E.I. Dupont India Pvt. Ltd. - IGMORIS - Indian GMO Research ...

No. BT/BS/17/255/2007-PID Dated: 24.12.2012ToDr. Ajin MandaokarM/s. E.I. DuPont India Pvt. Ltd.DuPont Knowledge Center,ICICI Knowledge Park, Genome Valley,Survey No. 542/2, DS-9,Turkapally Village, Shameerpet Mandal,R.R. District, Hyderabad – 500 078.Subject: Application submitted for permission to conduct confined field trial for event selection of 13 SPTtransgenic Rice (Oryza sativa L.) events containing Zm-AA1, Os-Msca1 and DsRed2 genes atKoppulapally village, Yeldurti mandal, Medak District, Andhra Pradesh in the appropriateseason in 2012.Gentleman,This has reference to your application dated 12.09.2011 on the above mentioned subject. It isinformed that your application was considered and examined by the Review Committee on GeneticManipulation (RCGM) in its 109 th meeting held on 24.01.2012. The recommendations of RCGM wereforwarded to Genetic Engineering Approval Committee (GEAC) which considered it in its 115 th meetingheld on 08.02.2012. In accordance with the communication issued by the GEAC vide letter No.13/7/2007-CS-III (GEAC) dated 02.03.2012, NOC received from Govt. of A.P. vide letter No. SRCell(2) 722/09 dated 16.10.2012, and as per the adopted new guidelines for confined field trials, theMember-Secretary, RCGM is communicating the approval of GEAC to conduct confined field trial forevent selection of transgenic rice (Oryza sativa L.) three SPT1 events (generated using SPT1 construct),namely JH04, JH02, DKC45 of BC5 generation and ten SPT6 events using SPT6 construct i.e. J6-1-105h,J6-1-126c, J6-1-129d, J6-1-130, J6-1-139c, J6-1-142d, J6-1-76-3a, J6-2-16c, J6-3-31-4c, J6-4-M-1a ofBC4 generation containing Zm-AA1, Os-Msca1 and DsRed2 genes at Koppulapally village, YeldurtiMandal, Medak District, Andhra Pradesh in Rabi season 2012; subject to the following conditions:a) Objectives: The objectives of the trials are generation of data on the following:i) To assess the frequency of transgene transmission through pollen in different events.ii) To assess the seed producibility of the events.iii) To evaluate the expression levels of DsRed2 and ZM-AA 1 proteins in tissues of Rice SPTmaintainer events.b) Trial-in-Charge: The name of the Trial-in-Charge responsible for all aspects of the trials will beDr. Debanajan Sanyal, as informed by applicant. The Trial-in-Charge will be responsible formanagement of the field trial, ensuring compliance with the terms and conditions of confined field trialauthorization and providing information required by regulatory bodies.c) Trial site:i) You would provide information on the trial site indicating the state/ district wise details of locations(area, village, name of the farmer in case of lease land on long term basis) along with a detailed map of

the confined field trial site to the Member-Secretary, RCGM/ GEAC/ State Department of Agriculture/State Agriculture Universities/ District Authorities and other field functionaries preferably 7 working daysbefore sowing/planting and positively within 7 working days after sowing/planting of 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)4. Accurate distances to physical landmarks or surrounding landmarks such as telephone poles,fences, alleys, roads, or steel poles.5. Total area planted with the regulated material, including negative controls and any border or guardrows 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 after the period of post-harvestland use restriction has been completed.ii) The Permitted Party should further inform the State Department of Agriculture/SBCC/DLC andany other concerned field functionaries, wherever applicable about full details on the confined field trialwith a copy of such intimation to RCGM/ GEAC within 7 working days of planting the trial.d) Trial Protocol: While conducting confined field trials for Event Selection, you are directed toinclude the following:i) The Event Selection trial shall be conducted in triplicate repeats with randomized block design(RBD) for 3 SPT1 events and 10 SPT6 events in single replicate on long leased land at Survey No. 22, 24and 25, Koppulapally Village, Yeldurti Mandal, Medak District, Andhra Pradesh in South Zone tokeep the research trials confined.e) Trial size and reproductive Isolation: The experimental area should not be more than one acreper trial/ per location. An isolation distance of 10 meters from the last row of transgenic plant on allfour sides will be maintained (as the events are in inbred background and not in hybrid) oftransgenic rice would be maintained by erecting physical barrier all around the experimental plot. Youshall further plant at least 5 rows of the non-transgenic counterparts (VIR54G9) to act as refugia at theimmediate vicinity around the periphery of the outer transgenic plant rows all around the plot.To prevent their establishment and spread within the environment, regulated GE plants within a confinedtrial must be reproductively isolated from sexually compatible plant species in proximity to the trial site,and any progeny plants that arise on the trial site after completion of the trial must be eliminated. It is tobe ensured that the conditions for reproductive isolation of all trial plants are met during the currentgrowing season and the post-harvest period.It may also be ensured that the plants in the border rows flower concurrently with the plants in theconfined field trial. If any of the trial plants flower before the onset of flowering of pollen trap row plants,

or if any of the trial plants have not completed flowering after the pollen trap row plants have completedthis stage, a breach of border row isolation will have occurred. All plants within the border row area mustbe disposed of in the same manner as the regulated trial plants. The border row area will be subject to thesame conditions of post-harvest land use restriction and monitoring as the trial site proper.f) Records and reporting:i) Compliance RecordsRecords 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://igmoris.nic.in/.ii) Field Trial ReportThe Permitted Party shall submit a field trial report to RCGM/GEAC within 3 months aftertermination/harvest of a confined field trial. The field trial report must summarize the completed trial,including methods, observations, data and analysis of any effects of the trial plants on other plants, nontargetorganisms, or the environment.iii) Mandatory Information Submissions by ApplicantPlanting Information Submission: RCGM/GEAC shall be informed in writing within 7 workingdays of planting at a trial site. A Record of Planting shall be submitted and must reference theconfined trial permit number, document the amount of material planted, the planting date, thetransportation of plant material to the trial site, the cleaning of any equipment used during planting,and the disposition of any surplus plant material remaining after planting.Harvest Information 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 ofRCGM/GEAC/SBCC/DLC/SAU authorized by RCGM/GEAC during the conduct of a trial siteinspection during harvest, or within 15 days of the completion of harvest.Accidental Release Information: The Permitted Party shall notify RCGM/GEAC immediatelyupon discovery by telephone but positively within 24 hours in writing (submission to be received byRCGM/GEAC within 24 hours by facsimile, e-mail or other means) 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 a containedfacility, or during any other activity associated with the conduct of a confined field trial. For thepurposes of these Guidelines, any breach of the authorized terms and conditions of reproductiveisolation shall be considered an accidental release and subject to risk assessment and management ifany at the cost of the applicant or 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, or anticipated andlisted in the application, or suffers any unusual occurrence, the Permitted Party shall notifyRCGM/GEAC in writing within five (5) days of such observations.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.2. No plants of the same or a sexually compatible species may be planted in the restricted area during thepost-harvest period.3. Land use of the restricted area must be compatible with requirements for monitoring and removal ofprohibited plants. No plants that could interfere with monitoring for prohibited plants can be planted.4. The restricted area is normally limited to the area of the trial site, if border rows were used as analternative method of reproductive isolation, and does not include the surrounding isolation area.However, if a breach of reproductive isolation occurred during the performance of the confined field trial,the restricted area will include the trial site and the surrounding isolation area.

J. Standard Terms and Conditions of AuthorizationThe following terms and conditions shall be strictly adhered to while conducting confined field trials.1. The trials are to be conducted as per the Guidelines and Standard operating procedures forconfined field trials of regulated GE crops 2008. (referred as Guidelines 2008) and available on thewebsites i.e. http://dbtbiosafety.nic.in and http://www.igmoris.nic.in. You would ensure that whileperforming the experiments, the “Recombinant DNA Safety Guidelines-1990” and Revised Guidelinesfor Research in transgenic plants, guidelines for confined field trials and other food and feed safetyassessment of GE crops adopted by of the Government of India from time to time.2. The Permitted Party should conduct detailed safety assessment studies for generation of data asper the regulatory requirements given in “Guidance for information/ data generation and documentationfor safety assessment of regulated, genetically engineered plants (GE) plants.3. Various protocols for different safety assessment studies, duly approved by the IBSCs of thePermitted Party and concerned contract research organizations (CROs), as applicable, would be submittedby 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 material forplanting is transported in clearly identified, secure containers and kept separate from other seed and/orplant material. All packing material, shipping containers, and any other material accompanying thegenetically engineered plant material shall be treated or disposed of in such a manner so as to prevent thedissemination and establishment of this material or any progeny plants.5. In the case of accidental release or spillage of genetically engineered plant material duringtransport, recoverable seeds or seedlings shall be collected and rendered non-viable and disposed of, thesite shall be marked and monitored, and a notification shall be immediately provided to RCGM/GEAC.Any plants arising from unrecoverable seed or seedlings must be rendered non-viable and disposed ofbefore flowering.6. Any equipment or tools used during planting shall be cleaned on the trial site prior to movementoff the site in order to remove residual plant material. Surplus seed, transplants, or other plant materialremaining after planting, or recovered during the cleaning of equipment, shall be rendered non-viable anddisposed of using a method acceptable to RCGM/GEAC such as: dry heat, steam heat, incineration,crushing, deep burial to one metre on the trial site, or chemical treatment.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 in theapplication and previously authorized by RCGM/GEAC. Any harvested seed and/or plant material mustbe 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 harvested materials,the disposition of harvested materials, the cleaning of any equipment used during harvest, and the methodof destruction of any residual plant material on the trial site, shall be prepared by the Permitted Party forverification and signature by monitoring agency. This harvest inspection shall occur either during harvestor 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, including observationsand data, methods of observation, and analysis of any deleterious effects on plants, non-target organisms,or the environment, to RCGM/GEAC within three months after the termination of the confined 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 the event ofthe following occurrences:a. 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.b. If the genetically engineered plant under trial is found to have characteristics substantially differentfrom those listed in the application or suffers any unusual occurrence, in writing as soon as possible butnot 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 confined field trial for event selection is valid for the Rabi season 2012 only from the dateof issue and would lapse automatically after above period.23. You are hereby directed to convey to the Co-Member Secretary/ Member Secretary, RCGMwithin 15 days after the receipt of this permission your unequivocal acceptance of the above conditionsalong with the information asked for as above. In case, you don’t intend to conduct the confined fieldtrials for Event Selection, 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/-(S.R. Rao)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 Director General, Indian Council of Agricultural Research, Krishi Bhawan, New Delhi -110 001.5. The Chief Secretary & Chairman, SBCC, Govt. of Andhra Pradesh, Secretariat, Hyderabad, A.P.6. Commissioner & Director of Agriculture, Department of Agriculture, GoAP, Hyderabad.7. The Principal Secretary to Govt. of A.P., Department of Agriculture & Cooperation (Agri.III),Govt. of A.P., Hyderabad.8. Director of Research, Acharya N.G. Ranga Agricultural University, (ANGRAU), RajendraNagar, Hyderabad, A.P.9. Guard file.Sd/-(S.R. Rao)Scientist-G, DBT