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Governance by Disclosure: Transnational Convergence in the Field of Nanotechnology†

Published online by Cambridge University Press:  27 March 2013

Reut Snir
Reut Snir*
Affiliation:
Faculty of Law, Bar Ilan University, Ramat Gan (Israel). Email: [email protected].
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Abstract

‘Nanotechnology’, the manipulation of matter on an atomic and molecular scale, is projected to profoundly alter manufacturing systems globally. However, along with the promise that these new technologies hold, there are concerns about the possibility of unknown latent risks to human health or the environment. Under current scientific uncertainties, regulators explore new strategies for overseeing the development and safe use of nanotechnologies. Information disclosure plays a prominent role among these strategies. Thus far, however, the informational strategies actually employed by governments have focused on means by which to collect information from industry, and the types of information requested do not allow for an adequate health risk assessment. Moreover, little effort has been made to make the information collected publicly available. The article addresses the question of what information is disclosed (or not disclosed) and why, highlighting the socio-political context within which these decisions are made, and their democratic implications. It argues that the current ‘light-touch’ disclosure-based approach may lie in technical, evidence-based, ‘risk’ conception, which is common to both the United States and the European Union. It further argues for a more democratic ‘governance-by-disclosure’ approach, which allows society to prioritize risks that it is willing to take to enjoy the benefit of technological progress.

Keywords

Nanotechnology RegulationScientific UncertaintyRisk Management ApproachInformation DisclosureRisk ConceptionTechnological Innovation
Type
Articles
Information
Transnational Environmental Law , Volume 2 , Issue 1 , April 2013 , pp. 69 - 94
Copyright
Copyright © Cambridge University Press 2013

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References

1 The term ‘nanotechnology’ is difficult to define. Institutes around the world define ‘nanotechnology’ and other related terms such as ‘nanomaterials’, ‘nano-objects’ and ‘nanostructures’ in different ways. There are no binding definitions in the regulatory context. The various definitions for ‘nanoscale’ and ‘nanomaterial’ proposed so far have sought mainly to identify an inclusive size range of 1–100 nanometers that help to understand the terminology that uses the prefix ‘nano’. The European Commission (EC) was the first to publish its recommended definition on nanomaterials for regulatory purposes in Oct. 2011: see EC Recommendation 2011/696/EU on the Definition of Nanomaterial [2011] OJ L 275/38.

2 This is a material with one, two or three external dimensions in the nanoscale: see ISO/TS 80004-1:2010, Nanotechnologies – Vocabulary – Part 1: Core Terms, available at: http://www.iso.org/iso/catalogue_detail.htm?csnumber=51240.

3 Dowling, A. et al. ., Nanoscience and Nanotechnologies: Opportunities and Uncertainties (Royal Society & Royal Academy of Engineering (UK), 2004)Google Scholar, available at: http://www.nanotec.org.uk/finalReport.htm.

4 US Environmental Protection Agency (EPA) Science Policy Council, Nanotechnology White Paper, EPA 100/B-07/001, Feb. 2007, available at: http://www.epa.gov/OSA/pdfs/nanotech/epa-nanotechnology-whitepaper-0207.pdf.

5 Nel, A. et al. ., ‘Toxic Potential of Materials at the Nanolevel’ (2006) 311(5761) Science, pp. 622–7, at 624.CrossRefGoogle ScholarPubMed

6 C. Lucas, ‘We Must Not Be Blinded by Science: Nanotechnology Will Revolutionise Our Lives – It Should Be Regulated’, The Guardian, 12 June 2003, available at: http://www.guardian.co.uk/politics/2003/jun/12/nanotechnology.science; ETC Group, ‘No Small Matter II: The Case for a Global Moratorium – Size Matters!’ (2003) 7(7) Occasional Paper Series, available at: http://www.etcgroup.org/upload/publication/165/01/occ.paper_nanosafety.pdf; Dowling et al., n. 3 above; EPA Science Policy Council, n. 4 above.

7 Project on Emerging Nanotechnologies (PEN), ‘A Nanotechnologies Consumers Products Inventory’ (2011), available at: http://www.nanotechproject.org/inventories/consumer/analysis_draft.

8 See, e.g., Case, D.W., ‘Corporate Environmental Reporting as Informational Regulation: A Law and Economics Perspective’ (2005) 76 Universtiy of Colorado Law Review, pp. 379–442Google Scholar; Esty, D.C., ‘Environmental Protection in the Information Age’ (2004) 79 New York University Law Review, pp. 115–211Google Scholar; E.W. Orts, ‘Reflexive Environmental Law’ (1995) 89 Northwestern University Law Review, pp. 1227–340; Sunstein, C.R., ‘Informing America: Risk, Disclosure, and the First Amendment’ (1992) 20 Florida State University Law Review, pp. 653–77Google Scholar; Rosenthal, I. et al. ., ‘Regulation of Existing Chemicals under TSCA: Information Disclosure as the Route to Reducing Risk and Increasing Available Data’ (1992) 1(2) Quality Assurance, pp. 89–97Google Scholar; Stewart, R.B., ‘A New Generation of Environmental Regulation?’ (2001) 29 Capital University Law Review, pp. 21–182Google Scholar; M. Graham, ‘Information as Risk Regulation: Lessons from Experience’ (2001), available at: http://www.transparencypolicy.net/assets/information.

9 See, e.g., Gupta, A., ‘Transparency in Global Environmental Governance: A Coming of Age?’ (2010) 10(3) Global Environmental Politics, pp. 1–9.CrossRefGoogle Scholar

10 For an elaboration on this ‘governance by disclosure’ typology, see Gupta, A., ‘Transparency to What End? Governing by Disclosure through the Biosafety Clearing House’ (2010) 28(1) Environment and Planning C: Government & Policy, pp. 128–44, at 131.CrossRefGoogle Scholar

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13 Ibid.

14 G. Kirmizidis, ‘Report on the European Commission’s Public Online Consultation: Towards a Strategic Nanotechnology Action Plan’, 2010, at pp. 16–7, available at: http://ec.europa.eu/research/consultations/snap/report_en.pdf.

15 See, e.g., US Environmental Working Group, ‘EWG Comments to FDA on Nano-Scale Ingredients in Cosmetics’, Oct. 2006, available at: http://www.ewg.org/node/21738; US Consumers Unions, ‘Re: Food and Drug Administration-Regulated Products Containing Nanotechnology Materials’, Docket No. 2006N-0107, 6 Oct. 2006, available at: http://www.consumersunion.org/pub/core_product_safety/004667.html (urging the US Food and Drug Administration (FDA) to require warning labels on products which cannot be substantiated for safety). Still, some NGOs show concerns regarding governance by disclosure in this field: see, e.g., M. Singer, ‘Safety Fear Over $150 Face Cream Ingredient’, The Sydney Morning Herald, 6 Sept. 2010, available at: http://www.smh.com.au/national/safety-fear-over-150-face-cream-ingredient-20100905-14w4h.html (citing Friends of the Earth Australia which was concerned that labelling was being used in place of a comprehensive assessment approach).

16 The database is based on an analysis of documents and electronic material available in English on publicly accessible websites conducted during the period Oct. 2009 to Dec. 2012. Data was collected mainly from Europe, the US, Canada and Australia, and only sporadically from Asian countries. It was verified using information reported in official OECD reports (available at: http://www.oecd.org/env/ehs/nanosafety), External Liaison Report to ISO/TC 229 ‘Nanotechnologies’ (on file with author), and other independent reviews such as ObservatoryNANO (available at: http://www.observatorynano.eu/project/catalogue/5). The first public regulatory initiative was introduced in 2004. All data, together with comprehensive analysis and review results, is on file with author and will be published in the future.

17 This includes requirements or recommendations for third party information disclosure regarding nanomaterials such as preparation of Material Safety Data Sheets (MSDSs), as well as requirements, recommendations or certification systems for labelling products containing ingredients obtained through nanotechnology. It does not include initiatives to collect data for regulatory purposes.

18 This includes requirements (obligatory) or requests (voluntary) by government authorities for information on production, handling, use, risk assessment, control measure methods and surveillance practices regarding nanomaterials. Initiatives can collect either data already existing by the information provider, or require/request the development of new data.

19 This includes requirements or recommendations to restrict, condition or ban the distribution and use of nano-enabled product or substances in the markets. This includes conditional registration, quantity limitations of production and selling, product bans, etc.

20 This includes documents providing general policy principles for risk assessment, risk management and risk communication of nanomaterials, or for health surveillance. Such documents may include corporate codes of conduct, regulatory advices, best practices, etc.

21 Rose, N. & Miller, P., ‘Political Power Beyond the State: Problematics of Government’ (1992) 43(2) British Journal of Sociology, pp. 173–205Google Scholar. According to Rose & Miller, the concept of ‘political rationalities’ refers to the morals, epistemology and language which support the rationalities (at pp. 178–9). By ‘governmental technologies’, they refer to the strategies, techniques and procedures which deploy government rationalities and programmes (at p. 183).

22 See, e.g., Falkner, R. & Jaspers, N., ‘Regulating Nanotechnologies: Risk, Uncertainty and the Global Governance Gap’ (2012) 12(1) Global Environmental Politics, pp. 30–55Google Scholar (arguing that recent EU nanotechnology-specific legislation on notification and labelling of cosmetics and novel foods set it on a path that may end up diverging from US regulatory practice); see also Vogel, D., The Politics of Precaution: Regulating Health, Safety, and Environmental Risks in Europe and the United States (Princeton University Press, 2012)Google Scholar (arguing that European policy-makers are more willing to regulate risks on precautionary grounds, whereas American policy-makers call for higher levels of scientific certainty before imposing additional regulatory controls on business).

23 Studying the regulation regimes for food and for pharmaceuticals, Demortain concludes that they share a similar outcome in the emergence of the logic of risk evaluation. The regulatory ‘scientization’ and ‘rationalization’ which demands scientific justification for the benefits or risks of a product creates, in fact, a convergence between domains and markets: Demortain, D., Scientists and the Regulation of Risk: Standardising Control (Edward Elgar, 2011), at p. 212.Google Scholar

24 A ‘risk object’ is a socially constructed definition that frames the ‘scope of what constitutes a risk for regulatory purposes. The existence of a risk object justifies regulatory intervention to control its impact on society, and the way it was defined determines how it should be managed: Hilgartner, S., ‘The Social Construction of Risk Objects: Or, How to Pry Open Networks of Risk’, in Short, F.J. & Lee, C. (eds), Organizations, Uncertainties, and Risk (Westview Press 1992), pp. 39–53.Google Scholar

25 Renn, O., ‘Concepts of Risk: A Classification’, in Krimsky, S. & Golding, D. (eds.), Social Theories of Risk (Praeger, 1992), pp. 53–79, at 59.Google Scholar

26 Klinke, A. & Renn, O., ‘A New Approach to Risk Evaluation and Management: Risk-Based, Precaution-Based, and Discourse-Based Strategies’ (2002) 22(6) Risk Analysis, pp. 1071–94.Google Scholar

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28 For a further discussion about the societal and ethical implications of nanotechnology, see David, K.H. & Thompson, P.B., What Can Nanotechnology Learn from Biotechnology? Social and Ethical Lessons for Nanoscience from the Debate over Agrifood Biotechnology and GMOs (Academic Press, 2008)Google Scholar; Lewenstein, B.V., ‘What Counts as a “Social and Ethical Issue” in Nanotechnology’, in Baird, D. (ed.), Nanotechnology Challenges: Implications for Philosophy, Ethics and Society (World Scientific Publishing, 2006), pp. 201–16.CrossRefGoogle Scholar

29 J.P. Holdren et al., ‘Memorandum for the Heads of Executive Departments and Agencies: Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials’, 9 June 2011, available at: http://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/nanotechnology-regulation-and-oversight-principles.pdf.

30 Ibid.

31 van den Daele, W., ‘Access to New Technology: In Defense of the Liberal Regime of Innovation’, in Goodwin, M.E.A., Koops, E.J. & Leenes, R.E. (eds.), Dimensions of Technology Regulation (Wolf Legal Publishers, 2010), pp. 85–105, at 87.Google Scholar

32 See, e.g., the statement of Steve Froggett (Scientific Advisor to the US Department of Agriculture) that ‘regulation that is not grounded in sound science could have harmful economic impacts without promoting health or safety’: S. Froggett, ‘Nanotechnology and Agricultural Trade’, OECD Conference on the Potential Environmental Benefits of Nanotechnology: Fostering Safe Innovation-Led Growth, Paris (France), 15–17 Jul. 2009, available at: http://www.oecd.org/science/nanosafety/44029039.pdf.

33 B.M. Hutter, ‘The Attractions of Risk-Based Regulation: Accounting for the Emergence of Risk Ideas in Regulation’ Centre for Analysis of Risk and Regulation (CARR), Discussion Paper DP 33 (2005), available at: http://webfirstlive.lse.ac.uk/researchAndExpertise/units/CARR/pdf/DPs/Disspaper33.pdf.

34 Jasanoff, S., ‘Contested Boundaries in Policy-Relevant Science’ (1987) 17(2) Social Studies of Science, pp. 195–230CrossRefGoogle Scholar; Merton, R.K., ‘The Normative Structure of Science (1942)’, rpt. in Merton, R.K., The Sociology of Science: Theoretical and Empirical Investigations (University of Chicago Press, 1979), pp. 267–78Google Scholar; Porter, T.M., Trust in Numbers: The Pursuit of Objectivity in Science and Public Life (Princeton University Press, 1996)Google Scholar. This rationale is embedded so strongly in the hegemonic environmental risk governance paradigm that it is often denied. For example, Ayal, Hareuveny & Perez criticized the Intergovernmental Panel on Climate Change (IPCC) leaders who tend to describe their job as providing policy relevant but not policy prescriptive data: A. Ayal, R. Hareuveny & O. Perez, ‘Science, Politics and Transnational Regulation: Regulatory Scientific Institutions and the Dilemmas of Hybrid Authority’ (2013) 2(1) Transnational Environmental Law, pp. 45–68, at 59–60.

35 Renn, n. 25 above.

36 McLain, R.J. & Lee, R.G., ‘Adaptive Management: Promises and Pitfalls’ (1996) 20(4) Environmental Management, pp. 437–48, at 438.Google Scholar

37 Doremus, H., ‘Adaptive Management as an Information Problem’ (2011) 89 North Carolina Law Review, pp. 1455–98.Google Scholar

38 See, e.g., the US legal debate over the decision of the EPA decision to grant HeiQ Materials conditional registration for its AGS-20 product (nanosilver powder) under s. 3(c)(7)(C) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) 7 U.S.C. §136a(c)(7)(C) (2012): P. Ambrosio, ‘EPA Announces Conditional Registration for Antimicrobial Containing Nanosilver’, Bloomberg BNA, 5 Dec. 2011; S. Struglinski, ‘Lawsuit Seeks to Block EPA’s “Free Pass” on Nanosilver’, NRDC Media Center, 26 Jan. 2012. The EPA issued conditional registration although the company could not show that the product ‘will not cause unreasonable adverse effects to the environment’, as required by the law. It justified its decision to avoid a competitive disadvantage for HeiQ because other companies already had products containing nanoscale silver on the market without the EPA’s knowledge. In response, the Natural Resources Defense Council filed a lawsuit to block the EPA from allowing nanosilver on the market without the legally required data.

39 Stewart, R.B., ‘A New Generation of Environmental Regulation?’ (2001) 29 Capital University Law Review, pp. 21–182, at 54.Google Scholar

40 Ibid., at p. 57.

41 EC, Communication from the Commission: Towards a European Strategy for Nanotechnology, COM(2004)338 final, 12 May 2004 (EC European Strategy for Nanotechnology), available at: http://ec.europa.eu/nanotechnology/pdf/nano_com_en.pdf (emphasis added).

42 Van den Daele, n. 31 above, at p. 88.

43 EC, Commission Working Document: Science, Society and the Citizen in Europe, SEC(2000) 1973, 14 Nov. 2000, available at: ftp://ftp.cordis.europa.eu/pub/rtd2002/docs/ss_en.pdf.

44 Unless the industry can prove that the technology and its enabled products are safe, they will not enter the market. See, e.g., the Austrian Nanotechnology Action Plan which states that ‘[i]n all proceedings that deal specifically with nanomaterials and nanotechnologies, it is important to insist on compliance with the precautionary or polluter-pays-principle. Solid documentation of the inherent properties as well as the risks resulting from the application should be a prerequisite for entering and remaining on the market’: Austrian Government, Austrian Nanotechnology Action Plan (Vienna (Austria), Dec. 2009), p. 14, available at: http://www.lebensministerium.at/dms/lmat/umwelt/chemie_pestizide_gentechnik/nanotechnologie/Nano-Aktionsplan/Austrian_Nanotechnology_Action-Plan.pdf.

45 The absence of quantifiable scientific proof of risk does not preclude the possibility for real risk, and therefore cannot not be used to justify regulatory inaction under the general duty to refrain from actions that would cause harm to others. See, generally, Raffensperger, C. & Tickner, J.A., Protecting Public Health & the Environment: Implementing the Precautionary Principle (Island Press, 1999)Google Scholar; EC, Communication from the Commission on the Precautionary Principle, COM(2000) 1, 2 Feb. 2000 (EC Precautionary Principle), available at: http://ec.europa.eu/dgs/health_consumer/library/pub/pub07_en.pdf.

46 See, e.g., Gupta, A., ‘Advance Informed Agreement: A Shared Basis for Governing Trade in Genetically Modified Organisms’ (2001) 9 Indiana Journal of Global Legal Studies, pp. 265–81Google Scholar (interpreting the implementation of the precautionary principle in the Cartagena Protocol, the author argued that the governance architecture of the Protocol does not allow for ‘socially precautionary’). See also van den Daele, W., ‘Legal Framework and Political Strategy in Dealing with the Risks of New Technology: The Two Faces of the Precautionary Principle’, in Somsen, H. (ed.), The Regulatory Challenge of Biotechnology: Human Genetics, Food and Patents (Edward Elgar, 2007) pp. 118–38Google Scholar, at 124 (arguing that the precautionary principle ‘does not provide a carte blanche to reject a technology that gives rise to unsubstantiated fears, or because it is undesirable for other reasons’).

47 EC Precautionary Principle, n. 45 above.

48 Van den Daele, n. 46, at p. 122. See also Fisher, E., ‘Precaution, Precaution Everywhere: Developing a Common Understanding of the Precautionary Principle in the European Community’ (2002) 9 Maastricht Journal of European & Comparative Law, pp. 7–28, at 11–12.Google Scholar

49 Perez, O., ‘Precautionary Governance and the Limits of Scientific Knowledge: A Democratic Framework for Regulating Nanotechnology’ (2010) 28 UCLA Journal of Environmental Law & Policy, pp. 29–76.Google Scholar

50 Ibid.

51 Van den Daele, n. 46 above, at p. 124.

52 EC Precautionary Principle, n. 45 above, at pp. 16–17.

53 EC European Strategy for Nanotechnology, n. 41 above, at p. 19.

54 Wiesner, M.R. et al. ., ‘Decreasing Uncertainties in Assessing Environmental Exposure, Risk, and Ecological Implications of Nanomaterials’ (2009) 43(17) Environmental Science & Technology, pp. 6458–62, at 6461.Google Scholar

55 K.D. Grieger, S.F. Hansen & A. Baun, ‘The Known Unknowns of Nanomaterials: Describing and Characterizing Uncertainty within Environmental, Health and Safety Risks’ (2009) 3(3) Nanotoxicology, pp. 222–33, at 231.

56 Pleus, R.C., ‘The State of the Science: Human Health, Toxicology, and Nanotechnology Risks’, in Shatkin, J.A. (ed.), Nanotechnology: Health and Environmental Risks (2nd ed., CRC Press, 2013), pp. 79–116, at 110–11.Google Scholar

57 J.C. Davies, ‘EPA and Nanotechnology: Oversight for the 21st Century’, Project on Emerging Nanotechnologies, May 2007, available at: http://eprints.internano.org/65/1/EPA_Nano_Oversight.pdf; K. Ludlow, D. Bowman & G. Hodge, ‘A Review of Possible Impacts of Nanotechnology on Australia’s Regulatory Framework’, Monash Centre for Regulatory Studies, Sept. 2007, available at: http://www.innovation.gov.au/Industry/Nanotechnology/NationalEnablingTechnologiesStrategy/Documents/MonashReport2007.pdf; EC, Nanomaterials in REACH, CA/59/2008 rev. 1, 16 Dec. 2008, available at http://ec.europa.eu/environment/chemicals/reach/pdf/nanomaterials.pdf; The Expert Panel on Nanotechnology, Small is Different: A Science Perspective on the Regulatory Challenges of the Nanoscale (Council of Canadian Academies, 2008); Hansen, S.F. & Baun, A., ‘European Regulation Affecting Nanomaterials – Review of Limitations and Future Recommendations’ (2012) 10(3) Dose-Response, pp. 364–83.Google Scholar

58 See, e.g., United Kingdom (UK) Department for Environment, Food and Rural Affairs (Defra), ‘UK Voluntary Reporting Scheme for Engineered Nanoscale Materials’, 2008 (Defra VRS), available at: http://www.defra.gov.uk/environment/quality/nanotech/policy.htm; US EPA, ‘Nanoscale Materials Stewardship Program’, 2011 (US EPA MNSP), available at: http://www.epa.gov/oppt/nano/stewardship.htm; J. DiLoreto, ‘European Commission Calls for Data on Nanoparticles in Cosmetics’, NanoRegNews, 19 Sept. 2008; Australian Government. ‘Nanomaterials – Call for Information’, Chemical Gazette, No. C.021, 7 Feb. 2006; Australian Government, ‘Industrial Nanomaterials – Voluntary Call for Information’ Chemical Gazette, No. C 10, 7 Oct. 2008, at p. 8; US EPA, ‘Toxic Substances Control Act Inventory Status of Carbon Nanotubes’ (2008) 73(212) Federal Register 64946; Regulation (EC) No. 987/2008 amending Regulation (EC) No. 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes IV and V [2008] OJ L 268/163; US EPA, ‘Request for Information on Carbon Nanotubes (CNTs) Including Single-Walled Carbon Nanotubes (SWCNTs) and Multi-Walled Carbon Nanotubes (MWCNTs)’ (2009) 74(66) Federal Register 56880; California Department of Toxic Substances Control (DTSC), ‘Carbon Nanotube Information Call-In’, 2009 (California DTSC Call-In programme 2009), available at: http://www.dtsc.ca.gov/TechnologyDevelopment/Nanotechnology/CNTcallin.cfm; California DTSC, ‘Chemical Information Call-In: Nano Metals, Nano Metal Oxides, and Quantum Dots’, 2010 (California DTSC Call-In programme 2010), available at: http://www.dtsc.ca.gov/PollutionPrevention/Round_Two.cfm; Australian Government, ‘Adjustment to NICNAS New Chemicals Processes for Industrial Nanomaterials’, Chemical Gazette, No. C 105, 5 Oct. 2010; US EPA, ‘Multi-Walled Carbon Nanotubes; Significant New Use Rule’ (2011) 76(88) Federal Register 26186; Danish EPA, ‘Survey of Nanotechnological Consumer Products’, 2007, available at: http://www2.mst.dk/Udgiv/publications/2007/978-87-7052-536-7/pdf/978-87-7052-537-4.pdf; German Federal Institute for Occupational Safety and Health (BAuA), ‘Exposure to Nanomaterials in Germany – Results of the Corporate Survey of the Federal Institute for Occupational Health and Safety (BAuA) and the Association of the Chemical Industry (VCI) Using Questionnaires’, 24 Apr. 2008 (German BAuA Corporate Survey), available at: http://www.baua.de/en/Topics-from-A-to-Z/Hazardous-Substances/Nanotechnology/pdf/survey.pdf?__blob=publicationFile&v=2.

59 Regulation (EC) No. 1907/2006 Registration, Evaluation, Authorization and Restriction of Chemical Substances (REACH) [2007] OJ L 136/3; Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures (CLP) [2008] OJ L 353/1.

60 According to interim results of the European Chemicals Agency’s (ECHA) search of REACH and CLP submissions for nanomaterials, out of 26,600 REACH registrations, 4,700 distinctive substances and 3.2 million CLP notifications, only three REACH dossiers for three substances, and 15 CLP notifications for 14 substances have been submitted for nanomaterials explicitly. Six additional dossiers, not classified in the International Uniform Chemical Information Database (IUCLID) 5.2 as ‘nanomaterials’, included nano-scale substances. See Nanotechnology Industries Association, ‘Topical Briefing: Interim Results: ECHA’s Search of REACH- and CLP-Submissions for Nanomaterials’, NIA Exclusive, 10 May 2011, available at: http://www.nanotechia.org/nia-internal-news/nia-exclusive---topical-briefing-interim-results-echa-s-search-of-reach--and-clp-submissions-for-nanomaterials.

61 Working Party on Manufactured Nanomaterials (WPMN), ‘Analysis of Information Gathering Initiatives on Manufactured Nanomaterials’, OECD Environment, Health and Safety Publications Series on the Safety of Manufactured Nanomaterials, ENV/JM/MONO(2009)45 (WPMN (2009)); Milieu Ltd & RPA Ltd, Proposal for an EU Reporting System for Nanomaterials, May 2010, available at: http://www.nanomaterialsconf.eu/documents/NanoReportingSystemFinalR; WPMN, ‘Information Gathering Schemes on Nanomaterials: Lessons Learned and Reported Information’, OECD Environment, Health and Safety Publications Series on the Safety of Manufactured Nanomaterials, ENV/JM/MONO(2011)53 (WPMN (2011)).

62 See, e.g., House of Lords, Science and Technology Committee, ‘Nanotechnologies and Food, Volume 1: Report’, 8 Jan. 2010, available at: http://www.publications.parliament.uk/pa/ld200910/ldselect/ldsctech/22/22i.pdf (citing the US FDA position that it only requires information to be included on a label if it is necessary in order for the consumer to use the product safely. It does not label on a ‘right to know’ basis as is sometimes the case in Europe.)

63 See, e.g., the EC statement regarding food labelling that ‘[t]he Commission does not also agree with a systematic labelling ... of all foods produced with the aid of nanotechnology. As defined in the common authorization procedure, labelling must be decided on a case by case basis, following the scientific assessment and after consideration of other relevant factors’: EC, Commission Communication on the Action Taken on Opinions and Resolutions Adopted by Parliament at the March I and II 2009 Part-Sessions, SP(2009)3060, 4 June 2009, at p. 24, available at: http://www.europarl.europa.eu/oeil/spdoc.do?i=16712&j=0&l=en.

64 These schemes mainly aim to avoid misleading claims and verify that company statements are correct. They are not intended to ensure health and safety: see Taiwan Ministry of Economic Affairs (MOEA), ‘NanoMark’, 2004, available at: http://proj3.moeaidb.gov.tw/nanomark/Eng; Iran Nanotechnology Initiative Council, ‘“Nano mark” Certificate Unveiled in Iran Nano 2009 Exhibit (2009), available at: http://en.nano.ir/index.php/news/show/1415; and Nanotechnology Association of Thailand, ‘NanoQ’, 2011, available at: http://www.nanoassociation.or.th/th/index.php?status=7.

65 See, e.g., the Canadian Organic Production Systems General Principles and Management Standards, which also authorizes organic labelling, forbidding completely the use of nanomaterials in organic products: Canadian General Standardization Board, ‘Organic Production Systems General Principles and Management Standards’, CAN/CGSB-32.310-2006 (CGSB, 2011). For comparison it is interesting to note that the EU’s Ecolabel Board rejected the request to exclude nanomaterials in eco-labelling of cleaning products and lubricants, owing to the lack of evidence of risk: see Nanotechnology Industries Association, ‘Flowers for Nanomaterials – European Ecolabel Includes Nano-products’, 15 Feb. 2011, available at: http://www.nanotechia.org/global-news/flowers-for-nanomaterials---european-ecolabel-includes-nano-products. Furthermore, in Queensland (Australia), the Code of Practice for Labelling of Workplace Hazardous Chemicals recommends that labels be used for all products containing nanomaterials in the workplace, unless there is evidence that the nanomaterials are not hazardous: see Workplace Health and Safety Queensland, ‘Labelling of Workplace Hazardous Chemicals Code of Practice 2011’, Queensland Government Gazette, 2 Dec. 2011.

66 Regulation (EC) No. 1223/2009 on Cosmetic Products (recast) [2009] OJ L 342/59. Following Europe, New Zealand amended its Cosmetic Products Group Standard 2006 to include additional labelling, aligning it with the EU Cosmetics Regulation, Art. 19 (Labelling) and Art. 6 (Obligations of Distributors): see New Zealand EPA, ‘Application to Amend the Cosmetic Products Group Standard 2006’, ERMA200782, 28 June 2012.

67 Regulation (EC) No. 1169/2011 on Food Information to Consumers [2011] OJ L 304/18. This regulation combines two previous Directives on labelling, presentation and advertising of foodstuffs (2000/13/EC), and nutrition labelling for foodstuffs (90/496/EEC). It was adopted in lieu of the attempt to require labelling in novel food regulation but the regulation was not adopted because of its cloning sections.

68 Regulation (EU) No. 528/2012 concerning the Making Available on the Market and Use of Biocidal Products [2012] OJ L 167/1.

69 For additional discussion on worldwide national nano-labelling schemes, see, e.g., Gruère, G.P., ‘Labeling Nano-Enabled Consumer Products’ (2011) 6 Nano Today, pp. 117–21Google Scholar; and R. Falkner et al., ‘Consumer Labelling of Nanomaterials in the EU and US: Convergence or Divergence?’, Briefing Paper, Chatham House, Oct. 2009, available at: http://eprints.lse.ac.uk/25422/1/Consumer_labelling_of_nanomaterials_in_the_EU_and_US(LSERO).pdf.

70 EC Joint Research Centre, ‘Requirements on Measurements for the Implementation of the European Commission Definition of the Term “Nanomaterial”’, July 2012, available at: http://publications.jrc.ec.europa.eu.

71 EC, Communication on Second Regulatory Review on Nanomaterials, COM(2012)572 final, at p. 9.

72 Ibid., at p. 10.

73 WPMN (2009), n. 61 above.

74 Ibid., at p. 17.

75 See, e.g., UK Defra, n. 58 above, at p. 2 (‘The Government is aiming to develop appropriate controls in respect of any risks to the environment and human health from free engineered nanoscale materials. In order to move towards appropriate controls, there is a need to build evidence on potential risks. This Voluntary Reporting Scheme is one strand of the Government’s approach to gathering this evidence’); US EPA NMSP, n. 58 above, at p. 4861 (‘The Nanoscale Materials Stewardship Program is intended to: [h]elp the Agency gather existing data and information from manufacturers, importers, processors, and users of existing chemical nanoscale materials to build EPA’s knowledge base in this area; [i]dentify and encourage use of risk management practices in developing and commercializing nanoscale materials; [e]ncourage the development of additional test data needed to provide a firmer scientific foundation for future work and regulatory/policy decisions; [e]ncourage responsible development of nanoscale materials’).

76 German BAuA Corporate Survey, n. 58 above.

77 German BAuA & German VCI, ‘Guidance for Handling and Use of Nanomaterials at the Workplace’, 27 Aug. 2007, available at: http://www.baua.de/en/Topics-from-A-to-Z/Hazardous-Substances/Nanotechnology/pdf/guidance.pdf?__blob=publicationFile&v=2.

78 UK Defra, ‘Update on the Voluntary Reporting Scheme for Engineered Nanoscale Materials: June 2009’, 2009, available at: http://archive.defra.gov.uk/environment/quality/nanotech/policy.htm.

79 US EPA NMSP, n. 58 above.

80 Australian Government, ‘NICNAS Information Sheet – Summary of Call for Information on the Use of Nanomaterials’, Jan. 2007 (NICNAS Information Sheet Summary 2007), available at: http://www.nicnas.gov.au/publications/information_sheets/general_information_sheets/nis_call_for_info_nanomaterials.pdf.

81 Australian Government, ‘NICNAS Information Sheet – Summary of 2008 Call for Information on the Use of Nanomaterials’, Nov. 2010 (NICNAS Information Sheet Summary 2010), available at: http://www.nicnas.gov.au/Publications/Information_Sheets/General_Information_Sheets/NIS_Results_Call_for_Information_2008_Nov_2010_PDF.pdf. For additional figures, see WPMN (2011), n. 61 above.

82 WPMN (2009), n. 61 above, at pp. 17–18.

83 UK Department for Business, Innovation and Skills (DBIS), ‘UK Nanotechnologies Strategy: Small Technologies, Great Opportunities’, Mar. 2010, available at: http://www.bis.gov.uk/assets/goscience/docs/u/10-825-uk-nanotechnologies-strategy.pdf (‘The Government’s preference is for a voluntary scheme, but it may be that a mandatory scheme will be the only way of ensuring that the necessary information is supplied’); US EPA. n. 58 above (‘Although the NMSP provided EPA with useful information regarding a limited number of nanoscale materials in commerce, a significant number of the environmental health and safety data gaps remain. To address these gaps and prevent potential risks that may be posed by nanoscale materials, EPA is taking a number of regulatory actions under the Toxic Substances Control Act’); Australian Government, n. 58 (‘NICNAS is progressing a regulatory strategy for nanomaterials that is expected to be progressed in a staged manner and includes administrative and legislative amendments to the regulation of these substances’). According to NICNAS, ‘Proposal for Regulatory Reform of Industrial Nanomaterials’ (2009), more adjustments to the scheme are under way, including a mandatory notification and assessment scheme for nano-forms of existing chemicals.

84 15 U.S.C. §2604(a)(2) (2013).

85 US EPA NMSP, n. 58 above.

86 Australian Government, n. 58 above.

87 California DTSC, ‘Carbon Nanotube Information Call-In’, 2009, available at: http://www.dtsc.ca.gov/PollutionPrevention/Round_One.cfm.

88 Beaudrie, C.E.H. & Kandlikar, M., ‘Horses for Courses: Risk Information and Decision Making in the Regulation of Nanomaterials’ (2011) 13(4) Journal of Nanoparticle Research, pp. 1477–88.Google Scholar

89 WPMN (2011), n. 61 above, at p. 14.

90 Hansen, S.F. & Tickner, J.A., ‘The Challenges of Adopting Voluntary Health, Safety and Environment Measures for Manufactured Nanomaterials: Lessons from the Past for More Effective Adoption in the Future’ (2007) 4 Nanotechnology Law & Business, pp. 341–59Google Scholar, at 353–4 (citing the example of the High Production Volume (HPV) Challenge Program in the US).

91 Ibid.

92 REACH–CLP, n. 59 above.

93 Milieu Ltd. & RPA Ltd, n. 61 above, at pp. 39–40.

94 European Chemicals Agency, ‘Updated Guidance on Information Requirements and Chemical Safety Assessment for Nanomaterials’, available at: http://echa.europa.eu/web/guest/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment.

95 See, e.g., J.P. Holdren et al. (n. 29 above) who state that one of the US policy principles is to ‘develop relevant information in an open and transparent manner, with ample opportunities for stakeholder involvement and public participation’. Australian Government, ‘Australian Government Approach to the Responsible Management of Nanotechnology’, 11 July 2008, available at: http://www.innovation.gov.au/Industry/Nanotechnology/NationalEnablingTechnologiesStrategy/Documents/ObjectivesPaper.pdf (states an objective to foster informed community debate by ensuring decision-making processes are open, transparent and engage stakeholders). The EC (n. 41 above) states that ‘an effective two-way dialogue is indispensable, whereby the general public’s views are taken into account and may be seen to influence decisions concerning R&D policy’).

96 Emerson, T.I., ‘Legal Foundations of the Right to Know’ (1976) Washington University Law Quarterly, pp. 1–24, at 14.Google Scholar

97 WPMN (2009), n. 61 above, at p. 19.

98 Hansen & Tickner. n. 90 above, at p. 357.

99 See German BAuA Corporate Survey and UK Defra VRS, both n. 58 above, and Australia NICNAS Information Sheet Summary 2007, n. 80 above; and NICNAS Information Sheet Summary 2010, n. 81 above.

100 See, e.g., US EPA NMSP and California DTSC Information Call-In programme 2009 and 2010, both n. 58 above.

101 Perez, O., ‘Complexity, Information Overload and Online Deliberation’ (2009) 5(1) I/S: A Journal of Law and Policy for the Information Society, pp. 43–85.Google Scholar

102 The TRI was established as part of the Emergency Planning and Community Right to Know Act (EPCRA) of 1986, §§ 301–330. The TRI requires manufacturing and certain other industrial facilities to disclose releases of hundreds of toxic chemicals. The information is available in a publicly accessible computerized database, in a standardized form enabling any interested party to aggregate the data in a variety of ways, and to generate inter-temporal, inter-facility, inter-firm, inter-sectoral, and inter-community comparisons: see Karkkainen, B.C., ‘Information as Environmental Regulation: TRI and Performance Benchmarking, Precursor to a New Paradigm?’ (2001) 89 Georgetown Law Journal, pp. 257–370, at 286–7.Google Scholar

103 Ibid., at pp. 318–19.

104 Dingwerth, K. & Eichinger, M., ‘Tamed Transparency: How Information Disclosure under the Global Reporting Initiative Fails to Empower’ (2010) 10(3) Global Environmental Politics, pp. 74–96.Google Scholar

105 Gupta, A., ‘Transparency under Scrutiny: Information Disclosure in Global Environmental Governance’ (2008) 8(2) Global Environmental Politics, pp. 1–7.Google Scholar

106 L.L. Bergenson, ‘ECHA Preparing Nano Inventory from REACH and CLP Submissions’, Nano and Other Emerging Chemical Technologies Blog, 17 May 2011, available at: http://nanotech.lawbc.com/2011/05/articles/international/echa-preparing-nano-inventory-from-reach-and-clp-submissions.

107 European Chemical Industry Council, ‘Cefic’s First Nano & REACH Workshop a Success’, 27 Jun. 2011, available at: http://www.cefic.org/newsroom/2011/Cefics-first-Nano--REACH-workshop-a-success.

108 Davies, J.C., Managing the Effects of Nanotechnology (Project on Emerging Nanotechnologies, 2006), at p. 29.Google Scholar

109 Hansen & Tickner, n. 90 above, at pp. 357–8.

110 See generally, Renn, n. 25 above, at pp. 58–61; Wynne, n. 27 above; Kuzma, J. & Besley, J.C., ‘Ethics of Risk Analysis and Regulatory Review: From Bio- to Nanotechnology’ (2008) 2(2) Nanoethics, pp. 149–62.Google Scholar

111 Hansen & Tickner, n. 90 above, at pp. 357–8.

112 US EPA, ‘Meeting Summary Report: Nanoscale Materials Stewardship Program’, 8 Aug. 2007, at pp. 2–8, available at: http://www.epa.gov/oppt/nano/mtgsummary080207.pdf.

113 Stebbing, M., ‘Avoiding the Trust Deficit: Public Engagement, Values, the Precautionary Principle and the Future of Nanotechnology’ (2009) 6(1) Journal of Bioethical Inquiry, pp. 37–48, at 41.Google Scholar

114 Feenberg, A., Questioning Technology (Routledge, 2002), at p. 89.Google Scholar

115 Ibid., at p. 90.

116 Slovic, P., ‘Trust, Emotion, Sex, Politics, and Science: Surveying the Risk-Assessment Battlefield’ (1999) 19(4) Risk Analysis, pp. 689–701, at 697.CrossRefGoogle ScholarPubMed

117 Ibid., at p. 334; Stebbing, n. 113 above.

118 Esty, n. 8 above, at p. 120; see also Perez, n. 101 above.

119 See, e.g., Harremoes, P. et al. . (eds.), Late Lessons from Early Warnings: The Precautionary Principle 1896–2000 (European Environment Agency, 2001).Google Scholar

120 In the EU, the concept of ‘other legitimate factors’ in risk management was recognized in the GMO food regulation context a decade ago. See Art. 3(12) of Regulation (EC) No. 178/2002 Laying Down the General Principles and Requirements of Food Law, Establishing the European Food Safety Authority and Laying Down Procedures in Matters of Food Safety [2002] OJ L 31/1. Still, in the context of nanotechnology regulation the EU does not seem to have gone in the same direction: see M. Lee, ‘Beyond Safety? The Broadening Scope of Risk Regulation’, in C. O'Cinneide (ed.), Current Legal Problems 2009 (Oxford University Press, 2010). In the US, a recent effort was made to apply the US EPA Comprehensive Environmental Assessment approach, to identify and prioritize research directions for engineered nanomaterials, incorporating input from diverse stakeholder perspectives to support environmental decision-making; the second phase of the implementation will focus on prioritization of ‘risk trade-offs’ for risk management: see Powers, C.M. et al. ., ‘Comprehensive Environmental Assessment: A Meta-Assessment Approach’ (2012) 46(17) Environmental Science & Technology, pp. 9202–8.Google Scholar

121 Perez (n. 49 above, at pp. 56–75) highlights five challenges in the democratization of risk regulation in the context of nanotechnology, relating to the development of institutional structures for participatory processes.

122 Haas, P.M., ‘Introduction: Epistemic Communities and International Policy Coordination’ (1992) 46(1) International Organization, pp. 1–35Google Scholar, at 3 (defines an epistemic community as ‘a network of professionals with recognized expertise and competence in a particular domain and an authoritative claim to policy-relevant knowledge within that domain or issue-area’).

123 Public deliberation results should be binding for regulators in developing the risk management approach and not a mere practice of transparency: see, e.g., A. Hullmann, ‘European Activities in the Field of Ethical, Legal and Social Aspects (ELSA) and Governance of Nanotechnology, European EC DG Research, Brussels, 2008, available at: ftp://ftp.cordis.europa.eu/pub/nanotechnology/docs/elsa_governance_nano.pdf (discussing the EC’s funded projects for public deliberation in the field of nanotechnology).

124 See, e.g., Kirmizidis, n. 14 above. In the biotechnology context, see also TNS Opinion & Social, Eurobarometer 73.1: Biotechnology, Oct. 2010, available at: http://ec.europa.eu/public_opinion/archives/ebs/ebs_341_en.pdf.