Journal of Nanoparticle Research

, Volume 13, Issue 4, pp 1427–1434 | Cite as

Dynamic oversight: implementation gaps and challenges

  • John Howard
Special Focus: Governance of Nanobiotechnology


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.


Benzene Hard law approaches International standards Nanobiotechnology Nanotoxicology National Technology Transfer and Advancement Act Occupational Safety and Health Act Occupational safety and health standard REACH Soft law approaches Governance 



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.


  1. 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 5:676–682CrossRefGoogle Scholar
  2. American Federation of Labor-Congress of Industrial Organizations v. OSHA, 965 F.2d 962 (11th Cir. 1992)Google Scholar
  3. Arnall AH (2003) Future technologies today’s choices. Greenpeace Environmental Trust, LondonGoogle Scholar
  4. Bell C, Marrapese M (2011) Nanotechnology standards and international legal considerations. In: Murashov V, Howard J (eds) Nanotechnology standards. Springer, New YorkGoogle Scholar
  5. Choi JY, Ramachandran G (2009) Review of the OSHA framework for oversight of occupational environments. J Law Med Ethics 37:633–650CrossRefGoogle Scholar
  6. Choi JY, Ramachandran G, Kandlikar M (2009) The impact of toxicity testing costs on nanomaterial regulation. Environ Sci Technol 43:3030–3034CrossRefGoogle Scholar
  7. Collins PG, Avouris P (2000) Nanotubes for electronics. Sci Am 283:62–69CrossRefGoogle Scholar
  8. Davies CJ (2009) Oversight of next generation nanotechnology. Project on Emerging Technologies, Washington, DC. Accessed 2 Oct 2010
  9. 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. Accessed 2 Oct 2010
  10. 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 20:1–9CrossRefGoogle Scholar
  11. Hansen ST, Maynard A, Baun A et al (2008) Late lessons from early warnings about nanotechnology. Nat Nanotechnol 3:444–447Google Scholar
  12. 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. Accessed 2 Oct 2010
  13. 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. Accessed 2 Oct 2010
  14. Howard J, Murashov V (2009) National nanotechnology partnership to protect workers. J Nanopart Res 11:1673–1683CrossRefGoogle Scholar
  15. Industrial Union Department vs. American Petroleum Institute (1980) 44 U.S. 607Google Scholar
  16. International Center for Technology Assessment (ICTA) (2008) Principles for the oversight of nanotechnologies and nanomaterials. International center for technology assessment, Washington, DC. Accessed 2 Oct 2010
  17. International Risk Governance Council (IRCG) (2007) Policy brief: nanotechnology risk governance. International risk governance council, Geneva. Accessed 2 Oct 2010
  18. Kuhlbusch TAJ, Fissan H (2006) Particle characteristics in the reactor and pelletizing areas of carbon black production. J Occup Environ Health 3:558–567Google Scholar
  19. Lin AC (2007) Size matters: regulating nanotechnology. Harvard Environ Law Rev 31:350–408Google Scholar
  20. Lux Research (2007) The nanotech report: investment overview and market research for nanotechnology, 5th edn. Lux Research Inc., New YorkGoogle Scholar
  21. Marchant GE, Sylvester DJ, Abbott KW (2009a) What does the history of technology regulation teach us about nano oversight? J Law Med Ethics 37:724–731CrossRefGoogle Scholar
  22. 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). Accessed 2 Oct 2010
  23. Maynard A (2009) Commentary: oversight of engineered nanomaterials in the workplace. J Law Med Ethics 37:651–658CrossRefGoogle Scholar
  24. McGarity TO (1992) Some thoughts on “deossifying” the rulemaking process. Duke Law J 41:1385–1462CrossRefGoogle Scholar
  25. McGarity T, Shapiro S (1993) Workers at risk: the failed promise of the occupational safety and health administration. Praeger, WestportGoogle Scholar
  26. 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–D130CrossRefGoogle Scholar
  27. Munich Re Group (2002) Nanotechnology: what is in store for us? Münchener. Rückversicherungs-Gesellschaft AG, MunichGoogle Scholar
  28. Murashov V, Howard J (2008) The U.S. must help set international standards in nanotechnology. Nat Nanotechnol 3:635–636CrossRefGoogle Scholar
  29. Murashov V, Howard J (2009) Essential features for proactive risk management. J Nanopart Res 4:467–470Google Scholar
  30. Murashov V, Howard J (2010) Nanotechnology standards. Springer (forthcoming)Google Scholar
  31. National Institute for Standards and Technology (2008) Eleventh annual report on federal agency use of voluntary consensus standards and conformity assessment. Accessed 2 Oct 2010
  32. National Science Foundation (2006) Active Nanostructures and Nanosystems (ANN). Program solicitation NSF 06-595. Accessed 2 Oct 2010
  33. National Technology Transfer and Advancement Act (1996) (P.L. 104-113) 15 U.S.C. § 4301. Accessed 2 October 2010
  34. Oberdörster G, Oberdörster E, Oberdörster J (2007) Concepts of nanoparticle dose metric and response metric. Environ Health Perspect 115:A290CrossRefGoogle Scholar
  35. Occupational Safety and Health Act of 1970, 29 U.S.C. §§ 651-678:2000Google Scholar
  36. Occupational Safety and Health Act of 1970, 29 U.S.C. § 652(8):2000Google Scholar
  37. Occupational Safety and Health Act of 1970, 29 U.S.C. § 667:2000Google Scholar
  38. Ogden T (2010) REACH—how is it going? Ann Occup Hyg 54:1–4CrossRefGoogle Scholar
  39. OSHA (1989) Air contaminants. Federal Register 54:2332–2983 (January 19, 1989). Accessed 2 Oct 2010Google Scholar
  40. Paradise J, Wolf SM, Kuzma J, Ramachandran G, Kokkoli E (2009a) Introduction: the challenge of developing oversight approaches to nanotechnology. J Law Med Ethics 37:543–545CrossRefGoogle Scholar
  41. 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 37:688–705CrossRefGoogle Scholar
  42. 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 50:1–9CrossRefGoogle Scholar
  43. Priest S, Greenbaugh T, Kramer V (2010) Risk perceptions starting to shift? U.S. citizens are forming opinions about nanotechnology. J Nanopart Res 12:11–20CrossRefGoogle Scholar
  44. Project on emerging nanotechnologies (PEN) (2010) consumer products inventory. Accessed 2 Oct 2010
  45. Schulte PA, Murashov V, Zumwalde R, Kuempel ED, Geraci CL (2010) Occupational exposure limits for nanomaterials: state of the art. J Nanopart Res 12:1971–1987CrossRefGoogle Scholar
  46. 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–L565CrossRefGoogle Scholar
  47. 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 121:192–204CrossRefGoogle Scholar
  48. Subramanian V, Youtie J, Porter AL, Shapira P (2010) Is there a shift to “active nanostructures”? J Nanopart Res 12:1–10CrossRefGoogle Scholar
  49. Swiss Re (2004) Nanotechnology: small matter, many unknowns. Accessed 2 Oct 2010
  50. Terrones M (2003) Science and technology of the 21st century: synthesis, properties, and applications of carbon nanotubes. Annu Rev Mater Res 33:419–501CrossRefGoogle Scholar
  51. 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 8:160–177Google Scholar
  52. Vincent JH (1998) International occupational exposure standards: a review and commentary. AIHA J 59:729–742CrossRefGoogle Scholar
  53. 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 183:72–80Google Scholar
  54. Wilson RF (2006) Nanotechnology: the challenge of regulating known unknowns. J Law Med Ethics 34:704–713CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media B.V.(outside the USA) 2011

Authors and Affiliations

  1. 1.National Institute for Occupational Safety and Health, Centers for Disease Control and PreventionU.S. Department of Health and Human ServicesWashingtonUSA

Personalised recommendations