Comments on the European Food Safety Authority draft version of the revised ‘Guidance on the post-market environmental monitoring (PMEM)’

Upon a request from the European Commission, EFSA is revising the scientific opinion on Post-Market Environmental Monitoring (PMEM) of genetically modified (GM) plants. The draft version of the revised guidance on PMEM is open for public consultation.
COGEM is pleased with the revised guidance document on PMEM which brings PMEM to a more elaborate level. It clearly describes the monitoring approach and possible subjects for monitoring. The approach of PMEM that is described in the guidance document is in line with previous COGEM advices on this topic
COGEM notes that the EFSA guidance contains apparent inconsistencies. On one hand difficulties associated with the detection of effects are pointed out, but on the other hand EFSA seems to adhere to rather rigid criteria for statistical design and analysis.
COGEM points out that due to the high variability present within the environment it is difficult, and might even be impossible, to obtain statistical significant data from monitoring (CSM and GS). Therefore, in first instance possible effects should not be neglected because they do not reach statistical significance. If too much emphasis is put on the statistical significance of an observed effect, a possible relevant effect might be overlooked. In COGEM’s view the guidance should also pay attention to observed effects when they do not reach statistical significance and should consider whether these effects require further research.