van der Voet Hilko, Goedhart Paul W, Lazebnik Jenny, Kessel Geert J T, Mullins Ewen, van Loon Joop J A, Arpaia Salvatore
Wageningen University & Research Wageningen The Netherlands.
Crop Science Department Teagasc Carlow Ireland.
Ecol Evol. 2019 Feb 14;9(5):2863-2882. doi: 10.1002/ece3.4964. eCollection 2019 Mar.
This paper considers the statistical analysis of entomological count data from field experiments with genetically modified (GM) plants. Such trials are carried out to assess environmental safety. Potential effects on nontarget organisms (NTOs), as indicators of biodiversity, are investigated. The European Food Safety Authority (EFSA) gives broad guidance on the environmental risk assessment (ERA) of GM plants. Field experiments must contain suitable comparator crops as a benchmark for the assessment of designated endpoints. In this paper, a detailed protocol is proposed to perform data analysis for the purpose of assessing environmental safety. The protocol includes the specification of a list of endpoints and their hierarchical relations, the specification of intended levels of data analysis, and the specification of provisional limits of concern to decide on the need for further investigation. The protocol emphasizes a graphical representation of estimates and confidence intervals for the ratio of mean abundances for the GM plant and its comparator crop. Interpretation relies mainly on equivalence testing in which confidence intervals are compared with the limits of concern. The proposed methodology is illustrated with entomological count data resulting from multiyear, multilocation field trials. A cisgenically modified potato line (with enhanced resistance to late blight disease) was compared to the original conventional potato variety in the Netherlands and Ireland in two successive years (2013, 2014). It is shown that the protocol encompasses alternative schemes for safety assessment resulting from different research questions and/or expert choices. Graphical displays of equivalence testing at several hierarchical levels and their interpretation are presented for one of these schemes. The proposed approaches should be of help in the ERA of GM or other novel plants.
本文探讨了对转基因植物田间试验昆虫学计数数据的统计分析。进行此类试验是为了评估环境安全性。研究了对作为生物多样性指标的非靶标生物（NTOs）的潜在影响。欧洲食品安全局（EFSA）对转基因植物的环境风险评估（ERA）给出了广泛指导。田间试验必须包含合适的对照作物，作为评估指定终点的基准。本文提出了一个详细的方案，用于为评估环境安全性而进行数据分析。该方案包括指定终点清单及其层次关系的说明、预期数据分析水平的说明，以及用于决定是否需要进一步调查的临时关注限值的说明。该方案强调以图形方式表示转基因植物与其对照作物平均丰度比的估计值和置信区间。解释主要依赖于等效性检验，即将置信区间与关注限值进行比较。利用多年、多地田间试验得到的昆虫学计数数据对所提出的方法进行了说明。在荷兰和爱尔兰，连续两年（2013年、2014年）将一个顺式转基因马铃薯品系（对晚疫病抗性增强）与原始常规马铃薯品种进行了比较。结果表明，该方案涵盖了因不同研究问题和/或专家选择而产生的安全评估替代方案。针对其中一种方案，给出了几个层次水平上等效性检验的图形展示及其解释。所提出的方法应有助于转基因植物或其他新型植物的环境风险评估。
