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转基因植物中的基因叠加:欧盟监管框架下定义、术语与检测之间的协调一致。

Gene stacking in transgenic plants: towards compliance between definitions, terminology, and detection within the EU regulatory framework.

作者信息

Taverniers Isabel, Papazova Nina, Bertheau Yves, De Loose Marc, Holst-Jensen Arne

机构信息

Institute for Agricultural and Fisheries Research (ILVO), Unit Technology and Food (T&V), Burg. Van Gansberghelaan 115 bus 2, 9820 Merelbeke, Belgium.

出版信息

Environ Biosafety Res. 2008 Oct-Dec;7(4):197-218. doi: 10.1051/ebr:2008018. Epub 2008 Oct 29.

DOI:10.1051/ebr:2008018
PMID:19081008
Abstract

The combination or stacking of different traits or genes in plants is rapidly gaining popularity in biotech crop production. Here we review the existing terminology regarding gene stacking in plants, and its implications in relation to genetics, biosafety, detectability and European regulations. Different methods of production of stacked gene traits, as well as the status of their cultivation and approval, are reviewed. Related to the different techniques of transformation and production, including classical breeding, and to differences in global authorization and commercialization practices, there are many types, definitions, and perceptions of stacking. These include: (1) stacking of traits and (2) stacking of events, which are the most widely accepted perceptions of stacking, and (3) stacking of genes, which from the analytical and traceability point of view may be a more appropriate perception. These differences in perceptions and definitions are discussed, as are their implications for analytical detection and regulatory compliance according to (in particular) European Union (EU) regulations. A comprehensive terminology regarding gene stacking with regulatory relevance is proposed. The haploid genome equivalent is proposed as the prevailing unit of measurement at all stages throughout the chain, in order to ensure that terminology and definitions of gene stacks are adapted to analytical detection, traceability, and compliance with EU regulations.

摘要

在转基因作物生产中,将不同性状或基因进行组合或堆叠的做法正迅速受到欢迎。在此,我们回顾了有关植物基因堆叠的现有术语,及其在遗传学、生物安全性、可检测性和欧洲法规方面的影响。我们还回顾了堆叠基因性状的不同生产方法,以及它们的种植和审批状况。由于涉及不同的转化和生产技术,包括传统育种,以及全球授权和商业化实践的差异,基因堆叠有多种类型、定义和理解方式。这些包括:(1)性状堆叠,(2)事件堆叠,这是最广泛接受的基因堆叠理解方式,以及(3)基因堆叠,从分析和可追溯性角度来看,这可能是更合适的理解方式。我们讨论了这些理解方式和定义上的差异,以及它们对分析检测和(特别是)根据欧盟法规进行合规性的影响。我们提出了一套与监管相关的关于基因堆叠的综合术语。建议将单倍体基因组当量作为整个链条各阶段的主要测量单位,以确保基因堆叠的术语和定义适用于分析检测、可追溯性以及符合欧盟法规。

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