ABSTRACT

In May 1995, NewLeaf Russet Burbank potatoes became the first genetically modified, insect-resistant crop to receive full federal approval for commercialization. NewLeaf potato plants express the Cry3A protein derived from Bacillus thuringiensis subsp. tenebrionis (Cry3A), which is selectively active against certain Coleopteran insects including the Colorado potato beetle (CPB). Three federal agencies evaluated various aspects of NewLeaf potatoes, including their food quality (FDA), potential for becoming a plant pest (USDA), and the human, environmental and non-target safety of the Cry3A protein itself (EPA). The EPA was the lead agency in this process, and their evaluation was as rigorous as that conducted for conventional pesticides. However, unlike their reviews of previous microbial or chemical insecticides, the EPA also considered the risk of insect resistance development to NewLeaf potatoes as part of their regulatory assessment.