Skip to main content

Advertisement

SpringerLink
Log in

Recommendations for oversight of nanobiotechnology: dynamic oversight for complex and convergent technology

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

Abstract

Federal oversight of nanobiotechnology in the U.S. has been fragmented and incremental. The prevailing approach has been to use existing laws and other administrative mechanisms for oversight. However, this “stay-the-course” approach will be inadequate for such a complex and convergent technology and may indeed undermine its promise. The technology demands a new, more dynamic approach to oversight. The authors are proposing a new oversight framework with three essential features: (a) the oversight trajectory needs to be able to move dynamically between “soft” and “hard” approaches as information and nano-products evolve; (b) it needs to integrate inputs from all stakeholders, with strong public engagement in decision-making to assure adequate analysis and transparency; and (c) it should include an overarching coordinating entity to assure strong inter-agency coordination and communication that can meet the challenge posed by the convergent nature of nanobiotechnology. The proposed framework arises from a detailed case analysis of several key oversight regimes relevant to nanobiotechnology and is informed by inputs from experts in academia, industry, NGOs, and government.

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

Access this article

Log in via an institution

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

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  • 21st Century Nanotechnology Research and Development Act. 15 U.S.C. § 7501 (2003)

  • Abbott KW, Marchant GE, Sylvester DJ (2006) A framework convention for nanotechnology? Environ Law Reporter 36:10931–10942

    Google Scholar 

  • Alexander LT (2009) Stakeholder participation in new governance: lessons from Chicago’s public housing reform experiment. Georgetown J Poverty Law Policy 16:117–185

    Google Scholar 

  • Beckstrom M (2010) The chemical revolt. Pioneer Press. Feb. 7, 2010

  • Birnbaum LS (2010) TSCA reform under way in congress. Environ Health Perspect 118:a106–a107. doi:10.1289/ehp.1001917

    Article  Google Scholar 

  • Bowman DM, Hodge GA (2006) Nanotechnology: mapping the wild regulatory frontier. Futures 38(9):1060–1073

    Article  Google Scholar 

  • Breggin LK, Carothers L (2006) Governing uncertainty: the nanotechnology environmental, health, and safety challenge. Columbia J Environ Law 31:286–329

    Google Scholar 

  • Center for Advancement of Informal Science Education (CAISE) (2009) Many experts, many audiences: public engagement with science and informal science education. A CAISE Inquiry Group Report. http://caise.insci.org/uploads/docs/public_engagement_with_science.pdf. Accessed 29 November 2010

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

    Article  Google Scholar 

  • Choi J, 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 FS, Gray GM, Bucher JR (2008) Transforming environmental health protection. Science 319:906–907

    Article  CAS  Google Scholar 

  • Crutchfield SR, Buzby JC, Roberts T, Ollinger M, Lin CTJ (1997) An economic assessment of food safety regulations: the new approach to meat and poultry inspection. Economic Research Service/USDA

  • Davies JC (2007) EPA and nanotechnology: oversight for the 21st century. Project on Emerging Nanotechnologies, Washington DC

  • Davies JC (2009) Oversight of next generation nanotechnology. Project on Emerging Nanotechnologies, Washington DC

  • Dryzek JS, Tucker A (2008) Deliberative innovation to different effect: consensus conferences in Denmark, France, and the United States. Public Admin Rev 68:864–876

    Article  Google Scholar 

  • DuPont, Environmental Defense (2007) Nano-risk framework. DuPont/Environmental Defense, Washington, DC

    Google Scholar 

  • Engel-Cox JA, Van Houten B, Phelps J, Rose SW (2008) Conceptual model of comprehensive research metrics for improved human health and environment. Environ Health Perspect 116:583–592

    Article  Google Scholar 

  • Environmental Protection Agency (EPA) (1998) Guidelines for ecological risk assessment. Federal Register 63:26846–26924

    Google Scholar 

  • Environmental Protection Agency (EPA) (2009a) Certain chemical substances; withdrawal of significant new use rules. Federal Register 40:42177–42178

    Google Scholar 

  • Environmental Protection Agency (EPA) (2009b) Proposed new rules on certain chemical substances. Federal Register 40:6160–6161

    Google Scholar 

  • ETC Group (2003) No small matter II: the case for a global moratorium. Occasional Paper Series 7(1). ETC Group, Ottawa

  • European Commission (2006) EC 1907/2006 REACH: what is reach? http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm. Accessed 29 November 2010

  • FDA Nanotechnology Task Force (2007) Nanotechnology: A Report of the U.S. Food and Drug Administration Nanotechnology Task Force. Food and Drug Administration, Washington, DC

    Google Scholar 

  • Federal Meat Inspection Act of 1906. Pub. L. 3913, 34 Stat. 674

  • Federal Plant Pest Act. 7 U.S.C §§ 150aa-150jj (1957) as amended 1968, 1981, 1983, 1988, and 1994

  • Fiorino DJ (1990) Citizen participation and environmental risk: a survey of institutional mechanisms. Sci Technol Human Values 15:226–243

    Article  Google Scholar 

  • Government Accountability Office (GAO) (2009) Chemical regulation: observations on improving the toxic substances control act. GAO-10-292T, Dec. 2, 2009

  • Greenwood M (2007) Thinking big about things small: creating and effective oversight system for nanotechnology. Project on Emerging Nanotechnologies, Washington, DC

  • Gunderson LH, Holling CS (2002) Panarchy: understanding transformations in human and natural systems. Island Press, Washington, DC

    Google Scholar 

  • Guston DH, Sarewitz D (2002) Real-time technology assessment. Technol Soc 24:93–109

    Article  Google Scholar 

  • Guthrie DM (2003) Engaged governance: an institutional approach to government-civil society engagement. http://unpan1.un.org/intradoc/groups/public/documents/un/unpan013171.pdf. Accessed 29 November 2010

  • Hamlett P, Cobb MD, Guston DH (2008) National citizens’ technology forum: nanotechnologies and human enhancement. CNS-ASU Report #R08-0003

  • Hendriks CM, Grin J (2006) Ground reflexive governance in practice and context: some democratic considerations. http://www.sozial-oekologische-forschung.org/_media/Hendriks_Grin.pdf. Accessed 29 November 2010

  • Holling CS (ed) (1978) Adaptive environmental assessment and management. John Wiley and Sons, London

    Google Scholar 

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

    Article  Google Scholar 

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

    Article  Google Scholar 

  • Inside EPA (2009) EPA poised to propose new reporting rules for nanomaterials. Dec. 25, 2009

  • International Center for Technology Assessment (ICTA) (2008) Citizen petition for rulemaking to the United States environmental protection agency. International Center for Technology Assessment, Washington, DC

    Google Scholar 

  • International Center for Technology Assessment (ICTA), Friends of the Earth (FOE) (2007) Principles for the oversight of nanotechnologies and nanomaterials. International Center for Technology Assessment, Washington, DC

    Google Scholar 

  • Kandlikar M, Ramachandran G, Maynard AD, Murdock B, Toscano WA (2007) Health risk assessment for nanoparticles: a case for using expert judgment. J Nanoparticle Res 9:137–156

    Article  Google Scholar 

  • Karkkainen BC (2005) Panarchy and adaptive change: around the loop and back again. Minnesota J Law Sci Technol 7:59–77

    Google Scholar 

  • Karkkainen BC (2006) Information-forcing environmental regulation. Fla State Univ Law Rev 33:861–902

    Google Scholar 

  • Keiner S (2008) Room at the bottom? Potential state and local strategies for managing the risks and benefits of nanotechnology. Project on Emerging Nanotechonologies, Washington, DC

  • Kuzma J (2006) Nanotechnology oversight: just do it. Environ Law Reporter 36:10913–10923

    Google Scholar 

  • Kuzma J, VerHage P (2006) Nanotechnology in agriculture and food protection. Project on Emerging Nanotechnologies, Washington, DC

  • Kuzma J, Romanchek J, Kokotovich A (2008) Upstream oversight assessment for agrifood nanotechnology. Risk Anal 28:1081–1098

    Article  Google Scholar 

  • Kuzma J, Larson J, Najmaie P (2009) Evaluating oversight systems for emerging technologies: a case study for genetically engineered organisms. J Law Med Ethics 37:546–586

    Article  Google Scholar 

  • Kysar DA (2004) Preferences for processes: the process/product distinction and the regulation of consumer choice. Harvard Law Rev 118:525–642

    Article  Google Scholar 

  • Linkov I, Satterstrom FK, Steevens J, Ferguson E, Pleus RC (2007) Multi-criteria decision analysis and environmental risk assessment for nanomaterials. J Nanoparticle Res 9:543–554

    Article  Google Scholar 

  • Lux Research (2007) The nanotech report, 5th edn. Lux Research Inc., New York

    Google Scholar 

  • Macoubrie J (2005) Informed public perception of nanotechnology and trust in government. Project on Emerging Nanotechnologies, Washington, DC

  • Macoubrie J (2006) Nanotechnology: public concerns, reasoning, and trust in government. Public Understanding Sci 15:221–241

    Article  Google Scholar 

  • Mandel GN (2009) Regulating emerging technologies. Law Innovation Technol 1:75–92

    Google Scholar 

  • Marchant GE, Sylvester D (2006) Transnational models for regulation of nanotechnology. J Law Med Ethics 34:714–725

    Article  Google Scholar 

  • Marchant GE, Sylvester DJ, Abbott KW (2008) Risk management principles for nanotechnology. Nanoethics 2:43–60

    Article  Google Scholar 

  • Maynard AD (2006) Nanotechnology: the next big thing, or much ado about nothing? Ann Occup Hyg 51:1–12

    Article  Google Scholar 

  • Meaney ME (2006) Lessons from the sustainability movement: toward an integrative decision-making framework for nanotechnology. J Law Med Ethics 34(4):682–688

    Article  Google Scholar 

  • National Nanotechnology Initiative (NNI) (2010) Supplement to the President’s 2011 Budget, Report prepared by National Science and Technology Council Committee of Technology, Subcommittee on Nanoscale Science, Engineering, and Technology, February 2010

  • National Nanotechnology Initiative Amendments Act of 2009. S.1482 §§ 6, 8, 11

  • National Research Council (NRC) (1983) Risk assessment in the federal government. National Academy Press, Washington, DC

    Google Scholar 

  • National Research Council (NRC) (1996) Understanding risk. National Academy Press, Washington, DC

    Google Scholar 

  • National Research Council (NRC) (2008) Evaluating research efficiency in the U.S. Environmental Protection Agency, National Academies Press, Washington, DC

    Google Scholar 

  • Neo BS, Chen G (2007) Dynamic governance: embedding culture, capabilities and change in Singapore. World Scientific, New Jersey

    Book  Google Scholar 

  • Office of Management, Budget (OMB) (2009) Federal Register 74:8819

    Google Scholar 

  • Office of Science and Technology Policy (OSTP) (1986) Coordinated framework for the regulation of biotechnology. Federal Register 51:23302–23393

  • Office of Science, Technology Policy (OSTP), Council on Environmental Quality (CEQ) (2001) CEQ and OSTP assessment: case studies of environmental regulations for biotechnology. Office of Science and Technology Policy, Washington, DC

    Google Scholar 

  • Office of Science, Technology Policy (OSTP), Council on Environmental Quality (CEQ) (2008) OSTP 2.0 critical upgrade enhanced capacity for White House science and technology policymaking: recommendations for the next president. Office of Science and Technology Policy, Washington, DC

    Google Scholar 

  • Olsen JP (2004) Citizens, public administration and the search for theoretical foundations. Polit Sci Polit 37:69–79

    Google Scholar 

  • Paradise J, Wolf SM, Ramachandran G, Kokkoli E, Hall R, Kuzma J (2008) Developing oversight frameworks for nanobiotechnology. Minnesota J Law Sci Technol 9:399–416

    Google Scholar 

  • Paradise J, Tisdale AW, Hall R, Kokkoli E (2009a) Evaluating oversight of human drugs and medical devices: a case study of the FDA and implications for nanobiotechnology. J Law Med Ethics 37:598–624

    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 

  • Philbrick M, Barandiaran J (2009) The national citizens’ technology forum: lessons for the future. Sci Public Policy 36:335–347

    Article  Google Scholar 

  • Powell MC, Kleinman DL (2008) Building citizen capacities for participation in nanotechnology decision-making: the democratic virtues of the consensus conference model. Public Underst Sci 17:329–348

    Article  Google Scholar 

  • Project on Emerging Nanotechnologies (PEN) (2007) Nanotechnology and life cycle assessment: A systems approach to nanotechnology and the environment. Project on Emerging Nanotechnologies, Washington DC

  • Roco MC (2008) Possibilities for global governance of converging technologies. J Nanoparticle Res 10:11–29

    Article  Google Scholar 

  • Rogers-Hayden T, Pidgeon N (2008) Developments in public participation in nanotechnology: towards sustainability. J Cleaner Prod 16:1010–1013

    Article  Google Scholar 

  • Scholz JT, Stiftel B (eds) (2005) Adaptive governance and water conflict. Resources for the Future Press, London

    Google Scholar 

  • Schot J, Rip A (1996) The past and future of constructive technology assessment. Technol Forecast Soc Change 54:251–268

    Article  Google Scholar 

  • Shatkin J (2008) Nanotechnology health and environmental risks. Taylor and Francis Group, LLC, Boca Raton, FL

    Book  Google Scholar 

  • Shaw SY, Westly EC, Pittet MJ, Subramanian A, Schreiber SL, Weissleder R (2008) Perturbational profiling of nanomaterial biologic activity. Proc Natl Acad Sci 105:7387–7392

    Article  CAS  Google Scholar 

  • Siegrist M (2000) The influence of trust and perceptions of risks and benefits on acceptance of gene technology. Risk Anal 20:195–203

    Article  CAS  Google Scholar 

  • Siegrist M, Keller C, Kastenholz H, Frey S, Wiek A (2007) Laypeople’s and experts’ perception of nanotechnology hazards. Risk Anal 27:59–69

    Article  Google Scholar 

  • Slovic P (1987) Perceptions of risk. Science 236:280–285

    Article  CAS  Google Scholar 

  • States’ Principles on Reform of the Toxic Substances Control Act, December 2, 2009, at http://www.saferchemicals.org/PDF/States%27_TSCA_Principles_TSCA_Reform_Principles_Signatures_FInal.pdf

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

    Article  Google Scholar 

  • Sunstein CR (2005) Group judgments: statistical means, deliberation, and information markets. New York University Law Rev 80:962–1049

    Google Scholar 

  • Tait J (2009) Upstream engagement and the governance of science: the shadow of the genetically modified crops experience in Europe. EMBO Reports 10:S18–S22

    Article  CAS  Google Scholar 

  • Tikhomorov A (2005) Engage governance and public policy during transition to a market economy. http://www.engagingcommunities2005.org/abstracts/Tikhomirov-Alexei-final.pdf. Accessed 29 November 2010

  • USDA-FSIS (1998) Preliminary pathways and data for a risk assessment of E. coli O157:H7 in beef. USDA-FSIS, Washington, DC

    Google Scholar 

  • Virus-Serum-Toxic Act 1985. 21 U.S.C. §§ 151-159

  • Voss JP, Kemp R (2005) Reflexive governance for sustainable development: incorporating feedback in social problem solving. Paper for ESEE Conference, June 14–17, 2005 in Lisbon

  • Wardak A, Gorman ME, Swami N, Deshpande S (2008) Identification of risks in the life cycle of nanotechnology-based products. J Ind Ecol 12:435–448

    Article  CAS  Google Scholar 

  • Wiener JB (2004) The regulation of technology, and the technology of regulation. Technol Soc 26:483–500

    Article  Google Scholar 

  • Wilsdon J, Willis R (2004) See through science: why public engagement needs to move upstream. Demos, London

    Google Scholar 

  • Wolf SM, Gupta R, Kohlhepp P (2009a) Gene therapy oversight: lessons for nanobiotechnology. J Law Med Ethics 37:659–684

    Article  Google Scholar 

  • Wolf SM, Ramachandran G, Kuzma J, Paradise J (eds) (2009b) Symposium on “Developing Oversight Approaches to Nanobiotechnology: The lessons of history. J Law Med Ethics 37:543–789

Download references

Acknowledgments

Preparation of this article was supported by the 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). Thanks are also due to Research Assistants Katie Wolf for work on Fig. 1 and Dan Lynch for work on capturing project group input.

Author information

Authors and Affiliations

  1. Division of Environmental Health Sciences, School of Public Health, University of Minnesota, Minneapolis, MN, 55455, USA

    Gurumurthy Ramachandran

  2. Consortium on Law and Values in Health, Environment & the Life Sciences; Law School; Medical School; Center for Bioethics, University of Minnesota, Minneapolis, MN, 55455, USA

    Susan M. Wolf

  3. Law School, Seton Hall University, Newark, NJ, 07102, USA

    Jordan Paradise

  4. Humphrey Institute of Public Affairs, University of Minnesota, Minneapolis, MN, 55455, USA

    Jennifer Kuzma

  5. Law School, University of Minnesota, Minneapolis, MN, 55455, USA

    Ralph Hall

  6. Department of Chemical Engineering and Materials Science, University of Minnesota, Minneapolis, MN, 55455, USA

    Efrosini Kokkoli

  7. Consortium on Law and Values in Health, Environment & the Life Sciences; Law School, University of Minnesota, Minneapolis, MN, 55455, USA

    Leili Fatehi

Authors
  1. Gurumurthy Ramachandran
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Susan M. Wolf
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Jordan Paradise
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Jennifer Kuzma
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Ralph Hall
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Efrosini Kokkoli
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Leili Fatehi
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Gurumurthy Ramachandran.

Additional information

The views expressed are those of the authors and do not necessarily reflect the views of NSF.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Ramachandran, G., Wolf, S.M., Paradise, J. et al. Recommendations for oversight of nanobiotechnology: dynamic oversight for complex and convergent technology. J Nanopart Res 13, 1345–1371 (2011). https://doi.org/10.1007/s11051-011-0233-2

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11051-011-0233-2

Keywords

Search

Navigation