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Notification report


General information

Notification Number
B/CZ/06/03

Member State to which the notification was sent
Czech Republic

Date of acknowledgement from the Member State Competent Authority
05/10/2006

Title of the Project
Release into the environment of genetically modified plum cv. Stanley clone C-5 containing the coat protein gene of Plum pox virus

Proposed period of release:
18/10/2006 to 31/12/2012

Name of the Institute(s) or Company(ies)
Research Institute of Crop Production, ;


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
plumrosaceaeprunusprunus domesticaStanley

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Coat protein gene of Plum pox virus
NPT II and GUS genes (tolerance to kanamycin and glucuronidase, respectively) as selectable marker genes to identify transgenic cells in a tissue culture


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:
- GUS gene, E. coli, chromogenic marker
- NPT II gene, resistance to kanamycin, selection marker
- 35S promoter from Cauliflower mosaic virus, gene regulation
- Terminator from nopaline synthase gene, A. tumefaciens, gene regulation
- Coat protein gene from Plum pox virus, induction of resistance against Plum pox virus infection


6. Brief description of the method used for the genetic modification:
Plasmid DNA was introduced into the plum lines by Agrobacterium-mediated gene transfer technology. This is a standard technology for plant transformation.

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:
The purpose of the release is, within the frame of safety studies to obtain data on interactions among transgene, homologous (Plum pox virus) and heterologous (Prune dwarf virus and Apple chlorotic leafspot virus) viruses and a host plant – plum. Plum pox virus infection should be diminished due to a post-transcriptional gene silencing induced by transgene. Impact on other viruses will be studied. Data on agronomical performance of plum will be also obtained.

2. Geographical location of the site:
The release site is located within the area of international airport Praha-Ruzyně.

Remark: planting of 16 more trees within the site was approved and the authorisation was prolonged to 31/12/2012


3. Size of the site (m2):
Approx. 260 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:
There have been previous releases of this plum cv. Stanley clone C-5 with inserted Plum pox virus coat protein gene in Poland, Romania and Spain. No adverse impacts on the environment or human health have been recorded in any of the trials.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
The genetically modified plum cv. Stanley, clone C-5 contains a coat protein gene of Plum pox virus (PPV). The insertion has to give the resistance against the virus based on a post-transcriptional gene silencing (PTGS) mechanism.
No difference regarding persistence in agricultural habitats or invasiveness in natural habitats compared to conventional plum varieties is expected. Nor is it expected that a selective advantage or disadvantage is conferred to the GM clone via the introduced traits.
Due to the measures to be taken during the release (distance to cultivated and wild relatives) the potential for gene transfer will be diminished.
No toxic or allergenic effects are expected from the presence of inserted gene. The inserted gene is not expressed; no foreign protein is produced.
Measures in place under current field trial practice will protect the trial from damage by animals. Location of the trial within the airport area excludes the presence of unwanted humans. No effects are expected on biogeochemical processes. The GM plum cv. Stanley clone C-5 will be cultivated under conventional agricultural practices.


Brief description of any measures taken for the management of risks:
The dispersion of a transgene will be diminished by planting of GM plants in space isolation - more than 1 km from any other plant of plum or related species. All fruits will be harvested to prevent spread of transgene. Potential plum seedlings will be monitored and removed.

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

Final report
-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
08/04/2007 00:00:00
Remarks:
The consent for notification B/CZ/06/03 was on 28/11/2012 prolonged for another 5 years, that is to 31/12/2017