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General information Notification Number B/ES/17/13 Member State to which the notification was sent Spain Date of acknowledgement from the Member State Competent Authority 23/06/2017 Title of the Project Validation under field conditions of flowering time and life cycle of transgenic Westar canola lines. Proposed period of release: 01/11/2017 to 30/06/2018 Name of the Institute(s) or Company(ies) Centro Nacional de Biotecnología- CSIC
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
canola	brassicaceae	brassica	brassica napus	napus (syn. oleifera)	Westar

Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications: Early flowering and extended life cycle, caused by expression of a circadian clock protein from Arabidopsis and a transcription factor that controls expression of the FT mobile signal. The modification includes the nptII and HPT marker genes. These plants showed early flowering and increased production in seeds, in addition to delayed senescence under controlled laboratory
conditions. 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: Lines carry two inserted genes from the donor plant Arabidopsis thaliana, i.e. a component of the endogenous clock and a transcription factor that acts as an activator of the FT flowering signal. Products of both genes interact at the protein level and negatively regulate each other’s activity. Because of this antagonistic function, plants display early flowering and bigger haulms, which leads to an increased number of seeds. In addition, they remain in a juvenile stage, and are capable of forming new branches after removal of the old floral stems. This character may allow for a second harvest in the same season. Brief description of the method used for the genetic modification: The genetic modification has been obtained by transformation of canola cells with Agrobacterium tumefaciens carrying the pGWB14 plasmid with the constructs, and selection of the nptII marker gene.
Lines show a unique insertion as deduced by the 3:1 segregation of the inserted genes. Expression of each of the constructs was assayed by western blot and RT-PCR analyses of the corresponding transcripts. 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 aim of the release is to validate in the field the early flowering response, bigger haulm and increased production in seeds observed under controlled laboratory conditions. After harvesting, old floral stems will be removed to test for their ability to re-grow and produce new seeds. Geographical location of the site: Municipality of Yéchar (Mula), Murcia. Size of the site (m2): 1.34 ha 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: It constitutes a first release. No impact to the environment or on human health is expected. Environmental Impact and Risk Management Summary of the potential environmental impact from the release of the GMPts: Canola is an important oilseed crop cultivated in template areas both during winter and spring seasons. Its culture is not suitable to warmer regions due to temperatures >35ºC cause pollen infertility and lead to floral abortion, which seriously compromises productivity.
As such, it cannot survive in natural habitats in southern Europe where elevated summer temperatures restrict production of seeds.
The introduced traits accelerate flowering, increase haulm size, and elevate production of seeds but do not confer increased tolerance to heat stress. Therefore, they do not confer a selective advantage under the natural setting in which the assay will be carried out.
Canola is not cultivated in the Murcia region, and therefore there is no risk of cross-contamination to nearby fields. Although the region is one of the largest national producers of Brassica oleracea, this species is sexually incompatible with canola. The culture of turnip(Brassica napa) is also well established in the area. This species is sexually compatible, but fertility of inter-specific hybrids is very low, what strongly reduces their persistence capacity. Turnip is cultivated in summer and harvested in autumn, and therefore its production will not overlap with the assay. We note that there are no comercial farms of the Brassica genus less than 30 km from the release site, and turnip is not cultivated in the nearest area. Brief description of any measures taken for the management of risks: The assay will be carried out from November to June. The transgenic lines will be grown intercalated with non-modified plants that will serve as a reference for the flowering time and production in seeds.
These plants will be grown bordered by a 8 m-perimeter of wild-type canola plants which will provide a barrier to pollen dispersal, in addition to serve as reference pattern for agronomical traits. Several studies reported that canola pollen is not dispersed to greater distances than 10 meter and is only viable for 4-5 days. The field will be isolated by a fence and only specialized personnel will have Access to it. Seeds will be collected manually and after completion of the test, the field will be treated twice with herbicide immediately after harvest and 4 month later, to assure destruction of any germinating seed that could have been left over. It will also be controlled for the presence of any possible escapes during the following two years.
Thus, a monthly monitoring will be done to detect possible outbreaks, which will be removed manually and destroyed by incineration in a metallic container in the plot. Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release: Planning of additional trials will depend on the relevance of the results and, in any case, will comply with a new release application. Final report - European Commission administrative Information Consent given by the Member State Competent Authority: Yes
10/31/2017
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