Dr Mahendra Sharma

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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


Insects 330 M yrs. Dinosaurs 160 M yrs Man 1.5 M yrs We inherited this planet from insects


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%


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


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 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.


Conventional 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: Agrobacterium-mediated transformation Particle bombardment Electric discharge transformation


Food and fiber production Increased yield Nutritional quality Insect and disease control Weed and abiotic stress tolerance Medicine and food processing Transgenic Crop Plants: Traits


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 Gut paralysis 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. 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: 

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: 

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 Biotechnology Dept. of Environment RCGM GEAC 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.

Commercialization of Transgenic Crops: 

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 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) 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) : 

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



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 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


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). Bt in IPM


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


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

Thank you!: 

Thank you!

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