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Protocol
- II: For Released Event
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Biosafety Committee (IBSC) |
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Committee on Genetic Manipulation (RCGM) (Need based trials) |
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Genetic
Engineering Approval Committee (GEAC) |
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Concurrent |
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Farmers Field Trials by Company / Institutions |
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ICAR Trials for VCU |
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GEAC |
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Evaluation of data |
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DAC/ICAR Ministry of Agriculture |
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Approval for commercial release / notification / registration of variety(ies)/hybrid(s) |
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DAC / ICAR |
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GEAC should issue permission to applicant
for (a) multi-location coordinated trials to be conducted by ICAR and (b)
conduct of field trials by applicant at suitable locations in different
agro-ecological zones as per approval of GEAC. The applicants will hand over
the seed/planting material of requisite quantity to ICAR for coordinated
trials. GEAC should inform all stakeholders including State Governments. In case of conduct of large scale trials of
transgenic crop, the experimental design and the number shall be decided by
GEAC in collaboration with ICAR. ICAR should organize a separate All-India
Coordinated Programme for testing GM crop varieties. The coordinators of
this programme should have expertise both in biotechnology and agriculture.
12.7
Realising the need for rationalization of the information needed to be
collected/ generated by the applicants on transgenic crops while applying to the
Review Committee on Genetic Manipulation (RCGM), the Task Force set up an Expert
Committee comprising representatives from Ministry of Agriculture, ICAR and DBT
for rationalization of parameters for development of transgenic crops by
incorporating bio-safety and agronomic evaluation requirements and environmental
safety aspects. The Task Force approved the recommendations submitted by the
Group of Experts. The Task Force recommends the following general, biosafety and
agronomic parameters on which information by applicants needs to be submitted to
RCGM.
A. General Information
Rationale
for development of transgenic crop
Description
of the host plant
Mode of Pollination
Centres of
origin/diversity of the crop species
Geographical
distribution of the target crop and sexually compatible plant species including
wild relatives
B.
Biosafety Parameters:
1. Genetic
and Molecular parameters
Genetic
analysis including copy number of inserts;
Stability
of the gene;
Level,
site(s) and duration of expression gene product;
Efficacy/utility of gene product
Compositional
analysis
2.
Environmental Parameters
Gene flow
Implications
of out-crossing
Effect on
target and non-target organisms
Effect on
soil biota
3.
Toxicity parameters including histo-pathological studies (need based)
Food/feed safety
evaluation in animals such as
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Effect on
small laboratory animals
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Effect on
livestock animals (representative goat studies of large animals)
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Effect of
birds/avian species
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Effect on
fish
4.
Allergenicity parameters (need based)
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Primary
skin irritation test in rabbit/guinea pigs
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Irritation
of mucous membrane test in rabbit/guinea pig
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Immunological
responses in a suitable animal system
C.
Agronomic Parameters
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Efficacy
of the gene at phenotypic level
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Yield
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Growth and
developmental parameters
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Responses
to major diseases and insect-pests
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Quality
parameters
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Economic
evaluation/cost: benefit ratio
(Operational protocols to be developed by RCGM for ‘B’ and by ICAR for ‘C’ depending upon the host crop). A case by case analysis will be needed
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