The Cry3Bb1 and CP4 EPSPS proteins have a low likelihood of adverse effects based on an assessment of their allergenic and toxicological potential. The donor organism for Cry3Bb1, Bacillus thuringiensis, has a history of safe use as a microbial insecticide since 1958. Since there are no receptors for Cry proteins in mammals, they do not show toxic effects to mammals.  The results of bioinformatics analyses indicate that Cry3Bb1 is not similar to known allergens, toxins or other pharmacologically active proteins relevant to animal or human health. Cry3Bb1 is readily digested and inactivated in simulated digestive matrices, hence no adverse effect to the biological activity of man and animals.
Acute oral toxicity assessment of Cry3Bb1 in mice, at a dose of 1930 mg/kg body weight showed no significant differences in food consumption, clinical abnormalities, mortality, body weight data and gross necropsy findings..
The donor organism for CP4 EPSPS, Agrobacterium sp. strain CP4, is not known to cause human pathogenicity or allergenicity.  The results of bioinformatics analyses indicate that CP4 EPSPS is not similar to known allergens, toxins or other pharmacologically active proteins relevant to animal or human health,.  CP4 EPSPS is rapidly digested in simulated digestive tract matrices.  Absence of both structural and immunological similarities of CP4 EPSPS with known allergens indicate that Cry3Bb1 is unlikely to be an allergen.
CP4 EPSPS produced no adverse effects at high dose in an acute oral rodent toxicity study.  The NOEL was found to be 572 mg/kg, the highest dose level tested.  These results show that the Cry3Bb1 and CP4 EPSPS proteins produced in MON 88017 will not cause adverse effects to human and animal health.