Hostname: page-component-cd9895bd7-gxg78 Total loading time: 0 Render date: 2024-12-26T08:18:26.910Z Has data issue: false hasContentIssue false
  • English
  • Français

Problem Formulation and Option Assessment (PFOA) Linking Governance and Environmental Risk Assessment for Technologies: A Methodology for Problem Analysis of Nanotechnologies and Genetically Engineered Organisms

Published online by Cambridge University Press:  01 January 2021

Kristen C. Nelson ,
David A. Andow  and
Michael J. Banker
Get access Rights & Permissions [Opens in a new window]

Extract

Societal evaluation of new technologies, specifically nanotechnology and genetically engineered organisms (GEOs), challenges current practices of governance and science. When a governing body is confronted by a technology whose use has potential environmental risks, some form of risk analysis is typically conducted to help decision makers consider the range of possible benefits and harms posed by the technology. Environmental risk assessment (ERA) is a critical component in the governance of nanotechnology and genetically engineered organisms because the uncertainties and complexities surrounding these technologies pose such risk potential. However, GEOs are unique technologies, and there is widespread, international recognition (e.g., the Cartagena Protocol on Biosafety of Living Modified Organisms) that many traditional forms of ERA are not well-suited for evaluating them. Nanotechnology products are also likely to need different models of risk assessment, as there is very little information on their fate, transport, and impacts in the environment.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 37 , Issue 4 , Winter 2009 , pp. 732 - 748
Copyright
Copyright © American Society of Law, Medicine and Ethics 2009

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Wiesner, M. et al., “Assessing the Risk of Manufactured Nanomaterials,” Environmental Science and Technology 40, no. 14 (2006): 4336–4345; Andow, D. and Hilbeck, A., “Science-Based Risk Assessment for Non-Target Effects of Transgenic Crops,” BioScience 54, no. 7 (2004): 637-649.CrossRefGoogle Scholar
Convention on Biological Diversity, “Frequently Asked Questions on the Biosafety Protocol,” available at <http://www.bio-div.org/biosafety/faqs.shtml?area=biotechnology&faq=2> (last visited September 11, 2009); Secretariat of the Convention on Biological Diversity, Cartagena Protocol on Biosafety to the Convention on Biological Diversity, 2000; Munson, A., “Genetically Manipulated Organisms: International Policy-Making and Implications,” International Affairs 69, no. 3 (1993): 497–517.CrossRefGoogle Scholar
See Wiesner, et al., supra note 1; Klaine, S. J. et al., “Nanomaterials in the Environment: Behavior, Fate, Bioavailability and Effects,” Environmental Toxicology and Chemistry 27, no. 9 (2008): 1825–1851.Google Scholar
A point-source pollutant is one that is released into the environment at a particular place and time, such as factory and sewage effluents.Google Scholar
National Research Council (NRC), Risk Assessment in the Federal Government: Managing the Process (Washington, D.C.: National Academy Press, 1983).Google Scholar
Suter, G. W. II, Ecological Risk Assessment, 2nd ed. (Boca Raton, FL: CRC Press, 2007).Google Scholar
U.S. Presidential/Congressional Commission on Risk Assessment and Risk Management, Framework for Environmental Health Risk Management, Final Report, vol. 1 (1997), available through <http://www.riskworld.com/Nreports/1997/risk-rpt/pdf/EPAJAN.pdf> (last visited September 11, 2009).+(last+visited+September+11,+2009).>Google Scholar
National Research Council (NRC), Environmental Effects of Transgenic Plants (Washington, D.C.: National Academy Press, 2002).Google Scholar
See Andow, and Hilbeck, , supra note 1; Cairns, J. Jr. and Mount, D. I., “Aquatic Toxicology: Part 2 of a Four-Part Series,” Environmental Science and Technology 24, no. 2 (1990): 154–161; Elmegaard, N. and Jagers, A., Safety Factors in Pesticide Risk Assessment, Differences in Species and Acute-Chronic Relations, Silkeborg, Denmark, National Environmental Research Institute, NERI Technical Report 325 (2000); Forbes, V. E. and Forbes, T. L., Ecotoxicology in Theory and Practice (London: Chapman & Hall, 1994); Forbes, V. E. and Calow, P., “Extrapolation in Ecological Risk Assessment: Balancing Pragmatism and Precaution in Chemical Controls Legislation,” BioScience 52, no. 3 (2002): 249-257; Stark, J. D., Banks, J. E. and Vargas, R., “How Risky Is Risk Assessment: The Role that Life History Strategies Play in Susceptibility of Species to Stress,” Proceedings of the National Academy of Sciences 101, no. 3 (2004): 732-736; see Suter, , supra note 6.Google Scholar
Hill, R., “Conceptualizing Risk Assessment Methodology for Genetically Modified Organisms,” Environmental Biosafety Research 4, no. 2 (2005): 67–70.CrossRefGoogle Scholar
Levidow, L., “Democratizing Technology – Or Technologizing Democracy? Regulating Agricultural Biotechnology in Europe,” Technology in Society 20, no. 2 (1998): 211–226; Wynne, B., “Uncertainty and Environmental Learning: Reconceiving Science and Policy in the Preventative Paradigm,” Global Environmental Change 2, no. 2 (1992): 111-127.CrossRefGoogle Scholar
Levidow, L., Carr, S. and Wield, D., “Genetically Modified Crops in the European Union: Regulatory Conflicts as Precautionary Opportunities,” Journal of Risk Research 3, no. 3 (2000): 109–208; Stirling, A., “Opening Up or Closing Down: Analysis, Participation and Power in the Social Appraisal of Technology,” in Leach, M., Scoones, I. and Wynne, B., eds., Science, Citizenship and Globalisation (London: Zed Books, 2005): at 218-231.Google Scholar
Susskind, L., Levy, P. F. and Thomas-Larmer, J., Negotiating Environmental Agreements: How to Avoid Escalating Confrontation, Needless Costs, And Unnecessary Litigation (Washington, D.C.: Island Press, 2000).Google Scholar
Id.Google Scholar
Wagner, V. et al., “The Emerging Nanomedicine Landscape,” Nature Biotechnology 24, no. 10 (2006): 1211–1217; Oberdorster, G., Oberdorster, E. and Oberdorster, J., “Nanotoxicology; An Emerging Discipline Evolving from Studying of Ultrafine Particles,” Environmental Health Perspectives 113, no. 7 (2005): 823-839.CrossRefGoogle Scholar
Id. (Wagner, et al.).Google Scholar
Maynard, A. D., “Nanotechnology: The Next Big Thing or Much Ado About Nothing?” Annals of Occupational Hygiene 51, no. 1 (2007): 1–12; Kuzma, J. and VerHage, P., Nanotechnology in Agriculture and Food Production: Anticipated Applications, Woodrow Wilson International Center for Scholars, Washington, D.C., September 2006.Google Scholar
U.S. Environmental Protection Agency, “Guidelines for Ecological Risk Assessment,” EPA/630/R-925/002F, 1998, available at <http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=12460> (last visited September 11, 2009); U.S. Environmental Protection Agency, “Nanoscale Materials Stewardship Program,” available at <http://www.epa.gov/EPA-TOX/2008/January/Day-28/t1411.htm> (last visited September 11, 2009).+(last+visited+September+11,+2009);+U.S.+Environmental+Protection+Agency,+“Nanoscale+Materials+Stewardship+Program,”+available+at++(last+visited+September+11,+2009).>Google Scholar
Walters, L., “The Oversight of Human Gene Transfer Research,” Kennedy Institute of Ethics Journal 10, no. 2 (2000): 171–174; Zallen, D. T., “US Gene Therapy in Crisis,” Genetics & Society 16, no. 6 (2000): 272-275; Abbott, K. W., Marchant, G. E. and Sylvester, D. J., “A Framework Convention for Nanotechnology?” Environmental Law Reporter 36 (2006): 10931-10942.CrossRefGoogle Scholar
Tiedje, J. M., Colwell, R. K., Grossman, Y. L., Hodson, R. E., Lenski, R. E., Mack, R. M. and Regal, P. J., “The Planned Introduction of Genetically Engineered Organisms: Ecological Considerations and Recommendations,” Ecology 70, no. 2 (1989): 298–315.CrossRefGoogle Scholar
Thitai, G. N. W., Mbaratha-Rurigi, J., Gakuru, O. and Amuyunzu, P., Kenya Biosafety Framework, UNEP/GEF Pilot Biosafety Enabling Activity Project, National Council for Science and Technology, Nairobi, Kenya, 1999.Google Scholar
Traynor, P. L., Fredrick, R. J. and Koch, M., “Biosafety and Risk Assessment,” in Agricultural Biotechnology: A Workbook for Technical Training, The Agricultural Biotechnology Support Project, Institute of International Agriculture, Michigan State University, Lansing, MI, 2002.Google Scholar
Skorupinski, B., “Debating Risks and Hazards: About Deliberation and Deliberate Release,” in Breckling, B. and Verhoeven, R., eds., Risk Hazard Damage: Specification of Criteria to Assess Environmental Impact of Genetically Modified Organisms, Naturschutz und Biologische Vielfalt, vol. 1 (Bonn, Germany: Federal Agency for Nature Conservation, 2004).Google Scholar
Miller, H. I., “A Need to Reinvent Biotechnology Regulation at the EPA,” Science 266, no. 5192 (1994): 1815–1818; McLean, M. A., Frederick, R. J., Traynor, P. L., Cohen, J. I. and Komen, J. A., A Conceptual Framework for Implementing Biosafety: Linking Policy, Capacity and Regulation. International Service for National Agricultural Research Briefing Paper 47 (New York: ISNAR, 2002).CrossRefGoogle Scholar
Modified for nanotechnology, based on the PFOA methodology presented in Nelson, K. C. and Banker, M. J., “Problem Formulation and Option Assessment Handbook: Science-Guided MultiStakeholder Deliberation,” in Ecological Risk Assessment of Genetically Engineered Organisms, GMO-ERA Project, 2007, and applied to Bt corn in Kenya, Bt cotton in Brazil and Vietnam, and genetically engineered fish in multiple countries. The methodology was refined over time through workshops with scientists, managers, and government decision makers. See Nelson, K. C., Kibata, G., Muhammad, L., Okuro, J. O., Muyekho, F., Odindo, M., Ely, A. and Waquil, J., “Problem Formulation and Options Assessment (PFOA) for Genetically Modified Organisms: The Kenya Case Study,” in Hilbeck, A. and Andow, D. A., eds., Environmental Risk Assessment of Genetically Modified Organisms, Vol. 1: A Case Study of Bt Maize in Kenya (Wallingford, UK: CABI Publishing, 2004): at 57–82; Capalbo, D. M. F., Simon, M. F., Nodari, R. O., Valle, S., dos Santos, R. F., Coradin, L., de O. Duarte, J., Miranda, J. E., Dias, E. P. F., Quyen, L. Q., Underwood, D. and Nelson, K. C., “Consideration of Problem Formulation and Option Assessment for Bt Cotton In Brazil,” in Hilbeck, A., Andow, D. A. and Fontes, E. M. G., eds., Environmental Risk Assessment of Genetically Modified Organisms, Vol. 2: Methodologies for Assessing Bt Cotton in Brazil (Wallingford, UK: CABI Publishing, 2006): at 67-92; Nelson, K. C., Basiao, Z., Cooper, A., Dey, M., Hernandez, M. L., Kunawasen, S., Li, S., Fonticiella, D., Ratner, B. D., Toledo, M. I. and Leelapatra, W., “Problem Formulation and Options Assessment (PFOA): Science-Guided Deliberation in Ecological Risk Assessment of Transgenic Fish,” in Kapuscinski, A., Li, S., Hayes, K. and Dana, G., eds., Environmental Risk Assessment of Genetically Modified Organisms: Methodologies for Transgenic Fish (London: CABI Publications, 2007): at 29-60; Nguyen, V. U., Phan, V. C., Nguyen, V. B., Nhan, H. T., Quyen, L. Q., Hong, N. X., Sat, L. M., Wals, A., Capalbo, D. M. F. and Nelson, K. C., “Consideration of Problem Formulation and Option Assessment (PFOA) for Environmental Risk Assessment: Bt cotton in Vietnam,” in Andow, D., Hilbeck, A. and Tuat, N. V., eds., Environmental Risk Assessment of Genetically Modified Organisms: Challenges and Opportunities with Bt Cotton in Viet Nam (London: CABI Publications, 2008): at 64-78.Google Scholar
Id. (Nelson and Banker).Google Scholar
The GMO ERA Project is an initiative driven by public sector scientists, which responded to the expressed need for ERA methodologies better suited for genetically modified organisms. The project worked to develop comprehensive, transparent, scientific methodologies and processes for testing, monitoring, and regulating transgenic genetically modified organisms. Information about the project is available at <http://www.gmo-era.umn.edu> (last visited September 11, 2009).+(last+visited+September+11,+2009).>Google Scholar
See Nelson, and Banker, , supra note 25.Google Scholar
Paradise, J., Wolf, S. M., Kuzma, J., Kuzhabekova, A., Kokolli, E. and Ramachandran, G., “Developing U.S. Oversight Strategies for Nanobiotechnology: Learning from Past Oversight Experiences,” Journal of Law, Medicine & Ethics 37, no. 4 (2009): 688–705.CrossRefGoogle Scholar
Kuzma, J., Paradise, J., Ramachandran, G., Kim, J., Kokotovich, A. and Wolf, S. M., “An Integrated Approach to Oversight Assessment for Emerging Technologies,” Risk Analysis 28, no. 4 (2008): 1179–1195; Harsh, M., “Formal and Informal Governance of Agricultural Biotechnology in Kenya: Participation and Accountability in Controversy Surrounding the Draft Biosafety Bill,” Journal of International Development 17, no. 5 (2005): 661-667; see Levidow, et al., supra note 12.CrossRefGoogle Scholar
National Research Council (NRC), Understanding Risk: Informing Decisions in a Democratic Society (Washington, D. C.: National Academies Press, 1996).Google Scholar
Mills, T. J., Quigley, T. M. and Everest, F. J., “Science-Based Natural Resource Management Decisions: What Are They?” Renewable Resources Journal 19, no. 2 (2001): 10–15.Google Scholar
See Hill, , supra note 10.Google Scholar
See Skorupinski, , supra note 23; Irwin, A., “Constructing the Scientific Citizen: Science and Democracy in the Biosciences,” Public Understanding of Science 10, no. 1 (2001): 1–18. International Risk Governance Council, Risk Governance: Towards an Integrative Approach, White Paper No. 1, Geneva, 2005.Google Scholar
Hallerman, E. M. and Kapuscinski, A. R., “Incorporating Risk Assessment and Risk Management into Public Policies on Genetically Modified Finfish And Shellfish,” Aquaculture 137, no. 1 (1995): 9–17.CrossRefGoogle Scholar
Priest, S., “The North American Opinion Climate for Nanotechnology and Its Products: Opportunities and Challenges,” Journal of Nanoparticle Research 8, no. 5 (2006): 563–568.CrossRefGoogle Scholar
Maynard, A. D., “Nanotechnology: Managing the Risks,” Nano Today 1 (2006): 22–33; Maynard, A. D., Aitken, R. J., Butz, T., Colvin, V., Donaldson, K., Oberdorster, G., Philbert, M. A., Ryan, J., Seaton, A., Stone, V., Tinkle, S. S., Tran, L., Walker, N. J. and Warheit, D. B., “Safe Handling of Nanotechnology,” Nature 444, no. 16 (2006): 267-269; Maynard, A. D., “Nanotechnology: The Next Big Thing or Much Ado About Nothing?” Annals of Occupational Hygiene 51, no. 1 (2007): 1-12.CrossRefGoogle Scholar
Forester, J., The Deliberative Practitioner: Encouraging Participatory Planning Processes (Cambridge: MIT Press, 1999).Google Scholar
Id.Google Scholar
Susskind, L., Levy, P. F. and Thomas-Larmer, J., Negotiating Environmental Agreements: How to Avoid Escalating Confrontation, Needless Costs, and Unnecessary Litigation (Washington, D.C.: Island Press, 2000).Google Scholar
Stirling, A., “Opening Up or Closing Down: Analysis, Participation and Power in the Social Appraisal of Technology,” in Leach, M., Scoones, I. and Wynne, B., eds., Science, Citizenship and Globalisation (London: Zed Books, 2005): at 218–231.Google Scholar
European Food Safety Authority (EFSA), Environmental Risk Assessment of Genetically Modified Plants: Challenges and Approaches, EFSA Scientific Colloquium Summary Report 8Parma, Italy, 2008.Google Scholar
National Research Council (NRC), Understanding Risk: Informing Decisions in a Democratic Society (Washington, D.C.: National Academies Press, 1996).Google Scholar
Sagar, A., Daemmrich, A. and Ashiya, M., “The Tragedy of the Commoners: Biotechnology and Its Publics,” Nature Biotechnology 18, no. 1 (2000): 2–4.CrossRefGoogle Scholar
See Kuzma, J., Najmaie, P. and Larson, J., “Evaluating Oversight Systems for Emerging Technologies: A Case Study of Genetically Engineered Organisms,” Journal of Law, Medicine & Ethics 37, no. 4 (2009): 546–586; Paradise, J. et al., “Evaluating Oversight of Human Drugs and Medical Devices: A Case Study of the FDA and Implications for Nanobiotechnology,” Journal of Law, Medicine & Ethics 37, no. 4 (2009): 688-705; Young Choi, J. and Ramachandran, G., “Review of the OSHA Framework for Oversight of Occupational Environments,” Journal of Law, Medicine & Ethics 37, no. 4 (2009): 633-650; and Wolf, S. M., Gupta, R. and Kohlhepp, P., “Gene Therapy Oversight: Lessons for Nanobiotechnology,” Journal of Law, Medicine & Ethics 37, no. 4 (2009): 659-684.Google Scholar
Bingham, L. B., Nabatchi, T. and O'Leary, R., “The New Governance: Practices and Processes for Stakeholder and Citizen Participation in the Work of Government,” Public Administration Review 65, no. 5 (2005): 547–558; Hemmati, M., MultiStakeholder Processes for Governance and Sustainability: Beyond the Deadlock and Conflict (London: Earthscan Publications Inc., 2002).CrossRefGoogle Scholar
See supra note 44.Google Scholar
See Susskind, et al., supra note 13.Google Scholar
Id.Google Scholar
Bingham, L. B., Nabatchi, T. and O'Leary, R., “The New Governance: Practices and Processes for Stakeholder and Citizen Participation in the Work of Government,” Public Administration Review 65, no. 5 (2005): 547–558.CrossRefGoogle Scholar
O'Brien, M., Making Better Environmental Decisions: An Alternative to Risk Assessment, 3rd ed. (Cambridge: MIT Press, 2000).Google Scholar
Wondolleck, J. M. and Yaffee, S. L., Making Collaboration Work: Lessons from Innovation in Natural Resource Management (Washington, D.C.: Island Press, 2000).Google Scholar
Id.Google Scholar
Glover, D., Keeley, J., McGee, R., Newell, P., Da Costa, P., Ortega, A. R., Loureiro, M. and Lin, L. L., Public Participation in National Biosafety Frameworks: A Report for UNEP-GEF and DFID, Institute of Development Studies, Brighton, U.K., 2003.Google Scholar
See Bingham, et al., supra note 49.Google Scholar
UNEP-GEF, Report of the Subregional Workshops for Asian Countries on: Risk Assessment and Management and Public Awareness and Participation, UNEP-GEF Project on Development of National Biosafety Frameworks, Asian Countries Subregional Workshop, January 21–24, 2003, Kuala Lumpur, Malaysia, UNEP-GEF Biosafety Unit, Geneva, 2003; UNEP- GEF, Sub-Regional Workshop for Latin American Countries on: Development of a Regulatory Regime and Administrative Systems, UNEP-GEF Project on Development of National Biosafety Frameworks, Latin American Sub-Regional Workshop on Development of a Regulatory Regime and Administrative Systems, November 25–28, 2003, Santiago, Chile, UNEP-GEF Biosafety Unit, Geneva, 2003.Google Scholar
Macoubrie, J., Informed Public Perceptions of Nanotechnology and Trust in Government, Woodrow Wilson International Center for Scholars, Washington, D.C., 2005.Google Scholar
See Nelson, and Banker, , supra note 25.Google Scholar
Hilbeck, A. and Andow, D. A., eds., Environmental Risk Assessment of Genetically Modified Organisms, Vol. 1: A Case Study of Bt Maize in Kenya (Wallingford, U.K.: CABI Publishing, 2004); Hilbeck, A., Andow, D. A. and Fontes, E. M. G., eds., Environmental Risk Assessment of Genetically Modified Organisms, Vol. 2: Methodologies for Assessing Bt Cotton in Brazil (Wallingford, U.K.: CABI Publishing, 2006); Andow, D. A., Tuat, N. V. and Hilbeck, A., eds., Environmental Risk Assessment of Genetically Modified Organisms, Vol. 4: Challenges and Opportunities with Bt Cotton in Vietnam (Wallingford, U.K.: CABI Publishing, 2008).CrossRefGoogle Scholar