Syngenta Biosciences Pvt. Ltd - IGMORIS - Indian GMO Research ...

No. BT/BS/17/04/2000-PID Dated: 06.08.2012
To
Dr. M. Vinod Kumar
Manager, Regulatory & Govt. Affairs,
M/s. Syngenta Biosciences Pvt. Ltd.
Amar Paradigm, S.No. 110/11/13,
Baner Road, Pune – 411 045.
Subject: Application submitted for permission to conduct Biosafety Research Level-1 (BRL-I) field trials
of transgenic corn (Zea mays) hybrids at PAU Research Station, Bathinda, Punjab during Kharif 2012.
Gentleman,
This has reference to your application dated 01.02.2012 on the above mentioned subject. It is
informed that your application was considered and examined by the Review Committee on Genetic
Manipulation (RCGM) in its 110 th meeting held on 22.02.2012. The recommendations of RCGM were
forwarded to Genetic Engineering Approval Committee (GEAC) which considered it in its 116 th meeting
held on 11.04.2012. In accordance with the communication issued by the GEAC vide letter No. C-
13/7/2007-CSIII (GEAC) dated 03.05.2012, NOC received from Govt. of Punjab vide letter No. 23-
24/GM Crops dated 01.08.2012, and as per the adopted new guidelines for confined field trials, the
Member-Secretary, RCGM is communicating the approval of GEAC to conduct the confined field trial for
Biosafety Research Level I Trial (BRL-I) on transgenic corn (Zea Mays) hybrids namely NK6240 Bt
(Bt11), NK6240 (GA21) and NK6240 Stack (Bt11 x GA21) containing events Bt11, GA21 and stack of
Bt11 x GA21 at PAU Research Station, Bathinda, Punjab during Kharif 2012, subject to the following
conditions:
a) Objectives: The objectives of the trials are the following:
1. To evaluate efficacy of cry1Ab gene (Event Bt 11) in terms of level of infestation of the target
lepidopteron insect pests i.e. Chilo partellus and Sesamia inferens as well as secondary pests on
transgenic corn hybrid.
2. To study the impact of transgenic corn hybrid containing events Bt11, GA21 and stack of Bt 11 x
GA 21 against target lepidopteron pests, secondary pests and non-target insect species.
3. To evaluate weed management efficiency with Glyphosate 41% SL (IPA Salt) formulation under
field conditions and carryover on succeeding crops.
4. Comparative assessment of soil ecosystem & weediness, morphology and phenotypic characters of
transgenic corn and its conventional non-transgenic counterpart hybrids.
5. To undertake gene expression studies of transgenic event GA21 and Bt11 at different crop growth
stages.
Sampling schedule:
Sl. Period Approx. days after Plant parts for expression
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No. emergence analysis
1. Early vegetative stage 15-20 L,S
2. Grand growth stage (knee height 35-45 L,S
stage)
3. Flowering stage (taselling/silking) 65-70 L,S, Si
4. Soft dough/milky stage 90-100 L,S, E
5. Hard dough/maturity (at harvest) 110 and above R,L,S, K
The estimation of candidate proteins expressed by the inserted genes shall be quantitated in
micrograms per gram dry weight of the plant material. The plant parts to be used are fully expanded
collar leaves (L), Roots (R), Stem (S), Ear (E), Silk (Si) and Kernel (K).
6. To produce sufficient plant material to under take biosafety research on feed and food safety
studies.
7. Generation of base line susceptibility data of candidate protein on representative insect pest
population of key target lepidopteron pests i.e. Chilo partellus and Sesamia inferens collected
from various locations including the field trial sites during the growing season /trial period by
rearing them in the bioassay laboratory and also the efficacy testing of Glyphosate herbicide
application.
8. In case of non occurrence of the target insect pests during the crop growth period, efficacy study of
the gene /event at the field level may be conducted by artificial infestation of key target pests on
trial plant at 10-15 days after germination. Minimum pest load should be maintained as 1 to 3
larve per plant/ 10-15% infested plants per plot in the trial field.
9. Biosafety studies, generation of pepsin digestibility, heat/ thermal stability, acute oral toxicity data
on the purified protein are to be carried out as per the protocols/ guidelines approved by
RCGM/GEAC and available on the website i.e. http://dbtbiosafety.nic.in. Separate applications
would be submitted by the applicant to the RCGM for approval of various protocols to conduct
food and feed safety assessment and other studies.
10. DNA fingerprinting data of the hybrid/ genotype.
b) Trial-in-Charge: Dr. Paramjit Singh, PAU Research Station, Bathinda, Punjab will be the
Trial-in-Charge responsible for all aspects of the trials as informed by the applicant. The trial In-charge will
be responsible for management of the field trial, ensuring compliance with the terms and conditions of
confined field trial authorization and providing information required by regulatory bodies.
c) Trial site:
i) The Permitted Party would provide a detailed map of the confined field trial site as per Guidelines
2008 to the Member-Secretary, RCGM/ GEAC/ State Department of Agriculture/ State Agriculture
Universities/ District Authorities and other field functionaries preferably 7 working days before
sowing/planting and positively within 7 working days after sowing/planting on 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 telephone poles, fences,
alleys, roads, or steel poles.
5. Total area planted with the regulated material, including negative controls and any border or guard
rows when used (hectares or square meters).
6. Label all fields within the isolation area by the common name of the crop.
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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-harvest land use
restriction has been completed.
ii) The Permitted Party should further inform the State Department of Agriculture/SBCC/DLC and any
other concerned field functionaries, wherever applicable about full details on the confined field trial with a
copy of such intimation to RCGM/ GEAC within 7 working days of planting the trial.
d) Trial Protocol: The replicated Biosafety Research Level I Trial (BRL-I) shall be conducted in
triplicate repeats with randomized block design (RBD) at PAU Research Station, Bathinda, Punjab, 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 in term
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 acre per
trial/ per location. Further, as per Indian Minimum Seed Certification Standards, an isolation distance of
300 meters or 25 days temporal isolation should be maintained and physical barrier of 10 or 13 rows
of African Tall Maize plants covering a distance of 6 to 7.8 meters all around the experimental plot.
The Permitted Party/trial-in-charge would not plant any sexually compatible or prohibited plant to the corn
crop within the 300 meters isolation distance. It is to be ensured that the conditions for reproductive
isolation of all trial plants are met during both the current growing season and the post-harvest restriction
period of the next growing season, as per Guidelines 2008. The trial should be conducted in hot spot
areas of particular insects and where weed load is more. The transgenic corn hybrids with event
Bt11 (NK6240 Bt), GA21 (NK6240 Bt ) and stacked event with Bt11 x GA21 (NK6240 Stack) will be
evaluated along with their non-transgenic counterparts, national and local check hybrids in three
replications each. Non transgenic hybrids as control entries for comparison, against the transgenic
hybrid and guard rows of African tall maize will be planted.
birds.
The applicant should take precautionary steps to avoid the possibility of spread of seeds by
f) Records and reporting:
i) Compliance Records:
Records of all confined field trials, including pre- and post-harvest site monitoring, activities related to
trial site compliance (including subcontracts), cleaning of equipment, transportation, disposition and
storage of all surplus and harvested seed and plant material, shall be maintained and shall be made
available to RCGM/GEAC or the designated monitoring agencies upon request. Mandatory recording
formats are referenced in the RCGM/GEAC Standard Operating Procedures (SOPs) for Confined Field
Trials of Genetically Engineered Crops: Transport, Storage, Management, Harvest or Termination and
Post Harvest Management and can be downloaded from http://www.igmoris.nic.in.
ii) Field Trial Report:
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The Permitted Party shall submit a field trial report through trial-in-charge to RCGM/GEAC within three
months after termination/harvest of the confined field trials. The field trial reports must summarize the
completed trial, including methods, observations, data and analysis of any effects of the trial plants on
other plants, non-target organisms, or the environment.
iii) Mandatory Information Submissions by Applicant/Permitted Party:
Planting Information Submission: RCGM and GEAC shall be informed in writing within 7 working
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 material
remaining after planting shall be submitted to RCGM and GEAC.
Harvest Information Submission: A Record of Harvest/Termination shall be prepared for each
confined field trial site and shall document the date and method of harvest, the amount of harvested
material, the disposition of any harvested materials, the cleaning of any equipment used during
harvest, and the method of destruction of any residual plant material on the trial site. This record must
be 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 during harvest, or within 15
days of the completion of harvest.
Accidental Release Information: The Permitted Party/trial-in-charge shall notify RCGM/GEAC
positively within 24 hours of discovery of any incident involving an accidental or unauthorized escape
like spillage, theft, encroachment by unauthorized persons, vandalization etc. of regulated GE plant
material during transportation, storage within a contained facility, or during any other activity
associated with the conduct of a confined field trial, in writing (submission to be received by
RCGM/GEAC by facsimile, e-mail or other means). As per the Guidelines 2008, any breach of the
authorized terms and conditions of reproductive isolation shall be considered an accidental release and
subject to risk assessment and 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 testing exhibit any
characteristics substantially different from those known for the host plant species i.e. its non-GM
counterpart, or anticipated and listed in the application, or suffers any unusual occurrence, the
Permitted Party/trial-in-charge shall notify RCGM/GEAC in writing within five (5) days of such
observations.
g) Disposition of Material from confined field trials: No harvested material or byproduct from a
confined field trial, under any circumstances, may be used as human food or livestock feed. Seed or other
plant material harvested from confined trials authorized by RCGM/GEAC to be retained for future
research work and must be disposed of by a method given in the Guidelines 2008 (e.g., dry heat, steam
heat, incineration, deep burial, chemical treatment, or crushing or burying on the trial site). Progeny from
any confined field trial cannot be retained for future planting without prior written authorization from
RCGM/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 the trial
site at least ONCE EVERY TWO WEEKS from the time of planting until the time of harvest of the trial.
This monitoring has to be recorded in a bound book provided by the Permitted Party as per the formats
given in the Guidelines 2008. The record of spatial isolation will be used to document all monitoring and
field activities needed to demonstrate reproductive isolation of the trial site. The growth and stage of any
prohibited plant found within the isolation distance of the trial site should be recorded during monitoring.
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Members of the CCC, monitoring teams of SAUs or any other authorized party by RCGM/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 for compliance with the terms and
conditions of authorization. Monitoring agencies also have the authority to inspect contained facilities that
may be used for the storage of regulated genetically engineered 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 of such activities is the responsibility of the Permitted Party.
i) Post Harvest land use restriction and post harvest monitoring: In addition to ensuring
reproductive isolation of the field trial site during the growing season of the confined field trial, it is also
necessary to prevent the establishment of any progeny plants at the field trial site during post harvest
period. The following precautions be implemented during this period of subsequent growing season
effective from the date of final harvesting.
1. The area under restriction must be monitored during the post-harvest period to ensure that any
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 restricted area during the
post-harvest period.
3. Land use of the restricted area must be compatible with requirements for monitoring and removal of
prohibited 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 an
alternative 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 Authorization
The following terms and conditions shall be strictly adhered to while conducting confined BRL-I field
trials.
1. The trials are to be conducted as per the Guidelines and Standard operating procedures for
confined field trials of regulated GE crops 2008. (referred as Guidelines 2008) and available on the
websites i.e. http://dbtbiosafety.nic.in and http://www.igmoris.nic.in. You would ensure that while
performing the experiments, the “Recombinant DNA Safety Guidelines-1990” and Revised Guidelines for
Research in transgenic plants, guidelines for confined field trials and other food and feed safety assessment
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 as per
the regulatory requirements given in “Guidance for information/ data generation and documentation for
safety assessment of regulated, genetically engineered plants (GE) plants.
3. Various protocols for different safety assessment studies, duly approved by the IBSCs of the
Permitted Party and concerned contract research organizations (CROs), as applicable, would be 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 material for planting is
transported in clearly identified, secure containers and kept separate from other seed and/or plant material.
All packing material, shipping containers, and any other material accompanying the genetically engineered
plant material shall be treated or disposed of in such a manner so as to prevent the dissemination and
establishment of this material or any progeny plants.
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5. In the case of accidental release or spillage of genetically engineered plant material during transport,
recoverable seeds or seedlings shall be collected and rendered non-viable and disposed of, the site 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 of before
flowering.
6. Any equipment or tools used during planting shall be cleaned on the trial site prior to movement off the
site in order to remove residual plant material. Surplus seed, transplants, or other plant material remaining
after planting, or recovered during the cleaning of equipment, shall be rendered non-viable and disposed 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- and postharvest
site monitoring, activities related to trial site compliance (including subcontracts), cleaning of
equipment, transportation, and disposition and storage of all surplus and harvested seed and plant material.
8. Planting information shall be submitted to RCGM/GEAC within 7 working days following the
completion of planting at a trial site. This notification must also include a detailed map of the trial site if it
was not provided with the original application.
9. The Permitted Party shall maintain adequate records of all confined field trials, including pre- and postharvest
site monitoring, activities related to trial site compliance (including subcontracts), cleaning of
equipment, transportation, and disposition and storage of all surplus and harvested seed and plant material.
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 the
application and previously authorized by RCGM/GEAC. Any harvested seed and/or plant material must 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 harvested materials,
the disposition of harvested materials, the cleaning of any equipment used during harvest, and the method
of destruction of any residual plant material on the trial site, shall be prepared by the Permitted Party for
verification and signature by monitoring agency. This harvest inspection shall occur either 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 advance
of 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 observations and
data, methods of observation, and analysis of any deleterious effects on plants, non-target organisms, or
the environment, to RCGM/GEAC within one months after the termination of the confined field trial.
15. Monitoring agencies shall be allowed access, during regular business hours, to the place where
regulated genetically engineered plant material is located and to any records relating to the transportation
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 sign must be
posted 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.
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17. RCGM/GEAC shall be informed within the time periods and manner specified below, in the event of
the following occurrences:
In the event of any accidental or unauthorized escape of genetically engineered plant material and
accidents, if any arising out of the experiments the Permitted Party must notify RCGM/GEAC
immediately upon discovery in writing but positively within 24 hours.
If the genetically engineered plant under trial is found to have characteristics substantially different
from those listed in the application or suffers any unusual occurrence, in writing as 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 crop under trial from
the trapper rows would be fully accounted for and the information would be documented and preserved in
a bound book that would be available to the Government as when requested for. The harvested crop from
the border rows and leftover plant and plant parts from entire experimental plot shall be destroyed by
burning 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 a
distance sufficient to indicate the transgenic plots in a single photograph; such photographs would be taken
at three intervals during the season to document the start of the experiments, the mid way of the
experiments and the end of the experiments. These photographs would 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 visit the
experimental plot and persons visiting the experimental plot shall enter the name, designation and purpose
of visiting the experimental plot in a bound book which should be made available to the Government when
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 the
experimental sites and to have access, for official use only, the experimental results of the above.
22. This BRL-I trial permit is valid for Kharif 2012 only from the date of issue and would lapse
automatically after that period.
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 unequivocal acceptance of the
above conditions along with the information asked for as above. In case, the Permitted Party does not
intend 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.
Yours faithfully,
Copy for information and necessary action wherever applicable to:
Sd/-
(K.K. Tripathi)
Member Secretary, RCGM &
Scientist-G, DBT
1. The Secretary, Ministry of Environment and Forests, Paryavaran Bhawan, CGO Complex, Lodi
Road, New Delhi - 3.
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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 (India), C.H.E.B.Campus, FDA Bhawan, Kotla Road, New Delhi –
110 002.
5. The Chief Secretary, Government of Punjab, Chandigarh.
6. Agriculture Commissioner, Department of Agriculture, Punjab State, Chandigarh.
7. Joint Director Agri. (HYVP), Directorate of Agriculture, Govt. of Punjab, SCO 85-88, Sector 34A,
Chandigarh
8. Director of Research, Punjab Agricultural University (PAU), Ludhaina, Punjab-141 004.
9. Guard file
Sd/-
(K.K. Tripathi)
Member Secretary, RCGM &
Scientist-G, DBT
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