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Comparative safety assessment of genetically modified crops: focus on equivalence with reference varieties could contribute to more efficient and effective field trials
Transgenic Research ( IF 3 ) Pub Date : 2023-05-22 , DOI: 10.1007/s11248-023-00344-y
Gijs A Kleter 1 , Hilko van der Voet 2 , Jasper Engel 2 , Jan-Pieter van der Berg 1
Affiliation  

The initial compositional analysis of plants plays an important role within the internationally harmonized comparative safety assessment approach for genetically modified plants. Current EFSA guidance prescribes two types of comparison, namely difference tests with regard to a conventional comparator or control, and equivalence tests with regard to a collection of commercial reference varieties. The experience gained so far shows that most of the statistically significant differences between the test and control can be discounted based on the fact that they are still within equivalence limits of reference varieties with a presumed history of safe use. Inclusion of a test variety and reference varieties into field trial design, and of the statistical equivalence test would already suffice for the purpose of finding relevant parameters that warrant further assessment, hence both the inclusion of a conventional counterpart and the performance of difference testing can be omitted. This would also allow for the inclusion of safety testing regimes into plant variety testing VCU (value for cultivation and use) or other, independent variety trials.



中文翻译:

转基因作物的比较安全性评估:关注与参考品种的等效性有助于提高田间试验的效率和效果

植物的初始成分分析在国际统一的转基因植物比较安全评估方法中发挥着重要作用。目前的 EFSA 指南规定了两种类型的比较,即针对传统比较器或对照的差异测试,以及针对商业参考品种集合的等效性测试。迄今为止获得的经验表明,测试和对照之间的大多数统计显着差异可以被忽略,因为它们仍然在具有假定安全使用历史的参考品种的等效范围内。将测试品种和参考品种纳入田间试验设计以及统计等效性测试已经足以找到需要进一步评估的相关参数,因此可以包括常规对应物和差异测试的性能省略。这也将允许将安全测试制度纳入植物品种测试 VCU(栽培和使用价值)或其他独立品种试验中。

更新日期:2023-05-22
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