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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.
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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 • 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 Commercial variety Result Desired gene Conventional 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 • 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 GEAC Applicant Monitoring -cum- Evaluation Committee RCGM Large Scale Imports, Production and Release R&D, Limited experimental field trials and imports for R&D. SBCC IBSC PI/ Applicant DLC
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 Normal cotton Rs. Bollgard cotton Economic Threshold level Population (Damage) Rs. Savings Rs. Rs. Rs. Time
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 IPM • Bt alone not the sole solution : Inconsistent expression of cry 1 Ac Bt protein throughout the growing seasons • Bt cotton can be viewed as : Foundation on which IPM has to be built with broad range of biological & cultural practices • 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 - 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 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 RCH-138 MRC-6322 RCH-144 MRC-6918(HB) Ankur-651 Bunny Ankur-09 Mallika Bunny Mallika
Details 2002-03 2003-04 Overall Bt hybrid Conventional Bt hybrid Conventional Bt hybrid Conventional Land Preparation 1345 (10.68) 1345 (12.86) 1420 (10.93) 1420 (13.24) 1382.5 (10.81) 1382.5 (13.05) Seeds and sowing 4476 (35.55) 1645 (15.72) 4325 (33.28) 1496 (13.95) 4400.5 (34.40) 1570.5 (18.32) Manures and fertilizers 1482 (11.77) 1482 (14.17) 1565 (12.04) 1565 (14.59) 1523.5 (11.91) 1523.5 (14.38) Gap filling 169 (1.34) 180 (1.72) 140 (1.08) 170 (1.58) 154.5 (1.21) 175.0 (1.65) Weeding and hoeing 1927 (15.30) 1730 (16.54) 1880 (14.47) 1740 (16.22) 1903.5 (14.88) 1735.0 (16.38) Plant protection 1097 (8.71) 2394 (22.88) 1170 (9.00) 2410 (22.47) 1133.5 (8.86) 2402.0 (22.67) Picking 2096 (16.65) 1686 (16.12) 2496 (19.21) 1926 (17.95) 2296 (17.95) 1806 (17.05) Total cost 12592 (100) 10462 (100) 12996 (100) 10727 (100) 12794.0 (100) 10594.5 (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 Table:- Cost of cultivation of Bt cotton in Maharashtra (Rs/ha)
“India has avoided famine. But hunger continues even today” Prof. Amartya Sen, Nobel Prize Laureate for Economics , 1998