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Notification report


General information

Notification Number
B/ES/04/10

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
17/03/2004

Title of the Project
Field trials with herbicide tolerant soybeans.

Proposed period of release:
15/04/2004 to 30/11/2004

Name of the Institute(s) or Company(ies)
Bayer CropScience, S.L., Pol.Industrial el Plá, parcela 30
46290-Alcacer (Valencia) España;


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

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

If yes, notification number(s):


Other notifications
- USA: (APHIS 96-032-03N, 96-071-14N, 96-099-07N, 96-338-01N, 97-020-09N, 97-077-07N, 97-077-08N, 97-077-09N, 97-077-10N, 97-077-11N, 97-077-12N, 97-077-13N,97-080-06N, 97-098-02N, 97-098-05N, 97-111-05N y 97-120-01N)
- Argentina: (CONABIA: 1996-1999)
- Brazil: (CTNBIO: 2000)
- Chile: (Department of Agricultural Protection: 2000)


Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
soybeanfabaceaeglycineglycine maxA2704, A5547

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Glufosinate ammonium herbicide tolerance

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:
Genetic elements which confer the phenotype of tolerance to the herbicide glufosinate ammonium:

-P35S3 : Promotor region of the 35S transcript from Cauliflower Mosaic Virus
-pat : Coding sequence of the phosphinothricin acetyltransferase gene (pat) from Streptomyces viridochromogenes
-T35S3 : Terminator region of the 35S transcript from Cauliflower Mosaic Virus


6. Brief description of the method used for the genetic modification:
The transgenic soybean lines are generated using a particle acceleration system

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 this study is to generate reference material from the Genetically Modified Organisms.

2. Geographical location of the site:
2004 : 1 location in Spain in the region of Aragón.

3. Size of the site (m2):
2004 : there will be a surface of approximately 700m² of for each transgenic event.

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:
The previous releases took place in the US from 1996 to 1997. A summary of the findings include:
- The genetic change is stable and the introduced gene produces a protein which has a proven safety profile.
- The new glufosinate-tolerant soybean events share the characteristics of soybean plants in agricultural production and of soybean seed in commerce.
- In side-by-side comparisons with the non-transgenic parent varieties of plant morphological characters and analysis of components of nutritional importance, no evidence of pleiotropic effects were detected.
- There is no cause for concern to non-target organisms presented by the new plant varieties or the new use of the herbicide, glufosinate.
- The potential for gene flow, the transfer of glufosinate herbicide tolerance to wild or weedy soybean relatives, is extremely low.
- The consequence of gene flow will not be detrimental to current agronomic systems and can be managed by current agricultural practices.
- There is no cause for concern for the human consumption and for animal feed use of the seed or plant products derived from the LibertyLink soybean varieties based upon transformation events A2704-12 and A5547-127.
- Liberty system complements current soybean field weed control practices.
- The agricultural requirements of soybean crops for human intervention and temperate climate prevent glufosinate-tolerant soybean from becoming invasive of new habitats as a result of export activities.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Genetically modified soybean has the same behaviour as conventional soybean except for the characters encoded by the inserted pat gene.
Due to flower development and the lack of wild relatives of soybean in Europe, BCS consider that gene transfer is unlikely to happen, neither to other species nor to conventional soybean.
However if a weed or a volunteer would receive the transgene, this would not confer any selective advantage in the absence of glufosinate treatment.
This transgenic soybean has been tested at various locations in the US, Argentina, Brazil and in Chile and post-harvest monitoring did not report any adverse effects on the environment.
The pat gene has been approved in various crops since 1995, for environmental release, food and feed by different agencies in the world including Argentina, Australia, Canada, Europe, Japan and the US. Regarding soybean specifically, transgenic lines tolerant to herbicides are also developed and approved in various countries since 1994.


Brief description of any measures taken for the management of risks:
The trials will be conducted with an isolation distance of at least 5 m from any other soybean.
The products harvested from the field trials will be used for the production of reference material.
Each site will be visited on a regular basis during the trial period.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
The planned field trials are designed in order to increase seed for the production of reference material.
The planned field trials are not designed to address the impact of the release on human health.


Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
14/07/2004 00:00:00
Remarks:
Consent given by Aragón Region.