Corteva Agriscience, 9330 Zionsville Road, Indianapolis, IN, 47968, USA.
Corteva Agriscience, 9330 Zionsville Road, Indianapolis, IN, 47968, USA.
Regul Toxicol Pharmacol. 2021 Mar;120:104841. doi: 10.1016/j.yrtph.2020.104841. Epub 2020 Dec 15.
The bioinformatic criteria adopted by regulatory agencies to predict the potential cross reactivity between newly expressed proteins in genetically engineered crops and known allergens involves amino acid identity thresholds and was formulated nearly two decades ago based on the opinion of allergy experts. Over the subsequent years, empirical evidence has been developed indicating that better bioinformatic tools based on amino acid similarity are available to detect real allergen cross-reactive risk while substantially reducing false-positive detections. Although the formulation of safety regulations, in the absence of empirical evidence, may require reliance on expert opinion, such expert opinion should not trump empirical evidence once it becomes available. The failure of regulation to maintain consistency with the best available scientific evidence diminishes its value and creates arbitrary barriers to the use of beneficial technologies by society.
监管机构采用的生物信息学标准来预测基因工程作物中新表达的蛋白质与已知过敏原之间的潜在交叉反应性，涉及到氨基酸同一性阈值，这是近二十年前根据过敏专家的意见制定的。在随后的几年中，已经有经验证据表明，基于氨基酸相似性的更好的生物信息学工具可用于检测真正的过敏原交叉反应风险，同时大大减少假阳性检测。尽管在缺乏经验证据的情况下制定安全法规可能需要依赖专家意见，但一旦有了经验证据，就不应该忽视专家意见。法规未能与现有最佳科学证据保持一致，降低了其价值，并为社会使用有益技术制造了任意障碍。
