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DOI10.1007/s11248-014-9785-0
Transportability of confined field trial data for environmental risk assessment of genetically engineered plants: a conceptual framework
Garcia-Alonso, Monica1; Hendley, Paul2; Bigler, Franz3; Mayeregger, Edgar4; Parker, Ronald5; Rubinstein, Clara6; Satorre, Emilio7; Solari, Fernando8; McLean, Morven A.9
发表日期2014-12-01
ISSN0962-8819
卷号23期号:6页码:1025-1041
英文摘要

It is commonly held that confined field trials (CFTs) used to evaluate the potential adverse environmental impacts of a genetically engineered (GE) plant should be conducted in each country where cultivation is intended, even when relevant and potentially sufficient data are already available from studies conducted elsewhere. The acceptance of data generated in CFTs "out of country" can only be realized in practice if the agro-climatic zone where a CFT is conducted is demonstrably representative of the agro-climatic zones in those geographies to which the data will be transported. In an attempt to elaborate this idea, a multi-disciplinary Working Group of scientists collaborated to develop a conceptual framework and associated process that can be used by the regulated and regulatory communities to support transportability of CFT data for environmental risk assessment (ERA). As proposed here, application of the conceptual framework provides a scientifically defensible process for evaluating if existing CFT data from remote sites are relevant and/or sufficient for local ERAs. Additionally, it promotes a strategic approach to identifying CFT site locations so that field data will be transportable from one regulatory jurisdiction to another. Application of the framework and process should be particularly beneficial to public sector product developers and small enterprises that develop innovative GE events but cannot afford to replicate redundant CFTs, and to regulatory authorities seeking to improve the deployment of limited institutional resources.


英文关键词Genetically engineered plant;Confined field trial;Regulatory framework;Transportability;Agro-climatic zone
语种英语
WOS记录号WOS:000344158800011
来源期刊TRANSGENIC RESEARCH
来源机构美国环保署
文献类型期刊论文
条目标识符http://gcip.llas.ac.cn/handle/2XKMVOVA/61421
作者单位1.Estel Consult Ltd, Binfield RG42 4HG, Berks, England;
2.Phasera Ltd, Bracknell RG12 2JJ, Berks, England;
3.Agroscope Reckenholz Tanikon, CH-8046 Zurich, Switzerland;
4.Minist Agr, Unidad Gest Riesgo, Asuncion, Paraguay;
5.US EPA, Off Pesticide Programs, Environm Fate & Effects Div, Arlington, VA 22202 USA;
6.ILSI Argentina, Buenos Aires, DF, Argentina;
7.Univ Buenos Aires, Fac Agron & Vet, Catedra Cerealicultura, IFEVA, Buenos Aires, DF, Argentina;
8.Monsanto Argentina SAIC, Estn Expt Fontezuela, Buenos Aires, DF, Argentina;
9.ILSI Res Fdn, Ctr Environm Risk Assessment, Washington, DC 20005 USA
推荐引用方式
GB/T 7714
Garcia-Alonso, Monica,Hendley, Paul,Bigler, Franz,et al. Transportability of confined field trial data for environmental risk assessment of genetically engineered plants: a conceptual framework[J]. 美国环保署,2014,23(6):1025-1041.
APA Garcia-Alonso, Monica.,Hendley, Paul.,Bigler, Franz.,Mayeregger, Edgar.,Parker, Ronald.,...&McLean, Morven A..(2014).Transportability of confined field trial data for environmental risk assessment of genetically engineered plants: a conceptual framework.TRANSGENIC RESEARCH,23(6),1025-1041.
MLA Garcia-Alonso, Monica,et al."Transportability of confined field trial data for environmental risk assessment of genetically engineered plants: a conceptual framework".TRANSGENIC RESEARCH 23.6(2014):1025-1041.
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