The US’ Food and Drug Administration, Normativity of Risk Assessment, GMOs, and American Democracy
- 482 Downloads
The process of risk assessment of biotechnologies, such as genetically modified organisms (GMOs), has normative dimensions. However, the US’ Food and Drug Administration (FDA) seems committed to the idea that such evaluations are objective. This essay makes the case that the agency’s regulatory approach should be changed such that the public is involved in deciding any ethical or social questions that might arise during risk assessment of GMOs. It is argued that, in the US, neither aggregative nor deliberative (representative) democracy ought to be used to make such determinations. Instead, participatory (deliberative) democracy should be the means by which members of the polity decide which normative concerns ought to underlie FDA’s assessment of GMOs. This paper uses a hypothetical case involving a new GM seed to make that argument.
KeywordsAgrifood biotechnologies Democracy Genetically modified organisms Normative Objectivity Risk assessment Scientific experts
Unable to display preview. Download preview PDF.
I would like to thank Cheryl Foster for her thoughtful comments on the first draft of the essay. I would also like to thank the three anonymous reviewers of an earlier version of this paper for their helpful comments and Richard Haynes for his careful editing of the final version. In addition, I would like to acknowledge that the impetus for this paper comes from my collaborative work with Inmaculada de Melo-Martin and builds on it.
- Barber, B. R. (1984). Strong democracy: Participatory politics for a new age. Berkeley: University of California Press.Google Scholar
- Cohen, J., & Rogers, J. (1983). On democracy: Toward a transformation of American society. New York: Penguin.Google Scholar
- Dahl, R. A. (1989). Democracy and its critics. US: Yale University Press.Google Scholar
- European Food Safety Authority. (EFSA). Home. Available at http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_home.htm.
- European Food Safety Authority (EFSA). (2008). Food safety, animal health and welfare and environmental impact of animals derived from cloning by somatic cell nucleus transfer (SCNT) and their offspring and products obtained from those animals. Available at http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/sc_op_ej767_animal_cloning_en.pdf?ssbinary=true.
- Fischhoff, B. (1996). Public values in risk research. Annals of the American Academy of Political and Social Science, 545, Challenges in Risk Assessment and Risk Management, 75–84.Google Scholar
- Freudenburg, W. R. (1996). Risky thinking: Irrational fears about risk and society. Annals of the American Academy of Political and Social Science, 545, Challenges in Risk Assessment and Risk Management, 44–53.Google Scholar
- Gaskell, G., Einsiedel, E., Priest, S., Eyck, T. T., Allum, N., & Torgersen, H. (2001). Troubled waters: The transatlantic divide on biotechnology policy. In G. Gaskell & M. Bauer (Eds.), Biotechnology 1996–1999: The years of controversy (pp. 96–115). London: Science Museum Press.Google Scholar
- Gutmann, A., & Thompson, D. (2004). Why deliberative democracy?. Princeton: Princeton University Press.Google Scholar
- Harvey, D. (2005). A brief history of neoliberalism. Oxford: Oxford University Press.Google Scholar
- Kunreuther, H. and Slovic, P. (1996). Science, values, and risk. Annals of the American Academy of Political and Social Science, 545, Challenges in Risk Assessment and Risk Management, 116–25.Google Scholar
- Lowi, T. J. (1989). The end of liberalism: The second republic of the United States. New York: Norton.Google Scholar
- Office of Science, Technology Policy (OSTP). (1986). Coordinated framework for regulation of biotechnology. Federal Register, 51, 23302–23393.Google Scholar
- Organization for Economic Co-operation and Development (OECD). (2000). Safety in Biotechnology News. 1 (23). Available at http://www.oecd.org/dataoecd/19/38/2412514.pdf.
- Polanyi, K. (2001 ). The great transformation. New York: Rinehart & Company.Google Scholar
- Richardson, H. S. (2002). Democratic autonomy: Public reasoning about the ends of policy. Oxford: Oxford University Press.Google Scholar
- Rollin, B. (1995). The Frankenstein syndrome: Ethical and social issues in the genetic engineering of animals. New York: Cambridge University Press.Google Scholar
- Schrader-Frechette, K. (1991). Risk and rationality: Philosophical foundations for populist reforms. Berkeley: University of California Press.Google Scholar
- U.S. Environmental Protection Agency (EPA). (2008). Step 2 - Dose-Response Assessment (DRAFT Mar 7, 2008). Retrieved 21 April 2008 from http://www.epa.gov/risk/dose-response.htm.
- U.S. FDA. (undated) FDA’s mission statement. Available at http://www.fda.gov/opacom/morechoices/mission.html.
- U.S. FDA (2008a). Animal cloning: A risk assessment. Rockville, MD: Department of Health and Human Services. Available at http://www.fda.gov/cvm/Documents/CloningRiskAssessment_FINAL.pdf.
- U.S. FDA (2008b). FDA’s response to public comment on the animal cloning risk assessment, risk management plan, and guidance for industry (Docket No. 2003N-0573). Available at http://www.fda.gov/cvm/CloningRA_FDAResponse.htm.
- U.S. Food and Drug Administration (FDA). (1992). Statement of policy: Foods derived from new plant varieties. Federal Register 57(104), 22984–23005. Retrieved 29 May 2008 from http://www.cfsan.fda.gov/~lrd/bio1992.html.
- Wagner, W., Krongerger, N., Gaskell, G., Allansdottir, A., Allum, N., de Cheveigne, S., et al. (2001). Nature in disorder: The troubled public of biotechnology. In G. Gaskell & M. Bauer (Eds.), Biotechnology 1996–1999: The years of controversy (pp. 80–95). London: Science Museum Press.Google Scholar