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Notification report


General information

Notification Number
B/RO/11/01

Member State to which the notification was sent
Romania

Date of acknowledgement from the Member State Competent Authority
03/01/2011

Title of the Project
Environmental use of safe virus-free plums

Proposed period of release:
01/03/2011 to 31/12/2019

Name of the Institute(s) or Company(ies)
Fruit Research and Development Station Bistrita, Drumul Dumitrei Nou Sreeet, no. 3,
Bistrita, Romania;


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/RO/07/04;

Genetically modified plant

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

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 insert contain also a promoter (35S) and a terminator (NOS).
The trangenes are inserted in three copies in the plant genome


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 components of the inserted foreign DNA and their functions are as following:
a) coat protein (CP) gene from PPV genome, D strain, codifies for the Plum pox virus coat protein. It was engineered for targeting the pathogen derived resistance approach.
b) npt II gene from Escherichia coli confers resistance to kanamycin. It was included as a selection marker in the transformation process.
c) beta-glucuronidase gene from Escherichia coli - is a chromogenic marker.
d) 35S promoter from Cauliflower mosaic virus - is a gene regulation.
e) NOS terminator from nopaline synthase gene, isolated from Agrobacterium tumefaciens, is a gene regulation.


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 .

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 main objective of field trial of C5 genetically modified plum resistant to Sharka is to gain further information relating to the agronomical and phenotype performance and compatibility of this event under PPV endemic area and geo-climatic conditions of Romania. The study will be performed in the context of Plum pox virus-free plum crops and decreasing the environmental pollution caused by the abuse of pesticides used for aphids control. The use of C5 in hybridization to obtain male sterile progenies resistant to PPV is also a goal of this field trial.

2. Geographical location of the site:
Experimental plot at Fruit Research and Development Station Bistrita (Statiunea de Cercetare-Dezvoltare pentru Pomicultura Bistrita), Bistrita-Nasaud county, Bistrita Hilly, Romania.

3. Size of the site (m2):
The size of the site plot proposed is 1200 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:
Transgenic plum trees containing the PPV CP gene were tested in experimental orchards under conditions of high PPV inoculums pressure in Spain (notification numbers B/ES/96/16, B/ES/05/14), Poland (ref DOPgmo 4301/02-4/2002), and Romania (import authorization by Ministry of Agriculture no. 1166/ 02/ 1996). Transgenic C5 plum trees were highly resistant to graft-inoculation with PPV and no tree became infected via aphid-mediated transmission of PPV over 10-years of field trials (Malinowski et al., 2006 - Plant disease). These data revealed the durability of resistance to PPV of C5 plum trees. The engineered resistance to PPV in C5 was also stable in the presence of heterologous viruses (Zagrai et. al., 2008 – Journal of Plant Pathology)
Because the transgenic plums carry the PPV CP gene, the environmental safety issues have been expressed on potential hazards concerning the emergence of PPV variants. The potential impact of transgenic plums expressing PPV CP gene construct on the diversity and dynamics of PPV populations was assessed under open and confined conditions in the frame of a research program sponsored by the European Commission (TRANSVIR QLK3-CT-2002-02140). Across field trials conducted in different locations (Romania and Spain) and environments (continental and Mediterranean), transgenic plums expressing the PPV CP gene had no detectable effect on the emergence of recombinant PPV species over ten years. Also, these transgenic plums had a neutral impact on non-target organisms over extended time (Capote et al., 2008 - Transgenic Research, Zagrai et al., 2010 – Journal of Plant Pathology).
Another field trial with C5 transgenic plum is in progress in Czech Republic (notification number B/CZ/06/03). This trial has shown that PPV resistance remains stable in C5 HoneySweet even in the presence of other Prunus-infecting viruses (Jarosova et al., 2010 - Julius-Kuhn-Archiv).


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. PPV resistance will not impart weediness to this plum. There is not possibility of an increase of the transgenic trees population nor the GM-trees have selective advantage compared to conventional ones, since they became resistant to PPV. The transgenic plum trees were exhaustively studied along 15 years period. Risk assessment studies demonstrated that the release of this GMO does not constitute an environmental risk. It was concluded that C5 transgenic plum and any progeny derived from hybrid crosses with nontransformed plum varieties will be no more of a plant pest than plum varieties in traditional breeding (USDA/APHIS -Federal Register Doc. E7-13649, July 12, 2007). In addition, there is a history of another GMO carrying a similar insert (transgenic papaya exhibiting „pathogen-derived resistance”) that attest the safe consumption and no adverse effect on environment. The safety of C5 HoneySweet is indicated by its deregulation in the U.S. by USDA-Animal and Plant Health Inspection Service (APHIS), the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA). These approvals were based on the extensive investigation of this plum in both the U.S. and Europe, including studies undertaken in Romania under previous permits.
An Environmental Risk Assessment study has been completed and submitted with this application. In summary, no immediate or delayed adverse effects as a result of the direct and indirect interaction of the genetically modified plum with the environment have been identified.


Brief description of any measures taken for the management of risks:
•The experimental plot will be surrounded by non-transgenic border trees, apple, pear and cherry (which are sexually incompatible with plums) to minimize pollen dispersal;
•Planting and harvesting will be conducted by SCDP Bistrita personnel trained on precaution measures;
•Carrying out regular visits to inspect field trail site, making observations, samples collecting and verifying that adequate measures are applied for preventing pests and diseases;
•No fruit products resulting from the field trail will be used as food or feed;
•Potential plum seedlings will be monitored and removed.
•All GMP debris will be removed from the test area and destroy. At the end of the experiment, the plants 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:
This trial includes a secondary objective to gain new data on the environment impact, such as coexistence of transgenic with conventional plums, including also wild Prunus. A few Prunus cerasifera and Prunus spinosa plants will be grown in the same experimental plot to check the potential of gene flow to these species. We expect an insignificant potential of natural transfer since the blooming time between C5 and the two wild species is different. A high level of incompatibility between C5 and the two species is also expected (Nielsen and Olrik, 2001 – Nordic Journal of Botany).
The producing of a limited numbers of male sterile progeny resistant to PPV (derived from hybridization between conventional male sterile plum cultivars and C5) is also a goal of the trial. These kinds of plants will avoid any controversy referring to coexistence.


Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
16/05/2012 00:00:00
Remarks: