Consideration of familiarity accumulated in the confined field trials for environmental risk assessment of genetically modified soybean (Glycine max) in Japan

Abstract

To date, there have been 160 regulatory approvals for environmental safety in Japan for the major genetically modified (GM) crops, including corn, soybean, canola and cotton. Confined field trials (CFTs) have been conducted in Japan for all single events, which contain various traits. The accumulated information from these previously conducted CFTs, as well as the agronomic field study data from other countries, provides a rich source of information to establish "familiarity" with the crops. This familiarity can be defined as the knowledge gained through experience over time, and used to inform the environmental risk assessments (ERA) of new GM crops in Japan. In this paper, we compiled agronomic data from the CFTs performed in Japan for 11 GM soybean events which obtained food, feed and environmental safety approvals from regulatory agencies in Japan. These CFTs were conducted by multiple developers according to Japan regulations to support the ERA of these GM soybean, covering standard measurement endpoints evaluated across developers in Japan. With this dataset, we demonstrate how familiarity gained from the CFTs of GM soybeans in Japan can be used to inform on the ERA of new GM soybean events. By leveraging this concept of familiarity, we discuss potential enhancements to the ERA process for GM soybean events in Japan.

Keywords: Confined field trials; Data transportability; Environmental risk assessment; Familiarity; Genetically modified crops.

Fig. 1

Correlation in key agronomic characteristics between GM soybean and non-GM comparator in Japan CFT. Each pair of the mean value of the major measurement endpoints for the 11 GM soybean (Y axis) and corresponding non-GM NIL soybean (X axis) were plotted, and Pearson’s r was calculated by dividing the covariance of X and Y by the standard deviations of X and Y. Dotted lines in each chart represent Y = X

Fig. 2

Distribution of 100 grain weight and stem length data collected for GM soybean and non-GM comparator in Japan and US CFTs. Each pair of the mean value of the two common measurement endpoints between Japan CFT (circle) and in US CFTs (diamond) for the 11 GM soybean (Y axis) and corresponding non-GM soybean (X axis) were plotted, and Pearson’s r was calculated by dividing the covariance of X and Y by the standard deviations of X and Y. Dot lines in each chart represent Y = X