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Notification report


General information

Notification Number
B/ES/09/10

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
23/01/2009

Title of the Project
Notification according to Directive 2001/18/EC, Part B, for the deliberate release of genetically modified 59122 maize (DAS-59122-7) to select inbred lines and obtain varieties.

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

Name of the Institute(s) or Company(ies)
Monsanto Europe, S.A., represented by Monsanto Agricultura España, S.L., ;


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
maizepoaceaezeazea maysmays

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
The genes introduced into 59122 maize, confer protection against certain Coleopteran insect pests, such as Western corn rootworm (Diabrotica virgifera virgifera) and tolerance to glufosinate-ammonium herbicide, used as a selectable marker.

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 following genetic material was inserted into 59122 maize:

- The cry34Ab1 gene from Bacillus thuringiensis strain PS149B1, confers protection against certain Coleopteran insect pests, driven by UbiZM promoter, the PINII terminator from Solanum tuberosum.

- The cry35Ab1 gene from Bacillus thuringiensis strain PS149B1, confers protection against certain Coleopteran insect pests, driven by the Peroxidase promoter from Triticum aestivum, the PINII terminator from Solanum tuberosum.

- The pat gene from Streptomyces viridochromogenes confers tolerance to glufosinate ammonium herbicide, driven by CaMV 35S promoter and terminator, from cauliflower mosaic virus.


6. Brief description of the method used for the genetic modification:
The 59122 maize was produced by means of Agrobacterium-mediated transformation. Transformation of 59122 maize resulted in the stable insertion of the T-DNA region of binary vector PHP17662 in the maize genome. The T-DNA region contains the cry34Ab1, cry35Ab1 and pat coding sequences in addition to the necessary regulatory components to drive gene expression. The plant regenerated from these maize cells expresses the Cry34Ab1, Cry35Ab1 and PAT proteins and is referred to as 59122 maize.

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 characterize inbred lines and increase the best ones, and to obtain hybrids varieties containing 59122 (DAS-59122-7) genetic modification.

2. Geographical location of the site:
Milagro (Navarra)

3. Size of the site (m2):
The total surface occupied by 59122 maize will be less than:
Milagro (Navarra): 1.000 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:
Field trials have already been conducted in South America, North America and Europe. 59122 maize plants were indistinguishable from the non GM maize plants, except for their resistance against certain Coleopteran insect pests and tolerance to glufosinate ammonium herbicide.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
No maize sexual compatible species have been found in Spain. Additionally, the field trials will be isolated from any other maize field by at least 200 m. Maize has a long history of safe use and been extensively domesticated by humans. The genes introduced into 59122 maize: cry34/35Ab1 and pat have a very specific mode of action, the first one conferring protection against some Coleopteran insect pests and the latter 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 environmental risk assessment has indicated that the environmental risk of this maize is negligible. Therefore, strategies for risk management for 59122 maize would be the same as for traditional maize.

In addition to the scheduled observations of phenotypic and agronomic parameters that form the basis of the planned research, the trial site will be checked regularly during the period of the deliberate release for potentially occurring, direct or indirect, adverse environmental effects. This will be done by visual inspection of the status of the 59122 crop and that of its receiving environment. In case of any adverse environmental effects linked to the deliberate release of 59122, observed during the period of release, these will be reported immediately to the Competent Authority.

The spatial isolation distance (200 m) from other maize crops and the four rows of non transgenic maize surrounding the trials will prevent the risk of hybridization with other maize plants.

Seeds will be transported in sealed and labeled bags, and their management for setting the trial will be done by qualified staff, informed about preventive measures to avoid any spill. The equipments, especially the experimental drill and combine, will be cleaned on the experimental site, thus preventing seed dissemination.

Plant products from trials will be only used for studies intended by this notification and will be destroyed at their end. After completion of harvest, the stalks will be chopped and then incorporated into the soil. Harvested grain not used in further analysis or studies will be destroyed by burying, grinding to no viable fractions, incineration or authorized dump.

Although regrowth in the rotation crops is unlikely because of poor winter survival, the site will be sown either with a crop different from maize or with experimental maize that will be destroyed and not used in any commercial, industrial or food application. Volunteer plants will be controlled by mechanical destruction or other non-selective herbicides.

At the end of the field-testing campaign, a report will be made available by the notifier to the Competent Authority. This report will detail any unexpected adverse environmental effects that were observed during the general surveillance, if any, and further actions elicited as an effect of these findings, if applicable.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Not applicable. However, if any unanticipated adverse effects on human health or the environment would be observed, it will be reported immediately to the Competent Authority.

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
01/06/2009 00:00:00
Remarks:
The competent authority for give the consent of these field trials is the Autonomous Community of Navarra.