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Notification report


General information

Notification Number
B/RO/07/03

Member State to which the notification was sent
Romania

Date of acknowledgement from the Member State Competent Authority
01/03/2007

Title of the Project
Notification according to Directive 2001/18/EC, Part B, for the deliberate release of Roundup Ready® soybean 40-3-2 for the use in field trials in Romania.

Proposed period of release:
01/01/2007 to 01/01/2016

Name of the Institute(s) or Company(ies)
MONSANTO ROMANIA SRL, B-DUL DIMITRIE POMPEI NR.9-9A, COMPLEX IRIDE, CLADIREA 24, ET.4, SECTOR 2, BUCUREŞTI, ROMANIA;


3. Is the same GMPt release planned elsewhere in the Community?
No

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

If yes, notification number(s):
B/ES/97/25; B/ES/98/11; B/FR/94/03/03; B/FR/95/03/02; B/FR/96/04/12; B/FR/97/10/10; B/FR/99/01/11; B/IT/94/09-CON; B/IT/95/18; B/IT/96/23; B/IT/99/04;

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
soyafabaceaeglycineglycine maxA5403

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
40-3-2 contains a fully functional intact gene derived from Agrobacterium sp. strain CP4 (cp4 epsps) encoding the CP4 EPSPS protein which confers tolerance to glyphosate, the active ingredient in Roundup herbicides. Glyphosate has excellent weed control capabilities and well-known, favourable environmental and safety characteristics. However, the sensitivity of crop plants to glyphosate has prevented the in-season use of this herbicide over-the-top of crops. The extension of its use to allow in-season application in major crops such as soybean provides a novel weed control option for farmers.

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:
The plasmid vector used to produce 40-3-2 by particle acceleration method is coded PV-GMGT04. PV-GMGT04 contains three gene cassettes intended for insertion, of which two contain the cp4 epsps coding sequence and one contains the uidA coding sequence.
In both cp4 epsps gene cassettes, the cp4 epsps coding sequence is linked to a chloroplast transit peptide sequence designated CTP4, based on the CTP sequence isolated from the Petunia hybrida 5-enolpyruvylshikimate-3-phosphate synthase (epsps) gene. CTP4 targets the CP4 EPSPS protein to the chloroplast, the location of EPSPS in plants and the site of aromatic amino acid biosynthesis.
In the first cp4 epsps gene cassette, the ctp4-cp4 epsps coding sequence is under the control of the enhanced 35S cauliflower mosaic virus promoter (P E35S). The second cassette contains the ctp4-cp4 epsps coding sequence under the control of the 35S figwort mosaic virus promoter (P-FMV). Both promoters are constitutively active in plants.
In both cp4 epsps gene cassettes, the cp4 epsps coding sequence is joined to the nopaline synthase 3’ non-translated sequence (NOS 3’) from Agrobacterium tumefaciens, which provides the polyadenylation sites directing mRNA processing and multiple adenylate addition.
The cp4 epsps coding sequence, isolated from Agrobacterium sp. strain CP4, confers a high level of tolerance to glyphosate. It encodes the 5-enolpyruvylshikimate-3-phosphate synthase (CP4 EPSPS), which unlike most native plant and microbial EPSPS enzymes, is naturally tolerant to glyphosate. EPSPS catalyzes the conversion of shikimate-3-phosphate (S3P) and phosphoenolpyruvate (PEP) into 5-enolpyruvylshikimate-3-phophate (EPSP), an intermediate required for the production of aromatic amino acids.
The uidA gene cassette contains the uidA coding sequence under the control of the TR 2’ mannopine synthase promoter and is joined to the 7S 3’ non-translated region of the alpha subunit of the soybean 7S seed storage protein complex. The GUS protein expressed by the uidA gene cassette is a 68 kD acid hydrolase that catalyzes the cleavage of several β-glucuronides and has been used as a scoreable marker in the transformation and regeneration of 40-3-2.
The molecular analyses of 40-3-2 support the conclusions that 40-3-2 genome contains a single functional DNA insert comprised of a single copy of the cp4 epsps gene cassette under the control of the E35S promoter (i.e. primary functional insert). At the 3’ proximal region of the functional insert, a 250 bp segment of cp4 epsps DNA is located adjacent to the NOS 3’ polyadenylation signal of the functional cp4 epsps gene cassette. In addition, a second co-segregating non-functional insert comprising a 72 bp cp4 epsps DNA segment was identified. No additional elements from vector PV-GMGT04 are present in 40-3-2.


6. Brief description of the method used for the genetic modification:
40-3-2 was produced by using the particle acceleration method. The original transformation was conducted on the soybean cultivar A5403.

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:
Purpose of the release (including any relevant information available at this stage) such as agronomic purposes, test of hybridisation, changed survivability or dissemination, test of effects on target or non-target organisms.

Official testing in ISTIS (StateVariety Testing Institute) network of agronomic performance for genetically modified soybean varieties in comparable plots with conventional soybean varieties, in order to get its registered in National list of registered varieties.


2. Geographical location of the site:
LIST OF SOYBEAN RR VARIETIES FOR OFFICIAL TESTING- ISTIS 2007

VARIETY; STATUS 2007; QUANTITY IMPORTED; COUNTRY OF ORIGIN; COMPANY; BORDER POINT; QUANTITY(kg); ISTIS NETWORK


AG 0602; Y2 OT; 25 KG; USA; MONSANTO; OTOPENI; 25; CTS Cogealac Constanta county
AG 0803; Y1 OT; 25 KG; USA; MONSANTO; OTOPENI; 25; CTS Ovidiu, Constanta county
AG 1001; Y2 OT; 25 KG; USA; MONSANTO; OTOPENI; 25; CTS Mircea Voda, Braila county
AG 2205; Y2 OT; 25 KG; USA; MONSANTO; OTOPENI; 25; CTS Peciu Nou, Timis county
AG 2405; Y2 OT; 25 KG; USA; MONSANTO; OTOPENI; 25; CTS Tincabesti, Ilfov county
DKB 08-51; Y2 OT; 25 KG; USA; MONSANTO; OTOPENI; 25; CTS Tecuci, Galati county
DKB 09-53; Y2 OT; 25 KG; USA; MONSANTO; OTOPENI; 25; CTS Calafat, Dolj county
DKB 10-52; Y1 OT; 25 KG; USA; MONSANTO; OTOPENI; 25; CTS Arad, Arad county
DKB 19-52; Y1 OT; 25 KG; USA; MONSANTO; OTOPENI; 25; CTS Inand, Bihor county
DKB 20-01; Y1 OT; 25 KG; USA; MONSANTO; OTOPENI; 25; CTS Ludus, Mures county
DKB 25-51; Y2 OT; 25 KG; USA; MONSANTO; OTOPENI; 25; CTS Negresti, Vaslui county
S 1300-4; Y3 OT; 25 KG; USA; STINE; OTOPENI; 25; CTS Satu Mare, SatMare county
S 1683-4; Y2 OT; 25 KG; USA; STINE; OTOPENI; 25; CTS Dalga, Calarasi county
S 1918-4; Y3 OT; 25 KG; USA; STINE; OTOPENI; 25; CTS Rm.Sarat, Buzau county
S 2402-4; Y3 OT; 25 KG; USA; STINE; OTOPENI; 25; CTS Targoviste, Dambovita county
S 2688-4; Y3 OT; 25 KG; USA; STINE; OTOPENI; 25;
DKB 08-01; Y1 OT; 25 KG; USA; MONSANTO; OTOPENI; 25;
DKB 14-01; Y1 OT; 25 KG; USA; MONSANTO; OTOPENI; 25;
DKB 24-01; Y1 OT; 25 KG; USA; MONSANTO; OTOPENI; 25;

TOTAL 475 kg
Area cultivated:60 m2 PER LOCATION AND VARIETY
Scope: VARIETY REGISTRATION


3. Size of the site (m2):
60 m2 PER LOCATION AND VARIETY ACCORDING ISTIS PROCEDURES AND IN RESPECT OF ROMANIAN LAW.

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:
Post-release general surveillance from environments inside and outside the EU has shown that 40-3-2 is unlikely to pose any risk of adverse effects to human or animal health or to the environment.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Note especially if the introduced traits could directly or indirectly confer an increased selective advantage in natural environments; also explain any significant expected environmental benefits

Analysis of the characteristics of 40-3-2, especially in comparison with the experience with cultivation of traditional soybeans within the EU, has shown that the risk for potential adverse effects on human and animal health and the receiving environment, resulting from the planned field trials with 40-3-2, is consistently negligible:
• The risk of the introduced trait in 40-3-2 to be the cause of any meaningful competitive advantage or disadvantage in natural environments is negligible. Like for any other soybean, the likelihood of this soybean to spread into non-agronomic environments is negligible, as its persistence in agricultural habitats and its invasiveness into natural habitats are unaltered compared to traditional soybean. Moreover, there is no potential for gene transfer from 40-3-2 to any wild plant species in Europe.
• Potential exposure of non-target organisms to the CP4 EPSPS protein presents no conceivable mechanism to cause adverse effects because of its properties.
• Any occupational health aspects of handling 40-3-2 are no different from traditional soybean, and this soybean was shown to be as safe and nutritious as any other soybean.
• The environmental impact of the cultivation, management and harvesting techniques applied in the planned trials is considered no different from the farming practices for traditional soybean.
Since no characteristics of 40-3-2 could be identified that may cause adverse effects on human health or the environment, no risk management strategies are considered necessary.
It is actually expected that the commercial production of 40-3-2 will positively impact current agronomic practices in soybean and provide benefits to farmers and the environment. The use of Roundup herbicides in soybean enables the farmer to take advantage of the herbicide’s favourable environmental and safety properties (see Annex I listing of glyphosate under Council Directive 91/414/EEC). Glyphosate-tolerant soybean benefits the farmer by providing (1) an additional broad-spectrum weed control option in soybean, (2) a new herbicidal mode of action for in-season soybean 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.


Brief description of any measures taken for the management of risks:
The environmental risk assessment has indicated that the environmental risks of this soybean are negligible. Therefore, strategies for risk management for 40-3-2 would be the same as for traditional soybean.
However, in addition to the scheduled observations of 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 effects. This will be done by visual inspection of the status of 40-3-2 crop and that of its receiving environment.
Around the experimental plots area a buffer zone of 4 m is required and it will be treated as a GM variety , all seeds will be burn after harvest. In case volunteers will appear after harvest, all the plants will be destroyed. Experimental plots will be cultivated next year with other crops and area will be monitor at least one season.
In case any adverse environmental effects, linked to the deliberate release of 40-3-2 are observed during the period of release, these will be reported immediately to the Romanian Authorities.
At the end of the field-testing campaign, a report of will be made available by the notifier to the Romanian Authorities. 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:
Any unanticipated adverse effects on human health or the environment would be reported immediately to the Romanian Authorities.

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
23/04/2007 00:00:00
Remarks: