Transcript No Slide Title

REGULATORY MECHANISMS, GUIDELINES
AND PROTOCOLS FOR TRANSGENIC CROPS;
FOOD AND FEED SENARIO
Dr. T.V. Ramanaiah
Scientist-F
Department of Biotechnology,
Ministry of Science & Technology
CGO Complex, Lodi Road, New Delhi - 110 003
Short-Term Orientation Course on Biosafety and Biotech Regulations
6th -11th Feb, 2006 at TERI
1
Biosafety
Protecting human & animal health
and environment from the possible
adverse effects of the products
of modern biotechnology
Precautionary Approach is adopted
for assessment of Biosafety
2
Objectives of Regulations
To facilitate & regulate
Modern biotechnology work
at different stages to achieve the
objectives of biosafety.
3
BIOSAFETY REGULATIONS & GUIDELINES
* International:
Cartagena Protocol on Biosafety
OECD Guidelines
* Country specific:
USA, EU, Canada, Australia, Egypt, Japan, China,
Philippines, Thailand, India, Pakistan, etc.
4
GENETICALLY MODIFIED ORGANISMS
(GMOs) AND r-DNA PRODUCTS
GOVERNED BY
Environment (Protection) Act, 1986
Came into force from 23.05.1986
Rules, 1989 on GMOs
Notified on 05.12.1989
Came into force from 01.10.1993
5
TRANSGENIC CROPS ARE ALSO GOVERNED BY
Industries (Development & Regulation) Act, 1951
- New Industrial Policy & Procedures, 1991
 Seeds Act, 1966
 Seeds Rules, 1968
 Seeds (Control) Order, 1983
 Seeds Policy, 1988, 2002
 Protection of Plant Varieties and Farmers’ Rights Act, 2001
6
The Indian Environment (Protection) Act (EPA), 1986
 Came into force from 23.5.1986.
 Provides protection and improvement of Environment.
 “Environment” includes water, air and land and the
interrelationship , which exists among and between water, air
and land, and human beings, other living creatures, plants,
microorganism and property
 “Environmental pollutant” means any solid, liquid or gaseous
substance present in such concentration as may be, or tend to be,
injurious to environment.
 “Environmental pollution” means the presence in the
environment of any environmental pollutant.
contd ......
7
Some Important Sections of EPA
Section -15
 Whoever fails to comply with or contravenes the act or any
rules can be punished with imprisonment for a term up to 5
years, or with a fine up to Rs. 100,000 or with both.
 If failure or contravention continues beyond one year, the
offender may be punishable with imprisonment which may
extend up to 7 years.
8
Rules for the Manufacture, Use / Import / Export and Storage of
Hazardous Microorganisms, Genetically Engineered Organisms
or Cells (Rules 1989)
* Notified in exercise of powers under sections 6,8 & 25 of the EPA, 1986 on
5thDec’89.
* Rules are came into force from 01.10.1993.
Application of Rules :
* Manufacture, import and storage of microorganisms and Gene-technological
products.
* Genetically engineered organisms, microorganisms and cells and
correspondingly to any substances and products and food stuffs, etc.
* Sale, any kind of handling, exportation, importation, production,
manufacture, processing, storage, drawing off, packaging, repackaging of
GMOs and drugs & pharmaceuticals, food stuffs etc. from GMOs and Gene
technology products.
9
Approval and prohibitions, etc. under Rules, 1989
• No person shall import, export, transport, manufacture, process, use or sell
any GMOs, substances or cells except with the approval of the GEAC.
• Use of pathogenic organisms or GMOs or cells for research purpose shall be
allowed under the Notification, 1989 of the EPA, 1986.
• Any person operating or using GMOs for scale up or pilot operations shall
have to obtain permission from GEAC.
• Deliberate or unintentional release of GMOs not allowed.
• Production in which GMOs are generated or used shall not be commenced
except with the approval of GEAC.
10
Approval and prohibitions, etc. under Rules 1989
* GEAC supervises the implementation of rules and guidelines.
* GEAC carries out supervision through SBCC, DLC or any authorized
person.
* If orders are not complied, SBCC/DLC may take suitable measures at the
expenses of the person who is responsible.
* In case of immediate interventions to prevent any damage, SBCC and DLC
can take suitable measures and the expenses incurred will be recovered from
the person responsible.
11
Approval and prohibitions, etc. under Rules 1989
*
All approvals shall be for a period of 4 years at first
instance renewable for 2 years at a time.
*
GEAC shall have powers to revoke approvals in case of:
a) any new information on harmful effects of GMOs.
b) GMOs cause such damage to the environment as
could not be envisaged when approval was given.
c) Non compliance of any conditions stipulated by GEAC.
12
COMPETENT AUTHORITIES
1.
Recombinant DNA Advisory Committee (RDAC)
2.
Review Committee on Genetic Manipulation (RCGM)
3.
Institutional Biosafety Committee (IBSC)
4.
Genetic Engineering Approval Committee (GEAC)
5.
State Biotechnology Co-ordination Committee (SBCC)
6.
District Level Committee (DLC)
13
Recombinant DNA Advisory Committee (RDAC)
Main functions
• Review developments in Biotechnology at National and
International level.
• Recommend suitable and appropriate safety regulations
for India in r-DNA research, use and applications.
14
Review Committee on Genetic Manipulation
Main functions
• To bring out manuals of guidelines specifying procedures for regulatory process
on GMOs in research, use and applications including industry with a view to ensure
environmental safety.
• To review all on going r-DNA projects involving high risk category and controlled
field experiments.
• To lay down procedures for restriction or prohibition, production, sale, import & use
of GMOs both for research and applications.
• To permit experiments with category III risks and above with appropriate
containment.
• To authorize imports of GMOs/ transgenes for research purposes.
• To authorize field experiments in 20 acres in multi-locations in one crop season
with up to one acre at one site.
• To generate relevant data on transgenic materials in appropriate systems.
15
Institutional Bio-Safety Committee (IBSC)
Main functions
• To note and to approve r-DNA work.
• To ensure adherence of r-DNA safety guidelines of government.
• To prepare emergency plan according to guidelines.
• To recommend to RCGM about category III risk or above
experiments and to seek RCGM’s approval.
• To inform DLC and SBCC as well as GEAC about the
experiments where ever needed.
• To act as nodal point for interaction with statutory bodies.
• To ensure experimentation at designated location, taking
into account approved protocols.
16
Genetic Engineering Approval Committee (GEAC)
Main functions
• To permit the use of GMOs and products thereof for commercial
applications.
• To adopt procedures for restriction or prohibition, production, sale,
import & use of GMOs both for research and applications under EPA.
• To authorize large scale production and release of GMOs and products
thereof into the environment.
• To authorize agencies or persons to have powers to take punitive
actions under the EPA.
17
State Biotechnology Co-Ordination Committee (SBCC)
Main functions
• Powers to inspect, investigate and to take punitive action in case of
violations of statutory provisions through the State Pollution Control
Board or the Directorate of Health etc.
• To review periodically the safety and control measures in various
institutions handling GMOs.
• To act as nodal agency at State level to assess the damage, if any, due
to release of GMOs and to take on site control measures.
18
District Level Committee (DLC)
Main functions
• To monitor the safety regulations in installations.
•
Have powers to inspect, investigate and report to the SBCC or the
GEAC about compliance or non compliance of r-DNA guidelines or
violations under EPA.
• To act as nodal agency at District level to assess the damage, if any,
due to release of GMOs and to take on site control measures.
19
r-DNA GUIDELINES
1990
“ Recombinant DNA Safety Guidelines”
1994
“ Revised Guidelines for Safety in Biotechnology”
1998
“ Revised Guidelines for Research in Transgenic Plants &
Guidelines for Toxicity and Allergenicity Evaluation of
Transgenic Seeds, Plants and Plant Parts ”
1999
“Guidelines for Generating pre-clinical and Clinical data for
r-DNA based Vaccines, Diagnostics and other Biologicals
20
COVERAGE OF REVISED GUIDELINES- 1998
*
*
*
*
*
*
*
*
*
Recombinant DNA Research on plants and statutory bodies
dealing with r- DNA work.
Classification of Genetic Engineering Experiments on plants a. Category - I
b. Category - II
c. Category - III
Containment measures followed in above categories.
Green House / Design for Field evaluation of transgenic plants.
Monitoring - cum - Evaluation Committee.
Biosafety aspects of the transgenic plants.
Import and shipment of genetically modified plants for research
use only.
Toxicity guidelines for testing transgenic plants and plant parts.
Application for seeking approval under EPA for transgenic crops.
21
CLASSIFICATION OF GENETIC ENGINEERING EXPERIMENTS
CATEGORY - I
CATEGORY - II
CATEGORY - III
Work involving defined
gene(s)/DNA of microbial,
plant and animal origin
which are Generally
Considered as safe for
humans, animals & plants.
Work involving defined
gene(s)/DNA of microbial,
plant and animal origin
which are non- pathogenic
to humans and animals but
can have implications on
plants and insects.
Work involving defined
gene(s)/DNA of microbial,
plant and animal origin
which can cause alterations in
the biosphere and does not
fall in category I & II .
Routine recombinant DNA
experiments in lab.
Lab & Green House/Net
House experiments in
contained environment
(except contained limited
field trials.)
All experiments including
Lab, Green House, limited
contained field trials and
limited experimental field
trials etc. of category I & II.
IBSC can approve the
experiments.
IBSC can approve the
experiments with
intimation to RCGM.
Experiments to be carried out
only after RCGM’s approval.
Monitoring - cum - Evaluation Committee (MEC)
Main functions
• To undertake field visits at the experimental site (s).
• To review the design of experiments / trials and collection of data
during limited open field trials.
• To collect information on the comparative agronomic advantages of
transgenic crop.
• To assess and advise on the risks and benefits from the use of
transgenic plants.
• To assist in collecting, consolidating and analyzing field data for
evaluating environmental risks emanating from transgenic plants.
• To recommend those transgenic crops which would be found to be
environmentally safe and economically viable to RCGM and to
GEAC for consideration to release into the environment.
23
Amendments in the Guidelines
Defining small experimental field trials:
Small experimental field trials should be limited to a total of 20 acres in
multi-locations in one crop season. In one location, where the
experiment is conducted with transgenic plants, the land used should
not be more than one acre. Any experiment beyond these limits in one
crop season would require the approval of GEAC.
Large scale experiments:
Experiments using fermentors beyond 20 ltrs capacities exclusively for
research purposes only to produce sufficient material/ products of
GMOs required for generating pre-clinical and other relevant data
required to establish the product for commercial use would not be
included in the category of large scale experimentation/ operations.
24
Protocol for development Transgenic crops
Institutional Biosafety Committee (IBSC)
Examination & forwarding applications for approval of RCGM
Review Committee on Genetic Manipulation (RCGM)
Green house experiments, contained field trials,
toxicity and allergenicity studies
Farmer’s Field trials by Company
ICAR trials
Monitoring-cum- Evaluation Committee (MEC)
Review Committee on Genetic Manipulation (RCGM)
Genetic Engineering Approval Committee (GEAC)
Evaluation of data and Environmental clearance of the event/ gene
25
CONSTITUTION OF TASK FORCES ON
BIOSAFETY REGULATIONS
Ministry of Agriculture constituted a Task Force on
‘Applications of Agricultural Biotechnology’
Ministry of Environment & Forests constituted a Task
Force on ‘Recombinant Pharma Sector’
26
Protocol-I For New Transgenic Event
Institutional Biosafety Committee (IBSC)
Preparation and/submission of application data
Review Committee on Genetic Manipulation (RCGM)
Evaluation of application data from IBSC*
Approval for Laboratory and Green House Trials & contained field trials. For generation of
environmental, toxicity and allergenicity data. Evaluation/monitoring of contained field trials through
Monitoring-cum- Evaluation Committee (MEC)
Genetic Engineering Approval Committee (GEAC)
Approval for large scale Field Trials and Evaluation Protocol**
Concurrent
Farmer’s Field trials by Company
ICAR trials for VCU involving SAUs and
other appropriate State Agencies
Genetic Engineering Approval Committee (GEAC)
Evaluation of data and Environmental clearance of the event/ gene
Ministry of Agriculture
Approval for commercial release/notification/registration
of variety(ies) / hybrid(s) by DAC/ICAR
DAC/ICAR
Ministry of Agriculture & State Governments
Post-release monitoring and vigilance
27
Protocol-II: For Released Event/ Gene
Institutional Biosafety Committee (IBSC)
Preparation/submission of application data
Review Committee on Genetic Manipulation (RCGM)
Case verification and Bio-safety clearance
(Need based trials)
Genetic Engineering Approval Committee (GEAC)
Approval for large scale Field Trials and Evaluation Protocol*
Farmer’s Field trials by Company
ICAR trials for VCU
Genetic Engineering Approval Committee (GEAC)
Evaluation of data for Environmental clearance of the event/ gene
DAC/ ICAR, Ministry of Agriculture
Approval for commercial release/ notification/ registration
of variety(ies)/ hybrid(s)
DAC/ ICAR
Ministry of Agriculture & State Governments
Post-release monitoring
28
Biosafety parameters on Transgenic crops
A.
General information

Rationale for the development

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
contd .......
29
Biosafety parameters on Transgenic crops
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 of transgene
 Characterization of expressed gene product
 Efficacy/utility of gene product
 Compositional analysis
contd ....
30
Biosafety parameters on Transgenic crops
2.
Environmental parameters

Gene flow

Implications of out-crossing

Effect on target and non-target organisms

Effect on soil biota
Contd….
31
Biosafety parameters on Transgenic crops
3.
Toxicity parameters including histo-pathological
studies (need based)
 Food/feed safety evaluation in animals such as:
* Effect on small laboratory animals
* Effect on livestock animals (representative goat studies
of large animals)
* Effect on birds/ avian species
* Effect on fish
Contd….
32
Biosafety parameters on Transgenic crops
4. Allergenicity parameters (need based)
 Primary skin irritation test in rabbit/
guinea pigs
 Irritation to mucous membrane test
in rabbit/ guinea pig
 Immunological responses in suitable
animal system
Contd….
33
Biosafety parameters on Transgenic crops
C.
Agronomic parameters
 Efficacy of the gene at phenotypic level
 Yield
 Growth and developmental parameters
 Responses to major diseases and insect-pests
 Quality parameters
 Economic evaluation/ cost: benefit ratio
34
GUIDELINES FOR TOXICICTY AND
ALLERGENICITY EVALUATION OF TRANSGENIC
SEEDS, PLANTS AND PLANT PARTS
Guidelines for Toxicity evaluation of transgenic seeds









Acute oral toxicity test of transgenic seeds in Rat
Sub-chronic (90 days) oral toxicity test of transgenic seeds in Rat
Sub-chronic oral toxicity – Goats – 90 days study
Feeding studies of transgenic plants/plant parts in Lactating
Crossbred Dairy Cows
Feeding studies of transgenic plants/plant parts in Chicken.
Feeding studies of transgenic plants/plant parts in Catfish
Primary skin irritation test of transgenic seeds in Rabbit
Irritation to mucous membrane test of transgenic sees in
female Rabbit
Skin sensitization test of transgenic seeds in Guinea pigs
35
GUIDELINES FOR TOXICICTY AND
ALLERGENICITY EVALUATION OF TRANSGENIC SEEDS,
PLANTS AND PLANT PARTS
Guidelines for Toxicity evaluation of transgenic vegetables
 Acute oral toxicity test of transgenic vegetables in Rat
 Sub-chronic (90 days) oral toxicity test of transgenic vegetables in Rat
 Primary skin irritation test of transgenic vegetables in Rabbit
 Irritation to mucous membrane test of transgenic vegetables in female
Rabbit
36
GUIDELINES FOR TOXICICTY AND
ALLERGENICITY EVALUATION OF TRANSGENIC
SEEDS, PLANTS AND PLANT PARTS
Guidelines for Toxicity evaluation of transgenic leaves

Sub-chronic (90 days) oral toxicity test of transgenic leaves in
male Rabbit
Protocol for Allergenicity testing of genetically transformed products
in Animal Model

Passive Cutaneous Anaphylaxis (PCA) test

Pransnitz-Kustner (PK) test

Radioallergosorbent (RAST)/RAST inhibition test

Enzyme Linked Immunosorbent Assay (ELISA)
37
Agencies Involved in
Environmental release of transgenic crops/ food
products by imports
MoA/ICAR, MoH&FW, DBT
Applicant
GEAC
Commercial
Release
38
MoE&F
GM Food & Feed Scenario
• No GM Food / Feed approved so far in India
• GM Food crops are being developed by several applicants
• Policies on labeling, traceability etc are yet to be finalized
39
Agencies Involved in Rules,1989 of EPA 1986
GOVERNMENT OF
INDIA
Min. of Environment
Applicant
Large Scale
Imports,
Production and
Release
Dept. of Biotechnology
GEAC
RCGM
SBCC
IBSC
PI/ Applicant
DLC
40
Monitoring
-cumEvaluation
Committee
R&D,
Limited
experimental
field trials and
imports for
R&D.
Summary of r-DNA Research in India
Number of Institutions engaged
~
240
Number of Institutions engaged in
transgenic research
~
95
(60+35)
Number of Private Institutions
engaged in r-DNA therapeutics
~
50
Other Institutions engaged in basic work ~
95
41
TRANSGENIC CROPS APPROVED GOBALLY
Sl. No. CROP
1.
Canola
TRAIT
COUNTRY
YEAR
Herbicide Tolerance
(CP4EPSPS)
Canada
US
Japan
1995
1999
1996
Herbicide Tolerance
(PAT)
Canada
US
Japan
Australia
1995
1995
1996
2003
Herbicide Tolerance
(bxn)
Canada
Japan
1997
1998
Herbicide Tolerance
(ALS)
Canada
1995
contd…
42
Sl. No. CROP
TRAIT
COUNTRY
YEAR
2. Carnation
Increased shelf life
Herbicide Tolerance
Australia
European Union
1995
1998
3. Chicory
Herbicide Tolerance
European Union
USA
1996
1997
4. Cotton
Insect Tolerance
USA
Australia
Japan
China
Mexico
South Africa
Argentina
India
1995
1996
1997
1997
1997
1997
1998
2002
USA
Japan
1994
1997
Herbicide Tolerance
(bxn gene)
43
contd…
Sl. No. CROP
TRAIT
COUNTRY
YEAR
Cotton
Herbicide Tolerance (bxn gene)
Insect Tolerance
USA
Japan
1997
1998
Cotton
Herbicide Tolerance (ALS gene)
USA
1996
Cotton
Herbicide Tolerance (CP4EPSPSgene)
USA
Japan
Australia
Argentina
Cotton
Herbicide Tolerance (CP4EPSPSgene)
Insect Tolerance
USA
Cotton
Herbicide Tolerance (PATgene)
USA
2003
Cotton
Insect Tolerance (Cry1Ac+Cry1F genes) USA
2004
44
Contd…
1995
1997
1999
2000
Sl. No. CROP
5.
Linseed
6.
Maize
TRAIT
Herbicide Tolerance (ALS gene)
Insect Tolerance
Herbicide Tolerance(CP4EPSPS gene)
COUNTRY
YEAR
Canada
USA
1996
1999
USA
Canada
Japan
1996
1996
1997
Maize
Herbicide Tolerance (PAT gene)
USA
Canada
Japan
Argentina
1995
1996
1997
1998
Maize
Herbicide Tolerance (PAT gene)
Insect Tolerance
USA
Canada
Japan
Argentina
EU
1995
1996
1996
1996
1997
Contd…
45
Sl. No. CROP
TRAIT
COUNTRY
YEAR
Maize
Herbicide Tolerance (PAT gene)
USA
Canada
1996
1996
Maize
Herbicide Tolerance (DAM gene)
USA
1998
Maize
Insect Tolerance ( cry3Bb1 gene)
USA
Canada
2003
2003
7. Melon
Delayed Ripening
USA
8. Polish Canola Herbicide Tolerance (PAT gene)
Polish Canola Herbicide Tolerance (CP4EPSPS gene)
9. Potato
Potato
Insect Tolerance (cry3A gene)
Insect Tolerance (cry3A gene)
Herbicide Tolerance (CP gene)
Canada
1998
Canada
1997
USA
Canada
USA
Canada
1995
1995
1999
1999
Contd…
46
Sl. No. CROP
10. Rice
11. Soybean
TRAIT
Herbicide Tolerance (PAT gene)
Herbicide Tolerance (CP4EPSPS gene)
Soybean
Herbicide Tolerance (
Soybean
Modified Oil (fad gene)
PATgene)
47
COUNTRY
YEAR
USA
1999
USA
Argentina
Japan
Canada
Uruguay
Mexico
Brazil
South Africa
1994
1996
1996
1995
1997
1998
1998
2001
USA
Canada
Japan
USA
Canada
Japan
Contd…
1996
1999
1999
1997
2000
1999
Sl. No. CROP
TRAIT
COUNTRY
12.
Squash
13.
Sugarbeet
Herbicide Tolerance (CP4EPSPS gene)
USA
1998
Sugarbeet
Herbicide Tolerance (PAT gene)
USA
Canada
1998
2001
14.
Resistance to viral infection (cp gene) USA
YEAR
Tomato
Increased Shelf life (ACC gene)USA
Tomato
Insect Tolerance
Tomato
Delayed ripening
Tomato
Delayed ripening
Tomato
Delayed ripening (PG gene)
1994
1995
USA
1998
(SAMase gene)
USA
1996
(ACCD gene)
USA
1995
48
USA
1992
Mexico 1995, Japan 1996
Transgenic crops approved for conducting contained limited
field trials including multi-location field trials during 2005
Sl. No Crop
1. Brinjal
Institute
Transgene
Mahyco, Mumbai
Sungro Seeds, N. Delhi
IARI, N. Delhi
cry1Ac
cry1Ac
cry1F
2. Cabbage Sungro Seeds, N. Delhi
cry1Ac
3. Cauliflower Sungro Seeds, N. Delhi
cry1Ab
4. Corn
cry1Ab
Turbo-Mu
Monsanto, Mumbai
Metahelix, Bangalore
49
Sl. No Crop
5. Cotton
Institute
Transgene
Ajeet Seeds, Aurangabad
Ankur Seeds P.Ltd., Nagpur
Bioseed, Hyd
Emergent P. Ltd, Hyd
Ganga Kaveri, Hyderabad
Green Gold, Aurangabad
JK Agri Genetics, Hyderabad
Kaveri Seeds Co. P. Ltd, S’bad
Krishidhan Seeds, Jalna
Mahyco, Mumbai
Metahelix, Bangalore
Nandi Seeds Pvt. Ltd Mehbubnagar
Namdhari Seeds Pvt. Ltd, Bangalore
Nath Seeds, Aurangabad
Nuziveedu Seeds, Hyderabad
50
cry1Ac, cryX
cry1Ac, cryX
cry1Ac, cryX
cry1Ac, cryX
cry1Ac
GFM cry1A
cry1Ac
cry1Ac
cry1Ac, cryX
cryX
cry1Ac
cry1Ac
cry1Ac
GFM cry1Aa
cry1Ac, cryX
Sl. No. Crop
Cotton
Institute
Prabhat. Hyderabad
Pravardhan, Hyderabad
Proagro, Hyderabad
Rasi Seeds Ltd., Attur
Syngenta India Ltd., Pune
Tulsi Seeds, Guntur
UAS, Dharwad
Vibha Agrotech Ltd. Hyderabad
Vikki’s Agrotech, Hyderabad
Vikram Seeds Ltd, Ahmedabad
Zuari Seeds Ltd. Bangalore
6. Groundnut ICRISAT, Hyderabad
7. Mustard
UDSC, New Delhi
51
Transgene
cry1Ac
cry1Ac
cry1Ac
cryX
Vip-3A
cry1Ac, cryX
cry1Ac
cry1Ac
cry1Ac
cry1Ac
GFM cry1A
coat protein of IPCV
barnase & barstar
Sl. No Crop
8. Okra
Institute
Transgene
Mahyco, Mumbai
cry1Ac
9. Pigeonpea ICARISAT, Hyderbad
10. Rice
IARI, N. Delhi
Mahyco, Mumbai
Metahelix, Bangalore
11. Tomato
IARI, New Delhi
cry1Ac
cry1Ac, cry1Aa +cry1B
cry1Ac
NHX gene
antisense replicase gene
of tomato LCV
cry1Ac
Mahyco, Mumbai
52
CROPS UNDER FIELDTRIALS

13 crops under various stages of
contained field trials

Include brinjal, cotton, cabbage,
groundnut, pigeon pea, mustard, potato,
sorghum, tomato, tobacco, rice, okra and
cauliflower
Traits include insect resistance, herbicide
tolerance, virus resistance, nutritional
enhancement, salt tolerance, fungal
resistance, etc

53
COMMERCIAL USE IN INDIA




Only one crop approved i.e. Bt. cotton
containing Cry1Ac gene
Three hybrids approved in 2002, one in
2004 and 16 hybrids in 2005
More hybrids under large scale trials
Large scale trials underway for Bt cotton
containing Cry1Ac & Cry2Ab genes
54
Bt. COTTON AREA UNDER CULTIVATION

2002 – 72,000 acres

2003 – 2,30,000 acres

2004 – 13,10,000 acres

2005 – 31,02,067 acres
55
Benefits of Bt Technology

Benefits of Bt Technology in a given crop =
Genetic potential of the crop in yield +
Factor Bt – differences in in-put costs

Factor Bt can be defined as “Realizable
benefits a of Bt Technology depends on the
levels of target pest infestation.”

a= amount saved due to reduction in the number
of sprays + crop saved due to Bt protein

Net benefit depends on the procurement price of
the cotton
56
CONCLUSIONS

All GMOs and r-DNA products are controlled commodities
under the Rules- 1989 OF EPA- 1986.

The Rules & Procedures under EPA are compliance friendly.

The Competent Authorities and their roles are well defined.

Familiarity with the Rules & Procedures is essential for
compliance.

The EPA to provide safe products to the society on existing
scientific knowledge.
57
CONCLUSIONS

Biosafety is real concern
 Biosafety regulations required to assess the
safety of transgenic crops before its release in to
environment

Biosafety concerns need to be addressed in a
scientific manner
 Continuous evolution of Biosafety Regulations are
required
58
THANK YOU
59