Accelerating the introduction of new hybrids containing approved gene events

Representation submitted by the

Seed Industry Associations

0

5

10

15

20

25

30

1966 1990 1998 2004

Nu

mb

er

Corn Sorghum Millet Cotton Sunflower Hybrid rice

Private seed companies with strong breeding programs

Post NSP 1988:

Private sector accounts for 70% turnover in seedAlmost 1/3 companies have a global technology/ financial partner

Private seed companies are spending 10-12% of their turnover in R&D

R&D budget of medium sized companies is growing @ 20% p.a.

Current status of the Indian seed industry

Contribution of seed industry to Indian agriculture

Public bred hybrids

9%

Open pollinated

50%

Vegetable 11%

Private bred

hybrids30%

0

10,000

20,000

30,000

40,000

50,000

60,000

70,000

Cotton Maize Sorghum Bajra Sunflower

0

20

40

60

80

100

120

140

Production (MT)

Value mil USD

(

Public-private share crop-wise

0%

20%

40%

60%

80%

100%

Cotton Maize Sorghum Bajra Sunflower

Private Sector Public Sector

Key Hybrid Crops: Sales

Market segmentation

0 1000 2000 3000 4000 5000 6000 7000 8000 9000

1

Cotton Area In million ha in 2001/02

India U.S.A. China Pakistan F.S.U-12 Uzbekistan Australia

0 200 400 600 800 1000 1200 1400 1600

Yield in kg/ha

1

Cotton Productivity in kg/ha in 2001/02

India U.S.A. China Pakistan F.S.U-12 Uzbekistan Australia

Three cotton growing zones: - North - Central- South

Light soil, drought proneEarly maturity, drought toleranceMedium bolls

Light soilsEarly maturityMedium bolls

Heavy, irrigated soilsLong duration, big bolls

Medium soil, rainfedEarly maturity, mediumand big bolls

Black soils, rainfedMedium durationmedium bolls

Saline soils

Heavy soils, high managementLong duration, big bolls

Light soils, undulatedEarly maturity, medium bolls

Medium soils, plainEarly-medium maturityMedium-big bolls

Heavy soils, rainfedMedium bolls, early

Early to medium maturityMedium to big bolls

Light soils, early maturityDrought tolerance

Light soils, low input, early

Light soils, early, medium bolls

Light soils, good managementMedium maturity, medium bolls

Heavy soils, drought pronePoor managementMedium indeterminate, medium bolls

Irrigated, medium maturity, early sown, double cropping

Heavy soils, big bollsMedium duration indeterminate

Heavy soils, good management, medium to big bolls, med to late maturity

Light to medium soils, good managementmedium bolls, medium maturity

Heavy soils, drought proneLarge holdingsEarly to medium, medium bolls

Medium soils, good management

Low inputs

Inter-specific hybrids

1

2

Cotton

0

10

20

30

40

50

60

70

80

1992-93

2002-03

However, the number of Bt hybrids approved so far are far too less

Legal Bt8%

Illegal Bt18%

Non Bt74%

Non Bt40%

Illegal Bt40%

Legal Bt20%

Adoption of approved Bt hybrid technology in India

0

200000

400000

600000

800000

1000000

1200000

1400000

2002 2003 2004

Ac

res

/ Fa

rme

rs

Acerage Farmers

Current Scenario• The benefit of the Bt technology in cotton has

been established beyond doubt (reduced pesticide use, increased yield)

• Comprehensive bio-safety and environmental safety analysis of Cry1Ac/Mon531 was done in 2002 and 20 hybrids have been commercialized so far

• However, this number is too small to meet the diverse genetic requirements of variable climates/areas/soil types/cropping patterns/crop management practices/farmer profiles/end use business requirements etc.

• In hybrid based approval system in India, new hybrids containing approved events are subjected to agronomic evaluation by different regulatory agencies

• This has slowed the introduction of new hybrids with diverse genetics, and resulted in an inconsistent, dicretionary and discriminatory approval system– This approval process has taken 1 to 5 years for different

hybrids/companies– ICAR testing of new hybrids was not done in 2005 even though it is

recommended in the NSP 2002– After 4 years of event’s release in environment, approval process is

getting slower, more unpredictable and more restrictive

• This testing protocol was designed when the bio-safety of the event Cry1Ac/Mon531 was still being tested

• For approved events which have been released in the environment, the process for commercialization of new hybrids can be revisited and modified

Current regulatory system

• Since the bio-safety profile is specific to a particular gene event and does not change with hybrids’ genetic background, in all other countries event based approval is given for GM technologies

• Registration of new hybrids containing an approved event is based on Gene Equivalence

• In countries which do not grow the GM crop(s), event based approvals are given for food and feed use (import)

Regulatory approval system in other countries

Transgenic event

• Each transgenic event is defined as an independently transformed plant individual

• The integrity and sanctity of the event is maintained over generations

• The bio-safety profile is specific to a defined transgenic event and does not change with the genetic background of the host

Approved events• Bio-safety and environmental safety evaluation of the

event includes:

– Food and feed safety

– Human health safety

– Environmental safety

– agronomic value

• For example, comprehensive bio-safety and environmental safety analysis of Cry1Ac/Mon531 was done in 2002

• New events are currently being evaluated

Development and testing protocol followed by the private industry

• Strong scientific capabilities and breeding programs

• Comprehensive multi location testing including on-farm testing of pre-commercial hybrids as per international testing protocols

• Research trial data supplemented by on-farm test data and farmer feedback on performance and preference to facilitate decisions on commercialization of new hybrids

• High adoption of private bred hybrids by the farmers all across the country is a testimony to the robustness and successes of the development and testing protocol followed by the private industry

Regulation of non-GM hybrids• As of now, conventional non-transgenic cotton hybrids

developed by the seed industry are commercialized based on their in-house testing for agronomic performance

• This self regulation concept is being further strengthened through the New Seeds Bill in the offing,

• The testing of hybrids by ICAR is not mandatory under the existing Seed Act and Rules legislating the seed industry

• The sale and quality of seed of Conventional non-transgenic cotton hybrids is regulated by the Seeds Act 1966, Seed Rules 1968, Seed Control Order 1983

• The farmer i.e. the end-user is further protected through Consumer Protection Act 1986

Request• Commercialization of new hybrids containing

approved events should be allowed through registration with GEAC based on the data submitted by companies to RCGM

• RCGM would verify the technical data on gene equivalence, morphological description and source of the technology submitted by the company

• Companies will comply with all GEAC’s approval conditions

• The selling and commercialization of new Bt cotton hybrids with approved event as proposed above will conform to the provisions of the Seed Act, 1966, Seed Rules, 1968, and the Seed Control Order, 1983, EPA 1986, EPA Rules 1989

• GEAC’s registration could be in compliance with the license agreement between the technology provider and the hybrid developer

• The Bt cotton hybrids can be regulated only by the provisions of the above Acts until the New Seed Act is enforced

• Interests of the farmers will continue to be protected by the provisions of the Consumer Protection Act, 1986

• Formal Self regulation mechanism by industry will be evolved through consensus to assure quality and to meet social obligations

Request contd..

Self regulation of GM crops

Pre-registration Registration Post-registration

Source of technology

Product development

Gene equivalence

Field trials

Multi-location trial data

Source of technology

Confirmation of event

Protein expression data

Morphological traits

Undertake to comply with GEAC stipulations

Compliance under EPA 1986, Rules 1989 Seed Act, 1966, Seed Rules 1968, Seed Control Order 1983 Consumer Protection Act 1986Self regulation Assured quality, IRM, IPM Socio Economic Responsibility Awareness, Extension

Pre-registration

• Transfer of technology under license agreement from technology provider

• Development of new Bt cotton parental lines– Back crossing/Pedigree method– Marker Assisted Selection– Protein Expression - ELISA– Zygosity – PCR– Gene Efficacy - Insect bio-assays

• Identification of promising hybrid candidates through in-house and replicated multi-location trials, and the performance and economic advantage as perceived in the market

Pre-registration

• RCGM protocol can be used for in-house station trials and multi-location trials (including efficacy of control of target pests and impact on non target pests)

• In view of the vast diversity within each zone, hybrids being targeted for a specific micro niche will be tested against the most appropriate check for that micro segment

• Hybrids will be advanced based on overall value to the farmer and the economic advantage perceived by him (yield/quality/drought tolerance/boll size/pest resistance/cropping system fit, etc.), rather than yield data only

• The in-house trials may be monitored by IBSC, which has a DBT nominee and an independent expert approved by DBT

Registration

• The following data to be submitted to RCGM – In-house trial data of proposed hybrids supported by

scientific analysis and recommendations of IBSC– Technology provider’s certificate for source of

technology, confirmation of event and protein expression

– Morphological description of hybrids as per the prevailing Acts/Rules of Agriculture

• GEAC to register the hybrids for selling and commercialization based on verification of above information by RCGM

• Companies to undertake to comply with all GEAC’s post-approval stipulations

Post-registration

• Compliance under

EPA 1986, Rules 1989Seed Act 1966 Seed Rules 1968Seed Control Order 1983Consumer Protection Act 1986

• Compliance with GEAC’s post-approval stipulations

• Self regulation to meet social responsibility

Seed Act

• Company responsible for meeting Government standards with respect to

• Germination

• Genetic purity

• Gene purity*

*Compulsory labeling requirement as per new G.O.

Compliance of conditions of GEAC approvalby the industry

Condition Compliance

Seed for planting refugia additional 120g seed in the packet

Label containing description of hybrids, technology, GEAC's approval, package of proactices, etc.

Information will be printed on the seed container

Dealer/agent agreements, crop details, etc.all requirements will be complied with using standard formats

Annual details of salewill be submitted annually in totality using standard formats

Information on Bt based IPM practicesInformation in local language will be inserted in the seed container

Baseliine susceptibility data data will be generated by the company

Awareness programsseminars, farmer meetings, etc. will be undertaken by the company

Studies on impact on non-target insectswill be undertaken by the company using standard protocols

Complete information in packetinformation in local languages will be inserted in the seed container

Seed of hybrid and parents to NBPGRseed samples will be deposited with NBPGR

Socio-economic responsibility

– Identity preservation tools at various stages by stakeholders i.e., breeding, seed production, seed storage, etc. for the benefit of the farmers

– Compliance of IRM regulations (refugia, etc.), fitting in IPM models

– Encourage farmers to participate in crop insurance schemes– Monitoring of technology performance and risk management

with the due approval of regulatory system– Liability and redressal for the products over their lifecycle in

the market– Farmer awareness and education programs at the grass root

level

Self Regulation

Enforcement

Acceptance of self regulatory guidelines by members of all seed industry associations

Associations to Monitor adherence to self regulatory guidelines

Enforcement of self regulation - detailed mechanism to be evolved through consensus among various seed industry associations

Benefits of suggested regulatory changes to farmers

• Faster introduction of new hybrids with diverse genetic backgrounds

• Increased number of hybrids offers choice to the farmers to meet their area specific adaptation requirements

• Availability of high quality seed to the farmers from responsible and organized seed industry

• Healthy competition leads to better offerings, i.e. products, quality, services, etc. at reasonable price

• Supplemented farm incomes through reduced use of pesticides

• Improved human health and environmental safety

Industry requests GEAC to accelerate the introduction of new hybrids containing approved event through registration with GEAC