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 insectsWe 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

• 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

0

200

400

600

800

1000

1200

1400

1995 1996 1997 1998 1999 2000 2001 2002

World China Pakistan 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 pesticidesb. 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

• 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 varietySource variety / species Result

By comparison, biotechnology offersmore precise 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

• 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

• 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.

22

Agencies Involved in Rules,1989 of EPAct 1986

GOVERNMENT OF INDIA

Dept. of BiotechnologyDept. of Environment

RCGMGEAC

IBSC

PI/ Applicant

SBCC

Large Scale Imports, Production and Release

DLC

Applicant Monitoring-cum-

EvaluationCommittee

R&D,Limited experimentalfield trials andimports for R&D.

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 applicationtriggered

Rs.Rs.

Time

Po

pu

lati

on

(D

am

ag

e)

Rs.Rs.

Rs.Rs.

Rs.Rs.

Rs.Rs.

Bollgard cotton

Savings

Damage in Squares & Flowers – NCIPM, Nanded trial

Fig. 8. Damage in Squares & Flowers in BT vs Non-BT

0

5

10

15

20

25

30

30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49

Standard Weeks

% d

amag

e

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 studyAllergenicity (Brown Norway rat) Goat Study – ITRC,LucknowFish Feeding study – CIFE, MumbaiCow feeding study – NDRI, KarnalBuffalo feeding study – GBPUA&T, PantnagarChicken feeding study – CARI, BareillyPresence 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 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 IndiaMahyco - Cry1AcMonsanto Cry1Ac+2AbNath seeds Cry1Ac modified (China)JK seeds Cry1Ac modified (IIT Khargpur)Syngenta Vip3ADow Agri. Science Cry1FICAR Cry1Aa3

Cry1FCry1Ia5Cry1Ab (Japan)Cry1Ac (Canada)

NBRI Cry1Ec

Recommended Bt cotton hybrids for commercial cultivation in

India 2005North Zone Central Zone South Zone (6) (12) (10)MRC-6301 MECH-12 MECH-12MRC-6304 MECH-162 MECH-162RCH-134 MECH-184 MECH-184RCH-317 MRC-6301 RCH-2(2004)Ankur-651 RCH-2 (2004) RCH-20Ankur-2534 RCH-118 RCH-368

RCH-138 MRC-6322RCH-144 MRC-

6918(HB)Ankur-651 BunnyAnkur-09 MallikaBunnyMallika

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

LandPreparation

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 andfertilizers

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 andhoeing

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

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

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

Prof. Amartya Sen, Prof. Amartya Sen,

Nobel Prize Laureate for Nobel Prize Laureate for Economics , 1998Economics , 1998

Prof. Amartya Sen, Prof. Amartya Sen,

Nobel Prize Laureate for Nobel Prize Laureate for Economics , 1998Economics , 1998

Thank you!