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首页> 美国卫生研究院文献>Springer Open Choice >Transportability of confined field trial data for environmental risk assessment of genetically engineered plants: a conceptual framework
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Transportability of confined field trial data for environmental risk assessment of genetically engineered plants: a conceptual framework

机译：用于基因工程植物环境风险评估的密闭田间试验数据的可运输性：概念框架

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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.
机译：通常认为，即使要从研究中获得相关且可能足够的数据，也应在打算种植的每个国家进行用于评估基因工程植物的潜在不利环境影响的密闭田间试验（CFT）。在其他地方进行。只有在进行CFT的农业气候区明显地代表了将数据传输到的那些地理区域中的农业气候区时，才能在实践中实现“国外” CFT中生成的数据的接受。为了阐明这一想法，一个跨学科的科学家工作组合作开发了一个概念框架和相关流程，监管机构可以使用此框架来支持CFT数据的可运输性，以进行环境风险评估（ERA）。如此处所建议的，概念框架的应用为评估远程站点的现有CFT数据是否与本地ERA相关和/或足够提供了科学依据。此外，它促进了确定CFT站点位置的战略方法，从而可以将现场数据从一个监管辖区转移到另一个监管辖区。框架和流程的应用应该特别有益于公共部门产品开发商和开展创新性GE活动但无力复制多余CFT的小型企业，以及寻求改善有限机构资源部署的监管机构。

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