Field trials and tribulations—making sense of the regulations for experimental field trials of transgenic crops in Europe

Transgenic plants that are being developed for commercial cultivation must be tested underfield conditions to monitor their effects on surrounding wildlife and conventional crops. Devel-opers also use this opportunity to evaluate the performance of transgenic crops in a typicalenvironment, although this is a matter of commercial necessity rather than regulatory compli-ance. Most countries have adapted existing regulations or developed new ones to deal specif-ically with transgenic crops and their commodities. The European Union (EU) is renowned, orperhaps notorious, for having the broadest and most stringent regulations governing suchfield trials in the world. This reflects its nominal adherence to the precautionary approach,which assumes all transgenic crops carry an inherent risk. Therefore, field trials in the EU needto demonstrate that the risk associated with deploying a transgenic crop has been reduced tothe level where it is regarded as acceptable within the narrowly defined limits of the regula-tions developed and enforced (albeit inconsistently) by national and regional governments,that is, that there is no greater risk than growing an equivalent conventional crop. Theinvolvement of national and regional competent authorities in the decision-making processcan add multiple layers of bureaucracy to an already-intricate process. In this review, we usecountry-based case studies to show how the EU, national and regional regulations are imple-mented, and we propose strategies that could increase the efficiency of regulation withoutburdening developers with further unnecessary bureaucracy.Research at the Universitat de Lleida is supported by MICINN,Spain (BFU2007-61413); European Union Framework 7 Pro-gram-SmartCell Integrated Project 222716; European UnionFramework 7 European Research Council IDEAS AdvancedGrant (to PC) Program-BIOFORCE; COST Action FA0804: Molecular farming: plants as a production platform for high valueproteins; Centre CONSOLIDER on Agrigenomics funded by MICINN, Spain