TY - JOUR
T1 - Field trials and tribulations--making sense of the regulations for experimental field trials of transgenic crops in Europe
AU - Gómez-Galera, Sonia
AU - Twyman, Richard M
AU - Sparrow, Penelope A C
AU - Van Droogenbroeck, Bart
AU - Custers, René
AU - Capell, Teresa
AU - Christou, Paul
N1 - © 2012 The Authors. Plant Biotechnology Journal © 2012 Society for Experimental Biology, Association of Applied Biologists and Blackwell Publishing Ltd.
PY - 2012
Y1 - 2012
N2 - 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.
AB - 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.
KW - Agriculture
KW - Biotechnology
KW - Crops, Agricultural
KW - European Union
KW - Government Regulation
KW - Plants, Genetically Modified
KW - Risk Assessment
KW - T490-biotechnology
KW - gm field trials
KW - regulatory aspects GM plants
U2 - 10.1111/j.1467-7652.2012.00681.x
DO - 10.1111/j.1467-7652.2012.00681.x
M3 - A1: Web of Science-article
C2 - 22284604
SN - 1467-7652
VL - 10
SP - 511
EP - 523
JO - Plant Biotechnology Journal
JF - Plant Biotechnology Journal
IS - 5
ER -