Slide1: 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
Mahyco Monsanto Biotech India Ltd., Mumbai Slide2: Insects 330 M yrs. Dinosaurs 160 M yrs Man 1.5 M yrs We inherited this planet from insects Slide3: 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 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 trends in India Cotton Yield – World & India: Cotton Yield – World & India Lint Yield Q/Ha 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% Slide6: 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. Pesticide Usage Slide7: 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 Constraints of Cotton Production Four components of Transgenic Cotton: Four components of Transgenic Cotton Laboratory phase:
Involves identification of the gene, achieving stable transformation and adequate expression
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.
plant breeding Desired gene Commercial variety Source variety / species Result By comparison, biotechnology offers
more precise plant breeding... X Modern
biotechnology Importance of Transgenic Crops for Developing Countries: 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: 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: Transgenic Crop Plants
Methods for gene transfer:
Electric discharge transformation
Food and fiber production
Insect and disease control
Weed and abiotic stress tolerance
Medicine and food processing Transgenic Crop Plants: Traits HISTORY OF Bt: 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
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: Mode of Action The activated protein crosses the peritrophic membrane
Binds to receptors on the midgut epithelium
Midgut lining disintegrates
Larva stops feeding
Dies in 2-3 days. Limitations of Bt Sprays: Limitations of Bt Sprays Low efficacy
UV-degradable, short field persistence.
Poor Coverage Concerns Associated with Transgenic crops: 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.
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: Concerns Associated with Transgenic crops (contd….)
I. Fear of economic concentration.
II. Intellectual property rights & ethics.
III. Failure to exercise regulatory oversight
Issues with Transgenic Crops: Issues with Transgenic Crops Evaluation of risk before release of transgenics.
Base decisions on validated information.
Regulating transgenics by Government.
International policies and trade.
Public awareness and education. Slide22: Agencies Involved in Rules,1989 of EPAct 1986 GOVERNMENT OF INDIA Dept. of Biotechnology Dept. of Environment RCGM GEAC IBSC PI/ Applicant SBCC Large Scale Imports, Production and Release DLC Applicant Monitoring
field trials and
R&D. Commercialization of Transgenic Crops: Commercialization of Transgenic Crops It involves:
ii. Risk Assessment
It needs: i. Regulatory Agencies
ii. Research Organizations Slide24: Sub-threshold Protection in Bollgard Cotton Economic Threshold level Normal cotton insecticide application
triggered Rs. Time Population (Damage) Rs. Rs. Rs. Rs. Bollgard cotton Savings Damage in Squares & Flowers – NCIPM, Nanded trial: Damage in Squares & Flowers – NCIPM, Nanded trial How can Bt. cotton help the farmer?: 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: 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: 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)
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) : 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: 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
Bt PROTEIN CONTENT STUDIES
MOLECULAR CHARACTERISATION STUDY
INSECT RESISTANCE STUDIES
Bollgard Performance – ICAR Trial Summary: 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: 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 : 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 Slide34: Bt alone not the sole solution :
Inconsistent expression of cry 1 Ac
Bt protein throughout the growing
Bt cotton can be viewed as :
Foundation on which IPM has to be
built with broad range of biological &
Bt as a component in IPM :
expected to reduce insecticide use by
40-50 % in Helicoverpa control
(Bennet, 1998). Bt in IPM Slide35: Research on Bt cotton development in India
Mahyco - Cry1Ac
Nath seeds Cry1Ac modified (China)
JK seeds Cry1Ac modified (IIT Khargpur)
Dow Agri. Science Cry1F
Slide36: Recommended Bt cotton hybrids for commercial cultivation in India 2005 North Zone 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
Mallika Slide37: Table:- Cost of cultivation of Bt cotton in Maharashtra (Rs/ha) Slide38:
“India has avoided famine. But hunger continues even today”
Prof. Amartya Sen,
Nobel Prize Laureate for Economics , 1998 Thank you!: Thank you!