Event-specific method for the detection of dried-killed bacterial biomass PT73 (TM) derived from E. coli GM strain AG3139 using real-time PCR : validation report and protocol

The JRC as Community Reference Laboratory for GM Food and Feed (CRL-GMFF), established by Regulation (EC) No 1829/2003, has carried out a verification study to assess the performance of two quantitative eventspecific methods on the maize event MON89034 x NK603 (unique identifier MON 89Ø34-3 x MON ØØ6Ø3-6) which combines the MON89034 and NK603 transformation events. The two methods have been validated individually on single-trait events, to detect and quantify each event in maize 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 extracted from seeds of MON89034 x NK603 maize (lot GLP-0701-17954-S), genomic DNA extracted from seeds of non-GM maize (lot GLP-0612-17871-S). The JRC prepared the verification samples (calibration samples and blind samples at different GM percentages). 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 study are made publicly available at http://gmo-crl.jrc.ec.europa.eu/.