转基因香石竹Moonlite 123.2.38的最终健康和环境风险评估

Å. Andreassen, N. Asare, A. Bakke, M. Finne, A. Jevnaker, O. Junttila, V. Sipinen, R. Vikse, P. Brandtzaeg, K. Dahl, K. T. Dalen, R. Meadow, K. Nielsen, M. Sanden, H. Sorteberg
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引用次数: 0

摘要

转基因石竹(Dianthus caryophyllus L.) 123.2.38号品名为Moonlite™,具有3个引进性状。矮牵牛(Petunia x hybrida)的dfr和f3 ' 5 ' h (Hf1)基因分别编码二氢黄酮醇4-还原酶(dfr)和类黄酮3 ',5 ' -羟化酶(f3 ' 5 ' h),导致花青素色素的生物合成,从而赋予花所需的紫色。从烟草中插入一个突变的als基因,编码一个乙酰乳酸合成酶(als)变异蛋白,从而使其对活性的、抑制als的除草剂氯脲、硫虫磺隆和磺脲具有耐受性,这有助于在遗传转化过程中选择转基因芽。对康乃馨123.2.38插入的DNA和侧翼序列的生物信息学分析未显示该基因修饰可能产生假定的有害蛋白质或多肽。功能插入的基因组稳定性和dfr和f3’5’h (Hf1)基因的一致表达已在几代康乃馨123.2.38中得到证实。几次田间试验报告的数据表明,与非转基因(传统)康乃馨123相比,康乃馨123.2.38花瓣含有更高水平的花青素飞鸽素和花青素。除花瓣颜色不同外,月石123.2.38与普通康乃馨123在一个性状上存在显著差异。一项小鼠急性毒性研究和两项体外研究,均采用叶或花瓣的水提取物,均未显示出不良反应。DFR、F3 ' 5'H和ALS蛋白与已知毒素或ige依赖性过敏原没有序列相似性,也没有引起ige介导的过敏反应的报道。许多食品中都含有花青素飞燕素和花青素,它们也是被批准的食品添加剂。康乃馨种植在挪威,但由于1)预期的使用包括进口鲜花装饰使用,2)从鲜切花花粉的传播和生存能力很低,3)种子形成鲜切花不太可能发生,和4)插入基因的传播目标和非目标生物不可能发生或者不是生物相关性,VKM GMO面板并不认为康乃馨123.2.38代表挪威的环境风险。考虑到康乃馨Moonlite 123.2.38并非用作种植或用作食物或饲料,VKM转基因生物小组认为,对其花瓣中新合成的花青素色素飞鸽苷、花青素和矮花苷进行比较分析,足以进行风险评估。据报道,月光石123.2.38与传统康乃馨123之间的形态差异并没有引起安全问题。DFR, F3 ' 5'H或ALS蛋白,或飞燕素或花蓝素色素不太可能在Moonlite 123.2.38中引入毒性或致敏性。根据申请人提供的现有知识和信息,并考虑到其预期用途(不包括种植和作为食品和饲料使用),VKM转基因生物小组得出结论,Moonlite 123.2.38与传统同类产品123一样安全。根据目前的知识,并考虑到其进口,分销和作为切花观赏用途,VKM转基因生物小组得出结论,康乃馨Moonlite 123.2.38不太可能对挪威的生物或非生物环境产生任何不利影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Final Health and Environmental Risk Assessment of Genetically Modified Carnation Moonlite 123.2.38
Genetically modified carnation (Dianthus caryophyllus L.) line 123.2.38 with product name Moonlite™, expresses three introduced traits. The dfr and f3′5′h (Hf1) genes from Petunia x hybrida coding for dihydroflavonol 4-reductase (DFR) and flavonoid 3′,5′-hydroxylase (F3′5′H), respectively, lead to the biosynthesis of anthocyanin pigments, which confer the desired violet colour to the flowers. A mutated als gene from Nicotiana tabacum has also been inserted, coding for an acetolactate synthase (ALS) variant protein and thereby conferring tolerance to the active, ALS-inhibiting, herbicidal substances chlorimuron, thifensulfuron and sulfonylureas, used to facilitate the selection of GM shoots during genetic transformation. Bioinformatics analyses of the inserted DNA and flanking sequences in carnation 123.2.38 have not indicated a potential production of putative harmful proteins or polypeptides caused by the genetic modification. Genomic stability of the functional insert and consistent expression of the dfr and f3′5′h (Hf1) genes, have been shown over several generations of carnation 123.2.38. Data reported from several field trials show that carnation 123.2.38 petals contain higher levels of the anthocyanins delphinidin and cyanidin compared to the non-GM (conventional) carnation counterpart 123. Other morphological traits were reported and along with differing petal colour, carnation Moonlite 123.2.38 differed significantly in one trait compared to conventional carnation counterpart 123. An acute toxicity study in mice and two in vitro studies, both employing aqueous extracts from leaves or petals, showed no adverse effects. DFR, F3’5’H and ALS proteins do not show sequence resemblance to known toxins or IgE-dependent allergens, nor have they been reported to cause IgE-mediated allergic reactions. The anthocyanins delphinidin and cyanidin are present in numerous foods and are also approved food additives. Carnations are cultivated in Norway, but since 1) the intended uses includes import of cut flowers for ornamental use only, 2) the spread and viability of pollen from the cut flowers is low, 3) seed formation in cut flowers is unlikely to occur, and 4) spread of inserted genes to target or non-target organisms is either unlikely to occur or is not of biological relevance, the VKM GMO Panel does not consider that carnation 123.2.38 represents an environmental risk in Norway.    Considering that carnation Moonlite 123.2.38 is not intended for cultivation or use as food or feed, the VKM GMO Panel considers that comparative analysis of the newly synthesised anthocyanin pigments delphinidin, cyanidin and petunidin in its petals is sufficient for the risk assessment. The reported morphological differences between Moonlite 123.2.38 and its conventional carnation counterpart 123 do not raise safety concerns. It is unlikely that the DFR, F3’5’H or ALS proteins, or the delphinidin or cyanidin pigments, will introduce a toxic or allergenic potential in Moonlite 123.2.38.   Based on current knowledge and information supplied by the applicant, and considering the intended uses, which exclude cultivation and use as food and feed, the VKM GMO Panel concludes that Moonlite 123.2.38 is as safe as its conventional counterpart 123.    Based on the current knowledge and considering its import, distribution and intended use as cut ornamental flowers, the VKM GMO Panel concludes that it is unlikely that carnation Moonlite 123.2.38 will have any adverse effects on the biotic or abiotic environment in Norway.
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