ABSTRACT

Event DP-2Ø2216-6 (referred to as DP202216 maize) was genetically modified to increase and extend the expression of the introduced zmm28 gene relative to endogenous zmm28 gene expression, resulting in plants with enhanced grain yield potential. The zmm28 gene expresses the ZMM28 protein, a MADS-box transcription factor. The safety assessment of DP202216 maize included an assessment of the potential hazard of the ZMM28 protein, as well as an assessment of potential unintended effects of the genetic insertion on agronomics, composition, and nutrition. The history of safe use (HOSU) of the ZMM28 protein was evaluated and a bioinformatics approach was used to compare the deduced amino acid sequence of the ZMM28 protein to databases of known allergens and toxins. Based on HOSU and the bioinformatics assessment, the ZMM28 protein was determined to be unlikely to be either allergenic or toxic to humans. The composition of DP202216 maize forage and grain was comparable to non-modified forage and grain, with no unintended effects on nutrition or food and feed safety. Additionally, feeding studies with broiler chickens and rats demonstrated a low likelihood of unintentional alterations in nutrition and low potential for adverse effects. Furthermore, the agronomics observed for DP202216 maize and non-modified maize were comparable, indicating that the likelihood of increased weediness or invasiveness of DP202216 maize in the environment is low. This comprehensive review serves as a reference for regulatory agencies and decision-makers in countries where authorization of DP202216 maize will be pursued, and for others interested in food, feed, and environmental safety.

摘要

事件DP-2Ø2216-6（简称DP202216玉米）中的溶液经遗传修饰，以增加和延长引入的表达zmm28相对于内源性基因zmm28基因表达，从而产生具有增强的产量潜力的植物。该zmm28基因表达 ZMM28 蛋白，一种 MADS-box 转录因子。DP202216 玉米的安全性评估包括对 ZMM28 蛋白潜在危害的评估，以及对基因插入对农艺、组成和营养的潜在意外影响的评估。对 ZMM28 蛋白的安全使用历史 (HOSU) 进行了评估，并使用生物信息学方法将 ZMM28 蛋白的推断氨基酸序列与已知过敏原和毒素的数据库进行了比较。根据 HOSU 和生物信息学评估，确定 ZMM28 蛋白不太可能对人类过敏或有毒。DP202216 玉米草料和谷物的成分与未改性的草料和谷物相当，对营养或食品和饲料安全没有意外影响。此外，对肉鸡和大鼠的喂养研究表明，意外改变营养的可能性很小，产生不良影响的可能性很小。此外，对 DP202216 玉米和未改性玉米观察到的农艺学具有可比性，表明 DP202216 玉米在环境中杂草增加或侵入性增加的可能性很低。该综合审查可为将寻求 DP202216 玉米授权的国家的监管机构和决策者以及对食品、饲料和环境安全感兴趣的其他人提供参考。表明 DP202216 玉米在环境中增加杂草或侵入性的可能性很低。该综合审查可为将寻求 DP202216 玉米授权的国家的监管机构和决策者以及对食品、饲料和环境安全感兴趣的其他人提供参考。表明 DP202216 玉米在环境中增加杂草或侵入性的可能性很低。该综合审查可为将寻求 DP202216 玉米授权的国家的监管机构和决策者以及对食品、饲料和环境安全感兴趣的其他人提供参考。