Accelerating the introduction of    new hybrids containing     approved gene events   Representation submitted by the     ...
Current status of the Indian seed industryPost NSP 1988:Private sector                             Private seed companies ...
Contribution of seed industry to Indian agriculture                                                                       ...
Cotton Area In million ha in 2001/02                                              Cotton Productivity in kg/ha in 2001/02 ...
Light soils          Light to medium soils, good management Inter-specific hybrids Medium soils, good management  Early ma...
80                                          2002-03         70         60         50         40         30           1992-...
Adoption of approved Bt hybrid technology                                                      in India                   ...
Current Scenario• The benefit of the Bt technology in cotton has  been established beyond doubt (reduced  pesticide use, i...
Current regulatory system• In hybrid based approval system in India, new hybrids  containing approved events are subjected...
Regulatory approval system in        other countries• Since the bio-safety profile is specific to a  particular gene event...
Transgenic event• Each transgenic event is defined as an  independently transformed plant individual• The integrity and sa...
Approved events• Bio-safety and environmental safety evaluation of the  event includes:   – Food and feed safety   – Human...
Development and testing protocol followed         by the private industry• Strong scientific capabilities and breeding pro...
Regulation of non-GM hybrids• As of now, conventional non-transgenic cotton hybrids  developed by the seed industry are co...
Request• Commercialization of new hybrids containing  approved events should be allowed through  registration with GEAC ba...
Request contd..• GEAC’s registration could be in compliance with the  license agreement between the technology provider  a...
Self regulation of GM crops        Pre-registration         Registration            Post-registrationSource of technology ...
Pre-registration• Transfer of technology under license agreement  from technology provider• Development of new Bt cotton p...
Pre-registration• RCGM protocol can be used for in-house station trials and  multi-location trials (including efficacy of ...
Registration• The following data to be submitted to RCGM  – In-house trial data of proposed hybrids supported by    scient...
Post-registration• Compliance under      EPA 1986, Rules 1989      Seed Act 1966      Seed Rules 1968      Seed Control Or...
Seed Act• Company responsible for meeting  Government standards with respect to    • Germination    • Genetic purity    • ...
Compliance of conditions of GEAC approval              by the industry                     Condition                      ...
Self RegulationSocio-economic responsibility  – Identity preservation tools at various stages by stakeholders    i.e., bre...
EnforcementAcceptance of self regulatory guidelines by members of all seed industry associationsAssociations to Monitor ad...
Benefits of suggested regulatory          changes to farmers• Faster introduction of new hybrids with diverse genetic  bac...
Industry requests GEAC toaccelerate the introduction of newhybrids containing approved eventthrough registration with GEAC
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Geac final presentation

  1. 1. Accelerating the introduction of new hybrids containing approved gene events Representation submitted by the Seed Industry Associations
  2. 2. Current status of the Indian seed industryPost NSP 1988:Private sector Private seed companies withaccounts for 70% strong breeding programsturnover in seedAlmost 1/3 30companies have aglobal technology/ 25financial partner 20 NumberPrivate seed 15companies are 10spending 10-12% of 5their turnover in R&D 0R&D budget of 1966 1990 1998 2004medium sizedcompanies is Corn Sorghum Millet Cotton Sunflower Hybrid ricegrowing @ 20% p.a.
  3. 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 Sunflower40,000 80 Private Sector Public Sector (30,000 60 Public bred20,000 40 Private hybrids bred 9% hybrids10,000 20 30% 0 0 Cotton Maize Sorghum Bajra Sunflower Vegetable Open 11% pollinated 50% Market segmentation
  4. 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/haIndia 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. 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 holdingsBlack soils, rainfed Early to medium, medium bollsMedium duration Heavy soils, rainfedmedium 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. 6. 80 2002-03 70 60 50 40 30 1992-93 20 10 Cotton 0 1 2However, the number of Bt hybrids approved so far are far too less
  7. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 17. Self regulation of GM crops Pre-registration Registration Post-registrationSource of technology Multi-location trial data Compliance under Source of technology EPA 1986, Rules 1989Product development Seed Act, 1966,Gene equivalence Confirmation of event Seed Rules 1968, Protein expression data Seed Control Order 1983Field 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. 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. 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. 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. 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. 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. 23. Compliance of conditions of GEAC approval by the industry Condition ComplianceSeed for planting refugia additional 120g seed in the packetLabel containing description of hybrids, technology, Information will be printed on the seedGEACs approval, package of proactices, etc. container all requirements will be complied withDealer/agent agreements, crop details, etc. using standard formats will be submitted annually in totality usingAnnual details of sale standard formats Information in local language will beInformation on Bt based IPM practices inserted in the seed containerBaseliine susceptibility data data will be generated by the company seminars, farmer meetings, etc. will beAwareness programs undertaken by the company will be undertaken by the company usingStudies on impact on non-target insects standard protocols information in local languages will beComplete information in packet inserted in the seed container seed samples will be deposited withSeed of hybrid and parents to NBPGR NBPGR
  24. 24. Self RegulationSocio-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. 25. EnforcementAcceptance of self regulatory guidelines by members of all seed industry associationsAssociations to Monitor adherence to self regulatory guidelinesEnforcement of self regulation - detailed mechanism to be evolved through consensus among various seed industry associations
  26. 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. 27. Industry requests GEAC toaccelerate the introduction of newhybrids containing approved eventthrough registration with GEAC

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