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Notification report


General information

Notification Number
B/RO/08/06

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 88017 maize, tolerant to glyphosate and protected against Corn Root Worm (Diabrotica virgifera) 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:
France;

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

If yes, notification number(s):
B/DE/05/169; B/DE/06/185; B/ES/06/02; B/ES/07/04; B/FR/06/01/02; B/FR/06/12/10;

Other notifications
Field trials have already been conducted across maize growing regions in North and South America and in Japan, as described in Section C.4. No environmental adverse effects were reported for these trials. In 2007, MON 88017 has been notified for release in Germany, France and Spain.

Genetically modified plant

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

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
MON 88017 is protected against certain coleopteran insect pests, such as members of the corn rootworm (CRW) complex (Diabrotica spp.), 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 Root Worm (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. A full description of the genetic elements in MON 88017, including the approximate size, source and function is provided bellow.

B-Left Border 0.02 Portion of the left border sequence from Agrobacterium tumefaciens involved in transfer of T-DNA (Barker et al., 1983)

P-Ract1 0.93 Promoter from the rice actin gene (McElroy et al., 1990)

I-Ract1 0.48 Intron from the rice actin gene (McElroy et al., 1991)

TS-CTP2 0.23 DNA sequence coding for the N-teminal chloroplast transit peptide (Klee et al., 1987)

CS-cp4 epsps 1.37 DNA sequence coding for the native CP4 EPSPS protein (Padgette et al., 1996)

T-nos 0.25 3' transcript termination sequence of the nopaline synthase (nos) coding sequence from Agrobacterium tumefaciens which terminates transcription and directs polyadenylation (Bevan et al., 1983)

P-e35S 0.61 Promoter and leader for the cauliflower mosaic virus (CaMV) 35S RNA (Odell et al., 1985) containing the duplicated enhancer region (Kay et al., 1987)

L-Cab 0.06 5’ untranslated leader of the wheat chlorophyll a/b binding protein (Lamppa et al., 1985)

I-Ract1 0.48 Intron from the rice actin gene (McElroy et al., 1991)

CS-cry3Bb1 1.96 DNA sequence coding for a synthetic variant of Cry3Bb1 protein from Bacillus thuringiensis (Romano, 2002)

T-Hsp17 0.21 3’ transcript termination sequence for wheat heat-shock protein 17.3, which ends transcription and directs polyadenylation (McElwain and Spiker, 1989)

B - Border region
P - Promoter
L - Leader
I - Intron
CS - Coding sequence
T - Transcript termination sequence
TS – Targeting sequence
Cry3Bb1 refers to the protein expressed by MON 88017, unless otherwise stated


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 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 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 2160m2 – County of Arad
Tudor Vladimirescu 120 m2 – County of Braila
II. Comparative studies corn 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:
Many field trials have already been conducted for performance assessments (efficacy, yield, breeding, etc.) at several locations across maize growing regions in the U.S.A since 2000 and Argentina in 2003-2004. Environmental assessments have been performed in Japan in 2002 and agronomic evaluations in Canada in 2003. It is also been tested in Germany, France and Spain for the regulatory studies (protein expression, composition and agronomic characteristics).
The results of the release in these countries 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 has shown that the risk for potential adverse effects on human and animal 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 88017 to be the cause of any meaningful competitive advantage or disadvantage in natural environments is negligible. The likelihood of unintended spreading of MON 88017 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 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).
• The effect of MON 88017 on target organisms is limited to specific conditions in the field, spatially limited and short in duration. By definition, the glyphosate-tolerance trait has no direct or indirect interaction with any target organism. The coleopteran-protection trait has activity only toward particular target coleopterans, 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, poses negligible risk for adverse environmental effects and are considered similar to the respective interactions caused by conventional maize.
• Any occupational health aspects of handling MON 88017 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.
It is actually expected that the commercial production of 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 glyphosate-tolerance trait since it 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. On the other hand, it is also expected that the planting of MON 88017 will provide important environmental benefits from its coleopteran- protection trait through 1) a reliable means to control specific coleopteran 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.
Since no characteristics of 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:
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 any adverse environmental effects, linked to the deliberate release of MON 88017, are 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 or the separation of at least one month in flowering times and the four rows of non transgenic maize surrounding the trials will prevent most of the possibility of hybridization with other maize plants.
The equipment, especially the experimental drill and combine, will be cleaned on the experimental site, thus preventing seed dissemination.
After completion of harvest, the stalks will be chopped and then incorporated into the soil. Any shattered seed will be allowed to germinate. The resulting seedlings will be destroyed by soil incorporation. Maize cobs will be harvested by experimental-plot combine, or by hand
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.
Seeds will be transported in sealed and labeled bags.
At the end of the field-testing campaign, a report of 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:
Not known