Newsletter. Website on Capacity Building in Biosafety. Comments. Meeting of the Project Steering Committee

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1 November 2005, Vol.1, Issue 2 Newsletter tgk gs gfj;kyha ogk gs [kq'kgkyhaa In this Issue Website on Capacity Building in Biosafety Comments Meeting of the Project Steering Committee Progress of GEF-World Bank Capacity Building Project on Biosafety Highlights of Training Needs Assessment Survey Project Mid-Term Review and Supervision Mission Genetically Modified Crops Under Field Trial in India during 2005 Highlights of Events Upcoming Events From the Desk of Editor I am delighted to place second issue of our Biosafety Newsletter in your hands. The response to our first issue has been overwhelming for which we are grateful to all our readers. Human resource development and training is one of the key elements for capacity building in biosafety of LMOs/GMOs for effective implementation of Cartagena Protocol on Biosafety. As part of the GEF-World Bank project, a training needs assessment survey has recently been undertaken to identify priority areas for training of various agricultural biotechnology stakeholders in both public and private sectors with regard to genetically engineered crops and derived products. The survey has been conducted through a process of consultation with experts and other stakeholders which suggest that a combination of national and international events, series of workshops for various stakeholders, laboratory/technical training, studies, circulation of publications and documents etc. are required to create awareness as well as to provide training on key issues. In view of the challenges with respect to the commercial release of more LMOs/GMOs as well as their transboundary movement, it has been envisaged to enhance the existing capacity through training and workshops under the GEF-World Bank project. We have, meanwhile also launched our website ( for wider dissemination of information to all stakeholders. I hope that you find this issue of newsletter as also the website, interesting and informative. Wishing you a HAPPY NEW YEAR. Recently Released Documents on Biosafety Recently Released Reports Links For Further Reading Do You Know? Desh Deepak Verma Project Director & Joint Secretary Ministry of Environment & Forests Website on Capacity Building in Biosafety Information on the activities under GEF-World Bank project on capacity building in biosafety is now available as part of the website of Ministry of Environment and New Forests (MoEF) i.e. (sub heading Biosafety ). The website also has information on the related topics such as regulatory framework, lists of various statutory committees, lists of approved GMOs and products thereof, links for further reading, list of upcoming events etc. Please visit for detailed information and send your suggestions/comments at pcmu-mef@nic.in. Prepared by Project Coordinating and Monitoring Unit (PCMU) of the MInistry of Environment & Forests in association with Biotech Consortium India Limited under the GEF-World Bank Capacity Building Project on Biosafety

2 Comments Congratulations! The Newsletter may be placed in the MoEF website. Dr. Prodipto Ghosh, Secretary, Ministry of Environment and Forests, This is a great newsletter. Nice layout, great content and excellent information piece to promote MoEF's Biosafety work and also the project. Dr. Eija Pehu, Task Manager, World Bank, Washington, D.C., USA Newsletter and Project website look really great. It is nice to see that the project is continuing to make progress. Dr. Joshua E. Brann, Global Environmental Facility Office of Monitoring and Evaluation, Washington, D.C., USA This is very interesting material and the website looks great. Dr. Jeffery A. Mcneely, Chief Scientist IUCN-The World Conservation Union, Gland, Switzerland This has been a long awaited service to biotechnology. I am very happy for this initiative to bring the newsletter. I hope that this service will receive more attention and support. A section on EMERGING AREAS focusing on issues like biosafety trade, and governance, may be added. Special features/ unified articles could also be thought of. Dr. Pisupati Balakrishna, Head, IUCN Regional Biodiversity Programme, Colombo, Sri Lanka Meeting of the Project Steering Committee The Second meeting of the GEF-World Bank Project on capacity building on biosafety was held on 31st October, 2005 under the Chairmanship of Shri Suresh Chandra, Special Secretary, Ministry of Environment & Forests. The Steering Committee while appreciating the progress of the project approved, interalia, the Training Needs Assessment Survey Report, the Annual Work Plan etc.

3 PROGRESS OF GEF-WORLD BANK CAPACITY BUILDING PROJECT ON BIOSAFETY Component 1 Strengthening institutional and legal frame work to improve capacity and coordination decision making within and across Ministries. The training needs for various stakeholders have been identified for providing training in the area of biosafety through a Training Needs Assessment (TNA) survey and a multistakeholder consultation. The TNA Report was approved by the Steering Committee which met on 31st October, Component 2 Improved capacity for risk evaluation & management. This component envisages a review and comparative analysis of the regulations, guidelines and procedures, with particular attention to information/ data requirements, used in India by regulatory authorities and/or their designates for the environmental risk assessment and approval of transgenic plants. This component is in progress. Component 3 Strengthening laboratories/institutions for analytical detection of LMOs (i) National Bureau of Plant Genetic Resources (NBPGR), The internal review of the first draft of the rice biology document has been completed and the external peer review is in process. The DNA extraction protocol both from leaf and seed material has been standardized for rice, maize, cotton, soybean and mustard. Development and optimization of PCR based detection protocols for GM maize and soybean have been successfully completed. (ii) G.B. Pant University of Agriculture and Technology, Pantnagar DNA isolation from cotton seeds has been standardized, and quality of DNA obtained compared. The detection limit of transgene in Bt-Express Kit is 1:100 and that in Bt-quant Kit is being standardized. Identification of critical control points in seed processing has been initiated. (iii) National Research Center on Plant Biotechnology (NRCPB), NRCPB has developed the general architecture for integrated database on use of GMOs in India with respect to biosafety. Linkages to other websites have also been envisaged under this database. The inputs for this database will not only be from the institutions involved in this project but also from other institutions engaged in transgenic activities. (iv) Central Food Technological Research Institute (CFTRI), Mysore Commercially available insect resistant cotton seeds were procured from MAHYCO, a Maharashtra based seed company. The testing methods were optimized and a commercial kit developed for the detection. Component 4 Establishment of Biosafety Clearing House (BCH) The draft format and matter for the Biosafety Clearing House (BCH) has been prepared ( indbch.nic.in) and is in the process of final launching. A Biosafety Project Website divisions/csurv/ biosafety/default.htm has been uploaded. The Biosafety Newsletter has been released which also can be seen at the project website. Project Mid-Term Review and Supervision Mission A Project Supervision Mission led by Dr. Eija Pehu, Task Team Leader of the Capacity Building Project visited India from November 7-11, The team members were Ms. Papia Bhattacharya, Financial Management Specialist and Mr. Om Prakash and Mr. Deepal Fernando, Procurement Specialists from Country Office of the World Bank. Progress of project implementation has been rated as satisfactory and in line with the development objectives to build capacity to meet obligations under the Cartagena Protocol related to transboundary movement of LMOs. Left to Right : Dr. Shashi Bhalla, NBPGR, Dr. T. R. Sharma, NRCPB, Prof. G. K. Garg, G. B. Pant University of Agriculture & Technology, Dr. Eija Pehu, Task Team Leader, World Bank, Shri Desh Deepak Verma, Project Director & Joint Secretary, MoEF, Dr. Manoranjan Hota, Project Coordinator & Additional Director, MoEF, Dr. G. A. Krishna & Dr. Lalita Gowda, CFTRI.

4 Highlights of the Training Needs Assessment Survey The Project Coordinating and Monitoring Unit (PCMU) of the GEF-World Bank Capacity Building Project has undertaken a Training Needs Assessment Survey through Biotech Consortium India Limited (BCIL). The study was a combination of field studies through questionnaires and personal discussions supplemented by extensive desk research. Developments in agricultural biotechnology, regulatory framework governing agriculture crops and food and status of implementation of Cartagena Protocol in India have been studied in detail to understand the training requirements. About 150 respondents from government, research institutions, universities, industry and NGOs have provided inputs in the form of priority ranking as well as suggestions on training areas. In addition, information on existing training initiatives and feedback from earlier surveys and presentation was used to draw a training needs matrix of following training areas and stakeholders: Development of LMOs/GMOs; Senior government officials (policy/decision makers); Risk assessment (impact on human health and environment); Regulators (e.g. application reviewers/assessors, advisors, administrators.) Risk management; Identification of LMOs/GMOs; Regulatory capacity building; Human resource development and training; Public awareness, education and participation; 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 exchange and data management; Scientific and institutional collaborations; Technology transfer; Information managers including IT specialists; Graduate and undergraduate students; Interest groups (e.g. consumer groups, farmer associations, professional associations, NGOs); Socio-economic considerations; Sustainable use and conservation of biodiversity Mass media and outreach/extension workers (e.g. journalists and agricultural extensionists) and General public and political leadership A variety of approaches are required to meet the training needs for strengthening the implementation of Cartagena Protocol on biosafety as well as domestic regulatory framework. Some of the training modules proposed in the study are as follows: Extensive public awareness and education through existing trusted networks using both print and electronic media, network of scientific communicators and educational documents in local languages Series of events across the country for custom, port, plant quarantine, agriculture, nutrition and health extension officials National consultations on various articles of Cartagena Protocol on Biosafety National workshops on various crops under development Seminars on specific research areas pertinent to biosafety Review and updation of national rules and guidelines particularly on handling, transport, packaging and detection of LMOs. Studies on status, impact and cost implication of labeling Baseline surveys for developing protocols for ecological risk assessments Resource material on biosafety issues Regular participation by scientists and regulators in international events and study tours. International conferences on LMO testing methods, risk assessment and management and regional harmonization of biosafety rules and guidelines. Directory of resource persons.

5 Genetically Modified (GM) Crops Under Field Trial in India during 2005 S. No Crop Trait Organization 1. Brinjal Insect resistance Indian Agricultural Research Institute (IARI), MAHYCO, Sungro Seeds Ltd. 2. Cabbage Insect resistance Sungro Seeds Ltd. 3. Cauliflower Insect resistance Sungro Seeds Ltd. 4. Corn Insect resistance Monsanto (India), Metahelix Life Sciences 5. Cotton Insect resistance University of Agricultural Sciences (UAS, Dharwad), Bioseed Research India Pvt. Ltd., Emergent Genetics India P. Ltd., Green Gold Seeds Ltd., Kaveri Seeds Co. P. Ltd., Metahelix Life Sciences, Namdhari Seeds Pvt. Ltd., Proagro Seeds Co. Ltd., Vibha Agrotech Ltd., Vikram Seeds Ltd., Zuari Seeds Ltd., Ankur Seeds, JK Agri Genetics, Krishidhan Seeds, MAHYCO, Nath Seeds, Rasi Seeds Ltd., Syngenta India, Nuziveedu Seeds, Mahendra Hybrid Seeds, Tulsi Seeds, Ganga Kaveri, Vikki's Agrotech, Pravardhan Seeds, Prabhat Agri Biotech., Ajeet Seeds. 6. Groundnut Virus resistance ICRISAT 7. Mustard Cytoplasmic male sterility University of Delhi South Campus (UDSC) 8. Okra Insect resistance MAHYCO 9. Pigeonpea Resistance to fungal pathogens ICRISAT 10. Rice Resistance to lepidopteran pests, IARI, MAHYCO, Metahelix Life Sciences bacterial blight and sucking pests, fungal infection, insect resistance, salt tolerance 11. Tomato Insect resistance, viral resistance MAHYCO, IARI Source: Dr T.V. Ramanaiah, Department of Biotechnology, Government of India

6 HIGHLIGHTS OF EVENTS Title Organized by Date and venue Outcome International Conference on Food Derived from GM Crops: Issues for Consumers, Regulators and Scientists Indian Council of Medical Research, AGBIOS Inc., Canada and Biotech Consortium India Limited September 26-27, 2005 Extensive discussions held on the regulations, key elements of food safety assessment, public participation and consumer issues among a cross section of stakeholders including regulators, policy makers and other concern government departments, scientists, industry and NGOs from India and Bangladesh. National Workshop on Management of Field Trials of Genetically Modified Crops CropLife International, AGBIOS Inc., International Service for the Acquisition of Agri-biotech Applications (ISAAA), and Biotech Consortium India Limited UPCOMING EVENTS August 9, 2005 Compliance management of confined field trials of genetically engineered plants as detailed in the CropLife International document and other issues related to field trials of GM crops in India were discussed. Title Organized by Date and venue International Conference on Biotechnology approaches for alleviating malnutrition and human health Biosafety Concerns of Transgenics and Detection of LMOs University of Agricultural Sciences, Bangalore MoEF with National Bureau of Plant Genetic Resources (NBPGR) January 9-11, 2006 Bangalore, Karnataka January 16-20, 2006 National Seminar on Transgenic Crops in Indian Agriculture: Status, Risks and Acceptance Biosafety Capacity Building Conference for Senior Custom Of ficers Short-term Orientation Course on Biosafety and Biotech Regulations Introduction to Biosafety and Risk Assessment for Environmental Release of Genetically Modified Organisms (GMOs): Theoretical Approach and Scientific Background Detection on Genetically Modified Organisms (GMOs) and Genetically Modified Food Practical Course in Evaluation of Field Releases of Genetically Modified Plants National Society of Plant Sciences, in collaboration with Department of Plant Breeding, CCS Haryana Agricultural University MoEF MoEF with The Energy and Resources Institute (TERI) International Centre for Genetic Engineering and Biotechnology (ICGEB) ICGEB ICGEB January 28-29, 2006 Hisar, Haryana February, 2006 February 6-11, 2006 March 6-10, 2006 Ca'Tron (Treviso), Italy March 22-24, 2006 Peradeniya, Sri Lanka May 15-19, 2006 Florence, Italy

7 Recently Released Documents on Biosafety Handbook for IBSC Members (2005) Asian Biotechnology Development Review, July Issue, Vol. 7. No. 3 (2005) Report of the Task Force on Recombinant Pharma (2005) DBT and BCIL have collectively prepared handbook for IBSC members with an objective to provide comprehensive and scientific information on the role of IBSCs and as a ready reckoner for biosafety regulations, associated rules and risk assessment and management approaches. For more information please contact (tvraman@dbt.nic.in/vibhaahuja@bi otech.co.in) The Asian Biotechnology Development Review (ABDR) is published by Research and Information System for Developing Countries (RIS),. This special edition of ABDR has valuable articles on some of the key issues on Capacity Building Activities in Biosafety. For more information please visit ( Ministry of Environment and Forests, Government of India has released the report of the Task Force on recombinant pharma chaired by Dr. R. A. Mashelkar, Director General, CSIR set up for streamlining the current regulatory framework. Full report available on ( RECENTLY RELEASED REPORTS i. Report on Training Needs Assessment Survey (2005) by Ministry of Environment & Forests and Biotech Consortium India Limited, ( ii. Food and Nutrition Biotechnology: Current Achievements, Prospects and Perceptions (2005) by A. Sasson, Visiting Professor, United Nations University, Institute of Advanced Studies. ( Foodbiotech.pdf). iii. Global traceability and labeling requirements for agricultural biotechnology-derived products: Impacts and implications for the United States (2005).( ac21/reports/tlpaperv37final.pdf). iv. Agricultural Biotechnology and Biosafety in India: Expectations, Outcomes and Lessons (2005) by A. Indira, M.R. Bhagavan and I. Virgin, Stockholm Environment Institute. ( docroot/articles/ pdf). LINKS FOR FURTHER READING covers all aspects of the application of biotechnology and genetic engineering in agricultural production, food processing and marketing and focuses on scientific reports, findings and technical analysis. devoted to bringing information about technological advances in agriculture to the developing world and provides information to scientists, teachers, journalists and the general public on the relevance of agricultural biotechnology to sustainable development. dedicated to biosafety and risk assessment for the environmental release of GM organisms and offers information on biosafety concerns, upcoming meetings, training courses and scientific publications on biosafety and risk assessment. involved in transfer and delivery of appropriate biotechnology applications to developing countries and the building of partnerships between institutions in the South and the private sector in the North, and by strengthening South-South collaboration.

8 Patron Shri Suresh Chandra Special Secretary, MoEF Editors Shri Desh Deepak Verma Project Director & Joint Secretary, MoEF Dr. Manoranjan Hota Project Coordinator & Additional Director, MoEF Editorial Board Dr. Vibha Ahuja DGM, BCIL Prof. Ashok Bhatnagar Dept. of Botany, Delhi University Prof. K. R. Koundal Project Director, NRCPB, IARI Dr. Gurinder Jit Randhawa Senior Scientist, NBPGR Dr. T. V. Ramanaiah Director, DBT Dr. S. N. Sharma Advisor, CSIR For Feedback and Any Other Information Please Contact: 1. Shri Desh Deepak Verma Project Director & Joint Secretary, MoEF Telefa x: Dr. Manoranjan Hota Project Coordinator & Additional Director, MoEF Paryavaran Bhawan, CGO Complex, Lodi Road, Telfa x: Dr. Vibha Ahuja Deputy General Manager Biotech Consortium India Limited Anuvrat Bhawan (5th Floor) Deen Dayal Upadhyaya Marg, Tel. No Fa x No vibhaahuja@biotech.co.in; bcildelhi@vsnl.com Do You Know? What is biotechnology? The term `biotechnology' refers to any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for a specific use. Biotechnology, in the form of traditional fermentation techniques, has been used for decades to make bread, cheese or beer. It has also been the basis of traditional animal and plant breeding techniques, such as hybridization and the selection of plants and animals with specific characteristics to create, for example, crops which produce higher yields of grain. The difference with modern biotechnology is that researchers can now take a single gene from a plant or animal cell and insert it in another plant or animal cell to give it a desired characteristic, such as a plant that is resistant to a specific pest or disease. In the Biosafety Protocol, modern biotechnology means the application of: a. In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles or b. Fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection. What is a Living Modified Organism (LMO)/Genetically Modified Organism (GMO)? A Living Modified Organism (LMO) is 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 (Genetically Modified organisms), but definitions and interpretations of the term GMO vary widely. Common LMOs include agricultural crops that have been genetically modified for greater productivity or for resistance to pests or diseases. Examples of modified crops include tomatoes, cassava, corn, cotton and soybeans. What are LMO products? LMOs form the basis of a range of products and agricultural commodities. Processed products containing dead modified organisms or non-living GMO components include certain vaccines; drugs; food additives; and many processed, canned, and preserved foods. They can also include corn and soybean derivatives used in many foods and nonfoods, cornstarch used for cardboard and adhesives, fuel ethanol for gasoline, vitamins, vaccines and pharmaceuticals, and yeast-based foods such as beer and bread. (Source: Project Website: ht tp://w w w.env for.nic.in/divisions/csurv/biosafety/default.htm Disclaimer : The information in this newsletter has been compiled from various sources and does not necessarily depict views of the Ministry of Environment & Forests, Government of India.