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General information Notification Number B/ES/17/15 Member State to which the notification was sent Spain Date of acknowledgement from the Member State Competent Authority 12/09/2017 Title of the Project Multiplication of transgenic wheat lines derived from IND-ØØ412-7 event containing the bar gene, which provide tolerance to ammonium glufosinate-based herbicides, and the HaHB4 gene that gives hydric stress tolerance. Proposed period of release: 01/01/2018 to 31/07/2018 Name of the Institute(s) or Company(ies) IDEN Biotechnology, (in representation of INDEAR).
Is the same GMPt been notified elsewhere by the same notifier? No Has the same GMPt been notified elsewhere by the same notifier? Yes If yes, notification number(s): Other notificationsArgentine:
- 2007 - 003945/07
- 2008 - 025864/08 and 394859/08
- 2009 - 303373/09
- 2010 - 011444/10
- 2011 - 001510/11
- 2012 - 505425/11
- 2013 - 345854/12 and 345854-1/12
- 2014 - 569130/13
- 2015 - 52881/14
- 2016 – 52881/14
USA:
- 2011 - 11-115-103n
- 2016 – 17-025-109r
Paraguay:
- 2015/2016: 41/2016 and 761/2016
Spain
- 2017: B/ES/17/01. This permit was approved by the granted but not executed (late seed arrival) Genetically modified plant Complete name of the recipient or parental plant(s):

Common Name	Family Name	Genus	Species	Subspecies	Cultivar/breeding line
wheat	poaceae	triticum	triticum aestivum

Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications: The IND-ØØ412-7 wheat has the HaHB4 gene, that expresses the HAHB4 transcription factor, which is related to a phenotype of tolerance to several environmental stresses including drought.
This trait allows the transgenic plants to provide a better yield tan conventional crops under adverse environment 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: The HaHB4 gen (Helianthus annuus Homeobox 4) is natural from sunflower and codes for the transcription factor (TF) HAHB4, whose expression is upregulated by hydric and saline stress (Gago et al., 2002; Dezar et al., 2005b; Manavella et al., 2006; Cabello et al., 2007). In a similar way than other TF, HAHB4 expression results in a complex phenotype. The expression of the tolerance to adverse environmental conditions showed by IND-ØØ412-7 wheat is based on the involvement of HAHB4 in the transduction pathways activated in response to environmental stresses, and the ability of transgenic plants that express this protein to manage drought better tan the plants that do not express it. Consequently, when IND-ØØ412-7 wheat and its conventional control are exposed to comparable stressing environments, the tolerance of IND-ØØ412-7 results in
higher yields.
IND-ØØ412-7 wheat also contains the coding region of the bar gene from Streptomyces hygroscopicus (Thompson y col., 1987), that codes for phosfinothricin N-acetyltransferase (PAT).
The expression of PAT in the IND-ØØ412-7 wheat results in an ammonium glufosinate tolerant phenotype.
- Cabello JV, Dezar CA, Manavella PA and Chan RL (2007). The intron of the Arabidopsis thaliana COX5c gene is able to improve the drought tolerance conferred by the sunflower Hahb-4 transcription factor.
Planta226(5):1143-1154.
- Dezar CA, Fedrigo GV and Chan RL (2005a). The promoter of the sunflower HD-Zip protein gene Hahb4 directs tissue-specific expression and is inducible by water stress, high salt concentrations and ABA. Plant Sci 169:447-459.
- Dezar CA, Gago GM, González DH and Chan RL (2005b). Hahb-4, a sunflower homeobox-leucine zipper gene, is a developmental regulator and confers drought tolerance to Arabidopsis thaliana plants. Transgenic Res 14:429-440.
- Gago MG, Almoguera C, Jordano J, Gonzalez DH and Chan RL (2002). Hahb-4, a homeobox-leucine zipper gene potentially involved in abscisic acid-dependent responses to water stress in sunflower.Plant Cell Environ 25:633–640.
- Manavella PA, Arce AL, Dezar CA, Bitton F, Renou J-P, Crespi M and Chan RL. (2006). Cross-talk between ethylene and drought signalling pathways is mediated by the sunflower Hahb-4transcription factor. Plant J 48:125–137.
- Thompson CJ, Movva NR, Tizard R, Crameri R, Davies JE, Lauwereys M and Botterman J (1987). Characterization of the herbicide-resistance gene bar from Streptomyces hygroscopicus. EMBO J. 6(9):2519–2523. Brief description of the method used for the genetic modification: IND-ØØ412-7 was obtained by co-transformation with plasmids pIND4-HB4 and pIND4-Bar using a method based on those developed by Barcelo and Lazzeri (1995), Pastori et al. (2001), and Rasco-Gaunt et al. (2001). 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 objective of the release is the multiplication of experimental transgenic lines derived from the wheat IND-ØØ412-7 event. These lines where obtained by conventional breeding (crossing and selection). Besides, efficacy of the trait will be evaluated by testing yield and tolerance to ammonium glufosinate. Geographical location of the site: The release site is: Municipio 20 Alcala de obispo (Huesca). Poligono 3. Parcela 208. Recinto 3 Size of the site (m2): The total size of the site is 0,5 Has. 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: In Argentina, 36 field trials were evaluated from 2009 to 2016. In these trials, efficacy of the trait as well as agronomic characteristics, composition, and environmental interactions were evaluated. No differences between the event and conventional bread wheat were found, with exception of the introduced characters of drought tolerance and ammonium glufosinate resistance. Environmental Impact and Risk Management Summary of the potential environmental impact from the release of the GMPts: When selection pressure is imposed by environmental stress, IND-ØØ412-7 is able to stay physiologically active allowing the plants to keep their metabolic activity. This characteristic does not involve a different physiological role compared to conventional wheat, but a magnified response of a normal physiological mechanism that exits in all plants. This response renders higher yields in IND-ØØ412-7 wheat growing under adverse environments when compared with its nontransgenic counterpart. In this context, the adaptive advantage would not be different from that found in drought tolerant wheat obtained by conventional breeding. Thus, in ecological terms, the introduction of the HB4 technology does not produce an adaptive advantage with regard to non-GM wheat.

Concerning bar gene, the selective advantage provided by its expression would only be observed under ammonium glufosinate-treatment. Therefore, it would not mean an adaptive advantage outside the usual crop farming environment, and there is no evidence to foresee a higher ability to survive or adapt in the absence of herbicide treatment. Brief description of any measures taken for the management of risks: Transport of transgenic seed for planting, and after harvest will be carried out by authorized personnel from IDEN. All seed movements will be notified to the regulatory authorities. The seed will always be kept under double containment.

The area planted with the genetically modified crop will be surrounded by a perimeter planted with conventional wheat, with similar cycle to flowering than the transgenic lines. This perimeter will be a contention border for the transgenic wheat in order to reduce the probability of gene flow. Conventional wheat border will be extended all over the perimeter of the transgenic wheat,
and will have a width of at least 5 m. Just outside the conventional border, an electric wired fence will be installed with the signal: “REGULATED MATERIAL – RESTRICTED ACCESS”. The points of the perimeter polygon will be registered with GPS. All the area included inside the electrical fence will be considered the “planting area”. This area will be clearly identified by permanent reference points (by GPS) to perform periodic monitoring of volunteer plants for one year after harvest.

Wheat is a predominantly self-pollinated crop, with very low rates of outcross, which occurrence is generally limited to plants in adjacent rows. To reduce the probability of gene flow, an isolation distance from other wheats will be kept. This distance will be of at least 60 m from the electric perimeter fence. The points of the polygon perimeter of the isolated area will be registered by
GPS. During growth cycle this area will be monitored to check absence of wheat and Aegilops spp. In case of detection of these species a chemical or mechanical control will be applied.

After planting and before transfer, all the planting equipment used will be exhaustively cleaned according to the bio-safety protocol implemented by IDEN.

During crop growth, the area will be supervised periodically to control weeds, pests and diseases. Any abnormal or unexpected effect observed in the crop will be registered and immediately informed to the regulatory agency. All the equipments used during the crop maintenance will be cleaned after use inside de planting area according to the bio-safety protocol implemented by IDEN.

Harvest: the harvest will be i) by hand and/or with power scythe, ii) by experimental combine. Crop residues, residues from the cleaning of the equipment, and any remaining plants will be destroyed by grinding and scatter inside the planting area, buried or plowed for natural degradation. Cleaning of the harvest equipment and the thresher will be carried out according to the IDEN bio-safety protocol.

A monitoring program will be established in the planting area for at least one year after harvest to control all volunteer wheat plants that could grow during the following cycle.

The monitoring program consists of periodic scouts to check the absence of wheat plants inside the planting area. Volunteer wheat will be destroyed by hoeing, or by plow, or by grind and plow inside the planting area, or by spray of total herbicide. Regulatory agency will be notified of these activities.
Planting area will not be planted again with wheat, or with other winter cereal or forage crop for at least one year after harvest, with exception of wheat with the same event. Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release: Not applicable Final report - European Commission administrative Information Consent given by the Member State Competent Authority: Not known