report "Scientific Research: Innovation with Controls"' (BRTF, London 2003).
9. Also see HM Government, 'The Better Regulation Task Force Report "Scientific Research: Innovation with Controls": The Government's Response', May 2003 accessed 20 August 2009.
10. Royal Society and Royal Academy Of Engineering (RS/RAEng), Nanoscience and Nanotechnologies: Opportunities and Uncertainties (Royal Society, London 2004) 82.
11. Ibid 85.
12. Health and Safety Executive (HSE), Review of the Adequacy of Current Regulatory Regimes to Secure Effective Regulation of Nanoparticles Created by Nanotechnology (HSE, London 2006).
13. Central Science Laboratory, A Scoping Study to Identify Gaps in Environmental Regulation for the Products and Applications of Nanotechnologies (Defra, London 2006).
14. Food Standards Agency (FSA), A Review of Potential Implications of Nanotechnologies for Regulations and Risk Assessment in Relation to Food (FSA, London 2008). Note that although the report has a 2008 publication date, a draft version was presented to the FSA Board and available in 2006.
15. Lori Frater and others, An Overview of the Framework of Current Regulation Affecting the Development and Marketing of Nanomaterials - A Report for the DTI (OSI, London 2006).
16. HM Government, Response to the Royal Society and Royal Academy of Engineering Report: 'Nanoscience and Nanotechnologies: Opportunities and Uncertainties' (Department of Trade and Industry, London 2005).
17. HSE (n 11) 14.
18. FSA (n 13) 16.
19. Commission (EC), 'Regulatory Aspects of Nanomaterials' (Communication) COM (2008) 366 final, 17 June 2008, 3.
20. RCEP 60.
21. Council and Parliament Regulation (EC) 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC [2006] OJ L396/1.
22. Council Directive (EC) 67/548 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances [1967] OJ 196/1.
23. Much has been written on REACH but for analyses relating specifically to nanotechnologies, see Diana Bowman and Geert van Calster, 'Reflecting REACH Global Implications of the European Union's Chemicals Regulation' (2007) 4 Nanotechnol LB 375-84
24. Geert van Calster 'Regulating Nanotechnology in the European Union' (2006) EELR 238-47.
25. RCEP 62.
26. For detailed discussion, see RCEP Chapter 2, especially 13-17.
27. Ken Donaldson and others, 'Carbon Nanotubes: A Review of Their Properties in Relation to Pulmonary Toxicology and Workplace Safety' (2006) 92 Toxicol Sci 5-22.
28. Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) Modified Opinion (after Public Consultation) on the Appropriateness of Existing Methodologies to Assess the Potential Risks associated with Engineered and Adventitious Products of Nanotechnologies 10 March 2006, SCENIHR/002/05 accessed 2 June 2009) 55 [3.10.9].
29. RCEP 62.
30. Commission (EC), 'Nanomaterials in REACH' (Follow-Up to the Sixth Meeting of the REACH Competent Authorities, 16 December 2008, CA/59/2008 rev.1: accessed 14 August 2009).
31. RCEP 63.
32. Ibid 65, emphasis added.
33. Ibid 64-5.
34. Ibid 68-9.
35. Noah Sachs, 'Planning the Funeral at the Birth: Extended Producer Responsibility in the European Union and the United States' (2006) 30 Harv Envtl L Rev 51-98.
36. RCEP 68-9.
37. Ibid 69.
38. Stokes (n 6) 297.
39. RCEP 69.
40. See eg Which?, Nanotech - Small Scale, Big Questions (Which?, London, September 2007).
41. Parliament Resolution (EC) on Regulatory Aspects of Nanomaterials TA/ 2009/328 (24 April 2009). The Council has also approved a political agreement on a draft regulation concerning novel foods. See supporting documentation, e.g. Commission (EC), 'Proposal for a Regulation of the European Parliament and of the Counc il on Novel Foods' COM (2007) 872 final, 14 January 2008.
42. Council Directive (EEC) 76/768 on the approximation of the laws of the Member States relating to cosmetic products [1976] OJ L262/169.
43. Parliament Legislative Resolution (EC) on the Proposal for a Regulation of the European Parliament and of the Council on Cosmetic Products (Recast),TA/2009/158 (24 March 2009), Art 19.
44. RCEP 69. For important insights into factors which can amplify perceptions of risk, see Timur Kuran and Cass R Sunstein, 'Availability Cascades and Risk Regulation' (1999) 51 Stan L Rev 683-768.
45. 70
46. Jim Kling, 'Nanotech Under Scrutiny, But Tighter Regulation Remains Distant' (2007) 25 Nat Biotechnol 1068-9.
47. Micro & Nano Technology (MNT), 'Industrial Map of UK MNT 2006' accessed 15 June 2009. Estimates of the number of UK firms involved in nano-technologies are difficult to obtain, and those which are available vary quite considerably, not least because 'nano' can be interpreted differently. For more conservative estimates, see Rob J Aitken and others, 'Manufacture and Use of Nanomaterials: Current Status in the UK and Global Trends' (2006) 56 Occup Med 300-6.
48. RCEP 70; see concerns raised in 2007 by the Council for Science and Technology that 'we are concerned that the first quarterly report records that only three organisations have submitted data, particularly given the strong support for the scheme expressed to us by industry... Industry must actively participate in this scheme if it is to be a success and if the need for a compulsory scheme is to be avoided', see CST, Nanosciences and Nanotechnologies: A Review of the Government's Progress on its Policy Commitments (CST, London 2007) 38
49. also see comments in HM Government, 'Statement by the UK Government about Nanotechnologies' (28 February 2008, accessed 8 July 2009) 29.
50. RCEP 70.
51. Ibid.
52. Mandatory reporting schemes are under consideration elsewhere, in Canada and France for instance, see eg SafeNano, 'Mandatory Nanomaterial Declaration Proposed by French Government' accessed 19 August 2009
53. and 'Proposed Regulatory Framework for Nanomaterials under the Canadian Environmental Protection Act, 1999' accessed 4 August 2009.
54. RCEP 70.
55. RCEP 12.
56. Paula Gould, 'Nanomaterials Face Control Measures' (2006) 1 NanoToday 34-9, 36, quoting Peter Hatto, Chair of the ISO and BSI committees on nanotechnologies (ISO/TC 229 and BSI NTI/1, respectively).
57. Lisa Carson and Robert Lee, 'Consumer Sovereignty and the Regulatory History of the European Market for GM Foods' (2005) Env L Rev 173.
58. In fact it seems highly unlikely that the UK Government will proceed with mandatory reporting but instead will opt for a revised version of voluntary reporting scheme under the threat of mandatory reporting in the event of non-engagement with the voluntary system. This is in order to preserve a 'light touch' approach and to avoid additional regulatory burdens: HM Government, 'UK Government Response to the Royal Commission on Environmental Pollution (RCEP) Report "Novel Materials in the Environment: The Case of Nanotechnology" (Cm 7620, 2009).
59. See European Parliament (n 38) for a critique of the current regulatory approach: 'the concept of the "safe, responsible and integrated approach" to nanotechnologies advocated by the European Union is jeopardised by the lack of information on the use and on the safety of nanomaterials that are already on the market, particularly in sensitive applications with direct exposure of consumers' [AA 4].
60. See n 52 above.
61. RCEP 68.
62. Ibid 69.
63. Ibid 70.
64. HM Government Response (n 52). The Department for Business, Innovation & Skills has recently launched a consultation on the UK's nano strategy, see http://interactive.bis.gov.uk/nano/.