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 1998 1999 2000 2001 2002

World China Pakistan 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

 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 Commercial variety Result

Conventional  Desired gene
plant breeding X

Modern 
biotechnology
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

• 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.
• It was a Bt variety kurstaki strain marketed as
“Thuricide”
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.
contd...
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 Dept. of Biotechnology

Applicant GEAC RCGM Monitoring

-cum-
Evaluation
Committee
Large Scale
Imports,
Production SBCC R&D,
and Release IBSC Limited
experimental
field trials and
imports for
R&D.
DLC   PI/ Applicant

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
insecticide application
triggered
Population (Damage)

Normal cotton

Bollgard cotton Rs.

Economic Threshold level

Savings Rs.

Rs. Rs.
Rs.

Time
 Damage in Squares &
Flowers – NCIPM, Nanded trial
Fig. 8. Damage in Squares & Flowers in BT vs Non-BT
30

25

20
% damage

15

10

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
• 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)
◆Toxicity Studies
◆Mouse ( acute oral )
◆Rat feeding study
◆Allergenicity (Brown Norway rat)
◆Goat Study – ITRC,Lucknow
◆Fish Feeding study – CIFE, Mumbai
◆Cow feeding study – NDRI, Karnal
◆Buffalo feeding study – GBPUA&T, Pantnagar
◆Chicken feeding study – CARI, Bareilly
◆Presence 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 in-
depth 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 ➊ Bt alone not the sole solution :
IPM Inconsistent expression of cry 1
Bt protein throughout the growi
seasons

➋ Bt cotton can be viewed as :

Foundation on which IPM has to
built with broad range of biologi
cultural practices

➌ Bt as a component in IPM :
expected to reduce insecticide
by
40-50 % in Helicoverpa control
(Bennet, 1998).
Research on Bt cotton development in India
Mahyco - Cry1Ac
Monsanto Cry1Ac+2Ab
Nath seeds Cry1Ac modified (China)
JK seeds Cry1Ac modified (IIT Khargpur)
Syngenta Vip3A
Dow Agri. Science Cry1F
ICAR Cry1Aa3
Cry1F
Cry1Ia5
Cry1Ab (Japan)
Cry1Ac (Canada)
NBRI                               Cry1Ec
 Recommended Bt cotton hybrids
for commercial cultivation in
North Zone
India 2005
Central Zone South
Zone
(6) (12) (10)
MRC-6301 MECH-12 MECH-12
MRC-6304 MECH-162 MECH-162
RCH-134 MECH-184 MECH-184
RCH-317 MRC-6301 RCH-2(2004)
Ankur-651 RCH-2 (2004) RCH-20
Ankur-2534 RCH-118 RCH-
368
RCH-138 MRC-6322
RCH-144 MRC-
6918(HB)
Ankur-651 Bunny
Ankur-09 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

Land 1345 1345 1420 1420 1382.5 1382.5

Preparation  (10.68) (12.86) (10.93) (13.24) (10.81) (13.05)
Seeds and  4476 1645 4325 1496 4400.5 1570.5
sowing (35.55) (15.72) (33.28) (13.95) (34.40) (18.32)
Manures and 1482 1482 1565 1565 1523.5 1523.5
fertilizers (11.77) (14.17) (12.04) (14.59) (11.91) (14.38)
Gap filling  169 180 140 170 154.5 175.0
(1.34) (1.72) (1.08) (1.58) (1.21) (1.65)
Weeding and 1927 1730 1880 1740 1903.5 1735.0
hoeing  (15.30) (16.54) (14.47) (16.22) (14.88) (16.38)
Plant  1097 2394 1170 2410 1133.5 2402.0
protection  (8.71) (22.88) (9.00) (22.47) (8.86) (22.67)
Picking  2096 1686 2496 1926 2296 1806
(16.65) (16.12) (19.21) (17.95) (17.95) (17.05)
Total cost  12592 10462 12996 10727 12794.0 10594.5
(100) (100) (100) (100) (100) (100)
Yield (q/ha) 11.73 9.72 12.48 9.63 12.10 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

Output/input ratio 1.94 2.00 2.16 1.89 1.96 1.94

“India has avoided famine. But
hunger continues even today”

Prof. Amartya Sen,

Nobel Prize Laureate for
Economics , 1998
Thank you!