Background

For market approval of genetically modified plants (GMPs), the evaluation of agronomic and phenotypic plant traits is a standard requirement and part of the comparative assessment of the GMP and its conventional counterpart. This comparative assessment is a starting point for environmental risk assessment (ERA) and should inform all areas of risk. We scrutinize frequently used approaches to characterize GMPs in EU market applications and discuss their usefulness for drawing conclusions on risks related to the plant’s ability to survive, persist or become invasive.

Results

Our analysis shows that the agronomic and phenotypic characterization of GMPs, although based on guidelines, is confined to plant traits and test designs that are relevant for the quality control and agronomic performance of genetically modified (GM) crops. We provide evidence of how methodological approaches frequently applied during the agronomic and phenotypic characterization of the GMP could be improved and complemented to better inform on potential phenotypic changes relevant to assessing environmental risks. These approaches refer to (i) the assessment of the survival of GM seeds and plants (e.g., volunteers); (ii) the consideration of environmental exposure and (iii) improved methodological approaches for the assessment of biotic and abiotic stress responses for GMPs.

Conclusions

The comparative assessment of agronomic and phenotypic plant traits currently does not provide suitable data to draw conclusions on environmental risks relating to the persistence and invasiveness of the GMP. Ecologically more realistic assessments should be part of the phenotypic characterization of GMPs and need guidance and decision criteria to be implemented in ERA. This is of considerable importance, as new genomic techniques are expected to increase the diversity and complexity of GM plants and traits, particularly stress tolerance, which may affect the survival of GMPs in the environment.

中文翻译：

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农艺和表型植物性状作为转基因植物环境风险的指标

背景

对于转基因植物（GMP）的市场批准，农艺和表型植物性状的评估是一项标准要求，也是 GMP 与传统植物比较评估的一部分。这种比较评估是环境风险评估 (ERA) 的起点，应告知所有风险领域。我们仔细研究了欧盟市场应用中常用的 GMP 表征方法，并讨论了它们对于得出与植物生存、持续或入侵能力相关的风险结论的有用性。

结果

我们的分析表明，GMP 的农艺和表型特征虽然基于指南，但仅限于与转基因 (GM) 作物的质量控制和农艺性能相关的植物性状和测试设计。我们提供了如何改进和补充在 GMP 农艺和表型表征过程中经常应用的方法学方法的证据，以更好地了解与评估环境风险相关的潜在表型变化。这些方法涉及 (i) 评估转基因种子和植物（例如志愿者）的存活率；(ii) 考虑环境暴露；(iii) 改进 GMP 生物和非生物胁迫反应评估方法。

结论

目前对植物农艺和表型性状的比较评估并没有提供合适的数据来得出与 GMP 的持久性和侵入性相关的环境风险的结论。生态学上更现实的评估应该成为 GMP 表型特征的一部分，并且需要在 ERA 中实施的指导和决策标准。这是相当重要的，因为新的基因组技术预计将增加转基因植物和性状的多样性和复杂性，特别是胁迫耐受性，这可能会影响 GMP 在环境中的生存。