Results of a 13-week safety assurance study with rats fed grain from corn rootworm-protected, glyphosate-tolerant MON 88017 corn

Presented are the results of a 13-week rat feeding study with grain from MON 88017 corn (brand name YieldGard VT Rootworm/RR2 (TM)), protected from feeding damage caused by corn rootworm and tolerant to glyphosate, the active ingredient in Roundup (R) agricultural herbicides. Corn rootworm protection is accomplished through the introduction of cryBb1 coding sequence from Bacillus thuringiensis into the corn genome for in planta production of a bioactive form of Cry3Bb1 protein. Also included in the genome is the coding sequence for the CP4 EPSPS protein from Agrobacterium sp. strain CP4 that confers glyphosate herbicidal tolerance. MON 88017 was formulated into rodent diets at 11 or 33% (w/w) levels with its near isogenic control at a level of 33% (w/w). Additionally, six diets containing grain from different conventional (non-biotechnology-derived), reference hybrids were formulated, each at 33% (w/w) levels of one of six reference grains. All diets were nutritionally balanced and conformed to PMI specifications for Certified LabDiet (R) 5002 (PMI Certified LabDiet 5002 is a registered trademark of Purina Mills, Inc.). The responses of rats fed diets containing MON 88017 were comparable to those of rats fed a diet containing grain from its near isogenic control. This study complements extensive agronomic, compositional, and farm animal feeding studies with MON 88017 grain, confirming that it is as safe and nutritious as grain from existing commercial corn hybrids. (C) 2008 Elsevier Ltd. All rights reserved.