Back

Notification report


General information

Notification Number
B/ES/09/02

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
13/11/2008

Title of the Project
Notification according to Directive 2001/18/EC, Part B, for the deliberate release of MON 89034 × 1507 × MON 88017 × 59122 for the use in field trials in Spain.

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:
Czech Republic; Slovak Republic; Romania;

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

If yes, notification number(s):


Other notifications
MON 89034 × 1507 × MON 88017 × 59122 was field tested in the U.S.A. in 2006, 2007 and 2008. It has also been tested in Chile during the 2006-2007 season.

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 89034 × 1507 × MON 88017 × 59122 consists in the combination, by conventional breeding, of four genetically modified parental inbred lines derived from MON 89034 (Monsanto Company), 1507 (Pioneer Hi-Bred International Inc. and Mycogen Seeds c/o Dow AgroSciences LLC), MON 88017 (Monsanto Company) and 59122 (Pioneer Hi-Bred International Inc. and Mycogen Seeds c/o Dow AgroSciences LLC).

- Like MON 89034, MON 89034 × 1507 × MON 88017 × 59122 produces two distinct Bacillus thuringiensis proteins, Cry1A.105 and Cry2Ab2 which provide a dual effective dose against feeding damage caused by the key lepidopteran pest complex in maize.

- Like 1507, MON 89034 × 1507 × MON 88017 × 59122 produces the B. thuringiensis subsp. aizawai Cry1F insecticidal protein which provides a third activity against the lepidopteran pest complex, and further expands the spectrum of activity in the combined trait product. Like 1507, MON 89034 × 1507 × MON 88017 × 59122 also produces the phosphinothricin acetyl transferase (PAT) protein from Streptomyces viridochromogenes which provides tolerance to glufosinate-ammonium, the active ingredient in Liberty herbicides.

- Like MON 88017, MON 89034 × 1507 × MON 88017 × 59122 produces the modified Cry3Bb1 protein, derived from B. thuringiensis subsp. kumamotoensis that provides protection against corn rootworm (Diabrotica spp.) larval feeding and the CP4 EPSPS protein, derived from Agrobacterium sp. strain CP4 which provides tolerance to glyphosate, the active ingredient in Roundup herbicides.

- Like 59122, MON 89034 × 1507 × MON 88017 × 59122 produces the B. thuringiensis Cry34/35Ab1 binary insecticidal protein that provides a second mode of activity against corn rootworm larval feeding (Diabrotica spp.). Like 59122, MON 89034 × 1507 × MON 88017 × 59122 also produces the PAT protein which provides tolerance to glufosinate-ammonium.


Genetic modification

3. Type of genetic modification:
Insertion; Other;
Other
MON 89034 × 1507 × MON 88017 × 59122 consists in the combination, by conventional breeding, of four genetically modified parental inbred lines derived from MON 89034, 1507, MON 88017 and 59122. No additional genetic modification is involved.

In case of insertion of genetic material, give the source and intended function of each constituent fragment of the region to be inserted:
MON 89034 x 1507 x MON 88017 x 59122 was produced by crossing plants containing MON 89034, 1507, MON 88017 and 59122 using conventional breeding methods. The inserted DNA fragments from each inbred parental lines are inherited in MON 89034 x 1507 x MON 88017 x 59122.

Genetic Element. Size (kb). Function:

Summary of the inserted DNA fragment inherited from MON 89034:
B-Left Border: 0.24 Kb. 239 bp DNA region from the B-Left Border region remaining after integration.
Pp-e35S: 0.30 Kb. Modified promoter and leader for the cauliflower mosaic virus (CaMV) 35S RNA containing the duplicated enhancer region.
L-Cab: 0.06 kb. 5' untranslated leader of the wheat chlorophyll a/b-binding protein.
I-Ract1: 0.48 kb. Intron from the rice actin gene.
CS-cry1A.105: 3.53 kb. Coding sequence for the B. thuringiensis Cry1A.105 protein.
T-Hsp17: 0.21 kb. 3' transcript termination sequence for wheat heat shock protein 17.3, which ends transcription and directs polyadenylation.
P-FMV: 0.56 kb. Figwort Mosaic Virus 35S promoter.
I-Hsp70: 0.80 kb. First intron from the maize heat shock protein 70 gene.
TS-SSU-CTP: 0.40 kb. DNA region containing the targeting sequence for the transit peptide region of maize ribulose 1,5-bisphosphate carboxylase small subunit and the first intron.
CS-cry2Ab2: 1.91 kb. Coding sequence for a Cry2Ab2 protein from B. thuringiensis. This coding sequence uses a modified codon usage.
T-nos: 0.25 kb. 3' transcript termination sequence of the nopaline synthase (nos) coding sequence from Agrobacterium tumefaciens which terminates transcription and directs polyadenylation.
B-Left Border: 0.23 kb. 230 bp DNA region from the B-Left Border region remaining after integration.


Summary of the inserted DNA fragment inherited from 1507:
ubiZM1 PRO: 1.98 kb. The ubiquitin promoter (plus 5’ untranslated region) from Zea mays.
cry1F: 1.82 kb. A synthetic version of truncated cry1F from B. thuringiensis subsp. aizawai (plant optimized).
ORF25 TERM: 0.72 kb. A terminator from Agrobacterium tumefaciens pTi15955.
35S PRO: 0.55 kb. 35S promoter from Cauliflower Mosaic Virus.
pat: 0.55 kb. The synthetic glufosinate-ammonium tolerance gene (plant optimized), based on a phosphinothricin acetyltransferase gene sequence from Streptomyces viridochromogenes.
35S TERM: 0.20 kb. 35S terminator from Cauliflower Mosaic Virus.

Summary of the inserted DNA fragment inherited from MON 88017:
B-Left Border: 0.29 kb. 292 bp DNA region from the B-Left Border region remaining after integration.
P-Ract1: 0.93 kb. Promoter from the rice actin gene.
I-Ract1: 0.48 kb. Intron from the rice actin gene.
TS-CTP2: 0.23 kb. DNA sequence coding for the N-teminal chloroplast transit peptide.
CS-cp4 epsps: 1.37 kb. DNA sequence coding for the native CP4 EPSPS protein.
T-nos: 0.25 kb. 3' nontranslated region of the nopaline synthase (nos) coding sequence from Agrobacterium tumefaciens which terminates transcription and directs polyadenylation.
P-e35S: 0.61 kb. Promoter and leader for the cauliflower mosaic virus (CaMV) 35S RNA containing the duplicated enhancer region.
L-Cab: 0.06 kb. 5’ untranslated leader of the wheat chlorophyll a/b-binding protein.
I-Ract1: 0.48 kb. Intron from the rice actin gene.
CS-cry3Bb1: 1.96 kb. DNA sequence coding for a synthetic variant of Cry3Bb1 protein from B. thuringiensis.
T-Hsp17: 0.21 kb. 3’ nontranslated region of the coding sequence for wheat heat-shock protein 17.3, which ends transcription and directs polyadenylation.
B-Right Border: 0.03 kb. 30 bp DNA region from the B-Right Border region remaining after integration.


Summary of the inserted DNA fragment inherited from 59122:
Right Border: 0.18 kb. Right T-DNA border region from Ti plasmid of Agrobacterium tumefaciens. T-DNA right border 25 bp repeat region located from bp 1 to bp 25.
Ubiquitin promoter: 1.99 kb. Ubiquitin promoter from Zea mays including 5’UTR (bp 1149 to bp 1231) and intron (bp 1232 to bp 2241).
cry34Ab1: 0.37 kb. Maize-optimised cry34Ab1 gene encoding the 14 kDa delta-endotoxin parasporal crystal protein from B. thuringiensis strain PS149B1. Coding region from start codon through stop codon.
Pin II Term: 0.31 kb. Terminator sequence from Solanum tuberosum proteinase inhibitor II gene.
Wheat Peroxidase promoter: 1.30 kb. Triticum aestivum peroxidase promoter (wheat peroxidase).
cry35Ab1: 1.15 kb. Maize-optimised cry35Ab1 gene encoding the 44 kDa delta-endotoxin parasporal crystal protein from B. thuringiensis strain PS149B1. Coding region from start codon through stop codon.
Pin II Term: 0.32 kb. Terminator sequence from Solanum tuberosum proteinase inhibitor II gene.
35S Promoter: 0.53 kb. 35S promoter from Cauliflower Mosaic Virus, Strasbourg strain.
Pat: 0.55 kb. Plant-optimised phosphinothricin acetyltransferase coding sequence from Streptomyces viridochromogenes. Coding region from start codon through stop codon.
35S Term: 0.19 kb. 35S terminator from Cauliflower Mosaic Virus.
Left Border: 0.08 kb. Left T-DNA border region from Ti plasmid of Agrobacterium tumefaciens. T-DNA Left Border 25 bp repeat region located from bp 7366 to bp 7390.


6. Brief description of the method used for the genetic modification:
While MON 89034 × 1507 × MON 88017 × 59122 results from traditional breeding, genetic modification was used in the development of the parental lines. MON 89034, MON 88017 and 59122 were produced by Agrobacterium-mediated transformation of maize cells. 1507 was developed by the particle acceleration method.

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 aim of the release is to evaluate and characterize the agronomic performance of MON 89034 x 1507 x MON 88017 x 59122 maize under Spanish crop environment.

2. Geographical location of the site:
- Grañén (Huesca).
- Bujaraloz (Zaragoza).
- Ejea de los Caballeros (Zaragoza).
- Zuera (Zaragoza).
- Daimiel (Ciudad Real).
- Yunquera de Henares (Guadalajara).
- Calera y Chozas (Toledo).
- Puebla de Montalbán (Toledo).
- Dueñas (Palencia).
- Peñarandilla (Salamanca).
- Santovenia de Pisuerga (Valladolid).
- Molacillos (Zamora).
- Gimenells (Lleida).
- Alcarrás (Lleida).


3. Size of the site (m2):
The total surface occupied by MON 89034 x 1507 x MON 88017 x 59122 maize in every site will be less than:
- Grañén (Huesca): 400 m².
- Bujaraloz (Zaragoza): 400 m².
- Ejea de los Caballeros (Zaragoza): 400 m².
- Zuera (Zaragoza): 400 m².
- Daimiel (Ciudad Real): 400 m².
- Yunquera de Henares (Guadalajara): 400 m².
- Calera y Chozas (Toledo): 400 m².
- Puebla de Montalbán (Toledo): 400 m².
- Dueñas (Palencia): 400 m².
- Peñarandilla (Salamanca): 400 m².
- Santovenia de Pisuerga (Valladolid): 400 m².
- Molacillos (Zamora): 400 m².
- Gimenells (Lleida): 400 m².
- Alcarrás (Lleida): 400 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:
MON 89034 × 1507 × MON 88017 × 59122 was field tested in multiple sites in maize producing states of the U.S. corn belt and southern maize growing regions to assess performance, efficacy, hybrid evaluation, seed production, yield and to collect regulatory data and materials. It was also tested in three locations in Chile to assess performance, efficacy, yield, breeding, and for hybrid evaluation.

The results of the releases in these countries showed no evidence that MON 89034 × 1507 × MON 88017 × 59122 is likely to cause any adverse effects to human or animal health and the environment. Except for its protection against certain lepidopteran and coleopteran insect pests and its tolerance to glyphosate and glufosinate herbicides, MON 89034 × 1507 × MON 88017 × 59122 could not be distinguished from conventional maize.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Analysis of the characteristics of MON 89034 × 1507 × MON 88017 × 59122 has shown that the risk of potential adverse effects on human and animal health or the environment, resulting from the planned deliberate release of this maize for field testing, is negligible:

- The risk of the inherited traits in MON 89034 × 1507 × MON 88017 × 59122 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-agricultural environments is negligible, as its persistence in agricultural habitats and its invasiveness into non-agricultural habitats are unaltered compared to conventional maize. In the unlikely event of the establishment of these plants in the environment, the introduced traits would confer only a limited selective advantage (protection against lepidopteran and coleopteran pests, tolerance to glyphosate and glufosinate-ammonium) of short duration, narrow spatial context and with negligible consequences for the environment.

- There is no potential for gene transfer from MON 89034 × 1507 × MON 88017 × 59122 to wild plant species in Europe and low to negligible likelihood for gene transfer to other maize crops. In the event that the introduced genes outcross to another maize plant, its transfer would, in any case, have negligible consequences for the environment. Therefore, no risk management strategies are considered necessary. Nevertheless, measures will be taken to avoid hybridization with other maize plants and seed dissemination at harvest and during transportation (see Point E).

- MON 89034 × 1507 × MON 88017 × 59122 poses negligible risk for adverse environmental effects through its interaction with target organisms. By definition, the glyphosate- and glufosinate-tolerance traits have no direct or indirect interaction with any target organism. The insect-protection traits have activity only toward the particular target lepidopteran and coleopteran pests, therefore the effect of MON 89034 × 1507 × MON 88017 × 59122 on target organisms is limited to specific conditions in the field, spatially limited and short in duration.

- Based on the selectivity of the Cry1A.105, Cry2Ab2 and Cry1F proteins for certain lepidopteran pests, and of the Cry3Bb1 and Cry34/35Ab1 proteins for certain coleopteran pests, their well-characterised mode of action and the confirmation through studies of no adverse effects found, the risk of an adverse effect on non-target organisms is considered negligible. The ecological interactions with non-target organisms or the biochemical processes in soil are considered similar to the respective caused by conventional maize.

- Any occupational health aspects of handling MON 89034 × 1507 × MON 88017 × 59122 maize are not different from conventional maize, and this maize was shown not to cause any toxic or allergenic effects in man or animal health and to be as safe and nutritious as any other maize without any consequences for the feed/food chain.

- 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 production of MON 89034 × 1507 × MON 88017 × 59122 will positively impact current agronomic practices in maize and provide benefits to farmers and the environment. The benefits of planting this maize result, in one hand, from its insect-protection traits and include: 1) a reliable means to control the target lepidopteran and coleopteran maize pests while maintaining beneficial species; 2) potential for reduced use of hazardous chemical insecticides ; 3) excellent fit with integrated pest management (IPM) and sustainable agricultural systems; 4) reduced likelihood for isects insects to develop resistance to Bt proteins, compared to the parental lines; 5) potential for reduced levels of mycotoxin in maize kernels that result from fungal invasion after insect feeding damage. On the other hand, benefits of planting this maize result from its herbicide-tolerance traits (glyphosate and glufosinate-ammonium), which include: 1) an additional broad-spectrum weed control option in maize, 2) new herbicidal modes of action for in-season maize weed control, 3) increased flexibility to treat weeds on an “as needed” basis, 4) cost-effective weed control and 5) an excellent fit with reduced-tillage systems. In turn, a number of environmental benefits arise from the use of conservation tillage including improved soil quality, improved water infiltration, reductions in erosion and sedimentation of water resources, reduced runoff of nutrients and pesticides to surface water, improved wildlife habitat, increased carbon retention in the soil, reduced fuel use and encouragement of sustainable agricultural practices.
Since no characteristics of MON 89034 × 1507 × MON 88017 × 59122 could be identified that may cause adverse effects on human health or the environment, no risk management strategies are considered necessary, except the isolation measures proposed in point 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 89034 × 1507 × MON 88017 × 59122 crop and that of its receiving environment. In case any adverse environmental effects, linked to the deliberate release of MON 89034 × 1507 × MON 88017 × 59122, observed during the period of release, 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 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, any unanticipated adverse effects on human health or the environment would 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.
- Aragón: 13/03/2009.
- Castilla-La Mancha: 25/03/2009.
- Castilla y León: 21/04/2009.