Biosafety Concerns and Regulatory Requirements For Transgenic Crops

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1 Biosafety Concerns and Regulatory Requirements For Transgenic Crops R.P. Sharma NRC on Plant Biotechnology Indian Agricultural Research Institute New Delhi

2 Transgenic Technology or Genetic Engineering owes its origin to the following major discoveries which led to the production and mobilization of recombinant DNA molecules 1953 Discovery of DNA structure by Watson & Crick 1968 Discovery of restriction enzymes by Messelson et al 1972 Production of recombinant DNA by Cohen & Boyer 1983 Demonstration of Agrobacterium mediated transformation in plants by Herrera-Estrella et al 1994 Development of Flavr Savr transgenic tomato by M/s Calgene Technically, these discoveries have brought in all living forms into a Single Genepool. Transgenic technology provides enormous power, enormous opportunities but enormous responsibilities

3 Three Phases of Biotechnology New Products Quality Traits Plants as Factories-Plant Made Pharmaceuticals Agronomic Traits

4 Summary of International Efforts in Commercialization of Transgenic Crops Years Crops Traits Countries 9 7 (major 4) Soybean Herbicide tolerance 21 (major 6) mha Maize Insect resistance USA, Argentina, mha mha Cotton Virus resistance Canada, Brazil, Reasons for Canola limiting the transgenic application to China, only 4 India, crops, South 3 traits Africa and 6 countries are : Commercial importance of the crops Novelty of traits, and Promotional rather than precautionary approach by these countries without sacrificing the biosafety requirements

5 Plant Molecular Farming Advantages of using higher plants as bioreactors: Lower production costs than with transgenic animals or bacterial or cellular production Infrastructure and expertise already exists for planting, harvesting and processing of crops Plants contain no known human pathogen that could contaminate the final product Synthesized proteins are correctly folded, glycosylated and activity retained Seeds can store proteins without degradation till processed

6 Molecular farming products thought to be close to or on the market in the next 5 years Product Company or companies Use Trypsin a ProdiGene Pharmaceutical intermediate GUS ProdiGene Diagnostic reagent Avidin a ProdiGene Immunological Reagent Aprotinin a Collagen a ProduGene, Large Scale Biology ProdiGene, Medicago, Meristem Therapeutics Reduce SIR and bleeding, promote wound closure, mammalian cell culture Exocrine pancreatic insufficiency, steatorrhea, cystic fibrosis Contd..

7 Product Company or companies Use Lipase a Meristem Therapeutics Exocrine pancreatic insufficiency, Steatorrhea Lactoferin a Ventria, Meristem Therapeutics Natural defense protein against infections, iron repository Lysozyme a Ventria Anti-viral, anti-bacterial, antifungal Brazzein ProdiGene Natural protein sweetener TGEV edible vaccine α-caries MAb α-herpes MAb ProdiGene Planet Biotechnology Epicyte Pharmaceutical TGEV vaccine in swine Prevention of dental caries Prevention of herpes transmission

8 GENETICALLY MODIFIED ORGANISMS (GMOs) AND r-dna PRODUCTS GOVERNED BY Environment (Protection) Act, 1986 Came into force from Rules, 1989 on GMOs Notified on Came into force from

9 Science and procedures values Trade and development CBD WHO FAO OECD Cooperation WTO FAO OECD CBD WHO FAO OECD CODEX WTO Existing agencies surrounding GMO regulation. Overlap in their functioning provide opportunities for harmonization

10 Agencies Involved in Rules,1989 of EP Act 1986 Dept. of Environment GOVERNMENT OF INDIA Dept. of Biotechnology Applicant GEAC RCGM Monitoring -cum- Evaluation Committee Large Scale Imports, Production and Release SBCC DLC IBSC PI/ Applicant R&D, Limited experimental field trials and imports for R&D. 10

11 PUBLIC Risk Communication Navigation in perpetual space POLICY MAKERS Risk Management Navigation in decision space BIOSAFETY SCIENTISTS Risk Assessment Navigation in physical space

12 BIOSAFETY ISSUES ARE SPECEFIC Crops Traits Agro-ecology Usage- food/non-food intake-quantity -duration Hence case by case study for each transgenic

13 Possible Risks from Transgenic Crop Environmental Health related Social & Ethical

14 Bollgard Development Process in India Mahyco Institutional Biosafety Committee established in 1995 Review Committee on Genetic Manipulation Import of Seeds 1996 Backcrossing Studies conducted Environmental Safety Bioefficacy & Agronomic benefit Biosafety studies Pollen Flow 1997 Field trials Allergenicity Study 1998 Aggressiveness Studies Year No. of trials Goat Study 1998 Pollen flow Cow Study 2001 Soil Studies Buffalo Study 2001 Gene stability Chicken Study Fish Study 2001 Protein detection in oil 2001 GEAC Data Evaluation 2001 Seed Bulk-up Approval 2001 Commercialization 5 th April, 2002

15 Acreage of Bt Cotton +58% (+294kg/Ac) in yields increase +163% (+ $132/Ac) in net return -50%(-$22.3/Ac) pesticide reduction Source: IMRB International, 2005 AC Nielsen - ORG Center for Social Research, Planting Acreage (M Ac) 3.1M Ac MAc Bt crop of 2004 helped farmers to earn US$ 172M additional income Additional $1.33B economic growth through cotton farmers Overall cotton production up by 3835K quintal of seed cotton or 788K bales of lint Bt cotton reduced pesticide loading worth US$29 million (1quintal = 100kg; 1 bale = 170kg)

16 Bt Transgenic Cotton Environmental Issues In case of Bt transgenic cotton, the environmental issues needed to be addressed are : Gene flow through pollen or soil residue to a. Closely related cutligens b. Wide and weedy relatives c. Soil bacteria-concern being not much of Bt gene but the selectable marker npt II d. Resistance to Bt in insects

17 Cotton species Grown in India Cotton genus Gossypium L. contains 44 diploid species and 5 tetraploid species of which two in each group have been domesticated 44 diploid species grouped into eight genomes A-G and K G. barbadense Tetraploid, AD genome G. Hirsutum G. Arboreum Diploid, A genome G.herbaceium Diploids are considered as secondary gene pool Interspecific F1 from direct hybridization between diploid and tertraploid cotton is sterile

18 Evolution of Resistant Pests

19 Relative susceptibility studies of the field population of Helicoverpa armigera to Bt cry1ac Laboratory Bioassay Insects collected from six locations (warangal, coibatore & Ranebennur South India and Jalna, Barwah and Baroda Central India) - *Showed varied mortality response to cry1ac LC μg / ml diet LC do- Moult inhibitory concentration (MIC) MIC μg / ml diet MIC do- Source : Mahyco LC μg cry1ac / ml of diet North India μg cry1ac / ml of diet Central India μg cry1ac / ml of diet South India Source : CICR, Nagpur Base line susceptibility values of LC & MIC are most important for monitoring the resistance development against Cry1Ac No change over the baseline susceptibility was recorded in populations studied in 2002, 2003 & 2004.

20 Adaptability of Helicoverpa to Bt-cotton Simulation studies showed that cultivation of Bt-cotton in 10, 20, 30 and 40% of the total area under cotton is likely to result in resistant allele frequency reaching 0.5, which would be adequate to cause crop failure, after 54, 25, 16 and 11 years respectively, if no pest control measures were adopted in both Bt-cotton and non Bt-cotton Source : Kranthi & Kranthi (2004), Current Science 87 : 1096 Management strategies : 1. Gene pyramiding 2. Reducing population of H. armigera that survives Bt-cotton 3. Enhancement of area under alternate host crops

21 Strategies for Delaying / Checking Development of Resistance Against Bt toxin High levels of Bt expression (killing even heterozygotes) Gene pyramiding More than one Bt-genes and other genes Providing adequate refugia unmanaged refugia could be catasrophic Bt-cotton based IPM

22 Bt-cotton based IPM Benefits Cotton variety Yield Net returns (Rs) Bt MECH IPM 12.4 q/ha / ha Non Bt + IPM 7.1 q/ha / ha Source : NCIPM, IARI, New Delhi

23 Summary Table showing Reduction in Pesticide use, Increase in yield and Net Profit in Bt-cotton in cotton growing States State Boll worm % Pesticide reduction saving in Rs/ac Yield income % Increase in net profit % % q/ac % Rs/ac Andhra Pradesh Karnataka Maharashtra Gujarat Madhya Pradesh All India weighted average Source : Ac Nielson ORG MARG

24 Commercialization of Bt-cotton feedback from different stake-holders FARMERS: Satisfied with technology 20-30% increase in yield Reduction in pesticide use Reluctant to use refugia High seed cost Existing cotton prices less remunerative Contd

25 Commercialization of Bt-cotton feedback SCIENTIST: from different stake-holders Third party assessment of GM crop in larger scale trials for obtaining unbiased data Large scale trials in all agro-climatic regions of the states Direct involvement of state agricultural universities in pre and post release monitoring More interaction between state agricultural department and seed companies Poor performance of Bt-cotton in rainfed conditions Agronomic evaluation of the Bt-hybrids before release Contd

26 Commercialization of Bt-cotton feedback from different stake-holders INDUSTRY: Satisfied with the technology Drastic reduction in sale of non-bt hybrids Partnership in the existing and acquisition of newer technologies Regulatory control for only biosafety analysis Further simplification of regulatory procedures Check on illegal/spurious seed Contd

27 Commercialization of Bt-cotton feedback NGOs: from different stake-holders No distinct advantage from the technology Crop failure in certain areas leading in increased indebt ness of the farmers No/marginal savings in pesticide use Non-transparent regulatory system Excessive/increasing control of multinational companies

28 Lessons Learnt from Commercialization of Bt-cotton Technology Over-whelming response from farmer Technological and/or trade compulsions for rapid spread of the technology Importance of genetic background per se Scepticism on the role and extent of refugia in insect resistance management Importance of awareness generation Inadequacies in the pre & post release monitoring Prevalence of unethical trade practices

29 Thank you