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Notification report


General information

Notification Number
B/ES/05/14

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
17/02/2005

Title of the Project
Environmental impact assessment of transgenic grapevines and plums on the diversity and dynamics of virus populations.

Proposed period of release:
01/01/2005 to 31/12/2010

Name of the Institute(s) or Company(ies)
Instituto Valenciano de Investigaciones Agrarias, Apartado oficial
46113 Moncada (Valencia)
Spain;


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/ES/96/16;

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
european plumrosaceaeprunusprunus domesticadomesticaStanley C5

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
-the Plum pox virus coat protein gene (PPV-CP)
-the neomycin phosphotransferase II gene (nptII) and
-the beta-glucuronidase gene (gus).
The trangene is inserted in three copies in the plant genome and confers to transgenic plums resistance to sharka.


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 three components of the inserted foreign DNA and their functions are the following:
a)npt II gene from Escherichia coli confers resistance to kanamycin. It is included as a selection marker in the transformation process.
b)beta-glucuronidasa gene from E. coli is a chromogenic marker.
c)coat protein (CP) gene from PPV genome, D strain, codifies for the Plum pox virus coat protein.


6. Brief description of the method used for the genetic modification:
Plum hypocotyl slices were transformed with the coat protein (CP) gene of Plum pox virus (PPV-CP) following cocultivation with Agrobacterium tumefaciens containing the plasmid pGA482GG/PPV-CP-33. This binary vector carries the PPV-CP gene construct, as well as the chimeric neomycin phosphotransferase and beta-glucuronidase genes. See Plant Cell Reports (1994).

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

Experimental Release

1. Purpose of the release:
The main objective of the project is to evaluate under field conditions the impact of the PPV-CP transgenic plums on the dynamics and variability of virus populations. Our safety assessment studies will determine the potential of heterologous viruses (Apple chlorotic leafspot virus [ACLSV], Prune dwarf virus [PDV] and Prunus necrotic ringspot virus [PNRSV]) at reverting the engineered protection to PPV in transgenic plums. Mixes of viruses will be inoculated by grafting onto transgenic plums and PPV infection on the grafted transgenic plums and the diversity of virus populations within, will be evaluated in successive Springs.

2. Geographical location of the site:
Experimental plot in Lliria, Campo del Turia area, province of Valencia.

3. Size of the site (m2):
The size of the site plot is 1200 m2 placed in an experimental farm of 26 ha. Only 8 transgenic European plums and 10 top-grafted Japanese plum trees planted in a 100 m2 area will be analysed.

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:
Transgenic plums that will be studied were established in the field in 1996 regarding the project "Field testing of transgenic plums containing Plum pox virus coat protein gene" (notification number B/ES/96/16). Results from these studies demonstrated that the transgenic line C5 is highly resistant to natural infection of PPV. Additionally, the C4 transgenic line showed a remarkable delay in the infection, and the rest of the analysed transgenic (C6, PT-6 and PT-23) and non-transgenic (non-transformed P. domestica and P. salicina) lines were not resistant to PPV. These result will be published by Malinowski et al. (2005) "Field trials of plum clones (Prunus domestica L.) transformed with the Plum pox virus coat protein (PPV-CP) gene demonstrate resistance to plum pox disease".

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
The release of GM-European plums carrying the coat protein gene of PPV is considered not to have any adverse effect on human, animals or plants. We consider that the stay of these trees in the field will not affect the dynamics and diversity of virus populations, since only 8 trees and 10 top-grafted trees surrounded by non-compatible guard trees will be studied. There is not possibility of an increase of the transgenic trees population nor the GM-trees have selective advantage compared to conventional ones.

The transgenic trees that will be studied were established in the field seven years ago. Along this time the trees have been exhaustively monitorized and it has been demonstrated that the release of the GMOs did not suppose an environmental risk since they are PPV resistant in natural conditions.


Brief description of any measures taken for the management of risks:
The transgenic plum trees are surrounded by non-transgenic border trees, hybrids peach x almond, which are sexually incompatible with plums. All GMP debris will be removed from the test area. At the end of the experiment, the planting will be herbicide-killed and then the trees eliminated by bulldozing into large piles and burning.

Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
The main objective of the study is to assess the ecological impact of the use of the PPV resistant transgenic plums on the diversity and dynamics of virus populations, particularly on the reversion of the resistance to PPV of transgenic plums by infection with challenger or heterologous viruses.

Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Not known