The equivalence testing approach for the statistical analysis of higher tier pollinator studies—recommendations and challenges
Abstract
The revised 2023 European Food Safety Authority (EFSA) guidance on the risk assessment of plant protection products on bees introduced a major change in the statistical evaluation of higher tier studies, replacing difference testing with the equivalence testing approach. This article evaluates several statistical models for equivalence testing of colony strength endpoints in honey bee semi-field studies, including a t-test, a two-way ANOVA, and a linear-mixed-effects model incorporating an autoregressive (AR) structure. Using a range of simulated scenarios, model performance was compared to determine suitability and the likely level of replication needed to conclude a low risk of a test substance with a true effect size of
Fields of Study & Subjects
Insect and Pesticide Research
Agricultural safety and regulations
Statistical Methods in Clinical Trials
Publication details
- Journal / source
- Integrated Environmental Assessment and Management
- Volume
- 22
- Issue
- 3
- Pages
- 910–918
- Publication date
- 27 January 2026
- Language
- EN