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6 Contents Page CHAPTERS Executive Summary i-ix 1. INTRODUCTION 1 2. METHODOLOGY 3 3. APPLICATIONS OF GMOs IN AGRICULTURE Global Status 3.2 Status in India 4. REGULATORY FRAMEWORK IN INDIA Government Rules for GMOs, Recombinant DNA Guidelines, Guidelines for Research in Transgenic Plants, Seed Policy, Prevention of Food Adulteration Act, The Food Safety and Standards Bill, Plant Quarantine Order Task Force on Application of Agricultural Biotechnology 4.9 Draft National Environment Policy, Draft National Biotechnology Strategy CARTAGENA PROTOCOL ON BIOSAFETY Introduction 5.2 Objective 5.3 Elements of the Protocol 5.4 Status of Implementation in India 5.5 Other International Agreements 6. AREAS COVERED FOR TRAINING NEEDS ASSESSMENT Development of GMOs 6.2 Risk Assessment 6.3 Risk Management 6.4 Regulatory Capacity Building 6.5 Identification of LMOs 6.6 Human Resources Development and Training 6.7 Public Awareness, Education and Participation 6.8 Information Exchange & Data Management 6.9 Scientific, Technical and Institutional Collaboration 6.10 Technology Transfer 6.11 Socio-Economic Considerations 6.12 Sustainable Use and Conservation of Biodiversity

7 Page 7. FINDINGS OF THE FIELD SURVEY Priority Ranking of Areas and Suggestions for Capacity Building 7.2 Means of Sharing Information 7.3 Duration of the Training Programmes 8. IDENTIFICATION OF TRAINING NEEDS Stakeholders 8.2 Training Needs Matrix 9. OVERVIEW OF EXISTING TRAINING PROGRAMMES Series of Workshops 9.2 National Events 9.3 International Events 9.4 Training Programmes by Private Sector 9.5 Websites 9.6 Publications 9.7 Capacity Building Projects 10. PROPOSED TRAINING MODULES 91 ANNEXES 1. QUESTIONNAIRES LIST OF RESPONDENTS COMPILATION OF SUGGESTED AREAS PROCEEDINGS OF THE STAKEHOLDER CONSULTATION 137 MEETING

8 TRAINING NEEDS ASSESSMENT SURVEY Executive Summary In the recent past, there has been a rapid increase in research and development activities involving genetically modified organisms (GMOs)/living modified organisms (LMOs). At the same time, there has also been considerable apprehension and concern about ensuring safety in use of GMOs, particularly with respect to their handling, containment and the impact on human health and environment. To address these concerns, the Ministry of Environment and Forests (MoEF) and the Department of Biotechnology (DBT), the two apex regulatory bodies, have formulated regulations and brought out guidelines on biosafety. India has also ratified the Cartagena Protocol on Biosafety, which has a specific focus on transboundary movements of LMOs so as to ensure adequate level of protection in their safe transfer, handling and use. There has been significant progress in building institutional capacities and regulatory framework in India through the cumulative efforts and initiatives of many organizations to keep pace with the advances in development and use of GMOs/LMOs. However, there is an urgent need to take stock of the situation and identify major components of capacity building requirements in terms of strengthening scientific institutions, development of human resources, research and technology, legislation, regulations, policies and programs for biosafety to have a consolidated action plan in place to meet the obligations of the Cartagena Protocol and effective implementation of the national regulatory framework. Under the sponsorship of GEF-World Bank, MoEF has initiated a Capacity Building project, to enhance India s national capacity to implement the Cartagena Protocol on Biosafety. The specific objectives of the project include strengthening the institutional and legal framework, to improve capacity and coordination in decision making across Ministries, improve capacity for risk evaluation and management etc. Training being one of the key elements for achieving the above, MoEF has carried out a Training Needs Assessment Survey with the assistance from Biotech Consortium India Limited (BCIL) to i

9 assess the requirements in these areas through a process of consultation with various stakeholders prior to initiating countrywide training programmes. The objective of the survey is to identify the training needs of agricultural biotechnology stakeholders in the public and private sectors as regards genetically engineered crops including plants used for biopharmaceuticals products, livestock and the products derived from these (including foods). The survey was a combination of field studies through questionnaires and personal discussions supplemented by extensive desk research. A detailed questionnaire was prepared covering the following areas for identifying the training needs as well as other capacity building requirements: identification and development of LMOs/GMOs; risk assessment (impact on human health and environment) and management; regulatory capacity building; human resource development and training; public awareness, education and participation; information exchange and data management; scientific and institutional collaborations; technology transfer; socio-economic considerations; sustainable use and conservation of biodiversity A scale of 1-5 was given for priority ranking in the above areas. Out of the detailed questionnaire, short questionnaires were also drafted for state level officials, quarantine officials, social experts etc. The questionnaire was prepared in such a way so as to get inputs for assessment of training needs as well as designing the training programmes. Personal interviews were held with selected stakeholders by visits and telephonic conversation. About 150 responses were received from various stakeholders viz. Central Government, State Government, research organizations, industry, regulatory bodies, civil organizations, social experts, agriculture service providers and others. A computerized programme was prepared for analyzing the results of the survey, which was used to generate different query based reports. Priority ranking of the areas for capacity building has been done for total number of responses as well as for individual stakeholders. The ii

10 written responses to questionnaires as well as personal discussions with the respondents were used for each area for assessment of the training needs. Extensive desk research included collection of information on country s obligations to the Cartagena Protocol, existing regulatory systems of approval as well as trade of LMOs/GMOs and overview of existing initiatives for capacity building etc. The status of implementation of Cartagena Protocol in India and the requirements for each Article have been studied. An overview of the existing training programmes has been prepared which includes the stakeholders targeted, course content and the recommendations that emerged out of such training programmes. Over 5000 participants have attended the events organized by MoEF, DBT and BCIL in the last few years. The feedback received from the participants in these programmes through surveys conducted from time to time (for IBSCs, state level officers, agriculture service providers, farmers etc.) as well as presentations made by eminent experts have also been taken into account for assessment of training needs. The field survey findings have been combined with the above to workout the requirements of various stakeholders by drawing a training needs matrix, based on which the training modules have been proposed. A stakeholder consultation was organized to discuss the field survey findings with experts from government, industry, institutions, etc. The participants endorsed the field survey findings and gave suggestions. The inputs received have been suitably incorporated in the report. The report was also presented to Steering Committee of the GEF-World Bank project. The members gave suggestions and approved the report. Review of regulatory framework in India for GMOs/LMOs including GM food is part of the desk research. This includes rules notified by MOEF in 1989 under Environment (Protection) Act, 1986 (EPA), guidelines issued by DBT in 1990 and 1998 and sections of Seed Policy, Food control system under Prevention of Food Adulteration Act has been studied with respect to applicability to food derived from GM crops. Provisions related to GM food under Food Safety Standards Bill, 2005 prepared by Ministry of Food Processing Industries have also been detailed. Report of the Task Force on Application of Agricultural Biotechnology set up by the Ministry of Agriculture under chairmanship of Prof. M.S. Swaminathan was also consulted. An overview of sections related to GM crops in the Draft National Environment Policy, 2004 and Draft Biotechnology Strategy, 2005 have iii

11 also been included. It is evident from this review along with study of major provisions of Cartagena Protocol on biosafety and corresponding capacity building requirements that there is an urgent need for strengthening of institutional capacity and human resource development, in addition to regulatory changes. Areas identified for training assessment have been further divided into subsections to address capacity building requirements. A review of the existing training programmes for various stakeholders has indicated that there has been ongoing efforts in implementing training through organizing national and international events, websites, publications etc. Most of these programmes have been under the aegis of apex regulatory bodies i.e. MoEF and DBT. Over 5000 participants have attended about 50 events organized by MoEF, DBT and BCIL in the last few years. There has been active participation of government officials, scientists, industry representatives, NGOs, farmers etc. in these events. The feedback received from the participants in these programmes through surveys conducted from time to time (for IBSCs, State level officers, agriculture service providers, farmers etc.) as well as presentations made by eminent experts have also been taken into account while drawing the recommendations. Other institutions who have conducted trainings include: National Bureau of Plant Genetic Resources (NBPGR), G.B. Pant University of Agriculture and Technology and Central Food Technological Research Institute (CFTRI). Organizations such as The Energy Resources Institute (TERI) and Research and Information System for Developing Countries (RIS) have organized stakeholders consultations on some issues related to GMOs/LMOs. The approval conditions for commercialization of Bt cotton in India in 2002 to MAHYCO included undertaking awareness and education programme, interalia through development and distribution of educational material on Bt cotton for farmers, dealers and others. In view of the above, M/s. MAHYCO had conducted awareness programmes for dealers, company executives, field assistants as well as agricultural department officials in the various districts of Bt cotton growing states. In addition farmer education programmes was organized in two phases i.e. pre sowing and post sowing through farmer meetings, mailers, audio cassettes and pamphlets in local languages. The training programmes covered information on various aspects related to cultivation of Bt cotton. Similar programmes have been taken up by other industries who are marketing Bt cotton hybrids. iv

12 In addition, representatives of private sector have been regularly participating in various training programmes and also have sponsored various events. MoEF and DBT have prepared various websites for information dissemination i.e. Capacity Building on Biosafety, Biosafety Clearing House (BCH), Indian GMO Research Information System (IGMORIS) and Biosafety regulations. Several publications as background documents or proceedings of various events have been widely circulated in the country. Industries such as Maharashtra Hybrid Seeds Company Ltd., Monsanto, Syngenta etc. are also circulating newsletters covering information about GMOs. MoEF has recently launched a quarterly biosafety newsletter in association with BCIL for circulation amongst stakeholders all over the country. DBT and BCIL have released a handbook for IBSC members. Risk assessment and management has emerged as the top most priority for imparting training followed by human resource development, training and regulatory capacity building. The other major priority areas listed are public awareness, education and participation followed by scientific, technical and institutional collaborations. Majority of the respondents have indicated that risk assessment capabilities in India are limited among molecular biologists engaged in development of GMOs. Those currently involved in the risk assessment are mainly agricultural scientists and the members of the regulatory bodies i.e. IBSC, RCGM and GEAC. For studying the impact on human health and environment, scientific data need to be generated by experts from several disciplines, thereby clearly indicating the need to provide training to a multiplicity of stakeholders. Foreign collaboration and training have been recommended not only for the areas for the development of scientific methods and protocols for risk assessment, but also to enhance competence to review/audit risk assessment and national biosafety research programmes. It has been suggested that there should be a dedicated technical cell within the two apex regulatory bodies i.e. DBT and MoEF equipped with requisite information technology tools to have rapid access to reference material/databases on risk assessment for effective review within the stipulated time. Under risk management, maximum emphasis has been given to detection, management and prevention of unintentional transfer of LMOs. The committees and v

13 institutions involved in the compliance and monitoring also need to be extensively trained particularly at the functional level. A multi pronged approach is required for human resource development in the country through focused training programmes for specific categories of stakeholders, participation in national and international events, circulation of various publications as well as long term training programmes. The status of regulatory capacity has been rated as medium in the legal framework and low in compliance mechanisms. Regulatory capacity building has been divided into three areas i.e. legislative, administrative and technical and scientific framework. Regular training of both regulators and compliance officers by noted national and international experts, at least once a year has been suggested. Development of handbooks and manuals for specific target segments viz. health inspectors, agriculture officials, pollution control board officials, border control and quarantine officials has also been suggested. Public awareness and education, risk communication skills and strategies, biosafety awareness documents (newsletters, bulletins, articles in the newspaper etc.) and organizing of biosafety awareness activities have been indicated as priority areas. The suggestions for achieving the same include training of risk communicators particularly among members of regulatory bodies and institutions involved, seminars, radio and television talk shows including reputed scientists, local case by case synthesis of information and dissemination, regular meetings with media to give authentic information etc. Guidelines for safe handling, packaging and transport of LMOs need to be developed along with methods and systems for their identification. Systems for inspection and segregation of LMOs have been listed as the priority areas. The target segment for providing training include organizations involved in trade and border control. Suggestions have also been given for training of social and economic experts for undertaking analysis of awareness levels in different strata of the society. Based on the above priorities, a training needs matrix has been drawn for the following stakeholders: (i) Senior government officials (policy/decision makers); vi

14 (ii) (iii) (iv) (v) (vi) (vii) (viii) (ix) (x) (xi) Regulators (e.g. application reviewers/assessors, advisors, administrators, etc,); Enforcement officials (e.g. field inspectors health, food and agriculture departments, custom and plant quarantine officers); Scientists/technical personnel who review or prepare applications (public and private sector); Legal experts; Economists; Information managers including IT specialists; Graduate and undergraduate students; Interest groups (e.g. consumer groups, farmer associations, professional associations, NGOs); Mass media and outreach/extension workers (e.g. journalists and agricultural extensionists) and General public and political leadership A variety of approaches have been proposed based on training need requirements, preferred communication media and duration of the training programmes by various target segments. These include a combination of national and international events, series of workshops for various stakeholders, laboratory/technical training, studies/surveys, publications and documents, use of electronic media, study tours, exchange of personnel etc. Extensive awareness programmes at the grass root level need to be initiated by using both print and electronic media through the existing networks in the country such as agricultural extension offices and departments, nutrition education departments, health education programmes etc., which are traditionally trusted by the target groups. Network of scientific risks communicators to be created who will interact with the media as well as deliver regular talks to different categories of stakeholders. Development of electronic educational programmes for TV, radio, internet etc. as well as printed documents such as primers/brochures/booklets/faqs/glossary of terms in local languages will be extremely useful in reaching out to specific stakeholders as well. Series of events across the country are required for officials involved in compliance of regulatory provisions such as customs, port, plant quarantine, agriculture, food with the focus on the basics of GMOs/LMOs, biosafety issues, identification procedures, national vii

15 regulatory framework, international commitments etc. The events may include visits to scientific institutions for gaining first hand idea of the new technologies. National consultations may be organized among various stakeholders particularly with those involved in trade and transboundary movements on various articles of Cartagena Protocol particularly Article 7-8 (AIA procedures), Article 15 (risk assessment and management), Article 18 (documentation requirements) and Article 27 (liability and redress). National workshop on various crops under development (one crop at a time) to review all aspects in a comprehensive manner are required for providing inputs for effective and expeditious decision making. Seminars on specific research areas pertinent to biosafety would help in planning national biosafety research. The researchers working in SAUs, universities, research institutions etc. may also be exposed to good laboratory practices by organizing programmes conducted at selected institutions. In view of the transitions of the world trade norms due to various international agreements, such as Cartagena Protocol, WTO and Codex, there is an urgent need to review and update the provisions of national rules and guidelines such as Rules, 1989, rdna Biosafety Guidelines 1990 as well as notify additional policies/rules/guidelines. Detailed guidelines for new GMOs and products thereof as well as newer applications of existing GMOs, e.g., transgenic animals including livestock and fish, use of plants and animals for production of pharmaceuticals/ biochemicals etc. need to be developed. Studies need to be conducted urgently for review of guidelines for transport of LMOs and global status, impact and cost implications of labelling. Baseline surveys for developing protocols for risk assessment particularly ecological issues such as impact on non-target organisms for sustainable use and conservation of biodiversity are required. Information on issues related to GMOs/LMOs needs to be provided in variety of formats such as resource material on specific topics, brochures, pamphlets, booklets, peer reviewed scientific publications, review articles/current expert opinions, conference proceedings, reports and documents form international organizations etc. These can be disseminated both through the print and electronic forms. Resource material on biosafety issues and handbooks for various regulatory bodies should be prepared and circulated for familiarizing specific categories of stakeholders about their responsibilities as well as to viii

16 create awareness on various aspects. Dedicated websites on biosafety, video films on successful case studies, CDs/videos on regulatory requirements are the other suggested means for providing authenticated science based information. Scientists and regulators should be encouraged to regularly participate in international conferences to get exposure to the international developments and procedures. Specific study tours may be undertaken to countries, which have approved GM crops particularly food for commercial use. International conferences on LMOs testing methods, facilities and equipments and risk assessment and management procedures including case studies by different countries (Issues related to impact on human and animal health and impact on environment) need to be organized on priority. Regional conferences (Asia or Asia Pacific) may be organized for understanding and harmonization of biosafety rules, guidelines and priorities/approach for effective implementation of Cartagena Protocol. It is proposed that a directory of resource persons may be prepared for undertaking such wide ranging capacity building activities. Similarly, a compendium of biosafety training programmes should also be prepared for circulating information about the same. In addition to the short term training programmes, there is a need to plan and organize long-term courses to provide both theoretical and practical training such as special post graduate diploma/degree, distance training programmes for beginners as well as advanced training modules and training programme for in service officials. ix

17 CHAPTER 1 INTRODUCTION India is a signatory to the Cartagena Protocol on Biosafety, which came into force on September 11, The objective of the Protocol is to contribute to ensuring an adequate level of protection in the field of safe transfer, handling and use of Living Modified Organisms (LMOs) taking also into account risks to human health, and specifically focusing on transboundary movement. There is a regulatory mechanism in place in India since 1989 for development and evaluation of genetically modified organisms (GMOs) and products thereof. The Ministry of Environment & Forests (MoEF) and the Department of Biotechnology (DBT) are the two apex regulatory bodies. There has been significant progress in building institutional capacities and regulatory framework in India through the cumulative efforts and initiatives of many organizations to keep pace with the advances in development and use of GMOs/LMOs. However, there is an urgent need to take stock of the situation and identify major components of capacity building requirements in terms of strengthening scientific institutions, development of human resources, research and technology, legislation, regulations, policies and programs for biosafety to have a consolidated action plan in place to meet the obligations of the Cartagena Protocol and effective implementation of the national regulatory framework. In line with the above, MoEF is implementing a project for capacity building in the area of biosafety related to use of LMOs/GMOs for effective implementation of the Cartagena Protocol on Biosafety, sponsored by GEF and World Bank. The specific objectives of the project include strengthening of the institutional and regulatory framework and building capacity in relevant Ministries and State Agencies and specialized organizations. Training constitutes a major component in the GEF- World Bank capacity building project to achieve the above objectives. It has been proposed that prior to initiating steps for countrywide training programmes, a realistic assessment of the training needs should be made. MoEF carried out a Training Needs Assessment Survey with the assistance of Biotech Consortium India Limited 1

18 (BCIL), a company promoted by the DBT and set up by all India financial institutions including IDBI, ICICI, IFCI etc. to accelerate commercialization of biotechnology in India. The objective of the survey is to identify the training needs of agricultural biotechnology stakeholders in the public and private sectors as regards genetically engineered crops (including plant used for biopharmaceutical production), livestock and the products derived from these (including foods). The survey has been conducted by collecting responses by various stakeholders to questionnaires, personal discussions with the experts and extensive desk research. Priority areas where training is required have been identified and training modules suggested for various stakeholders for capacity building of the country for implementation of the Cartagena Protocol. Approximately 150 respondents including Central and State Governments, research scientists, industry, social organizations and NGOs responded to the questionnaire. However, biotechnology being an emerging sector in India, the information from filled questionnaires was limited. This was supplemented by extensive desk research and feedback from various stakeholders during earlier interactions for identifying the priority areas and proposed training modules. A stakeholder consultation was organized to discuss the field survey findings with experts from government, industry, institutions etc. The participants endorsed the field survey findings and gave suggestions. The inputs received were suitably incorporated in the report. The report was also presented to the Steering Committee of the GEF-World Bank Project, which approved the report. 2

19 CHAPTER 2 METHODOLOGY The present report of Training Need Assessment Survey is a combination of field survey through questionnaires and personal discussions supplemented by extensive desk research. The study was initiated by preparing a detailed questionnaire covering the following areas for identifying the training needs as well as other capacity building requirements in the area of LMOs/GMOs: identification and development of LMOs/GMOs; risk assessment (impact on human health and environment) and management; regulatory capacity building; human resource development and training; public awareness, education and participation; information exchange and data management; scientific and institutional collaborations; technology transfer; socio-economic considerations; sustainable use and conservation of biodiversity A scale of 1-5 was given for priority ranking by the respondents in the above areas (1-not important, 2- a little important, 3- relatively important, 4- fairly important, 5- very important). Subsequently the detailed elements of each of the above mentioned areas were elaborated for prioritization on the scale 1-5. Respondents were requested to give their views on the present status, existing facilities/activities, suggested areas for the training/capacity building and the target segments for each of the listed areas. Out of the detailed questionnaire, short questionnaires were drafted for some specific stakeholders i.e. state level agricultural officials, agriculture service providers (seed distributors), farmers, plant quarantine officials and social experts. The questionnaires were prepared in such a way so as to get inputs in both quantitative 3

20 and qualitative terms for assessment of training needs as well as designing the training programmes. The questionnaire was also placed on the BCIL and MoEF websites for wider circulation and easy accessibility for the respondents. Copies of questionnaires are placed in Annex-1. A database of 400 target respondents covering different categories viz. Central Government, State Government, research organizations, industry, regulatory bodies, civil organizations, social experts, agriculture service providers and others was prepared (Table 2.1). S.No. Category Component Table 2.1: Categories of target respondents 1. Central government MoEF, DBT, MoA, MoC&I, MoH&FW, MoFPI, DST, ICAR, CSIR, APEDA 2. State government State departments of environment, agriculture, health, agriculture commissionerate, councils for science and technology 3. Regulatory bodies GEAC, RCGM, SBCCs and DLCs, 4. Private industry (including importers and exporters) 5. Public sector research organizations Seed companies, processed food companies R&D institutes affiliated to CSIR, ICAR, university departments, state agriculture universities 6. Social experts Social scientists, legal experts, media representatives 7. Agriculture service providers 8. Civil organizations and others Seed distributors and dealers, agriculture extension workers, input (agrochemicals) suppliers Farmers organizations, NGOs, consumer organizations, industry and trade associations The questionnaires were sent by post, fax, and courier and extensive follow up was done by sending reminders and phone calls. An introductory note on the Cartagena Protocol was attached with each questionnaire to familiarize the respondents with the terms used in the questionnaire such as AIA procedure. Personal interviews were held with selected stakeholders by both visits as well as through telephonic conversation. About 150 responses to the questionnaires were collected from various stakeholders. A computerized programme was prepared for analyzing the results of the survey, which was extensively used to generate different query based reports. 4

21 The quantitative analysis on the priority ranking was done for total number of responses as well as for individual stakeholders. The qualitative findings were based on both the written questions in the questionnaires as well as a set of open questions, which were discussed with the respondents. The findings were compiled for each of the identified areas for assessment of training needs. Extensive desk research included collection of information on country s obligations to the Cartagena Protocol, existing regulatory systems of approval as well as trade of LMOs/GMOs and overview of existing initiatives for capacity building etc. The status of implementation of Cartagena Protocol in India and the requirements for each Article have been studied. An overview of the existing training programmes has been prepared which includes the stakeholders targeted, course content and the recommendations that emerged out of such training programmes. Over 5000 participants have attended the events organized by MoEF, DBT and BCIL in the last few years. The feedback received from the participants in these programmes through surveys conducted from time to time (for IBSCs, state level officers, agriculture service providers, farmers etc.) as well as presentations made by eminent experts have also been taken into account for assessment of training needs. The field survey findings have been combined with the above to workout the requirements of various stakeholders by drawing a training needs matrix, based on which the training modules have been proposed. A stakeholder consultation was organized to discuss the field survey findings with experts from government, industry, institutions, etc. The participants endorsed the field survey findings and gave suggestions. The inputs received have been suitably incorporated in the report. The report was also presented to Steering Committee of the GEF-World Bank project which approved the report. 5

22 CHAPTER 3 APPLICATIONS OF GMOs IN AGRICULTURE In modern science, a Genetically Modified Organism (GMO) is that in which the basic genetic material (DNA) has been altered by rearranging, deleting or adding genes by recombinant DNA technology. The term Living Modified Organism (LMO) has been defined in the Cartagena Protocol on Biosafety as any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology. In everyday usage, LMOs are usually considered to be the same as GMOs, but definitions and interpretations of the term vary widely. Sequences from mammals or any other animals, plants, fungi, bacteria or even sequences synthesized in vitro can be introduced into and expressed in almost any other organism. The genetic manipulation using rdna technology are more precise and outcomes more certain over other methods resulting in faster production of organisms with desired traits. GMOs have been developed and applied successfully since early 1970s under contained conditions and since mid 1980s for commercial applications in the field and open environment. The areas of crop improvement currently being targeted using transgenic techniques include resistance to a variety of pests, pathogens and weed control agents, improvement in nutritional content and improved survival during environmental stress. Research is also being carried out for the use of GM crops for production of a wide range of products including medicines. 3.1 GLOBAL STATUS: Several commercially important transgenic crops such as maize, soyabean, tomato, cotton, potato, mustard, rice etc. have been genetically modified. Table 3.1 lists these products along with the genetically improved trait and countries where they have been approved. 6

23 Table 3.1: Transgenic crops approved for commercial use S. No. Crop Uses Countries where approved 1. Alfalfa Herbicide tolerance U.S., Canada, Mexico 2. Argentine Herbicide tolerance and Canada, US, Japan, Australia Canola improved protection against weeds 3. Carnation Increased shelf life by delayed Australia, European Union ripening, modified flower colour and herbicide tolerance 4. Chicory Herbicide tolerance, improved protection against weeds and higher yields European Union 5. Cotton Improved insect protection, herbicide tolerance and improved protection against weeds 6. Flax, Linseed 7. Green pepper Herbicide tolerance, antibiotic resistance and improved weed protection Virus resistance 8. Maize Herbicide tolerance, improved weed protection, resistance against insects and restored fertility of seeds Japan, Australia, US, China, Mexico, South Africa, Argentina, India, Indonesia, Philippines, Brazil Canada, US China 9. Melon Delayed ripening U.S.A 10. Papaya Virus Resistance U.S.A., Canada 11. Polish Canola Herbicide tolerance and improved weed control Canada 12. Potato Improved protection from insect and leaf roll virus 13. Rice Herbicide resistance US 14. Soybean Improved weed control and herbicide tolerance, increased cooking quality 15. Squash Resistance against watermelon mosaic virus and zucchini yellow mosaic virus 16. Sugar Herbicide tolerance beet Canada, Japan, US, Argentina, European Union, South Africa, Philippines, Switzerland, Taiwan,China,U.K.,Korea,Russia,Urugua y US, Canada,Japan,Australia,Philippines US, Argentina, Japan, Canada, Uruguay, Mexico, Brazil and South Africa, Czech Republic, European Union, Korea, Russia, Switzerland, Taiwan, U.K., Philippines and Australia US, Canada US, Canada, Japan, Philippines,Australia 17. Sunflower Herbicide tolerance Canada 18. Tobacco Herbicide tolerance US 19. Tomato Improved shelf life, taste, US, Mexico, Japan, China, Canada color and texture, improved insect resistance, virus resistance 20. Wheat Herbicide Tolerance U.S. Source: 7

24 Out of the above, four major transgenic crops have come to market in various countries namely maize or corn, cotton, soybean and canola. Commercial production of papaya, squash and tobacco has been initiated in USA. Others such as chicory, tomatoes, rice, potatoes, flax etc. have been approved for commercial use in one or more countries, but have not yet been marketed. In the nine year period since the commercial cultivation of transgenic crops started, the global area under these crops increased by more than 47 fold, from 1.7 million hectares in 1996 to 81.0 million hectares in 2004 (Figure 3.1). There has been a 20% increase in 2004 in the area over the same in 2003 equivalent to 13.3 million hectares. Seventeen countries have so far adopted biotech crops Figure 3.1: Global area of transgenic crops from 1996 to 2004 (million hectares) Source: International Service for the Acquisition of Agri-biotech Applications ( More than one third (34%) of the global biotech crop area of 81 million hectares in 2004, which is equivalent to 27.6 million hectares was grown in developing countries. In 2004, there were 14 countries referred to as biotech mega countries which have 50,000 hectares or more under transgenic. These included nine developing countries and five industrial countries. In decreasing order of hectarage under transgenics, they are USA, Argentina, Canada, Brazil, China, Paraguay, India, South Africa, Uruguay, Australia, Romania, Mexico, Spain and the Philippines (Figure 3.2). 8

25 Figure 3.2: Biotech crop countries and mega countries, 2004 Source: International Service for the Acquisition of Agri-biotech Applications ( There is cautious optimism that the global area and the number of farmers planting GM crops will continue to grow as new and novel products become available for commercialization in the coming years. There is intensive research going on to develop transgenic crops with more direct benefits to consumers. It has been reported that 63 countries are in transgenic crop research and development programs ranging from laboratory/greenhouse experiments, field trials, regulatory approval and commercial production. 57 plants divided into four groups i.e. field crops, vegetables, fruits and plants, have been identified for further research. Some of products that are likely be available to consumers in the near future are: Soybean and canola oils containing more unsaturated fatty acids Higher yielding peas that remain sweeter longer Smaller seedless melons Bananas and pineapples with delayed-ripening qualities Bananas resistant to fungi High protein rice Tomatoes with higher antioxidant content Fruits and vegetables with higher levels of vitamins 9

26 Further down the road are products that include: Crops tolerant to certain stresses e.g. drought, floods, salts, metals, heat, and cold Safer foods through reduction of allergenic proteins Edible vaccines Nitrogen fixing crops Plants that produce latex 3.2 STATUS IN INDIA: In view of the importance and potential of transgenic crops, extensive efforts have been initiated in India for development of transgenic crops. As of now, Bt cotton containing the Cry1Ac gene from Bacillus thuringiensis is the only transgenic crop approved for commercial cultivation in India. The approval was first accorded to M/s Maharashtra Hybrid Seeds Company Ltd. (MAHYCO) in Subsequently, several other companies have taken sub-licenses from MAHYCO and as of now, 20 hybrids of Bt cotton are approved for commercial cultivation in nine states in the country. The area under cultivation has increased from 72,000 acres to 13,10,000 acres in Besides, Bt cotton, ten food crops were under contained limited field trials in India in 2005 (Table 3.2). The trials are being conducted by both public and private sector institutions and are mainly for insect resistance using Cry genes. 10

27 Table 3.2: Transgenic crops under development and field trials S. No Crop Organization Transgene 1. Brinjal Mahyco, Mumbai cry1ac Sungro Seeds Ltd, New Delhi cry1ac IARI, New Delhi cry1f 2. Cabbage Sungro Seeds Ltd, New Delhi cry1ac 3. Cauliflower Sungro Seeds Ltd, New Delhi cry1ac 4. Corn Monsanto, Mumbai Cry1Ab Metahelix Life Sciences, Bangalore Modified Mu-element (Turbo-Mu) 5. Cotton Ajeet Seeds, Aurangabad cry1ac, cryx Ankur Seeds P. Ltd., Nagpur cry1ac, cryx M/s Bioseed Research India Pvt Ltd, Hyd cry1ac, cryx M/s Emergent Genetics India P. Ltd, Hyd cry1ac, cryx Ganga Kaveri Seeds Ltd, Hyderabad cry1ac Green Gold Seeds Ltd, Aurangabad GFM cry1aa JK Agri Genetics, Hyderabad cry1ac M/s Kaveri Seeds Co. P. Ltd, S bad cry1ac Krishidhan Seeds, Jalna cry1ac, cryx Mahyco, Mumbai cryx Metahelix Life Sciences, Bangalore cry1ac Nandi Seeds Pvt. Ltd Mehbubnagar cry1ac Namdhari Seeds Pvt. Ltd, Bangalore cry1ac Nath Seeds, Aurangabad GFM cry1aa Nuziveedu Seeds, Hyderabad cry1ac, cryx Prabhat Agri Biotech Ltd. Hyderabad cry1ac Pravardhan Seeds Pvt. Ltd Hyderabad cry1ac Proagro Seeds Co. Ltd Hyderabad cry1ac Rasi Seeds Ltd., Attur cryx Syngenta India Ltd., Pune Vip-3A Tulsi Seeds, Guntur cry1ac, cryx UAS, Dharwad cry1ac Vibha Agrotech Ltd. Hyderabad cry1ac Vikki s Agrotech, Hyderabad cry1ac Vikram Seeds Ltd, Ahmedabad cry1ac Zuari Seeds Ltd. Bangalore GFM cry1aa 6. Groundnut ICRISAT, Hyderabad Coat protein of IPCV Nucleo Capsid Protein of PBNV 7. Mustard UDSC, New Delhi barnase & barstar 8. Okra Mahyco, Mumbai cry1ac, 9. Pigeonpea ICRISAT, Hyderabad cry1ac, 10. Rice IARI, New Delhi cry1ac, cry1aa + cry1b Mahyco, Mumbai cry1ac Metahelix Life Sciences, Bangalore NHX gene 11. Tomato IARI, New Delhi antisense replicase gene of tomoto leaf curl virus Mahyco, Mumbai cry1ac Source: Department of Biotechnology, Government of India 11

28 More than 50 institutions both in the public and the private sector are engaged in research and development of transgenic crops, some of which are listed below: A. RESEARCH INSTITUTIONS 1. Assam Agricultural University, Jorhat 2. Bose Institute, Kolkata 3. Central Institute for Cotton Research, Nagpur 4. Central Potato Research Institute, Shimla 5. Central Tobacco Research Institute, Rajahmundry 6. Centre for Plant Molecular Biology, Osmania Univ., Hyderabad 7. Delhi University South Campus, New Delhi 8. G B Pant University of Agriculture and Technology, Pantnagar 9. Indian Agricultural Research Institute, New Delhi 10. International Centre for Genetic Engineering and Biotechnology, New Delhi 11. International Crop Research Institute for Semi-Arid Tropics, Hyderabad 12. Indian Institute of Chemical Biology, Kolkata 13. Jawaharlal Nehru University, New Delhi 14. Madurai Kamraj University, Madurai 15. Mahatama Phule Krishi Vidyapeeth, Rahuri 16. National Botanical Research Institute, Lucknow 17. National Centre for Plant Genome Research, New Delhi 18. The Energy and Resources Institute (TERI), New Delhi 19. Tamil Nadu Agricultural University, Coimbatore 20. University of Agricultural Sciences, Dharwad B. COMPANIES 1. Ajeet Seeds, Aurangabad 2. Ankur Seeds P. Ltd., Nagpur 3. Bioseed Research India Pvt Ltd, Hyd 4. Emergent Genetics India P. Ltd, Hyd 5. Ganga Kaveri Seeds Ltd, Hyderabad 6. Green Gold Seeds Ltd, Aurangabad 7. JK Agri Genetics, Hyderabad 8. Kaveri Seeds Co. P. Ltd, S bad 9. Krishidhan Seeds, Jalna 10. Mahyco, Mumbai 11. Metahelix Life Sciences, Bangalore 12. Monsanto, Mumbai 12

29 13. Namdhari Seeds Pvt. Ltd, Bangalore 14. Nandi Seeds Pvt. Ltd Mehbubnagar 15. Nath Seeds, Aurangabad 16. Nuziveedu Seeds, Hyderabad 17. Prabhat Agri Biotech Ltd. Hyderabad 18. Pravardhan Seeds Pvt. Ltd Hyderabad 19. Proagro Seeds Co. Ltd Hyderabad 20. Rasi Seeds Ltd., Attur 21. Sungro Seeds Ltd, New Delhi 22. Syngenta India Ltd., Pune 23. Tulsi Seeds, Guntur 24. Vibha Agrotech Ltd. Hyderabad 25. Vikki s Agrotech, Hyderabad 26. Vikram Seeds Ltd, Ahmedabad 27. Zuari Seeds Ltd. Bangalore 13

30 CHAPTER 4 REGULATORY FRAMEWORK IN INDIA As more and more GMOs/LMOs are released for field-testing and commercialization, concerns have been expressed regarding potential risks to both human health and environment. Risks to human health are related mainly to toxicity, allergenicity and antibiotic resistance of the new organisms/products. Risks to environment include impact of introduced traits introgressing into other related species through out crossing, the potential buildup of resistance in insect populations, effect on biodiversity and unintended effects on non-targeted organisms. These apprehensions arise because rdna technology crosses the species barrier as compared to classical selection techniques, thereby permitting the gene transfer among microorganisms, plants and animals. The concerns associated with use of GMOs/LMOs can differ greatly depending on the particular gene-organism combination and therefore a case-by-case approach is required for risk assessment and management. These biosafety concerns have led to the development of regulatory regimes in various countries for testing, safe use and handling of GMOs/LMOs and products thereof. An overview of the regulatory framework in India governing GMOs/LMOs and their applications in agriculture and food is given below: 4.1 GOVERNMENT RULES FOR GMOs: The Ministry of Environment & Forests, Government of India notified the rules and procedures for the manufacture, import, use, research and release of GMOs as well as products made by the use of such organisms on December 5, 1989 under the Environmental Protection Act 1986 (EPA). These rules and regulations, commonly referred as Rules 1989 cover the areas of research as well as large scale applications of GMOs and products made therefrom throughout India. The two main agencies identified for implementation of the rules are the Ministry of Environment & 14

31 Forests and the Department of Biotechnology, Government of India. The rules have also defined competent authorities and the composition of such authorities for handling of various aspects of the rules. There are six competent authorities as per the rules. i. Recombinant DNA Advisory Committee (RDAC) ii. Review Committee on Genetic Manipulation (RCGM) iii. Genetic Engineering Approval Committee (GEAC) iv. Institutional Biosafety Committees (IBSC) v. State Biosafety Coordination Committees (SBCC) vi. District Level Committees (DLC). (i) The Recombinant DNA Advisory Committee (RDAC): This committee constituted by the Department of Biotechnology takes note of developments in biotechnology at national and international levels. The RDAC prepares recommendations from time to time that are suitable for implementation for upholding the safety regulations in research and applications of GMOs and products thereof. This Committee prepared the Recombinant DNA Biosafety Guidelines in 1990, which was adopted by the Government for conducting research and handling of GMOs in India. (ii) Institutional Biosafety Committee (IBSC): It is necessary that every institution intending to carry out research activities involving genetic manipulation of microorganisms, plants or animals should constitute the IBSC. All the IBSCs have to induct one DBT nominee. The IBSC is the nodal point for interaction within the institution for implementation of the guidelines. The main activities of IBSCs are: To note and to approve r-dna work. To ensure adherence of r-dna safety guidelines of government. To prepare emergency plan according to guidelines. To recommend to RCGM about category III risk or above experiments and to seek RCGM s approval. To inform DLC and SBCC as well as GEAC about the experiments where ever needed. 15

32 To act as nodal point for interaction with statutory bodies. To ensure experimentation at designated location, taking into account approved protocols. (iii) Review Committee on Genetic Manipulation (RCGM): The RCGM under the Department of Biotechnology has the following functions: To bring out manuals of guidelines specifying producers for regulatory process on GMOs in research, use and applications including industry with a view to ensure environmental safety. To review all on going r-dna projects involving high risk category and controlled field experiments. To lay down producers for restriction or prohibition, production, sale, import & use of GMOs both for research and applications. To permit experiments with category III risks and above with appropriate containment. To authorize imports of GMOs/ transgenes for research purposes. To authorize field experiments in 20 acres in multi-locations in one crop season with up to one acre at one site. To generate relevant data on transgenic materials in appropriate systems. To undertake visits of sites of experimental facilities periodically, where projects with biohazard potentials are being pursued and also at a time prior to the commencement of the activity to ensure that adequate safety measures are taken as per the guidelines. (iv) Genetic Engineering Approval Committee (GEAC): Genetic Engineering Approval Committee (GEAC) functions as a body under the Ministry of Environment and Forests and is responsible for approval of activities involving large scale use of hazardous microorganisms and recombinant products in research and industrial production from the environment angle. To permit the use of GMOs and products thereof for commercial applications. To adopt producers for restriction or prohibition, production, sale, import & use of GMOs both for research and applications under EPA. To authorize large scale production and release of GMOs and products 16

33 thereof into the environment. To authorize agencies or persons to have powers to take punitive actions under the EPA. (v) State Biotechnology Coordination Committee (SBCC): This Committee, headed by the Chief Secretary of the State is constituted in each state where research and applications of GMOs are contemplated. It has: Powers to inspect, investigate and to take punitive action in case of violations of statutory provisions through the State Pollution Control Board or the Directorate of Health etc. To review periodically the safety and control measures in various institutions handling GMOs. To act as nodal agency at State level to assess the damage, if any, due to release of GMOs and to take on site control measures. The Committee coordinates the activities related to GMOs in the State with the Central Ministries. This committee also nominates State Government representatives in the activities requiring field inspection of activities concerning GMOs. (vi) District Level Committee (DLC): This Committee constituted at the district level is considered to be smallest authoritative unit to monitor the safety regulations in installations engaged in the use of GMOs in research and applications. The District Collector heads the Committee who can induct representatives from State agencies to enable the smooth functioning and inspection of the installations with a view to ensure the implementation of safety guidelines while handling GMOs, under the Indian EPA. Its functions are: To monitor the safety regulations in installations. Has powers to inspect, investigate and report to the SBCC or the GEAC about compliance or non compliance of r-dna guidelines or violations under EPA. To act as nodal agency at District level to assess the damage, if any, due to release of GMOs and to take on site control measures. 17