Report on the Verification of the Performance of MON89034 and MON88017 Event-specific Methods on the Maize Event MON89034 x MON88017 Using Real-Time PCR

摘要

The JRC as Community Reference Laboratory for GM Food and Feed (CRL-GMFF), establishedby Regulation (EC) No 1829/2003, has carried out an in-house verification study to assess theperformance of two quantitative event-specific methods on the maize event MON89034 xMON88017 (unique identifier MON-89Ø34-3 x MON-88Ø17-3) which combines the MON89034and MON88017 transformation events. The two methods have been validated individually onsingle-trait events, to detect and quantify each event in maize samples. This study wasconducted according to internationally accepted guidelines (1, 2).In accordance to Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modifiedfood and feed and to Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for theimplementation of Regulation (EC) No 1829/2003, Monsanto Company provided the detectionmethods and the control samples: genomic DNA extracted from seeds of MON89034 xMON88017 maize, genomic DNA extracted from seeds of non-GM maize, seeds of MON89034 xMON88017 and seed of conventional maize. The JRC prepared the in-house verificationsamples (calibration samples and blind samples at different GM percentages).The results of the in-house verification study were evaluated with reference to ENGL methodperformance requirements (http://gmo-crl.jrc.ec.europa.eu/guidancedocs.htm) and to thevalidation results on the parental events (http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm).The results of this CRL-GMFF in-house verification studies are made publicly available athttp://gmo-crl.jrc.ec.europa.eu/