Genetically Modified Food & GRAS | jgersen | February 11, 2016


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Genetically Modified Food & GRAS

by jgersen Show/Hide

Genetically Modified foods are discussed elsewhere in this casebook as well. Our concern in this section is the relationship between GM food and safety. As should be no surprise by this point in the book, federal administrative responsibility for addressing genetic modification of foods is split among multiple agencies. The FDA has authority for food safety issues having to do with the GE plants and animals. The EPA has authority to address health and environmental effects and pest-protected plants. The USDA has authority for the effect of GM plans on other plants and animals.

In the 1980s, President Reagan created the Domestic Policy Council Working Group to develop a unifying framework for biotechnology. Guide to U.S. Regulation of Genetically Modified Food and Agricultural Biotechnology Products 5, Pew Initiative on Food and Biotechnology (2001). The process resulted in the “Coordinated Framework for the Regulation of Biotechnology.” The organizing principle of the Coordinated Framework was that existing legal and institutional structure could adequately address any concerns about genetic modification.


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  1. 1 Show/Hide More FDA 1992 GRAS Strategy
    Original Creator: jgersen

    In 1992, FDA announced a new policy under which the agency would presume that all GE foods were GRAS and therefore not subject to regulation as food additives. See Statement of Policy—Foods Derived from new Plant Varieties, 57 Fed. Reg 22984, 22986 (May 29, 1992). The policy did not require companies to submit products for review prior to bringing them to market.

    The key premise of FDA's policy is that the safety is best protected by focusing not on the means of production—genetic engineer or conventional techniques—but rather on the characteristics and features of a food. This so-called “product/process” distinction has resulted in the “substantial equivalence” doctrine. If the GE product is substantially the same as its conventional equivalent, it is not subject to differential regulation. Rather, the FDA simply advises that producers voluntarily consult with the agency prior to marketing.


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