Abstract
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.
Highlights
Between 1996 and 2013, global production of genetically modified (GM) crops increased from 1.7 million hectares to over 175 million hectares, and the number of countries in which GM crops are produced increased from six to 27 (James 2013)
This paper considers the transportability of confined field trial data obtained in cultivation countries to import countries such as Japan for environmental risk assessment (ERA) of GM crops regardless of the characteristics of inserted gene(s) by reviewing: (1) the purpose of confined field trial assessment, (2) weediness potential of host crops, and (3) reliability of the confined field trial data obtained in cultivation countries
To consider the transportability of confined field trial data from cultivation countries to import countries for the ERA of GM crops from cultivation to import countries, it is important to have a clear understanding of the purpose of the confined field trial
Summary
Between 1996 and 2013, global production of genetically modified (GM) crops increased from 1.7 million hectares to over 175 million hectares, and the number of countries in which GM crops are produced increased from six to 27 (James 2013). For these highly domesticated commodity crops except canola, strict similarity of environmental conditions is not necessary to consider transportability of confined field trial data to detect any changes related to invasive weediness potential.
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