Page 1 ROMANIAN AVIAN INFLUENZA & HUMAN PANDEMIC PREPAREDNESS AND RESPONSE PROJECT November, 2006 Bucharest E1558 Page 2 ii Table of Contents 1. INTRODUCTION...............................................................................................................................1 2 . PROJECT DESCRIPTION................................................................................................................2 2.1 P ROJECT COMPONENTS .................................................................................................................2 2.2 G EOGRAPHIC AREAS OF COVERAGE ..............................................................................................5 3. OVERVIEW OF APPLICABLE NATIONAL AND INTERNATIONAL LEGAL PROVISIONS AND GUIDANCES.............................................................................................................6 3.1 EIA PROCESS ................................................................................................................................6 3.2 O PERATING PERMIT ......................................................................................................................6 3.3 E NVIRONMENTAL M ONITORING AND C ONTROL ...........................................................................7 3.4 W ASTE MANAGEMENT ..................................................................................................................8 3.5 W ATER POLLUTION PREVENTION ..................................................................................................8 3.6 A IR POLLUTION PREVENTION ........................................................................................................9 3.7 S ANITARY VETERINARY ACTIVITY ................................................................................................9 3.8. M ANAGEMENT OF WASTE GENERATED FROM VETERINARY ACTIVITY ........................................10 3.9 M ANAGEMENT OF ANIMAL BY - PRODUCTS ..................................................................................10 3.10 L ABORATORY CERTIFICATION ON GLP.......................................................................................11 3.11 P RODUCTION OF PHARMACEUTICAL PRODUCTS INCLUDING VACCINE .........................................11 3.12 D ANGEROUS CHEMICALS ............................................................................................................12 3.13 P OPULATION HYGIENE AND LIVING ENVIRONMENT ....................................................................12 3.14 E NVIRONMENTAL M ANAGEMENT S YSTEM .................................................................................12 4. MITIGATION MEASURES FOR PROJECT COMPONENTS..................................................13 4.1 A NIMAL H EALTH C OMPONENT ...................................................................................................13 4.1.1 Mobile incinerators...............................................................................................................15 4.1.1.1 Potential environmental impacts and mitigation measures ......................................................15 4.1.1.2 Institutional Mitigation Measures to be included in the Environmental Management Plan ..17 4.1.2 Village-level-enterprises.......................................................................................................20 4.2 H UMAN H EALTH C OMPONENT ...................................................................................................21 5. MONITORING PLAN......................................................................................................................22 6. IMPLEMENTATION ARRANGEMENTS....................................................................................23 Tables Table 1: Sub-components and actions of Animal Health component Table 2: Mitigation Plan – Institutional measures Table 3: Sub-components and actions of Human Health component Annexes Annex 1: Guidance on the Bio-Safety Levels for Laboratories Annex 2: International Best Practice in Safety of Research Laboratories Annex 3: Environmental and safety considerations on mobile incinerators Annex 4: MITIGATION PLAN - Carcass Disposal by Incineration Annex 5: Reference emission limits, monitoring and other provisions based on UK regulations for small incinerators Annex 6: Stakeholder Consultations Page 3 iii ABBREVIATIONS AI Avian Influenza AIHP Avian Influenza and Human pandemic Preparedness and Response Project ANAR National Administration “Romanian Waters” ANSVSA National Sanitary Veterinary and Food safety Authority BAT Best Available Techniques BSL Bio-Safety Level CEU Central Executive Unit EA Environmental Assessment EMP Environmental Management Plan EMAS Environmental Management and Audit Scheme EMS Environmental Management System EOG Emergency Ordinance of Government EU European Union EWS Early Warning System FAO Food and Agriculture Organization GSISC General State Inspectorate for Safety of Construction GOR Government of Romania HPAI Highly Pathogenic Avian Influenza HIV/AIDS Human Immuno-deficiency HWM Hazardous Waste Management IBRD International Bank for Reconstruction and Development (World Bank) ICBPVD Institute for Control of Biological Products and Veterinary Drugs IDA International Development Agency IDAH Institute for Diagnostic and Animal Health IEP Integrated Environmental Permit IPPC Integrated Pollution Prevention and Control MAFDR Ministry of Agriculture, Forests and Rural Development MoE Ministry of Environment (generic name) MEWM Ministry of Environment and Water Management MPH Ministry of Public Health MoPWTH Ministry of Public Works, Transports and Housing NAWR National Administration “Romanian Waters” OIE World Organization for Animal Health OP Operational Manual (World Bank) PCDD/Fs Dioxins and Furans PAH Polycyclic Aromatic Hydrocarbons PMU Project Management Unit PVC Polyvinyl Chloride SARS Severe Acute Respiratory Sendrome TF Trust Fund UNDP United Nations Development Program UNICEF……..United Nations Children Fund WHO World Health Organization WID Waste Incineration Directive WWTP Wastewater Treatment Plant Page 4 1 1. INTRODUCTION 1. This Environmental Management Plan is prepared for the project proposed to the Government of Romania by World Bank within its Global Program for Avian Influenza (GPAI) and Human Pandemic Preparedness. The project would support and constitute 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. 2. The overall objective of the Project is to minimize the threat in Romania posed to humans by highly pathogenic avian influenza (HPAI) and other zoonoses in domestic poultry, and to prepare for the control and response to an influenza pandemic and other infectious disease emergencies in humans. To achieve these goals, three areas will be supported: (i) prevention, (ii) preparedness and planning and (iii) response and containment. Achieving these goals will contribute to diminishing the burden of disease and loss of productivity in Romania, limiting the regional spread of HPAI, and enhancing economic and social prospects at the national, regional, and global levels. The proposed project would finance activities under four components: i) animal health; ii) human health; iii) public awareness and communications; and iv) implementation support, monitoring and evaluation. 3. Although project activities supporting Avian Influenza (AI) prevention, preparedness and planning, and response and containment are not expected to generate significant adverse environmental effects, they might present a moderate environmental and human health risk from inadvertent spread of the AI virus and waste management. Overall the AI prevention and response-focused activities are expected to have a positive environmental impact, as the investments in facilities, equipment, and training for veterinary and public health service staff and laboratories will improve the effectiveness and safety over existing avian influenza handling and testing procedures by meeting international standards established by the World Organization for Animal Health (OIE) and the World Health Organization (WHO). This would be reinforced by the mainstreaming of environmental safeguards into protocols and procedures for the culling and disposal of animals during AI outbreaks. 4. The Romanian Avian Influenza and Human Pandemic Preparedness and Response Project (AIHP) has been assigned World Bank environmental category B. The potential adverse impacts could be prevented or mitigated by preparing country/project specific environmental management plans (EMP) only, with no separate EA report. 5. This EMP addresses the moderate adverse environmental effects of the Animal Health and Human Health Components. For these components, the EMP addresses: waste management as pertain to disposal of special waste; emissions and materials at laboratories; training for veterinary services workers to include procedures for safe handling of AI materials; safe disposal of carcasses and infected materials; safe production of human influenza vaccine. The EMP provides mitigation plans and monitoring plans to ensure appropriate attention to environmental issues, and tracking progress or problems in their management. Page 5 2 2. PROJECT DESCRIPTION 2.1 Project components 6. The Animal Health Component would comprise the following four sub- components: (a) Strengthening the Institutional Framework: i. The project would provide technical assistance for the Evaluation of 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. ii. Based on this evaluation (above), the project would provide support for Strengthening Veterinary and Food Safety Institution by realigning institutional structures and resources at national and local levels with priority objectives, mandates, and tasks. In particular, the project would support the establishment of animal disease control centers at the national and regional levels. iii. The project would also provide technical assistance to support the process of reviewing, integrating, and consolidating existing contingency plans and to develop the necessary detailed implementation guidelines and manuals for all relevant agencies and services. (b) Strengthening Disease Surveillance, Diagnostic Capacity, and Research: i. In order to enhance the Surveillance Capacity of Veterinary Services, the project would provide technical assistance and training for staff of veterinary service institutions at national and local levels, focusing on collecting and analyzing epidemiological data and performing risk assessments. The project would also support transportation facilities and arrangements for surveillance field work as needed. The procurement of mobile laboratories is being discussed. The project would also provide technical assistance and training for epidemiological surveys . ii. In order to equip existing laboratories for the increased work load under active surveillance schemes and to minimize the high risk period, the project would upgrade the diagnostic capacity of national and regional laboratories by financing priority equipment and laboratory consumables including sampling kits, materials for transporting and conditioning of samples, reagents, and personal and laboratory protective equipment. The project would also enhance the capacity of the Institute for Control of Biological Products and Veterinary Drugs to fulfill its responsibility in providing quality control for vaccine imports and other veterinary medicinal products for which formal quality assurance has to be provided Page 6 3 by the state. iii. The design, establishment, and use of a comprehensive national animal disease information system would be supported in order to enable an effective and efficient flow of information among relevant agencies and individuals and providing the necessary support to decision-makers charged with the prevention and control of animal diseases at local and national levels. iv. Applied Veterinary Research would be supported by providing essential equipment, consumables, and technical assistance for ANSVSA's core research responsibilities and through a competitive research grant program. One veterinary laboratory would be upgraded to bio-safety level 4 in order to build Romania's capacity to conduct vaccine tests on live animals for highly infectious animal diseases. (c) Strengthening HPAI Control Programs: The project would contribute to the enhancement of disease control capacities by providing mobile incinerators for the safe disposal of carcasses in small-holder systems, and it would provide technical assistance and training to develop Romania's vaccination policy and action plan , and train officials in the implementation of vaccination campaigns and post-vaccination monitoring. (d) Improving Bio-security in poultry production and trade: The project would support enhancements of bio-security on small-holder farms through knowledge transfers and demonstrations aimed at managerial and behavioral changes; as well as pilot projects for village-level enterprises (micro-farms). 7. The Human Health Component would comprise the following three sub- components: (a) Enhancing Coordination and Program Planning: The project would help further operationalize the national plan and enhance coordination with both other sectors and neighboring countries. More specifically the project would finance: i. Additional studies and research and, ii. Workshops, conferences and consensus meetings. (b) Strengthening the National Public Surveillance System: The project would finance: i. The 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; ii. The strengthening of regional laboratories , in particular through the supply of real time PCR equipment and the training of staff; iii. The strengthening of the capacity of the regional and district public health teams to investigate and control outbreaks through the supply of Page 7 4 equipment and - when needed - the re-training of staff. (c) Strengthening the Health Care System Capacity: The project would finance: i. The strengthening of the isolation and case management capacity through the equipment of the two Bucharest infectious diseases hospitals and the establishment of isolation and intensive care units in 7 of the regional hospitals 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 part of the MOH strategy to ensure high quality care to suspected or confirmed AI human cases. However, there is a need to develop isolation and intensive care capacities in regional infectious diseases hospitals. 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. 8. The Public Awareness and Communications Component would support the GOR ’s efforts in designing and implementing an integrated and comprehensive communications strategy and action plan for AI. The component will be jointly implemented by MPH and ANSVSA, and would comprise the following three sub- components: (a) Strengthening institutional capacity for MPH and ANSVSA: the project would support assistance for and training of communications staff, and additional equipment and operating costs for the communications teams in the two agencies; (b) Development of an integrated strategy and action plan based on qualitative and quantitative research: the project would build on the experience gained from the information campaigns of UNDP, UNICEF, USAID, as well as on the sectorial communications strategies of WHO and UNICEF, and the communications needs assessment of ANSVSA. The strategy would 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 would need to be persuasive without creating panic, and the most efficient delivery tools and vehicles for a nation wide campaign. (c) Delivery of several information campaigns: these would aim to obtain the Page 8 5 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, children, teachers, health care workers, food inspectors, front line workers, consumers, other stakeholders). 9. Implementation Support, Monitoring and Evaluation. The project would be implemented by the MPH and ANSVSA, and would build upon the already existing Project Management Units in the two respective agencies. The project would finance: (a) Incremental support to the two PMUs in terms of staff and operating costs; (b) Studies, technical services, manuals; and (c) Surveys for monitoring and evaluation. 2.2 Geographic areas of coverage 10. The project will cover the whole territory of Romania. Some of project’s actions target to staff of veterinary service institutions at national, regional and local levels, others to well defined institutes or hospitals already mentioned above. Page 9 6 3. OVERVIEW OF APPLICABLE NATIONAL AND INTERNATIONAL LEGAL PROVISIONS AND GUIDANCES 11. A summary from international guidance on best practice in safety of research laboratories is attached in Annex 1 and Annex 2. Some environmental and safety considerations on mobile incinerators used in disposal of animal carcasses as presented in the World Bank Guidelines for GPAI projects are summarized in Annex 3. 12. The national legislation is very comprehensive and fully transposes the EU directives. Considering the project’s overall objective as well as the specific actions of the project’s sub-components and sub-sub-components described in chapter 2 above only the main legal provisions related to EIA, activity permitting, sanitary-veterinary activity and laboratory practice, hazardous waste management and air pollution are briefly presented in the following 3.1 – 3.14 sections. 3.1 EIA process 13. Any development project involving a building process needs the “development consent” and the “construction permit”. Prior to these legal acts, the “ environmental agreement ” as legal act is mandatory for projects with significant environmental impact; this is issued on the basis of EIA process, according to the procedure described in MO 860/2002 of MoE, as subsequently modified by MO 1037/2005 of MoE. The projects with potential significant environmental impact due to their nature are subject first to a screening procedure that takes into account especially the project location. The competent authorities for conducting the EIA process are the local, regional and central environmental authorities. 3.2 Operating permit 14. Operating permits for existing activities or new activities prior to commissioning are issued by the involved authorities (Law 359/2004), for instance: Local representatives under ANSVSA for veterinary permit; Local Work Inspectorate (authorities under MoL) and Public Health Directorate for the health & safety permit; local representatives of ANAR for water permit. 15. The environmental permit is issued by the local or regional environmental authorities for activities with significant and moderate environmental impact (OM 876/2004 of MoE). The present environmental legislation does not provide for permitting of temporary activities such as incineration of animal carcasses in case of avian influenza. 16. The IPPC installations should obtain the integrated environmental permit; this is issued by the regional environmental authorities (EOG 152/2005 transposing the IPPC Directive 96/61/EC), on the basis of a very detailed application by whom the installation operators have to demonstrate that the activity is in compliance with requirements of best available techniques (BAT) both for technological processes and for management techniques; “technique” include both the technology used and the way in which the installation is designed, built, maintained, operated and decommissioned while “best” 'best` means the most effective in achieving a high general level of protection of the environment as a whole. Considerations to be taken into account generally or in specific Page 10 7 cases when determining best available techniques, are the following: - the use of low-waste technology; - the use of less hazardous substances; - the furthering of recovery and recycling of substances generated and used in the process and of waste, where appropriate; - comparable processes, facilities or methods of operation which have been tried with success on an industrial scale; - technological advances and changes in scientific knowledge and understanding; - the nature, effects and volume of the emissions concerned; - the commissioning dates for new or existing installations; - the length of time needed to introduce the best available technique; - the consumption and nature of raw materials (including water) used in the process and their energy efficiency; - the need to prevent or reduce to a minimum the overall impact of the emissions on the environment and the risks to it; - the need to prevent accidents and to minimize the consequences for the environment. Implementation of an EMS – certified or not – is also encouraged. 3.3 Environmental Monitoring and Control 17. Any social and economic activity is monitored and controlled with regard to its the effects on the physical and biological environment and on public health. Monitoring will be performed by means of two types of actions: · Monitoring by the relevant authorities with control powers, such as: - Authorities of the local administration – on municipality and county level - Public authorities for environmental protection - Environmental Guard - National Administration Romanian Waters (ANAR) through its local subsidiaries - General state inspectorate for safety of constructions (GSISC) - Local public health and sanitary-veterinary authorities - Other authorities (e.g. occupational safety, fire department and so on.) · Self-monitoring carried out by the activity holder/operator who has the obligation to set up its own internal monitoring system according to the requirements provided by the environmental agreement and permit 18. Environmental Monitoring is carried out both by the environmental authorities and by the activity holder/operator who has the obligation to set up its own internal monitoring system according to the requirements provided by the environmental agreement and permit (MO 541/2000 of MoE). 19. Environmental Control of activities is performed by relevant authorities with control competencies (Environmental Guard and NARW) that have the power to apply penalties and fines. Page 11 8 3.4 Waste management 20. Law 426/2001 establishes: the general principles of waste management activities ; waste classification; categories of hazardous waste based on their generic types, constituents and properties; operations for waste recovery and disposal. 21. GD 856/2002 covers the provisions for registration of waste management activities and approves the list of wastes including hazardous wastes by transposing the European Waste Catalogue. 22. According to the GD 162/2001 amended by GD 349/2005 on the landfill of wastes, the hazardous wastes from human or animal health care and/or related research are not accepted on landfills. These are infectious waste from hospitals or other sanitary or veterinary units (having property H9) defined as – substances containing viable micro- organisms or their toxins which are known as being able to induce diseases for humans or other live organisms. It results in specific requirements for management of such waste in order to prevent infection: - each type of waste should be collected separately; - the solid non-hazardous waste might be transported to the urban landfill; - the liquid hazardous waste should be neutralized and then might be discharged to the sewerage system; - the solid hazardous waste should be treated if possible and then transported to the urban landfill; - the solid hazardous waste that can not be treated should be securely contained, transported and incinerated. 23. Operation, surveillance and control of waste incineration and co-incineration process are regulated by the GD 128/2002 amended by GD 268/2005 which fully transposes the EU Waste Incineration Directive 2000/76/CE (WID). It provides norms for: - waste reception - work conditions - maximum allowable limits for air and water pollutant emissions and rules to establish them - residue control - monitoring - measurement techniques. Anyway, these norms are not applicable to the animal carcasses as regulated by the Directive 90/667/EEC. 3.5 Water pollution prevention 24. The GD 188/2002 amended by GD 352/2005 comprises norms for liquid effluents discharged into natural receivers such as surface water courses, groundwater, valleys with natural runoff or permeable soils – NTPA 001 – as well as for industrial liquid effluent discharged into urban sewerage networks connected to an urban WWTP soils – NTPA 002 – . According to its provisions, the liquid hazardous waste originated from Page 12 9 the sanitary or veterinary health care facilities should be first decontaminated/sterilized and neutralized and only then discharged to the urban sewerage system. 25. According to the Water Law (Law 107/1996), buffer zones of sanitary protection or hydro-geological protection perimeters have to be set up around sources and facilities for drinking water supply, mineral water sources and lakes with therapeutic waters; principles for dimensioning of these zones are established by GD 101/1997 which also provides some minimum dimensions of sanitary protections zones in case of water withdrawals from rivers and lakes as well as in case of aqueducts and any other constructions and facilities for drinking water supply. 26. Animal farming should apply the Code of Best Agricultural Practice as regards the manure management for protection of surface and groundwater against pollution by nitrates (General Plan for implementing the 91/676/EEC Council Directive and GD 964/2000). An internal ANAR decision dated 2005 requests all owners of animal farms to develop a manure management plan as part of the application for water permit. Such a plan should comprise: - arrangements for temporary storage of manure on platforms, - contracts with users of manure as natural fertilizer (agricultural land owners) - registration of manure produced: quantity, buyer, date of selling. 3.6 Air pollution prevention 27. General principles, policies, programs and legal, administrative, and technical requirements related to the protection of atmosphere quality are established by Law 655/2001 for approving and amending the EGO 243/2000. 28. General norms for limitation of air pollutants emissions are set up by the MO 462/2003 of MoE. Other norms for limitation of emissions generated at industry sector level are set up for large combustion plants, incinerators, industries using organic solvents, oil terminals. 29. Air quality in residential areas is regulated by two legal documents which comprise values of MAC in ambient air for certain pollutants: OM 592/2002 of MoE for SO 2 , CO, NO 2 , ozone, suspended particulates, lead and benzene and air quality standard STAS- 12574/1987 for other pollutants. 3.7 Sanitary veterinary activity 30. The specific measures for the control of avian influenza are comprised in the OM no. 87 of April, 13 th , 2006 of ANSVSA that fully transposes the EU Directive 2005/94/EC (repealing the former 92/40/EEC Directive): (a) certain preventive measures relating to the surveillance and the early detection of avian influenza and increasing the level of the competent authorities' and the farming community's awareness of, and preparation for, the risks of that disease; (b) the minimum control measures to be applied in the event of an outbreak of avian influenza in poultry or other captive birds and the early detection of possible spread of avian influenza viruses to mammals; (c) other subsidiary measures to avoid the spread of influenza viruses of avian origin to other species. It establishes permanent bio-safety measures for surveillance and prevention of Page 13 10 virus spreading into bird holdings. The responsibilities are established for: ANSVSA, Institute for Diagnostic and Animal Health and the National Reference Laboratory for Avian Influenza and Newcastle Disease within the institute, Institute for Control of Veterinary Bio-products and Drugs, local sanitary-veterinary laboratories. 3.8. Management of waste generated from veterinary activity 31. Regulations for hazardous waste generated from sanitary-veterinary laboratories , including the research, diagnosis, treatment and disease prevention activity, are provided by MO 373/2001 as amended by 483/2001 of MoA: - organizing and equipping of the sanitary-veterinary laboratories, - regulation on sampling, conditioning, packaging and transport of samples; - health & safety rules; handling of hazardous waste and contamination prevention; collection, containment, storage and disposal of solid, liquid and radioactive waste, testing of the hazardous waste management; - waste incineration; - staff training. 32. These regulations stipulate that: - liquid and solid waste resulting from sample processing should be i) sterilized, neutralized or only collected, ii) packaged in sterile and tight closed recipients, and iii) directed to one of the following compartments: a) sterilization and neutralization room; b) platform for waste temporary storage; c) incinerator; - the Laboratory for hygiene and environmental protection within the Animal welfare department is responsible for the control of hazardous waste management (HWM) on the technological flow in all departments and laboratories; - control of HWM is realized through inspection, quick tests or complex laboratory tests, periodical reporting of incidents to the department top management; - testing is focused on inside surfaces, wastewater from sanitary-veterinary laboratory, air pollutant emission, soil samples, ash resulting from incinerator. - incineration is recommended as the most efficient final disposal method for the solid hazardous waste; - liquid hazardous waste should be first decontaminated/sterilized and neutralized and only then discharged to the urban sewerage system. 3.9 Management of animal by-products 33. General provisions are comprised by MO 723/2003 of MoA that fully transposes the CE Regulation 1774/2002 laying down health rules concerning animal by-products not intended for human consumption. Animal by- products named also „materials” are classified in three categories. Wild birds dead from avian influenza fall under category 1 acc. to art. 4, point.1, while poultry killed due to avian influenza reasons fall under category 2 acc. to art. 5, point 1 (e). Anyway, in both cases, the incineration or co- incineration is the disposal method recommended in the first place. Low-capacity incineration or co-incineration plants are those handling an animal by-product inflow less than 50 kg / hour. 34. The incineration and co-incineration of animal by-products shall take place either in Page 14 11 incinerators falling under provisions of Directive 2000/76/EC or, when that Directive does not apply, in incineration or co-incineration plants approved by the competent authority if they comply with a number of requirements laid down in Annex IV of the Regulation, regarding: general and operating conditions, other conditions concerning water discharges and residues, temperature measurement requirements, abnormal operating conditions. These conditions are different for high-capacity incineration or co- incineration plants and low-capacity incineration or co-incineration plants. 35. The general strategy and provisions for neutralization of animal by-products by processing or incineration/ co-incineration are further developed in EOG 47/2005 amended and approved by Law 73/2006. According to these regulations the neutralization facilities should be permitted by both sanitary-veterinary and environmental authorities. This act does not refer to the right of sanitary-veterinary authorities to permit the incineration and/or burial of animal by-products in case of an epizootic outbreak. 36. The legislation is still rather unclear as regarding especially the low-capacity neutralization facilities . If the “installations for the disposal or recycling of animal carcasses and animal waste with a treatment capacity exceeding 10 tonnes per day” fall under IPPC Directive and should be issued an integrated environmental permit, the installations under this capacity are not specifically mentioned in the list of MO 876/2005 (Annex1); they might be considered in the category “collection and treatment of other residues (than wastewater)” – position 281, NACE code -9002- or “Sanitation, de- pollution and similar activities” – position 282, NACE code -9003-. 37. Few or maybe none permitted incinerators for animal by-products are operated now since the existing installations are not complying with the requirements laid down in the MO 723/2003. Consequently there is little experience in this field. 3.10 Laboratory certification on GLP 38. MO 370/2003 of MoE establishes rules on GLP certification of laboratories with activities related to environmental protection. The same kind of rules for veterinary laboratories are established by MO 146/2000 of MoA while the MO 117-56-248/2002 of MoI, MoH and MoA provides for inspection of compliance with GPL principles and requirements. The certification system is based on principles laid down in the following international standards and guidelines: OECD – Principles of Good Laboratory Practice and Compliance Monitoring, ISO 17025:2001, ISO 43-1,2:1997, ISO 45002:1994, ISO 45003:1997, ISO 9000:2001, Guide ISO 58:1993, ISO 10011:1994. 3.11 Production of pharmaceutical products including vaccine 39. EOG 152/1999 amended and approved by Law 336/2002 defines human drugs products including vaccines and provides conditions and norms for their production and trade as well as for quality-efficiency-safety assurance. According to this act: - the National Medicines Agency sets up rules of GMP which have to be approved by the MoH and issues the GMP Certificate for national drugs producers. Page 15 12 - MoH decides on permitting a national drugs producer on the basis of a favorable inspection report drafted by MoH accredited inspectors. 40. From environmental point of view, the pharmaceutical industry is included on the list of IPPC instalations, Annex 1 of EU Directive 96/61/EC, in category 4. Chemical industry 4.4. Chemical installations for the production of basic plant health products and of biocides and 4.5. Installations using a chemical or biological process for the production of basic pharmaceutical products. This means that the production units should obtain the IEP regardless their production capacity. 3.12 Dangerous chemicals 41. Regime for production, trading and use of the dangerous chemical substances and products are regulated by UOG 200/2000 modified by L451/2001 and L 324/2005. This act provides for a classification, packaging and labeling of the dangerous chemical substances and products. Placing on market of the products containing the substances falling under this regulation (such as disinfectants) is permitted only with the corresponding label which include the instructions for use. 3.13 Population hygiene and living environment 42. Some norms and recommendations for protection of population living environment are established by OM 536/1997 of MoH. Buffer zones of sanitary protection have to be provided between the so called “protected areas” - that include inhabited areas, parks, natural reservations, resorts, medical and social-cultural institutions human settlements - and the sites of activities producing discomfort and health risk. The buffer zones dimensions should be the results of environmental impact studies but the recommended minimum distances are already listed in the mentioned act. 3.14 Environmental Management System 43. The international standards form the series ISO 14000 have been adopted in Romania as RN Standards series 14000 from last nineties and many organizations have already been certified ISO 14001. The Community Regulation on Environmental Management and Audit Scheme (EMAS) was also transposed into national legislation. Page 16 13 4. MITIGATION MEASURES FOR PROJECT COMPONENTS 4.1 Animal Health Component Table 1: Sub-components and actions of Animal Health Component Sub- component Sub-sub-component Actions a) Strengthening the Institutional Framework i.Evaluation of National Veterinary Services based on OIE's "Performance, Vision and Strategy for Veterinary Services" Technical assistance for: - 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 ii. Strengthening Veterinary and Food Safety Institution by realigning institutional structures and resources at national and local levels with priority objectives, mandates, and tasks. Support, in particular for: - the establishment of animal disease control centers at the national and regional levels iii. Reviewing, integrating, and consolidating existing contingency plans and develop the necessary detailed implementation guidelines and manuals for all relevant agencies and services. Support through knowledge transfer b) Strengthening Disease Surveillance, Diagnostic Capacity, and Research i. Enhance the Surveillance Capacity of Veterinary Services - technical assistance and training for staff of veterinary service institutions at national and local levels, focusing on collecting and analyzing epidemiological data and performing risk assessments - support transportation facilities and arrangements for surveillance field work as needed - the procurement of mobile laboratories (is being discussed)|. - technical assistance and training for epidemiological surveys Page 17 14 Sub- component Sub-sub-component Actions ii. upgrade the diagnostic capacity of national and regional laboratories and e nhance the capacity of the ICBPVD to in providing quality control for vaccine imports and other veterinary medicinal products . - financing priority equipment and laboratory consumables including s ampling kits, materials for transporting and conditioning of samples, reagents, and personal and laboratory protective equipment. iii. establishment, and use of a comprehensive national animal disease information system in order to enable an effective and efficient flow of information among relevant agencies and individuals and provide the necessary support to decision-makers charged with the prevention and control of animal diseases at local and national levels. - technical support iv. Applied Veterinary Research essential equipment, consumables, and technical assistance for ANSVSA's core research responsibilities and through a competitive research grant program. - provide equipment, consumables, and technical assistance for ANSVSA's core research responsibilities - a competitive research grant program - one veterinary laboratory would be upgraded to bio-safety level 4 in order to build Romania's capacity to conduct vaccine tests on live animals for highly infectious animal diseases c) Strengthening HPAI Control Programs: - Enhancement of disease control capacities: - provide mobile incinerators for the safe disposal of carcasses in small-holder systems, - provide technical assistance and training to develop Romania's vaccination policy and action plan , - train officials in the implementation of vaccination campaigns and post-vaccination monitoring d) Improving Bio-security in poultry production and trade Support enhancements of bio-security on small-holder farms through: - knowledge transfers and demonstrations aimed at managerial and behavioral changes - pilot projects for village-level enterprises (micro-farms). Page 18 15 44. All sub-components are focused on public sector capacity building and improved readiness for dealing with outbreaks of avian influenza in domestic poultry and comprise mostly actions of support in terms of technical assistance and training/knowledge transfer with no environmental impact. They will improve the effectiveness and bio-safety of the existing avian influenza handling and testing procedures by meeting international standards established by the OIE. 45. The activity conducted within the upgraded national/regional laboratories and ICBPVD following the Project's investments in facilities, equipment, consumables and training for laboratory staff (sub-component b.iv ) would be reinforced by the mainstreaming of environmental safeguards into protocols and procedures. The specific waste generated might hardly have any adverse impact as long as GLP are applied and all environmental regulation requirements described in chapter 3 are complied with. 4.1.1 Mobile incinerators 46. Under sub-component c.) the Project will support the purchase of mobile incinerators for the safe disposal of carcasses in small-holder systems. The main actions required are: - select location; - construction of an impermeable hardstand necessary for laying the incineration facility; additionally, this has to be provided with a catchment channel and a tank to collect and contain both the disinfectants used in the equipment cleaning and eventually wastewater from vehicle cleaning; - operate the incinerator. 4.1.1.1 Potential environmental impacts and mitigation measures Facility site 47. An existing hardstand may be used if available. Otherwise a new one has to be constructed; in both cases the location should be: - outside the sanitary protection zone for sources or facilities of drinking water supply; - at minimum 200 m from protected areas. Hardstand Construction 48. The minor building works required for construction or rehabilitation of the existing structures will not imply the use of any valuable resources. The fertile soil removed should be stored in a special place in order to be used later. Main adverse effects are those characteristic to any construction activity that implies digging works and eventually the use of heavy equipment and transport vehicles: - dust from digging process; - exhausted gas emission and noise & vibrations from construction equipment and vehicles; - disturbance of small wild fauna and vegetation; - soil pollution caused by oil and grease leakage and improper solid waste disposal. Page 19 16 49. Due to the small area used as well as to the short time period necessary for construction, the environmental impact is low and temporary. The construction company has full responsibility to take all necessary mitigation measures : strict delimitation of construction area by fence and/or warning belts; sound-absorbent panels around the construction area; use of dust-absorbing screens; compliance with construction work regulations; setting up of waste management system; maintenance of vehicles and construction equipment in special places only. Costs for these measures should be supported by the local administration. 50. Such building works are usually considered with insignificant environmental impacts and should not require an environmental agreement. The MoPWTH should make the necessary arrangements for such works to obtain the construction permitting in emergency regime. Facility Operation 51. The incineration facilities will be procured and the process will be operated in compliance with the provisions of the already mentioned MO 723/2003 of MoA that fully transposes the CE Regulation 1774/2002. The actions involved, potential impacts and mitigation measures are summarized in Annex 4. The key emissions to the air from operation of the incinerators are odor, particulate matter, hydrogen chloride, nitrogen oxides, sulphur dioxide, carbon monoxide, volatile organic compounds (from methane to polycyclic aromatic hydrocarbons (PAH), and dioxins and furans (PCDD/F). There will also be noise when the incinerator is operating. In addition, there is also risk from airborne release of virus as the dead poultry are loaded into the incinerator. The key actions of mitigation are to ensure that the formation of harmful substances is avoided through operation of the incinerator at the design temperatures and combustion air supply. The burning of materials e.g. polyvinyl chloride (PVC) materials that could lead to the formation of harmful substances when burnt will be avoided. 52. The operator will be responsible for emission monitoring and the environmental authorities will be responsible for air quality monitoring, as required by national legislation. 53. Since there is little experience if any in this field up to now, as regarding the proper incinerators for animal carcasses, the process will be operated and monitored within established guidelines drawn from published documents in other countries . For reference, the emission limits used in the UK for air pollutants are presented in Annex 5. 54. The key emissions to water from the incineration process might arise from the water and disinfectants that are used in the cleaning of the incinerator and the vehicle used in transport as well as of the slaughter of poultry. There is also a risk from fuel spillage during transport and on site commissioning of the facility or overflow of fat from the incinerator. The key actions of mitigation are to provide training and working materials to the incinerator operators, drivers and other personnel, and to ensure that sites are prepared in advance with lined hardstands and catchment and containment facility for disinfectants. The contained wastewater should then be discharged in the nearest WWTP. Page 20 17 4.1.1.2 Institutional Mitigation Measures to be included in the Environmental Management Plan 55. The mitigation measures described above are those related to the actual use of the mobile incinerators whose procurement is supported by the Project. In fact it is not possible to know in advance where and when an outbreak of avian influenza would appear and more than that those incinerators might hopefully not be used during the Project lifetime. 56. Consequently, the proper EMP for the Project should comprise the following preventive measures for the better preparedness of the emergency response. General measures: - make the necessary arrangements to obtain the approval of type if required for incinerators; - assign the potential operator of the incinerator depending on the property right (probably ANSVSA and the local sanitary-veterinary authorities); - develop the handbook for incinerator installation and operation by taking into account the issued identified in Annex 4 and the appropriate provisions in EOG 47/2007 (ANSVSA); take into account different alternatives of incinerator location (in the closest vicinity of infected holding or at longer distance since different conditions for the transport of infected load might apply). - prepare and develop the training program for the potential incinerator operators and the other actors involved (truck drivers and other personnel, local administration, holding owners, local environmental authorities) at least at county level; (ANSVSA) Incinerator site location - identify the existing structures available to be used as incinerator hardstands in all localities, in locality clusters or at county level; this measure might be included in the Emergency plan which should be amended for this purpose (Commandment for Emergencies) - identify the appropriate locations for new incinerator sites (same as above). Construction - MoPWTH should make the necessary arrangements for such works to obtain the construction permitting in emergency regime. Operation - make the necessary arrangements to issue the environmental permit for these operators since the present environmental legislation does not provide for permitting the temporary activities (see section 3.2). Page 21 T a b l e 2 : M i t i g a t i o n P l a n – I n s t i t u t i o n a l m e a s u r e s M e a s u r e R e s p o n s i b i l i t y O t h e r f a c t o r s i n v o l v e d D a t e C o s t M o n i t o r i n g i n d i c a t o r G e n e r a l A s s i g n t h e p o t e n t i a l o p e r a t o r o f t h e i n c i n e r a t o r A N S V S A - A S A P * N A * * R e g i s t r a t i o n a t t h e R e g i s t e r o f C o m m e r c e M a k e t h e n e c e s s a r y a r r a n g e m e n t s t o o b t a i n t h e a p p r o v a l o f t y p e f o r i n c i n e r a t o r s , i f r e q u i r e d A N S V S A T B D a f t e r p r o c u r e m e n t T B D A p p r o v a l o f t y p e c e r t i f i c a t e D e v e l o p t h e h a n d b o o k f o r i n c i n e r a t o r i n s t a l l a t i o n a n d o p e r a t i o n A N S V S A E n v i r o n m e n t a l a u t h o r i t i e s ( p o s s i b l e ) A S A P T B D H a n d b o o k P r e p a r e a n d d e v e l o p t h e t r a i n i n g p r o g r a m f o r t h e p o t e n t i a l i n c i n e r a t o r o p e r a t o r s A N S V S A L o c a l a d m i n i s t r a t i o n E n v i r o n m e n t a l a u t h o r i t i e s T r a i n e e s A S A P I n c l u d e d i n P r o j e c t c o s t s * * * R e p o r t s o n : - t r a i n i n g p r o g r a m - a c c o m p l i s h m e n t o f t r a i n i n g e v e n t s - L o c a t i o n o f t h e i n c i n e r a t o r s i t e I d e n t i f y p o t e n t i a l e x i s t i n g s t r u c t u r e s A N S V S A L o c a l a d m i n i s t r a t i o n C o m m a n d m e n t f o r E m e r g e n c y S i t u a t i o n s T B D , e n v i r o n m e n t a l a u t h o r i t i e s ( p o s s i b l e ) A S A P T o b e s u p p o r t e d b y l o c a l a d m i n i s t r a t i o n R e p o r t w i t h L i s t s o f l o c a t i o n s i d e n t i f i e d I d e n t i f y p o t e n t i a l n e w l o c a t i o n s s a m e a s a b o v e s a m e a s a b o v e s a m e a s a b o v e s a m e a s a b o v e s a m e a s a b o v e Page 22 1 9 M e a s u r e R e s p o n s i b i l i t y O t h e r f a c t o r s i n v o l v e d D a t e C o s t M o n i t o r i n g i n d i c a t o r C o n s t r u c t i o n M a k e t h e n e c e s s a r y a r r a n g e m e n t s f o r s u c h w o r k s t o o b t a i n t h e c o n s t r u c t i o n p e r m i t t i n g i n e m e r g e n c y r e g i m e A m e n d l e g i s l a t i o n t o i n c l u d e s u c h a p r o v i s i o n , i f d o e s n o t e x i s t s y e t A N S V S A M o P W T H A S A P N A T e x t o f t h e a m e n d e d l e g i s l a t i o n , u p o n t h e c a s e O p e r a t i o n M a k e t h e n e c e s s a r y a r r a n g e m e n t s t o i s s u e t h e e n v i r o n m e n t a l p e r m i t f o r o p e r a t o r s o f m o b i l e i n c i n e r a t o r s A m e n d e n v i r o n m e n t a l l e g i s l a t i o n t o i n c l u d e t h e n e c e s s a r y p r o v i s i o n M o E A N S V S A A S A P N A T e x t o f t h e a m e n d e d l e g i s l a t i o n , u p o n t h e c a s e * A S A P – a s s o o n a s p o s s i b l e * * N A – n o t a p p l i c a b l e * * * R e a l c o s t d e p e n d s o n n u m b e r o f t r a i n e e s & n u m b e r , d u r a t i o n a n d l o c a t i o n o f t r a i n i n g e v e n t s Page 23 20 4.1.2 Village-level-enterprises 57. Under sub-component d) the Project would eventually finance pilot projects for village-level enterprises (micro-farms). The discussed prospective is being to support the establishment of some micro-poultry farms at village level in which the poultry from village husbandries to be gathered. Such a farm should be provided with all bio-security means and measures whose efficiency and advantages might be demonstrated. 58. This is a questionable action with respect to a number of issues out of which the following are of interest from the environmental point of view: - site selection - construction or rehabilitation of buildings - farm size and layout - poultry species, as long as all variety can be found in villages: chicken, layers, ducks, geese, guinea fowls, turkeys - housing system - feed composition, supply and store - feeding regime - water and energy supply - heating and lighting system - fuel store - bedding procurement and storage - medical care - premises maintenance and cleaning - wastewater catchment & containment and after use or discharge - use of disinfectants - manure and other waste management - carcasses disposal - bio-safety assurance and control. 59. More than that, such a farm should have a legal status over property and operation and, will need all permits and contracts with services suppliers required by the national legislation for an economic activity, even if the products are intended for owner use. The actual environmental potential impact will depend on the answers to the issues mentioned above and the mitigation measures will be described in the form of conditions provided by the environmental permit. 60. Usually neither pollutant emissions nor air quality are monitored in animal farms. Monitoring will be the focused on the usual aspects: poultry inputs and outputs, feed amounts, water, energy, disinfectants, costs, manure movement, and so on. Page 24 21 4.2 Human Health Component Table 3: Sub-components and actions of Human Health Component S ub-component S ub-subcomponent A ctions a) Enhancing Coordination and Program Planning i. Additional studies and research - financing ii. Workshops, conferences and consensus meetings - financing b) Strengthening the National Public Surveillance System i. upgrading of the National Influenza Laboratory to BSL 3 Financing of - minor civil works (partitioning and creation of decontamination rooms), - supply and installation of additional security devices, - installation of a system for maintaining negative pressure in the rooms ii. strengthening of regional laboratories Financing of: - supply of real time PCR equipment, and - training of staff iii. strengthening of the capacity of the regional and district public health teams to investigate and control outbreaks Financing of: - supply of equipment, and - re-training of staff - when needed - c) Strengthening the Health Care System Capacity i. strengthening of the isolation and case management capacity Financing of - equipment for the two Bucharest infectious diseases hospitals, and - establishment of isolation and intensive care units in 7 of the regional hospitals for infectious diseases (Brasov, Craiova, Constanta, Cluj, Iasi, Timisoara and Tg. Mures). ii. upgrading of the influenza vaccine production unit at the Cantacuzino Institute in order to increase the production capacity and to ensure that the production is at the required Good Manufacturing Practice standards - rehabilitation and equipment of the influenza production department up to 2.5 million doses, and - completion and equipment of the filling and sealing unit Page 25 22 61. The Project’ s subcomponent again comprise mostly actions of financial support in terms of technical assistance and training/knowledge transfer with no environmental impact as well as of financing the necessary equipment for upgrading and refurbishment of laboratories and intensive care units in infectious disease hospitals. The specific waste generated by the activity performed in the upgraded units might hardly have any adverse impact as long as GLP are applied and all environmental regulation requirements described in chapter 3 are complied with. 62. Some minor civil works are envisaged under sub-component b.i) since the laboratories have to comply with the requirements necessary for safety-level 3 (see Annex 1). These involve only inside modifications to existing buildings and have no significant environmental impacts but might require the construction permit if some walls were to be removed. Specific mitigation measures against dust particulates and noise emissions should be taken, particularly considering the sensitive human receptors. The general entrepreneur is responsible for that. Debris from building works shall be removed according to the local arrangements, specified in the construction permit. 63. From the environmental point of view, the upgrading of the influenza vaccine production unit at the Cantacuzino Institute in order to increase the production capacity up to 2.5 million doses by supporting the rehabilitation and equipment of this department, and completion and equipment of the filling and sealing unit, proposed under sub- component c.ii) , is not going to change the present status of the production unit, described below in para 64., from the reasons presented . 64. The Production unit at the Cantacuzino Institute has presently the following status: - it is GMP certified by the NMA, - it is authorized by the MoH as a national medicine producer according to the national legislation presented in section 3.11 para 39; - it is operating on the basis of the environmental permit; - even at the present capacity for vaccine production, it is an IPPC installation from th ereasons mentioned in section 3.11 para 40; and - it is being now under evaluation to obtain the IEP according to the environmental national legislation. 65. From the environmental point of view, the upgrading of the influenza vaccine production unit in order to increase the production capacity up to 2.5 million doses by supporting the rehabilitation and equipment of this department, and completion and equipment of the filling and sealing unit, proposed under sub-component c.ii) , is not going to change the present status of the production unit as an IPPC installation. 66. Prior to the commissioning of the new capacity, the change has to be notified to the Bucharest Environmental Protection Agency for the assessment of the eventual significant adverse environmental impacts; the necessary mitigation measures will be described as new conditions included in the revised IEP. 5. MONITORING PLAN 67. The monitoring requirements for operation stage of activities developed within Page 26 23 project components “incinerators” and “micro-farms” have been presented in chapter 4. 68. Providing the compliance with GLP and GMP especially for the waste management, the have no significant or even moderate environmental impact and do not require specific environmental monitoring. 69. The implementation of the institutional measures described in table 2 should be monitored and evaluated along the Project progress, according to the Bank operational procedures and on the basis of indicators identified in the same table. 6. IMPLEMENTATION ARRANGEMENTS 70. The Project Management Units established in the ANSVSA and MPH are responsible for coordination and communications between all other agencies involved. Page 27 24 Annex 1 Guidance on the Bio-Safety Levels for Laboratories Bio-Safety Level REQUIREMENTS OF THE LABORATORY 2 3 4 A) Laboratory location and structure 1. Not next to known fire hazard Yes Yes Yes 2. Workplace separated from other activities Yes Yes Yes 3. Personnel access limited Yes Yes Yes 4. Protected against entry/exit of rodents and insects Yes Yes Yes 5. Liquid effluent must be sterilized Yes and monitored Yes and monitored 6. Isolated by airlock. Continuous internal airflow Yes Yes 7. Input and extract air to be filtered using HEPA or equivalent Single on extract Single for input, double for extract 8. Mechanical air supply system with fail-safe system Yes Yes 9. Laboratory sealable to permit fumigation Yes Yes 10. Incinerator for disposal of carcasses and waste Available Yes Yes on site B) Laboratory facilities 11. Class 1/2/3 exhaust protective cabinet available Yes Yes Yes 12. Direct access to autoclave Yes Yes with double doors Yes with double doors 13. Specified pathogens stored in laboratory Yes Yes Yes 14. Double ended dunk tank required Preferable Yes 15. Protective clothing not worn outside laboratory Yes Yes Yes 16. Showering required before exiting laboratory Yes 17. Safety Officer responsible for containment Yes Yes Yes 18. Staff receive special training in the requirements needed Yes Yes Yes Page 28 25 Bio-Safety Level REQUIREMENTS OF THE LABORATORY 2 3 4 C) Laboratory discipline 19. Warning notices for containment area Yes Yes Yes 20. Laboratory must be lockable Yes Yes Yes 21. Authorized entry of personnel Yes Yes Yes 22. On entering all clothing removed and clean clothes put on Yes Yes 23. On exiting all laboratory clothes removed, individual must wash and transfer to clean side Yes 24. Individual must shower prior to transfer to clean side Yes 25. All accidents reported Yes Yes Yes D) Handling of specimens 26. Packaging requirements to be advised prior to submission Yes Yes Yes 27. Incoming packages opened by trained staff Yes Yes Yes 28. Movement of pathogens from an approved laboratory to another requires a license Yes Yes Yes 29. Standard Operating Procedures covering all areas must be available Yes Yes Yes (Source: OIE) Page 29 26 Annex 2 International Best Practice in Safety of Research Laboratories 1 P rocurement / Transport y Minimize acquisition / quantity of hazardous materials, minimize storage time needed y Identify mechanism of waste disposal before acquisition y For chemicals, have Material Safety Data Sheets (MSDSs) accessible/confine deliveries to areas that are equipped to handle them (and train relevant personnel) y Ensure container is intact and appropriately labeled (US regulations detail how hazardous materials have to be identified, packaged, marked, labeled, documented and placarded) y Transport in appropriate (secondary) containers y Use triple packaging system for infectious and potentially infectious substances y Adhere to international air transport regulations Storage / Management y Inventory should have name as printed on the container y For chemicals: include molecular formula for further identification and to provide a simple means of searching chemicals; include CAS (Chemical Abstract Service) registry number for unambiguous identification of chemicals despite the use of different naming conventions y Source y Size of container y Hazard classification, as a guide to safe storage, handling, and disposal y Date of acquisition, to ensure that unstable chemicals are not stored beyond their useful life, and storage location Procedures y Dispose of materials anticipated to not be needed within a reasonable time frame y Use approved containers; make sure storage containers remain intact and sealed y Dispose of chemicals prior to expiration date, monitor reactive chemicals y Replace deteriorating labels before information is obscured or lost y Follow regulations for safe storage in stockroom or lab y Avoid storing chemicals on bench tops or lab hoods y Store volatile chemicals in ventilated cabinet (near hood) y If ventilation is not required, store in closable cabinet or on shelf with lip to prevent sliding y Do not expose stored chemicals to heat or direct sunlight y Observe all precautions regarding the storage of incompatible chemicals y Provide vented cabinets beneath hoods for storing hazardous materials y Use chemical storage refrigerators for storing chemicals y Have fire protection system (sprinklers) y Follow storage limits for flammable and combustible liquids y Restrict access to storage facility 1 US National Institutes of Health Page 30 27 Protocols / Facilities for Use in Research y Wear and use appropriate personal protection materials to minimize exposure y Wash hands y Reduce the possibility of creating splashes or aerosols y Contain in biological safety cabinets operations that generate aerosols y Use good housekeeping y Use mechanical pipetting devices y Promptly decontaminate work surfaces y Never eat, ring, smoke, handle contact lenses, apply cosmetics, or take medicine in the lab y Take special care when using sharps y Keep lab doors closed when experiments are in progress y Use secondary leak-proof containers to move or transfer cultures y Decontaminate infectious waste before disposal y Post appropriate warning signs y Mark emergency equipment, maintain it, inspect it; list telephone numbers to call in case of accident y Control access For Radioisotopes y Use only in designated areas y Allow the presence of essential staff only y Use personal protective equipment y Monitor personal radiation exposures y Use spill trays lined with disposable absorbent materials y Limit radionuclide quantities y Shield radiation sources y Mark radiation containers with the radiation symbol, including radionuclide identity, activity, and assay date y Use radiation meters to monitor working areas, protective clothing, and hands after completion of work y Use appropriately shielded transport containers y Remove radioactive waste frequently from the working area y Maintain accurate records of use and disposal of radioactive materials y Screen dosimetry records for materials exceeding the dose limits y Establish and regularly exercise emergency response plans y In emergencies, assist injured persons first y Clean contaminated areas thoroughly y Write and keep incident reports For Animal laboratories y Require good microbiological techniques y Establish policies and protocols for all operations and for access to vivarium y Establish appropriate medical surveillance program and supervision for staff y Prepare and adopt safety or operations manual y Post warning signs y Decontaminate work surfaces after use y Use appropriate biological safety cabinets or isolator cages; handle and decontaminate animal bedding and waste materials appropriately y Transport material for autoclaving or incineration safely, in closed containers y Treat, report, and record injuries Page 31 28 Training of Personnel Employer develops Chemical Hygiene Plan containing (models available from U.S. government and from some professional societies) Employee i nformation and training about the hazards of chemicals in the work area: How to detect their presence or release Work practices and how to use protective equipment Emergency response procedures Circumstances under which a lab operation requires prior approval from the institution Standard operating procedures for work with hazardous chemicals Criteria for use of control measures Measures to ensure proper operation of fume hoods and other protective equipment Provisions for additional employee protection for work with select carcinogens and toxins Provisions for medical consultations and examinations for employees Labs should establish their own safety groups at the department level (include students and support staff) Labs should provide training in safety and waste management for all lab workers, including students in laboratory classes Labs should incorporate institutionally supported lab and equipment inspection programs into their overall health and safety programs Review exit / evacuation routes Know how to report fire, injury, chemical spill, or summon emergency response Know first aid Know location and use of emergency equipment such as safety showers and eyewashes Know location and use of fire extinguishers and spill control equipment (have appropriate kits readily available) Lab personnel should establish ongoing relationships and clear lines of communication with emergency response teams Include information on safe methods for highly hazardous procedures commonly encountered by lab personnel that involve: · Inhalation risks · Ingestion risks · Risks of percutaneous exposures · Bites and scratches when handling animals · Handling of blood and other potentially hazardous pathological materials · Decontamination and disposal of infectious material Segregation / Triage of Waste Multihazardous waste – goal is reduction of waste to a waste that presents a single hazard. Consider frequency and amount of waste generated; assess risk Identify / characterize waste: - Physical description - Water reactivity - Water solubility - pH and possibly neutralization information - ignitability / flammability - presence of oxidizer - presence of sulfides / cyanides - presence of halogens - presence of radioactive materials - presence of biohazardous materials - presence of toxic constituents Page 32 29 Minimize waste’s hazards Determine options for management of hazards If appropriate, take steps to neutralize waste or render it non-hazardous When possible, select a single management option E stablish procedures for dealing with unstable waste, or waste that requires special storage or handling Store safely: - Designated room or facility modified to contain the waste (with ventilation and effluent trapping) - Protect workers - Minimize risk of fire or spill - Minimize radiation levels outside of area - Consider compatibility of materials being accumulated (e.g., aqueous and non-aqueous waste should be separated) Give particular attention to the handling or cleaning of radioactive laboratory ware, and to the proper disposal of sharps. - Non-contaminated (non-infectious) waste can be reused or recycled or disposed of as general waste - Contaminated (infectious) sharps – collect in puncture-proof containers fitted with covers and treated as infectious; autoclave if appropriate - Contaminated material for decontamination by autoclaving and thereafter washing and reuse or recycling - Contaminated material for direct incineration Disposal No activity should begin unless a plan for the disposal of hazardous waste has been formulated · Use appropriate disposal method for each category of waste · Use appropriate containers · Label and securely close waste containers · Separate wastes as appropriate For low level radioactive waste, options include · Storage time for decay and indefinite on site storage, · Burial at a low-level radioactive waste site, · Incineration, or · Sanitary sewer disposal For biological waste, options include · Disinfection · Autoclaving · For liquidsdisposal in sanitary sewer putrescible waste disposed of by incineration needles and sharps require destructiontypically by incineration or grinding Page 33 30 Collection and storage of waste · At satellite area near lab: - should be clearly identified, ventilated if necessary - determine whether to recycle, reuse, or dispose - hold here for less than one year; when containment volume limits reached, move to central accumulation area – package appropriately · At central accumulation area: - separate according to compatibility, commingle solvents when appropriate - label clearly, store in appropriate containers - limit storage time to 90 days - Ensure that employees are trained to handle waste materials as well as contingency planning for emergencies - When transporting, make provisions for spill control in case of accident; have internal tracking system to follow movement of waste - Ensure that all necessary records have been generated (Quantities and identification of waste generated and shipped; Documentation and analyses of unknown materials; Manifests for waste shipping as well as verification of waste disposal; Any other information required to ensure compliance and safety from long-term liability) · Disposal options: - Incineration – is method of choice for most wastes, but is most expensive - Normal trash – only where appropriate, must be clearly identified and appropriately labeled - Sanitary sewer – not commonly used; solutions must be aqueous and biodegradable, or low toxicity inorganics – make sure sewer doesn’t drain into water supply inappropriate for waste disposal, and make sure waste is highly diluted - Release to the atmosphere – not acceptable; fume hoods must have trapping devices to prevent discharge to atmosphere · If hazardous and non-hazardous wastes are mixed, entire waste volume must be treated as hazardous · Preparation for transport to a treatment, storage, and disposal facility (TSDF) · Waste generator must obtain assurance (in terms of documentation, permits, records) that provider is reliable For infectious material · Decontaminate, autoclave, or incinerate in lab · Package appropriately (for incineration or for transfer to another facility for incineration) · Protect against hazards to others to those who might contact discarded items Page 34 31 Annex 3 Environmental and safety considerations on mobile incinerators 2 DESCRIPTION ENVIRONMENTAL CONSIDERATIONS SAFETY CONSIDERATIONS This method is based on thermal destruction of infective pathogens, animal carcasses and other wastes in an incinerator. It involves: · Transporting the mobile incinerator to the culling site · Incinerating carcasses and other wastes (using fuel and air) at a high temperature · Transporting incineration residues (bottom ash/slag and flyash) to the disposal site and disposal at the sanitary landfill Technology Requirements : · Incinerator at a minimum temperature of 850 o C and with a minimum residence time of 2 seconds. Temperature must be measured and recorded · Incinerator equipped with an auxiliary burner that can be switched on when the temperature falls below 850 o C · Incinerator automatic feed system connected to temperature measurement · Storage areas for animal carcasses and other wastes as well as incineration residues must be covered. These areas must be ventilated, labeled, and designed and operated to prevent accidental releases of polluting substances to the environment. · Transportation of bottom ash/slag and flyash in closed containers to prevent environmental releases · Disposal of bottom ash/slag and flyash in a sanitary landfill Waste Pretreatment/Containment : To avoid emission of dioxins or furans during incineration, carcasses should not be pretreated with a chlorine-bearing disinfectant or should not be contained in PVC bags. For the same reason, no other material destined for incineration should contain chlorine-bearing chemicals · Use of PPE to ensure personnel hygiene of personnel working at the site (incinerator operators must change their PPE before handling animal carcasses and other wastes) · Established and documented cleaning/disinfection procedures · Established and documented emergency response procedures · Availability of cleaning/ disinfection supplies/equipment · Availability of emergency response equipment (e.g. first aid, fire fighting) Personnel training on personnel hygiene/cleaning, safety and emergency response measures 2 World Bank Interim Guidelines for Managing Potential Environmental and Social Safeguard Issues in Bank-Assisted Avian Influenza Control Projects Page 35 32 Annex 4 MITIGATION PLAN - Carcass Disposal by Incineration Actions Hazard Mitigation measures Road traffic emissions Short transport distances Emission of virus to air Covered & Sealed container Short transport distances Operator training and supervision Emission of virus & body fluids from dead stock Sealed covered container Quick transportation Emission of virus on transport vehicles Disinfectant used at recommended rates Use of appropriate sprays for wash down Operator training and supervision Transport of killed poultry Contamination of personnel Mechanical handling Operator training and supervision Disinfecting procedures Unloading of killed poultry Leaching of nutrients Groundwater pollution Release of virus to air Operator training and supervision Apply the prescribed operation rules Use of mechanical loader Close transfer Carcasses in bags Temporary storage for killed birds accumulated between burning runs Leaching of nutrients Groundwater pollution Release of virus to air Rupture of vessel or bags Rodent contact Enclosed building Shelter from weather Operator training and supervision. Minimal storage times. Impermeable surfaces. Birds may not be effectively killed Serious animal welfare issues. Virus spread form escaped poultry Supervision and monitoring Slaughter Operator Training Storage of fuel oil Groundwater pollution Soil contamination Tank bunds Impermeable surfaces Run off containment tank Incineration Gaseous emissions Ash Fat Hot surfaces Other waste Training and operation manual Apply the prescribed operation rules Operator supervision Minimal burning of other wastes e.g. personal protective clothing. Access restricted to operators Ash disposal Particulates Damping down Enclosed container Regular de-ashing Training and operation manual Apply the prescribed operation rules Operator supervision Page 36 33 A ctions H azard M itigation measures Washdown of i ncinerator, transport vehicles, transport containers Disinfectant O rganic liquor Influenza virus Groundwater pollution Surface water pollution Use disinfectants in recommended types and rates. K illed by biocide Impermeable surfaces Lined catchment Tank installed with connecting pipe at hardstand Tank enclosed Liquid stored until certified safe to spread to land Operator training and supervision Handling of waste from infected premises Disinfectants Leaching of nutrients surface and groundwater pollution Influenza virus release Odour Impermeable surfaces Drainage to impermeable vessel. Treatment on site Operator training and supervision Disposal of stored wash water with disinfectant mixed in Pollution of groundwater Toxicity to soil organisms Pollution of surface water Disinfectant used at recommended dilution. Further dilution by clean water Degradation of biocide in storage Discharge into the closest WWTP Operator training and supervision Page 37 34 Annex 5 Reference emission limits, monitoring and other provisions based on UK regulations for small incinerators Row Determinant Emission limits/provisions Monitoring Monitoring frequency 1 Total particulate matter 100 mg/m 3 Indicative monitoring and recording Manual extractive test Continuous Annual 2 Hydrogen Chloride (excluding particulate matter 100 mg/m 3 as total carbon Manual extractive test Annual 3 Carbon monoxide 100 mg/m 3 as an hourly average 150 mg/m 3 for 95% of all measurements, determined as 10 minute averages, in any 24 hour period Quantitative monitoring and recording Manual extractive test Continuous Annual 4 Sulphur dioxide 300 mg/m 3 or limit sulphur in fuel oil to 0.2% ww until 1 Jan, 08 and 0.1%ww after 1 Jan, 08 Manual extractive tests Or for fuel oil limit- certificate from supplier Annual On change of supplier 5 Organic compounds excluding particulate matter 10 mg/m 3 Manual extractive tests Annual manual extractive tests 6 Organic carbon in ash 1% carbon See ash monitoring protocols See ash monitoring protocols Oxygen Minimum 3% and average 6% by volume Measure at or after the end of retention zone in secondary chamber Measure at same location as annual manual extractive tests Continuous Concurrently throughout annual manual extractive tests 7 Oxygen Measure at same location as annual manual extractive tests Concurrently throughout annual manual extractive tests Page 38 35 Annex 6 PUBLIC CONSULTATION FIRST MEETING October 16, 2006 Minutes of the Meeting 1. The Public Consultation Process for Environmental Management Plan (EMP) included two actions: i) making the EMP publicly available through the websites of both authorities involved, namely the ANSVA and Ministry of Public Health, ii) organizing a debate meeting with the interested stakeholders. 2. As long as no persons from the large public showed interest in attending the debate, the meeting was held at the headquarters of ANSVA in presence of the Consultant in charge with the preparation of EMP (Dr. Violeta Visan) with participants representing ANSVA and Ministry of Public Health as well as some Institutes involved: - Dr. Razvan Taru, General Secretary, ANSVA - Dr. Marcela Vladareanu, PMU-ANSVA - Dr. Mircea Popa, Ministry of Public Health - Dr. Virginia Ciocoiu, PMU-Ministry of Public Health - Dr. Radu Dorel Lucian, General Manager, “Cantacuzino” Institute - Dr. Dan Otelea, “Matei Bals” Institute for Infectious Disease - Dr. Catalin Apostolescu, “Matei Bals” Institute for Infectious Disease 3. An opening statement was made by Dr. Taru explaining that the draft EMP had been prepared as a requisite for the Romania Avian Influenza (AIHP) Project according to the WB procedures. 4. The Consultant made a presentation to aquaint the participants with the EMP: overview of the identified potential impacts of the Project components, detailed explanation of the mitigation measures and monitoring indicators. 5. The restricted number of participants made possible an an interactive discussion along the presentation. The prevailing questions related to the use of incinerators, this being actually the main component of the Project with a potential significant impact on environment. Although no mitigation measures have been identified for the Human Health Component, the participants from Ministry of Health, Cantacuzino Institute and Matei Bals Institute have been active in discussions and made valuable comments. 6. It was pointed out that the use of incinerators is the prefered solution for the disposal of dead poultry. Dr.Taru was very much in favour with the idea of preparing a team of incinerator operators as soon as the type of the incinerators to be purchased is established and the operation Page 39 36 manual is available. Operating procedures for burial and incineration should be well documented and detailed within the Project Operation Manual. 8. The responsibilities of ANSVA representatives, their relation with the environmental authorities, and the role of the later in the monitoring of incineration process (particularly for air emissions), have been discussed also. 9. There were also comments regarding the necessity of identifying sites of incinerator settlement prior to outbreaks and the necessity of local administration in this respect. 10. No written comments were received. PUBLIC CONSULTATION SECOND MEETING November 02, 2006 Minutes of the Meeting 1. The Second Public Consultation Meeting for Environmental Management Plan (EMP) has been organized especially for Animal Health Component, at the headquarters of ANSVA. The ANSVA announced the date of the meeting on website and written invitations have been sent to the interested stakeholders, including the representatives of Ministry of Public Health. 2. The full list of participants is attached at the end of this minute. 3. An opening statement was made by Dr. Nicolae Manolescu, ANSVA president’s counsellor, who addressed some words about the importance of this WB project for Romania preparedness in case of avian influenza and human pandemic. 4. Dr. Taru presented also outlined the importance of the Project and also stressed on the fact that a PMU is needed to be organized within the ANSVA. He presented the Project components and explained that the EMP had been prepared as a requisite for the Romania Avian Influenza (AIHP) Project according to the WB procedures. 5. The Consultant made a presentation to aquaint the participants with the EMP: overview of the identified potential impacts of the Project components, detailed explanation of the mitigation measures and monitoring indicators. Page 40 37 6. Dan Hulea, president of the Romanian Ornithology Society made the comment that the Communication component, although not having an adverse environmental impact, is very important and should be addressed in such a way as to increase the benefits. He also mentioned that different research results - such as a map with the migration routes – would be helpful in establishing the most vulnerable zones of the country territory; this way the preffered location for the mobile incinerators could be bestimated in advance. The map showing the migration corridors will be overlapped with the map provided by the Romanian Association of Poultry Producers, showing the locations of the poultry farms across Romania, and the resulted map will be extremely useful for the assessment of the most vulnerable areas in the country. He proposed a close collaboration between the Ornithology Society and ANSVA for the goal of avian influenza prevention and preparedness . 7. It was again pointed out that the use of incinerators is the prefered solution for the disposal of dead poultry. Gheorghe Barboi from the Institute of Diagnosys and Animal Health gave some details about the capacity of incinerators to be procured and their operation. He mentioned that the incineration is the most expensive method but the only one accepted by the environmental authorities. 8. Prof. Ilie Van, president of the Romanian Association of Poultry Producers appreciated the proposed actions of the project as very valuable and the EMP findings as right. The most appropriate methods for poultry culling in farms have been discussed. 9. The representatives of Ministry of Environment discussed the role of the environmental authorities in the monitoring of incineration process (particularly for air emissions). The monitoring is very expensive and less large incinerators instead of many small ones would be prefferable in this respect. Of course this would not be necessary providing that the incinerators will be operated properly. 10. There were also comments regarding the necessity of identifying sites of incinerator settlement prior to outbreaks and the necessity of local administration in this respect. 11. No written comments were received. List of participants No. Name Institution/ position e-mail address Phone number 1 Nicolae Manolescu ANSVA/ member of the Romanian Science Academy, ANSVSA president’s counsellor 0740 114402 2 Razvan Tiru ANSVA/ general secretary tiru@ansv.ro 0741 192574 3 Nicolae Stefan ANSVA/director of sanitary-veterinary department nicolae.stefan@idah.ro 0744 499155 4 Radu Roatis ANSVA/vice-president , deputy secretary of state roatis@ansv.ro 0741 065901 5 Gheorghe Barboi Institute for Diagnosis and Animal Health barboi.gheorghe@idah.ro 021 4104933 6 Eugen Olaru Institute for Diagnosis and Animal Health olaru.eugen@idsa.ro 021 4101390 021 4101299 Page 41 38 7 Dan Hulea Romanian Ornithology Society/ president dan.hulea@sor.ro 021 3184701 0788 264601 8 Cristina Petcu Ministry of Public Health cpetcu2002@yahoo.co.uk 021 3072589 9 Catalina Iordan Ministry of Environment catalina.iordan@mmediu.ro 021 3192532 10 Gabriela Osiceanu Ministry of Environment gabriela.osiceanu@mmediu.ro 021 3166154 11 Ilie Van Romanian Association of Poultry Producers/ president ilievan@yahoo.com 021 6663765 12 Teodora Iancu National Environmental Guard iancutdr@yahoo.com 021 3192532 13 Marcela Vladareanu ANSVSA/procurement specialist marcelavladareanu@pcnet.ro 0745 074350 14 Violeta Visan Environmental Independent Consultant vfvisan@yahoo.co.uk 0729 881 222 15 Amy Evans World Bank aevans@worldbank.org