Department of Plant Production and Forestry Science-ETSEA, University of Lleida-CRA, Lleida, Spain.
Plant Biotechnol J. 2012 Jun;10(5):511-23. doi: 10.1111/j.1467-7652.2012.00681.x. Epub 2012 Jan 30.
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.
正在开发用于商业种植的转基因植物必须在田间条件下进行测试，以监测它们对周围野生动物和常规作物的影响。开发商还利用这个机会评估转基因作物在典型环境中的表现，尽管这是出于商业必要性，而不是监管合规性。大多数国家都调整了现有的规定或制定了新的规定，专门针对转基因作物及其商品。欧盟（EU）以其对世界上此类田间试验的最广泛和最严格的规定而闻名，或许是臭名昭著。这反映了其名义上对预防原则的坚持，即假定所有转基因作物都存在固有风险。因此，在欧盟进行的田间试验需要证明，与部署转基因作物相关的风险已经降低到在国家和地区政府制定和执行（尽管不一致）的严格规定所界定的可接受范围内，也就是说，与种植同等常规作物相比，风险没有增加。国家和地区主管当局参与决策过程可能会给已经复杂的过程增加多层官僚机构。在这篇综述中，我们使用基于国家的案例研究来展示欧盟、国家和地区的规定是如何实施的，并提出了一些策略，可以在不增加开发者不必要的官僚负担的情况下提高监管效率。
