Genetically Modified Organisms
Report no: 2012: 24
The Norwegian Committee for Food Safety (VKM) has performed a preliminary health and environmental risk assessment of the genetically modified and herbicide tolerant oilseed rape GT73. The assessment has been performed in connection with EFSA´s official hearing of application EFSA/GMO/NL/2010/87, and on request from the Norwegian Food Safety Authority and the Norwegian Directorate for Nature Management.
GT73 is already notified for import and processing, and for feed and food (refined oil) uses in the EU, and the application under Regulation (EC) No. 1829/2003 is for authorization of oilseed rape GT73 for uses not covered by any previous authorization or applications.
VKM concludes that the data for comparative assessments presented by the notifier do not meet EFSA Guidance standards for risk assessment of GM plants and derived food and feed.
VKM points out that limited agronomic data from field trials in Canada and Europa are provided by the applicant, and that the description of the experimental design is incomplete. An assessment of the results of the studies is therefore not possible, and the applicant is requested to provide updated agronomic studies in compliance with the EFSA Guidelines.
VKM has also commented that the toxicological studies available are outdated and not according to OECD guidelines.
VKM presumes that the application indirectly includes import of viable seeds. VKM points out that oilseed rape can establish feral populations outside cultivated areas (e.g. roadsides, railway ground and ports). Germination and establishment of volunteer GT73 plants may result in a gene flow into cultivated and closely related wild relatives.
In Norway glyphosate may be used for weed control in non-agricultural environments including traffic areas, and spilled GT73 might have a selective advantage over conventional oilseed rape along some transport routes.
The applicant should therefore be requested to provide an updated environmental risk assessment for GT73 covering accidental spillage of seeds during transport, handling and processing along transport routes and ports.
The assessment of the oilseed rape GT73 (EFSA/GMO/NL/2010/87) is carried out by VKM´s Panel on Genetically Modified Organisms and will be finalized when additional documentation from EFSA and the applicant are available.