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Notification report


General information

Notification Number
B/IS/09/01

Member State to which the notification was sent
Iceland

Date of acknowledgement from the Member State Competent Authority
15/04/2009

Title of the Project
In-field production of transgenic barley, comparison of cultivars, processing and purification of non-food/non-feed proteins

Proposed period of release:
01/05/2009 to 01/10/2013

Name of the Institute(s) or Company(ies)
ORF Genetics, Keldnaholti, 112 Reykjavík, Iceland, tel.: +3545911570, fax:+3545911580, e-mail: orf@orf.is;


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
barleypoaceaehordeumhordeum vulgarevulgareGolden Promise / Dimma

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Two genes introduced: A gene expressing a growth factor in the endosperm tissue of the seed and a gene expressing hygromycin B phosphotransferase. The marker gene has an intron.

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 respective growth factor gene is synthesized, according to a sequence information originally from a mammal. The gene and the respective protein has no function in the plant but it is solely for non-food/non-feed processing purposes. The marker gene is from E.coli. The marker gene is crucial during early tissue culture stage.

6. Brief description of the method used for the genetic modification:
Transformation with Agrobacterium tumefaciens

Experimental Release

1. Purpose of the release:
Purpose is to monitor protein accumulation in seeds, the processing and purification process of the non-food/non-feed protein. To compare varieties GP and Dimma in field conditions and to develop and exercise containment procedures releveant to these cultivars of barley. One purpose is to establish Dimma as an trackable cultivar for molecular farming.

2. Geographical location of the site:
Rangarvellir, South-west Iceland

3. Size of the site (m2):
200 m2 first year gradually increasing to 10 ha by 2013

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:
Containment studies have been performed by the Agricultural University of Iceland on this same site with GP cultivar GMO and non-GMO for the purpose of measuring likelihood of cross pollination, survival inside and outside field, and wind dispersal of seeds. In short, the results strongly suggest that crosspollination of barley is very rare event in Icelandic conditions (0 cases of crosspollination out of 700.000 individual offspring plants analyzed), Barley does not survive outside field, in a carefully maintained field; leftover (intentional) seeds from a previous year may germinate the first year but no plants appear or germinate in the second year. Barley seeds are heavy and dispersal by wind is limited; an autumn storm of 45 m/sec at the time of harvesting resulted in maximal distance of 35 meters for a seed from closest barley plant.
Seeds dispersed by wind were monitored for a year and found not to germinate.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Barley is unable to live and propagate outside cultivated fields in Iceland and escapees are not a problem since over-wintering is very rare in barley; barley fields rested for two years contain no barley escapees. Barley is a self-pollinator and without any relatives in the icelandic flora. The proteins expressed in plants do not have counterparts in the barley plant and have no physiological function in the plants. The proteins are only accumulated in the storage organ of the plant, the seeds, therefore not affecting fitness or conferring any selective advantage for the plant.
The protein expression is contained in time and space to the maturation of seeds, they are not present in roots, stems or leafs of the plant but confined to the late stage of seed development in an adult plant therefore only present in the last quarter of the life-cycle of the plant. This simplifies monitoring and control of risk significantly.


Brief description of any measures taken for the management of risks:
Test-site is surrounded by electrical fence, wire fence. Lines with bird deterrant tape are placed over the plot as deterring measures for birds.
Barley seed dispersal is very limited and 98,5% of seeds fall within 1 meter from the plant in the hardest of storms. Oat buffer zone, barley buffer zone and distance from other barley fields. Signs put up and the site monitored regularly. Sowing, harvesting and transport with dedicated equipment.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Comparison will be made on cultivation, harvest, seed processing and protein content between two varieties, GP which has been extesively studied at this site and Dimma, a new variety based on GP but with a distinct coloring feature of the seeds. Dimma provides an unique safety feature as it opens the possibility to track and identify single seeds facilitating monitoring and preventing post harvest mixture of GM Dimma with ordinary non-GM barley.
The field trials provide necessary comparisons on field performance, experience in the field monitoring and post-harvest monitoring, seed processing and protein content. The results are important for the assessment of the Dimma cultivar as a future platform for visual segregation of molecular farming cultivation.


Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Not known