Scrutinizing the current practice of the environmental risk assessment of GM maize applications for cultivation in the EU

摘要

Purpose The prevailing controversies on the potential environmental risks of genetically modified organisms [GMOs] still fuel ongoing discussions among European Union [EU] member states, risk assessors, applicants and scientists, even several years after the commercial introduction of GMOs. The disagreements mainly derive from the current risk assessment practice of GMOs and differences in the perceived environmental risks. Against this background, the aim of this study was to scrutinize the current practice of environmental risk assessment [ERA] of several GMO applications currently pending for authorisation in the EU. Methods We analysed the data presented for three assessment categories of the ERA of genetically modified [GM] maize applications for cultivation in the European Union: the agronomic evaluations and the assessments of the effects of GM maize on target organisms and of its potential adverse effects on non-target organisms. Results Major shortcomings causing considerable uncertainties related to the risk assessment were identified in all three categories. In addition, two principles of Directive 2001/18/EC are largely not fulfilled - the consideration of the receiving environment and the indirect effects, as mediated, e.g. by the application of the complementary herbicide in the case of herbicide-tolerant GM maize. Conclusions We conclude that the current practice of ERA does not comprehensively fulfil the scientific and legal requirements of Directive 2001/18/EC, and we propose improvements and needs for further guidance and development of standards. The recommendations address likewise applicants, risk assessors as well as decision makers.