ENEA, DTE-BBC, Research Centre Trisaia, Rotondella (MT), Italy.
The James Hutton Institute, Dundee, UK.
Sci Total Environ. 2017 Apr 1;583:123-132. doi: 10.1016/j.scitotenv.2017.01.039. Epub 2017 Jan 15.
In legal frameworks worldwide, genetically modified plants (GMPs) are subjected to pre-market environmental risk assessment (ERA) with the aim of identifying potential effects on the environment. In the European Union, the EFSA Guidance Document introduces the rationale that GMPs, as well as their newly produced metabolites, represent the potential stressor to be evaluated during ERA. As a consequence, during several phases of ERA for cultivation purposes, it is considered necessary to use whole plants or plant parts in experimental protocols. The importance of in planta studies as a strategy to address impacts of GMPs on non-target organisms is demonstrated, to evaluate both effects due to the intended modification in plant phenotype (e.g. expression of Cry proteins) and effects due to unintended modifications in plant phenotype resulting from the transformation process (e.g. due to somaclonal variations or pleiotropic effects). In planta tests are also necessary for GMPs in which newly expressed metabolites cannot easily be studied in vitro. This paper reviews the scientific literature supporting the choice of in planta studies as a fundamental tool in ERA of GMPs in cultivation dossiers; the evidence indicates they can realistically mimic the ecological relationships occurring in their receiving environments and provide important insights into the biology and sustainable management of GMPs.
在全球法律框架下，转基因植物（GMP）需要进行上市前环境风险评估（ERA），以确定其对环境的潜在影响。在欧盟，EFSA 指导文件提出了一个基本原理，即 GMP 及其新产生的代谢物，代表了 ERA 期间需要评估的潜在胁迫因子。因此，在为种植目的进行的 ERA 的几个阶段中，有必要在实验方案中使用整株植物或植物部分。研究表明，在植物体内进行研究是解决 GMP 对非靶标生物影响的一种策略，以评估由于植物表型的预期修饰（例如 Cry 蛋白的表达）而产生的影响，以及由于转化过程中植物表型的非预期修饰（例如，由于体细胞变异或多效性效应）而产生的影响。对于那些新表达的代谢物难以在体外进行研究的 GMP 也需要进行体内测试。本文综述了支持将体内研究作为种植档案中 GMP ERA 基本工具的科学文献；证据表明，它们可以真实地模拟其接受环境中发生的生态关系，并为 GMP 的生物学和可持续管理提供重要见解。
