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Looking Back to the Future of Regulating New Technologies: The Cases of Nanotechnologies and Synthetic Biology

Published online by Cambridge University Press:  20 January 2017

Elen Stokes  and
Diana M. Bowman
Elen Stokes
Affiliation:
Cardiff Law School, ESRC Research Centre for Business Relationships, Accountability, Sustainability and Society (BRASS), Cardiff University. Email:
Diana M. Bowman
Affiliation:
Risk Science CentreandDepartment of Health Management and Policy, School of Public Health, The University of Michigan and Faculty of Management and Governance, University of Twente. Email:
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Abstract

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Type
Reports
Information
European Journal of Risk Regulation , Volume 3 , Issue 2 , June 2012 , pp. 235 - 241
Copyright
Copyright © Cambridge University Press 2012

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References

2 For further detail, see Stokes, Elen, “Nanotechnology and the Products of Inherited Regulation”, 39(1) Journal of Law & Society (2012), pp. 92–112 CrossRefGoogle Scholar.

3 Ibid.

4 For instance, consumer products containing nanomaterials have been described as “virtually unregulated”, see European Parliament Debate No. 4, Thursday, 28 September 2006, MEP Hiltrud Breyer.

5 See, for example, Davies, Clarence J., Managing the Effects of Nanotechnology (Washington, DC: Project on Emerging Nanotechnologies, 2006)Google Scholar; Taylor, Mike, Regulating the Products of Nanotechnology: Does FDA Have the Tools It Needs? (Washington, DC: Project on Emerging Nanotechnologies, 2006)Google Scholar; Frater, Lori, Stokes, Elen, Lee, Robert, Oriola, Taiwo, An Overview of the Framework of Current Regulation affecting the Development and Marketing of Nanomaterials: A Report for the DTI (London: DTI, 2006)Google Scholar; Ludlow, Karinne, Bowman, Diana M. and Hodge, Graeme A., A Review of the Possible Impacts of Nanotechnology on Australia's Regulatory Framework (Melbourne: Monash University, 2007)Google Scholar; and European Commission, Regulatory Aspects of Nanomaterials (Brussels: European Commission, 2008)Google ScholarPubMed.

6 NICNAS, Guidance on new chemical requirements for notification of industrial nanomaterials (Canberra: Australian Government, 2010)Google Scholar.

7 European Commission, Regulatory Aspects of Nanomaterials, supra note 5.

8 Frater, Stokes, Lee and Oriola, An Overview of the Framework of Current Regulation affecting the Development and Marketing of Nanomaterials, supra note 5; Council for Science and Technology, Nanosciences and Nanotechnologies: A Review of Government’s Progress on its Policy Commitments (CST: London, 2007)Google Scholar; Royal Commission on Environmental Pollution, Novel Materials in the Environment: The Case of Nanotechnology, Cm 7468 (London: RCEP, 2008)Google Scholar; Stokes, Elen, “Regulating Nanotechnology: Sizing Up the Options”, 29(2) Legal Studies (2009), pp. 281–304 CrossRefGoogle Scholar; Lee, Robert G. and Vaughan, Steven, “REACHing Down: Nanomaterials and Chemical Safety in the European Union”, 2(2) Law, Innovation and Technology (2010), pp. 193–217 CrossRefGoogle Scholar.

9 Bowman, Diana, van Calster, Geert and Friedrichs, Steffi, “Nanomaterials and Regulation of Cosmetics”, 5(2) Nature Nanotechnology (2010), p. 92 et sqq CrossRefGoogle ScholarPubMed.

10 Stokes, “Nanotechnology and the Products of Inherited Regulation”, supra note 2.

11 Meili, Christoph and Widmer, Markus, “Voluntary Measures in Nanotechnology Risk Governance: The Difficulty of Holding the Wolf by the Ears”, in Hodge, Graeme A., Bowman, Diana M. and Maynard, Andrew D. (eds.), International Handbook on Regulating Nanotechnologies (Cheltenham: Edward Elgar, 2010), pp. 446–461 Google Scholar.

12 John Miles, “Nanotechnology Captured”, in Hodge, Bowman and Maynard (eds.), International Handbook on Regulation Nanotechnologies, supra note 13, pp. 83–106.

13 European Commission, “Recommendation on the Definition of Nanomaterial”, 2011/696/EU, 2011 OJ L275/38.

14 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on Cosmetic Products 2009 OJ L342/59.

15 European Commission, “Recommendation on the Definition of Nanomaterial”, supra note 13.

16 Bowman, van Calster and Friedrichs, “Nanomaterials and Regulation of Cosmetics”, supra note 9.

17 Council Statement on Proposal for a Regulation of the European Parliament and of the Council on Cosmetic Products (recast) 17 November 2009 12682/09 ADD1 REV1, page 2: statement by the Federal Republic of Germany: “it cannot in Germany's view be excluded that the general mention on labels of nano-scale materials in cosmetic products using the term ‘nano’ might be misunderstood by consumers as a warning”.

18 Even if information disclosure and transparency initiatives can in fact be much more complex and burdensome than polices portray. For illustration see Fisher, Elizabeth, “Transparency and Administrative Law: A Critical Evaluation”, 63(1) Current Legal Problems (2010), pp. 272–314 CrossRefGoogle Scholar; Jasanoff, Sheila, “Transparency in Public Science: Purposes, Reasons, Limits”, 69 Law and Contemporary Problems (2006), pp. 21–45.Google Scholar

19 Stokes, Elen, “You Are What You Eat: Market Citizens and the Right to Know About Nano Foods”, 2(2) Journal of Human Rights and the Environment (2011), pp. 178–200 CrossRefGoogle Scholar.

20 Miller, Georgia and Scrinis, Gyorgy, “The Role of NGO in Governing Nanotechnologies: Challenging the ‘Benefits Versus Risks’ Framing of Nanotech Innovation”, in Hodge, , Bowman, and Maynard, (eds.), International Handbook on Regulating Nanotechnologies, supra note 13, pp. 409–445 Google Scholar.

21 Presidential Commission for the Study of Bioethical Issue, New Directions: The Ethics of Synthetic Biology and Emerging Technologies (Washington, DC: PCSBI, 2010), at p. 2 Google Scholar.

22 Serrano, Luis, “Synthetic Biology: Promises and Challenges”, 3 Molecular Systems Biology (2008), p. 158 et sqq.Google ScholarPubMed; Calvert, Jane and Martin, Paul, “The Role of Social Scientists in Synthetic Biology”, 10 Science & Society Series on Convergence Research, EMBO reports (2009), pp. 201–204 Google ScholarPubMed; Caruso, Denise, Synthetic Biology: An Overview and Recommendations for Anticipating and Addressing Emerging Risks (Washington, DC: Center for American Progress, 2008)Google Scholar.

23 For further detail, see Gibson, Daniel G., Glass, John I., Lartiguue, Carole, et al. “Creation of a Bacterial Cell Controlled by a Chemically Synthesized Genome”, 329 Science (2010), pp. 52–56 CrossRefGoogle ScholarPubMed; Editorial, “Synthetic Cell Created in a Laboratory”, 375(5) The Lancet (2010), at p. 1940; Pennisi, Elizabeth, “Synthetic Genome Brings New Life to Bacterium”, 328 Science (2010), pp. 958–959 CrossRefGoogle Scholar.

24 Letter from President Barack Obama to Dr. Amy Gutmann, Chair, Presidential Commission for the Study of Bioethical Issues, 20 May 2010, available on the Internet at <http://bioethics.gov/documents/Letter-from-President-Obama-05.20.10.pdf> (last accessed on 15 April 2012); see also Bhattacharjee, Yudhijit, “U.S. Panel Weighs Guidelines for Synthetic Biology”, 329 Science (2010), pp. 264–265 CrossRefGoogle Scholar.

25 OECD/Royal Society, Symposium on Opportunities and Challenges in the Emerging Field of Synthetic Biology: A Synthesis Report (OECD, Royal Society, 2010) at page 32.

26 Royal Academy of Engineering (RAEng), Synthetic Biology: Scope, Applications and Implications (London: RAEng, 2009) at page 48Google Scholar.

27 Lloyd’s, Synthetic Biology: Influencing Development (London: Lloyd’s, 2009), at page 4.

28 Samuel, Gabrielle N., Selgelid, Michael J. and Kerridge, Ian, “Managing the Unimaginable: Regulatory Reponses to the Challenges Posed by Synthetic Biology and Synthetic Genomics”, 19(1) European Molecular Biology Organization Reports (2009), pp. 7–11 Google Scholar.

29 Bhutkar, Arjun, “Synthetic Biology: Navigating the Challenges Ahead”, 8(2) Journal of Biolaw & Business (2005), pp. 19–29 Google ScholarPubMed.

30 OECD/Royal Society, Symposium on Opportunities and Challenges in the Emerging Field of Synthetic Biology, supra note 25, at page 33.

31 RAEng, Synthetic Biology, supra note 26, at page 43.

32 OECD/Royal Society, Symposium on Opportunities and Challenges in the Emerging Field of Synthetic Biology, supra note 25, at page 32.

33 RAEng, Synthetic Biology, supra note 26, at page 44.

34 For detailed discussion on the regulatory framework applicable to nanotechnologies and its capacity to address ethical concerns, see Lee, Maria, “Risk and Beyond: EU Regulation of Nanotechnology”, 35(6) European Law Review (2010), pp. 799–821 Google Scholar.

35 RAEng, Synthetic Biology, supra note 26, at page 45.

36 Stokes, “Nanotechnology and the Products of Inherited Regulation”, supra note 2.

37 Bowman, Diana M., “Governing Nanotechnologies: Weaving New Regulatory Webs or Patching Up the Old?”, 2(2) NanoEthics (2008), pp. 179–182 CrossRefGoogle Scholar.