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Abstract：
The safety of food produced from genetically engineered (GE) crops is assessed for potential risks of food allergy on the basis of an international consensus guideline outlined by the Codex Alimentarius Commission (2003). The assessment focuses on evaluation of the potential allergenicity of the newly expressed protein(s) as the primary potential risk using a process that markedly limits risks to allergic consumers. However, Codex also recommended evaluating a second concern, potential increases in endogenous allergens of commonly allergenic food crops that might occur due to insertion of the gene. Unfortunately, potential risks and natural variation of endogenous allergens in non-GE varieties are not understood, and risks from increases have not been demonstrated. Because regulatory approvals in some countries are delayed due to increasing demands for measuring endogenous allergens, we present a review of the potential risks of food allergy, risk management for food allergy, and test methods that may be used in these evaluations. We also present new data from our laboratory studies on the variation of the allergenic lipid transfer protein in non-GE maize hybrids as well as data from two studies of endogenous allergen comparisons for three GE soybean lines, their nearest genetic soy lines, and other commercial lines. We conclude that scientifically based limits of acceptable variation cannot been established without an understanding of natural variation in non-GE crops. Furthermore, the risks from increased allergen expression are minimal as the risk management strategy for food allergy is for allergic individuals to avoid consuming any food containing their allergenic source, regardless of the crop variety.
摘要：
根据食品法典委员会（2003年）概述的国际共识指南，对由基因工程（GE）作物生产的食品的安全性进行了食物过敏的潜在风险评估。评估的重点是评估新表达的蛋白质的潜在变应原性作为主要的潜在风险，使用一个显著限制过敏消费者的风险的过程。然而,食典委还建议评估第二个问题，可能由于基因的插入而发生的常见过敏性粮食作物的内源性过敏原的潜在增加。不幸的是,不了解非转基因品种内源性过敏原的潜在风险和自然变异，增加带来的风险尚未得到证实。由于测量内源性过敏原的需求不断增加，一些国家的监管批准被推迟，我们对食物过敏的潜在风险进行了综述，食物过敏的风险管理，以及这些评估中可能使用的测试方法。我们还提供了来自非转基因玉米杂种中过敏性脂质转移蛋白变化的实验室研究的新数据，以及来自三个转基因大豆品系的内源性过敏原比较的两项研究的数据。他们最近的遗传大豆系，和其他商业线路。我们得出的结论是，如果不了解非转基因作物的自然变异，就无法建立基于科学的可接受变异极限。此外，过敏原表达增加的风险很小，因为食物过敏的风险管理策略是过敏个体避免食用任何含有其过敏原来源的食物，无论作物品种。
