Safety assessment of EPA+DHA canola oil by fatty acid profile comparison to various edible oils and fat-containing foods and a 28-day repeated dose toxicity study in rats.

The omega-3 long-chain polyunsaturated fatty acids (LC-PUFAs) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are recognized for their health-promoting qualities. Marine fish and fish oil currently provide the main sources of EPA and DHA for human consumption. An alternative plant-based source of EPA and DHA is provided by EPA + DHA canola event LBFLFK (LBFLFK). A comparative analysis and a 28-day toxicity study assessed the safety of LBFLFK refined, bleached, and deodorized (RBD) oil. Thirty-one different commercially-obtained fat and oil samples were tested, and principal component analysis showed that the overall fatty acid profile of LBFLFK RBD oil was most similar to Mortierella alpina oil and salmon flesh. Samples with the fewest differences in the presence or absence of individual fatty acids compared to LBFLFK RBD oil were menhaden oil and some other fish oils. In a 28-day toxicity study, LBFLFK RBD oil was administered by oral gavage to male and female Wistar rats. No signs of toxicity were evident and no adverse effects were noted in clinical observations, clinical pathology, or histopathology. Overall, these studies support the safety of LBFLFK RBD oil as a source of EPA and DHA for human consumption.

Bringing a transgenic crop to market: where compositional analysis fits.

In the process of developing a biotechnology product, thousands of genes and transformation events are evaluated to select the event that will be commercialized. The ideal event is identified on the basis of multiple characteristics including trait efficacy, the molecular characteristics of the insert, and agronomic performance. Once selected, the commercial event is subjected to a rigorous safety evaluation taking a multipronged approach including examination of the safety of the gene and gene product - the protein, plant performance, impact of cultivating the crop on the environment, agronomic performance, and equivalence of the crop/food to conventional crops/food - by compositional analysis. The compositional analysis is composed of a comparison of the nutrient and antinutrient composition of the crop containing the event, its parental line (variety), and other conventional lines (varieties). Different geographies have different requirements for the compositional analysis studies. Parameters that vary include the number of years (seasons) and locations (environments) to be evaluated, the appropriate comparator(s), analytes to be evaluated, and statistical analysis. Specific examples of compositional analysis results will be presented.

Health and nutritional status of Wistar rats following subchronic exposure to CV127 soybeans.

This subchronic duration feeding study evaluated the nutritional and health status of rats fed diets containing CV127 at incorporation levels of 11% and 33%. For control comparisons, rats were also exposed to similar incorporation levels of the near isogenic conventional soybean variety (Conquista) and two other conventional soybean varieties (Monsoy, Coodetec). In spite of phenotypic differences among these four soybean varieties, there were no quantitative differences in their respective proximate and other compositional properties, including proteins, amino acids, antinutrients and nutritional cofactors. All diets were prepared by blending the respective processed soybean meal with ground Kliba maintenance meal at high (33%) and low (11%) incorporation levels, and the blended diets were fed to Wistar rats for about 91 days. Although there were some isolated parameters indicating statistically significant changes, these lacked consistency and a plausible mechanism and were thus assessed to be incidental. The totality of results demonstrate that CV127 soybeans are similar with respect to their nutritional value and systemic effects as its near isogenic conventional counterpart, as well as other conventional soybean varieties. Hence, introduction of AHAS gene into soybeans does not substantially alter its compositional properties, nor adversely affect its nutritional or safety status to mammals.