6. CD Mayee.pdf
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The document discusses the development and adoption of genetically modified organisms (GMOs) in India, specifically Bt cotton. It notes that Bt cotton was the first GM crop released in India in 2002. Since then, India has established a complex web of regulations for GMOs under various acts and guidelines. Over 1,400 Bt cotton hybrids have been approved, leading to widespread adoption among cotton farmers and tripling of cotton production. However, the regulatory system remains ambiguous and uncertain, with a lack of coordination and bottlenecks. Key challenges for Indian cotton include low yields, secondary pests, and high costs of cultivation.
6. CD Mayee.pdf
- 1. Genetically Modified Organism (GMO) Development and Adoption Under Indian Seed Regulations @ IFPRI “Regulations and Governance Issues in Indian Seed Sector”, 26-27 Sept 2023,New Delhi DR CD MAYEE SOUTH ASIA BIOTECHNOLOGY CENTRE (SABC), JODHPUR WWW.SABC.ASIA
- 2. Evolved with the first application of GM crop, Bt cotton Got in to complex web of regulations Considered Robust? Or Defensive Regulatory System for GM in India
- 3. • Environment (Protection) Act 1986 ( EPA) • GE organism rules framed under EPA 1989 • First GM crop Bt Cotton application was made in 1996 and released for cultivation in May 2002 • Then followed plethora of acts and rules like Biological Diversity,2002; PQO 2003; DGFT policy on GM,2006-09; • FSS Act,2006; Special provision for registration of GM varieties under New Seed Bill,2004 (clause 15-I) • PPV&FR Authority GM crops: ACTS AND RULES
- 4. ➢Recombinant DNA safety guidelines, 1990 Department of Biotechnology (DBT) ➢Revised Guidelines for Safety in Biotechnology, 1994 DBT ➢Revised guidelines for research in transgenic plants, 1998 DBT ➢Guidelines For The Safety Assessment Of Foods Derived From Genetically Engineered (GE) Plants, 2008 DBT ➢Protocols for Food and Feed Safety Assessment of GE crops 2008, DBT ➢Guidelines for the Safety Assessment of Foods Derived from Genetically Engineered Plants 2008, ICMR ➢Guidelines and Handbook for Institutional Biosafety Committees (IBSCs) DBT & BCIL 2011, ➢Guidelines and SOPs for Confined Field Trials of Regulated Genetically Engineered (GE) Plants 2008, DBT & MoEF ➢Regulations and Guidelines on Biosafety of Recombinant DNA Research and Biocontainment, 2017, DBT THEN PLETHORA OF GUIDELINES
- 5. Biosafety guidelines Vs Implementation Recombinant DNA Safety Guidelines Revised in 2017 1989 1998 Conduct of confined field trials 2008 2008 Safety Assessment of Foods Derived from GE Plants 2011 Institutional Biosafety Committees (IBSCs) Revised in 2020 2016 Environmental Risk Assessment of GE Plants 2022 Guidelines for the Safety Assessment of Genome Edited Plants, 2022 Research with transgenic plants Source: Analysed by South Asia Biotechnology Centre, 2023
- 6. Trial/Scope/Auth ority Approving Authority Monitoring Authority Number and size of each trial Prior approval from State Event Selection Trial Recommended by IBSC and approved by RCGM IBSC Few rows in contained condition Not required BRL-I Recommended by RCGM Approval by GEAC Permit by RCGM Central Compliance Committee (CCC) 1 acre each, 4 zones Total: 20 acres Required BRL-II Approval & permit issued by GEAC Central Compliance Committee (CCC) 1 hectare each Case by case basis Required Commercial Release Approval and permit issued by GEAC DLC/SBCC Conditional (mustard) or full release (cotton) n/a Biosafety Assessment: Multi-layered field evaluation system Source: Analysed by South Asia Biotechnology Centre, 2023
- 7. • Lack of coordination between RCGM (DBT) and GEAC (MOEF) • GEAC’s over dependance on a handful of individual scientist (ex-officio) & absence of a systematic biosafety evaluation framework • Excessive involvement of GEAC in field testing of GM crops, no BRL-I and BRL-II trials without GEAC approval • Mandatory condition of seeking NOC from States for conducting BRL-I/BRL-II trials, despite issuance of field trial permit from GEAC (MOEF) –States refuse to comply Centre’s permit • Confusion re field testing continues – draft Notified field trial sites (NFTS) by DBT whereas ICAR is working on AICRP on GM crops • In addition to preparing a comprehensive Biosafety dossier, GEAC’s new requirement for RARM document prior to commercial approval • Ambiguities in the process of EBAM, commercial release of varieties/hybrid of approved events • Pending PIL and litigation on the process of approval in Hon’ble Supreme Court of India Regulatory Bottlenecks
- 8. Impact of Draft Guidelines on Cotton Sector Fixing of license fee and licensing guidelines will compound ongoing breach of contracts & litigations by anticipatory repudiation seeking immunity by involving MOA&FW of Government of India in violating bilateral contracts Salvaging license fees in the name of technology failure and escaping the responsibility of stewardship issues by involving GOI in Gazetting different notifications will harm industry & farmers Convolute the disputes, invoking all sorts of tricks of the trade including monopoly, violation of IP & provisions of the compulsory licensing engaging multiple agencies including PPV&FRA, DIPP & CCI Stifle innovation, investment and inclusive development of seeds, biotech and agriculture sector Less job & Laying off highly paid jobs in seed, biotech & agriculture sector Discontinuation of major R&D projects and withdrawal of many innovative biotech trait(s) in cotton Source: Analyzed by SABC, 2016
- 10. Technology Adoption “Biotech Cotton – A structural transformation” Source: GEAC, 2022; SABC, 2023
- 11. Regulatory Approvals of Biotech Crops, 2002 to 2022 ~1400 cotton hybrids expressing approved Bt events deregulated between 2002 to 2020 under EABM by DBT/MOA&FW Source: GEAC, 2022; SABC, 2022 Crop Gene(s) Event Developer Status Year of Approval Cotton cry1Ac MON-531 Mahyco/Monsanto Commercialized 2002 Cotton cry1Ac and cry2Ab2 MON-15985 Mahyco/Monsanto Commercialized 2006 Cotton cry1Ac Event-1 JK Agri-Genetics Commercialized 2006 Cotton fused genes cry1Ab & cry1Ac GFM Event Nath Seeds Commercialized 2006 Cotton cry1Ac BNLA-601 CICR (ICAR) & UAS, Dharwad Commercialized 2008* Cotton synthetic cry1C MLS-9124 Metahelix Life Sciences Commercialized 2009** Mustard Barnase, Barstar Varuna bn 3.6, EH-2 modbs 2.99 and DMH-11 Delhi University Commercialized 2022 * BNLA-601 discontinued, **MLS-9124 never commercialized
- 12. Adoption of Biotech Cotton, 2002-2021 Source: MOA&FW, Ministry of Textile; Analyzed by South Asia Biotechnology Centre, 2023 0 5 10 15 20 25 30 35 40 0 2 4 6 8 10 12 14 16 1950-51 1960-61 1970-71 1980-81 1990-91 2000-01 2010-11 2020-21 Production (M Bales) Area (Mha) Cotton Area (Mha) Bt Cotton Area (Mha) Cotton Production (M Bales)
- 14. Cotton Transformation Export and Import of Cotton in India, 2002 to 2021 Source: MOA&FW; Ministry of Textile: Analyzed by South Asia Biotechnology Centre, 2022
- 15. Cotton: A Multipurpose Crop Source: Analysed by South Asia Biotechnology Centre, 2020 Seed Cotton Lint (fibre) (33%) Cottonseeds (67%) Linter (Industrial uses) Hull (Feed) Kernel Oil (Food) Meal (Feed) Cottonseed byproducts: Linters: Short fibres still clinging to the seed after ginning Hulls: A tough protective covering of the kernel Oil: Extracted from kernel and used for human consumption Meal: Residue after extraction of oil Cotton Plant Cotton Plant Stalks • Particle Boards • Pulps & papers • Corrogated boxes • Briquettes as fuel • Bio- enriched compost • Growing Mushrooms
- 16. Value Addition to Cotton Plant By-Produce Cotton lint 6.0 million tons per annum Cotton Seed 12.5 million tons per annum Cotton Plant Stalks 30 million tons per annum By- products of Cotton seed By-produce of Cotton Cotton Linter 0.5 million tons per annum Cotton seed Hulls 3.4 million tons per annum Cotton Seed oil 1.5 million tons per annum Meal 4.4 million tons per annum Cotton Seed Cotton Linters Cotton seed Hulls Cotton Seed oil Meal Cotton seed cake
- 17. Cottonseed Oil Production, 2002-2020 Source: CAB, 2020; Analysed by South Asia Biotechnology Centre (SABC), 2020
- 18. Cottonseed Oilcake Production, 2019-20 Source: COOIT, 2022; Analysed by South Asia Biotechnology Centre (SABC), 2022
- 19. Cottonseed de-oiled cake constitutes the largest share in terms of total availability of meal, followed by soy cake, rapeseed and rice bran in India • Cotton de-oiled cake or meal contributes one third of the total meal consumed, and is the preferred feed for cattle and buffaloes in the country • Cottonseed is also a major source of protein, as its by- product oil cake contains a high quality protein (23%) – a necessary ingredient for animal feed • AICOSCA estimates that the availability de-oiled cake significantly boost the manufacturing prospects of compound cattle feed, fish feed and poultry feed Source: COOIT, 2020; AICOSCA, 2020; Analyzed by South Asia Biotechnology Centre, 2020
- 20. Socio Economic Benefits 2002-2018 • Macro level Impact: Tripling cotton production • Micro level Impact: Bt cotton replaced the Chemical-based crop protection method • Insecticides sprays reduced by half, NO spray required to control Helicoverpa armigera • A very high level of repeat adoption for 20 consecutive years Brookes and Barfoot provisionally estimated that India enhanced farm income from Bt cotton by US$24.3 billion in the 17-year period 2002 to 2018 Source: Brookes and Barfoot, 2022
- 21. Low cotton yields, yield stagnation & low harvest index Source: MOA&FW; Ministry of Textile: Analyzed by South Asia Biotechnology Centre, 2023
- 22. • Low yields, Yield stagnation, Low harvest index, • Degraded soils and high fertilizer usage, • Bt resistant pink bollworms, • Increased usage of insecticides, • Usage of spurious Bt-HT-seeds, • Long duration Bt-hybrids kept longer for multiple pickings, • Farmers do not follow the ‘refuge strategy’, • High cost of cultivation and reduced profitability. Major Challenges of Indian Cotton Production • Non-compliance of the ‘refuge strategy’ • Bt resistant pink bollworm, emergence of secondary pests/diseases such as sucking pest, white fly, boll rot & TSV • Usage of spurious Bt/HT seeds • Long duration Bt hybrids kept longer for multiple pickings • High cost of cultivation and reduced profitability • Low cotton yields, yield stagnation & low harvest index Source: MOA&FW; Ministry of Textile: Analyzed by South Asia Biotechnology Centre, 2023
- 23. GM CROPS: AMBIGUOUS POLICY & REGULATORY UNCERTAINITY
- 24. Indian Seed Companies – Global Footprint • JK Agri Genetics : Bt cotton (Event-1) in Sudan & Ethiopia in Africa; Bt cotton (Event-1) in Bangladesh in 2023 • Nath Biogene: Bt cotton (GFM event) in the Philippines in 2023 • Mahyco: Bt cotton (BGII) in Kenya, Swaziland, Nigeria, and Bt brinjal in Bangladesh in 2016 & the Philippines in 2023 Indian companies such as Mahyco (BG-IIRRF cotton & Bt brinjal); Nath Biogene, JK Agri Genetics, Tata Rallis (Corn, Cotton) & Beej Sheetal (Brinjal) are struggling to receive any commercial approval from GOI’s GEAC since 2006 –indefinite procedural delays, regulatory uncertainty, no-NOC from State & Supreme Court litigation and impossible to navigate bureaucracy dominated GEAC Source: Compiled by South Asia Biotechnology Centre, 2023
- 25. Africa-Asia GM Crop Experience • The Philippines – Bt/HT Corn, Golden Rice, Bt brinjal, Bt cotton • Indonesia: Bt/HT Corn, Dt Cane? • Vietnam: Bt/HT corn • Bangladesh: Bt brinjal, Bt cotton (nearing approval of Golden rice) • China: Bt cotton (Bt/HT corn & HT soybean nearing approval) • Africa: Cotton (Kenya, Ethiopia, Sudan, Swaziland, South Africa, Nigeria); Cowpea, casava (Nigeria); Corn (South Africa) • Pakistan & Myanmar-- Bt cotton Source: Compiled by South Asia Biotechnology Centre, 2023
- 26. Near-Mid term: Industrial Countries ◦ Multiple mode of HT (glyphosate, glufosinate, 2-4 D, Dicamba etc) ◦ Gene pyramiding ◦ Stacked multiple mode HT/Gene pyramiding ◦ Lygus control ◦ Water use efficiency ◦ Reduced gossypol Near-Mid Term: Developing Countries ◦ Gene pyramiding ◦ Staked IR/HT ◦ Diversification of cotton events ◦ Virus resistance (CLCV, TSV etc) NextGenerationBiotechCotton Source: Analyzed by South Asia Biotechnology Centre, 2023 Developer Trait(s) Technology Status Bayer/Mahyco IR/HT BG-IIIRRF Awaiting commercial approval
- 27. Global Status & Transboundary Movement of GM Crops
- 28. Global Status of Commercial GE Crops Source: ISAAA, 2021
- 29. Distribution of Commercial GM Crops Source: ISAAA, 2021
- 30. Global Adoption of Commercial GM Crops
- 31. Why GM Crops- Prioritization • Cotton competitiveness and unauthorized use of Bt/HT cotton • Edible oil & Animal feed • Endemic & invasive pests & pathogens
- 32. EdibleOilScenario inIndia,2022-23 Source: Analysed by South Asia Biotechnology Centre, 2022-23 21-22 MT DOMESTIC 8.0-8.5 MT IMPORT 14.1-15.1 MT GM IMPORT Soy: 3.8-4.2 MT Canola: 0.3-0.4 MT Total: 4.1-4.6 MT GM DOMESTIC Cotton: 1.0-1.5 MT 5-6 MT OF EDIBLE OIL DERIEVED FROM GM SOY, CANOLA & COTTON CONSUMED ANNUALLY OR ALMOST 20% OF TOTAL CONSUMPTION OF EDIBLE OIL IN INDIA
- 33. Import Approval of Soybean events for food & feed in India, 2010 to 2022 No. Crop Event Developer Purpose Year of approval by GEAC 1 Soybean MON87701xMON89788 (Genuity Insect Protected Roundup Ready 2 Yield – BtRR2Y) Monsanto India Import for Food & Feed 18 July 2014 2 Soybean A5547-127 (Liberty Link) Bayer Biosciences Import for Food & Feed 18 July 2014 3 Soybean A2704-12 (Liberty Link) Bayer Biosciences Import for Food & Feed 18 July 2014 4 Soybean BPS-CV-127-9 (CV127) BASF India Import for Food & Feed 18 July 2014 5 Soybean MON89788 (RR2Y) Monsanto India Import for Food & Feed 12 May 2010 Source: GEAC, 2010 & 2014; Compiled by South Asia Biotechnology Centre, 2022
- 34. India allows import of GM derived soymeal, 2021-22
- 35. Transboundary movement of invasive pests 2004 to 2021 Fall Armyworm Tropical Race-4 (TR-4)
- 36. • First conditional approval of Drone for controlling locust in May 2020 • Drone Rules, 2021 issued on 25 August 2021 by Ministry of Civil Aviation • Standard Operating Procedure (SOP) for use of Drone in Pesticide Application for Crop Protection and for spraying soil & crop nutrients in agricultural, forestry, non-cropped area, etc in Nov 2021 by MOA&FW • Operationalization of Digital Sky Platform for registration/operation of different types of drones • Permission for spray operation of already registered pesticides formulations, biopesticides and formulations of combined pesticides through drones except herbicides in April 2022 • Incentivizing drone purchase under Sub-Mission on Agricultural Mechanization (SMAM) • Launching of Kisan Drone for crop assessment, digitization of land records, spraying of pesticides and nutrients • Drones for the convenience of the farmers, reducing the cost and increasing the income Genome Editing Kisan Drone Building Sound Regulatory Framework • Draft document on Genome Edited Organisms: Regulatory Framework and Guidelines for Risk Assessment” by the Department of Biotechnology in early 2020 • Gazette Notification Exemption of Genome Edited Plants falling under the categories of SDN-1 &SDN-2 from the provisions of Rules 1989, dated 30 March 2022 by MOEF&CC • Guidelines for the Safety Assessment of Genome Edited Plants, 2022 issued on 17 May 2022 by Department of Biotechnology • Standard Operating Procedures for Regulatory Reviews of Genome Edited Plants underSDN-1 andSDN-2 categories, 2022 issued on 04 October 2022 by Department of Biotechnology • DBT - Call for Proposals on 'Genome Editing of Crops for Enhanced Attributes” from 21-27 Feb 2023 Source: Ministry of Civil Aviation, MOA&FW, MOEF&CC, DBT Analysed by South Asia Biotechnology Centre, 2023
- 37. ARenewed Thruston BiotechCrops inIndia • Genome Editing: Genome edited guideline, exempting SDN1 & SDN2; SOPs issued by Govt of India in 2022, Rice (enhanced yield of Sambha Masuri (BPT5204)/quality trait/yield/HT); Maize (HT); Pigeon pea (HT); Banana (quality), pearlmillet, Biofuel (Microbes) • GM Mustard – Barnase Barstar pollination control system approved for commercial cultivation in Oct 2022 • Bt/HT Cotton – Awaiting commercial release since Nov 2021 • Bt brinjal – Under consideration for commercial release • Bt/HT maize – Approved for BRL trials, issuance of NOC from States – invasive Spodoptera frugiperda FAW resistant maize hybrids and seed treatment critical to manage FAW • RR Soybean – Imported for testing and trait introgression in locally adapted soybean germplasm by ICAR • Non-GM HT rice – Fast tracking of non-GM imazethapyr tolerant rice, expanding imi label to rice – boosting prospects for DSR cropping system • Products under BRL trials: Bt/HT cotton, Bt/HT maize, Bt brinjal, GM soybean, LBR potato, Bt Chickpea etc • Drought tolerance, yield + tech, insect & virus Resistance in fruits & vegetables such as invasive Black thrips, TR4 etc Source: MOEF&CC, MOA&FW, DBT, ICAR ; Analyzed by South Asia Biotechnology Centre, 2023
- 38. THANK YOU! www.sabc.asia THERE DOESN’T SEEM TO BE ANY OTHER WAY OF CREATING NEXT GENERATION GREEN REVOLUTION WITHOUT GMOs E. O. WILSON OR NOW WITHOUT THE GENE-GENOME ENGINEERING