The Cry3A protein introduced into the Russet Burbank and Superior varieties has a long history of safe use. The Cry3A protein expressed in NewLeaf potato plants is indistinguishable from the Cry3A protein contained in microbial formulations that have been used safely commercially for the past six years (EPA 2000; Lüthy et al., 1982). These microbial formulations have been used on a wide variety of crops, including fresh produce like eggplant, potato and tomato, with no reported allergenic or toxic responses, establishing a basis for the lack of allergenic or toxic concern for the Cry3A protein. Cry3A and NPTII proteins have been shown to have no sequence similarity with known allergens or celiac disease and are considered safe and are not likely to cause harm to humans and animals. This was shown by mammalian digestive system model wherein the proteins were rapidly degraded and possible deactivated by digestive enzymes. Likewise, Bt.t. has no significant sequence similarity with known allergens or celiac disease.   Compositional studies of the potato tubers derived from NewLeaf lines showed that the nutritional properties of the potato tubers were substantially equivalent to those of conventional white potato varieties and that the tubers have normal low levels of naturally occurring anti-nutrients. The results of compositional analysis confirm that genetic improvement, through Agrobacterium mediated transformation, of NewLeaf potatoes’ nutrient composition is not altered from that of conventionally bred potatoes. As a result of the analyses of molecular characterization, protein safety and expression and nutrient composition, it was concluded that tubers produced by NewLeaf potato plants are as safe for consumption as conventional potatoes.