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Regulatory aspects of gene editing in Argentina.
Transgenic Research ( IF 3 ) Pub Date : 2019-08-01 , DOI: 10.1007/s11248-019-00145-2
Martin Alfredo Lema 1, 2
Affiliation  

Argentina is a world leader in regards to regulation and adoption of genetically modified (GM) crops. As a consequence, the regulatory aspects of gene editing applied to agriculture were considered proactively by the Argentinian regulators, who implemented simple but solid pioneering regulatory criteria for gene edited crops. At present, the Argentine regulatory system is fully able to establish if a gene-edited crop should be classified (and handled) either as a GM crop or a conventional new variety. To this end, the concept of "novel combination of genetic material" derived from the Cartagena Protocol on Biosafety is of decisive importance. After some pilot cases that have been managed under this criteria, now applicants appreciate the ease, speed and predictability of the regulation. Moreover, it has been considered by other countries in the course of developing their own regulations, thus acting also as a harmonization factor for the safe and effective insertion of these technologies in the global market.

中文翻译:

阿根廷基因编辑的监管方面。

阿根廷在转基因作物的监管和采用方面处于世界领先地位。因此,阿根廷监管机构积极考虑了应用于农业的基因编辑监管方面,他们对基因编辑作物实施了简单但扎实的开拓性监管标准。目前,阿根廷监管系统完全有能力确定是否应将基因编辑作物归为转基因作物或常规新品种。为此,源于《卡塔赫纳生物安全议定书》的“遗传材料的新型结合”概念具有决定性的重要性。在按照此标准进行管理的一些试点案例之后,现在的申请人赞赏该法规的简便性,速度和可预测性。此外,
更新日期:2019-11-01
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