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Notification report


General information

Notification Number
B/ES/09/03

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 MON 89034 × 1507 × MON 88017 maize, 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?
No

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 maysmaysMON 89034 × 1507 × MON 88017

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
MON 89034 × 1507 × MON 88017 consists in the combination, by conventional breeding, of three 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) and MON 88017 (Monsanto Company).

- Like MON 89034, MON 89034 × 1507 × MON 88017 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 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. 1507 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 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.


Genetic modification

3. Type of genetic modification:
Insertion; Other;
Other
MON 89034 × 1507 × MON 88017 consists in the combination, by conventional breeding, of genetically modified parental inbred lines derived from MON 89034, 1507 and MON 88017. 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 × 1507 × MON 88017 was produced by crossing plants containing MON 89034, 1507 and MON 88017 using conventional breeding methods. The inserted DNA fragments from each inbred parental lines are inherited in MON 89034 × 1507 × MON 88017.

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.


6. Brief description of the method used for the genetic modification:
While MON 89034 × 1507 × MON 88017 results from traditional breeding, genetic modification was used in the development of the parental lines. MON 89034 and MON 88017 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 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 MON 89034 × 1507 × MON 88017 genetic modification.

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

3. Size of the site (m2):
The total surface occupied by MON 89034 × 1507 × MON 88017 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:
MON 89034 × 1507 × MON 88017 has not been field tested in Europe previously. However, the parental lines MON 89034, 1507 and MON 88017 have been released at several locations. Results of the releases showed no evidence that MON 89034, 1507 or MON 88017 are likely to cause any adverse effects to human or animal health and the environment.

According to EFSA Guidance Document for the risk assessment of genetically modified plants containing stacked transformation events (EFSA-Q-2003-005D), a single risk assessment for the highest number of stacked events could cover all combinations with fewer of these events. The safety of MON 89034 × 1507 × MON 88017 × 59122 (as well of the parental lines MON 89034, 1507, MON 88017 and 59122) and its substantial equivalence to conventional maize, except for the respective introduced traits, were previously established (see Notification B/ES/09/02 for the deliberate release of MON 89034 × 1507 × MON 88017 × 59122 in field trials in Spain).

Therefore, given that the deliberate release of MON 89034 × 1507 × MON 88017 × 59122 in field trials performed in the U.S. and Chile concluded with no evidences that this maize is likely to cause any adverse effects to human or animal health and the environment, the same results can be deduced for the deliberate release of MON 89034 × 1507 × MON 88017 in the environment.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
According to EFSA Guidance Document for the risk assessment of genetically modified plants containing stacked transformation events (EFSA-Q-2003-005D), a single risk assessment for the highest number of stacked events could cover all combinations with fewer of these events. The safety of MON 89034 × 1507 × MON 88017 × 59122 (as well of the parental lines MON 89034, 1507, MON 88017 and 59122) and its substantial equivalence to conventional maize, except for the respective introduced traits, were previously established (see Notification B/ES/09/02 for the deliberate release of MON 89034 × 1507 × MON 88017 × 59122 in field trials in Spain).

Therefore, given that the environmental risk assessment of MON 89034 × 1507 × MON 88017 × 59122 remains unchanged compared to conventional maize, it can be deduced that the environmental risk assessment of MON 89034 × 1507 × MON 88017 will remain equally unchanged compared to conventional maize.

The risk of the inherited traits in MON 89034 × 1507 × MON 88017 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 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 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 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 protein 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 maize are not different from conventional maize, and this maize does not cause any toxic or allergenic effects in man or animal health and is 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.


Brief description of any measures taken for the management of risks:
Since no characteristics of MON 89034 × 1507 × MON 88017 could be identified that may cause adverse effects on human health or the environment, no risk management strategies are considered necessary.

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 crop and that of its receiving environment. In case any adverse environmental effects, linked to the deliberate release of MON 89034 × 1507 × MON 88017 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 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.