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Notification report


General information

Notification Number
B/DE/03/140

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
09/08/2003

Title of the Project
Evaluation of horticultural characteristics and their stability in genetically modified apple plants (Malus domestica Borkh.)

Proposed period of release:
23/09/2003 to 31/12/2023

Name of the Institute(s) or Company(ies)
Federal Centre for Breeding Research on Cultivated Plants, ;


3. Is the same GMPt release planned elsewhere in the Community?
No

Has the same GMPt been notified elsewhere by the same notifier?
No

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
applerosaceaemalusmalus domestica1. Pinova, 2. Pilot, 3. Reka, 4. Remo, 5. Elstar, 6. Royal Gala, 7. AU 56-83

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Resistance to fungal and bacterial pathogens
Resistance to kanamycin (marker gene)


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:
Plasmid /Transgene /Source / Promoter (P) / Terminator (T)/ Translation enhancer

pGUS-int /ß-Glucuronidase-Gene with intron / E. coli / 35S RNA-P and T from CaMV

pLDB15 / Attacin E gene(Att E) / Hyalophora cecropia / P and T of the potato proteinase inhibitor II gene

p35SAMVT4 / Lysozyme gene (T4L) / Bacteriophage T4 / 35 S RNA - P from CaMV; T of the nos gene / Alfalfa mosaic virus RNA4 leader sequence

pPinAtt35S AMVT4 / Att E + T4L /.../ P and T of the potato proteinase inhibitor II gene for Att E and CaMV35S as P; NOS as T for T4L / Alfalfa mosaic virus RNA4 leader sequence for T4L

pBINAR19 Dpo / EPS-depolymerase gene / Bacteriophage Ea1h / 35 S RNA - P from CaMV; T of the octopinsynthase gene from A. tumefaciens /

pBINESR1 / Endochitinase gene (ech42) / Trichoderma harzianum / CaMV35S as P; NOS as T / Alfalfa mosaic virus RNA4 leader sequence

pBI121cNag / N-acetyl-ß-D-glucosaminidase(nag70)gene / Trichoderma harzianum / CaMV35S as P; NOS as T / Alfalfa mosaic virus RNA4 leader sequence

pBIN(Endo+Nag) / ech42 + nag70/.../ CaMV35S as P; NOS as T / Alfalfa mosaic virus RNA4 leader sequence

All constructs contain the neomycin phosphotransferase II gene with promoter and terminator of the nopalin synthase gene (nos) from A. tumefaciens.


6. Brief description of the method used for the genetic modification:
Transformation was carried out by Agrobacterium tumefaciens- mediated transfer of foreign genes into leaf explants. Wounded leaf explants of proliferating in vitro cultures of apple were incubated and co-cultured with Agrobacterium, the bacteria were washed off after 2 days, and the leaf explants were cultured on a selection medium containing an antibiotic to kill the bacteria and kanamycin for selection of transgenic shootlets. The kanamycin selection was based on the selectable marker gene nptII of the T-DNA. Regenerated transgenic shoots were transferred on a proliferation and later on a rooting medium for further transfer to the greenhouse.

7. If the recipient or parental plant is a forest tree species, describe ways and extent of dissemination and specific factors affecting dissemination:
not applicable

Experimental Release

1. Purpose of the release:
- Assessment of pomological traits (Alteration of disease resistance, non alteration of other traits) in GM-trees
- Evaluation of expression and environmental stability of transgenes / traits in field conditions
- Hybridisation for breeding purposes and evaluation of heritability of transgenes
- Risk assessment on transgenic trees (interactions between GM-plants and target pathogens or non-target organisms)


2. Geographical location of the site:
1. Germany, Dresden, East Germany
2. Germany, Quedlinburg, Middle Germany


3. Size of the site (m2):
- Dresden 1 ha
- Quedlinburg 0.2 ha


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:
not applicable

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Possibility of increased persistence / invasion of GM-plants in environment:
Apple plants have an extreme low potential for dissemination and establishment in horticultural and natural habitats based on generative or vegetative propagation.
Inadvertent escape of pollen or seeds:
Since the apple trees in the field trial will be managed in such a manner that pollen or seeds will not escape, the reproduction structure with sexual compatible plants is highly unlikely.
Increased selective advantage in natural environment:
The described trial is aimed on the increase of disease resistance. The trees will be planted in a horticultural orchard. A selective advantage of the GM-plants in this habitat is non relevant because the trees have to be propagated vegetatively. There have been no intentional modifications that would cause enhanced weediness characteristics being of advantage in natural populations.
Impact on other organisms:
The risk of horizontal movement of the newly introduced genes from the genetically engineered apple trees into the environment is negligible because the genes are incorporated into the plant genome. It is expected that target organisms will be inhibited in their development. No factor unique to this field test trial has been identified that would have an effect on any non target organism. The relationship between GM-plants and target / non target organisms will be studied during the field trial.
Impact on human health:
No apple for human consumption and no feed will be produced. No potential impact on the human population can be identified.


Brief description of any measures taken for the management of risks:
The proposed field tests are designed to minimize movement of the introduced genes from the test sites. At the Quedlinburg test site, the formation of flowers will be prevented and at the Dresden site, appropriate physical measures will be employed to prevent movement of the new genes via pollen.

Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Not appropriate at this time

Final report
-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known