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Notification report


General information

Notification Number
B/RO/08/08

Member State to which the notification was sent
Romania

Date of acknowledgement from the Member State Competent Authority
14/02/2008

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

Proposed period of release:
01/04/2008 to 01/12/2010

Name of the Institute(s) or Company(ies)
Monsanto Europe, S.A., Represented by Monsanto Romania SRL, address: B-dul D. Pompei nr 9-9A, Builduing 24, 4th floor, district 2, postal code 020335, Bucharest, Telefone, Fax: 305 71 40/65;


3. Is the same GMPt release planned elsewhere in the Community?
Yes:
Germany; Slovak Republic;

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

If yes, notification number(s):
B/DE/06/185; B/ES/07/03; B/FR/06/12/14;

Other notifications
Additionally, MON 89034 x MON 88017 was field tested in several regions of North and South America, as described in Section C.4. No environmental adverse effects were reported for these trials.

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
maizepoaceaezeazea maysmaysMON 89034 × MON 88017

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
MON 89034 × MON 88017 consists in the combination, by traditional breeding, of two genetically modified parental inbred lines derived from MON 89034 and MON 88017.

• Like MON 89034, MON 89034 × MON 88017 produces the Cry1A.105 and Cry2Ab2 insecticidal proteins, which impart protection against feeding damage caused by the European corn borer (ECB, Ostrinia nubilalis) and other lepidopteran insect pests.
• Like MON 88017, MON 89034 × MON 88017 expresses the modified Cry3Bb1 protein, derived from Bacillus thuringiensis subsp. kumamotoensis. Expression of this protein provides protection against certain coleopteran insect pests including members of the corn rootworm (CRW) complex (Diabrotica spp.). In addition, like MON 88017, MON 89034 × MON 88017 expresses the CP4 EPSPS protein, derived from Agrobacterium sp. strain CP4, which provides tolerance to glyphosate.


Genetic modification

3. Type of genetic modification:
Insertion; Other;
Other
MON 89034 × MON 88017 consists in the combination, by traditional breeding, of two genetically modified parental inbred lines derived from MON 89034 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  MON 88017 results form traditional breeding of MON 89034 and MON 88017. The inserted DNA fragments from both inbred parental lines are inherited in MON 89034  MON 88017. The individual components and the size, source and function of these inherited DNA sequences are given bellow
B-Left Border 0.24 239 bp DNA region from the B Left Border region remaining after integration
Pp-e35S 0.30 Modified promoter and leader for the cauliflower mosaic virus (CaMV) 35S RNA containing the duplicated enhancer region

L-Cab 0.06 5' untranslated leader of the wheat chlorophyll a/b binding protein
I-Ract1 0.48 Intron from the rice actin gene
CS-cry1A.105 3.53 Coding sequence for the Bacillus thuringiensis Cry1A.105 protein
T-Hsp17 0.21 3' transcript termination sequence for wheat heat shock protein 17.3, which ends transcription and directs polyadenylation
P-FMV 0.56 Figwort Mosaic Virus 35S promoter
I-Hsp70 0.80 First intron from the maize heat shock protein 70 gene
TS-SSU-CTP 0.40 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 Coding sequence for a Cry2Ab2 protein from Bacillus thuringiensis. This coding sequence uses a modified codon usage.
T-nos 0.25 3' transcript termination sequence of the nopaline synthase (nos) coding sequence from Agrobacterium tumefaciens which terminates transcription and directs polyadenylation
B-Left Border 0.23 230 bp DNA region from the B Left Border region remaining after integration


B-Left Border 0.02 Portion of the left border sequence from Agrobacterium tumefaciens involved in transfer of T-DNA
P-Ract1 0.93 Promoter from the rice actin gene
I-Ract1 0.48 Intron from the rice actin gene
TS-CTP2 0.23 DNA sequence coding for the N teminal chloroplast transit peptide
CS-cp4 epsps 1.37 DNA sequence coding for the native CP4 EPSPS protein
T-nos 0.25 3' nontranslated region of the nopaline synthase (nos) coding sequence from Agrobacterium tumefaciens which terminates transcription and directs polyadenylation
P-e35S 0.61 Promoter and leader for the cauliflower mosaic virus (CaMV) 35S RNA containing the duplicated enhancer region
L-Cab 0.06 5’ untranslated leader of the wheat chlorophyll a/b binding protein
I-Ract1 0.48 Intron from the rice actin gene
CS-cry3Bb1 1.96 DNA sequence coding for a synthetic variant of Cry3Bb1 protein from Bacillus thuringiensis
T-Hsp17 0.21 3’ nontranslated region of the coding sequence for wheat heat-shock protein 17.3, which ends transcription and directs polyadenylation


B – border region
CS coding sequence
I intron
L leader
P – promoter
Pp –modified promoter
T – transcript termination sequence
TS – targeting sequence
Cry2Ab2 refers to the protein expressed by MON 89034 ´ MON 88017 and MON 89034, unless otherwise stated
Cry3Bb1 refers to the protein expressed by MON 89034 ´ MON 88017 and MON 88017, unless otherwise stated


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

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 purpose of the deliberate introduction in the environment consists in observations and establishments in experimental fields for selectivity / bio-efficiency in four locations: Lovrin and Timisoara - County of Timis, Nadlac - County of Arad, Tudor Vladimirescu - County of Braila and the comparative study of corn MON 89034 x MON 88017 versus conventional corn regarding the fauna of non-target arthropods - one location: Periam – County of Timis.

2. Geographical location of the site:
Latitude / Longitude : degree-minutes-secondes
Lovrin: 45-58-26,9 / 20-46-32,62
Timisoara: 45-46-53,89 / 21-12-47,37
Nadlac: 46-10-18,97 / 20-45-25,88
Tudor Vladimirescu: 45-15-32,71 / 27-51-42,38
Periam : 46-02-28,06 / 20-52-55,44


3. Size of the site (m2):
I. Experimental fields: 4
Lovrin 2160 m2 – County of Timis
Timisoara 2160 m2 – County of Timis
Nadlac 2160 m2 – County of Arad
Tudor Vladimirescu 120 m2 – County of Braila
II. Comparative studies corn MON 89034 x MON 88017 versus conventional corn related to non target artropode fauna: 1
Periam - 4032 m2 County of Timis


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  MON 88017 was first field tested for efficacy in Puerto Rico during the 2004/2005 winter season. Field trials were also conducted in U.S.A. and Argentina, where agronomic performance was assessed. It has also been tested in France, Germany and Spain for regulatory purposes (protein expression, composition and agronomic characteristics).

The results of the releases in these countries showed no evidence that MON 89034 x MON 88017 is likely to cause any adverse effects to human or animal health and the environment. Except for its protection against certain lepidopteran and coleopteran insects and its tolerance to glyohosate, MON 89034 x MON 88017 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 ´ MON 88017 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 introduced traits in MON 89034 × 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.
• There is no potential for gene transfer from MON 89034 x 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 would 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).
• As for parental lines MON 89034 and MON 88017, MON 89034 x MON 88017 poses negligible risk for adverse environmental effects through its interaction with target organisms. By definition, the glyphosate tolerance trait has no direct or indirect interaction with any target organism. The insect-protection trait has activity only toward the larvae of particular target lepidopterans and coleopterans; therefore the effect of MON 89034 x 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 Cry3Bb1 toxins for certain lepidopteran and 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 x MON 88017 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 x MON 88017 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; 2) control of target insects while maintaining beneficial species; 3) potential for reduced use of hazardous chemical insecticides and reduced applicator exposure to these products; 4) fit with integrated pest management (IPM) and sustainable agricultural systems; 5) potential for reduced mycotoxin levels in maize kernels; 6) reduced likelihood for lepidopteran insects to develop resistance to Bt proteins and 7) no additional labour or machinery requirements, allowing both large and small growers to maximize hybrid yields. Likewise, the use of glyphosate-tolerant maize enables the farmer to take advantage of the herbicides favourable environmental and safety properties (see Annex I listing of glyphosate under Council Directive 91/414/EEC). Glyphosate-tolerant maize benefits the farmer by providing (1) an additional broad-spectrum weed control option in maize, (2) a new herbicidal mode 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 × MON 88017 could be identified that may cause adverse effects on human health or the environment, no risk management strategies are considered necessary.


Brief description of any measures taken for the management of risks:
Beside the scheduled observations of phenotypical and agronomic parameters representing the basis of the planned research, the trial site will be regularly checked during the deliberate release, for potentially occurring direct or indirect, adverse effects on the environment. Maize batches of MON 89034 × MON 88017 will be visually inspected as well as the receiving environment. In case any adverse effects on the environment related to the deliberate release of MON 89034 × MON 88017 occurred during the testing period, these will be immediately reported to the Competent Authority.
In order to prevent the possibility of hybridization with other maize plants, the following measures will be taken: the maize testing fields will be placed 200 meters away from other maize crops and will be surrounded by a buffer zone made of 4 rows of conventional maize; the batches will be set up so that there is a difference of at least one month between the blooming period of MON 89034 × MON 88017 and the conventional maize.
The equipment, especially the seeder and the combine harvester, will be cleaned on the experimental batch, thus preventing the dissemination of the seeds.
After harvesting, the stems will be chopped and then incorporated in the soil. The seeds dropped accidentally on the soil will be left to germinate, and the plantlets will be destroyed by incorporation into the soil. The maize cobs will be harvested with the combine harvester for experimental batches or manually.

Seeds will be transported in sealed and labeled bags.
At the end of the field-testing campaign, the notifier will submit to the Competent Authority a report presenting in detail any unexpected adverse environmental effects observed during the general surveillance, if any, and further actions taken 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


Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Not known