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Notification report


General information

Notification Number
B/NL/04/02

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
23/06/2004

Title of the Project
Evaluation of non-flowering genetically modified apple trees with increased resistance to fungi in the field.

Remark NL: This is a continuation of permit B/NL/02/03.


Proposed period of release:
01/07/2004 to 31/12/2008

Name 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?
No

Has the same GMPt been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):
B/BE/02/V1; B/NL/00/04; B/NL/02/03; B/NL/98/06;

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
applerosaceaemalusmalus domestica

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 modification

3. 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:
-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 fungi


6. Brief description of the method used for the genetic modification:
The genetic material is inserted by Agrobacterium tumefaciens mediated transformation.

Experimental Release

1. 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:
One location to be chosen in municipalities Wageningen or Ede or Elst.

3. Size of the site (m2):
1. Maximum of 1 site per year.
2. Maximum area of the site 3850 m2


4. 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:
In field trials under permit B/NL/02/03 no effects were observed on mature caterpillars of three different species. Although damage by insects was observed, the caterpillars did not apparently suffer by the genetic modification.
Also no effects were observed on greenhouse spider mites which infected the plants in the greenhouse.


Environmental Impact and Risk Management

Summary 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 report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
25/01/2005 00:00:00
Remarks: