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B. M. CHASSY, Office of Research, Univ. of Illinois, Urbana-Champaign, 1101 W. Peabody Dr., 238 National Soybean Research Center, MC-637, Urbana, IL 61801 The first Biotechnology-derived crops consisted primarily of varieties with improved agronomic characteristics. A newly emerging class of crops is being developed with a focus on improved human or animal nutrition, and a number of these have reached the field trial stage and/or are advancing through regulatory approval to commercialization. Nutritionally improved foods should be evaluated for their potential impact on human/animal nutrition and health regardless of the technology used to develop them. The evaluation includes assessing both the change in the composition of the individual foods/feeds or ingredients and the impact of the changes on the overall composition of the diets of the projected population(s). The safety assessment begins with a comparative assessment of the new food/feed with an appropriate comparator that has a history of safe use. Compositional analysis is the starting point for this assessment. Current approaches of targeted compositional analysis are recommended for the detection of any alterations. The list of components recommended by OECD plus additional components defined in the biosynthetic and catabolic pathways of the newly expressed trait should be compared for the improved crop and the appropriate conventional counterparts. For nutritionally enhanced or altered products, the dietary exposure to nutrient(s) whose content is changed should be estimated and the appropriate set of studies carried out to assess the nutritional quality and the safety of any newly expressed protein(s) and metabolites. Examples of such studies are structure-activity relationships, in vitro determinations of digestibility of the proteins and animal feeding studies with the relevant target species. It is concluded that the food safety and diet-health assessment methods currently employed are sufficiently robust to be applied to nutritionally enhanced novel foods.
Session 26, The safety and nutrional assessment of nutrionally improved crops
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