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首页> 美国卫生研究院文献>Frontiers in Bioengineering and Biotechnology >A General Safety Assessment for Purified Food Ingredients Derived From Biotechnology Crops: Case Study of Brazilian Sugar and Beverages Produced From Insect-Protected Sugarcane
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A General Safety Assessment for Purified Food Ingredients Derived From Biotechnology Crops: Case Study of Brazilian Sugar and Beverages Produced From Insect-Protected Sugarcane

机译：从生物技术农作物中提纯的食品成分的一般安全性评估：巴西蔗糖和用昆虫保护的甘蔗生产的饮料的案例研究

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Insect-protected sugarcane that expresses Cry1Ab has been developed in Brazil. Analysis of trade information has shown that effectively all the sugarcane-derived Brazilian exports are raw or refined sugar and ethanol. The fact that raw and refined sugar are highly purified food ingredients, with no detectable transgenic protein, provides an interesting case study of a generalized safety assessment approach. In this study, both the theoretical protein intakes and safety assessments of Cry1Ab, Cry1Ac, NPTII, and Bar proteins used in insect-protected biotechnology crops were examined. The potential consumption of these proteins was examined using local market research data of average added sugar intakes in eight diverse and representative Brazilian raw and refined sugar export markets (Brazil, Canada, China, Indonesia, India, Japan, Russia, and the USA). The average sugar intakes, which ranged from 5.1 g of added sugar/person/day (India) to 126 g sugar/p/day (USA) were used to calculated possible human exposure. The theoretical protein intake estimates were carried out in the “Worst-case” scenario, assumed that 1 μg of newly-expressed protein is detected/g of raw or refined sugar; and the “Reasonable-case” scenario assumed 1 ng protein/g sugar. The “Worst-case” scenario was based on results of detailed studies of sugarcane processing in Brazil that showed that refined sugar contains less than 1 μg of total plant protein /g refined sugar. The “Reasonable-case” scenario was based on assumption that the expression levels in stalk of newly-expressed proteins were less than 0.1% of total stalk protein. Using these calculated protein intake values from the consumption of sugar, along with the accepted NOAEL levels of the four representative proteins we concluded that safety margins for the “Worst-case” scenario ranged from 6.9 × 105 to 5.9 × 107 and for the “Reasonable-case” scenario ranged from 6.9 × 108 to 5.9 × 1010. These safety margins are very high due to the extremely low possible exposures and the high NOAELs for these non-toxic proteins. This generalized approach to the safety assessment of highly purified food ingredients like sugar illustrates that sugar processed from Brazilian GM varieties are safe for consumption in representative markets globally.
机译：在巴西开发了表达Cry1Ab的昆虫保护甘蔗。对贸易信息的分析表明，实际上，所有源自甘蔗的巴西出口商品都是原糖或精制糖和乙醇。生糖和精制糖是高度纯化的食品成分，没有可检测到的转基因蛋白，这一事实为通用安全性评估方法提供了有趣的案例研究。在这项研究中，研究了昆虫保护性生物技术作物中Cry1Ab，Cry1Ac，NPTII和Bar蛋白的理论蛋白质摄入量和安全性评估。这些蛋白质的潜在消耗量是使用巴西八个，具有代表性的原糖和精制糖出口市场（巴西，加拿大，中国，印度尼西亚，印度，日本，俄罗斯和美国）的平均平均糖摄入量的当地市场研究数据进行检验的。平均糖摄入量（从印度每人每天增加糖量5.1克（印度）到每天每人每天摄入糖量126克）被用于计算可能的人体暴露量。理论蛋白质摄入量估算是在“最坏情况”场景中进行的，假设检测到每微克原糖或精制糖中检测到1微克新表达的蛋白质；而“合理情况”方案则假设1 ng蛋白/ g糖。 “最坏情况”方案是基于对巴西甘蔗加工的详细研究结果得出的，结果表明，精制糖所含的总植物蛋白少于1μg/ g精制糖。 “合理情况”方案是基于这样的假设，即新表达的蛋白质在茎中的表达水平小于总茎蛋白的0.1％。使用从糖的消耗中计算出的这些蛋白质摄入量值以及四种代表性蛋白质的公认NOAEL水平，我们得出结论，“最坏情况”场景的安全裕度范围为6.9×10 5 至5.9×10 7 ，对于“合理情况”方案，范围从6.9×10 8 到5.9×10 10 。由于这些无毒蛋白质的极低暴露量和高NOAEL，因此这些安全边际非常高。这种对高纯度食品成分（如糖）进行安全性评估的通用方法表明，使用巴西转基因品种加工的糖可安全用于全球代表性市场。

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