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Monsanto India Ltd. - IGMORIS - Indian GMO Research Information ...

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4. Soft dough/milky stage 90-100 L,S, E5. Hard dough/maturity (at 110 and above R,L,S, Kharvest)The estimation of candidate proteins expressed by the inserted genes shall be quantitated inmicrograms per gram dry weight of the plant material. The plant parts to be used are fullyexpanded collar leaves (L), Roots (R), Stem (S), Ear (E), Silk (Si) and Kernel (K).5. Biosafety studies are to be carried out as per the protocols/ guidelines approved byRCGM/GEAC and available on the website i.e. http://dbtbiosafety.nic.in. Separateapplications would be submitted by the applicant to the RCGM for approval of variousprotocols to conduct food and feed safety assessment and other studies.6. DNA fingerprinting data of the hybrid/ genotype.b) Trial-in-Charge: Dr. M.S. Bhullar, Agronomist, Department of Agronomy, PAU,Ludhiana will be the Trial-in-Charge responsible for all aspects of the trials as informed by theapplicant. The trial In-charge will be responsible for management of the field trial, ensuringcompliance with the terms and conditions of confined field trial authorization and providinginformation required by regulatory bodies.c) Trial site:i) The Permitted Party would provide a detailed map of the confined field trial site as perGuidelines 2008 to the Member-Secretary, RCGM/ GEAC/ State Department of Agriculture/State Agriculture Universities/ District Authorities and other field functionaries preferably 7working days before sowing/planting and positively within 7 working days after sowing/plantingon the trial site.The following items shall be included on each map of a field trial site:1. Trial-in-Charge’s name and contact details.2. Permit number from the regulatory authority.3. Legal or descriptive land location (name of the village, taluka, district, state or university)4. Accurate distances to physical landmarks or surrounding landmarks such as telephonepoles, fences, alleys, roads, or steel poles.5. Total area planted with the regulated material, including negative controls and any borderor guard rows when used (hectares or square meters).6. Label all fields within the isolation area by the common name of the crop.7. Indicate any fields of same/related crops that fall within, or border on, the isolation area.8. Include any natural ecosystems adjacent to the trial site (natural habitats, waterways,garden, orchard, forests, and woodlots, hedgerows), wherever reasonable.9. Planting date.10. Compass directions, with North at the top of the page.A signboard at the site with the above information must be erected until the period of post-harvestland use restriction has been completed.ii) The Permitted Party should further inform the State Department of Agriculture/SBCC/DLCand any other concerned field functionaries, wherever applicable about full details on theconfined field trial with a copy of such intimation to RCGM/ GEAC within 7 working days ofplanting the trial.


d) Trial Protocol: The replicated Biosafety <strong>Research</strong> Level I Trial (BRL-I) shall beconducted in triplicate repeats with randomized block design (RBD) at Field No. 37 & 62, E-Block, Plant Breeding Experimental Area, Punjab Agriculture University, Ludhiana,Punjab, to keep the research trials confined. While conducting confined BRL-I trials, permittedparty/trial-in-charge is directed to follow the trial specification as submitted to RCGM.Appropriate checks and spacing are to be included for comparison of the efficacy of thegenes in term of productivity of the transgenic corn, germination, weediness, aggressiveness andother parameters.e) Trial size and reproductive Isolation: The experimental area should not be more than oneacre per trial/ per location. Further, as per <strong>India</strong>n Minimum Seed Certification Standards, anisolation distance of 300 meters and physical barrier of 10 or 13 rows of African Tall Maizeplants covering a distance of 6 to 7.8 meters all around the experimental plot. The PermittedParty/trial-in-charge would not plant any sexually compatible or prohibited plant within the 300meters isolation distance. It is to be ensured that the conditions for reproductive isolation of alltrial plants are met during both the current growing season and the post-harvest restriction periodof the next growing season, as per Guidelines 2008. The trial should be conducted in hotspotareas of particular insectsThe applicant should take precautionary steps to avoid the possibility of spread ofseeds by birds.f) Records and reporting:i) Compliance Records:Records of all confined field trials, including pre- and post-harvest site monitoring, activitiesrelated to trial site compliance (including subcontracts), cleaning of equipment, transportation,disposition and storage of all surplus and harvested seed and plant material, shall be maintainedand shall be made available to RCGM/GEAC or the designated monitoring agencies uponrequest. Mandatory recording formats are referenced in the RCGM/GEAC Standard OperatingProcedures (SOPs) for Confined Field Trials of Genetically Engineered Crops: Transport,Storage, Management, Harvest or Termination and Post Harvest Management and can bedownloaded from http://www.igmoris.nic.in.ii) Field Trial Report:The Permitted Party shall submit a field trial report through trial-in-charge to RCGM/GEACwithin three months after termination/harvest of the confined field trials. The field trial reportsmust summarize the completed trial, including methods, observations, data and analysis of anyeffects of the trial plants on other plants, non-target organisms, or the environment.iii) Mandatory <strong>Information</strong> Submissions by Applicant/Permitted Party: Planting <strong>Information</strong> Submission: RCGM and GEAC shall be informed in writing within 7working days of planting at a trial site. A record of planting with a confined field trial permitnumber, the amount of material planted, the planting date, the transportation of plant materialto the trial site, the cleaning of any equipment used during planting, and the disposition ofany surplus plant material remaining after planting shall be submitted to RCGM and GEAC.


Harvest <strong>Information</strong> Submission: A Record of Harvest/Termination shall be prepared foreach confined field trial site and shall document the date and method of harvest, the amountof harvested material, the disposition of any harvested materials, the cleaning of anyequipment used during harvest, and the method of destruction of any residual plant materialon the trial site. This record must be verified and signed by a member of the MonitoringAgency or any nominee of RCGM/GEAC/SAU authorized by RCGM/GEAC during theconduct of a trial site inspection during harvest, or within 15 days of the completion ofharvest.Accidental Release <strong>Information</strong>: The Permitted Party/trial-in-charge shall notifyRCGM/GEAC positively within 24 hours of discovery of any incident involving anaccidental or unauthorized escape like spillage, theft, encroachment by unauthorized persons,vandalization etc. of regulated GE plant material during transportation, storage within acontained facility, or during any other activity associated with the conduct of a confined fieldtrial, in writing (submission to be received by RCGM/GEAC by facsimile, e-mail or othermeans). As per the Guidelines 2008, any breach of the authorized terms and conditions ofreproductive isolation shall be considered an accidental release and subject to risk assessmentand management, if any, is to be carried out at the cost of the applicant or Permitted Party.Other Submissions : In the event that the plants undergoing confined field trial testingexhibit any characteristics substantially different from those known for the host plant speciesi.e. its non-GM counterpart, or anticipated and listed in the application, or suffers any unusualoccurrence, the Permitted Party/trial-in-charge shall notify RCGM/GEAC in writing withinfive (5) days of such observations.g) Disposition of Material from confined field trials: No harvested material or byproductfrom a confined field trial, under any circumstances, may be used as human food or livestockfeed. Seed or other plant material harvested from confined trials authorized by RCGM/GEAC tobe retained for future research work and must be disposed of by a method given in the Guidelines2008 (e.g., dry heat, steam heat, incineration, deep burial, chemical treatment, or crushing orburying on the trial site). Progeny from any confined field trial cannot be retained for futureplanting without prior written authorization from RCGM/GEAC, and this must be specificallyrequested in the field trial application.h) Monitoring of Confined Field Trials: The trial-in-charge or his/her designate mustmonitor the trial site at least ONCE EVERY TWO WEEKS from the time of planting until thetime of harvest of the trial. This monitoring has to be recorded in a bound book provided by thePermitted Party as per the formats given in the Guidelines 2008. The record of spatial isolationwill be used to document all monitoring and field activities needed to demonstrate reproductiveisolation of the trial site. The growth and stage of any prohibited plant found within the isolationdistance of the trial site should be recorded during monitoring.Members of the CCC, monitoring teams of SAUs or any other authorized party byRCGM/GEAC have the authority to inspect confined field trial sites at the time of planting,during the growing, harvesting season, and the period of post-harvest land use restriction forcompliance with the terms and conditions of authorization. Monitoring agencies also have theauthority to inspect contained facilities that may be used for the storage of regulated geneticallyengineered plant material. The trial-in-charge, or Facility-in-Charge (for storage facilities) as


appropriate, may accompany the monitoring teams on inspections; however, the coordination ofsuch activities is the responsibility of the Permitted Party.i) Post Harvest land use restriction and post harvest monitoring: In addition to ensuringreproductive isolation of the field trial site during the growing season of the confined field trial, itis also necessary to prevent the establishment of any progeny plants at the field trial site duringpost harvest period. The following precautions be implemented during this period of subsequentgrowing season effective from the date of final harvesting.1. The area under restriction must be monitored during the post-harvest period to ensure thatany prohibited plants (volunteers or sexually compatible species) are destroyed prior to flowering.2. No plants of the same or a sexually compatible species may be planted in the restrictedarea during the post-harvest period.3. Land use of the restricted area must be compatible with requirements for monitoring andremoval of prohibited plants. No plants that could interfere with monitoring for prohibited plantscan be planted.4. The restricted area is normally limited to the area of the trial site, if border rows wereused as an alternative method of reproductive isolation, and does not include the surroundingisolation area. However, if a breach of reproductive isolation occurred during the performance ofthe confined field trial, the restricted area will include the trial site and the surrounding isolationarea.j) Standard Terms and Conditions of AuthorizationThe following terms and conditions shall be strictly adhered to while conducting confined BRL-Ifield trials.1. The trials are to be conducted as per the Guidelines and Standard operating proceduresfor confined field trials of regulated GE crops 2008. (referred as Guidelines 2008) and availableon the websites i.e. http://dbtbiosafety.nic.in and http://www.igmoris.nic.in. You would ensurethat while performing the experiments, the “Recombinant DNA Safety Guidelines-1990” andRevised Guidelines for <strong>Research</strong> in transgenic plants, guidelines for confined field trials and otherfood and feed safety assessment of GE crops adopted by of the Government of <strong>India</strong> from time totime.2. The Permitted Party should conduct detailed safety assessment studies for generation ofdata as per the regulatory requirements given in “Guidance for information/ data generation anddocumentation for safety assessment of regulated, genetically engineered plants (GE) plants.3. Various protocols for different safety assessment studies, duly approved by the IBSCs ofthe Permitted Party and concerned contract research organizations (CROs), as applicable, wouldbe submitted by the Permitted Party to the RCGM for approval prior to initiating these studies.4. The Permitted Party shall ensure that genetically engineered seed and/or plant materialfor planting is transported in clearly identified, secure containers and kept separate from otherseed and/or plant material. All packing material, shipping containers, and any other materialaccompanying the genetically engineered plant material shall be treated or disposed of in such a


non-target organisms, or the environment, to RCGM/GEAC within three months after thetermination of the confined field trial.15. Monitoring agencies shall be allowed access, during regular business hours, to the placewhere regulated genetically engineered plant material is located and to any records relating to thetransportation or use of the genetically engineered plant material in a confined field trial.16. If a chemical treatment is used on the trial site that requires a time until safe entry, a signmust be posted at the access to the trial indicating the date and time of spraying as well as thetime until safe entry. This condition is intended to protect the health and safety of monitoringagencies.17. RCGM/GEAC shall be informed within the time periods and manner specified below, inthe event of the following occurrences:In the event of any accidental or unauthorized escape of genetically engineered plantmaterial and accidents, if any arising out of the experiments the Permitted Party mustnotify RCGM/GEAC immediately upon discovery in writing but positively within 24hours.If the genetically engineered plant under trial is found to have characteristics substantiallydifferent from those listed in the application or suffers any unusual occurrence, in writingas soon as possible but not later than within five days.18. The Permitted Party would keep full account of the transgenic materials and seeds, if any,set in the transgenic plants. All materials after experimentation including the seeds of the cropunder trial from the trapper rows would be fully accounted for and the information would bedocumented and preserved in a bound book that would be available to the Government as whenrequested for. The harvested crop from the border rows and leftover plant and plant parts fromentire experimental plot shall be destroyed by burning after completion of the experiment, in thepresence of the local authority.19. The Permitted Party would provide with three photographs of experimental site, takenfrom a distance sufficient to indicate the transgenic plots in a single photograph; suchphotographs would be taken at three intervals during the season to document the start of theexperiments, the mid way of the experiments and the end of the experiments. These photographswould be submitted along with the field trial report at the conclusion of the experiments.20. It is further to ensure that only company authorized personnel would be allowed to visitthe experimental plot and persons visiting the experimental plot shall enter the name, designationand purpose of visiting the experimental plot in a bound book which should be made available tothe Government when requested for.21. The Permitted Party would extend full cooperation to the authorized personnel of theGEAC/ RCGM/ CCC/ State Government Officials/ State Agriculture University or their nomineeto inspect the experimental sites and to have access, for official use only, the experimental resultsof the above.22. This BRL-I trial permit is valid for Kharif 2012 only from the date of issue and wouldlapse automatically after that period. The NOC given by Govt. of Punjab is for Kharif 2012.


23. Permitted Party/ Applicant is hereby directed to convey to the Co-Member Secretary/Member Secretary, RCGM within 15 days after the receipt of this permission an unequivocalacceptance of the above conditions along with the information asked for as above. In case, thePermitted Party does not intend to conduct the BRL-I trial, the same must also be intimated inwriting to the RCGM Secretariat.Please acknowledge the receipt of this letter.Yours faithfully,Copy for information and necessary action wherever applicable to:Sd/(K.K. Tripathi)Member Secretary, RCGM &Scientist-G, DBT1. The Secretary, Ministry of Environment and Forests, Paryavaran Bhawan, CGO Complex,Lodi Road, New Delhi - 3.2. The Secretary, Ministry of Agriculture, Krishi Bhawan, New Delhi -110 001.3. The Chairman, GEAC, MoE&F, Paryavaran Bhawan, CGO Complex, Lodi Road, ND-03.4. The Drugs Controller General (<strong>India</strong>), C.H.E.B.Campus, FDA Bhawan, Kotla Road, NewDelhi –110 002.5. The Chief Secretary, Government of Punjab, Chandigarh.6. Agriculture Commissioner, Department of Agriculture, Punjab State, Chandigarh.7. Director of <strong>Research</strong>, Punjab Agricultural University (PAU), Ludhaina, Punjab.8. Guard fileSd/(K.K. Tripathi)Member Secretary, RCGM &Scientist-G, DBT


,-'l)MAP Details of the confined field trial siteBIOSAFETY RESEARCH TRIALS LEVEL-l OF HERBICIDE TOLERANT. TRANSGENIC CORN HYBRIDS (EVENT NK603) DURING KllarifZ01Z ATPUNJAB AGRICULTURAL UNIVERSITY, LUDHIANADr. M.S. BhullarAgronomistTrial In charge name and contact Department of Agronomy1 detail: Punjab Agricultural University,Ludhiana, PunjabEmail: bhullarms@pau.eduPhone: 0161-2457160,0987281135Permit number from the regulatory RCGM approval No. BT/BS/17/44/97 dated2 authority 05.06.2012Legal or descriptive land location3 (village, taluka, district, state)Field No. 2 & 3, New E - BlockPlant Breeding Experimental Area,. Punjab Agricultural University,Ludhiana, Punjab4 Accurate distances to landmarks0.2 km W of CIPHET building. Total area planted with regulated Transgenic area = 324 sq.m.5 material Gross plot size = 2632 sq.m,678910Label all fields within the isolationareaAny field of related cropsName natural ecosystemPlanting Date:Compass directionLeveled but not planted as on dateNilForest- 1000 mNext few daysIndicated on the map.· \June 29, 2012 111I,


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