ABSTRACT

Compositional analysis is an important component of an integrated comparative approach to assessing the food and feed safety of new crops developed using biotechnology. As part of the safety assessment of cassava brown streak disease resistant 4046 cassava, a comprehensive assessment of proximates, minerals, amino acids, fatty acids, vitamins, anti-nutrients, and secondary metabolites was performed on leaf and storage root samples of 4046 cassava and its non-transgenic parental control, TME 204, collected from confined field trials in Kenya and Uganda over two successive cropping cycles. Among the 100 compositional components that were assessed in samples of 4046 and control TME 204 cassava roots (47 components) and leaves (53 components), there were no nutritionally relevant differences noted. Although there were statistically significant differences between the transgenic and control samples for some parameters, in most cases the magnitudes of these differences were small ($<$20%), and in every case where comparative literature data were available, the mean values for 4046 and control cassava samples were within the range of normal variation reported for the compositional component in question. Overall, no consistent patterns emerged to suggest that biologically meaningful adverse changes in the composition or nutritive value of the leaves or storage roots occurred as an unintended or unexpected consequence of the genetic modification resulting in 4046 cassava. The data presented here provide convincing evidence of the safety of 4046 cassava with respect to its biochemical composition for food and feed, and it could be considered as safe as its non-transgenic control.

摘要

成分分析是评估使用生物技术开发的新作物的食品和饲料安全的综合比较方法的重要组成部分。作为抗木薯褐条病 4046 木薯安全性评估的一部分，对 4046 木薯的叶和贮藏根样品进行了近似物、矿物质、氨基酸、脂肪酸、维生素、抗营养素和次生代谢物的综合评估。其非转基因亲本对照 TME 204 从肯尼亚和乌干达的密闭田间试验中收集，经过两个连续的种植周期。在 4046 和对照 TME 204 木薯根（47 种成分）和叶（53 种成分）的样品中评估的 100 种成分中，没有发现与营养相关的差异。$<$20%），并且在可获取比较文献数据的每种情况下，4046 和对照木薯样品的平均值都在所讨论的组成成分报告的正常变化范围内。总体而言，没有出现一致的模式表明叶子或储藏根的组成或营养价值的生物学上有意义的不利变化是导致 4046 木薯的基因改造的意外或意外结果。此处提供的数据提供了令人信服的证据，证明 4046 木薯在其食品和饲料生化成分方面的安全性，并且可以被认为与其非转基因对照一样安全。