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The Novelty of Nano and the Regulatory Challenge of Newness

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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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Notes

  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.

  14. See http://www.epa.gov/oppt/newchems/pubs/accomplishments.htm (accessed 7/3/09)

  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.

  17. Environment News Service, 2009 - http://www.ens-newswire.com/ens/feb2009/2009-02-26-10.asp

  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).

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Author information

Authors and Affiliations

  1. Department of Philosophy, University of Montana, Missoula, MT, 59812, USA

    Christopher J. Preston

  2. Department of Physics, Cornell University, Ithaca, NY, 14853, USA

    Maxim Y. Sheinin

  3. Philosophy Section, International School for Communities, Rights, and Inclusion, University of Central Lancashire, Preston, PR1 2HE, UK

    Denyse J. Sproat

  4. Department of Biomedical Engineering, University of Utah, Salt Lake City, UT, 84112, USA

    Vimal P. Swarup

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  1. Christopher J. Preston
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  2. Maxim Y. Sheinin
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  4. Vimal P. Swarup
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Correspondence to Christopher J. Preston.

Additional information

Initial research for this paper took place during a workshop and follow-up course titled “Debating Science” held at the University of Montana and supported by the National Science Foundation (Award # SES-062920). The authors wish to thank the students on the course for providing stimulation and content during the workshop and the on-line study period.

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Preston, C.J., Sheinin, M.Y., Sproat, D.J. et al. The Novelty of Nano and the Regulatory Challenge of Newness. Nanoethics 4, 13–26 (2010). https://doi.org/10.1007/s11569-010-0083-x

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