General informationNotification NumberB/NL/02/03Member State to which the notification was sentNetherlandsDate of acknowledgement from the Member State Competent Authority25/07/2002Title of the ProjectEvaluation of non-flowering genetically modified apple trees with increased resistance to fungi in the field.Proposed period of release:01/01/2003 to 31/12/2007Name of the Institute(s) or Company(ies)Plant Research International - Dept. Genetics and Breeding, NL-6700 AA Wageningen;
3. Is the same GMPt release planned elsewhere in the Community?NoHas the same GMPt been notified elsewhere by the same notifier?YesIf yes, notification number(s): B/BE/02/V1; B/NL/00/04; B/NL/98/06; Genetically modified plantComplete name of the recipient or parental plant(s)
2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:The genetically modified apple trees are inoculated onto non-modified rootstocks. The GM apples carry a kanamycin resistance gene nptII, a modified beta-glucuronidase gene (GUS-intron) and a hth gene encoding a type 1 alpha-hordothionine precursor conferring resistance to fungi.Genetic modification3. Type of genetic modification:Insertion; In case of insertion of genetic material, give the source and intended function of each constituent fragment of the region to be inserted:The binary vector pMOG402.hth.gusintron contains between the borders the following elements:
|Common Name||Family Name||Genus||Species||Subspecies||Cultivar/breeding line|
-P35S: promoter derived from the CaMV 35S gene for transcription start, consitutive expression and enhanced expression
-T35S: terminator derived from the CaMV 35S gene
-Pnos: promoter derived from the nopaline synthase gene from the Ti plasmid of Agrobacterium tumefaciens
-Tnos: terminator derived from the nopaline synthase gene from the Ti plasmid of Agrobacterium tumefaciens
-nptII: kanamycin resistance gene from Tn5, can be derived from Escherichia coli
-gus(int): B-glucuronidase gene, besides original version also a version with an intron inserted which originates from plants
-hth: alpha-hordothionine gene derived from barley, conferring resistance to fungi6. Brief description of the method used for the genetic modification:The genetic material is inserted by Agrobacterium tumefaciens mediated transformation.Experimental Release1. Purpose of the release:1. Evaluation of resistance to apple scab (Venturia inequalis) in the open field.
2. Evaluation of specifity of resistance to other plant-pathogenic organisms, such as mildew (Podosphora leucotricha) and fruittree cancer (Erwinia amylovora).2. Geographical location of the site:Municipality Wageningen3. Size of the site (m2):1. Maximum of 1 site per year.
2. Maximum area of the site 3850 m24. Relevant data regarding previous releases carried out with the same GM-plant, if any, specifically related to the potential environmental and human health impacts from the release:not available at this stageEnvironmental Impact and Risk ManagementSummary of the potential environmental impact from the release of the GMPts:The gene encoding hordothionin confers resistance to Venturia inequalis and Nectria galligena. It might also affect Podosphora leucotricha and Erwinia amylovora.
Since it is at this stage unknown whether there will be any effect of the modification in relation to sensitivity to other fungal or bacterial diseases, dispersal or introgression of the trait should be avoided.
In case of upscaling of the field trials, experimental data should be supplied regarding the degradation patterns of the hordothionin proteins in the soil and if this will affect soil organisms. Furthermore, data should be supplied regarding the possible effects of the GMPs on (visiting) insects.Brief description of any measures taken for the management of risks:- All plant lines are or will be checked for the absence of the genes trfA and nptIII, which are present on the vector backbone, before the plant lines are introduced into the field.
- Trees must be treated with giberellines to prevent flowering. The experimental object must be frequently observed on inflorescence. Inflorescence must be removed before flowering, in case this may occur.
- Inactivation of the waste will be conducted according to standard regulations, or by shredding and subsequent burning of the plants/trees.Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:In case of upscaling of the field trials, experimental data should be supplied regarding the degradation patterns of the hordothionin proteins in the soil and if this will affect soil organisms. Furthermore, data should be supplied regarding the possible effects of the GMPs on (visiting) insects.
If upscaling is foreseen by the applicant, the field release will also focus on the above mentioned aspects.Final reportEuropean Commission administrative informationConsent given by the Member State Competent Authority:Yes21/05/2003 00:00:00Remarks: