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Notification report


General information

Notification Number
B/ES/09/06

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
22/12/2008

Title of the Project
Field trials continuation to advance in the evaluation, agronomic characterization and development of maize derived from MON 88017 line, genetically modified for tolerance to glyphosate and protected against Corn Rootworm (Diabrotica virgifera).

Proposed period of release:
01/02/2009 to 28/02/2010

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?
Yes:
France; Czech Republic; Slovak Republic; Romania;

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

If yes, notification number(s):
B/CZ/08/03; B/DE/05/169; B/DE/06/185; B/ES/06/02; B/ES/07/04; B/ES/08/08; B/FR/06/01/02; B/FR/06/12/10; B/FR/06/12/11; B/RO/08/06; B/SK/08/02;

Other notifications
B/FR/08/01/06

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:
MON 88017 that will be tested in these field trials is protected against certain Coleopteran insects, such as Corn Rootworm (Diabrotica virgifera) and is tolerant to glyphosate herbicide.

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:
MON 88017 contains the following genetic elements:
- the cry3Bb1 gene from Bacillus thuringiensis subsp. kumamotoensis which confers protection against Corn Rootworm (Diabrotica virgifera).
- the cp4 epsps gene from Agrobacterium sp., strain CP4, which provides tolerance to ghyphosate herbicide.
These genes have been introduced with regulatory components necessary for expression in plant cells.


6. Brief description of the method used for the genetic modification:
MON 88017 was produced by Agrobacterium-mediated transformation of immature embryos of maize tissue.

7. 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

1. Purpose of the release:
The release has the aim to advance in the agronomic characterization and development of corn hybrids derived from MON 88017 line, genetically modified for tolerance to glyphosate and protected against corn rootworm (Diabrotica virgifera).

2. Geographical location of the site:
The selected sites are located in the following localities:
- Albesa (Lleida).
- Alcarrás (Lleida).
- Milagro (Navarra).


3. Size of the site (m2):
The total surface occupied by MON 88017 maize in every site will be less than:
- Albesa (Lleida): 1.000 m2.
- Alcarrás (Lleida): 1.000 m2.
- Milagro (Navarra): 4.000 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:
Many field trials have already been conducted at several locations across maize growing regions in North, South America and EU. No environmental problems were reported for these trials. Except for its protection against certain coleopteran insects and its tolerance to glyphosate herbicide, MON 88017 could not be distinguished from the non-genetically modified maize.
Insect-protection and glyphosate tolerance traits present in MON 88017 are already present in two commercial products, MON 863 and NK603, respectively.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Analysis of the characteristics of MON 88017 maize, especially in comparison with extensive experience with cultivation of conventional maize within the EU, has shown that the risk for potential adverse effects on human and animal health and the receiving environment, resulting from the planned field trials with MON 88017 maize, is negligible:

- The risk of the introduced trait in MON 88017 maize to be the cause of any meaningful competitive advantage or disadvantage in natural environments is negligible. As for any other maize, the likelihood of this maize to spread into non-agronomic environments is negligible, as its persistence in agricultural habitats and its invasiveness into natural habitats are unaltered compared to conventional maize.

- Potential exposure of non-target organisms to CP4 EPSPS presents no conceivable mechanism to cause adverse effects because of its properties. Due to the high selectivity of Cry3Bb1 protein to certain Coleopteran insects and based on studies with different species, the risk for non target organisms is considered negligible. The ecological interactions of MON 88017 maize with non target organisms or soil process are considered similar to the respective caused by conventional corn.

- Any occupational health aspects of handling MON 88017 maize are not different from conventional maize, and this maize was shown to be as safe and as nutritious as any other maize.

- The environmental impact of the cultivation, management and harvesting techniques applied in the planned trials is considered no different from the farming practices for conventional maize.

It is actually expected that the commercial production of MON 88017 maize will positively impact current agronomic practices in maize and provide benefits to farmers and the environment. The protection against D. virgifera would offer a new tool for IPM and would reduce the reliance on chemical pesticides whereas the use of glyphosate in maize would enable the farmer to take advantage of the herbicide’s favorable environmental and safety properties (see Annex I listing of glyphosate under Council Directive 91/414/EEC) as well as facilitate adoption of conservation tillage practice in corn production.

Maize can hybridize with teosinte but these plants are not present in Europe. Measures will be taken to avoid hybridization with other maize plants and seed dissemination at harvest and during transportation (see E.)


Brief description of any measures taken for the management of risks:
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 MON 88017 crop and that of its receiving environment. In case of any adverse environmental effects, linked to the deliberate release of MON 88017 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 most of the possibility 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
06/03/2009 00:00:00
Remarks:
There are several Autonomous Communities as competent authorities for give the consent of these field trials:

- Cataluña: 06/03/2009.
- Navarra: 07/04/2009