title: Field trials and tribulations--making sense of the regulations for experimental field trials of transgenic crops in Europe.
abstract: Transgenic plants that are being developed for commercial cultivation must be tested under field conditions to monitor their effects on surrounding wildlife and conventional crops. Developers also use this opportunity to evaluate the performance of transgenic crops in a typical environment, although this is a matter of commercial necessity rather than regulatory compliance. Most countries have adapted existing regulations or developed new ones to deal specifically with transgenic crops and their commodities. The European Union (EU) is renowned, or perhaps notorious, for having the broadest and most stringent regulations governing such field 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 need to demonstrate that the risk associated with deploying a transgenic crop has been reduced to the level where it is regarded as acceptable within the narrowly defined limits of the regulations developed and enforced (albeit inconsistently) by national and regional governments, that is, that there is no greater risk than growing an equivalent conventional crop. The involvement of national and regional competent authorities in the decision-making process can add multiple layers of bureaucracy to an already-intricate process. In this review, we use country-based case studies to show how the EU, national and regional regulations are implemented, and we propose strategies that could increase the efficiency of regulation without burdening developers with further unnecessary bureaucracy.
authors.affiliation: Department of Plant Production and Forestry Science-ETSEA, University of Lleida-CRA, Lleida, Spain.
authors.forename: Sonia
authors.initials: S
authors.lastname: Gómez-Galera
authors.forename: Richard M
authors.initials: RM
authors.lastname: Twyman
authors.forename: Penelope A C
authors.initials: PA
authors.lastname: Sparrow
authors.forename: Bart
authors.initials: B
authors.lastname: Van Droogenbroeck
authors.forename: René
authors.initials: R
authors.lastname: Custers
authors.forename: Teresa
authors.initials: T
authors.lastname: Capell
authors.forename: Paul
authors.initials: P
authors.lastname: Christou
mesh_terms: D000383:Agriculture / Q000331:legislation & jurisprudence*; D001709:Biotechnology / Q000331:legislation & jurisprudence*; D018556:Crops, Agricultural / Q000235:genetics* / Q000254:growth & development; D005062:European Union; D033161:Government Regulation; D030821:Plants, Genetically Modified / Q000254:growth & development; D018570:Risk Assessment