Background An expert group, on behalf of the Italian Ministry of the Environment, has designed a methodology for assessing the environmental safety of deliberately realeasing genetically modified organisms (GMOs). The technique has been tested in a theoretical framework but it has not been validated in field conditions. This latter experience is considered necessary by the Italian Ministry of Environment, prior to the methodology being used in practice. Objectives The main goal of this LIFE+ Biodiversity project is to validate a methodology for monitoring and managing possible environmental effects of genetically modified plants (GMPs) on plant and animal biodiversity. This will involve setting specific protection goals for sensitive or protected areas near genetically modified agro-ecosystems and monitoring any threat caused by the GMPs to the protected sites. The process will help identify optimal operational parameters for the monitoring system, and thus help improve knowledge about how best to manage environmental impacts from genetically modified plants.