Biometris, Wageningen University & Research, Droevendaalsesteeg 1, 6708 PB, Wageningen, the Netherlands.
Biometris, Wageningen University & Research, Droevendaalsesteeg 1, 6708 PB, Wageningen, the Netherlands.
Food Chem Toxicol. 2021 Oct;156:112517. doi: 10.1016/j.fct.2021.112517. Epub 2021 Aug 17.
The evaluation of compositional characteristics of plants harvested from field trials is an important step in the safety assessment of a genetically modified crop and its derived products for food and feed. The European Food Safety Authority (EFSA) evaluates safety by testing for equivalence between the GM genotype and other genotypes, typically with a history of safe use. Here, a new equivalence test is proposed, which addresses issues with the EFSA test. The method is motivated by a recently proposed equivalence test for analysis of data from animal feeding trials. In order to be suitable for practical safety assessment, the new method has a statistical power set to a desired value, e.g. 95%, by construction. In addition, we assess distributions rather than average values. This way, equivalence limits can also be established when there is limited genotypic variation. The original EFSA equivalence test breaks down in this case. The method is illustrated by its application to data from a field study on maize grain. Simulation studies indicate that the proposed test has appropriate performance characteristics and is competitive with respect to recently proposed alternatives, including the EFSA/EU equivalence test.
对田间试验中收获的植物的组成特征进行评估，是对转基因作物及其衍生食品和饲料进行安全性评估的重要步骤。欧洲食品安全局（EFSA）通过测试转基因基因型与其他通常具有安全使用历史的基因型之间的等效性来评估安全性。在这里，提出了一种新的等效性测试方法，以解决 EFSA 测试中的问题。该方法的灵感来自最近提出的用于分析动物饲养试验数据的等效性测试。为了适合实际的安全性评估，新方法通过构造将统计功效设置为所需的值，例如 95%。此外，我们评估分布而不是平均值。这样，即使基因型变异有限，也可以建立等效性限制。在这种情况下，原始的 EFSA 等效性测试会失败。该方法通过将其应用于玉米籽粒田间研究的数据进行说明。模拟研究表明，所提出的测试具有适当的性能特征，并与最近提出的替代方法（包括 EFSA/EU 等效性测试）具有竞争力。
