Risk Assessment of Genetically Modified Food and Neoliberalism: An Argument for Democratizing the Regulatory Review Protocol of the Food and Drug Administration
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The primary responsibility of the US Food and Drug Administration (FDA) is to protect public health by ensuring the safety of the food supply. To that end, it sometimes conducts risk assessments of novel food products, such as genetically modified (GM) food. The FDA describes its regulatory review of GM food (of both the plant and the animal variety) as a purely scientific activity, untainted by any normative considerations. This paper provides evidence that the regulatory agency is not justified in making that claim. It is argued that the FDA’s policy stance on GM food is shaped by neoliberal considerations. The agency’s review of a genetically engineered animal, the AquAdvantage salmon, is used as a case study to track the influence of neoliberalism on its regulatory review protocol. After that, an epistemic argument justifying public engagement in the risk assessment of new GM food is outlined. It is because risk evaluations involve normative judgments, in a democracy, layperson representatives of informal epistemic communities that could be affected by a new GM food should have the opportunity to decide the ethical, political or other normative questions that arise during the regulatory review of that entity.
KeywordsGenetically modified (GM) food Genetically engineered (GE) animals Neoliberalism Democracy US Food and Drug Administration (FDA) GM salmon
Research for this paper was funded by a Career Enhancement Grant from the University of Rhode Island’s Council for Research. I would also like to thank Jeffrey Burkhardt, the editor, for kindly extending the deadline for submitting the revised paper and the two anonymous reviewers for their comments.
- Aqua Bounty Technologies. (2010). Environmental assessment for AquAdvantage salmon. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/UCM224760.pdf. Accessed 12 July 2014.
- Cattani, D., de Liz Oliveira Cavalli, V. L., Heinz Rieg, C. E., Domingues, J. T., Dal-Cim, T., Tasca, C. I., et al. (2014). Mechanisms underlying the neurotoxicity induced by glyphosate-based herbicide in immature rat hippocampus: Involvement of glutamate excitotoxicity. Toxicology, 5(320), 34–45. doi: 10.1016/j.tox.2014.03.001.CrossRefGoogle Scholar
- Council on Environmental Quality and Office of Science and Technology Policy (CEQ/OSTP). (2001). CEQ/OSTP assessment: Case studies of environmental regulation for biotechnology. http://www.ostp.gov/html/012201.html. Accessed 11 June 2014.
- Domhoff, G. W. (2013). Wealth, income, and power. http://www2.ucsc.edu/whorulesamerica/power/wealth.html. Accessed 11 June 2014.
- Federal Register 13193. Executive Order 12291. 17 Feb 1981.Google Scholar
- Federal Register 10084. Volume 49. 31 December 1984.Google Scholar
- Federal Food, Drug, and Cosmetic Act. (FFDCA, 2004). 21 U.S.C. section, pp. 301–397.Google Scholar
- Food and Agriculture Organization (FAO) of the United Nations. (2008). The state of world fisheries and aquaculture. Electronic Publishing Policy and Support Branch Communication Division, FAO: Rome.Google Scholar
- FoodRisk.org. (2011). Biographies. http://foodrisk.org/irac/events/2003-09-30/bios/. Accessed 11 June 2014.
- Gilens, M., & Page, B. (2014). Testing theories of American politics: Elites, interest groups, and average citizens. Perspectives on Politics, forthcoming. http://www.princeton.edu/~mgilens/Gilens%20homepage%20materials/Gilens%20and%20Page/Gilens%20and%20Page%202014-Testing%20Theories%203-7-14.pdf. Accessed 8 June 2014.
- Goldburg, R. (2002). Testimony of Rebecca Goldburg, PhD, Environmental Defense, concerning marine aquaculture, before the US Commission on Ocean Policy. Boston, MA: Environmental Defense.Google Scholar
- Harvey, D. (2005). A brief history of neoliberalism. Oxford: Oxford University Press.Google Scholar
- Hempel, C. (1966). Philosophy of natural science. Englewood Cliffs NJ: Prentice-Hall.Google Scholar
- Hempel, C. (2001). Valuation and objectivity in science. In J. H. Fetzer (Ed.), The philosophy of Carl G. Hempel. Oxford: Oxford University Press.Google Scholar
- Hoffman, E. (2011). GE mosquito release “remains on indefinite hold”—But for how long? http://www.foe.org/news/blog/2012-05-ge-mosquito-release-remains-on-indefinite-hold. Accessed 11 June 2014.
- Jasanoff, S. (1991). Acceptable evidence in a pluralistic society. In D. G. Mayo & R. D. Hollander (Eds.), Acceptable evidence: Science and values in risk management (pp. 29–47). New York: Oxford UP.Google Scholar
- Jasanoff, S. (2003). A living legacy: the precautionary ideal in American law. In J. Tickner (Ed.), Precaution, environmental science, and preventive public policy (pp. 227–240). Washington, DC: Island Press.Google Scholar
- Jasanoff, S. (2005). Designs on nature: Science and democracy in Europe and the United States. Princeton, NJ: Princeton University Press.Google Scholar
- Jones, M. E. (1999). Politically corrected science: The early negotiation of U.S. agricultural biotechnology policy. (Dissertation).Google Scholar
- Longino, H. (1990). Science as social knowledge. Princeton University Press, NJ: Princeton University Press.Google Scholar
- Menozzi, D., Mora, C., & Merigo, A. (2012). Genetically modified salmon for dinner? Transgenic salmon marketing scenarios. AgBioForum,15(3), 276–293. http://www.agbioforum.org/v15n3/v15n3a04-menozzi.pdf. Accessed 8 June 2014.
- National Research Council (NRC). (1983). Risk assessment in the federal government. Washington, DC: National Academy Press.Google Scholar
- National Research Council (NRC). (2002). Animal biotechnology: Identifying science-based concerns. Washington, DC: National Research Council.Google Scholar
- Nelson, L. H. (1993). Epistemological Communities. In Linda Alcoff (Ed.), Feminist epistemologies. New York: Routledge.Google Scholar
- Nielson, K. (1984). Equality and liberty: A defense of radical egalitarianism. Allanheld: Rowman.Google Scholar
- Office of Science, Technology Policy (OSTP). (1986). Coordinated framework for regulation of biotechnology. Federal Register, 51, 23302–23393.Google Scholar
- Office of Science & Technology Policy, Executive Office of The President. (2001). Case study no. 1: Growth-enhanced salmon. Case Studies of Environmental Regulation for Biotechnology. http://www.whitehouse.gov/files/documents/ostp/Issues/ceq_ostp_study2.pdf. Accessed 11 June 2014.
- Pollack, A. (2010). Genetically altered salmon get closer to the table. NY Times. Business Day section, online edition. http://www.nytimes.com/2010/06/26/business/26salmon.html?pagewanted=all. Accessed 24 July 2014.
- President’s Council on Competitiveness. (1991). Report on national biotechnology policy. http://babel.hathitrust.org/cgi/pt?id=umn.31951003088116i;seq=5;view=1up;num=iii. Accessed 17 Mar 2013.
- Rabin, R. C. (2014). Labs are told to start including a neglected variable: Females. NY Times. http://www.nytimes.com/2014/05/15/health/nih-tells-researchers-to-end-sex-bias-in-early-studies.html?_r=1. Accessed 8 June 2014.
- Reagan, R. (1982). Message to the congress transmitting the annual economic report of the President. http://www.reagan.utexas.edu/archives/speeches/1982/21082a.htm. Accessed 11 June 2014.
- Schrader-Frechette, K. (1991). Risk and rationality: Philosophical foundations for populist reforms. California: University of California Press.Google Scholar
- Sunstein, C. R. (2002). Risk and reason. Cambridge: Cambridge University Press.Google Scholar
- Union of Concerned Scientists (UCS). (2001). Update on genetically engineered fish. www.ucsusa.org/food/upd-gefish.html. Accessed 12 Feb 2014.
- Unknown. (2013). AquaBounty cleared to produce salmon eggs in Canada for commercial purposes (Press release). Wall Street Journal. http://online.wsj.com/article/PR-CO-20131125-903183.html. Accessed 14 June 2014.
- US EPA. (unknown). Environmental assessments & environmental impact statements. http://www.epa.gov/reg3esd1/nepa/eis.htm. Accessed 11 June 2014.
- US FDA. (1999). Genetically engineered foods: Statement of James H. Maryanski before the Subcommittee on Basic Research House Committee on Science. October 19. http://www.fda.gov/newsevents/testimony/ucm115032.htm. Accessed 11 June 2014.
- US FDA. (2008). FDA’s response to public comment on the animal cloning risk assessment, risk management plan, and guidance for industry (Docket No. 2003 N-0573). Available at http://www.fda.gov/AnimalVeterinary/SafetyHealth/AnimalCloning/ucm055491.htm. Accessed 11 June 2014.
- US FDA (2009). Guidance for industry regulation of genetically engineered animals containing heritable recombinant DNA constructs final guidance. http://www.fda.gov/downloads/%20AnimalVeterinary/GuidanceComplianceEnforcement/%20%20GuidanceforIndustry/UCM113903.pdf. Accessed 11 June 2014.
- US FDA. (2010a). Charter of the Veterinary Medicine Advisory Committee. http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/ucm123835.htm 33.
- US FDA. (2010b). Transcript for the September 20, 2010 Veterinary Medicine Advisory Committee Meeting. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/UCM230471.pdf. Accessed 11 June 2014.
- US FDA. (unknown). About FDA: Trade secrets. http://www.fda.gov/downloads/AboutFDA/Transparency/PublicDisclosure/GlossaryofAcronymsandAbbreviations/UCM212053.pdf. Accessed 16 November 2012.
- US FDA. (unknown). About FDA: What we do. http://www.fda.gov/AboutFDA/WhatWeDo/default.htm. Accessed 11 June 2014.
- US FDA. (2012c). Briefing packet for AquAdvantage salmon Veterinary Medicine Advisory Committee. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/UCM224762.pdf. Accessed 11 June 2014.
- US FDA. (unknown). Advisory committees: Veterinary Medicine Advisory Committee. http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/default.htm. Accessed 14 June 2014.
- US FDA. (2014). Importation of Active Pharmaceutical Ingredients (APIs) Requirements FD&C Act 201(g) & (p) [21 USC 321(g) & (p)]: Definitions; generally (Tab B). http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ucm118000.pdf. Accessed 11 June 2014.
- US Congress, House of Representatives, Committee on Science and Technology. (1982). US science and technology under budget stress. US Government Printing Office, Washington, DC. December 10, 1981 and February 2, 3, 4, 1982. Hearings. 97/118.Google Scholar
- US DHHS, USDA, US EPA. (2011). Memorandum of understanding among Department of Health and Human Services, FDA, and Department of Agriculture, Animal and Plant Health Inspection Service, Biotechnology Regulation Services and EPA, Office of Chemical Safety and Pollution Prevention, Office of Pesticide Programs. 10-2000-0058-MU 225-11-0001. http://www.epa.gov/oppbppd1/biopesticides/pips/biotech-mou.pdf. Accessed 11 June 2014.
- USDA. (unknown). Dietary Guidance: MyPlate and Historical Food Pyramid Resources: Special Audience MyPlate Resources. http://fnic.nal.usda.gov/dietary-guidance/myplate-and-historical-food-pyramid-resources/special-audience-myplate-resources. Accessed 24 July 2014.
- World Health Organization. (2008). Guideline for the conduct of food safety assessment of foods derived from recombinant-DNA animals CAC/GL 68-2008. http://www.who.int/foodsafety/biotech/codex_taskforce/en/. Accessed 11 June 2014.
- Wynne, B. (1989). Sheep farming after Chernobyl: a case study in communicating scientific information. Environment, 31(2), 11–39.Google Scholar