InfoShop. Integrated Safeguards Data Sheet (Initial) Report No: AC85. Section I - Basic Information. A. Basic Project Data Country: INDIA

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1 Public Disclosure Authorized Public Disclosure Authorized Public Disclosure Authorized Public Disclosure Authorized THfE WORLD BANK GROUP InfoShop Date Prepared/Updated: 05/22/2003 Section I - Basic Information Integrated Safeguards Data Sheet (Initial) A Wortif Fr,i: of Proverty Report No: AC85 A. Basic Project Data Country: INDIA Project ID: P Project: GEF Biosafety Project Task Team Leader: Eija Pehu Authorized to Appraise Date: November 1, 2002 IBRD Amount ($m): Bank Approval: June 23, 2003 IDA Amount ($m): Managing Unit: SASRD Sector: General agriculture; fishing and forestry Lending Instrument: Specific Investment Loan (SIL) sector (100%) Status: GEF Medium Sized Project (Preparation) Theme: Biodiversity (P) I.A.2. Project Objectives: The immediate objective is that at the end of the three year capacity building project there will be sufficient capacity in the country and effective coordination between the responsible agencies to assess and manage risks associated with the transboundary movement of LMOs (Living Modified Organisms). This will be achieved through the strengthening of the biosafety framework with the necessary regulations, enhanced technical capacity and enforcement and monitoring capacities as well as a well managed information and coordination network. Within three years, the country will build sufficient capacity to assess and manage environmental and health risks associated with the trans-boundary movement of LMOs through the strengthening of the legal and regulatory frameworks, enhanced institutional capacity and effective communication strategies. Knowledge and methodologies on Biosafety will be shared and transferred to the state agencies through training programmes conducted across the country. The project's specific objectives are to: 1. strengthen the legal framework and institutional capacity for coordination and decision making across ministries, specialized agencies and state governments in areas related to biosafety and the Cartagena Protocol. 2. strengthen technical capacity to assess, manage and monitor environmental and health risks associated with LMOs through the provision of training for core capacity development in relevant stakeholder ministries, specialized agencies and in state governments. 3. establish the biosafety database system and Biosafety Clearinghouse Mechanism (BCH); 4. support centres of excellence and a network for research, risk assessment, and monitoring; and, 5. establish the Project Coordination and Monitoring Unit (PCMU). Components:

2 2 Component 1:Strengthening the institutional and legal framework to improve capacity and coordination in decision making at the Federal and State levels and in relevant specialized agencies. Component 2: Improving capacity for risk evaluation and management Component 3: Strengthening laboratories/institutions for analytical evaluation of GM ingredients and for certification services. Component 4: Biosafety Clearing House and Enhanced information sharing and public awareness Component 5: Project Coordinating and Monitoring Unit (PCMU) I.A.3. Project Description: In order to achieve the above objectives the project will seek to achieve the following components: Component 1:Strengthening the institutional and legal framework to improve capacity and coordination in decision making at the Federal and State levels and in relevant specialized agencies. In order to improve capacity and coordination in decision making on issues relating to biosafety of LMOs, the GEF resources will be used to strengthen institutional and legal framework within as well as across the concerned Ministries, including MoEF, DBT, Ministry of Agriculture (MoA) Ministry of Food Processing Industries (MoFPI) Ministry of Health and Family Welfare ( MoH&FW), Ministry of Commerce and Industries (MoC&I). This component will be achieved interalia through training for core capacity development in relevant Ministries and State Agencies and other specialized organizations including oversight and review bodies (NPBGR, NRC on DNAF etc.). Training modules which comprise the training program will include: Agriculture - inspection and monitoring of laboratory experiments and field trials, safe handling of Genetically Modified (GM) materials and quarantine, extension and training of farmers. Environment - pollen transfer, out crossing/hybridisation, effect on biodiversity, effect on non-target species. Biotechnology - Gene constructs, development of protocols for evaluation of safety, development of guidelines and training materials. Health and Food processing - food safety evaluation, compositional analysis for assessment for substantial equivalence in GM-commodities. a Commerce- monitoring and regulating trade in commercial food, feed and industrial products potentially and knowledge and patent concerns. containing GM-ingredients, intellectual property rights Training and awareness for policy makers in relevant Ministries in LMO risk assessment and management. Social - training and awareness building on ethical, equity and other socio-economic issues relating to LMOs, including potential impacts on labor markets, land holding consolidation and poverty; Minimum infrastructure and equipment to support core capacity. Training to develop capacity to support implementation of international agreements (e.g. CBD, Cartagena participate in negotiation of new agreements or amendments Protocol, Codex Alementarius) and to effectively on biosafety of LMOs. Component 2: Improving capacity for risk evaluation and management

3 3 GEF resources will be used specifically for training experts in molecular genetics to detect and track LMOs presented under AIA. The capacity developed will increase India's potential to monitor and manage potential risks associated with in-country movements of LMOs. GEF support will also be used to develop field capacity to monitor possible gene flow between introduced LMOs and semi domestic and wild relatives. This training will allow supervision of the implementation of biosafety measurers and over the medium term to identify potential gene flow, as well as the effect on non-target species. Data on transboundary shipments of LMOs at points of entry would be registered, collected and validated by Customs through ad-hoc methodologies designed with the help of GEF resources. The outcome will be achieved through activities such as: Operational manuals to guide scientists in managing field trials, and training in their implementation. Access to and provision of risk-related ecological and environmental information to all stakeholders. Training for scientists and research managers in risk evaluation procedures in selected institutions. The development and adaptation of methodologies for risk evaluation of LMOs. Training and capacity building for the monitoring of LMOs after release. The training programs would be oriented for capacity building for techniques and monitoring methodologies for risk evaluation and management of LMOs. It is envisaged that eight training courses/workshops encompassing four zones of the Country would include about 1600 participants. The training would also include content on the socio-economic and ethical considertions associated with LMOs. All the outputs generated from this project would be utilized by all the stakeholders and also would be disseminated across the Country. Component 3: Strengthening laboratories/institutions for analytical evaluation of GM ingredients and for certification services. This outcome will be achieved through: Identification of laboratories/institutions for analytical evaluation of GM ingredients. Training the personnel for certification services of commodities and food potentially containing GM elements. Infrastructure and equipment for the identified laboratories/institutions. Risks related to LMOs, including labelling issues, trace-ability etc. Based on criteria established during the project preparation process, four laboratories have been selected for strengthening: (I) Central Food Technological Institute, Mysore, Karnataka (2)National Bureau of Plant Genetic Resources (NPBGR), New Delhi (3)National Research Centre on Plant Biotechnology (NRCPB), a member centre of IARI (4) G.B. Pant University of Agriculture and Technology, Pantnagar, Uttaranchal These organisations/laboratories would be strengthened by providing equipment to the laboratories so as to develop their capacities to evaluate and mitigate risks. The equipment needs would be identified by the PCMU in consultation with these institutions. Component 4: Biosafety Clearing House and Enhanced information sharing and public awareness Targeted information needs to be simple and reliable and should make best use of the different available media options under an overall strategy. GEF resources would be used to design a targeted information campaign on potential risks and benefits of LMOs. This information would be reviewed during project implementation to take into account the results of capacity building efforts in outputs 1 and 2. Replication efforts would ensure that lessons learned and scientific and technical innovations on biosafety efforts would be directly incorporated into the human

4 4 resource preparation efforts over the mid and long term. Norms and guidelines, the abstracts of each risk evaluations, final decisions and reports of the procedure for the AIA (Art. 20) will also be included in the Biosafety Clearing House (BCH). The outcome will be achieved interalia through: websites LMOs. Support for establishing the national node for the Biosafety Clearing House and linkages with associated and list servers of relevant Ministries. Activities to improve information sharing and networking (workshops, exchange visits etc.). Training in information management, website construction etc. Stakeholder workshops with farmer groups, consumers, NGOs etc. on biosafety and risk management of Development of relevant materials on biosafety of LMOs for key stakeholders. The BCH would hire staff, procure equipment and software, and establish a local information network. Training would be imparted to the BCH staff for discharging their duties so as to achieve the objectives of the Project and so also to achieve the objectives of the CP. This would involve the detailed design of the information components including Web Page along with the design of information capturing mechanisms. The BCH would design and manage the database, prepare the Manual and operational design, information gathering and also implement the information system targeted at stakeholder departments and Ministries. The BCH would also impart training for the capacity enhancement of stakeholder departments and Ministries. Component 5: Project Coordinating and Monitoring Unit (PCMU) A PCMU will be created and supported within the MoEF to administer the project. The tasks of the PCMU will include overall project management, coordination with other Ministries, reporting and evaluation. The PCMU will also prepare work plans, budgets, and terms of reference for subcontractors and consultants, and will be responsible for maintaining financial accounts and records according to World Bank's guidelines for nationally executed projects. I.A.4. Project Location: (Geographic location, information about the key environmental and social characteristics of the area and population likely to be affected, and proximity to any protected areas, or sites or critical natural habitats, or any other culturally or socially sensitive areas.) National Project - the project is a capacity building effort and consequently no enviornmental or social impacts expected B. Check Environmental Classification: C (Not Required) Comments: The project is exclusively focused on building institutional capacity and strengthening the legal framework in India for assessing and managing the environmental and ecological risks associated with the importation and use of LMOs. Consequently, the proposed project is expected to contribute profoundly to enhancing capacity and understanding in India to address any potential risks associated with LMOs C. Safeguard Policies Triggered Policy Environmental Assessment (OP/BP/GP 4.01) Natural Habitats (OP/BP/GP 4.04) Forestry (OP/GP 4.36) Pest Management (OP 4.09) Cultural Property (OPN 11.03) Indigenous Peoples (OD 4.20) Applicability 0 Yes No No No No No No TBD C

5 5 Involuntary Resettlement (OP/BP 4.12) Safety of Dams (OP/BP 4.37) Projects in International Waterways (OP/BP/GP 7.50) Projects in Disputed Areas (OP/BP/GP 7.60) 0 Yes No No 0 Yes No 0 Yes No By supportingthe proposedproject, the Bank does not intend to prejudice the final determination of the parties'claim, on the disputed areas Section II - Key Safeguard Issues and Their Management D. Summary of Key Safeguard Issues. Pleasefill in all relevant questions. If information is not available, describe steps to be taken to obtain necessary data. II.D. 1a. Describe any safeguard issues and impacts associated with the proposed project. Identify and describe any potential large scale, significant and/or irreversible impacts. The potential contribution of biotechnology to sustainable agricultutes expected to be highbut the introduction of transgenic varieties in tropical ecosystems deserves careful oversight and monitoring. This issue is of particular importance in India due to its high level of genetic diversity for a large number of species and the concern overthe likelihood of genes spreading from transgenic crops to wildrelativesandthe potential impacts on crop genetic diversity. Risk assessment related to the natural environment is a necessary element of any biosafety program and is a key element of the proposed GEF/GOI project. Since the proposed project is exclusively an institutional capacity building effort, no environmental impacts are anticipated from proposed project activities. The project is expected to provide limited resources for updating and upgrading laboratory equipment for detecting GM-ingredients. The project operations manual will set in place procedures for dealing with any waste products produced during testing and with risk management resulting from possible unintentional introduction of LMOs. No construction activities either large or small are foreseen in this project. II.D. lb. Describe any potential cumulative impacts due to application of more than one safeguard policy or due to multiple project component. none expected II.D. 1c Describe any potential long term impacts due to anticipated future activities in the project area. none expected II.D.2. In light of 1, describe the proposed treatment of alternatives (if required) NA II.D.3. Describe arrangement for the borrower to address safeguard issues The operations manual to be developed during early project implementation will provide guidelines and procedures for dealing with any potential waste products produced during the testing and risk management resulting from possible intentional or unintentional introduction of LMOs II.D.4. Identify the key stakeholders and describe the mechanisms for consultation and disclosure on safeguard policies, with an emphasis on potentially affected people. a) b) c) d) e) Ministry of Environment and Forests Ministry of Agriculture Department of Biotechnology Ministry of Commerce & Industry Ministry of Health Family Welfare

6 6 f) Indian Council for Agricultural Resources g) h) National Bureau of Plant Genetic Resources Non-governmental organizations (environmental, consumers, producers,) i) Other stakeholders (farmers etc.) Workshops will be organised involving not only technical experts and government officials, but also key representatives of society (i.e. NGOs, consumer association, the press) to ensure a collective foundation for reaching a broad understanding and endorsement of priority biosafety issues. Such consultation with diverse stakeholders would be fundamental to implementation of this project. E. Safeguards Classification. Category is determined by the highest impact in any policy. Or on basis of cumulative impacts from multiple safeguards. Whenever an individual safeguard policy is triggered the provisions of that policy apply. SI. - Significant, cumulative and/or irreversible impacts; or significant technical and institutional risks in management of one or more safeguard areas [ S2. - One or more safeguard policies are triggered, but effects are limited in their impact and are technically and institutionally manageable [XI S3. - No safeguard issues SF. - Financial intermediary projects, social development funds, community driven development or similar projects which require a safeguard framework or programmatic approach to address safeguard issues. F. Disclosure Requirements Environmental Assessment/Analysis/Management Plan. Expected Actual Date of distributing the Exec. Summary of the EA to the ED (For category A projects) Resettlement Action Plan/Framework: Expected Actual Indigenous Peoples Development Plan/Framework: Expected Actual Pest Management Plan: Expected Actual Dam Safety Management Plan: Expected Actual If in-country disclosure of any of the above documents is not expected, please explain why.

7 7 Signed and submitted by Name Date Task Team Leader: Eija Pehu May 14, 2003 Project Safeguards Specialists 1: Project Safeguards Specialists 2: Project Safeguards Specialists 3: Approved by: Name Date Regional Safeguards Coordinator: L. Panneer Selvam May 21, 2003 Sector Manager/Director: Constance A. Bernard May 21, 2003 For a list of World Bank news releases on projects and reports, click here SEfARCh FEEDBACK WTE MAP SVWCASIE