Skip to main content
Log in

Dynamic oversight: implementation gaps and challenges

  • Special Focus: Governance of Nanobiotechnology
  • Published:
Journal of Nanoparticle Research Aims and scope Submit manuscript

Abstract

Nanotechnology is touted as a transformative technology in that it is predicted to improve many aspects of human life. There are hundreds of products in the market that utilize nanostructures in their design, such as composite materials made out of carbon or metal oxides. Potential risks to consumers, to the environment, and to workers from the most common passive nanomaterial—carbon nanotubes—are emerging through scientific research. Newer more active nanostructures—such as cancer therapies and targeted drug systems—are also increasing in use and are raising similar risk concerns. Governing the risks to workers is the subject of this commentary. The Occupational Safety and Health Act of 1970 grants the Occupational Safety and Health Administration the legal authority to set occupational health standards to insure that no worker suffers material impairment of health from work. However, setting a standard to protect workers from nanotechnology risks may occur some time in the future because the risks to workers have not been well characterized scientifically. Alternative risk governances—such as dynamic oversight through stakeholder partnerships, “soft law” approaches, and national adoption of international consensus standards—are evaluated in this article.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  • Afonin KA, Bindewald E, Yaghoubian AJ, Voss N, Jacovetty E, Shapiro BA, Jaeger L (2010) In vitro assembly of cubic RNA-based scaffolds designed in silico. Nat Nanotechnol 5:676–682

    Article  CAS  Google Scholar 

  • American Federation of Labor-Congress of Industrial Organizations v. OSHA, 965 F.2d 962 (11th Cir. 1992)

  • Arnall AH (2003) Future technologies today’s choices. Greenpeace Environmental Trust, London

    Google Scholar 

  • Bell C, Marrapese M (2011) Nanotechnology standards and international legal considerations. In: Murashov V, Howard J (eds) Nanotechnology standards. Springer, New York

    Google Scholar 

  • Choi JY, Ramachandran G (2009) Review of the OSHA framework for oversight of occupational environments. J Law Med Ethics 37:633–650

    Article  Google Scholar 

  • Choi JY, Ramachandran G, Kandlikar M (2009) The impact of toxicity testing costs on nanomaterial regulation. Environ Sci Technol 43:3030–3034

    Article  CAS  Google Scholar 

  • Collins PG, Avouris P (2000) Nanotubes for electronics. Sci Am 283:62–69

    Article  CAS  Google Scholar 

  • Davies CJ (2009) Oversight of next generation nanotechnology. Project on Emerging Technologies, Washington, DC. http://www.nanotechproject.org/process/assets/files/7316/pen-18.pdf. Accessed 2 Oct 2010

  • European Union (E.U.) (2006) Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Off J Eur Commun; L1363–280. http://www.reach-21compliance.eu/english/legislation/docs/launchers/launch-2006-1907-EC.html. Accessed 2 Oct 2010

  • Han JH, Lee EJ, Lee JH, So KP, Lee YH, Bae GN, Lee SB, Ji JH, Cho MH, Yu IJ (2008) Monitoring multi-walled carbon nanotube exposure in carbon nanotube research facility. Inhal Tox 20:1–9

    Article  Google Scholar 

  • Hansen ST, Maynard A, Baun A et al (2008) Late lessons from early warnings about nanotechnology. Nat Nanotechnol 3:444–447

    Google Scholar 

  • Harremoës P, Gee D, MacGavin M, Stirling A, Keys J, Wynne B, Guedes Vaz S (2001) Late lessons from early warnings: the precautionary principle 1896-2000. European environmental agency, Copenhagen. http://www.eea.europa.eu/publications/environmental_issue_report_2001_22. Accessed 2 Oct 2010

  • Haufler V (2010) Private sector and international standard-setting: the challenge for business and government. Carnegie discussion paper 3, Study Group on the role of the private sector. http://www.carnegieendowment.org/publications/index.cfm?fa=view&id=220. Accessed 2 Oct 2010

  • Howard J, Murashov V (2009) National nanotechnology partnership to protect workers. J Nanopart Res 11:1673–1683

    Article  Google Scholar 

  • Industrial Union Department vs. American Petroleum Institute (1980) 44 U.S. 607

  • International Center for Technology Assessment (ICTA) (2008) Principles for the oversight of nanotechnologies and nanomaterials. International center for technology assessment, Washington, DC. http://www.icta.org/doc/Principles%20for%20the%20Oversight%20of%20Nanotechnologies%20and%20Nanomaterials_final.pdf. Accessed 2 Oct 2010

  • International Risk Governance Council (IRCG) (2007) Policy brief: nanotechnology risk governance. International risk governance council, Geneva. http://www.irgc.org/IMG/pdf/PB_nanoFINAL2_2_.pdf. Accessed 2 Oct 2010

  • Kuhlbusch TAJ, Fissan H (2006) Particle characteristics in the reactor and pelletizing areas of carbon black production. J Occup Environ Health 3:558–567

    CAS  Google Scholar 

  • Lin AC (2007) Size matters: regulating nanotechnology. Harvard Environ Law Rev 31:350–408

    Google Scholar 

  • Lux Research (2007) The nanotech report: investment overview and market research for nanotechnology, 5th edn. Lux Research Inc., New York

    Google Scholar 

  • Marchant GE, Sylvester DJ, Abbott KW (2009a) What does the history of technology regulation teach us about nano oversight? J Law Med Ethics 37:724–731

    Article  Google Scholar 

  • Marchant GE, Sylvester DJ, Abbott KW (2009b) A new soft law approach to nanotechnology oversight: a voluntary product certification scheme. UCLA J Environ Law Policy (forthcoming). http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1483910 Accessed 2 Oct 2010

  • Maynard A (2009) Commentary: oversight of engineered nanomaterials in the workplace. J Law Med Ethics 37:651–658

    Article  Google Scholar 

  • McGarity TO (1992) Some thoughts on “deossifying” the rulemaking process. Duke Law J 41:1385–1462

    Article  Google Scholar 

  • McGarity T, Shapiro S (1993) Workers at risk: the failed promise of the occupational safety and health administration. Praeger, Westport

    Google Scholar 

  • Methner MM, Birch ME, Evans DE, Ku BK, Crouch K, Hoover MD (2007) Case study: identification and characterization of potential sources of worker exposure to carbon nanofibers during polymer composite laboratory operations. J Occup Environ Hyg 4:D125–D130

    Article  Google Scholar 

  • Munich Re Group (2002) Nanotechnology: what is in store for us? Münchener. Rückversicherungs-Gesellschaft AG, Munich

    Google Scholar 

  • Murashov V, Howard J (2008) The U.S. must help set international standards in nanotechnology. Nat Nanotechnol 3:635–636

    Article  CAS  Google Scholar 

  • Murashov V, Howard J (2009) Essential features for proactive risk management. J Nanopart Res 4:467–470

    CAS  Google Scholar 

  • Murashov V, Howard J (2010) Nanotechnology standards. Springer (forthcoming)

  • National Institute for Standards and Technology (2008) Eleventh annual report on federal agency use of voluntary consensus standards and conformity assessment. https://standards.gov/NTTAA/resources/nttaa_ar_2008.pdf. Accessed 2 Oct 2010

  • National Science Foundation (2006) Active Nanostructures and Nanosystems (ANN). Program solicitation NSF 06-595. http://www.nsf.gov/pubs/2006/nsf06595/nsf06595.htm. Accessed 2 Oct 2010

  • National Technology Transfer and Advancement Act (1996) (P.L. 104-113) 15 U.S.C. § 4301. http://standards.gov/standards_gov/nttaa.cfm Accessed 2 October 2010

  • Oberdörster G, Oberdörster E, Oberdörster J (2007) Concepts of nanoparticle dose metric and response metric. Environ Health Perspect 115:A290

    Article  Google Scholar 

  • Occupational Safety and Health Act of 1970, 29 U.S.C. §§ 651-678:2000

  • Occupational Safety and Health Act of 1970, 29 U.S.C. § 652(8):2000

  • Occupational Safety and Health Act of 1970, 29 U.S.C. § 667:2000

  • Ogden T (2010) REACH—how is it going? Ann Occup Hyg 54:1–4

    Article  Google Scholar 

  • OSHA (1989) Air contaminants. Federal Register 54:2332–2983 (January 19, 1989). http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=FEDERAL_REGISTER&p_id=12908. Accessed 2 Oct 2010

    Google Scholar 

  • Paradise J, Wolf SM, Kuzma J, Ramachandran G, Kokkoli E (2009a) Introduction: the challenge of developing oversight approaches to nanotechnology. J Law Med Ethics 37:543–545

    Article  Google Scholar 

  • Paradise J, Wolf SM, Kuzma J, Kuzhabekova A, Tisdale AW, Kokkoli E, Ramachandran G (2009b) Developing U.S. oversight strategies for nanobiotechnology: learning from past oversight experiences. J Law Med Ethics 37:688–705

    Article  Google Scholar 

  • Peters TM, Heitbrink WA, Evans DE, Slavin TJ, Maynard AD (2006) The mapping of fine and ultrafine particle concentrations in an engine machining and assembly facility. Ann Occup Hyg 50:1–9

    Article  Google Scholar 

  • Priest S, Greenbaugh T, Kramer V (2010) Risk perceptions starting to shift? U.S. citizens are forming opinions about nanotechnology. J Nanopart Res 12:11–20

    Article  Google Scholar 

  • Project on emerging nanotechnologies (PEN) (2010) consumer products inventory. http://www.nanotechproject.org/inventories/consumer/. Accessed 2 Oct 2010

  • Schulte PA, Murashov V, Zumwalde R, Kuempel ED, Geraci CL (2010) Occupational exposure limits for nanomaterials: state of the art. J Nanopart Res 12:1971–1987

    Article  CAS  Google Scholar 

  • Shvedova AA, Kisin ER, Murray AR, Johnson VJ, Gorelik O, Arepalli S, Hubbs AF, Mercer RR, Keohavong P, Sussman N, Jin J, Yin J, Stone S, Chen BT, Deye G, Maynard A, Castranova V, Baron PA, Kagan VE (2008) Inhalation versus aspiration of single walled carbon nanotubes in C57BL/6 mice: inflammation, fibrosis, oxidative stress and mutagenesis. Am J Physiol Lung Cell Mol Physiol 295:L552–L565

    Article  CAS  Google Scholar 

  • Shvedova AA, Kisin ER, Porter D, Schulte P, Kagan VE, Fadeel B, Castranova V (2009) Mechanisms of pulmonary toxicity and medical applications of carbon nanotubes: two faces of Janus? Pharm Ther 121:192–204

    Article  CAS  Google Scholar 

  • Subramanian V, Youtie J, Porter AL, Shapira P (2010) Is there a shift to “active nanostructures”? J Nanopart Res 12:1–10

    Article  Google Scholar 

  • Swiss Re (2004) Nanotechnology: small matter, many unknowns. http://www.asse.org/nanotechnology/pdfs/govupdate_02-3-05_nanosafety.pdf. Accessed 2 Oct 2010

  • Terrones M (2003) Science and technology of the 21st century: synthesis, properties, and applications of carbon nanotubes. Annu Rev Mater Res 33:419–501

    Article  CAS  Google Scholar 

  • Tsai SJC, Ashter A, Ada E, Mead JL, Barry CF, Ellenbecker MJ (2008) Airborne nanoparticle release associated with the compounding of nanocomposites using nanoalumina as fillers. Aerosol Air Qual Res 8:160–177

    CAS  Google Scholar 

  • Vincent JH (1998) International occupational exposure standards: a review and commentary. AIHA J 59:729–742

    Article  CAS  Google Scholar 

  • Wang J, Chen C, Liu Y et al (2008) Potential neurological lesion after nasal instillation of TiO2 nanoparticles in the anatase and rutile crystal phases. Toxicol Lett 183:72–80

    Google Scholar 

  • Wilson RF (2006) Nanotechnology: the challenge of regulating known unknowns. J Law Med Ethics 34:704–713

    Article  Google Scholar 

Download references

Acknowledgments

Preparation of this article was supported by National Science Foundation (NSF) grant #0608791, “NIRT: evaluating oversight models for active nanostructures and nanosystems: learning from past technologies in a societal context” (Principal investigator: S. M. Wolf; Co-PIs: E. Kokkoli, J. Kuzma, J. Paradise, and G. Ramachandran). The views expressed are those of the author and do not necessarily reflect the views of NSF, the National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, or the U.S. Department of Health and Human Services.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to John Howard.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Howard, J. Dynamic oversight: implementation gaps and challenges. J Nanopart Res 13, 1427–1434 (2011). https://doi.org/10.1007/s11051-011-0225-2

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11051-011-0225-2

Keywords

Navigation