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General information Notification Number B/LV/02/15276 Member State to which the notification was sent Latvia Date of acknowledgement from the Member State Competent Authority 21/03/2023 Title of the Project SIA Pestivene CPB Resistant Potato field tests Proposed period of release: 01/05/2023 to 30/04/2028 Name of the Institute(s) or Company(ies) SIA "PESTEVENE", Ropažu nov., Stopiņu pag., Rumbula, Šķeltu iela 1 - 1 LV-2121
Is the same GMPt been notified elsewhere by the same notifier? 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 Name	Family Name	Genus	Species	Subspecies	Cultivar/breeding line
potato	solanaceae	solanum	solanum tuberosum	tuberosum	cv. Desirée

Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications: Cytolytic bi-component protein complexes consisting of a plurality of molecules of a member of the aegerolysin family and a plurality of molecules of a member of the MACPF superfamily have successfully been incorporated into Desiree potato plants with the intention of producing potato plants that are resistant to major pests, including but not limited to Leptinotarsa decemlineata (Colorado potato beetle). 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 source of the genetic material inserted into potato plants is an edible mushroom belonging to the genus Pleurotus. This mushroom produces protein complexes that are selectively toxic against the larvae of the Colorado potato beetle (CPB, Leptinorsa decemlineata). These protein complexes consist of (i) aegerolysin family proteins and (ii) proteins containing the membrane attack complex/perforin (MACPF) domain. Upon ingestion, the aegerolysins bind to a specific insect lipid receptor in the membranes of insect intestinal epithelial cells. This step is followed by binding of the MACPF protein partner and successive formation of multimeric bi-component aegerolysin/MACPF transmembrane pores that permeabilize insect gut cell membranes and lead to insect death. Brief description of the method used for the genetic modification: Transgenic potato plants were produced by genetic engineering using Agrobacterium transformation and plasmids containing the genes encoding the aegerolysin and MACPF proteins regulated under constitutive viral and plant promoters.The genetic code for the genes encoding protein complexes toxic to CPB was optimized for expression in potato. The localization of the proteins was chosen based on the characteristics of the cell compartments and the properties of the proteins. 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 purpose of the release is to test the use of transgenic potato plants with an incorporated two-component protein complex on a larger scale in fields and to develop the invention to TRL 9.The following scientific questions will be answered:Can the potato plants with the incorporated two-component protein complex be used as biopesticides against Colorado potato beetle?Are the potato plants with the incorporated two-component protein complex less susceptible to feeding by CPB?Does feeding CPB larvae to potato plants with the incorporated two-component protein complex affect feeding rates and reduce damage to plants?Does feeding CPB larvae on potato plants with the incorporated two-component protein complex increase CPB larval mortality rate?How does the feeding of CPB larvae on potato plants with the incorporated two-component protein complex affect the larval behavior and vitality of CPB larvae in comparison with selected bioinsecticide and standard chemical insecticide?Does feeding on transgenic potato induce any sub-lethal effects in CPB larvae, namely, does it decrease CPB larval weight gain? Geographical location of the site: Trials will be held on field with legal address SIA Flourishing, Atvases, Liepas pag., Ķekavas novads. LV-2123 Size of the site (m2): Experiments will be performed on 200 plants (100 modified plants + 100 control plants) in a high tunnel covered by insect mesh. Plants of each treatment will grow in a single plot. Each plot will consist of 100 plants, which will grow in rows (ridges): for example, 5 rows of 20 plants; interrow space of 70cm, intrarow space of 30 cm giving ca. dimension of the plots 4 x 6 m, 25m 2 . 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: Not applicable Environmental Impact and Risk Management Summary of the potential environmental impact from the release of the GMPts: nhe transgenic potato is unlikely to be more persistent in agricultural habitats than the recipient or to become more invasive in natural habitats.The main advantages of the transgenic potato are:-use when currently available biopesticides are no longer effective,- the probability of resistance development should be negligible- they are human and environmentally friendly.We do not expect any immediate and/or delayed environmental effects from direct and indirect interactions between the transgenic potato and the Colorado potato beetle.The transgenic potatoes show a moderate toxic effect on Colorado potato beetle in the form of a significant increase in larval mortality and a pronounced effect on reducing Colorado potato beetle larval feeding. The activity of the protein complexes from the Pleurotus mushrooms is comparable to the activity of the Cry toxins from B. thuringiensis that bind to membrane protein receptors and that have already been introduced into CPB-resistant genetically modified potatoes.These transgenic plants express proteins originally produced by an edible mushroom. These proteins are immediately degraded by mammalian gastric enzymes and are non-toxic to mammals and other non-target organisms, so the use of plants transformed with these proteins is considered safe for human consumption. The recombinant protein complexes from Pleurotus mushrooms showed toxic effects on bees in in vitro tests. Further experiments to verify the effect of the transgenic plants on bees are needed. For the experimental field trials, the flowers of the transgenic potatoes are regularly cut off to avoid possible effects on bees.Delayed, direct and indirect effects on the environment from the transgenic potato cultivation, management and harvesting techniques are not expected. The field research/trial will be conducted and designed according to EPPO guidelines (EPPO Standard PP1/012(4)).65.1 Information regarding the specific areas of risk: Brief description of any measures taken for the management of risks: All handling of transgenic tubers and plants will be done according to good agricultural practices, experiments will be performed in a high tunnel covered by insect mesh. Regular monitoring program will be established with the aim of ensuring reproductive isolation, confinement of the trial, and the collection of data on the characteristics and agronomical performance of the tested transgenic plants. In order to minimize potential gene flow, the plants of the trial will be isolated from neighboring field crops and sexually compatible wild relatives by establishing a spatial isolation zone between the experimental plots and neighboring fields. Additionally reproductive isolation will be achieved by identifying and removing all floral parts before pollen maturity. The trial site will be surrounded by monitoring zones in which sexually compatible species will be removed prior to flowering. Plant waste material will be destroyed in an appropriate manner. All equipment required to perform seeding, harvest and site maintenance will be cleaned free of plant material both before entering the trial site, and before removing it from the trial site. Potato harvesting will occur either by hand or with commercial equipment. Plant material will be removed from the trial site, secured appropriately during transport, and destroyed in an appropriate manner to prevent any accidental release. In the post harvest period the test site will be monitored regularly to remove any volunteer plants, herbicides will be used in order to ensure there is no remaining test plants. Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release: Plant field trials are not designed to generate new data on the environmental and human health effects of the release. Human health effects have already been assessed. A number of tests have also been conducted to test environmental effects, particularly on non-target organisms. The results are explained in more detail in the answers to the previous questions. Final report - European Commission administrative Information Consent given by the Member State Competent Authority: Yes
06/26/2023