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54425-001: Asia Pacific Vaccine Access Facility for Responsive Initial Environmental Examination Project Number: 54425-001 January 2021 Republic of Indonesia: Asia Pacific Vaccine Access Facility - Responsive COVID-19 Vaccines For Recovery (APVAX RECOVER) Project Prepared by PT Bio Farma for the Asian Development Bank. CURRENCY EQUIVALENTS (as of 10 November 2020) Currency unit – Indonesian Rupiah (Rp) Rp1.00 = $0.0000688 $1.00 = Rp.14,529 ABBREVIATIONS ADB - Asian Development Bank AMDAL - Analisis Mengenai Dampak Lingkungan (equivalent to environmental impact assessment) ANDAL - Analisis Dampak Lingkungan (equivalent to environmental impact assessment report) APVAX - Asia Pacific Vaccine Access Facility - Responsive COVID-19 Vaccines for RECOVER Recovery (APVAX RECOVER) Project BCG - Bacillus Calmette-Guerin vaccine against tuberculosis BPOM - Badan Pengawas Obat & Makanan (National Agency of Drug and Food Control of Indonesia) COCP - Code of Construction Practice DT - Diptheria DTP - Diptheria-Tetanus-Pertussis DTP-HB - Diptheria and tetanus toxoids and whole-cell pertussis and hepatitis B EARF - Environmental assessment and review framework EHS - Environment, health and safety EMS - Environmental Management System FDA - Food and Drug Agency GAVI - Global Alliance of Vaccines and Immunization GMP - Good Manufacturing Practice HEP B - Hepatitis B HiB - Haemiphilus influenzae type B HPV - Human Papillomavirus IEE - Initial environmental examination MOEF - Ministry of Environment and Forestry MOH - Ministry of Health MSOE - Ministry of State-Owned Enterprises NRA - National Regulatory Authorities OHSaS - Occupational Health and Safety Accreditation System PAHO - Pan American Health Organization PIU - Project Implementation Unit PMU - Project Management Unit PROPER - Environmental Management Performance Assessment Program of MOEF SPPL - Surat Pernyataan Pengelolaan Lingkungan (equivalent to an environmental commitment) UKL/UPL - Upaya Pengelolaan Lingkungan Hidup dan Upaya Pemantauan Lingkungan Hidup (equivalent to an initial environmental examination) UNICEF - United Nations Children’s Fund WHO - World Health Organization WHO-EPI - Expanded Program on Immunization of WHO NOTE In this report, "$" refers to US dollars. This initial environmental examination is a document of the borrower. The views expressed herein do not necessarily represent those of ADB's Board of Directors, Management, or staff, and may be preliminary in nature. Your attention is directed to the “terms of use” section of this website. In preparing any country program or strategy, financing any project, or by making any designation of or reference to a particular territory or geographic area in this document, the Asian Development Bank does not intend to make any judgments as to the legal or other status of any territory or area. 3 TABLE OF CONTENTS I. EXECUTIVE SUMMARY 8 A. Project Rationale 8 B. Project Scope (Impact, Outcome, Outputs) 10 C. Environment Safeguards Category, Due Diligence 12 D. Environmental Conditions 14 E. Environmental Impacts and Mitigation Measures 15 F. Environmental Management Plan, Monitoring, Reporting 18 G. Information Disclosure, Meaningful Consultation, Grievance Redress Mechanism 19 H. Conclusion 20 II. PROJECT DESCRIPTION 21 Background Information and Project Rationale 21 Project Scope (Impact, Outcome, Outputs) 23 1. Output 1: COVID-19 vaccines procured and deployed to provinces 24 2. Output 2: Bio Farma’s vaccine production capacity strengthened 24 3. Output 3: Bio Farma’s institutional capacity enhanced and knowledge disseminated 30 Description of Production Process 30 Institutional arrangements and project implementation schedule 32 III. POLICY, LEGAL, AND ADMINISTRATIVE FRAMEWORK 34 A. ADB Safeguard Policy Statement 2009 34 B. Government of Indonesia’s Environmental Policy and Regulatory Framework 37 C. National environmental regulatory framework 38 D. Regulations and guidelines related to pharmaceutical manufacturing 41 E. Regulations on Pollution Prevention and Waste Management 45 F. Regulations on Labor Management 48 G. International Agreements, Conventions and Programs 48 IV. DESCRIPTION OF THE ENVIRONMENT 50 A. Physical 50 1. Geography, Location 50 2. Topography, Geology, Soils 53 3. Air Quality 53 4. Noise 53 5. Water Resources 54 6. Climate 54 7. Natural Hazards and Disaster 55 B. Ecology 55 C. Socioeconomic Conditions 56 1. Population, economy, socio-economic resources 56 2. Land Uses 57 3. Physical Cultural Resources 58 D. Environmental Due Diligence (Audit) of Existing Bio Farma Facilities 58 V. ANTICIPATED ENVIRONMENTAL IMPACTS AND MITIGATION MEASURES 72 A. Impact Screening and Scoping 72 B. Anticipated impacts during construction 74 C. Anticipated impacts during operation 78 D. Indirect, cumulative impacts 82 VI. INFORMATION DISCLOSURE, CONSULTATION, AND PARTICIPATION 88 A. Introduction 88 B. Information disclosure 88 4 C. Consultation 89 VII. GRIEVANCE REDRESS MECHANISM 94 VIII. ENVIRONMENTAL MANAGEMENT PLAN 97 A. Environmental Management and Mitigation 97 B. Institutional Arrangements and Responsibilities 108 C. Monitoring and Reporting 110 IX. CONCLUSION AND RECOMMENDATION 116 APPENDIX 1: ENVIRONMENTAL MONITORING REPORT OUTLINE 119 APPENDIX 2: WHO GOOD MANUFACTURING PRACTICE (GMP) AND OTHER GUIDELINES 122 APPENDIX 3: COMPLAINTS ACCEPTANCE FORM 125 5 List of Tables Table 1: Environment safeguard categorization of project components ..................................................... 13 Table 2: Scope of subcomponents under output 2a ................................................................................... 26 Table 3: Scope of subcomponents under output 2b ................................................................................... 28 Table 4: IFC guidelines applicable to all activities supported under RECOVER project ............................ 34 Table 5: WHO Good Manufacturing Practice (GMP) guidelines applicable to all activities supported under RECOVER project ....................................................................................................................................... 36 Table 6: ADB and Indonesia Project Categorization Systems .................................................................... 41 Table 7: Government Regulations on Pollution Control and Waste Management ..................................... 47 Table 8: Ambient air quality monitoring results in Bio Farma’s Bandung site, 2019................................... 53 Table 9: Noise monitoring results in Bio Farma’s Bandung site, October 2019 ......................................... 54 Table 10: Current Uses and Activities of Each Floor of Building 43 ........................................................... 61 Table 11: Wastewater treatment plant No. 1 effluent monitoring results, 2019 .......................................... 65 Table 12: Wastewater treatment plant No. 2 effluent monitoring results, 2019 .......................................... 65 Table 13: Incinerator stack emission monitoring results in Bio Farma’s Bandung site............................... 68 Table 14: Screening and classification of project components per the ADB Safeguard Policy Statement (2009) .......................................................................................................................................................... 72 Table 15: Offices and agencies consulted during project and IEE preparation .......................................... 90 Table 16: Environmental Management Plan ............................................................................................... 98 Table 17: Environmental Monitoring Plan ................................................................................................. 112 List of Figures Figure 1: Plant Layout of Bio Farma’s Bandung site, location of Building 43 (all buildings are existing) ... 25 Figure 2: Photography of Building No. 43, Pasteur site, Bandung ............................................................. 26 Figure 3: Site plan of Bio Farma’s planned facility in Indotaisei, Karawang Regency ................................ 28 Figure 4: Upstream Vaccine Production Process ....................................................................................... 31 Figure 5: Downstream Vaccine Production Process .................................................................................. 32 Figure 6: Project Implementation Schedule ................................................................................................ 33 Figure 7: Flowchart of Indonesian Environmental Screening and Clearance ............................................. 40 Figure 8: Simplified Illustration of the GMP (CPOB) Certification Process for Marketed Pharmaceutical Products ...................................................................................................................................................... 44 Figure 9: Simplified Illustration of the Certification Process for Imported Vaccines ................................... 45 Figure 10: Map of Indotaisei industrial complex ......................................................................................... 51 Figure 11: Aerial view of Bio Farma’s site in Indotaisei industrial complex ................................................ 52 Figure 12: View of the project site and immediate vicinity .......................................................................... 52 Figure 13: Average monthly temperature and rainfall in West Java (1901-2016) ...................................... 54 Figure 14: Current land cover at Bio Farma’s
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