Requirement of in-country confined field trials for genetically modified (GM) crops prior to unrestricted release is well-established among countries with domestic regulations for the cultivation approval of GM crops. However, the requirement of in-country confined field trials is not common in countries where the scope of the application does not include cultivation. Nonetheless, Japan and China request in-country confined field trials for GM crops which are intended only for use as food, feed and processing. This paper considers the transportability of confined field trial data from cultivation countries (e.g. United States, Canada, and South American countries) to import countries like Japan for the environmental risk assessment of GM crops by reviewing: (1) the purpose of confined field trial assessment, (2) weediness potential, defined as “an ability to establish and persist in an unmanaged area that is frequently disturbed by human activity”, of host crops, and (3) reliability of the confined field trial data obtained from cultivation countries. To review the reliability of the confined field data obtained in the US, this paper describes actual examples of three confined field trials of approved GM corn events conducted both in the US and Japan. Based on the above considerations, this paper concludes that confined field data of GM corn and cotton is transportable from cultivation countries to importing countries (e.g. from the US to Japan), regardless of the characteristics of the inserted gene(s). In addition, this paper advocates harmonization of protocols for confined field trials to facilitate more efficient data transportability across different geographies.Electronic supplementary materialThe online version of this article (doi:10.1007/s11248-015-9892-6) contains supplementary material, which is available to authorized users.
An expanding trend for genetically engineered (GE) crops is to cultivate varieties in which two or more single trait products have been combined using conventional breeding to produce a stacked trait product that provides a useful grouping of traits. Here, we report results from compositional analysis of several GE stacked trait products from maize and soybean. The results demonstrate that these products are each compositionally equivalent to a relevant non-GE comparator variety, except for predictable shifts in the fatty acid profile in the case of stacked trait products that contain a trait, MON 87705, that confers a high-oleic-acid phenotype in soybean. In each case, the conclusion on compositional equivalence for the stacked trait product reflects the conclusions obtained for the single trait products. These results provide strong support for conducting a reassessment of those regulatory guidelines that mandate explicit characterization of stacked trait products produced through conventional breeding.
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