Page 1 INTEGRATED SAFEGUARDS DATASHEET APPRAISAL STAGE I. Basic Information Date prepared/updated: 08/02/2006 Report No.: AC2427 1. Basic Project Data Country: Romania Project ID: P100470 Project Name: Avian Influenza Control & Human Pandemic Preparedness & Response Project Task Team Leader: Matthias Grueninger Estimated Appraisal Date: July 5, 2006 Estimated Board Date: September 1, 2006 Managing Unit: ECSSD Lending Instrument: Emergency Recovery Loan Sector: General agriculture, fishing and forestry sector (50%);Health (50%) Theme: Rural services and infrastructure (P);Other communicable diseases (P);Rural policies and institutions (S);Health system performance (S);Participation and civic engagement (S) IBRD Amount (US$m.): 37.10 IDA Amount (US$m.): 0.00 GEF Amount (US$m.): 0.00 PCF Amount (US$m.): 0.00 Other financing amounts by source: BORROWER 20.60 Financing Gap 7.68 28.28 Environmental Category: B - Partial Assessment Simplified Processing Simple [] Repeater [] Is this project processed under OP 8.50 (Emergency Recovery) Yes [X] No [ ] 2. Project Objectives The project will support and constitutes an integral part of a national program to increase Romania's avian and human influenza preparedness, i.e. the country's capacity to prevent and control the spread of influenza among animals and humans. In this context, the overall development objective of the project is to reduce the threat posed to humans and the poultry sector in Romania by HPAI and other zoonoses, and to support the preparation for, control of, and response to influenza pandemics and other infectious disease emergencies in humans. To achieve this, the project will support activities in the three areas of prevention, preparedness and contingency planning, response and containment under the three components: (i) animal health; (ii) human health; and (iii) public awareness, communications and implementation support. 3. Project Description The project will finance activities under four components: (i) Animal Health; (ii) Human Health; and (iii) Public Awareness, Communications and (Implementation Support. Even though the activities are organized by sectoral components, the project strongly endorses Page 2 an integrated national plan that ensures common objectives across sectors for dealing with the avian flu issue. COMPONENT 1: ANIMAL HEALTH Total component cost are estimated at EUR19.8 million, with Bank financing in the amount of EUR10.2 million and a Government contribution of EUR9.7 million. (A) Strengthening National HPAI Preparedness and Prevention Capability A1 - Strengthening the Institutional Framework (EUR2.5 million) Evaluation of National Veterinary Services. The organizational and functional review of the main governmental veterinary services undertaken by experts from EU member countries and international organizations, and the rapid assessment undertaken by the Bank team, suggest the need for an in-depth assessment of the national veterinary services, followed by appropriate reforms as may be warranted. To meet international standards set by the World Organization for Animal Health (OIE), the EU requirements, and the recommendations developed by FAO and EU experts, the veterinary services need to develop and document appropriate procedures and standards for the implementation and management of animal health measures and international veterinary certification activities. As a basis for activities in support of institutional enhancements (below), the project will provide technical assistance to support the self-evaluation of and by the national veterinary services based on OIE's "Performance, Vision and Strategy for Veterinary Services" evaluation guidelines in order to establish the current level of performance, form a shared vision with service providers and clients in the private sector, establish priorities, and facilitate strategic planning. Strengthening Veterinary and Food Safety Institutions. Once the evaluation of veterinary and related services (above) has been completed, the project will provide technical support for realigning institutional structures and resources with priority objectives, mandates, and tasks. In collaboration with and complementary to ongoing and planned advisory activities funded by donors and international organizations, the project will provide technical assistance for institutional and organizational restructuring at national and county levels as may be warranted; training of staff; equipment and materials. In particular, the project will support the establishment of animal disease control centers at the national and county levels. A2 - Improving HPAI Prevention and Control Planning (EUR1.0 million) Contingency Plan Implementation Guidelines and Manuals. While governmental authorities have developed individual contingency plans for animal and human health, overall national contingency planning and coordination still needs improvements. The Government has established a National Disease (AI) Control Center that has started a comprehensive process of reviewing, integrating, and consolidating existing contingency plans. The project will provide technical assistance to support this process of refining and Page 3 finalizing the draft contingency plan(s) and to develop the necessary detailed implementation guidelines and manuals for relevant agencies and services. (B) Strengthening Disease Surveillance, Diagnostic Capacity, and Research B1 - Strengthening Monitoring and Surveillance Systems (EUR0.2 million) Surveillance Capacity of Veterinary Services. The project will provide technical assistance and training for staff of veterinary service institutions at national and local levels, focusing on the structured routine collection of samples on a national scale, on intensive follow-up sampling around outbreaks areas, as well as routine investigation of dead wild birds that are regularly collected for such purposes (support for serological testing under active surveillance schemes is provided under the diagnostic capacity component B2 and support to local mobility is provided under the institutional strengthening component A1). Epidemiological Surveys. The second wave of HPAI outbreaks in Romania, starting on May 11, 2006, has shown that the lack of reliable epidemiological information, and the sound analysis thereof, has hampered the development of rational, targeted disease control measures and slowed down the containment of the disease. The project will provide technical assistance and training for epidemiological studies and surveillance programs to support decision makers in continuously fine-tuning and improving disease control measures based on improved risk assessment. In Romania where 70 percent of poultry is produced in backyard systems, small-scale and semi-commercial poultry production systems are the major control target. B2 - Strengthening Diagnostic Capacity (EUR11.2 million) Diagnostic capacity in Romania's national reference laboratory (IDAH) and county laboratories. In order to equip existing laboratories for the increased work load under active surveillance schemes and to minimize the length of the period between infection and control action (i.e. the high risk period being the time needed for detection, reporting, sampling, testing, and decision-making for response), the project will finance priority laboratory equipment and laboratory consumables including sampling kits, materials for transporting and conditioning of samples, reagents, as well as technical assistance and training, in order to increase the capacity for virology and serological tests, screening surveys for the confirmation of the disease and the preparation for the differentiation of AI sub-types. The sub-component will also provide personal protective and laboratory waste disposal equipment. Twinning arrangements with appropriate institutions outside Romania will be explored in order to facilitate sustained capacity strengthening. Quality control of veterinary medicinal products. This sub-component will provide equipment, consumables, technical assistance and training for increasing the capacity of the Institute for Control of Biological Products and Veterinary Drugs to fulfill its responsibility in providing quality control for vaccines and other veterinary medicinal products for which formal quality assurance has to be provided by the State. Page 4 B3 - Strengthening Animal Diseases Information Systems (EUR2.3 million) This sub-component will support the development of a comprehensive integrated national animal disease information system which will enable Romania to participate in global disease information sharing and comply with its obligations as a member of OIE, contributing towards progressively better global and regional control and eradication. The system will be linked with rapid and standardized methods of routine analysis of surveillance data in order to track important changes in the H5N1 situation and promptly supply this information to field personnel. The system supported under the project is intended to enable an effective and efficient flow of information among relevant agencies and individuals (esp. field veterinarians, laboratory experts, epidemiologists, etc.), providing the necessary support to decision-makers charged with the prevention and control of animal diseases at local and national levels. The project will provide technical assistance, priority equipment and supplies, and training, for the design, establishment and use of the system. The animal health information system also includes a geo- referenced database for all poultry farms, confirming to the requirement of municipalities to register all backyard flocks under their authority. B4 - Strengthening Applied Veterinary Research Capacity (EUR0.3 million) Applied Veterinary Research Program. A Government Decision under preparation at the time of project appraisal is to provide ANSVSA in the near future with a new mandate on establishing the Research Center for Cross border Diseases, Emergencies, Reemergence and Zoonoses of the Institute for Diagnosis and Animal Health, situated on premises at Tulcea. This sub-component will be limited to the provision of preparatory support to initiate applied research on epidemiology, bird migration and ecology, and other subjects related to HPAI (and other zoonotic diseases) by providing technical assistance for ANSVSA to assist with the design a research program as well as to assist with the design, construction and refurbishment plans for the physical facilities for the Research Center. Twinning arrangements with appropriate institutions outside Romania will be explored in order to facilitate sustained capacity strengthening. Upon completion of the design additional project funds may be made available subject to a separate request and subsequent appraisal. Infectious disease research on live animals. Research with highly infectious agents (such as HPAI virus) on live animals - as may be required for the testing of vaccines and the practicing of vaccination and post-vaccination sampling - requires a high-containment laboratory environment. The project will finance goods, consumables, and civil works for minor refurbishments in existing laboratory facilities for the installation and operation of isolators at the Institute for Control of Biological Products and Veterinary Drugs. (C) Strengthening HPAI Control Programs C1 - Targeting Virus Eradication at the Source (EUR1.9 million) Page 5 Quarantine, Culling and Disposal. Although capable teams are in place to effectively control HPAI outbreaks, the recent wave of out outbreaks has overwhelmed authorities and veterinary services. The wide distribution of small flocks across a country where 70 percent of poultry are produced in backyard systems is a particular challenge for the control of the disease. The project will contribute to the enhancement of existing capacities for the control of HPAI outbreaks as required by existing national contingency plans. Weaknesses have been identified in the areas of quarantining (disinfection stations), culling of infected and at-risk poultry, and the safe disposal of poultry carcasses and potentially infectious materials in a bio-secure and environmentally acceptable manner. Disinfection practices will be improved with support from other than project sources. The project will focus its assistance on the culling of poultry and on the disposal of carcasses in small-holder systems - which dominate Romania's poultry sector. The project will finance the purchase and operation of containers where CO2 is applied in an animal welfare acceptable manner. The project will also finance the purchase and operation of mobile incinerators with a combined daily capacity of about 40,000 kg. C2 - Supporting Poultry Vaccination Campaigns (EUR0.1 million) Vaccination planning and implementation. A policy on the use of vaccination for the containment of HPAI outbreaks has not yet been formulated. In situations where other measures failed to control the spread of the disease and where the virus has become endemic, vaccination might in future become an option for the containment of the disease. The project will therefore provide technical assistance and training to develop Romania's vaccination policy, contingency plan and implementation manuals in the context of its near-future EU membership, and train officials, as a contingency planning exercise, in the implementation of poultry vaccination campaigns and post-vaccination monitoring. (D) Improving Bio-security in poultry production and trade (EUR0.3 million) Bio-security on small-scale poultry farms. The level of bio-security both on commercial and on backyard farms is insufficient and represents a major risk for new waves of infections. The project will support enhancements of bio-security on small-holder farms with the following instruments: (i) Bio-security on poultry farms is - primarily - the result of managerial decisions and behavior (such as restricted access to poultry production farms, quarantining of new purchases, separation of sick animals, separation of species, personal hygiene, etc). The project will therefore support awareness campaigns and knowledge transfer activities - including on-farm demonstrations and training of farmers, extension agents, and other rural services providers - aimed at managerial and behavioral changes. (ii) The project will also finance technical assistance for a comprehensive poultry sector assessment which - together with improved epidemiological evidence - will help shape state support to increased bio-security on small-holder farms. This study will assess the structure of the poultry production sector, assess bio-security issues in different production systems, and formulate technical options for upgrading on-farm bio- security, especially in small-holdings. It will result in the publication of biosecurity manuals for different stakeholders (iii) Investment incentives (on a matching grant basis) Page 6 for infrastructure upgrades on small-holder farms in compliance with enhanced bio- security requirements (such as fencing, compartmentalization, caging, and manure disposal.), based on the results of the poultry sector assessment and successful pilot activities, could be an option for project follow-up activities and were endorsed by the appraisal mission but have not been included in the final project design. COMPONENT 2: HUMAN HEALTH The Human Health Component will comprise three subcomponents for a total estimated cost of EUR21.7 million, with Bank financing in the amount of EUR16.8 million and a Government contribution of EUR4.9 million: (A) Enhancing Public Health Program Planning and Coordination (EUR0.3 million) Activities under the first subcomponent will aim at enhancing coordination and program planning by providing financial and technical support for additional studies and research as well as for conferences and workshops, including the organization of a regional coordination meeting on preparations for a human influenza pandemic. (B) Strengthening of National Public Health Surveillance Systems (EUR1.8 million) The second subcomponent will help strengthen the national public surveillance system by: (i) Upgrading of the National Influenza Laboratory to BSL 3 through the financing of minor civil works (partitioning and creation of decontamination rooms), the supply and installation of additional security devices, and the installation of a system for maintaining negative pressure in the rooms; and (ii) Strengthening of regional laboratories by providing critical equipment and training of staff. (C) Strengthening Health System Response Capacity (EUR19.6 million) The third subcomponent will help strengthen the capacity of the health care system to respond to the disease, through: (i) The strengthening of the isolation and case management capacity in both national and regional hospitals. The project will finance equipment for the intensive care units of the two Bucharest infectious diseases hospitals and the establishment of isolation and intensive care units in the 7 regional centers for infectious diseases (Brasov, Craiova, Constanta, Cluj, Iasi, Timisoara and Tg. Mures). According to the National Plan, during the inter-pandemic period, all suspected cases shall be transported to and isolated at the Institute of Infectious Diseases Prof Dr Matei Bals, where medical assistance can be provided by specialized dedicated personnel. The centralization of patient care is the only possible way at this point in time as there is no medical unit able to ensure high quality care to suspected or confirmed AI human cases in the rest of the country. However, in the future, patients would have to be hospitalized within their region of residence. Therefore, there is a need to develop isolation and intensive care capacities in the regional centers for infectious diseases. Page 7 (ii) The upgrading of the influenza vaccine production unit at the Cantacuzino Institute including the rehabilitation and equipment of the influenza production department, and the completion and equipment of the filling and sealing unit. A significant part of the vaccines needed in Romania during the inter-pandemic and pandemic periods can be produced by the Cantacuzino Institute. Making the Institute able to significantly increase up to 2.5 million doses and its production in full compliance with GMP standards requires the upgrading of both the production unit and the filling and sealing station. This intervention will help both to increase the production capacity and to ensure that the production is at the required Good Manufacturing Practice standards. COMPONENT 3: PUBLIC AWARENESS, COMMUNICATIONS, AND IMPLEMENTATION SUPPORT (A) Public Awareness and Communications (EUR2.8 million) The Public Awareness and Communications Sub-Component will support the GOR's efforts in designing and implementing an integrated and comprehensive communications strategy and action plan. The component will be implemented by ANSVSA, and will comprise the following three sub-components: (i) Strengthening institutional capacity for ANSVSA: the project will support assistance for and training of communications staff, and additional equipment and operating costs for the communications teams in the two agencies. (ii) Development of an integrated communications strategy and action plan for both human and animal health based on qualitative and quantitative research: the project will build on the experience gained from the information campaigns of UNDP, UNICEF, USAID, as well as on the sectoral communications strategies of WHO and UNICEF, and the communications needs assessment of ANSVSA. The strategy will define parameters of specific audiences in various generic target groups, the degree of social acceptance of proposed hygiene and bio-security measures, the associated messages which will need to be persuasive without creating panic, and the most efficient delivery tools and vehicles for a nation wide campaign. (iii) Delivery of several information campaigns: these will aim to obtain the public's support and participation in reporting and monitoring; to promote and induce a set of behavior changes which will diminish the possibility of AI outbreaks and contamination; and to educate different key audiences (farmers, people living in villages, traders, local authorities, media, food inspectors, front line workers, consumers, other stakeholders). The campaigns, even if targeted especially for HPAI, will lead to other important positive externalities. The proposed bio-security measures and associated campaigns will also affect the spreading and prevention of other animal diseases such as Newcastle disease, Classical swine fever, or Rabies, and will provide support for other on-going ANSVSA programs such as animal welfare, identification and registration of animals and traceability. Also, the campaigns will improve the general hygiene and sanitation of the Page 8 population. In close collaboration with and complementary to the animal health related and overall coordination activities supported under the project, human health related communications activities will be entirely financed through USAID support and from governmental budgets under MOPH. (B) Implementation Support, Monitoring and Evaluation (EUR2.2 million) The project will be implemented by the MOPH and ANSVSA, and will build upon the already existing Project Management Units in the two agencies. In order to ensure effective implementation of the project in accordance with Bank fiduciary and procurement policies and guidelines, the project will finance: (i) Incremental support to the two PMUs in terms of staff and operating costs; (ii) Studies, technical services, manuals; and (iii) Surveys for monitoring and evaluation. 4. Project Location and salient physical characteristics relevant to the safeguard analysis The project is a national project which covers the entire country, to varying degrees, depending on the location of outbreaks for purposes of virus eradication at the source. Capacity will be strengthened to allow proper disease monitoring throughout the country. This will require specific interventions at the local level through country animal health laboratories. On the human health side, project activities will be both country-wide and regional. 5. Environmental and Social Safeguards Specialists Ms Radhika Srinivasan (ECSSD) Ms Amy Evans (ECSSD) 6. Safeguard Policies Triggered Yes No Environmental Assessment (OP/BP 4.01) X Natural Habitats (OP/BP 4.04) X Forests (OP/BP 4.36) X Pest Management (OP 4.09) X Cultural Property (OPN 11.03) X Indigenous Peoples (OP/BP 4.10) X Involuntary Resettlement (OP/BP 4.12) X Safety of Dams (OP/BP 4.37) X Projects on International Waterways (OP/BP 7.50) X Projects in Disputed Areas (OP/BP 7.60) X II. Key Safeguard Policy Issues and Their Management A. Summary of Key Safeguard Issues 1. Describe any safeguard issues and impacts associated with the proposed project. Identify and describe any potential large scale, significant and/or irreversible impacts: The Project's prevention-focused activities are expected to have a positive environmental impact as the Project's investments in facilities, equipment, and training for animal and Page 9 public health workers and facilities will develop capacity to improve the effectiveness and safety over existing avian influenza handling and testing procedures. This would be reinforced by the mainstreaming of environmental safeguards into protocols and procedures for the culling and disposal of animals during AI outbreaks, and for laboratory safety and appropriate waste management procedures. The Environmental Management Plan (EMP) will address culling methods and carcass disposal by (mobile) incineration, burial and composting, use of disinfectants, and laboratory and medical facility biosafety and waste management practices. No large scale, significant or irreversible impacts are anticipated. Involuntary Resettlement Policy will not be triggered as acquisition of private land or relocation of households is not expected under the project. 2. Describe any potential indirect and/or long term impacts due to anticipated future activities in the project area: n/a 3. Describe any project alternatives (if relevant) considered to help avoid or minimize adverse impacts. The cost, operating considerations, safety and environmental impact of several different carcass disposal methods were reviewed during project preparation and appraisal so that the most appropriate methods could be identified for support from project proceeds, consistent with Romanian and EU legislation and OIE guidelines. 4. Describe measures taken by the borrower to address safeguard policy issues. Provide an assessment of borrower capacity to plan and implement the measures described. Since the Project is assessed as a B-category project, an Environmental Management Plan (EMP) will be prepared and implemented with project support (see project components). The EMP will address safe culling practices, and disposal of carcasses, laboratory wastes, and medical waste. The EMP will also cover the clean up of animal wastes of culled poultry by the local public veterinary services and minor civil works supported under the Project. A waiver for the requirement to complete the EMP during project preparation has been sought per para. 12 of OP 4.01. and approved. Preparation of the EMP is ongoing, and its adoption by the Government is set as a disbursement condition for goods and workds under the Animal Health and Human Health components of the Project. The borrower's institutional capacity for safeguard policies will be assessed during appraisal. 5. Identify the key stakeholders and describe the mechanisms for consultation and disclosure on safeguard policies, with an emphasis on potentially affected people. Meetings will be held to discuss the EMP provisions with representatives of commercial poultry producers and farmer organizations familiar with the socio-economic issues currently faced by backyard and commercial poultry producers, particularly in the areas where AI outbreaks in poultry have been concentrated. Other stakeholders including Page 10 implementing and regulatory agencies, financing and technical cooperation partners, community organizations and NGOs will also be consulted. Formal disclosure of the EMP will be arranged in cooperation with the implementation team and the Ministry of Environment. B. Disclosure Requirements Date Environmental Assessment/Audit/Management Plan/Other: Date of receipt by the Bank 11/01/2006 Date of "in-country" disclosure 10/30/2006 Date of submission to InfoShop 11/02/2006 For category A projects, date of distributing the Executive Summary of the EA to the Executive Directors * If the project triggers the Pest Management and/or Cultural Property, the respective issues are to be addressed and disclosed as part of the Environmental Assessment/Audit/or EMP. If in-country disclosure of any of the above documents is not expected, please explain why: Disclosure is expected prior to disbursement of project funds for goods and works under the Animal Health and Human Health Components of the project, in accordance with the waiver that was sought per para. 12 of OP 4.01. C. Compliance Monitoring Indicators at the Corporate Level (to be filled in when the ISDS is finalized by the project decision meeting) OP/BP/GP 4.01 - Environment Assessment Does the project require a stand-alone EA (including EMP) report? Yes If yes, then did the Regional Environment Unit or Sector Manager (SM) review and approve the EA report? No Are the cost and the accountabilities for the EMP incorporated in the credit/loan? No The World Bank Policy on Disclosure of Information Have relevant safeguard policies documents been sent to the World Bank's Infoshop? No Have relevant documents been disclosed in-country in a public place in a form and language that are understandable and accessible to project-affected groups and local NGOs? No All Safeguard Policies Have satisfactory calendar, budget and clear institutional responsibilities been prepared for the implementation of measures related to safeguard policies? Yes Have costs related to safeguard policy measures been included in the project cost? Yes Does the Monitoring and Evaluation system of the project include the Yes Page 11 monitoring of safeguard impacts and measures related to safeguard policies? Have satisfactory implementation arrangements been agreed with the borrower and the same been adequately reflected in the project legal documents? Yes D. Approvals Signed and submitted by: Name Date Task Team Leader: Mr Matthias Grueninger 07/06/2006 Environmental Specialist: Ms Amy Evans 07/06/2006 Social Development Specialist Ms Radhika Srinivasan 07/06/2006 Additional Environmental and/or Social Development Specialist(s): Approved by: Regional Safeguards Coordinator: Mr Ronald N. Hoffer 07/06/2006 Comments: Cleared for safeguards Sector Manager: Mr Benoit Paul Blarel 07/07/2006 Comments: Cleared for sector management