Back

Notification report


General information

Notification Number
B/ES/11/09

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
03/12/2010

Title of the Project
Field trials continuation under official supervision with maize derived from MON 88017 line, genetically modified for tolerance to glyphosate and protected against Corn Rootworm (Diabrotica virgifera), for variety registration.

Proposed period of release:
01/02/2011 to 28/02/2012

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:
Germany; 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/DE/08/201; B/ES/06/02; B/ES/07/04; B/ES/08/08; B/ES/09/06; B/ES/09/14; B/ES/10/11; B/FR/06/01/02; B/FR/06/12/10; B/FR/06/12/11; B/RO/08/06; B/RO/09/17; B/SK/08/02;

Other notifications
Additionally, field trials have been conducted across maize growing regions in North and South America, and in Japan. MON 88017 maize varieties were first commercialized in the US in 2007, and in Canada in 2009. MON 88017 has also received regulatory approvals for import in many countries around the world, namely, Australia/New Zealand, China, Japan, Korea, Philippines, Singapore, Taiwan, Mexico and the Russian Federation.
MON 88017 maize is approved in EU for food, feed, import and processing in 2009 (Commission Decision 2009/814/CE). The cultivation MON 88017 maize has been submitted according to Regulation (EC) 1829/2003 in EFSA-GMO-CZ-2008-54.


Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
maizepoaceaezeazea maysmaysMON 88017 maize

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 of genetically modified maize derived from transformation event MON 88017 line, genetically modified for tolerance to glyphosate and protected against corn rootworm (Diabrotica virgifera), has the aim to collect regulatory data (DUS and Agronomic Value).

2. Geographical location of the site:
The selected sites are located in the following localities:
- Fuente Palmera (Sevilla)
- El Cuervo (Sevilla)
- Guillena (Sevilla)
- Lebrija (Sevilla)
- Utrera (Sevilla)
- Grañén (Huesca)
- Ejea de los Caballeros (Zaragoza)
- Tauste (Zaragoza)
- Zuera (Zaragoza)
- Daimiel (Ciudad Real)
- Calera y Chozas (Toledo)
- Corbillos de los Oteros (León)
- Valdevimbre (León)
- Arabayona de Mógica (Salamanca)
- Pelabravo (Salamanca)
- Coreses (Zamora)
- Cotanes del Monte (Zamora)
- Molacillos (Zamora)
- Alcarrás (Lleida)
- Bell-Lloc d’Urgell (Lleida)
- Gimenells (Lleida)
- Valdetorres (Badajoz)


3. Size of the site (m2):
The total surface occupied by MON 88017 maize in every site will be less than:
- Fuente Palmera (Sevilla): 1000 m²
- El Cuervo (Sevilla): 1000 m²
- Guillena (Sevilla): 1000 m²
- Lebrija (Sevilla): 1000 m²
- Utrera (Sevilla): 1000 m²
- Grañén (Huesca): 1000 m²
- Ejea de los Caballeros (Zaragoza): 1000 m²
- Tauste (Zaragoza): 1000 m²
- Zuera (Zaragoza): 1000 m²
- Daimiel (Ciudad Real): 1000 m²
- Calera y Chozas (Toledo): 1000 m²
- Corbillos de los Oteros (León): 1000 m²
- Valdevimbre (León): 1000 m²
- Arabayona de Mógica (Salamanca): 1000 m²
- Pelabravo (Salamanca): 1000 m²
- Coreses (Zamora): 1000 m²
- Cotanes del Monte (Zamora): 1000 m²
- Molacillos (Zamora): 1000 m²
- Alcarrás (Lleida): 1000 m²
- Bell-Lloc d’Urgell (Lleida): 1000 m²
- Gimenells (Lleida): 1000 m²
- Valdetorres (Badajoz): 1000 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 since 2000 and in EU, since 2007, without environmental problems reported from these trials. Also, environmental assessments have been performed in Japan in 2002 and agronomic evaluations in Canada in 2003. The results of the releases showed no evidence that MON 88017 is likely to cause any adverse effects to human or animal health and the environment. Except for its tolerance to glyphosate and its protection against certain coleopteran insects, MON 88017 could not be distinguished from conventional maize.
Additionally, glyphosate-tolerance and coleopteran-protection traits present in MON 88017 are already present in two commercial products, NK603 and MON 863, respectively, from which no adverse effect have been reported.


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 not significantly different from the conventional corn because:

- 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.

- There is no risk of genetic transfer from MON 88017 to wild plants in EU. Likelihood of genetic transfer to other maize crops is low, and in case of such transference took place it will have negligible consequences for the environment. However field trials will be isolated to avoid cross-pollination and trial management will be carefully conducted in order to avoid any seed dispersal out of the test site (see E point).

- By definition, the glyphosate-tolerance trait has no direct or indirect interaction with any target organism. The protein intended for protection against the target pest Diabrotica virgifera has activity only toward particular target coleopterans, and provides a more selective control method against an important pest. Therefore the effect of MON 88017 on target organisms is limited to specific conditions in the field, spatially limited and short in duration.

- Potential exposure of non-target organisms to CP4 EPSPS presents no conceivable mechanism to cause adverse effects because of its properties. Exposure of non-target organisms to the Cry3Bb1 protein is not considered to have any adverse effect, due to the high selectivity of this protein to beetles within the family chrysomelidae of the order coleoptera, its well-characterised mode of action and the confirmation through studies of no adverse effects found on insects of other orders of insects. Therefore, the ecological interactions of MON 88017 with non-target organisms or the biochemical processes in soil are considered similar to the respective interactions caused by conventional maize.

- 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.

Additionally, it has to be considered that MON 88017 maize is approved in EU for food, feed, import and processing in accordance with Regulation (EC) No 1829/2003 (Commission Decision 2009/814/CE).

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 non selective 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.


Brief description of any measures taken for the management of risks:
The environmental risk assessment has indicated that the environmental risks of this maize is not different from the conventional maize. Therefore, strategies for risk management for MON 88017 maize would be the same as for conventional maize.

However, 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.
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
15/03/2011 00:00:00
Remarks: