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The US’ Food and Drug Administration, Normativity of Risk Assessment, GMOs, and American Democracy

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Abstract

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.

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Acknowledgments

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.

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Correspondence to Zahra Meghani.

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Meghani, Z. The US’ Food and Drug Administration, Normativity of Risk Assessment, GMOs, and American Democracy. J Agric Environ Ethics 22, 125–139 (2009). https://doi.org/10.1007/s10806-008-9133-6

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