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NanoEthics

, Volume 2, Issue 2, pp 149–162 | Cite as

Ethics of Risk Analysis and Regulatory Review: From Bio- to Nanotechnology

  • Jennifer KuzmaEmail author
  • John C. Besley
Original Paper

Abstract

Risk analysis and regulatory systems are usually evaluated according to utilitarian frameworks, as they are viewed to operate “objectively” by considering the health, environmental, and economic impacts of technological applications. Yet, the estimation of impacts during risk analysis and the decisions in regulatory review are affected by value choices of actors and stakeholders; attention to principles such as autonomy, justice, and integrity; and power relationships. In this article, case studies of biotechnology are used to illustrate how non-utilitarian principles are prominent in risk analysis and regulatory review and to argue that these relationships should be carefully considered as we consider nanotechnology oversight systems for its products. We argue that there are not distinct separations between “science-based” review systems, in which evaluations of the consequences of technological products are primarily considered, and principles of integrity, justice, non-maleficence, and autonomy. It should further be expected that, given research into fair treatment during decision-making processes, attention to ethics will affect how citizens assess emerging technologies. Finally, a more holistic approach for evaluating oversight systems for the products of nanotechnology is suggested, one which does not draw a sharp distinction between risk analysis, regulation, and respect for non-utilitarian values.

Keywords

Agricultural biotechnology Risk Regulation Nanotechnology 

Notes

Acknowledgements

This work was in part supported by National Science Foundation NIRT grant SES-0608791 (Wolf, Kokkoli, Kuzma, Paradise, Ramachandran, co-PIs). Any opinions, findings, and conclusions or recommendations expressed in this material are those of the authors and do not necessarily reflect the views of the National Science Foundation.

References

  1. 1.
    Adams JS (1965) Inequity in social exchange. In: Berkowitz L (ed) Advances in Experimental Social Psychology. Academic Press, New York, pp 267–299Google Scholar
  2. 2.
    Ag BiotechBuzz (2002a) Journal and Mexican government disagree over corn contamination. Volume 2, Issue 4. April 30. Retrieved August 8, 2007 from http://pewagbiotech.org/buzz/display.php3?StoryID=55
  3. 3.
    AgBiotech Buzz (2002b) Of famine and food aid: GM food internationally global GM volume 2, issue 9, spotlight, October 2. Retrieved August 8, 2007 from http://pewagbiotech.org/buzz/print.php3?StoryID=77
  4. 4.
    APHA (2002) Preserving right-to-know information and encouraging hazard reduction to reduce the risk of exposure to toxic substances. APHA, Washington, DC (November 13). Policy number 2002–2003. Retrieved August 8, 2007 from http://www.apha.org/legislative/policy/policysearch/index.cfm?fuseaction=view&id=279
  5. 5.
    Beauchamp TL, Walters L (1999) Ethical theory and bioethics. In: Beauchamp T, Walters L (eds) Contemporary issues in bioethics. 5th edn. Wadsworth, Belmont, CA, pp 1–32Google Scholar
  6. 6.
    Beauchamp TL, Childress JF (2001) Principles of biomedical ethics, 5th edn. Oxford University Press, Oxford, UKGoogle Scholar
  7. 7.
    Bekelman JE, Li Y, Gross CP (2003) Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA 289:454–465CrossRefGoogle Scholar
  8. 8.
    Besley JC, McComas KA (2005) Framing justice: using the concept of procedural justice to advance political communication research. Commun Theory 15(4):414–436CrossRefGoogle Scholar
  9. 9.
    Besley JC, McComas KA, Waks L (2006) Media use and the perceived justice of local science authorities. Journal Mass Commun Q 83(4):801–818Google Scholar
  10. 10.
    Bohannon J (2002) Zambia rejects GM corn on scientists’ advice. Science 298:1153–1154CrossRefGoogle Scholar
  11. 11.
    Bozeman B, Sarewitz D (2005) Public values and public failure in U.S. Science policy. Sci Public Policy 32(2):119–136CrossRefGoogle Scholar
  12. 12.
    Burkhardt J (2001) The GMO debates: taking ethics seriously. Retrieved August 8, 2007 from http://www.farmfoundation.org/2001NPPEC/burkhardt.pdf
  13. 13.
    CNS-ASU (2005) RTTA program 3: deliberation and participation. Retrieved December 31, 2007 from http://cns.asu.edu/program/rtta3.htm
  14. 14.
    CNS-UCSB (2007) Education and public engagement. Retrieved January 3, 2007 from http://www.cns.ucsb.edu/education-public-engagement/
  15. 15.
    Cho M, Bero L (1996) The quality of drug studies published in symposium proceedings. Ann Intern Med 124:495–489Google Scholar
  16. 16.
    Cobb MD, Macoubrie J (2004) Public perceptions about nanotechnology: risks benefits and trust. J Nanopart Res 6:395–405CrossRefGoogle Scholar
  17. 17.
    Colquitt JA (2001) On the dimensionality of organizational justice: A construct validation of a measure. J Appl Psychol 86(3):386–400CrossRefGoogle Scholar
  18. 18.
    Colquitt JA, Shaw JC (2005) How should organizational justice be measured? In: Greenberg J, Colquitt JA (eds) Handbook of Organizational Justice. Lawrence Erlbaum Associates, Mahwah, NJ, pp 113–152Google Scholar
  19. 19.
    Colquitt JA, Greenberg J, Zapata-Phelan CP (2005) What is organizational justice? A historical overview. In: Greenberg J, Colquitt JA (eds) Handbook of organizational justice. Lawrence Erlbaum, Mahwah, NJ, pp 3–58Google Scholar
  20. 20.
    Davies C (2006) Managing the effects of nanotechnology. PEN 2, Washington, DC. Retrieved August 8, 2007 from project on emerging nanotechnologies website: www.nanotechproejct.org
  21. 21.
    Davies C (2007) EPA and nanotechnology: oversight for the 21st century. PEN 9, Washington, DC. Retrieved August 8, 2007 from project on emerging nanotechnologies website: www.nanotechproejct.org
  22. 22.
    Ebbesen M, Andersen S, Besenbacher F (2006) Ethics in nanotechnology: starting from scratch? Bull Sci Technol Soc 26(6):451–462CrossRefGoogle Scholar
  23. 23.
    Einsiedel EF, Goldenberg L (2006) Dwarfing the social? Nanotechnology lessons from the biotechnology front. In: Hunt G, Mehta M (eds) Nanotechnology: risk, ethics, and law. Earthscan, London, UK, pp 213–221Google Scholar
  24. 24.
    EPA (1983) Guidelines for performing regulatory impact analysis, EPA-230-01-84-003. US Government Printing Office, Washington, DCGoogle Scholar
  25. 25.
    EPA (2007) Nanoscale materials stewardship program and inventory status of nanoscale substances under the Toxic Substances Control Act; notice of availability. Fed Regist 72(133):38083–38085 JulyGoogle Scholar
  26. 26.
    EOP (1993) Executive office of the president: regulatory review and planning, executive order 12866. Federal Register 58(190):51735–51744 OctoberGoogle Scholar
  27. 27.
    FDA (1995) U. S. food and drug administration center for food safety and applied nutrition CFSAN handout: 1995 FDA’S policy for foods developed by biotechnology. Retrieved August 8, 2007 from http://vm.cfsan.fda.gov/∼lrd/biopolcy.html
  28. 28.
    FDA (2007) Nanotechnology: a report of the U.S. food and drug administration nanotechnology task force, July 25, 2007. Retrieved August 8, 2007 from http://www.fda.gov/nanotechnology/taskforce/report2007.pdf
  29. 29.
    Gastil J, Levine P (eds) (2005) The deliberative democracy handbook: strategies for effective engagement in the twenty-first century. Jossey-Bass, San Francisco, CAGoogle Scholar
  30. 30.
    Greenberg J (1993) The social side of fairness: Interpersonal and informational classes of organizational justice. In: Cropanzano R (ed) Justice in the Workplace: Approaching Fairness in Human Resource Management. Erlbaum, Hillsdale, NJ, pp 79–103Google Scholar
  31. 31.
    Guston DH, Sarewitz D (2002) Real-time technology assessment. Technol Soc 24:93–109CrossRefGoogle Scholar
  32. 32.
    Gutmann A, Thompson D (2004) Why deliberative democracy. Princeton University Press, Princeton, NJGoogle Scholar
  33. 33.
    Hart PD (2006) Attitudes toward nanotechnology. Woodrow Wilson International Center, Washington DC (September). Retrieved August 8, 2007 from http://www.nanotechproject.org
  34. 34.
    ICTA (2007) International Center for Technology Assessment (ICTA) (2007). Principles for the oversight of nanotechnologies and nanomaterials. August 5, 2007. Retrieved August 8, 2007 from http://www.icta.org/doc/Principles%20for%20the%20Oversight%20of%20Nanotechnologies%20and%20Nanomaterials_final.pdf
  35. 35.
    James C (2007) Global status of commercialized biotech/GM crops: 2006. ISAAA Brief 35–2006Google Scholar
  36. 36.
    Joss S, Belluci S (eds) (2002) Participatory technology assessment: European perspectives. Athenaeum, Gateshead, UKGoogle Scholar
  37. 37.
    Kaiser J (2007) Stung by controversy, biomedical groups urge consistent guidelines. Science 317:441CrossRefGoogle Scholar
  38. 38.
    Khushf G (2004) The ethics of nanotechnology: vision and values for a new generation of science and engineering. In: Emerging technologies and ethical issues in engineering: papers from a workshop, October 14–15, 2003. National Academies Press, Washington, DC, pp 29–56Google Scholar
  39. 39.
    Krimsky S, Rothenberg LS, Stott P, Kyle G (1998) Scientific journals and their authors’ financial interests: a pilot study. Psychother Psychosom 67:194–201CrossRefGoogle Scholar
  40. 40.
    Kuzma J (2006) Nanotechnology oversight: just do it. Environ Law Rep 36:10913–10923Google Scholar
  41. 41.
    Kuzma J (2007) Moving forward responsibility: oversight for the nanotechnology biology interface. J Nanopart Res 9:65–182Google Scholar
  42. 42.
    Kuzma J, Romanchek J, Kokotovich A (2007) Upstream oversight assessment for agrifood nanotechnology: a case studies approach. Risk Analysis (in press)Google Scholar
  43. 43.
    Lane N, Kalil T (2005) The national nanotechnology initiative: present at the creation. Issues Sci Technol 21(4):51–52 SummerGoogle Scholar
  44. 44.
    Lee CJ, Scheufele DA, Lewenstein BV (2005) Public attitudes toward emerging technologies—examining the interactive effects of cognitions and affect on public attitudes toward nanotechnology. Sci Commun 27(2):240–267CrossRefGoogle Scholar
  45. 45.
    Lewenstein B (2005) What counts as a ‘social and ethical issue’ in nanotechnology? HYLE 11(1):5–18Google Scholar
  46. 46.
    Losey JE, Rayor LS, Carter ME (1999) Transgenic pollen harms monarch larvae. Nature 399:214CrossRefGoogle Scholar
  47. 47.
    Macnaghten P, Kearnes MB, Wynne B (2005) Nanotechnology, governance, and public deliberation: what role for the social sciences? Sci Commun 27(2):268–291CrossRefGoogle Scholar
  48. 48.
    Macoubrie J (2005) Informed public perceptions of nanotechnology and trust in government. Projects on emerging nanotechnologies, Woodrow Wilson International Center for Scholars. Retrieved August 8, 2007 from http://www.wilsoncenter.org/index.cfm?topic_id=166192&fuseaction=topics.event_summary&event_id=143410, September
  49. 49.
    Macoubrie J (2006) Nanotechnology: public concerns, reasoning, and trust in government. Public Underst Sci 15:221–241CrossRefGoogle Scholar
  50. 50.
    Mann C (2002a) Has GM corn ‘invaded’ Mexico? Science 295:1617–1618CrossRefGoogle Scholar
  51. 51.
    Mann C (2002b) Transgene data deemed unconvincing. Science 296:236–237CrossRefGoogle Scholar
  52. 52.
    Maynard A (2006) Nanotechnology: a research strategy for addressing risk. Project on emerging nanotechnologies: Washington DC. Retrieved August 8, 2007 from http://www.nanotechproject.org
  53. 53.
    McComas KA, Trumbo CW, Besley JC (2007) Public meetings about suspected cancer clusters: the impact of voice, interactional justice, and risk perception on attendees’ attitudes in six communities. J Health Commun 12:527–549CrossRefGoogle Scholar
  54. 54.
    Miller HI, Conko G (2001) Precaution without principle. Nat Biotechnol 19:302–303CrossRefGoogle Scholar
  55. 55.
    Miller HI (2002) Nescience, not science, from the academy. Scientist 16(19):12–14Google Scholar
  56. 56.
    Morgan G, Henrion M (1990) The nature and sources of uncertainty. In: Morgan G, Henrion M (eds) Uncertainty. Cambridge University Press, Cambridge, pp 16–46Google Scholar
  57. 57.
    Michigan State University (MSU) (2005) First international IFAS conference on nanotechnology. What can nano learn from bio? Lessons from the debate over agrifood biotechnology and GMOs, October 26–27, 2005, at Michigan State University (USA). Retrieved August 8, 2007 from http://www.ifas.msu.edu/nanoconference.htm
  58. 58.
    National Nanotechnology Initiative (NNI) (2007) What is nanotechnology? Retrieved on June 5, 2007, from http://www.nano.gov/html/facts/whatIsNano.html
  59. 59.
    Nelson R, Weiss R (1999) Hasty decisions in the race to a cure?: Gene therapy study proceeded despite safety, ethics concerns,” Washington Post, November 21, p A1Google Scholar
  60. 60.
    National Research Council (NRC) (1996) Understanding risk. National Academy, Washington, DCGoogle Scholar
  61. 61.
    National Research Council (NRC) (2000) Genetically modified pest-protected plants: Science and regulation. National Academy, Washington, D.C.Google Scholar
  62. 62.
    National Research Council (NRC) (2002) Environmental effects of transgenic plants. National research council. National Academy, Washington, D.C.Google Scholar
  63. 63.
    OMBWatch (2007) Assistance for 10.219: biotechnology risk assessment research, (FY 2000–2006) Retrieved August 8, 2007 from http://www.fedspending.org/faads/faads.php?&cfda_program_num=10.219&sortby=u&datype=T&reptype=a&database=faads&detail=2
  64. 64.
    Office of Science and Technology Policy (OSTP) (2000) Food and agricultural biotechnology initiatives: strengthening science-based regulation. May 3, 2000. Retrieved August 8, 2007 from http://clinton4.nara.gov/WH/EOP/OSTP/html/0058.html
  65. 65.
    Pidgeon N (2006) Opportunities and uncertainties—the British nanotechnologies report and the case for upstream societal dialogue. Conference-paper: VALDOR. Stockholm, Sweeden. Retrieved August 8, 2007 from http://www.congrex.com/valdor2006/papers/53_Pidgeon.pdf
  66. 66.
    Pew Initiative on Food and Biotechnology (PIFB) (2002) Three years later: lessons learned from the monarch butterfly controversy. Retrieved August 8, 2007 from http://pewagbiotech.org/resources/issuebriefs/monarch.pdf
  67. 67.
    Pew Initiative on Food and Biotechnology (PIFB) (2003a) Have genes, will travel. Retrieved August 8, 2007 from http://pewagbiotech.org/resources/issuebriefs/geneflow.pdf
  68. 68.
    Pew Initiative on Food and Biotechnology (PIFB) (2003b) University-industry relationship: framing the issues for academic research in agricultural biotechnology. Retrieved August 8, 2007 from http://pewagbiotech.org/research/UIR.pdf
  69. 69.
    Pew Initiative on Food and Biotechnology (PIFB) (2005) An examination of the trade issues surrounding genetically modified food. Retrieved August 8, 2007 from http://pewagbiotech.org/resources/issuebriefs/useu.pdf
  70. 70.
    Press E, Washburn J (2000) The kept university. Atl Mon 285:39–54Google Scholar
  71. 71.
    Quist D, Chapela I (2001) Transgenic DNA introgressed into traditional maize landraces in Oaxaca, Mexico. Nature 414:541–543CrossRefGoogle Scholar
  72. 72.
    Rendtorff JD, Kemp P (2000) Basic ethical principles in European bioethics and biolaw, vol i–ii. Institut Borja di bioètica and Centre for Ethics and Law, Barcelona and CopenhagenGoogle Scholar
  73. 73.
    Rendtorff JD (2002) Basic ethical principles in European bioethics and biolaw: autonomy, dignity, integrity and vulnerability—towards a foundation of bioethics and biolaw. Med Health Care Philos 5:235–244CrossRefGoogle Scholar
  74. 74.
    Rodenmeyer M (2002) Corn fight: science suffers when the debate gets personal. San Francisco Chronicle, Tuesday, April 30Google Scholar
  75. 75.
    Rowe G, Frewer LJ (2004) Evaluating public-participation exercises: a research agenda. Sci Technol Human Values 29(4):512–557CrossRefGoogle Scholar
  76. 76.
    Rollin B (1986) The Frankenstein thing. In: Evans JW, Hollaender A (eds) Genetic engineering of animals: an agricultural perspective. Plenum, New York, pp 285–298Google Scholar
  77. 77.
    The Royal Society and Royal Academy of Engineering (2004) Nanoscience and nanotechnologies: opportunities and uncertainties. The Royal Society, London JulyGoogle Scholar
  78. 78.
    Science (2003) On campus. Science 302:2065Google Scholar
  79. 79.
    Sears MK, Hellmich RL, Stanley-Horn DE, Oberhauser KS, Pleasants JM, Mattila HR, Siegfriedi BD, Dively GP (2001) Impact of Bt corn pollen on monarch butterfly populations: a risk assessment. PNAS 98:11937–11942CrossRefGoogle Scholar
  80. 80.
    Shrader-Frechete K (2007) Nanotoxicology and ethical considerations for informed consent. Nanoethics 1:47–56CrossRefGoogle Scholar
  81. 81.
    Singer P, Daar AS (2000) Avoiding frankendrugs. Nat Biotechnol 18:1225CrossRefGoogle Scholar
  82. 82.
    Singer PA, Salamanca-Buentello F, Daar AS (2005) Harnessing nanotechnology to improve global equity. Issues in Science and Technology 21(4):57–64 SummerGoogle Scholar
  83. 83.
    Skokstad E (2005) Embattled Berkeley ecologist wins tenure. Science 308:1239CrossRefGoogle Scholar
  84. 84.
    SourceWatch (2007) Government-industry revolving door. Retrieved August 8, 2007 from http://www.sourcewatch.org/index.php?title=Government-industry_revolving_door
  85. 85.
    Stitch S (1978) The recombinant DNA debate. Philos Public Aff 7:187–205Google Scholar
  86. 86.
    Taylor MR (2003) Rethinking U.S. leadership in food biotechnology. Nat Biotechnol 21:852–854CrossRefGoogle Scholar
  87. 87.
    Taylor M, Tick JS (2003) Post-market oversight of biotech foods. Pew initiative on food and biotechnology. Retrieved August 8, 2007 from http://www.pewagbiotech.org
  88. 88.
    Taylor MR (2006) Regulating the products of nanotechnology: does FDA have the tools it needs? Project on emerging nanotechnologies. Washington, DC: PEN 5. Retrieved August 7, 2007 from http://www.nanotechproject.org
  89. 89.
    Thompson P (2007) Food biotechnology in ethical perspective, 2nd edn. Springer, Dordrecht, NetherlandsGoogle Scholar
  90. 90.
    Toumey C (2006) Science and democracy. Nature Nanotechnol 1:6–7CrossRefGoogle Scholar
  91. 91.
    Tyler TR, Boeckmann RJ, Smith HJ, Huo YJ (1997) Social justice in a diverse society. Westview, Boulder, COGoogle Scholar
  92. 92.
    USDA (2007) Adoption of genetically engineered crops in the U.S. Retrieved August 8, 2007 from http://www.ers.usda.gov/Data/BiotechCrops/
  93. 93.
    Valent F, Little DA, Bertollini R, Nemer LE, Barbanc G, Tamburlini G (2004) Burden of disease attributable to selected environmental factors and injury among children and adolescents in Europe. Lancet 363:2032–2039CrossRefGoogle Scholar
  94. 94.
    Wilsdon J, Willis R (2004) See-through science. Demos, London Retrieved August 8, 2007 from www.demos.co.uk

Copyright information

© Springer Science+Business Media B.V. 2008

Authors and Affiliations

  1. 1.Center for Science, Technology and Public Policy, Humphrey Institute of Public AffairsUniversity of MinnesotaMinneapolisUSA
  2. 2.School of Journalism and Mass CommunicationsUniversity of South CarolinaColumbiaUSA

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