Development of Construct Based Risk Assessment Criteria for GE crops

Abstract

Introduction Experience gained through the successful adoption of GE crops by more than 18 million farmers in 30 countries allows revisiting some current Risk Assessment (RA) approaches. These exercises have led to the refinement of scientific criteria over time in Argentina and other countries. In line with its mission, ILSI Argentina (International Life Sciences Institute) convened a tripartite Task Force (TF) to discuss science-based evaluation criteria for events containing genetic constructs identical or similar to those already used in previously evaluated or approved GE crops. The robust performance of the current RA systems, plus the growing evidence showing that conventional breeding and the intrinsic plasticity of plant genomes are more significant sources of genomic changes than transgenesis, provided both context and background for the TF work. Methods, Scope was limited to transgenic crops. Discussion was focused on the identification of science-based criteria for the evaluation of new events within the same or different species, transformed with identical or similar genetic constructs in GE crops favorably reviewed or commercially approved by regulatory authorities. Both Environmental Risk Assessment and Food Safety aspects have been considered. A construct similarity concept was defined based on functional similarity. Key factors analyzed were: environmental and dietary exposure, familiarity with the modification, the crop/construct combination, the crop biology, cultivation management, intended uses and event selection process. Results and Conclusions The experience with gene insertion technologies allowed the TF to identify key elements for a simplified RA approach for identical or similar genetic constructs. Criteria were identified based on a Problem Formulation process and would allow to apply a bridging approach, on a crop specific basis.