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Assignment
Subject : Breeding Designer Crops (GPB822)
Presented by: Mr. Indranil Bhattacharjee
Student I.D. No.: 17PHGPB102
Presented to : Prof. (Dr.) B.G.Suresh
Sam Higginbottom University of Agriculture, Technology &
Sciences
Allahabad-211007
REGULATORY MECHANISMS, GUIDELINES
AND PROTOCOLS FOR TRANSGENIC
CROPS; FOOD AND FEED SENARIO
2
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
3
Objectives of Regulations
To facilitate & regulate
Modern biotechnology work
at different stages to achieve the
objectives of biosafety.
4
BIOSAFETY REGULATIONS & GUIDELINES
* International:
Cartagena Protocol on Biosafety
OECD Guidelines
* Country specific:
USA, EU, Canada, Australia, Egypt, Japan, China,
Philippines, Thailand, India, Pakistan, etc.
5
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
GENETICALLY MODIFIED ORGANISMS
(GMOs) AND r-DNA PRODUCTS
GOVERNED BY
6
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
TRANSGENIC CROPS ARE ALSO GOVERNED BY
7
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 ......
8
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.
9
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.
10
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.
11
* 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.
Approval and prohibitions, etc. under Rules 1989
12
* 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.
Approval and prohibitions, etc. under Rules 1989
13
COMPETENT AUTHORITIES
1. Recombinant DNAAdvisory 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)
14
Recombinant DNAAdvisory 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.
15
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.
16
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.
17
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.
18
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.
19
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.
20
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 ”
“Guidelines for Generating pre-clinical and Clinical data for
r-DNA based Vaccines, Diagnostics and other Biologicals
1999
21
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.
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.
CLASSIFICATION OF GENETIC ENGINEERING EXPERIMENTS
23
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.
24
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.
25
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
26
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’
27
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 EngineeringApproval 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
28
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 EngineeringApproval 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
29
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 .......
30
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 ....
Biosafety parameters on Transgenic crops
31
2. Environmental parameters
 Gene flow
 Implications of out-crossing
 Effect on target and non-target organisms
 Effect on soil biota
Contd….
Biosafety parameters on Transgenic crops
32
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….
33
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….
34
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
35
GUIDELINES FOR TOXICICTYAND
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
36
GUIDELINES FOR TOXICICTYAND
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
37
GUIDELINES FOR TOXICICTYAND
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)
38
Agencies Involved in
Environmental release of transgenic crops/ food
products by imports
Applicant GEAC
Commercial
Release
MoE&F
MoA/ICAR, MoH&FW, DBT
39
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
40
Agencies Involved in Rules,1989 of EPA 1986
GOVERNMENT OF
INDIA
Dept. of BiotechnologyMin. of Environment
RCGMGEAC
IBSC
PI/ Applicant
SBCC
Large Scale
Imports,
Production and
Release
DLC
Applicant Monitoring
-cum-
Evaluation
Committee
R&D,
Limited
experimental
field trials and
imports for
R&D.
41
Summary of r-DNA Research in India
Number of Institutions engaged ~ 240
Number of Institutions engaged in ~ 95
transgenic research (60+35)
Number of Private Institutions ~ 50
engaged in r-DNA therapeutics
Other Institutions engaged in basic work ~ 95
42
TRANSGENIC CROPS APPROVED GOBALLY
Sl. No. CROP TRAIT COUNTRY YEAR
1. Canola Herbicide Tolerance Canada 1995
(CP4EPSPS) US 1999
Japan 1996
Herbicide Tolerance Canada 1995
(PAT) US 1995
Japan 1996
Australia 2003
Herbicide Tolerance Canada 1997
(bxn) Japan 1998
Herbicide Tolerance Canada 1995
(ALS)
contd…
43
Sl. No. CROP TRAIT COUNTRY YEAR
2. Carnation Increased shelf life Australia 1995
Herbicide Tolerance European Union 1998
3. Chicory Herbicide Tolerance European Union 1996
USA 1997
4. Cotton Insect Tolerance USA 1995
Australia 1996
Japan 1997
China 1997
Mexico 1997
South Africa 1997
Argentina 1998
India 2002
Herbicide Tolerance USA 1994
(bxn gene) Japan 1997
contd…
44
Sl. No. CROP TRAIT COUNTRY YEAR
Cotton Herbicide Tolerance (bxn gene) USA 1997
Insect Tolerance Japan 1998
Cotton Herbicide Tolerance (ALS gene) USA 1996
Cotton Herbicide Tolerance (CP4EPSPSgene) USA 1995
Japan 1997
Australia 1999
Argentina 2000
Cotton Herbicide Tolerance (CP4EPSPSgene) USA
Insect Tolerance
Cotton Herbicide Tolerance (PATgene) USA 2003
Cotton Insect Tolerance (Cry1Ac+Cry1F genes) USA 2004
Contd…
45
Sl. No. CROP TRAIT COUNTRY YEAR
5. Linseed Herbicide Tolerance (ALS gene) Canada 1996
USA 1999
6. Maize Insect Tolerance USA 1996
Herbicide Tolerance(CP4EPSPS gene) Canada 1996
Japan 1997
Maize Herbicide Tolerance (PAT gene) USA 1995
Canada 1996
Japan 1997
Argentina 1998
Maize Herbicide Tolerance (PAT gene) USA 1995
Insect Tolerance Canada 1996
Japan 1996
Argentina 1996
EU 1997
Contd…
46
Sl. No. CROP TRAIT COUNTRY YEAR
Maize Herbicide Tolerance (PAT gene) USA 1996
Canada 1996
Maize Herbicide Tolerance (DAM gene) USA 1998
Maize Insect Tolerance ( cry3Bb1 gene) USA 2003
Canada 2003
7. Melon Delayed Ripening USA
8. Polish Canola Herbicide Tolerance (PAT gene) Canada 1998
Polish Canola Herbicide Tolerance (CP4EPSPS gene) Canada 1997
9. Potato Insect Tolerance (cry3A gene) USA 1995
Canada 1995
Potato Insect Tolerance (cry3A gene) USA 1999
Herbicide Tolerance (CP gene) Canada 1999
Contd…
47
Sl. No. CROP TRAIT COUNTRY YEAR
10. Rice Herbicide Tolerance (PAT gene) USA 1999
11. Soybean Herbicide Tolerance (CP4EPSPS gene) USA 1994
Argentina 1996
Japan 1996
Canada 1995
Uruguay 1997
Mexico 1998
Brazil 1998
South Africa 2001
Soybean Herbicide Tolerance ( PATgene) USA 1996
Canada 1999
Japan 1999
Soybean Modified Oil (fad gene) USA 1997
Canada 2000
Japan 1999
Contd…
48
Sl. No. CROP TRAIT COUNTRY YEAR
12. Squash Resistance to viral infection (cp gene) USA 1994
13. Sugarbeet Herbicide Tolerance (CP4EPSPS gene) USA 1998
Sugarbeet Herbicide Tolerance (PAT gene) USA 1998
Canada 2001
14. Tomato Increased Shelf life (ACC gene)USA 1995
Tomato Insect Tolerance USA 1998
Tomato Delayed ripening (SAMase gene) USA 1996
Tomato Delayed ripening (ACCD gene) USA 1995
Tomato Delayed ripening (PG gene) USA 1992
Mexico 1995, Japan 1996
49
Transgenic crops approved for conducting contained limited
field trials including multi-location field trials during 2005
Sl. No Crop Institute Transgene
1. Brinjal Mahyco, Mumbai cry1Ac
Sungro Seeds, N. Delhi cry1Ac
IARI, N. Delhi cry1F
2. Cabbage Sungro Seeds, N. Delhi cry1Ac
3. Cauliflower Sungro Seeds, N. Delhi cry1Ab
4. Corn Monsanto, Mumbai cry1Ab
Metahelix, Bangalore Turbo-Mu
50
Sl. No Crop Institute Transgene
5. Cotton Ajeet Seeds, Aurangabad cry1Ac, cryX
Ankur Seeds P.Ltd., Nagpur cry1Ac, cryX
Bioseed, Hyd cry1Ac, cryX
Emergent P. Ltd, Hyd cry1Ac, cryX
Ganga Kaveri, Hyderabad cry1Ac
Green Gold, Aurangabad GFM cry1A
JK Agri Genetics, Hyderabad cry1Ac
Kaveri Seeds Co. P. Ltd, S’bad cry1Ac
Krishidhan Seeds, Jalna cry1Ac, cryX
Mahyco, Mumbai cryX
Metahelix, Bangalore cry1Ac
Nandi Seeds Pvt. Ltd Mehbubnagar cry1Ac
Namdhari Seeds Pvt. Ltd, Bangalore cry1Ac
Nath Seeds, Aurangabad GFM cry1Aa
Nuziveedu Seeds, Hyderabad cry1Ac, cryX
51
Sl. No. Crop Institute Transgene
Cotton Prabhat. Hyderabad cry1Ac
Pravardhan, Hyderabad cry1Ac
Proagro, Hyderabad cry1Ac
Rasi Seeds Ltd., Attur cryX
Syngenta India Ltd., Pune Vip-3A
Tulsi Seeds, Guntur cry1Ac, cryX
UAS, Dharwad cry1Ac
Vibha Agrotech Ltd. Hyderabad cry1Ac
Vikki’s Agrotech, Hyderabad cry1Ac
Vikram Seeds Ltd, Ahmedabad cry1Ac
Zuari Seeds Ltd. Bangalore GFM cry1A
6. Groundnut ICRISAT, Hyderabad coat protein of IPCV
7. Mustard UDSC, New Delhi barnase & barstar
52
Sl. No Crop Institute Transgene
8. Okra Mahyco, Mumbai cry1Ac
9. Pigeonpea ICARISAT, Hyderbad cry1Ac
10. Rice IARI, N. Delhi cry1Ac, cry1Aa +cry1B
Mahyco, Mumbai cry1Ac
Metahelix, Bangalore NHX gene
11. Tomato IARI, New Delhi antisense replicase gene
of tomato LCV
Mahyco, Mumbai cry1Ac
53
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
54
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
55
Bt. COTTON AREA UNDER CULTIVATION
 2002 – 72,000 acres
 2003 – 2,30,000 acres
 2004 – 13,10,000 acres
 2005 – 31,02,067 acres
56
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
57
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.
58
 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
CONCLUSIONS
59
THANK YOUTHANK YOU

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07 regulatory mechanisms, guidelines

  • 1. Assignment Subject : Breeding Designer Crops (GPB822) Presented by: Mr. Indranil Bhattacharjee Student I.D. No.: 17PHGPB102 Presented to : Prof. (Dr.) B.G.Suresh Sam Higginbottom University of Agriculture, Technology & Sciences Allahabad-211007 REGULATORY MECHANISMS, GUIDELINES AND PROTOCOLS FOR TRANSGENIC CROPS; FOOD AND FEED SENARIO
  • 2. 2 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
  • 3. 3 Objectives of Regulations To facilitate & regulate Modern biotechnology work at different stages to achieve the objectives of biosafety.
  • 4. 4 BIOSAFETY REGULATIONS & GUIDELINES * International: Cartagena Protocol on Biosafety OECD Guidelines * Country specific: USA, EU, Canada, Australia, Egypt, Japan, China, Philippines, Thailand, India, Pakistan, etc.
  • 5. 5 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 GENETICALLY MODIFIED ORGANISMS (GMOs) AND r-DNA PRODUCTS GOVERNED BY
  • 6. 6 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 TRANSGENIC CROPS ARE ALSO GOVERNED BY
  • 7. 7 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 ......
  • 8. 8 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.
  • 9. 9 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.
  • 10. 10 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.
  • 11. 11 * 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. Approval and prohibitions, etc. under Rules 1989
  • 12. 12 * 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. Approval and prohibitions, etc. under Rules 1989
  • 13. 13 COMPETENT AUTHORITIES 1. Recombinant DNAAdvisory 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)
  • 14. 14 Recombinant DNAAdvisory 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.
  • 15. 15 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.
  • 16. 16 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.
  • 17. 17 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.
  • 18. 18 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.
  • 19. 19 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.
  • 20. 20 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 ” “Guidelines for Generating pre-clinical and Clinical data for r-DNA based Vaccines, Diagnostics and other Biologicals 1999
  • 21. 21 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.
  • 22. 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. CLASSIFICATION OF GENETIC ENGINEERING EXPERIMENTS
  • 23. 23 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.
  • 24. 24 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.
  • 25. 25 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
  • 26. 26 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’
  • 27. 27 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 EngineeringApproval 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
  • 28. 28 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 EngineeringApproval 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
  • 29. 29 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 .......
  • 30. 30 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 .... Biosafety parameters on Transgenic crops
  • 31. 31 2. Environmental parameters  Gene flow  Implications of out-crossing  Effect on target and non-target organisms  Effect on soil biota Contd…. Biosafety parameters on Transgenic crops
  • 32. 32 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….
  • 33. 33 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….
  • 34. 34 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
  • 35. 35 GUIDELINES FOR TOXICICTYAND 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
  • 36. 36 GUIDELINES FOR TOXICICTYAND 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
  • 37. 37 GUIDELINES FOR TOXICICTYAND 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)
  • 38. 38 Agencies Involved in Environmental release of transgenic crops/ food products by imports Applicant GEAC Commercial Release MoE&F MoA/ICAR, MoH&FW, DBT
  • 39. 39 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
  • 40. 40 Agencies Involved in Rules,1989 of EPA 1986 GOVERNMENT OF INDIA Dept. of BiotechnologyMin. of Environment RCGMGEAC IBSC PI/ Applicant SBCC Large Scale Imports, Production and Release DLC Applicant Monitoring -cum- Evaluation Committee R&D, Limited experimental field trials and imports for R&D.
  • 41. 41 Summary of r-DNA Research in India Number of Institutions engaged ~ 240 Number of Institutions engaged in ~ 95 transgenic research (60+35) Number of Private Institutions ~ 50 engaged in r-DNA therapeutics Other Institutions engaged in basic work ~ 95
  • 42. 42 TRANSGENIC CROPS APPROVED GOBALLY Sl. No. CROP TRAIT COUNTRY YEAR 1. Canola Herbicide Tolerance Canada 1995 (CP4EPSPS) US 1999 Japan 1996 Herbicide Tolerance Canada 1995 (PAT) US 1995 Japan 1996 Australia 2003 Herbicide Tolerance Canada 1997 (bxn) Japan 1998 Herbicide Tolerance Canada 1995 (ALS) contd…
  • 43. 43 Sl. No. CROP TRAIT COUNTRY YEAR 2. Carnation Increased shelf life Australia 1995 Herbicide Tolerance European Union 1998 3. Chicory Herbicide Tolerance European Union 1996 USA 1997 4. Cotton Insect Tolerance USA 1995 Australia 1996 Japan 1997 China 1997 Mexico 1997 South Africa 1997 Argentina 1998 India 2002 Herbicide Tolerance USA 1994 (bxn gene) Japan 1997 contd…
  • 44. 44 Sl. No. CROP TRAIT COUNTRY YEAR Cotton Herbicide Tolerance (bxn gene) USA 1997 Insect Tolerance Japan 1998 Cotton Herbicide Tolerance (ALS gene) USA 1996 Cotton Herbicide Tolerance (CP4EPSPSgene) USA 1995 Japan 1997 Australia 1999 Argentina 2000 Cotton Herbicide Tolerance (CP4EPSPSgene) USA Insect Tolerance Cotton Herbicide Tolerance (PATgene) USA 2003 Cotton Insect Tolerance (Cry1Ac+Cry1F genes) USA 2004 Contd…
  • 45. 45 Sl. No. CROP TRAIT COUNTRY YEAR 5. Linseed Herbicide Tolerance (ALS gene) Canada 1996 USA 1999 6. Maize Insect Tolerance USA 1996 Herbicide Tolerance(CP4EPSPS gene) Canada 1996 Japan 1997 Maize Herbicide Tolerance (PAT gene) USA 1995 Canada 1996 Japan 1997 Argentina 1998 Maize Herbicide Tolerance (PAT gene) USA 1995 Insect Tolerance Canada 1996 Japan 1996 Argentina 1996 EU 1997 Contd…
  • 46. 46 Sl. No. CROP TRAIT COUNTRY YEAR Maize Herbicide Tolerance (PAT gene) USA 1996 Canada 1996 Maize Herbicide Tolerance (DAM gene) USA 1998 Maize Insect Tolerance ( cry3Bb1 gene) USA 2003 Canada 2003 7. Melon Delayed Ripening USA 8. Polish Canola Herbicide Tolerance (PAT gene) Canada 1998 Polish Canola Herbicide Tolerance (CP4EPSPS gene) Canada 1997 9. Potato Insect Tolerance (cry3A gene) USA 1995 Canada 1995 Potato Insect Tolerance (cry3A gene) USA 1999 Herbicide Tolerance (CP gene) Canada 1999 Contd…
  • 47. 47 Sl. No. CROP TRAIT COUNTRY YEAR 10. Rice Herbicide Tolerance (PAT gene) USA 1999 11. Soybean Herbicide Tolerance (CP4EPSPS gene) USA 1994 Argentina 1996 Japan 1996 Canada 1995 Uruguay 1997 Mexico 1998 Brazil 1998 South Africa 2001 Soybean Herbicide Tolerance ( PATgene) USA 1996 Canada 1999 Japan 1999 Soybean Modified Oil (fad gene) USA 1997 Canada 2000 Japan 1999 Contd…
  • 48. 48 Sl. No. CROP TRAIT COUNTRY YEAR 12. Squash Resistance to viral infection (cp gene) USA 1994 13. Sugarbeet Herbicide Tolerance (CP4EPSPS gene) USA 1998 Sugarbeet Herbicide Tolerance (PAT gene) USA 1998 Canada 2001 14. Tomato Increased Shelf life (ACC gene)USA 1995 Tomato Insect Tolerance USA 1998 Tomato Delayed ripening (SAMase gene) USA 1996 Tomato Delayed ripening (ACCD gene) USA 1995 Tomato Delayed ripening (PG gene) USA 1992 Mexico 1995, Japan 1996
  • 49. 49 Transgenic crops approved for conducting contained limited field trials including multi-location field trials during 2005 Sl. No Crop Institute Transgene 1. Brinjal Mahyco, Mumbai cry1Ac Sungro Seeds, N. Delhi cry1Ac IARI, N. Delhi cry1F 2. Cabbage Sungro Seeds, N. Delhi cry1Ac 3. Cauliflower Sungro Seeds, N. Delhi cry1Ab 4. Corn Monsanto, Mumbai cry1Ab Metahelix, Bangalore Turbo-Mu
  • 50. 50 Sl. No Crop Institute Transgene 5. Cotton Ajeet Seeds, Aurangabad cry1Ac, cryX Ankur Seeds P.Ltd., Nagpur cry1Ac, cryX Bioseed, Hyd cry1Ac, cryX Emergent P. Ltd, Hyd cry1Ac, cryX Ganga Kaveri, Hyderabad cry1Ac Green Gold, Aurangabad GFM cry1A JK Agri Genetics, Hyderabad cry1Ac Kaveri Seeds Co. P. Ltd, S’bad cry1Ac Krishidhan Seeds, Jalna cry1Ac, cryX Mahyco, Mumbai cryX Metahelix, Bangalore cry1Ac Nandi Seeds Pvt. Ltd Mehbubnagar cry1Ac Namdhari Seeds Pvt. Ltd, Bangalore cry1Ac Nath Seeds, Aurangabad GFM cry1Aa Nuziveedu Seeds, Hyderabad cry1Ac, cryX
  • 51. 51 Sl. No. Crop Institute Transgene Cotton Prabhat. Hyderabad cry1Ac Pravardhan, Hyderabad cry1Ac Proagro, Hyderabad cry1Ac Rasi Seeds Ltd., Attur cryX Syngenta India Ltd., Pune Vip-3A Tulsi Seeds, Guntur cry1Ac, cryX UAS, Dharwad cry1Ac Vibha Agrotech Ltd. Hyderabad cry1Ac Vikki’s Agrotech, Hyderabad cry1Ac Vikram Seeds Ltd, Ahmedabad cry1Ac Zuari Seeds Ltd. Bangalore GFM cry1A 6. Groundnut ICRISAT, Hyderabad coat protein of IPCV 7. Mustard UDSC, New Delhi barnase & barstar
  • 52. 52 Sl. No Crop Institute Transgene 8. Okra Mahyco, Mumbai cry1Ac 9. Pigeonpea ICARISAT, Hyderbad cry1Ac 10. Rice IARI, N. Delhi cry1Ac, cry1Aa +cry1B Mahyco, Mumbai cry1Ac Metahelix, Bangalore NHX gene 11. Tomato IARI, New Delhi antisense replicase gene of tomato LCV Mahyco, Mumbai cry1Ac
  • 53. 53 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
  • 54. 54 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
  • 55. 55 Bt. COTTON AREA UNDER CULTIVATION  2002 – 72,000 acres  2003 – 2,30,000 acres  2004 – 13,10,000 acres  2005 – 31,02,067 acres
  • 56. 56 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
  • 57. 57 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.
  • 58. 58  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 CONCLUSIONS