Corteva Agriscience, Agriculture Division of DowDuPont, USA , 9330 Zionsville Road , Indianapolis , Indiana 46268 , United States.
Corteva Agriscience, Agriculture Division of DowDuPont, USA , 8325 Northwest 62nd Avenue , Johnston , Iowa 50131 , United States.
J Agric Food Chem. 2019 Apr 10;67(14):4080-4088. doi: 10.1021/acs.jafc.9b00156. Epub 2019 Mar 28.
The European Food Safety Authority (EFSA) oversees the safety assessment of genetically engineered (GE) crops in the European Union and has developed a study design and statistical approach for assessing the compositional equivalency between a GE crop and the corresponding non-GE crop on the basis of the results from a small number of concurrently grown reference lines. Confidence limits around the differences in mean analyte composition between the GE variety and the reference lines are compared with equivalence limits on the basis of the variability of the reference lines. Here, we evaluated the performance and consistency of the equivalence conclusions using a non-GE variety that is, by definition, equivalent to the non-GE crop. Using this approach across the same analytes with the same non-GE variety, it was found that equivalence could not be concluded for 19.7, 22.9, 25.4, and 53.5% of the analytes in four separate studies. In addition, equivalency conclusions for the same analyte often differed from study to study. These results call into question the consistency and value of this approach in the risk assessment of GE crops.
欧洲食品安全局（EFSA）负责监督欧盟内基因工程（GE）作物的安全性评估，并制定了研究设计和统计方法，用于根据少数同时种植的参照系的结果，评估 GE 作物与相应的非 GE 作物在组成上的等效性。根据参照系的变异性，将 GE 品种与参照系之间平均分析物组成差异的置信限与等效限进行比较。在这里，我们使用一种非 GE 品种来评估等效结论的性能和一致性，根据定义，该品种与非 GE 作物等效。使用相同的非 GE 品种和相同的分析物，在四项独立研究中，有 19.7%、22.9%、25.4%和 53.5%的分析物无法得出等效结论。此外，对于同一分析物的等效结论往往因研究而异。这些结果质疑了这种方法在 GE 作物风险评估中的一致性和价值。
