FDA’s regulation of genetically engineered foods: Scientific, legal and political dimensions

The controversy over genetically engineered (GE) food during the southern Africa drought in 2002/03 raised questions concerning the safety of GE foods and the basis for the safety assurances issued by national and international agencies. In the case of foods grown in the US, these assurances must be interpreted in relation to the Food and Drug Administration’s (FDA) 1992 policy, which remains in effect today. This paper provides a detailed examination of the roles of scientific, legal and political considerations in the development of that policy.This paper reveals that the FDA responded to political pressure for a permissive regulatory approach by exploiting gaps in scientific knowledge, creatively interpreting existing food law and limiting public involvement in the policy’s development. Common statements by the government and other proponents concerning sound science, rigorous testing, no evidence of harm and “as safe as conventional foods” are found to be misleading unless the scientific, legal and political basis for the US policy is taken into account.While this paper finds that the evidence for the safety of GE foods has been exaggerated by government agencies and other parties, nothing in this paper suggests that GE foods currently on the market are harmful to human health. To the contrary, the situation is one of great uncertainty. Repeated recommendations that this issue be the topic of a major public research effort have yet to be acted upon.