New Delhi, India
November 9, 2007
The 80th meeting of
the Genetically Engineering Approval Committee (GEAC) was
held on 1.10.2007 in the Ministry of Environment and Forests
under the Chairmanship of Shri B. S. Parsheera, Additional
Secretary, MoEF and Chairman, GEAC.
[excerpts relevant to seed
professionals]
Full report:
http://www.envfor.nic.in/divisions/csurv/geac/decision-sep-80.htm
3.0 Action taken report
1.0 The Member Secretary, GEAC informed the Committee that
decisions taken in the meeting held on 8.8.2007 have been
communicated to the project proponents, concerned government
departments and other agencies. Details of action taken were
placed before and noted by the Committee.
2.0 The Committee further considered the communication received
from Dr. Mathura Rai, Director, IIVR, Varanasi regarding the
progress made in the large scale field trials of Bt Brinjal and
briefly discussed the constraints in conducting the pollen flow
studies in the IIVR/ICAR institutions due to non availability of
land. It was noted that 240 acres (approx 100 ha) of land per
location is required for conducting pollen flow studies. The
Committee considered the two options suggested by Director IIVR
viz; (i) either reduce the number of locations from 6 to 3 or
(ii) redesign the protocol for pollen flow studies. The expert
members were of the view that 2-3 locations are adequate for
assessing the pollen flow. The committee therefore recommended
that pollen flow studies may be conducted at a minimum of 3
locations in different agro-climatic zones within the
institution research farm of the Company or long leased land
(minimum of 3 years lease) or SAU research farms under the
supervision of Director IIVR.
3.0 The Committee also took note of the clarifications forwarded
by Member Secretary, RCGM to Dr. Mathura Rai in response to the
representation from M/s Greenpeace and endorsed the same. The
Committee requested Member Secretary GEAC to issue a
communication in this regard to Director IIVR.
4.0 The representative of Ministry of Food processing and
Industry informed the Committee that the department does not
have adequate expertise to evaluate the adverse impact on health
(if any) arising from LMOs and products thereof. The Committee
clarified that import of GM food / seeds which can propagate in
the environment would require prior approval of GEAC. In case of
processed food, the mandate would fall under the purview of Food
Safety and Standard Act, 2006 which is being implemented by the
Ministry of Health and Family Welfare. In response to a query
raised by the representative of Ministry of Food processing and
Industry regarding the mechanism for evaluating the food safety
in processed food it was clarified that if the product is
approved for human consumption in the country of origin,
food-feed safety dossier generated in the country of origin may
form the basis for initial evaluation. The Committee requested
Member Secretary GEAC to forward a copy of the Gazette
notification (S.O. 1519(E) dated 11.9.2007) exempting food/ food
stuffs/ ingredients derived from LMO where the end product is
not an LMO from the purview of the GEAC to the concerned
ministries/ department along with a brief note on the same.
5.0 Member Secretary GEAC further informed that in Writ Petition
(Civil) No. 115/2004 filed by M/s Gene Campaign vs UoI, the
Hon’ble Supreme Court has advised that the suggestions made by
the Petitioner regarding improvement in the regulatory system as
well as names of Experts to be consulted may be forwarded to the
appropriate authority. The Committee opined that DBT is in the
process of setting up the NBRA and modality for implementation
of the same is under active consideration of the Govt.
Therefore, suggestions made by the Petitioner including names of
some of the members who may be consulted in the formulation of a
robust regulatory mechanism, may be forwarded to DBT for
consideration to incorporate in the NBRA regulatory mechanism,
as considered appropriate.
Agenda Item No 4: Consideration of New Proposals
[...]
C. Transgenic crops
4.5 Permission to conduct Large Scale trials on Bt Brinjal
hybrids SBJ 1 Bt, SBJ 2 Bt SBJ 4 Bt, SBJ 6 Bt, SBJ 7 Bt and SBJ
8 Bt expressing cry 1Ac gene by M/s Sungro Seeds Research Ltd.
Delhi.
4.5.1 The Committee considered the request from M/s Sungro Seeds
Research Ltd. for Large Scale trials of Six Bt Brinjal hybrids
namely SBJ 1 Bt, SBJ 2 Bt SBJ 4 Bt, SBJ 6 Bt, SBJ 7 Bt and
SBJ 8 Bt expressing cry 1Ac gene. Transgenic seeds of Bt.
brinjal event developed by M/s Mayhco were transferred to Sungro
Seeds Ltd. vide transfer clearance letter no.
BT/BS/17112/2003-PID dated 8.12.2003 for introgression into
their genotypes by traditional back crossing method.
4.5.2 The Committee was of the view that the Bt brinjal hybrids
developed by the parent company namely M/s Mahyco is still under
review and therefore the present request cannot be considered at
this stage.
4.6 Permission to conduct confined Multi Location Research
Trial (MLRT) on 2 Bt cabbage hybrids namely SCB-3 Bt and SCB-7
Bt expressing cry1Ac gene by conducting Multi Location Research
Trial (MLRT) during Rabi 2007 by M/s. Sungro Seeds Research
Ltd., New Delhi
4.6.1 The Committee noted that the Hon’ble Supreme Court
directions dated 8.5.200, in respect of field trials of GM crops
with new events was specific to the 24 items approved by the
GEAC during 1.5.2006 to 22.9.2006. The transgenic crops approved
for MLRT during this period includes rice, okra, groundnut,
potato, tomato, brinjal, castor, cauliflower, mustard and
cotton. As Bt cabbage is not listed in the 24 items approved by
the GEAC during 1.5.2006 to 22.9.2006, the request for MLRT
cannot be considered without informing the Hon’ble Supreme
Court. The Member Secretary GEAC informed the Committee that an
application for modification of the Court orders dated 8.5.2007
has been filed by the UoI. As the applicant has completed the
requisite regulatory testing and evaluation process, the
Committee opined that subject to the outcome of the Hon’ble
Supreme Court decision, the proposal for MLRT with Bt cabbage
may be approved subject to the following conditions:
1. The applicant should submit to the RCGM/GEAC the name of the
Lead Scientist responsible for the trials before undertaking the
trials.
2. The applicant should submit to the RCGM/GEAC an event
specific test protocol duly validated/ verified by ICGEB, New
Delhi / NBRI, Lucknow or any other accredited laboratory before
undertaking the trials.
3. An isolation distance of minimum 200 m shall be maintained.
In cases where the Seed Standards Certification mandates a
larger isolation distance, the same shall be maintained.
4. The MLRT shall not be conducted in farmers’ field. MLRT
should be undertaken by the Companies/Institutions either in
their own premises, research farms, long leased land (a minimum
of three years lease) or at the SAU/ICAR institutions.
4.7 Permission to conduct contained limited field research
trial (strip trial) with transgenic tomato (cv. Pusa. Ruby)
expressing antisense ACC synthase gene at the IARI, New Delhi
during Rabi season (Oct.-2007 to April-2008) by National
Research Centre on Plant Biotechnology, IARI, New Delhi.
4.7.1 The Committee considered the above proposal and noted that
the RCGM in its meeting held on 3.9.2007 has recommended the
strip trial with transgenic tomato subject to the following
conditions-.
1 Strip trials, for new events should be undertaken by the
Companies/ Institutions in their own premises/ research farms.
In accordance with the Hon’ble Supreme Court directions an
isolation distance of 200 m should be maintained
2- The applicant should submit a validated event specific test
protocol before undertaking the rials.
4.7.2 After detailed deliberations the GEAC approved the request
for strip trials subject to the following conditions:
1. The applicant should submit to the RCGM/GEAC the name of the
Lead Scientist responsible for the trials before undertaking the
trials.
2. The applicant should submit to the RCGM/GEAC an event
specific test protocol duly validated/ verified by ICGEB, New
Delhi / NBRI, Lucknow or any other accredited laboratory before
undertaking the trials.
3. An isolation distance of minimum 200 m shall be maintained.
In cases where the Seed Standards Certification mandates a
larger isolation distance, the same shall be maintained.
4. The Strip trials shall not be conducted in farmers’ field.
Strip trials should be undertaken by the Companies/Institutions
in their own premises or research farms.
5.0 Other Items
5.1 Permission for commercial release of Bt cotton hybrids
namely 113 Bt and 302 Bt expressing cry 1 Ac gene (MON- 531) in
the South zone by M/s Bioseed Research India Pvt. Ltd.
&
5.2 Permission for commercial release ACH 21-1 expressing cry 1
Ac gene (MON-531) in the Central zone by M/s Ajeet Seeds Ltd.
&
5.3 Permission to conduct Strip trial of 40 F1 Bt cotton hybrids
namely TPHCN07-011 to TPHCN07-050 under contained open field
condition at RJ Biotech’s Research farm by M/s. RJ Biotech,
Aurangabad.
&
5.4 Permission to conduct Strip trial 56 BG-1 hybrids (HXH) and
4 hybrids (HXB) containing cry1Ac (Event MON 531) and 9 BG-II
hybrids (HXH) and 1 (HXB) containing cryX (cry1Ac & cry2Ab)
(Event MON 15985) at own R&D Farm Gundlapochampally, via
Hakimpet Medchal, R.R.Dist. Andhra Pradesh during Kharif-2007 in
South zone by M/s. Amar Bio-Tech Ltd., Hyderabad.
1.0 The Committee considered agenda items at 5.1 to 5.4
pertaining to commercial release / strip trials of Bt cotton
hybrids with approved gene events. The Member Secretary RCGM
informed the Committee that the above applications were
inadvertently missed out and only considered in the recently
held RCGM meeting. The Committee noted that the proposals for
commercial release and strip trials have completed the requisite
regulatory testing and evaluation process. The MEC and RCGM have
recommended the proposals. The GEAC therefore approved the above
proposals. As the sowing season for cotton is over in all three
zones, it was further decided that the approval would be valid
for Kharif 2008 only.
5.5 Permission for extension of the period for conducting
replicated confined Multi-Location Research Trial (MLRT) on Bt
rice hybrid containing cry1Ac gene from Kharif 2007 to Rabi 2007
and to generate the biosafety data by M/s. Maharashtra Hybrid
Seeds Company Limited, Mumbai.
&
5.6 Permission to extension of the period for conducting
contained limited field research trial (strip trial) on
RB-transgenic potato lines (SP-951) from kharif-2007 to
Rabi-2007 by Central Potato Research Institute, Shimla.
1.0 The Committee noted that in respect of agenda item No. 5.5
and 5.6, the GEAC in its earlier meeting had approved the
proposal for conduct of MLRT with Bt rice by M/s Mahyco and
transgenic potato by CPRI during Kharif, 2007. Since, the
applicants were unable to undertake the trials during Kharif,
2007, approval has been requested for conducting the trials
during Rabi 2007. Trials for potato will, however be conducted
at Modipuram (Modinagar) instead of Shimla. The RCGM in its
meeting held on 03.09.2007 has agreed with the above request.
The GEAC conveyed its no objection for conducting the trials in
Rabi 2007.
5.7 Representation received from M/s Metahelix Life Science,
Bangalore regarding the GEAC decision with respect to the
proposal for large scale field trials of Bt cotton hybrids
developed by the Company.
1.0 The Committee took note of the representations received from
M/s Metahelix and was of the view that further action can be
taken by the Committee only after receipt of complete biosafety
dossier and further direction
Full report:
http://www.envfor.nic.in/divisions/csurv/geac/decision-sep-80.htm |
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