Chapter 16 - Safety Assessment of Insect-Protected Cotton

Abstract

This chapter provides information on the methods for developing Bollgard cotton event 531 and a summary of the food, feed, and environmental safety studies that support the safety of the Bollgard cotton. It discusses molecular characterization, the safety of the produced proteins, food/feed composition, and environment. On the basis of this evaluation, Bollgard cotton and its processed factions are found to be comparable to conveniently bred cotton, taking into consideration the natural variation seen among cotton varieties. Cotton is the leading plant fiber crop in the world, and the most important in the United States. Lepidopteran insects are the main pest problem on most cotton grown in the U.S. The incorporation of Bt protein into cotton reduces and in some cases eliminates the need to spray insecticides. The chapter discusses how Bollgard cotton is produced and the analyses that are performed to assess its nutritional and compositional equivalence to conventional varieties. Its molecular characterization is analyzed. Cry1Ac and NPTII protein levels in Bollgard cotton are discussed and their safety assessed. A compositional analysis and nutritional assessment of Bollgard cotton is provided, horizontal gene transfer and the assessment of marker genes are described, and an environmental assessment is provided.