Transcript Slide 1

Release of Bt Cotton in India: A Case
Study
Short Term Orientation Course on
Bio-safety and Biotech Regulations
Organized by TERI-SAS & Sponsored by MoEF
By
M.K.Sharma,
Mahyco Monsanto Biotech India Ltd., Mumbai
We inherited this planet from insects
Insects 330 M yrs.
Dinosaurs 160 M yrs
Man 1.5 M yrs
Cotton trends in India
• A crop of significant
economic importance,
valued at over Rs.
15000 crores
• Approx. 20 Mn acres
of cotton provides
livelihood to almost 4
million farmers.
• Damage by Insect
pests reduce yields
by 50%
Cotton trends in India
• Farmers spend most
money on controlling
bollworms; up to 15 sprays
and over RS. 1400 Cr
• Insects resistance to
chemicals is increasing
• Yields are reduced in spite
of sprays
Cotton Yield – World & India
Lint Yield Q/Ha
1400
1200
1000
800
600
400
200
0
1995
1996
1997
World
1998
China
1999
2000
Pakistan
2001
2002
India
• Indian cotton yields are half of world avg. and 1/3rd of China avg.
• Overall a compound growth of –2% since 1995, yield from China are growing by 3%
Pesticide Usage
22.5 % of all crop pesticide in the world
55% of total insecticides used is on Cotton majority on bollworm
control
Helicoverpa a common major pest, causing epidemics resulting
into calamity
H. armigera comes in more than one peak along with pink boll
worm in all cotton growing zones
Other pests: Jassids,Aphids,White flies and Thrips
Rs. 2600 crores is spent in controlling insect pests on cotton.
Constraints of Cotton Production
Change in pest Scenario
a. Excessive and indiscriminate use of pesticides
b. Improper choice, quantity and application of pesticides.
c. Use of pesticide mixtures
(Has lead to)
a. Resurgence of minor pests
b. Resistance to pesticides
c. Increase in cost of protection
Four components of Transgenic
Cotton
• Laboratory phase:
– Involves identification of the gene, achieving stable
transformation and adequate expression
• Breeding phase:
– Involves using the transformant as a donor parent
for transferring the trait to other elite germplasm
• Bio-Safety & Field studies:
– Required to establish the safety of the transgenic
product
– Both small scale and large scale needed to
establish the agronomic superiority and determine
parameters like yield, quality etc
• Regulatory Process for Transgenic Crops:
– IBSC, RCGM, MEC, ICAR & GEAC.
By comparison, biotechnology offers
more precise plant breeding...
Source variety / species
Conventional
plant breeding
Modern
biotechnology
Commercial variety
X
Result
Desired gene
Importance of Transgenic Crops for
Developing Countries
• Greater crop area, variety of crops.
• Better crop protection.
• Greater need for more food and nutrition.
Transgenic Plant
A transgenic plant is a normal crop
plant with one or more additional
genes from diverse sources
engineered into the plant genome; the
plant thus acquires new, stable and
inherited trait/traits.
Transgenic Crop Plants
Methods for gene transfer:
• Agrobacterium-mediated transformation
• Particle bombardment
• Electric discharge transformation
Transgenic Crop Plants: Traits
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Food and fiber production
Increased yield
Nutritional quality
Insect and disease control
Weed and abiotic stress tolerance
Medicine and food processing
HISTORY OF Bt
• First reported from diseased silkworm from
Japan.
• Berliner coined the name Bacillus
thuringiensis, isolated the strain from a grain
mill in German district of Thuriengien
• First commercial preparation prepared in
1927
• First large scale Bt based product released
for sale in 1957 by Sandoz Corp.
Mode of Action
Mode of Action
• Insecticidal activity in crystalline bodies
produced during sporulation of the bacteria.
• Composed of proteins (delta endotoxins).
• The crystals dissolve in the alkaline conditions of
insect midgut.
• Release proteins (protoxins) of relative
molecular mass 65KD-160KD.
• These are proteolytically processed by midgut
proteases to yield smaller toxic fragments
(65KD).
Mode of Action
• The activated protein crosses the
peritrophic membrane
• Binds to receptors on the midgut
epithelium
• Gut paralysis
• Midgut lining disintegrates
• Larva stops feeding
• Dies in 2-3 days.
Limitations of Bt Sprays
• Low efficacy
• UV-degradable, short field
persistence.
• Poor Coverage
Concerns Associated with Transgenic
crops
• Human health risks.
i. Risk of possible allergies
ii. Extensive testing required.
iii. Labeling of GM food required.
vi. Fear of danger to human health from foreign
gene.
• Environmental risks.
i. Unintended harm to other organisms
ii. Pests develop resistance to traqnsgenics.
Iii. Gene transfer to non-target species.
Concerns Associated with Transgenic
crops
(contd….)
• Economic concerns.
I. Fear of economic concentration.
II. Intellectual property rights & ethics.
III. Failure to exercise regulatory oversight
Issues with Transgenic Crops
• Evaluation of risk before release of
transgenics.
• Base decisions on validated information.
• Regulating transgenics by Government.
• Safety testing.
• International policies and trade.
• Public awareness and education.
Agencies Involved in Rules,1989 of EPAct 1986
GOVERNMENT OF
INDIA
Dept. of Environment
Applicant
Large Scale
Imports,
Production
and Release
GEAC
Dept. of Biotechnology
RCGM
SBCC
IBSC
DLC
PI/ Applicant
Monitoring
-cumEvaluation
Committee
R&D,
Limited
experimental
field trials and
imports for
R&D.
22
Commercialization of
Transgenic Crops
It involves:
i. Regulations
ii. Risk Assessment
iii. Release
It needs:
i. Regulatory Agencies
ii. Research Organizations
Sub-threshold Protection in Bollgard
Cotton
Population (Damage)
insecticide application
triggered
Normal cotton
Rs.
Bollgard cotton
Economic Threshold level
Savings
Rs.
Rs.
Rs.
Time
Rs.
Damage in Squares &
Flowers – NCIPM, Nanded trial
Fig. 8. Damage in Squares & Flowers in BT vs Non-BT
30
% damage
25
20
15
10
5
0
30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49
Standard Weeks
BT
NON-BT
How can Bt. cotton help the
farmer?
• Bt cotton provides in built protection to cotton
against lepidopteran pests (Helicoverpa)
• Can significantly reduce the number of sprays
for Helicoverpa therefore reducing farmers costs
and debt
• Potential for large yield increase
• Is completely safe to crop and environment
• Fits into the IPM strategy in India
• Peace of Mind
Development Of Bt Cotton In India
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1994 Formation of IBSC & application for seed import
1995 Permit to import seed (100 gm Coker 312)
1996 Imported seed, Greenhouse trial (Coker 312)
1996 Limited field trial -1 Location
1997-98 Limited field trials-5 Locations
1998 Ruminant (goat) and Allerginicity studies
1998-99 Multi centric replicated trials-15+25 Locations
1999-00 Multi centric replicated trials-11 Locations
2000-01 Large Scale field Trials & Hybrid Seed
Production, Conduction of various Studies, ICAR Trials
• 2001-02 Large Scale & ICAR trials, Hybrid Seed Prodn.
• 2002: Approval for commercialization by GEAC
Bio-safety data generation
• Followed DBT Guidelines and Recommendations
• Studies conducted in India from 1997 to 1999
– Goat study at ITRC, Lucknow
– Aggresiveness, germination, weediness
– Pollen flow studies
– Substantial Equivalence (oil and food/feed properties)
– Soil microflora
– Effect on beneficial and non target insects
– protein expression in different plant parts
• Supplemented with published data and studies conducted by
Monsanto
Biosafety Data (Food/Feed)
uToxicity
Studies
uMouse ( acute oral )
uRat feeding study
uAllergenicity (Brown Norway rat)
uGoat Study – ITRC,Lucknow
uFish Feeding study – CIFE, Mumbai
uCow feeding study – NDRI, Karnal
uBuffalo feeding study – GBPUA&T, Pantnagar
uChicken feeding study – CARI, Bareilly
uPresence of Bt protein in lint & oil cake – CICR,
Nagpur
OTHER STUDIES CONDUCTED IN 2000-01
• ABSENCE OF TERMINATOR GENE, Delhi
University, South Campus, New Delhi
• BASE LINE STUDY –PDBC, Banglore
• SOCIO-ECONOMIC BENEFIT STUDY, IIM,
Ahmedabad
• GENE STABILITY
• Bt PROTEIN CONTENT STUDIES
• MOLECULAR CHARACTERISATION STUDY
• INSECT RESISTANCE STUDIES
• SOIL STUDIES
• POLLEN ESCAPE
Bollgard Performance – ICAR Trial
Summary
Bollgard Hybrids mature 15 days earlier
The increase in yield over non-Bt counterparts by 31%.
Bollgard recorded 20q/ha highest yield
Insecticide spray reduction to the tune of 65%.
Under unprotected conditions also performance of Bollgard
cotton was better.
The Bollgard cotton hybrids fit well in IPM module.
Bollgard yielded additional economic benefit of Rs.10000/ha.
Approval
• The GEAC considered the proposal in its 32nd
meeting held on 26.3.02. After careful and indepth consideration, the GEAC hereby accords
approval for release into the environment of three
transgenic Bt hybrid cotton varieties, developed
by Maharashtra Hybrid Seed Company MAHYCO,
namely, Bt MECH 12, Bt MECH 162, and Bt
MECH 184, containing Cry 1Ac gene and nptll
and aad marker genes subject to conditions.
Approval conditions for commercialization
of Bt cotton in India
• Valid for three years: April 02 to March, 05
• Three hybrids namely MECH12Bt, MECH162Bt and
MECH184Bt
• Provide same non Bt seed to meet refuge
requirements
• Conduct studies to monitor resistance development
• Provide information to government on distribution of
the seed through its dealers and agents
• Labeling requirements such as GEAC number, etc.,
• Develop Bt based IPM program
• Undertake education and awareness program
• Meet other requirements as stipulated
Bt in
IPM
Ê Bt alone not the sole solution :
Inconsistent expression of cry 1 Ac
Bt protein throughout the growing
seasons
Ë Bt cotton can be viewed as :
Foundation on which IPM has to be
built with broad range of biological &
cultural practices
Ì Bt as a component in IPM :
expected to reduce insecticide use by
40-50 % in Helicoverpa control
(Bennet, 1998).
Research on Bt cotton development in India
Mahyco Monsanto
Nath seeds
JK seeds
Syngenta
Dow Agri. Science
ICAR
NBRI
Cry1Ac
Cry1Ac+2Ab
Cry1Ac modified (China)
Cry1Ac modified (IIT Khargpur)
Vip3A
Cry1F
Cry1Aa3
Cry1F
Cry1Ia5
Cry1Ab (Japan)
Cry1Ac (Canada)
Cry1Ec
Recommended Bt cotton hybrids for
commercial cultivation in India 2005
North Zone
(6)
MRC-6301
MRC-6304
RCH-134
RCH-317
Ankur-651
Ankur-2534
Central Zone
(12)
MECH-12
MECH-162
MECH-184
MRC-6301
RCH-2 (2004)
RCH-118
RCH-138
RCH-144
Ankur-651
Ankur-09
Bunny
Mallika
South Zone
(10)
MECH-12
MECH-162
MECH-184
RCH-2(2004)
RCH-20
RCH-368
MRC-6322
MRC-6918(HB)
Bunny
Mallika
Table:- Cost of cultivation of Bt cotton in Maharashtra (Rs/ha)
Details
2002-03
2003-04
Overall
Bt hybrid
Conventional
Bt hybrid
Conventional
Bt hybrid
Conventional
Yield (q/ha)
1345
(10.68)
4476
(35.55)
1482
(11.77)
169
(1.34)
1927
(15.30)
1097
(8.71)
2096
(16.65)
12592
(100)
11.73
1345
(12.86)
1645
(15.72)
1482
(14.17)
180
(1.72)
1730
(16.54)
2394
(22.88)
1686
(16.12)
10462
(100)
9.72
1420
(10.93)
4325
(33.28)
1565
(12.04)
140
(1.08)
1880
(14.47)
1170
(9.00)
2496
(19.21)
12996
(100)
12.48
1420
(13.24)
1496
(13.95)
1565
(14.59)
170
(1.58)
1740
(16.22)
2410
(22.47)
1926
(17.95)
10727
(100)
9.63
1382.5
(10.81)
4400.5
(34.40)
1523.5
(11.91)
154.5
(1.21)
1903.5
(14.88)
1133.5
(8.86)
2296
(17.95)
12794.0
(100)
12.10
1382.5
(13.05)
1570.5
(18.32)
1523.5
(14.38)
175.0
(1.65)
1735.0
(16.38)
2402.0
(22.67)
1806
(17.05)
10594.5
(100)
9.69
Price (Rs/q)
2078
2029
2250
2225
2127
2078
Gross return
24375
19722
28080
21427
26227.5
20148.2
Net return
11783
9260
15084
10700
13433.5
9620.0
1.94
2.00
2.16
1.89
1.96
1.94
Land
Preparation
Seeds and
sowing
Manures and
fertilizers
Gap filling
Weeding and
hoeing
Plant
protection
Picking
Total cost
Output/input ratio
“India has avoided famine.
But hunger continues even
today”
Prof. Amartya Sen,
Nobel Prize Laureate for Economics , 1998
Thank you!