Report on the Verification of the Performance of MON87701 and MON89788 Event-specific Methods on the Soybean Event MON87701 x MON89788 Using Real-time PCR

Abstract

The European Union Reference Laboratory for GM Food and Feed (EU-RL GMFF), established by Regulation (EC) No 1829/2003, has carried out an in-house verification study to assess the performance of two quantitative event-specific methods on the soybean event MON87701 x MON89788 (unique identifier MON-877Ø1-2 x MON-89788-1) which combines the MON87701 and the MON89788 transformation events. The two methods have been validated individually on single-trait events, to detect and quantify each event in soybean samples. This study was conducted according to internationally accepted guidelines (1, 2). In accordance to Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed and to Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003, Monsanto Company provided the detection methods and the control samples: genomic DNA from homogenised seeds of MON87701 x MON89788 soybean and from homogenised seeds of conventional soybean. The EU-RL GMFF prepared the verification samples (calibration samples and blind samples at different unknown GM percentages [DNA/DNA]). The results of the verification study were evaluated with reference to ENGL method performance requirements (http://gmo-crl.jrc.ec.europa.eu/guidancedocs.htm) and to the validation results on the individual parental events (http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm) The results of this EU-RL GMFF in-house verification studies are made publicly available at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htmJRC.I.3-Molecular Biology and Genomic