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

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CCSHAU, Hisar, Haryana to keep the research trials confined. While conducting confined BRL-I trials,permitted party/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 the genes interm of productivity of the transgenic corn, germination, weediness, aggressiveness and other parameters.e) Trial size and reproductive Isolation: The experimental area should not be more than one acreper trial/ per location. Further, as per <strong>India</strong>n Minimum Seed Certification Standards, an isolation distanceof 300 meters and physical barrier of 10 or 13 rows of African Tall Maize plants covering a distanceof 6 to 7.8 meters all around the experimental plot. The Permitted Party/trial-in-charge would not plantany sexually compatible or prohibited plant to the corn crop within the 300 meters isolation distance. It isto be ensured that the conditions for reproductive isolation of all trial plants are met during both thecurrent growing season and the post-harvest restriction period of the next growing season, as perGuidelines 2008.birds.The applicant should take precautionary steps to avoid the possibility of spread of seeds byf) Records and reporting:i) Compliance Records:Records of all confined field trials, including pre- and post-harvest site monitoring, activities related totrial site compliance (including subcontracts), cleaning of equipment, transportation, disposition andstorage of all surplus and harvested seed and plant material, shall be maintained and shall be madeavailable to RCGM/GEAC or the designated monitoring agencies upon request. Mandatory recordingformats are referenced in the RCGM/GEAC Standard Operating Procedures (SOPs) for Confined FieldTrials of Genetically Engineered Crops: Transport, Storage, Management, Harvest or Termination andPost Harvest Management and can be downloaded 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/GEAC withinthree months after termination/harvest of the confined field trials. The field trial reports must summarizethe completed trial, including methods, observations, data and analysis of any effects of the trial plants onother 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 permit number,the amount of material planted, the planting date, the transportation of plant material to the trial site,the cleaning of any equipment used during planting, and the disposition of any surplus plant materialremaining after planting shall be submitted to RCGM and GEAC.Harvest <strong>Information</strong> Submission: A Record of Harvest/Termination shall be prepared for eachconfined field trial site and shall document the date and method of harvest, the amount of harvestedmaterial, the disposition of any harvested materials, the cleaning of any equipment used duringharvest, and the method of destruction of any residual plant material on the trial site. This record mustbe verified and signed by a member of the Monitoring Agency or any nominee of


RCGM/GEAC/SAU authorized by RCGM/GEAC during the conduct of a trial site inspection duringharvest, or within 15 days of the completion of harvest.Accidental Release <strong>Information</strong>: The Permitted Party/trial-in-charge shall notify RCGM/GEACpositively within 24 hours of discovery of any incident involving an accidental or unauthorizedescape like spillage, theft, encroachment by unauthorized persons, vandalization etc. of regulated GEplant material during transportation, storage within a contained facility, or during any other activityassociated with the conduct of a confined field trial, in writing (submission to be received byRCGM/GEAC by facsimile, e-mail or other means). As per the Guidelines 2008, any breach of theauthorized terms and conditions of reproductive isolation shall be considered an accidental releaseand subject to risk assessment and management, if any, is to be carried out at the cost of the applicantor Permitted Party.Other Submissions : In the event that the plants undergoing confined field trial testing exhibit anycharacteristics substantially different from those known for the host plant species i.e. its non-GMcounterpart, or anticipated and listed in the application, or suffers any unusual occurrence, thePermitted Party/trial-in-charge shall notify RCGM/GEAC in writing within five (5) days of suchobservations.g) Disposition of Material from confined field trials: No harvested material or byproduct from aconfined field trial, under any circumstances, may be used as human food or livestock feed. Seed or otherplant material harvested from confined trials authorized by RCGM/GEAC to be retained for futureresearch work and must be disposed of by a method given in the Guidelines 2008 (e.g., dry heat, steamheat, incineration, deep burial, chemical treatment, or crushing or burying on the trial site). Progeny fromany confined field trial cannot be retained for future planting without prior written authorization fromRCGM/GEAC, and this must be specifically requested in the field trial application.h) Monitoring of Confined Field Trials: The trial-in-charge or his/her designate must monitor thetrial site at least ONCE EVERY TWO WEEKS from the time of planting until the time of harvest of thetrial. This monitoring has to be recorded in a bound book provided by the Permitted Party as per theformats given in the Guidelines 2008. The record of spatial isolation will be used to document allmonitoring and field activities needed to demonstrate reproductive isolation of the trial site. The growthand stage of any prohibited plant found within the isolation distance of the trial site should be recordedduring monitoring.Members of the CCC, monitoring teams of SAUs or any other authorized party by RCGM/GEAChave 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 for compliance with the terms andconditions of authorization. Monitoring agencies also have the authority to inspect contained facilities thatmay be used for the storage of regulated genetically engineered plant material. The trial-in-charge, orFacility-in-Charge (for storage facilities) as appropriate, may accompany the monitoring teams oninspections; however, the coordination of such 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, it is alsonecessary to prevent the establishment of any progeny plants at the field trial site during post harvestperiod. The following precautions be implemented during this period of subsequent growing seasoneffective from the date of final harvesting.1. The area under restriction must be monitored during the post-harvest period to ensure that anyprohibited plants (volunteers or sexually compatible species) are destroyed prior to flowering.


7. The Permitted Party shall maintain adequate records of all confined field trials, including pre- andpost-harvest site monitoring, activities related to trial site compliance (including subcontracts), cleaningof equipment, transportation, and disposition and storage of all surplus and harvested seed and plantmaterial.8. Planting information shall be submitted to RCGM/GEAC within 7 working days following thecompletion of planting at a trial site. This notification must also include a detailed map of the trial site if itwas not provided with the original application.9. The Permitted Party shall maintain adequate records of all confined field trials, including pre- andpost-harvest site monitoring, activities related to trial site compliance (including subcontracts), cleaningof equipment, transportation, and disposition and storage of all surplus and harvested seed and plantmaterial.10. No seed or other plant material from the confined field trial may enter the food or feed chains.11. Harvested seed and/or plant material from the confined trial may only be retained if requested inthe application and previously authorized by RCGM/GEAC. Any harvested seed and/or plant materialmust be clearly labelled, securely transported, and stored separately from other seed and/or plant material.12. A record of harvest documenting the date and method of harvest, the amount of harvestedmaterials, the disposition of harvested materials, the cleaning of any equipment used during harvest, andthe method of destruction of any residual plant material on the trial site, shall be prepared by thePermitted Party for verification and signature by monitoring agency. This harvest inspection shall occureither during harvest or within 15 days of the completion of harvest.13. The Permitted Party/trial-in-charge shall notify RCGM/GEAC in writing at least 15 days in advanceof planting any plant species on the trial site during the post-harvest period.14. The Permitted Party shall submit a report summarizing the completed trial, includingobservations and data, methods of observation, and analysis of any deleterious effects on plants, nontargetorganisms, or the environment, to RCGM/GEAC within three months after the termination of theconfined field trial.15. Monitoring agencies shall be allowed access, during regular business hours, to the place whereregulated genetically engineered plant material is located and to any records relating to the transportationor 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 sign must beposted at the access to the trial indicating the date and time of spraying as well as the time until safe entry.This condition is intended to protect the health and safety of monitoring agencies.17. RCGM/GEAC shall be informed within the time periods and manner specified below, in theevent of the following occurrences:In the event of any accidental or unauthorized escape of genetically engineered plant material andaccidents, if any arising out of the experiments the Permitted Party must notify RCGM/GEACimmediately upon discovery in writing but positively within 24 hours.


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 writing as soonas 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 inthe transgenic plants. All materials after experimentation including the seeds of the crop under trial fromthe trapper rows would be fully accounted for and the information would be documented and preserved ina bound book that would be available to the Government as when requested for. The harvested crop fromthe border rows and leftover plant and plant parts from entire experimental plot shall be destroyed byburning after completion of the experiment, in the presence of the local authority.19. The Permitted Party would provide with three photographs of experimental site, taken from adistance sufficient to indicate the transgenic plots in a single photograph; such photographs would betaken at three intervals during the season to document the start of the experiments, the mid way of theexperiments and the end of the experiments. These photographs would be submitted along with the fieldtrial report at the conclusion of the experiments.20. It is further to ensure that only company authorized personnel would be allowed to visit theexperimental plot and persons visiting the experimental plot shall enter the name, designation and purposeof visiting the experimental plot in a bound book which should be made available to the Governmentwhen requested for.21. The Permitted Party would extend full cooperation to the authorized personnel of the GEAC/RCGM/ CCC/ State Government Officials/ State Agriculture University or their nominee to inspect theexperimental sites and to have access, for official use only, the experimental results of the above.22. This BRL-I trial permit for Haryana is valid for appropriate seasons in 2012-13 only from thedate of issue and would lapse automatically after that period, as the NOC given by Govt. of Haryana is forthe year 2012-13.23. Permitted Party/ Applicant is hereby directed to convey to the Co-Member Secretary/ MemberSecretary, RCGM within 15 days after the receipt of this permission an unequivocal acceptance of theabove conditions along with the information asked for as above. In case, the Permitted Party does notintend to conduct the BRL-I trial, the same must also be intimated in writing to the RCGM Secretariat.Please acknowledge the receipt of this letter.Copy for information and necessary action wherever applicable to:Yours faithfully,Sd/-(K.K. Tripathi)Member Secretary, RCGM &Scientist-G, DBT1. The Secretary, Ministry of Environment and Forests, Paryavaran Bhawan, CGO Complex, LodiRoad, 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, New Delhi –110002.


5. The Chief Secretary, Government of Haryana, Chandigarh.6. Agriculture Commissioner, Department of Agriculture, Haryana State, Chandigarh.7. Director of <strong>Research</strong>, Choudhary Charan Singh Haryana Agricultural University (CCSHAU), Hissar,Haryana.8. District Collector/ Chairman, DLC, Karnal, Haryana.9. Guard fileSd/-(K.K. Tripathi)Member Secretary, RCGM &Scientist-G, DBT

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