Report on the verification of the performance of MON 88017 and MON 810 event-specific methods on the maize event MON 88017 x MON 810 using real-time PCR : validation report and protocols

The JRC as Community Reference Laboratory for GM Food and Feed (CRL-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 maize event MON 88017 x MON 810 (unique identifier MON 88Ø17-3 x MONØØ810- 6) which combines the MON 88017 and MON 810 transformation events. The two methods have been previously validated individually on single-trait event, to detect and quantify each event in maize samples; a validation report for each method is available at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm. 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 Europe S.A. provided the detection methods and the control samples: whole seeds of MON 88017 x MON 810 maize (TPX151-DT, GLP-0409-15526-S) and whole conventional maize seeds of EXP258 (GLP-0409-15528-S). The JRC prepared the in-house verification samples (calibration samples and blind samples at different GM percentages). The results of the in-house 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 CRL-GMFF in-house verification studies are made publicly available at http://gmocrl.jrc.ec.europa.eu/.