Report on the Verification of the Performance of 59122 and NK603 Event-specific Methods on the Hybrid Maize Line 59122xNK603 Using Real-Time PCR. Validation Report and Protocol

Abstract

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 hybrid maize line 59122xNK603 (unique identifier DAS-59122-7xMON-ØØ6Ø3-6) which combines the 59122 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, Pioneer Hi-Bred Intl. Inc. provided the detection methods and the control samples (59122xNK603 ground maize flour, conventional ground maize flour and non genetically modified control DNA). 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.it/doc/Method%20requirements.pdf) and to the validation results on the individual parental events (http://gmo-crl.jrc.it/statusofdoss.htm). The results of this CRL-GMFF in-house verification studies are made publicly available at http://gmo-crl.jrc.it/. CRL-JRC.I.6-Biotechnology and GMO