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Notification report


General information

Notification Number
B/ES/02/18

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
09/12/2002

Title of the Project
Field efficacy trials testing for Cry1F/Cry1Ac stack insecticidal protein in cotton cultivars.

Proposed period of release:
01/04/2003 to 30/11/2004

Name of the Institute(s) or Company(ies)
Dow AgroSciences Ibérica, S.A., ;


3. Is the same GMPt release planned elsewhere in the Community?
No

Has the same GMPt been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):
B/ES/02/02-CON;

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
cottonmalvaceaegossypiumgossypium hirsutum

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
The cry1F(synpro) gene was inserted into the cotton genome to express the Cry1F protein in cotton event 281-24-236. Concomitantly, the synthetic cry1Ac(synpro) gene was inserted into the cotton genome to express the Cry1Ac protein in cotton event 3006-210-23.
Transgenic cotton plants from the events 281-24-236 and 3006-210-23 expressing the synthetic delta -endotoxins Cry1F and Cry1Ac respectively, were crossed to generate cotton plants expressing both Cry1F and Cry1Ac proteins in the stack 281-24-236/3006-210-23.


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:
Event 281-24-236: Promoter: Ubiquitin and first intron from maize. Gene: synthetic full-length version cry1A(c) from B.t. var. kurstaki. Terminator: Orf from A. tumefaciens. Promoter: deleted version of MAS. Gene: pat. Terminator : Orf from A. tumefaciens
Event 3006-210-23: Promoter: deleted version of MAS, Gene: synthetic full-length version Cry1F from B.t. var. aizawai, Terminator Orf from A. tumefaciens.
Promoter: Ubiquitin and first intron from maize. Gene: pat, Terminator: Orf from A. tumefacien


6. Brief description of the method used for the genetic modification:
(1) The cry1F-(synpro) gene was inserted into the cotton genome using Agrobacterium mediated transformation carrying the binary vector pAGM281.
(2) The synthetic cry1Ac-(synpro) gene was inserted into the cotton genome using Agrobacterium-meditated transformation carrying the binary vector pMYC3006.
Transgenic cotton plants containing the synthetic delta -endotoxins Cry1F and Cry1Ac were sexually crossed to generate plants expressing both Cry1F and Cry1Ac proteins in the cotton stack 281-24-236/3006-210-23.


Experimental Release

1. Purpose of the release:
The purpose of the release is to determine the field efficacy of the Cry1Ac and Cry1F proteins expressed in transgenic cotton stack 281-24-236/3006-210-23 against some lepidopteran insect pests under natural infestation conditions. The Cry proteins are known to be very specific against certain lepidopteran insects and no effects on non-target organisms are expected.
No changes on survivability, weediness or dissemination were observed in the field trials performed during the years 2000 and 2001 in the US when compared with conventional cotton varieties as a consequence of the expression of Cry1F, Cry1Ac or PAT proteins in cotton stack 281-24-236/3006-210-23.


2. Geographical location of the site:
The releases will take place in two different localities of Spain: Sevilla and Murcia.

The releases will take place in two different localities of Spain: Sevilla and Murcia.
Sevilla: One trial will be performed in Burguillos (Sevilla) in one farm belonging to Don Manuel Gómez Cabrera. The area of the trial will be about 15000 m2 including the safety borders.

Murcia: Two field trials will be performed in Torrepacho (Murcia). One of them, in a farm leased to "Prado Jumilla", called "El barranquillo". The second trial will be performed in a farm leased to "Plansur", called "El tribunal". The area of each trial will be about 15000 m2 including safety borders.


3. Size of the site (m2):
The total area will be: 45000 m2 as follows
Murcia: 30000 m2
Sevilla: 15000 m2


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:
During the field trials performed in the US during the years 2000 and 2001, no particular characteristics that could have a negative impact on the environment or human health were observed. Moreover, no significant differences between the cotton stack 281-24-236/3006-210-23 and the conventional cotton plants were detected.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
No cotton sexual compatible species have been found in Spain. Additionally, the field trials will be isolated from any other cotton field by at least 60 m. Cotton has a long history of safe use and been extensively domesticated by humans. The genes introduced into the cotton stack 281-24-236/3006-210-23, cry1Ac cry1F and pat have a very specific mode of action, the first two conferring resistance to some lepidopteran insect pests and the latter one conferring tolerance to the ammonium glufosinate herbicide. With the adoption of this technology the insecticide will be localised within the transgenic plants, reducing the environmental impact to surrounding areas and the farmers will reduce fuel costs and soil compaction through a substantial reduction in the numbers of applications required to control insect pests.

Brief description of any measures taken for the management of risks:
The trials are going to be isolated from any other cotton plot by a minimum distance of 60m. A non-GMO cotton 4 row border will be planted and subsequently destroyed at the end of the experiment. Strict biosafety practices will be implemented according to the Junta de Andalucia's guidelines. The following year a different crop will be planted in these lots to facilitate the detection and destruction of any volunteer plant. All the plant products from these trials will be manually or chemically destroyed. Trained people will carry on the experiment and follow up closely. Regular monitoring visits will be implemented during the growing season to evaluate the performance and looking for any unintended effects and in the following season to control volunteers.

Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
These field trials are implemented to assess the efficacy of the Cry1Ac and Cry1F proteins expressed in cotton stack 281-24-236/3006-210-23 against certain lepidopteran insect pests. According to the results obtained in the trials, the commercial strategy will be drawn.

Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Not known