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首页> 外文期刊>Transgenic research >The assessment of field trials in GMO research around the world and their possible integration in field trials for variety registration
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The assessment of field trials in GMO research around the world and their possible integration in field trials for variety registration

机译：在世界各地的GMO研究中评估现场试验及其在各种注册的现场试验中的可能集成

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Most regulations worldwide stipulate that a new genetically modified (GM) crop event has to be compared to its closest non-GM counterpart as a corner stone of the pre-market risk assessment. To this end the GM crop and its comparator should be grown in field trials for a phenotypic comparison as well as for subsequent detailed analysis of the composition of the two crop varieties. A more in-depth globally harmonised approach for the conduct of these field trials is lacking. Only a few countries have formulated detailed protocols for the set-up of GM field trials. In some countries, commercial non-GM reference varieties need to be included in a field study to compile reliable data that indicate the range of natural variation for the compounds tested at the specific location. Detailed analysis of pre-market assessment reports have so far not shown the added value of including these reference varieties in the field trials. In all cases where specific values were found to be outside of the range of the reference varieties, it proved possible to draw conclusions on the part of the pre-market risk assessment that relates to the compositional analysis, on the basis of already available compositional data. With the increasing quality of several databases on compositional data of a growing number of crop species, it seems unlikely that reference varieties will become more important on future occasions. It was furthermore investigated whether this part of the risk assessment can be related to field trial requirements for variety registration with the explicit intention of reducing the data burden on producers of new GM plant varieties. Field trials for variety registration so far include an assessment of phenotypic characteristics that do not cover safety aspects, with the exception of establishment of the glycoalkaloid content in potatoes in the Netherlands and Sweden. It may, however, under certain conditions be relatively easy to exchange data from compositional measurements between variety registration and GM testing procedures, thus laying a foundation for testing the feasibility of combining both pre-market assessment procedures in a single pre-market evaluation path.
机译：大多数法规全球规定，必须将新的转基因（GM）作物事件与其最近的非GM对应物相比，作为市场预测风险评估的角落。为此，转基因作物及其比较剂应在现场试验中生长，以进行表型比较，以及随后对两种作物品种组成的详细分析。缺乏对这些现场试验进行的更深入的全球统一方法。只有一些国家制定了GM现场试验的详细协议。在一些国家，商业非GM参考品种需要包括在现场研究中，以编译可靠数据，该数据表明在特定位置测试的化合物的自然变化范围。迄今为止对预市前评估报告进行了详细分析，目前没有显示包括这些参考品种的附加值。在发现特定值在参考品种的范围之外的所有情况下，它证明可以在市场预售风险评估中得出结论，如已经可用的组成数据涉及组合分析。随着若干数据库质量越来越多的作物数据，越来越多的作物物种，似乎不太可能在未来的场合变得更加重要。还研究了风险评估的这一部分是否可以与各种登记的现场试验要求有关，并明确意图降低新的通用植物品种生产者的数据负担。迄今为止各种注册的现场试验包括评估不包括安全方面的表型特征，除了荷兰和瑞典土豆的甘薯碱含量。然而，它可以在某些条件下相对容易地交换来自各种登记和转基因检测程序之间的组成测量的数据，从而奠定了测试在单一的市场预先评估路径中结合市场预先评估程序的可行性。

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