The document discusses the current status of the Indian seed industry and the introduction of new hybrids containing approved gene events. It notes that the private sector now accounts for 70% of seed industry turnover in India. It argues that the current hybrid-based regulatory system for approving new hybrids containing approved events is too slow, inconsistent, and restrictive. It has resulted in far too few Bt cotton hybrids being approved to meet India's diverse agricultural needs. The document advocates changing to an event-based approval system similar to other countries, which would allow faster introduction of new hybrids based on gene equivalence to approved events.

1. Accelerating the introduction of
new hybrids containing
approved gene events
Representation submitted by the
Seed Industry Associations

2. Current status of the Indian seed industry
Post NSP 1988:
Private sector Private seed companies with
accounts for 70% strong breeding programs
turnover in seed
Almost 1/3
30
companies have a
global technology/ 25
financial partner 20
Number
Private seed 15
companies are 10
spending 10-12% of
5
their turnover in R&D
0
R&D budget of
1966 1990 1998 2004
medium sized
companies is Corn Sorghum Millet Cotton Sunflower Hybrid rice
growing @ 20% p.a.

3. Contribution of seed industry to Indian agriculture
Public-private share crop-wise
Key Hybrid Crops: Sales 100%
80%
70,000 140 60%
Production (MT) 40%
60,000 Value mil USD 120
20%
50,000 100 0%
Cotton Maize Sorghum Bajra Sunflower
40,000 80 Private Sector Public Sector
(
30,000 60
Public bred
20,000 40 Private hybrids
bred 9%
hybrids
10,000 20
30%
0 0
Cotton Maize Sorghum Bajra Sunflower
Vegetable Open
11% pollinated
50%
Market segmentation

4. Cotton Area In million ha in 2001/02 Cotton Productivity in kg/ha in 2001/02
1
1
0 200 400 600 800 1000 1200 1400 1600
0 1000 2000 3000 4000 5000 6000 7000 8000 9000 Yield in kg/ha
India U.S.A. China Pakistan F.S.U-12 Uzbekistan Australia India U.S.A. China Pakistan F.S.U-12 Uzbekistan Australia
Three cotton growing zones:
- North
- Central
- South

5. Light soils Light to medium soils, good management Inter-specific hybrids Medium soils, good management
Early maturity medium bolls, medium maturity Low inputs
Medium bolls
Heavy soils, drought prone
Large holdings
Black soils, rainfed Early to medium, medium bolls
Medium duration Heavy soils, rainfed
medium bolls Medium bolls, early
Saline soils
Light soil, drought prone
Early maturity, drought tolerance
Medium soil, rainfed Medium bolls
Early maturity, medium
and big bolls Light soils, undulated
Heavy, irrigated soils Early maturity, medium bolls
Long duration, big bolls
Light soils, low input, early Medium soils, plain
Early to medium maturity Early-medium maturity
Medium to big bolls Medium-big bolls
Light soils, early maturity
Light soils, early, medium bolls
Drought tolerance
Heavy soils, high management
Irrigated, medium maturity, Long duration, big bolls
early sown, double cropping
Heavy soils, drought prone
Light soils, good management Poor management Heavy soils, big bolls
Medium maturity, medium bolls Medium indeterminate, medium bolls Medium duration indeterminate
Heavy soils, good management, medium to big bolls, med to late maturity

6. 80 2002-03
70
60
50
40
30 1992-93
20
10
Cotton
0
1
2
However, the number of Bt hybrids approved so far are far too less

7. Adoption of approved Bt hybrid technology
in India
1400000
1200000
1000000
Acres/ Farmers
800000
600000
400000
200000
Legal Bt 0
8% 2002 2003 2004
Legal Bt
Acerage Farmers
20%
Illegal Bt
18%
Non Bt
40%
Non Bt
74% Illegal Bt
40%

8. 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.

9. Current regulatory system
• 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

10. Regulatory approval system in
other countries
• 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)

11. 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

12. 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

13. 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

14. 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

15. 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

16. Request contd..
• 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

17. Self regulation of GM crops
Pre-registration Registration Post-registration
Source of technology Multi-location trial data Compliance under
Source of technology EPA 1986, Rules 1989
Product development
Seed Act, 1966,
Gene equivalence Confirmation of event Seed Rules 1968,
Protein expression data Seed Control Order 1983
Field trials
Consumer Protection Act 1986
Morphological traits Self regulation
Undertake to comply Assured quality, IRM, IPM
with GEAC stipulations Socio Economic Responsibility
Awareness, Extension

18. 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

19. 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

20. 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

21. Post-registration
• Compliance under
EPA 1986, Rules 1989
Seed Act 1966
Seed Rules 1968
Seed Control Order 1983
Consumer Protection Act 1986
• Compliance with GEAC’s post-approval
stipulations
• Self regulation to meet social responsibility

22. Seed Act
• Company responsible for meeting
Government standards with respect to
• Germination
• Genetic purity
• Gene purity*
*Compulsory labeling requirement as
per new G.O.

23. Compliance of conditions of GEAC approval
by the industry
Condition Compliance
Seed for planting refugia additional 120g seed in the packet
Label containing description of hybrids, technology, Information will be printed on the seed
GEAC's approval, package of proactices, etc. container
all requirements will be complied with
Dealer/agent agreements, crop details, etc.
using standard formats
will be submitted annually in totality using
Annual details of sale
standard formats
Information in local language will be
Information on Bt based IPM practices
inserted in the seed container
Baseliine susceptibility data data will be generated by the company
seminars, farmer meetings, etc. will be
Awareness programs
undertaken by the company
will be undertaken by the company using
Studies on impact on non-target insects
standard protocols
information in local languages will be
Complete information in packet
inserted in the seed container
seed samples will be deposited with
Seed of hybrid and parents to NBPGR
NBPGR

24. Self Regulation
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

25. 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

26. 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

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