General informationNotification NumberB/RO/09/16Member State to which the notification was sentRomaniaDate of acknowledgement from the Member State Competent Authority23/03/2009Title of the ProjectNotification according to Directive 2001/18/EC Part B, for the deliberate release of MON 89034 maize for the use in field trials in Romania.Proposed period of release:01/04/2009 to 01/12/2013Name 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; Spain; France; Has the same GMPt been notified elsewhere by the same notifier?YesIf yes, notification number(s): B/DE/06/185; B/DE/08/201; B/ES/07/01; B/ES/08/11; B/ES/09/07; B/FR/06/12/12; B/RO/08/07; B/SK/08/02; Other notificationsB/FR/08/01/07
Many field trials have already been conducted across maize growing regions in North and South America.Genetically modified plantComplete name of the recipient or parental plant(s)
2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:MON 89034 is protected against certain lepidopteran insect pests, such as European corn borer (ECB, Ostrinia nubilalis).Genetic modification3. 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 89034 contains the cry1A.105 gene which codes for a protein comprised of naturally occurring Cry1Ab, Cry1F, and Cry1Ac proteins from Bacillus thuringiensis, and the cry2Ab2 gene which codes for a variant of the Bacillus thuringiensis subsp. kurstaki Cry2Ab2 protein. These proteins provide protection against feeding damage caused by lepidopteran insect pests such as the European corn borer (ECB, Ostrinia nubilalis) and the corn earworm (CEW, Helicoverpa zea).
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A full description of the genetic elements in MON 89034, including the approximate size, source and function of these inherited DNA sequence are given below:
Summary of the genetic elements inserted in MON 89034
Genetic Element (~ size): Function
B1-Left Border (0.24 kb):
239 bp DNA region from the B Left Border region remaining after integration
Pp2-e35S (0.30 kb):
Modified promoter and leader for the cauliflower mosaic virus (CaMV) 35S RNA containing the duplicated enhancer region
L3-Cab (0.06 kb):
5' untranslated leader of the wheat chlorophyll a/b binding protein
I4-Ract1 (0.48 kb):
Intron from the rice actin gene
CS5-cry1A.105 (3.53 kb):
Coding sequence for the Bacillus thuringiensis Cry1A.105 protein
T6-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
TS7-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 Bacillus 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
1. B – border region
2. Pp –modified promoter
3. L - leader
4. I - intron
5. CS - coding sequence
6. T – transcript termination sequence
7. P – promoter
8. TS – targeting sequence
9. Cry2Ab2 refers to the protein expressed by MON 89034, unless otherwise stated6. Brief description of the method used for the genetic modification:MON 89034 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 Release1. 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 one location: Carpinis – Timis county2. Geographical location of the site:Carpinis – Timis county3. Size of the site (m2):Carpinis – Timis county – 2500 m24. 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 has been released for field-testing at several locations in the U.S.A. and Argentina since 2002. These field trials were conducted to produce material for the regulatory studies and to assess agronomic performance (efficacy, selectivity, yield assessment). It has also been tested in Canada in 2005 for agronomic characterization and evaluations.
The results of the release in these countries showed no evidence that MON 89034 is likely to cause any adverse effects to human or animal health and the environment. Except for its protection against certain lepidopteran insects, MON 89034 could not be distinguished from conventional maize.Environmental Impact and Risk ManagementSummary of the potential environmental impact from the release of the GMPts:Analysis of the characteristics of MON 89034 has shown that the risk of potential adverse effects on human health or the environment, resulting from the deliberate release of this maize for field testing, is negligible:
•The risk of the introduced trait in MON 89034 to be the cause of any meaningful competitive advantage or disadvantage in natural environments is negligible. The likelihood of unintended spreading of MON 89034 in the non-agricultural environments is negligible, as maize is neither persistent nor invasive and these parameters are unaltered when compared to conventional maize.
•There is no potential for gene transfer from MON 89034 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.
•The effect of MON 89034 on target organisms is limited to specific conditions in the field, spatially limited and short in duration. Therefore MON 89034 poses negligible risk for adverse environmental effects through its interaction with target organisms. It is actually expected that the planting of MON 89034 will provide important environmental benefits, relevant to the discussion on target organisms, including: 1) a reliable means to control specific lepidopteran maize pests while maintaining beneficial species; 2) potential for reduced use of hazardous chemical insecticides; 3) excellent fit with Integrated Pest Management and sustainable agricultural systems; 4) reduced likelihood for lepidopteran insects to develop resistance to Bt proteins; 5) potentially reduced levels of mycotoxins such as fumonisins in maize kernels.
•Based on the selectivity of the Cry1A.105 and the Cry2Ab2 toxins for certain lepidopteran 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 are not different from conventional maize. Additionally 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 cultivation of any other maize.
Since no characteristics of MON 89034 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 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 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 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 labelled 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:No applicable.
However, any unanticipated adverse effects on human health or the environment would be reported immediately to the Competent AuthorityFinal reportEuropean Commission administrative informationConsent given by the Member State Competent Authority:Yes02/06/2009 00:00:00Remarks: