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Published in: NanoEthics 1/2010

01-04-2010 | Original Paper

The Novelty of Nano and the Regulatory Challenge of Newness

Authors: Christopher J. Preston, Maxim Y. Sheinin, Denyse J. Sproat, Vimal P. Swarup

Published in: NanoEthics | Issue 1/2010

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Abstract

A great deal has been made of the question of whether nano-materials provide a unique set of ethical challenges. Equally important is the question of whether they provide a unique set of regulatory challenges. In the last 18 months, the US Environmental Protection Agency has begun the process of trying to meet the regulatory challenge of nano using the Toxic Substances Control Act (1976)(TSCA). In this central piece of legislation, ‘newness’ is a critical concept. Current EPA policy, we argue, does not adequately (or ethically) deal with the novelty of nano. This paper is an exploration of how to do a better job of accounting for nanomaterials as ‘new.’ We explore three alternative ways that nanomaterials might be made to fall under the TSCA regulatory umbrella. Since nanomaterials are of interest precisely because of the exciting new properties that emerge at the nano-scale, each of these three alternatives must meet what we call the ‘novelty condition’ and avoid what we call the ‘central paradox’ of existing regulatory policy. Failure to meet either of these conditions is a moral failure. We examine both the strengths and weaknesses of each alternative in order to illuminate the conceptual, practical, and moral challenges of novelty.

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Footnotes
1
See the Project on Emerging Nanotechnology Consumer Products Inventory (accessible at http://​www.​nanotechproject.​org/​inventories/​consumer).
 
2
Current research on nanomaterial health and safety is collected at the Organization of Economic Cooperation and Development website (http://​webnet.​oecd.​org/​NanoMaterials/​Pagelet/​Front/​Default.​aspx?​) An inventory of environment, health, and safety research is also available at the Project on Emerging Nanotechnologies (http://​www.​nanotechproject.​org/​inventories/​ehs).
 
3
We will not consider in this paper the effectiveness of TSCA as a whole, only the mechanisms it contains for regulating nanomaterials. Questions about TSCA’s effectiveness (e.g. the workload it involves, the burden of proof it imposes) need to be addressed elsewhere. A congressional hearing on TSCA by the U.S. House Subcommittee on Trade, Commerce, and Consumer Protection held on 02/26/09 probed the effectiveness of the 33 year old act. Many at the hearing suggested that the TSCA needed updating, independent of the challenges presented by nanomaterials.
 
4
See the decisions by EPA on nanomaterials and TSCA issued on 10/31/08 (73 Federal Register, 64946-7), 11/05/08 (73 Federal Register, 65743, 65751-2), 6/24/09 (74 Federal Register, 29982-29998), and 11/6/09 (74 Federal Register 57430). The EPA also issued a consent order to British firm Thomas Swan in September 2008 to commence commercial production of carbon nanotubes at its facility in New Jersey.
 
5
This was the methodology utilized in the NSF sponsored project cited on p.1. For more details, see the “Debating Science” link at www.​umt.​edu/​ethics (last accessed 12/7/09).
 
6
Aspect ratio, for chemicals and nanomaterials, is usually defined as the ratio of depth to width, or diameter to length, depending on how the material is being observed and categorized.
 
7
This text is amended from language used in Davies [9].
 
8
A dispersity index is a measure of the distribution of molecular mass in a given sample of the material. To this end, section 8(a)(2) of TSCA would also need to specify that the manufacturer submit information on size distribution of the new chemical to EPA.
 
9
The language below was suggested by Davies for amending TSCA to cover all nanomaterials. However, it appears that Davies’ language is qualified to apply only to nanomaterials that have ‘significant’ emergent properties. The language we used above (p. 11) for a size-only TSCA amendment is the more inclusive phrasing. We use Davis’ language here to cover the size-plus-one case.
 
10
The unresolved question this raises is whether the size-plus-one criterion will, de facto, revert to the size-only criterion.
 
11
See the decision by EPA issued on 11/05/08 (73 Federal Register, 65743, 65751-2).
 
12
See the regulations issued by EPA on carbon nanotubes issued on 06/24/09 (74 Federal Register, 29982-29998 and on 11/06/09 (74 Federal Register 57430-57436).
 
13
These are known as 5(e) Consent Order SNURs. See EPA’s TSCA Summary of Accomplishments, available at http://​www.​epa.​gov/​oppt/​newchems/​pubs/​accomplishments.​htm.
 
15
This ruling was, in fact, for a 5(e) SNUR.
 
16
Size-only and size-plus-one do require minor amendments as noted above.
 
18
Testimony of John Stephenson, Director, Natural Resources and the Environment, Government Accountability Office at the House Subcommittee on Commerce, Trade, and Consumer Protection hearing on TSCA (2/26/09). Text available at: http://​energycommerce.​house.​gov/​index.​php?​option=​com_​content&​task=​view&​id=​1505&​Itemid=​95 (accessed 7/15/09).
 
19
Also in the ENS article cited above. For specifics on REACH and Nanotechnology regulation, see http://​www.​safenano.​org/​nanoREACH.​aspx (accessed 7/15/09).
 
Literature
2.
go back to reference Auffan M, Rose J, Bottero J, Lowry G, Jolivet J, Wiesner M (2009) Towards a definition of inorganic nanoparticles from an environmental, health and safety perspective. Nature Nanotechnology 4:634–641CrossRef Auffan M, Rose J, Bottero J, Lowry G, Jolivet J, Wiesner M (2009) Towards a definition of inorganic nanoparticles from an environmental, health and safety perspective. Nature Nanotechnology 4:634–641CrossRef
4.
go back to reference Buzea C, Pacheco Blandino II, Robbie K (2007) Nanomaterials and nanoparticles: sources and toxicity. Biointerphases 2:MR17–MR172CrossRef Buzea C, Pacheco Blandino II, Robbie K (2007) Nanomaterials and nanoparticles: sources and toxicity. Biointerphases 2:MR17–MR172CrossRef
5.
go back to reference Cortie MB, van der Lingen E (2002) Catalytic gold nanoparticles. Materials Forum 26:1–14 Cortie MB, van der Lingen E (2002) Catalytic gold nanoparticles. Materials Forum 26:1–14
6.
go back to reference Dai HJ (2002) Carbon nanotubes: opportunities and challenges. Surface Science 500:218–224CrossRef Dai HJ (2002) Carbon nanotubes: opportunities and challenges. Surface Science 500:218–224CrossRef
7.
go back to reference David K, Thompson P (eds) (2008) What can nanotechnology learn from biotechnology? Societal and ethical lessons for nanoscience from the debate over agrifood biotechnology and GMO’s. Elsevier, Amsterdam David K, Thompson P (eds) (2008) What can nanotechnology learn from biotechnology? Societal and ethical lessons for nanoscience from the debate over agrifood biotechnology and GMO’s. Elsevier, Amsterdam
14.
go back to reference Federal Register (2008) Toxic Substances Control Act Inventory Status of Carbon Nanotubes, 73, 212, 64946–64947, October Federal Register (2008) Toxic Substances Control Act Inventory Status of Carbon Nanotubes, 73, 212, 64946–64947, October
15.
go back to reference Gupta AK, Gupta M (2005) Cytotoxicity suppression and cellular uptake enhancement of surface modified magnetic nanoparticles. Biomaterials 26:1565–1573CrossRef Gupta AK, Gupta M (2005) Cytotoxicity suppression and cellular uptake enhancement of surface modified magnetic nanoparticles. Biomaterials 26:1565–1573CrossRef
16.
go back to reference Gurr J-R, Wang ASS, Chen C-H, Jan K-Y (2005) Ultrafine titanium dioxide particles in the absence of photoactivation can induce oxidative damage to human bronchial epithelial cells. Toxicology 213:66–73CrossRef Gurr J-R, Wang ASS, Chen C-H, Jan K-Y (2005) Ultrafine titanium dioxide particles in the absence of photoactivation can induce oxidative damage to human bronchial epithelial cells. Toxicology 213:66–73CrossRef
17.
go back to reference Hester RE and Harrison RM (eds) (2007) Nanotechnology: consequences for human health and environment. Issues in Environmental Science and Technology, 24. The Royal Society of Chemistry Hester RE and Harrison RM (eds) (2007) Nanotechnology: consequences for human health and environment. Issues in Environmental Science and Technology, 24. The Royal Society of Chemistry
18.
go back to reference Hoet PHM, Brüske-Hohlfeld I, Salata OV (2004) Nanoparticles—known and unknown health risks. Journal of Nanobiotechnology 2:12–27CrossRef Hoet PHM, Brüske-Hohlfeld I, Salata OV (2004) Nanoparticles—known and unknown health risks. Journal of Nanobiotechnology 2:12–27CrossRef
19.
go back to reference Jan E, Byrne SJ, Cuddihy M, Davies AM, Volkov Y, Gun’ko YK, Kotov NA (2008) High-content screening as a universal tool for finger printing of cytotoxicity of nanoparticles. ACS Nano 2:928–938CrossRef Jan E, Byrne SJ, Cuddihy M, Davies AM, Volkov Y, Gun’ko YK, Kotov NA (2008) High-content screening as a universal tool for finger printing of cytotoxicity of nanoparticles. ACS Nano 2:928–938CrossRef
20.
go back to reference Kaji N, Tokeshi M, Baba Y (2007) Quantum dots for single bio-molecule imaging. Analytical Sciences 23:21–24CrossRef Kaji N, Tokeshi M, Baba Y (2007) Quantum dots for single bio-molecule imaging. Analytical Sciences 23:21–24CrossRef
21.
go back to reference Klaine SJ, Alvarez PJJ, Batley GE, Fernandes TF, Handy RD, Lyon DY, Mahendra S, McLaughlin MJ, Lead JR (2008) Nanomaterials in the environment: behavior, fate, bioavailability, and effects. Environmental Toxicology and Chemistry 27:1825–1851CrossRef Klaine SJ, Alvarez PJJ, Batley GE, Fernandes TF, Handy RD, Lyon DY, Mahendra S, McLaughlin MJ, Lead JR (2008) Nanomaterials in the environment: behavior, fate, bioavailability, and effects. Environmental Toxicology and Chemistry 27:1825–1851CrossRef
22.
go back to reference Kostarelos K (2008) The long and short of carbon nanotube toxicity. Nature Biotechnology 26:774–776CrossRef Kostarelos K (2008) The long and short of carbon nanotube toxicity. Nature Biotechnology 26:774–776CrossRef
23.
go back to reference Lam C-W, James JT, McCluskey R, Hunter RL (2004) Pulmonary toxicity of single-wall carbon nanotubes in mice 7 and 90 days after intratracheal instillation. Toxicological Sciences 77:126–134CrossRef Lam C-W, James JT, McCluskey R, Hunter RL (2004) Pulmonary toxicity of single-wall carbon nanotubes in mice 7 and 90 days after intratracheal instillation. Toxicological Sciences 77:126–134CrossRef
24.
go back to reference Lam C-W, James JT, McCluskey R, Arepalli S, Hunter RL (2006) A review of carbon nanotube toxicity and assessment of potential occupational and environmental health risks. Critical Reviews in Toxicology 36:189–217CrossRef Lam C-W, James JT, McCluskey R, Arepalli S, Hunter RL (2006) A review of carbon nanotube toxicity and assessment of potential occupational and environmental health risks. Critical Reviews in Toxicology 36:189–217CrossRef
25.
go back to reference Lin A (2007) Size matters: regulating nanotechnology. Harvard Law Review 31:349–408 Lin A (2007) Size matters: regulating nanotechnology. Harvard Law Review 31:349–408
26.
go back to reference Mandel G (2008) Nanotechnology governance. Alabama Law Review 59(5):1323–1384 Mandel G (2008) Nanotechnology governance. Alabama Law Review 59(5):1323–1384
27.
go back to reference Maynard AD, Aitken RJ, Butz T, Colvin V, Donaldson K, Oberdörster G, Philbert MA, Ryan J, Seaton A, Stone V, Tinkle SS, Tran L, Walker NJ, Warheit DB (2006) Safe handling of nanotechnology. Nature 444:267–269CrossRef Maynard AD, Aitken RJ, Butz T, Colvin V, Donaldson K, Oberdörster G, Philbert MA, Ryan J, Seaton A, Stone V, Tinkle SS, Tran L, Walker NJ, Warheit DB (2006) Safe handling of nanotechnology. Nature 444:267–269CrossRef
28.
go back to reference Muller J, Huaux F, Moreau N, Misson P, Heilier JF, Delos M, Arras M, Fonseca A, Nagy JB, Lison D (2005) Respiratory toxicity of multi-wall carbon nanotubes. Toxicology and Applied Pharmacology 207:221–231 Muller J, Huaux F, Moreau N, Misson P, Heilier JF, Delos M, Arras M, Fonseca A, Nagy JB, Lison D (2005) Respiratory toxicity of multi-wall carbon nanotubes. Toxicology and Applied Pharmacology 207:221–231
30.
go back to reference Nemmar A, Vanbilloen H, Hoylaerts MP, Hoet PHM, Verbruggen A, Nemery B (2001) Passage of intratracheally instilled ultrafine particles from the lung into the systemic circulation in hamster. American Journal of Respiratory and Critical Care Medicine 164:1665–1668 Nemmar A, Vanbilloen H, Hoylaerts MP, Hoet PHM, Verbruggen A, Nemery B (2001) Passage of intratracheally instilled ultrafine particles from the lung into the systemic circulation in hamster. American Journal of Respiratory and Critical Care Medicine 164:1665–1668
31.
go back to reference Nel A, Xia T, Mädler L, Li N (2006) Toxic potential of nanomaterials at the nanolevel. Science 311:622–627CrossRef Nel A, Xia T, Mädler L, Li N (2006) Toxic potential of nanomaterials at the nanolevel. Science 311:622–627CrossRef
33.
go back to reference Oberdörster G (2002) Toxicokinetics and effects of fibrous and nonfibrous particles. Inhalation Toxicology 14:29–56CrossRef Oberdörster G (2002) Toxicokinetics and effects of fibrous and nonfibrous particles. Inhalation Toxicology 14:29–56CrossRef
34.
go back to reference Oberdörster G, Oberdörster E, Oberdörster J (2005) Nanotoxicology: an emerging discipline evolving from studies of ultrafine particles. Environmental Health Perspectives 113:823–839CrossRef Oberdörster G, Oberdörster E, Oberdörster J (2005) Nanotoxicology: an emerging discipline evolving from studies of ultrafine particles. Environmental Health Perspectives 113:823–839CrossRef
35.
go back to reference Oberdörster G, Stone V, Donaldson K (2007) Toxicology of nanoparticles: A historical perspective. Nanotoxicology 1:2–25CrossRef Oberdörster G, Stone V, Donaldson K (2007) Toxicology of nanoparticles: A historical perspective. Nanotoxicology 1:2–25CrossRef
36.
go back to reference Oldenburg SJ, Averitt RD, Westcott SL, Halas NJ (1998) Nanoengineering of optical resonances. Chemical Physics Letters 288:243–247CrossRef Oldenburg SJ, Averitt RD, Westcott SL, Halas NJ (1998) Nanoengineering of optical resonances. Chemical Physics Letters 288:243–247CrossRef
39.
go back to reference Rejeski D, Lekas D (2008) Nanotechnology field observations: scouting the new industrial west. Journal of Cleaner Production 16:1014–1017CrossRef Rejeski D, Lekas D (2008) Nanotechnology field observations: scouting the new industrial west. Journal of Cleaner Production 16:1014–1017CrossRef
40.
go back to reference Risom L, Møller P, Loft S (2005) Oxidative stress-induced DNA damage by particulate air pollution. Mutation Research-Fundamental and Molecular Mechanisms of Mutagenesis 592:119–137CrossRef Risom L, Møller P, Loft S (2005) Oxidative stress-induced DNA damage by particulate air pollution. Mutation Research-Fundamental and Molecular Mechanisms of Mutagenesis 592:119–137CrossRef
41.
go back to reference Roduner E (2006) Size matters: why nanomaterials are different. Chemical Society Reviews 35:583–592CrossRef Roduner E (2006) Size matters: why nanomaterials are different. Chemical Society Reviews 35:583–592CrossRef
43.
go back to reference Veiseh O et al (2009) Specific targeting of brain tumors with an optical/magnetic resonance imaging nanoprobe across the blood-brain barrier. Cancer Research 6:6200–6207CrossRef Veiseh O et al (2009) Specific targeting of brain tumors with an optical/magnetic resonance imaging nanoprobe across the blood-brain barrier. Cancer Research 6:6200–6207CrossRef
Metadata
Title
The Novelty of Nano and the Regulatory Challenge of Newness
Authors
Christopher J. Preston
Maxim Y. Sheinin
Denyse J. Sproat
Vimal P. Swarup
Publication date
01-04-2010
Publisher
Springer Netherlands
Published in
NanoEthics / Issue 1/2010
Print ISSN: 1871-4757
Electronic ISSN: 1871-4765
DOI
https://doi.org/10.1007/s11569-010-0083-x

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