Evaluation of compositional equivalence for multitrait biotechnology crops.

Compositional analysis is an important tool in the evaluation of the safety and nutritional status of biotechnology-derived crops. As part of the comparative assessment of a biotechnology-derived crop, its composition is evaluated by quantitative measurement of the levels of key nutrients, antinutrients, and secondary metabolites and compared to that of conventional crops. To evaluate the effect of combining multiple biotech traits through conventional breeding, the forage and grain compositions of the double combinations MON 810 × NK603, MON 863 × MON 810, and MON 863 × NK603 and the triple combination MON 863 × NK603 × MON 810 were compared to their respective near-isogenic, conventional control hybrids. Overall, a total of 241 statistical comparisons between the multitrait biotechnology crop and its corresponding conventional controls were conducted. Of these comparisons 192 (79.7%) were not statistically significantly different (p > 0.05), and all 49 of the differences were within the 99% tolerance interval for commercial hybrids grown in the same field or related field trials. These data on combined trait biotechnology-derived products demonstrated that the forage and grain were compositionally equivalent to their conventional comparators, indicating the absence of any influence of combining insect protection and herbicide tolerance traits by conventional breeding on compositional variation.

Comparison of the forage and grain composition from insect-protected and glyphosate-tolerant MON 88017 corn to conventional corn (Zea mays L.).

The next generation of biotechnology-derived products with the combined benefit of herbicide tolerance and insect protection (MON 88017) was developed to withstand feeding damage caused by the coleopteran pest corn rootworm and over-the-top applications of glyphosate, the active ingredient in Roundup herbicides. As a part of a larger safety and characterization assessment, MON 88017 was grown under field conditions at geographically diverse locations within the United States and Argentina during the 2002 and 2003-2004 field seasons, respectively, along with a near-isogenic control and other conventional corn hybrids for compositional assessment. Field trials were conducted using a randomized complete block design with three replication blocks at each site. Corn forage samples were harvested at the late dough/early dent stage, ground, and analyzed for the concentration of proximate constituents, fibers, and minerals. Samples of mature grain were harvested, ground, and analyzed for the concentration of proximate constituents, fiber, minerals, amino acids, fatty acids, vitamins, antinutrients, and secondary metabolites. The results showed that the forage and grain from MON 88017 are compositionally equivalent to forage and grain from control and conventional corn hybrids.

Comparison of the nutritional profile of glyphosate-tolerant corn event NK603 with that of conventional corn (Zea mays L.).

The composition of glyphosate-tolerant (Roundup Ready) corn event NK603 was compared with that of conventional corn grown in the United States in 1998 and in the European Union in 1999 to assess compositional equivalence. Grain and forage samples were collected from both replicated and nonreplicated field trials, and compositional analyses were performed to measure proximates, fiber, amino acids, fatty acids, vitamin E, nine minerals, phytic acid, trypsin inhibitor, and secondary metabolites in grain as well as proximates and fiber in forage. Statistical analysis of the data was conducted to assess statistical significance at the p < 0.05 level. The values for all of the biochemical components assessed for corn event NK603 were similar to those of the nontransgenic control or were within the published range observed for nontransgenic commercial corn hybrids. In addition, the compositional profile of Roundup Ready corn event NK603 was compared with that of traditional corn hybrids grown in Europe by calculating a 99% tolerance interval to describe compositional variability in the population of traditional corn varieties in the marketplace. These comparisons, together with the history of the safe use of corn as a common component of animal feed and human food, support the conclusion that Roundup Ready corn event NK603 is compositionally equivalent to, and as safe and nutritious as, conventional corn hybrids grown commercially today.