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Actero Pharma Pvt. Ltd. Draft Eia Report

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ACTERO PHARMA PVT. LTD. SY.NO. 407 (PART) AND 411, VELIMINEDU VILLAGE, CHITYAL MANDAL, NALGONDA DISTRICT, TELANGANA DRAFT EIA REPORT 1. ENVIRONMENTAL IMPACT ASSESSMENT 2. ENVIRONMENT MANAGEMENT PLAN 3. COMPLIANCE OF TERMS OF REFERENCE 4. ANNEXURES Project No. 0118‐21‐03 January 2018 M/s. Actero Pharma Pvt. Ltd. STUDIES AND DOCUMENTATION BY C/o. Hetero Drugs Limited TEAM Labs and Consultants Plot No: 7‐2‐A2 Hetero Corp, Industrial Estate, B‐115‐117 & 509, Annapurna Block, Sanathnagar, Hyderabad‐500018 Aditya Enclave, Ameerpet, Phone: 040‐23704923/23704924 Hyderabad‐500 038. E‐mail: [email protected]; Phone: 040‐23748 555/23748616, [email protected] Telefax: 040‐23748666 SUBMITTED TO TELANGANA STATE POLLUTION CONTROL BOARD, REGIONAL OFFICE, NALGONDA ACTERO PHARMA PVT. LTD. SY.NO. 407 (PART) AND 411, VELIMINEDU VILLAGE, CHITYAL MANDAL, NALGONDA DISTRICT, TELANGANA 1. ENVIRONMENTAL IMPACT ASSESSMENT REPORT Project No. 0118‐21‐03 January 2018 M/s. Actero Pharma Pvt. Ltd. STUDIES AND DOCUMENTATION BY C/o. Hetero Drugs Limited TEAM Labs and Consultants Plot No: 7‐2‐A2 Hetero Corp, Industrial Estate, B‐115‐117 & 509, Annapurna Block, Sanathnagar, Hyderabad‐500018 Aditya Enclave, Ameerpet, Phone: 040‐23704923/23704924 Hyderabad‐500 038. E‐mail: [email protected]; Phone: 040‐23748 555/23748616, [email protected] Telefax: 040‐23748666 SUBMITTED TO TELANGANA STATE POLLUTION CONTROL BOARD, REGIONAL OFFICE, NALGONDA Actero Pharma Pvt. Ltd., Contents CONTENTS Section Description Page No. 1.0 Introduction of The Project 1-1 1.1 Product Profile 1-3 1.2 Technology 1-4 1.3 Plant Location & Layout 1-4 1.4 Scope of EIA Studies 1-8 2 Process Description and Pollution control Facilities 2-1 2.1 Process Description 2-2 2.1.1 Process Description of Abiraterone Acetate 2-2 2.1.2 Process Description of Afatinib 2-6 2.1.3 Process Description of Anastrazole 2-12 2.1.4 Process Description of Bicalutamide 2-15 2.1.5 Process Description of Bendamustine HCl 2-17 2.1.6 Process Description of Bexarotene 2-20 2.1.7 Process Description of Bosutinib 2-23 2.1.8 Process Description of Capecitabine 2-28 2.1.9 Process Description of Carfilzomib 2-30 2.1.10 Process Description of Ceritinib 2-34 2.1.11 Process Description of Cyclophosphamide 2-37 2.1.12 Process Description of Dasatinib 2-39 2.1.13 Process Description of Docetaxel 2-41 2.1.14 Process Description of Enzalutamide 2-43 2.1.15 Process Description of Erlotinib HCl 2-48 2.1.16 Process Description of Gefitinib 2-50 2.1.17 Process Description of Gemcitabine HCl 2-52 2.1.18 Process Description of Ibrutinib 2-55 2.1.19 Process Description of Imatinib Mesylate 2-60 2.1.20 Process Description of Lapatanib 2-63 2.1.21 Process Description of Lenvatinib 2-66 2.1.22 Process Description of Olaparib 2-67 2.1.23 Process Description of Palbociclib 2-72 2.1.24 Process Description of Pazopanib 2-76 2.1.25 Process Description of Sorefinib 2-78 2.1.26 Process Description of Sunitinib 2-80 2.1.27 Process Description of Tamoxifene 2-82 2.2 Utilities 2-84 2.3 Water Requirement 2-84 2.4 Pollution Control Facilities 2-86 2.4.1 Water Pollution 2-86 2.4.1.1 Process Description and Technical Specification of Effluent Treatment System 2-91 2.4.2 Air Pollution 2-97 2.4.2.1 Emissions from Utilities 2-98 2.4.2.2 Emissions from Process 2-99 2.4.2.3 Diffuse Emissions 2-101 2.4.2.4 Fugitive Emissions 2-101 Actero Pharma Pvt. Ltd., Contents 2.4.3 Solvent Use and Recycle 2-102 2.4.4 Solid Waste 2-109 2.4.5 Noise Pollution 2-115 3.0 Baseline Environmental Status 3-1 3.1 Introduction 3-1 3.2 Land Environment 3-1 3.2.1 Physiography 3-1 3.2.2 Geology 3-5 3.2.3 Hydrogeology 3-7 3.2.4 Soils 3-9 3.3 Water environment 3-14 3.3.1 Surface Water Resources 3-14 3.3.1.1 Surface water Quality 3-14 3.3.1.2 Ground Water resources 3-15 3.3.1.3 Quality Of Ground Water 3-15 3.4 Air environment 3-20 3.4.1 Meteorology 3-20 3.4.2 Meteorological Station at Plant Site 3-23 3.4.3 Ambient air quality 3-26 3.4.4 Scope of field study 3-28 3.4.5 Description of sampling locations 3-30 3.4.6 Ambient Air Quality Status 3-32 3.4.7 Noise environment 3-34 3.4.8 Traffic Study 3-36 3.5 Socio economic environment 3-37 3.6 Demography 3-37 3.6.1 Population Distribution 3-38 3.6.1.1 Literacy 3-39 3.6.1.2 Employment/Occupation 3-39 3.6.1.3 Living standards and Infrastructure 3-42 3.6.2 Land Utilization 3-44 3.6.3 Project Economy 3-44 3.7 Flora and Fauna 3-45 4 Identification of Impacts 4.1 Identification of Impacts 4-1 4.1.1 Impact Networks 4-1 4.2 Prediction of Impacts 4-8 4.2.1 Air Environment 4-8 4.2.1.1 Details of Mathematical Modeling 4-9 4.2.1.2 Utility Emissions 4-12 4.2.1.3 Air Quality Predictions 4-13 4.2.1.4 Prediction of Concentration of Solvents in the Indoor Environment Due to 4-21 Solvent Loss and Fugitive Emissions 4.2.2 Water Environment 4-22 4.2.3 Noise Environment 4-23 4.2.3.1 Prediction of Impact on Noise Quality 4-23 4.2.4 Land Environment 4-24 4.2.5 Biological Environment 4-25 Actero Pharma Pvt. Ltd., Contents 4.2.6 Socio-economic Environment 4-26 4.2.7 Prediction of Impact on Vehicular Traffic 4-26 5 Analysis of Alternatives 5-1 5.1 Alternative sites 5-1 5.2 Alternative in Process 5-1 5.2.1 Alternatives in Technology 5-2 5.2.2 Alternatives in treatment/mitigation options 5-3 6 Environmental Monitoring 6-1 6.1.1 Introduction 6-1 6.1.2 Objectives 6-1 6.1.3 Methodology 6-1 6.1.4 Ambient Air Quality (AAQ) Monitoring 6-2 6.1.5 Water Quality Monitoring 6-3 6.1.6 Noise Level Monitoring 6-8 6.1.7 Responsibility of Monitoring And Reporting System 6-9 6.1.7.1 Work Zone Monitoring for Hazardous Chemicals 6-10 6.2 Environmental Monitoring Budget 6-10 7 Risk Assessment and Damage Control 7-1 7.0 Introduction 7-1 7.1 Objectives and Scope 7-1 7.2 Project Details 7-2 7.3 Process Description 7-10 7.4 Plant Facilities 7-10 7.4.1 Production Blocks 7-10 7.4.2 Utilities 7-10 7.4.3 Quality Control, R&D Lab 7-11 7.4.4 ETP and Solid Waste storage 7-11 7.4.5 Ware Houses 7-11 7.4.6 Tank Farm Area 7-11 7.4.7 Cylinders Storage Area 7-12 7.4.8 Administrative Office 7-12 7.4.9 House Keeping 7-12 7.4.10 Coal and Ash Storage 7-12 7.4.11 Facility Layout and Design 7-12 7.5 Hazard Analysis and Risk Assessment 7-16 7.5.1 Introduction 7-16 7.5.2 Hazard Identification 7-16 7.5.3 Fire & Explosion Index (F & EI) 7-20 7.5.3.1 Methodology 7-20 7.5.4 Hazard and Operability Study (HAZOP) 7-22 7.5.5 Hazard Factors 7-23 7.5.6 Common Causes of Accidents 7-24 7.6 Maximum Credible Accident and Consequence Analysis (MCACA) 7-25 7.6.1 Methodology 7-26 7.6.2 Identification of Vulnerable Areas 7-26 7.6.3 Representative Accident Scenarios 7-27 7.7 Consequence Analysis 7-28 7.7.1 Release Models and Source strength 7-28 Actero Pharma Pvt. Ltd., Contents 7.7.2 Results of Consequence Analysis 7-30 7.7.2.1 Analysis of Hazardous Scenarios 7-31 7.7.2.1.1 Heat radiation effects 7-31 7.7.2.1.2 Overpressure effects 7-32 7.7.3 Observations 7-32 7.7.4 Recommendations 7-32 7.7.5 Toxic management plan 7-33 7.7.6 Transportation 7-35 7.7.7 Control measures for accidental spillage of chemicals 7-38 7.8 Disaster Management Plan 7-40 7.8.1 Introduction 7-40 7.8.2 Objectives Of Emergency Management Plan (On-Site) 7-41 7.8.3 Scope Of ONSEP 7-42 7.8.4 Methodology Of Developing ONSET 7-42 7.8.5 Element Of ONSITE Emergency Plan 7-42 7.8.5.1 Emergencies Identified 7-436 7.8.5.2 Emergency Organization 7-43 7.8.5.3 Emergency Facilities 7-43 7.8.5.4 Emergency Procedures 7-46 7.8.5.5 Rescue and Rehabilitation 7-47 7.8.5.6 Emergency Responsibilities 7-48 7.8.6 Remedial Action 7-53 7.8.7 Basic Action In Emergencies 7-54 7.8.8 Fire Fighting Operation 7-54 8 Project Benefits 8-1 8.1 Introduction 8-1 8.2 Employment Potential 8-1 8.3 Corporate Social Responsibility 8-1 9 Environment Cost Benefit Analysis 9-1 10 Environment Management Plan 10-1 10.0 Introduction 10-1 10.1 Environment Management Plan 10-2 10.1.1 Construction Phase 10-2 10.1.2 Operation Phase 10-3 10.2 Sources of Pollution from Manufacturing Process 10-3 10.2.1 Water Pollution 10-3 10.2.1.1 Process Description and Technical Specification of Effluent Treatment System 10-5 10.2.2 Air Pollution 10-11 10.2.2.1 Emissions from Utilities 10-11 10.2.2.2 Emissions from Process 10-13 10.2.2.3 Diffuse Emissions 10-15 10.2.2.4 Fugitive Emissions 10-15 10.2.2.5 Odor Management 10-16 10.2.3 Solvent Use and Recycle 10-16 10.2.4 Solid Waste 10-19 10.2.5 Noise Pollution 10-20 10.3 Rainwater Harvesting 10-21 10.4 Occupational Safety and Health 10-24 Actero Pharma Pvt.
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