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General information Notification Number B/IS/21/01 Member State to which the notification was sent Iceland Date of acknowledgement from the Member State Competent Authority 03/03/2021 Title of the Project Confined in-field trial production of transgenic barley, comparison of cultivars for processing and purification of non-food/non-feed proteins (molecular farming) Proposed period of release: 01/05/2021 to 01/10/2025 Name of the Institute(s) or Company(ies) ORF Genetics, Keldnaholti, 112 Reykjavík, Iceland, tel.: +3545911570, fax:+3545911580, e-mail: orf@orf.is
Is the same GMPt been notified elsewhere by the same notifier? Yes 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 Name	Family Name	Genus	Species	Subspecies	Cultivar/breeding line
barley	poaceae	hordeum	hordeum vulgare	vulgare	Golden Promise, Kola, Conlon, Risö, Austenson, Kria, Teista, Smyrill

Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications: Two synthesized 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. The recombinant target proteins are of a natural origin such as the highly purified ISOkine human growth factors (GFs) sold for e.g. stem cell based research and MESOkine GFs for cell cultured meat.
Target proteins are EGF, Thaumatin, IGF-1, KGF, FGFb146, Noggin, mLIF. Genetic modification 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 gene expression cassette is inserted into the barley genome by random integration. The novel trait does not affect the host plant as none of them have any physiological function in barley plants, and it is therefore a “silent” trait from barleys perspective. The purpose with the trait is to have the barley produce the target proteins and thereafter purify them from the grains post-harvest. The transgenic barley plants are not intended for food or feed, but for purposes of molecular farming, i.e., purification of the target proteins from the harvest by specific protein purification techniques performed by ORF Genetics Protein Department. Brief description of the method used for the genetic modification: The transgenic barley plants were generated using a standard Agrobacterium-mediated transformation procedure where immature barley embryos were co-cultivated with the recombinant Agrobacterium bacteria containing the gene expression cassette. This results in transfer and random integration of the gene expression cassette into the barley genome. 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 Purpose of the release: The main purpose of the trial is to verify the feasibility of growing transgenic barley in Iceland for molecular farming as well as to compare the crop characteristics of the selected barley cultivars and offspring, in particular with regards to accumulation of the non-feed/non-food target protein in the seeds. The results will be compared with corresponding cultivations in ORFs greenhouse as well as in-field-trials in Canada where ORF has been conducting in-field trials since 2013 with favorable results. Geographical location of the site: Rangarvellir, South-west Iceland Size of the site (m2): Trial site in 2021 is around 2.000 m2 and then gradually increasing each year up to 50.000 m2 by 2026. 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 location (Gunnarholt) with Golden Promise (GP) cultivar that were either 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 (less than 1/500.000 individual offspring plants analyzed).
The Agency has previously issued a permit to ORF for releasing GM-Barley at the same location, last permit was from 2009 till 2013. No sign of cross pollination has been seen from past trials. Environmental Impact and Risk Management Summary of the potential environmental impact from the release of the GMPts: Field trials in Iceland have confirmed that frequency of intra-species cross-fertilization is extremely low under field conditions; less than 1/ 500.000 between GP and other barley cultivars according to studies performed by Icelandic Agricultural University. Studies indicate that the pollen of GP is dead by the time the flower opens further minimizing any chance of crossbreeding. Barley does not survive outside field, a study done in a carefully maintained field showed that 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.
The target protein expression is contained in time and space to the maturation of seeds, they are not present in roots, stems or leaves 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: The trial site is at Gunnarsholt, a 12.000-hectare site owned by The Soil Conservation Service of Iceland (SCSI). No traditional commercial cultivation is performed at SCSI, it is only used as a test site. No domesticated animals close to the site and the main wild animals known in the area are birds. The expected size of ORFs trial site 2021 is only around 0.2 hectares.
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.
The seeds will be harvested, and the remaining non-viable plant material will be disposed of according to the permit requirements. The trial site will then be monitored two years following the trial cultivation. Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release: The gain of new data will enable ORF to evaluate the viability of cultivating these breeding lines of GM-barley outside in Iceland. The risk on environmental and human health impact from the release is considered low by the Environment Agency of Iceland. This assessment is backed up by the statements of the Ministry‘s Panel on genetically modified organisms and the Icelandic Institute of Natural History.
The field trials provide necessary comparisons on field performance, experience in the field monitoring and post-harvest monitoring, seed processing and protein content. ORF has developed a product from growth factors that was developed for the rapidly expanding cell-cultured meat (CCM) market and aims at significantly bringing down the cost of GFs for CCM which is crucial for the future of this field. Final report - European Commission administrative Information Consent given by the Member State Competent Authority: Yes
04/30/2021
Remarks:The Environment Agnecy of Icelands has issued a permit for this release. It was issued on the 30th of April 2021 and it's durations is until 1. November 2027 but the last release of gmo barley will be in the year 2025. Yearly reports will be sent.