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Notification report


General information

Notification Number
B/ES/06/28-CON

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
28/12/2005

Title of the Project
Field trials to test expression, composition, agronomics (Cataluña). Efficacy and evaluation of impact to non-target organisms of lepidopteran resistant cotton cultivars.(Andalucía)

Proposed period of release:
01/04/2006 to 31/12/2009

Name of the Institute(s) or Company(ies)
Dow AgroSciences, ;


3. Is the same GMPt release planned elsewhere in the Community?
Not known

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 NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
cottonmalvaceaegossypiumgossypium hirsutumPSC355/MXB13

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
This variety has been created by crossing two genetically modified lines, resistant to certain lepidopteran insect pests.

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:
The list of the genetic elements inserted in the parental lines is provided in Annex to SNIF (confidential business information).

6. Brief description of the method used for the genetic modification:
The genetic modification has been applied to the parental lines, which then were sexually crossed to produce the variety tested.

7. If the recipient or parental plant is a forest tree species, describe ways and extent of dissemination and specific factors affecting dissemination:
Not relevant.

Experimental Release

1. Purpose of the release:
The purpose of the release is to determine the field efficacy of two different Bt proteins, expressed simultaneously in this cotton variety, 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.


2. Geographical location of the site:
The releases will take place in Cataluña (Tarragona and Lleida) and Andalucía.

3. Size of the site (m2):
The total area, covered by these studies, will be 20.000 m2 in Seville (Ecija) and 50.000 m2 in Tarragona (La Aldea) and LLeida (Alcarrás, Termens and Linyola).

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, 2001 and 2003, no particular characteristics that could have a negative impact on the environment or human health were observed. Moreover, no significant differences between this cotton stack 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 have a very specific mode of action, the first two conferring resistance to some lepidopteran insect pests. 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 Government Authorities requirements. 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:
Not applicable.

Final report
-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
25/04/2006 00:00:00
Remarks:
There are several Autonomous Communities as competent authorities for give the consent of these field trials:
- Cataluña: 25/04/2006.
- Andalucía: Denied.