Food and feed safety assessment of crops developed through plant biotechnology: overview and case study
2001
Fuchs, R. | Astwood, J. (Monsanto Co., St. Louis, Missouri (USA))
To date, a number of plant biotechnology products have been approved by regulatory agencies in numerous countries around the world. Over 125 million hectares of plant varieties derived through biotechnology have been planted in 13 countries around the world. These products have been extensively tested and assessed to assure the food, feed and environmental safety of these crops and the products derived from these crops. The general approach to assess the food and feed safety of plant biotechnology products involves: rigorous molecular characterization to define the inserted DNA, extensive compositional analyses of the biotech product compared to conventional plant varieties to assess for unintended changes in key nutrients and/or anti-nutrient, detailed biochemical and function characterization of the newly expressed proteins, assessment of this history of safe use of the newly expressed protein or related protein(s), and assessment of the potential of the newly expressed protein(s) to be toxic or cause allergy. In addition, the nutritional equivalence and animal feed performance of the food or feed product relative to the products from conventional plant varieties is often evaluated in appropriately designed animal feed performance (not safety) trials. A specific case study, using Bt corn, will be used to describe, in detail, the types and extend of data generated and submitted to regulatory agencies around the world to gain regulatory approval of this product
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