Published online by Cambridge University Press: 20 January 2017
This section is meant to give readers an insight into the emerging field of nanotechnologies and risk regulation. It informs and updates readers on the latest European and international developments in nanotechnologies and risk regulation across different sectors (e.g., chemicals, food, cosmetics, pharmaceuticals) and policy areas (e.g., environmental protection, occupational health and consumer product, food and drug safety). The section analyzes how existing regulatory systems deal with new kinds of risks and reviews recent regulatory developments with a focus on how best to combine scientific freedom and technological progress with a responsible development and commercialization of nanotechnologies.
1 Acknowledgements: My thanks go to Robert Falkner, Steffi Friedrichs, Michael Knowles and Cornelis Brekelmans for useful comments on an earlier version of this paper. The usual disclaimers apply.
2 Thompson, Barry C. and Fréchet, Jean M.J., “Polymer-Fullerene Composite Solar Cells”, 47 Angewandte Chemie (2007), pp. 58–77 CrossRefGoogle Scholar; and Stefan Lovgren, “Spray-On Solar-Power Cells are True Breakthrough”, National Geographic News, 14 January 2005, available on the Internet at <http://news.nationalgeographic.com/news/2005/01/0114_050114_solarplastic.html> (last accessed on 9 April 2010).
3 Patrick O’Neal, D. et al., “Photo-Thermal Tumor Ablation in Mice Using Near Infrared-Absorbing Nanoparticles”, 209 Cancer Letters (2003), pp. 171–6Google Scholar.
4 Yuan, Jikang et al., “Superwetting Nanowire Membranes for Selective Absorption”, 3 Nature Nanotechnology (2008), pp. 332–6CrossRefGoogle ScholarPubMed.
5 Theron, Jacques et al., “Nanotechnology and Water Treatment: Applications and Emerging Opportunities”, 34 Critical Reviews in Microbiology (2008), pp. 43–69 CrossRefGoogle ScholarPubMed.
6 Zhang, Wei-Ming et al., “Tin-Nanoparticles Encapsulated in Elastic Hollow Carbon Spheres for High-Performance Anode Material in Lithium-Ion Batteries”, 20 Advanced Materials (2008), pp. 1160–5CrossRefGoogle Scholar.
7 The Project on Emerging Nanotechnologies, “An Inventory of Nanotechnology-Based Consumer Products Currently on the Market”, available on the Internet at <http://www.nanotechproject.org/inventories/consumer/> (last accessed on 9 April 2010).
8 See, for example, Mihail Roco and William Bainbridge, Societal Implications of Nanoscience and Nanotechnology (NSET Workshop Report 2001); and Christine Peterson, “Molecular Nanotechnology: the Next Industrial Revolution”, available on the Internet at <http://www.foresight.org/nano/ieeecomputer.html> (last accessed on 9 April 2010).
9 Cientifica, Nanotechnology Takes a Deep Breath … and Prepares to Save the World (Cientifica Report 2009).
10 Monteiro-Riviere, Nancy et al., “Multi-Walled Carbon Nanotube Interactions with Human Epidermal Keratinocytes”, 155 Toxicology Letters (2005), pp. 377–384 CrossRefGoogle ScholarPubMed; Shvedova, Anna et al., “Exposure to Carbon Nanotube Material: Assessment of the Biological Effects of Nanotube Materials Using Human Keratinocyte Cells”, 66 Journal of Toxicology and Environmental Health (2003), pp. 1909–1926 CrossRefGoogle Scholar.
11 Takagi, Atsuya et al., “Induction of Mesothelioma in p53+/– Mouse by Intraperitoneal Application of Multi-Wall Carbon Nanotube”, 33 Journal of Toxicological Sciences (2008), pp. 105–16CrossRefGoogle Scholar; Poland, Craig A. et al., “Carbon Nanotubes Introduced Into the Abdominal cavity of Mice Show Asbestos-Like Pathogenicity in a Pilot Study”, 3 Nature Nanotechnology (2008), pp. 423–8CrossRefGoogle Scholar.
12 See, for example, Senjen Rye, Nanosilver – A Threat to Soil, Water and Human Health? (Friends of the Earth Report 2007); International Center for Technology Assessment et al., “Petition for Rulemaking Requesting EPA Regulate Nano-Silver Products as Pesticides” (2008), available on the Internet at <http://icta.org/nanoaction/doc/CTA_nano-silver%20petition__final_5_1_08.pdf> (last accessed on 9 April 2010). The exposure of biological systems and aquatic species to nanosilver, however, is much debated in scientific circles. See, for example, Kristen Kulinowski, “Environmental Impacts of Nanosilver, An ICON Backgrounder”, 18 November 2008, available on the Internet at <http://cohesion.rice.edu/centersandinst/icon/resources.cfm?doc_id=12722> (last accessed on 9 April 2010).
13 One of the rare exceptions is a report by a Chinese toxicologist from 2009 on an industrial accident where seven workers were exposed to unspecified nanoparticles over five to thirteen months, which is said to have caused two of these workers to die and the remaining workers to be severely disabled ( Song, Y. et al., “Exposure to Nanoparticles is Related to Pleural Effusion, Pulmonary Fibrosis and Granuloma”, 34 European Respiratory Journal (2009), pp. 559–67CrossRefGoogle Scholar). However, the toxicologist's claim that polyacrylate consisting of nanoparticles caused pulmonary inflammation and pulmonary fibrosis remains contested (see, for example, Andrew Maynard, “Nanoparticle Exposure and Occupational Lung Lisease – Six Expert Perspectives on a New Clinical Study”, 18 August 2009, available on the Internet at <http://community.safenano.org/blogs/andrew_maynard/archive/2009/08/18/nanoparticle-exposure-and-occupational-lung-disease-six-expertperspectives-on-a-new-clinical-study.aspx> (last accessed on 9 April 2010)).
14 ICON, Towards Predicting Nano-Biointeractions (ICON Workshop Report 2008).
15 See, for example, Royal Society and Royal Academy of Engineering, Nanoscience and Nanotechnologies: Opportunities and Uncertainties (RS&RAE Report 2004); SCENIHR, The Appropriateness of Existing Methodologies to Assess the Potential Risks Associated with Engineered and Adventitious Products of Nanotechnologies (SCENIHR Opinion 2006); CDC and NIOSH, Approaches to Safe Nanotechnology: Managing the Health and Safety Concerns Associated with Engineered Nanoparticles (DHSS Report 2009); SCCP, Safety of Nanomaterials in Cosmetic Products (SCCP Opinion 2008); RCEP, Novel Materials in the Environment: The Case of Nanotechnology (Royal Commission on Environmental Pollution Twenty-Seventh Report 2008); House of Lords, Nanotechnologies and Food (Science and Technology Committee 1st Report Session 2009–10).
16 EPA, “Pesticide Registration; Clarification for Ion-Generating Equipment”, Federal Register 72(183), (2007)Google Scholar.
17 EPA, “Toxic Substances Control Act Inventory Status of Carbon Nanotubes”, Federal Register 73(212), (2008)Google Scholar.
18 EPA, “Enhancing EPA's Chemical Management Program” (2009), available on the Internet at <http://www.epa.gov/oppt/existingchemicals/pubs/Existing.Chem.Fact.sheet.pdf> (last accessed on 9 April 2010).
19 FDA, Nanotechnology Task Force Report 2007 (FDA Report 2007).
20 European Commission (2008), “Regulatory Aspects of Nanomaterials”, Commission Staff Working Document, SEC(2008) 2036, available on the Internet at <http://www.euractiv.com/29/images/SEC%282008%29%202036_tcm29-173474.pdf>.
21 European Commission (2004), “Towards a European Strategy for Nanotechnology”, Communication from the Commission, COM(2004) 338 final, available on the Internet at <http://ec.europa.eu/nanotechnology/pdf/nano_com_en.pdf>, p. 18.
22 European Commission (2008), “Regulatory Aspects of Nanomaterials”, Commission Staff Working Document, SEC(2008) 2036, available on the Internet at <http://www.euractiv.com/29/images/SEC%282008%29%202036_tcm29-173474.pdf>.
23 Commission of the European Communities, Commission Recommendation on a Code of Conduct for Responsible Nanosciences and Nanotechnologies Research, C (2008) 424 final (7 February 2008), available on the Internet at <ftp://ftp.cordis.europa.eu/pub/fp7/docs/nanocode-recommendation.pdf>, p. 6.
24 Falkner, Robert, Breggin, Linda, Jaspers, Nico, Pendergrass, John and Porter, Read, “Consumer Labelling of Nanomaterials in the EU and US: Convergence or Divergence?”, EERG Briefing Paper 2009/03 (London: Chatham House, 2009)Google Scholar.
25 European Commission. 2008, Regulatory Aspects of Nanomaterials. Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee, COM(2008) 366 final, available on the Internet at <http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2008:0366:FIN:EN:PDF>.
26 Annex 1 of REACH on the ‘General Provisions for Assessing Substances and Preparing Chemical Safety Reports’ provides specific guidelines to all four areas of safety assessment. See European Commission (2006b: Annex I).
27 European Commission (2008), “Regulatory Aspects of Nanomaterials”, Commission Staff Working Document, SEC(2008) 2036, available on the Internet at <http://www.euractiv.com/29/images/SEC%282008%29%202036_tcm29-173474.pdf>.
28 The OECD Working Party on Manufactured Nanomaterials (WPMN) publishes an annual update of regulatory and risk assessment activities in participating countries, available on the Internet at <http://www.oecd.org/document/53/0,3343,en_2649_37015404_37760309_1_1_1_1,00.html>.
29 For example, the International Cooperation on Cosmetics Regulation (ICCR), available on the Internet at <http://www.fda.gov/InternationalPrograms/HarmonisationInitiatives/ucm114513.htm>; the Strategic Approach to International Chemicals Management (SAICM), available on the Internet at <http://www.saicm.org/index.php?ql=h&content=home>; and planned future activities in the area of nanomedicines, see <http://www.ema.europa.eu/pdfs/conferenceflyers/nanotech_workshop/Agenda.pdf>.
30 The Project on Emerging Nanotechnologies (PEN) at the Woodrow Wilson International Center for Scholars has counted over 1000 commercially available nano-enabled consumer products in 2009, but its inventory relies on the work of a small team conducting online research on credible “nano-claims” by producers on final products, see <http://www.nanotechproject.org/inventories/consumer/>. Following the request of the European Parliament, the European Commission is currently developing a more thorough inventory that is to be published in 2010, see <http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P6-TA-2009-0328>.
31 Lux Research, 2009, The Recession's Impact on Nanotechnology, available on the Internet at <http://www.luxresearchinc.com/blog/2010/02/the-recessions-impact-on-nanotechnology/>.
32 This figure is based on an estimate of global manufacturing output worth $ 15.8 trillion by 2015. See IHS Global Insight (2008), “Revised Forecast Advances Date of China Becoming the Preeminent Global Manufacturer”, 12 August 2008, available on the Internet at <http://www.ihsglobalinsight.com/Perspective/PerspectiveDetail13718.htm>. This is very close to earlier predictions of nano-enabled products accounting for 15 % of global manufacturing output, reported in OECD and Allianz (2005), “Small Sizes that Matter: Opportunities and Risks of Nanotechnologies”, Report in co-operation with the OECD International Futures Programme, available on the Internet at <http://www.oecd.org/dataoecd/32/1/44108334.pdf>; and Angela Hullmann (2006), “The Economic Development of Nanotechnology – An Indicator Based Analysis”, European Commission, DG Research Report, available on the Internet at <ftp://ftp.cordis.europa.eu/pub/nanotechnology/docs/nanoarticle_hullmann_nov2006.pdf>.
33 WTO (2009), “International Trade Statistics 2009” available on the Internet at <http://www.wto.org/english/res_e/statis_e/its2009_e/its2009_e.pdf>, chapter 2, “Merchandise Trade by Product”, p. 41.
35 Timothy E. Josling, “The Beef Hormone Dispute and Its Implications for Trade Policy”, Stanford University Forum on Contemporary Europe Working Paper (2001), available on the Internet at <http://fce.stanford.edu/publications/beefhormone_dispute_and_its_implications_for_trade_policy_the/>.