The 70th Meeting of the Genetic Engineering
Approval Committee (GEAC) was held on 17.8.2006 in the
Ministry of Environment and Forests under the Chairmanship
of Shri B S Parsheera Additional Secretary, MoEF and
Chairman GEAC.
1.0 Consideration of Proposals
1.1 Permission
for import of Indiage MAX L from M/s Genecor International,
The Netherlands by M/s Lumis Pvt. Ltd.
1.1.1
The Committee noted that the present application is for
import of
Indiage MAX L
–A
cellulase enzyme produced by
M/s Genecor International for use in denim
washing.
The present purpose of import is for value addition and
subsequent export.
1.1.2
The Committee also considered the certificate from the
supplier confirming that the enzyme is produced by different
selected micro-organisms which have been genetically
modified. However due to efficient separation process, no
production strain is present in the final enzyme product.
On this issue one of the Members opined that the presence
or absence of production strain in the final product depends
on the type of processing namely solid state fermentation
process or submerged formation process. In the instant case
the Committee noted that the product has been derived from
the submerged fermentation process and therefore the
presence of production strain is unlikely.
1.1.3
During the deliberations the Committee further noted that
only importers availing import duty exemption under the
Advance Licensing Scheme offered by DGFT are approaching the
GEAC for clearance of such products. However there are
several companies importing the recombinant enzymes for
indigenous use. The Committee therefore desired that list
of companies importing similar products be obtained from the
applicant.
1.1.4
The Member Secretary informed the Committee that, the GEAC
in its earlier meetings had approved the import of
Denimax399S, Aquazyme and Denimax Acid XCL (cellulose
enzymes) used by the textile industry for denim washing from
M/s Novonenzyme Denmark by M/s Lumis Biotech Ltd after
obtaining a declaration that the import is for value
addition and subsequent export only subject to the following
conditions:.
a)
The DGFT would
monitor the quantity of import and subsequent export after
value addition.
b)
The DGFT should
direct the Company to follow ‘Rules 1989’ and obtain
approval of GEAC prior to such imports in future.
1.1.5
Since the proposal under consideration is similar to the
proposals earlier approved by the GEAC, the GEAC approved
the import of
Indiage MAX L from M/s Genecor International,
by M/s Lumis Pvt. Ltd for value addition and subsequent
export.
1.2 Permission
for import and marketing of Phytase Enzyme (Poultry feed
supplement) from Suson Industry Group Co. Ltd. Beijing,
China by Elder Pharmaceuticals Ltd. Mumbai.
1.2.1
The Committee noted that the present request is for import
and marketing of enzyme (Phytase) from China. The product is
used for Poultry feed supplement.
1.2.2
The Member Secretary informed the Committee that the GEAC
had earlier considered two applications namely import of
the same product from the same source submitted by M/s
Chembond Chemicals and the
import of Finase PC enzyme (poultry feed
supplement) from Germany by M/s Textan Chemicals Pvt. Both
the proposals are pending consideration of the GEAC for want
of comments from Department of Animal Husbandry.
1.2.3 After detailed deliberations it was
decided that the three proposals may be referred to Food
Technology Division, BARC and CFTRI for comments. The
Committee also requested the Chairman GEAC to take up the
matter with the Department of Animal Husbandry at the
highest level. It was decided to reconsider the proposals in
the next GEAC meeting.
1.3 Permission for import of
Lecithin (DNA –ve) and Standard
Lecithin derived from Roundup Ready Soybean from ADM, USA
by M/s Tina oils.
1.3.1 The Committee noted that the
present request from M/s Tinna Oil is for import of DNA –ve
lecithin for use in confectionary industry and standard
lecithin for use in the paint industry from ADM, USA. The
Committee gave an opportunity to the applicant to present
their case. During the deliberations the following points
were noted:
1. M/s Tinna Oils and Chemicals
Limited, JV partner of Archer Danniel Midland Company (ADM),
headquartered at Decatur, USA, ADM is one of the largest
agri-processors; processing com, wheat, soy and cocoa and
are manufacturing value added ingredients from these basic
crops.
2. Lecithin (DNA –ve) derived from
Roundup Ready Soybean (a genetically modified soybean) is
used by various food processing sectors like bakery,
confectionery, dairy etc.
3. Even though the EC regulation and
ANZFC –FSC standard A18 standards applicable for Australia
and New Zealand exempts highly refined foods where modified
DNA/ PROTEIN is not detectable, to assist the food
manufactures , ADM has developed a documented program for
the manufacture of GMO DNA Negative Specialty lecithin using
mixed –source soybeans. The product has not been tested in
any of the laboratories in India.
1.3.2 Standard Lecithin derived
from roundup ready soybean is used in the paint industry.
But since this material is meant for non edible application,
no testing for presence of DNA have been carried out. The
Committee sought clarification on the environmental
implication of use of such product. The representative
informed the Committee that the information will be obtained
from the supplier and submitted to the GEAC.
1.3.3 After detailed deliberations, the
Committee decided to obtain the following clarifications:
a.
Details of the test results/
analytical report of Lecithin (DNA –ve) and Standard
Lecithin from Sri Ram Laboratories / CFTRI / NIN. During the
deliberations, one of the Expert Members advised that NIPER,
Chandigarh which is a WHO accredited laboratory may also be
considered. The Committee was of the view that for the
present the three laboratories recommended in respect of
Soybean oil may be considered. The Committee further
requested the Member Secretary GEAC to seek the consent of
NIPER in undertaking such assignments so that future
proposal may be referred to them.
b.
The list of countries importing
Lecithin (DNA –ve) and Standard Lecithin.
c.
The composition of the
indigenously manufactured lecithin vs imported lecithin.
d.
List of clients to whom the
product is supplied.
e.
Environmental implications and
safeguards, if any for use of standard lecithin.
1.4 Permission for export of
transgenic groundnut seeds to South Africa for research
purposes by International Crops Research Institute for
Semi-Arid Tropics (ICRISAT), Patanacheru A.P.
1.4.1 The Committee considered the
request received from ICRISAT for export of 61 transgenic
events in groundnut varieties JL 24 and ICGS 44 expressing
the coat protein gene of the groundnut rosette assistor
virus (GRAV) to South Africa for research purpose.
1.4.2 The Committee noted that JL 24
variety is an indigenous variety (ICAR variety) developed
by National Research Centre for Groundnut , Junagarh Gujarat
and ICGS 44 is a variety developed by ICRISAT. Both the
varieties have been notified by the Central Seed Committee.
1.4.3 To a query on why the proposal has
been referred to the GEAC, it was clarified:
a. Import of any Indian germplasm
requires the approval of NBA under the Biodiversity Act
b. As per Rules 1989, approval of
GEAC is mandatory prior to export of transgenic material.
c. In compliance with the
requirement under the Cartagena Biosafety Protocol, approval
of the National Competent Authority of the exporting country
is necessary prior to import of the transgenic material.
1.4.4 It was further clarified that the
proposal for export of Bt eggplant to Philippines and
Bangladesh by M/s Mahyco was approved by the GEAC after
seeking the recommendations of the Agro Biodiversity Task
Force constituted by National Biodiversity Authority (NBA)
and comments of Ministry of Agriculture and NBPGR. The
export permission by GEAC was subject to the condition that
the germplasm were initially bought from the country to
where it is being exported.
1.4.5 In view of the above and taking
into consideration that JL 24 is an Indian germplasm, it was
decided that ICRISAT may be advised to obtain the approval
of NBA. It was also decided to refer the proposal to
Ministry of Agriculture and NBPGR.
Reconsideration cases
1.5 Permission for manufacture of
indigenous r-hepatitis C viral antigen core NS-3, NS-4 and
NS-5 by Sundershan Biotech Ltd. Hyderabad.
1.5.1 The present
application is to commercialize the indigenously developed
recombinant hepatitis C Viral antigens - Core NS3, NS4 and
NS5 for use in diagnostic kits. The Committee noted that the
proposal was considered by the GEAC in the meeting on
10.8.2005 wherein it was decided to obtain following
information from the company:
·
Details/results of the tests conducted at
Centre for Liver Research & Diagnostics, Hyderabad. The
results have been submitted.
·
To obtain validation report from National
Institute of Biological (NIB), which is the referral
laboratory notified by Ministry of Health. The Company vide
their letter dated 17th November, 2005 has
informed that NIB is willing to take up the validation of
complete diagnostic kit upon recommendation by Drug and
Controller General of India (DCGI) but not the individual
ingredients like antigens.
1.5.2 The proposal was reconsidered by
the Committee in light of the recommendations of the Dr.
Mashelkar Committee Report on R-Pharma adopted by the GEAC
in its meeting held on 4.4.2006. As per the revised
procedure, the present proposal falls under Protocol I as it
involves use of LMOs during the manufacturing process. In
such cases recommendation of RCGM on the containment
facility is mandatory prior to approval by GEAC. In the
instant case since the same has not been received, decision
on the proposal was deferred.
1.6
Permission for
import and marketing of purified Rabies Vaccine for human
use (vero cell) manufactured by M/s Liaoning Cheng da
Biotechnology Co. Ltd., China by May (India) Laboratories
Pvt Ltd. Chennai.
1.6.1
The Committee reconsidered the proposal in
light of the recommendations of the Dr.
Mashelkar Committee Report on R-Pharma adopted by the GEAC
in its meeting held on 4.4.2006. It was noted that the
Rabies Vaccine is an inactivated vaccine and
has not
been derived from a genetically modified organism. The
Committee also considered the comments received from DBT
vide their letter dated 20.2.2006.
1.6.2
In view of the above, the Committee decided to convey its no
objection to the proposal subject to DCGI clearance. It was
also decided to forward the views of DBT for consideration
of DCGI.
1.7
Permission for import of Finase PC enzyme for
formulation from Germany and marketing in India by M/s.
Textan Chemicals Pvt. Ltd.
1.7.1 The proposal
being similar to the proposal at agenda 4.2, decision taken
therein would be applicable in this case also.
1.8 Permission for import and
marketing of enzyme Phytase (poultry feed supplement) from
M/s Suson Industry Group Co. Ltd, Beijing, China by M/s.
Chembond Chemicals Ltd. Mumbai.
1.8.1 The proposal
being similar to the proposal at agenda 4.2, decision taken
therein would be applicable in this case also.
1.9 Permission for import and
conduct of Phase II clinical trials of Chimerivax tm – JE in
children of descending age from USA by M/s Quintiles
1.9.1 The Committee noted that the GEAC
in its meeting held on 8.2.2006 had approved the conduct of
Phase II clinical trials in children of descending age in
India subject to the conditions that patients would be
recruited in a phased manner. Subsequently in the GEAC
meeting held on 2.5.2006, it was further clarified that in
the first instance, the Company would complete the clinical
trials in children of the higher age group (5 to 10 years)
and submit the data for consideration of the GEAC before
initiating the clinical trials in the lower age group.
1.9.2 The Committee considered the
request of the Company to reconsider the decision taken in
the GEAC meeting on 2.5.2006 on the grounds that this
approach would cause delay (1 to 2 months) in completion of
the clinical trials study and release of the product in
India. Views were expressed that the clinical trials are
conducted in healthy individuals and there is no recruitment
of patients for the study. Besides, the total time for
completion of the trials is not likely to be very long.
Further it was noted that the vaccine has not been tested
under phase-1 clinical trials.
1.9.3 In view of the above the Committee
opined that the request of the Company does not merit
consideration.
2.0 Other Items
2.1 Import of GM Soybean oil
2.1.1
The GEAC in its meeting held on 2.5.2006 had accorded
approval as an interim measure for import of GM Soybean
(RSVO and CDSO) subject to declaration that it has been
derived from Round up Ready Soybean. For obtaining the
final approval, the importers of GM Soybean oil have been
advised to submit test result from either CFTRI /NIN/ Shri
Ram Laboratories on the composition of the CDSO both pre and
post processing as well as in the residue. The parameters
to be monitored should include the herbicide level.
2.1.2
The Member Secretary briefed the Committee on the latest
developments of the Soybean oil imports. It was noted that
the test results are awaited since May 2006. Meanwhile DGFT
with the approval of the Cabinet have extended the date for
implementation of the DGFT notification for import of
Soybean oil up to March, 2007.
2.1.3
The Committee was of the view that the Rules 1989 under EPA,
1986 is in force since, 1993. While the mandatory
declaration under DGFT notification can be dispensed with
until March, 2007, the statutory approval of the GEAC under
Rules 1989 notified under EPA 1986 cannot be dispensed with
until Rule 11 of the above mentioned Rules is suitably
amended.
2.1.4
After detailed deliberations, the Committee opined that, the
Soybean Oil Importers/ Association may be advised to submit
the analytical report in respect of CDSO within a period of
one month.
2.2 Representation received from Seed Industries
2.2.1
The GEAC in its meeting held on 30.6.2006 had taken a view
that no specific approval for seed production is necessary
for Bt Cotton expressing CRY 1 Ac gene (MON 531 Event).
However, RCGM may obtain a declaration from the applicant
along with the application that no seed production for
commercial sale shall be undertaken till the hybrid is
approved for commercial release.
2.2.2
The Committee considered the request received from seed
industries to amendment the wordings of the declaration as
that would imply no seed production on a commercial scale
can be initiated until the hybrid is approved for commercial
release. Therefore it would take two years before the hybrid
is commercially released.
2.2.3
Views were expressed that the request of the seed industry
merits consideration as the objective of deregulating the
hybrids expressing cry1 Ac gene (Mon 531 event) gets
defeated. After detailed deliberations it was decided to
amend the wordings of the declaration as follows:
“RCGM may
obtain a declaration from the applicant along with the
application for MLT that in case the hybrid ( name of
hybrid to be indicated) is not approved for environmental
release by the GEAC, the seeds if produced shall not be sold
or used for any other purpose.”
2.2.4
The sub-committee had recommended at Page 17 para E (1) of
the report that the yield comparison should be with a non Bt
check. However in the GEAC meeting after extensive
deliberation it was agreed that though the yield cannot be
the primary parameter, for holistic assessment it should be
compared with a recently released and related Bt check. The
main objective of this amendment was to compare the efficacy
of the technology and performance of the hybrid. This can be
evaluated only when compared with the Bt check.
2.2.5
The request of the seed industry for amendment /deletion of
the sentence that the “However the yield comparison should
be with a recently released and related Bt check” was
discussed and it was decided to amend the above sentence as
“However, the performance of the
test hybrid would be evaluated holistically with non Bt
check, zonal check as well as Bt check as recommended by
RCGM.”
2.3 Representation received from Centre for
Sustainable Agriculture regarding mortality in Sheep flocks
after grazing on Bt Cotton field at Warangal Andhra
Pradesh.
2.3.1
The issues raised by the NGO regarding the adverse impact on
cattle feeding with Bt cotton leaves was discussed in the
GEAC meeting held on 1.6.2006 wherein the Committee
decided to refer the matter to the State Department of
Agriculture for a factual report on the allegation made by
the NGOS and the findings of the post mortem report. It was
noted that the response of the State Govt is awaited. The
Committee also considered the representation dated 28th
July 2005 received from Centre for Sustainable Agriculture
forwarding the investigation report on sheep mortality and
was of the view that comments of the State Government and
IVRI needs to be obtained on the matter expeditiously.
2.3.2
The Committee sought clarification from the representative
of DBT on the action taken regarding sponsoring a study to
assess the problem at Warangal District with the help of
local Veterinary Hospital in the district. It was informed
that no proposal for conducting the study has been received.
The Committee requested DBT to expedite the leaf toxicity
studies study with the help of IVRI and local veterinary
hospitals on a priority basis.
2.3.3
The Committee also requested the Chairman to take up the
matter with the Principal Secretary, State Dept of
Agriculture, Andhra Pradesh for expediting the factual
report on the sheep mortality case at Warangal.
3.0 Additional Agenda
3.1 Permission for 100 ha seed production of NCEH
2 R and NCEH 3 R Bt cotton by M/s Nath seeds.
3.1.1
The Committee noted that the GEAC has approved conduct of
LST with NCER 3 R Bt. in the Central Zone and NCEH 2 R Bt.
in the South Zone subject to two years of LST and 10 ha seed
production during first year LST. The Committee considered
the request of the Company for 100 ha seed production.
3.1.2
The Member Secretary informed the Committee that a similar
request was earlier received from M/s J.K.Seeds in respect
of their hybrids JHCH 1050 Bt in North Zone, JKCH 666 Bt and
JKCH 226 Bt. in Central Zone and JKCH 634 in the South Zone
as these hybrids have completed 2 years ICAR trials. The
request received from individual cases was referred by the
GEAC to the Sub – Committee under Dr. C. D. Mayee, Chairman,
ASRB and Co-Chair GEAC in the meeting held on 30.6,.2006.
The Sub Committee in its meeting held on 12.7.2006 opined
that cases which cannot be synchronized with the new
procedure may be considered on a case to case basis based on
one year LST and two year ICAR trial data. In cases such
cases 100 ha seed production may be permitted during first
year LST.
3.1.3
Since the request of M/s Nath Seeds is similar to that of J.
K. Seeds, the Committee was of the view that the same
decision would be applicable.
3.2
Permission for
100 ha. Seed production of Bt cotton hybrid Dhruv Bt (SCH
50064) by M/s Zuari seeds limited
3.2.1
The Committee noted that the GEAC in its meeting held on
2.5.2006 had approved conduct of LST with Dhruv Bt subject
to 2 years LST and 10 ha seed production during first year
LST. The Committee considered the request of the Company
for 100 ha seed production on the ground that the hybrid has
been recommended for notification during AICCIP workshop
held at Dharwad during 7-9th April, 2006. The
Committee noted that the recommendation for central
notification is yet to be considered by the Central
Varietals Release Committee of MoA only after which the
hybrid can be notified.
3.2.2
After detailed deliberation the Committee opined that the
case is pre-mature for consideration at this stage. The
Applicant may be advised to submit their request along with
the requisite details after issuance of the formal
notification by MOA.
3.3
Permission for
100 ha. seed production of Bt cotton hybrid NCS 145 BG II
(Bunny) and NCS 207 BG II (Mallika) by M/s Nuziveedu seeds
limited
3.3.1
The GEAC in its meeting held on 4.2.2006, and 22.5.2006 had
approved conduct of LST with NCS 145 BG II in all three
Zones and NCS 207 BG II in the Central and South Zones
subject to 2 years LST and 10 ha seed production during
first year LST. The Committee considered the request for 1
year LST and 100 ha seed production with NCS 145 BG II
(Bunny) and NCS 207 BG II (Mallika) on the grounds both the
hybrids are Centrally Notified hybrids. As per the
prevailing practice only one year of LST and one year ICAR
trials is mandatory. In such cases 100 ha seed production is
also permitted during first year LST. Since, NCS 145
and NCS 207 are centrally notified hybids, the Committee
approved the request for one year LST and 100 ha seed
production during first year LST.
3.4 Consideration of proposal for
multi-locational trials recommended by RCGM in its meeting
held on 31.7.2006.
3.4.1
In compliance with the Hon’ble Supreme Court Order dated
1.5.2006 in respect of WP NO 260/2005 – Aruna Rodrigues &
Others vs Union of India, the Committee considered the
recommendations made by RCGM in its meeting held on 31st
July 2006 in respect of fifteen proposals for conduct of
multi-location field trials of transgenic crops
3.4.2
After careful and in-depth consideration of the proposals
and the recommendations of RCGM, the GEAC approved the
proposals recommended by RCGM in the meeting held on
31.7.2006 and authorized Member Secretary, RCGM to issue
the requisite communications in this regard.
3.5 Request for
using different non Bt hybrids as refugia instead of the non
Bt counterpart by M/s Rasi Seeds Ltd.
3.5.1
The Committee noted that sub-Committee on Bt Cotton and
related issues has recommended that before taking a final
view on the matter, it is advisable that studies on
alternate IRM strategies be conducted with the help of SAU
Punjab, CICR, Nagpur and SAU Dharwad for which RCGM may
formulate different study modules. In view of the above the
Committee opined that the request does not merit
consideration at this stage.
