DRAFT

ENVIRONMENTAL IMPACT ASSESSMENT

AND EMP REPORT

FOR

PROPOSED EXPANSION OF PHARMACEUTICAL PRODUCTS MANUFACTURING UNIT 138 MTPM (EXISTING 3.25 MTPM AND PROPOSED 134.75 MTPM)

AT

BLOCK NO. 155/1, 159, CHHATRAL-KADI ROAD, VILLAGE DHANOT, TALUKA KALOL, DISTRICT GANDHINAGAR, GUJARAT

PROJECT CATEGORY: A, 5(f), SYNTHETIC ORGANIC CHEMICALS INDUSTRY

STUDY PERIOD: OCTOBER TO DECEMBER, 2016

PROJECT PROPONENT:

ORBIT PHARMA LABORATORIES

PREPARED BY:

en -VISIOn ENVIRO TECHNOLOGIES PVT. LTD.

2nd FLOOR, SHRI RAM COMPLEX, ABIVE BANK OF INDIA, NEAR KARGIL CHOWK, SURAT-DUMAS ROAD, ORBIT PHARMA LABORATORIES PIPLOD, SURAT-395007 GUJARAT.

Phone No.: (0261) 2223003, 2224004 Email Add.: [email protected] Website: www.en-vision.in

Accreditation by QCI / NABET Certificate No. 1417/IA 003 ISO 9001:2008 Certificate No. BN9180/8576:0614 JULY, 2017 171011_116034_170717 en-vιsι
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Declaration by Experts contributing to the EIA/EMP Report

“Proposed Expansion of Pharmaceutical Products Manufacturing Unit” at Block No. 155/1, 159, Chhatral- Kadi Road, Village Dhanot, Taluka Kalol, District Gandhinagar, Gujarat.

I, hereby, certify that I was a part of the EIA team in the following capacity that developed the above EIA. EIA Coordinator : Synthetic Organic Chemicals Industry

Name : Smitha Rajesh

Signature and Date : 25/04/2016

Period of involvement : October 2016 to December, 2016

Contact information : [email protected] Ph. No. 0261 - 2223003

Functional Area Experts

Functional Name of the Involvement Sr. No. Signature Areas Expert/S Period Task Site visit, selection of monitoring locations, selection of parameters, evaluation of air quality results, impact identification and mitigation measures suggestion.

Site visit, Selection of monitoring locations for wat er quality, evaluation water quality results, evaluation of AP proposed ETP treatment scheme, impact October to WP identification and mitigation measures 1 Niha r Doctor December, SHW suggestion of the project. 2016 AQ Site visit, Identification of solid and Hazardous Wastes generated storage facility and disposal management.

Site visit, selection of monitoring locations, supervision of air quality modeling and prediction, identification of impacts.

Collecting GPS reading of proposed site, geo reference of toposheets and satellite image, preparation of base map from October to Dr. Y. toposheets, preparation of landuse/land 2 LU December, Ramamohan cover map from the satellite image. 2016 Identification of impacts and suggest mitigation measures.

Prepared list of villages present within October to study area, Collected primary and Dr. Rumjhum Ray 3 SE December, secondary data, identify impact of Caudhuary 2016 project on community, prepare CSR activities, Prepared SE report.

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Functional Name of the Involvement Sr. No. Signature Areas Expert/S Period Task Identified locations for the sample collection of terrestrial biodiversity on the basis of Land Use and Land cover October to map. 4 EB Dr. Manoj Eledath December, Identified flora and fauna within study 2016 area. Identification of Impacts and suggested mitigation measures. Suggested the conservation plan for the schedule-1 fauna. Determine the groundwater flow October to direction by measuring the water level in 5 HG Naresh Goar December, existing water wells, study the 2016 groundwater development and hydrology in the study area. Identifying possible source of Noise October to pollution from process equipments and 6 N Haneesh Panicker December, other transportation activity. Delineating 2016 measures to curb Noise Pollution. Monitoring related work. October to Studied project prop osal, Identified 7 RH Sundara Rajulu December, potential hazards of proposed activities. 2016 Suggested safety measures for Hazards.

Name of Laboratory: En-Tech Laboratories NABL/MoEF Certificate No.: T-3750 Period of Involvement: October to December, 2016

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Declaration by the Head of the accredited consultant organization/ authorized person

I, Nihar Doctor, hereby, confirm that the above mentioned experts prepared the EIA of proposed of Synthetic organic Chemicals Industry at Block No. 155/1, 159, Chhatral-Kadi Road, Village Dhanot, Taluka Kalol, District Gandhinagar, Gujarat by M/s. Orbit Pharma Laboratories.

I also confirm that the consultant organization shall be fully accountable for any mis-leading information mentioned in this statement.

Signature :

Name : Nihar Doctor Designation : Director Name of the EIA consultant : Envision Enviro Technologies Pvt. Ltd. organization NABET Certificate No. & Issue : NABET/EIA/1417/IA 003 valid up to December 03, 2017 Date

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INDEX

Se. No. Title Page No.

EXECUTIVE SUMMARY OF EIA REPORT

CHAPTER-1 : INTRODUCTION

1.1 PURPOSE OF EIA 1-1 1.2 IDENTIFICATION OF PROJECT & PROJECT PROPONENT 1-1 1.3 BRIEF DESCRIPTION OF THE PROJECT 1-1 1.4 SCOPE OF THE STUDY 1-1 1.5 STRUCTURE OF THE EIA REPORT 1-2

CHAPTER-2 : PROJECT DESCRIPTION

2.1 BRIEF PROJECT DISCRIPTION 2-1 2.2 TYPE OF PROJECT 2.1 2.3 NEED OF PROJECT 2-1 2.4 LOCATION 2-1 2.4.1 KEY INFRASTRUCTURE F EATURES AND SETTLEME NTS 2-6 2.5 MAGNITUDE OF OPERATION 2-8 2.5.1 PROJECT COST 2-8 2.6 SCHEDULE OF OPERATION AND IMPLEMENTATION 2-8 2.7 TECHNICAL AND PROJECT DESCRIPTION 2-9 2.7.1 CONSTRUCTION ACTIVITIES 2-9 2.7.2 PRODUCTION ACTIVITIES 2-9 2.7.3 RAW MATERIALS REQUIREMENTS 2-10 2.7.4 MANUFACTURING PROCESS 2-11 2.7.5 SOLVENT MANAGEMENT 2-35 2.8 COMPONENTS OF PROJECT 2-35 2.8.1 LAND 2-35 2.8.2 POWER REQUIREMENT 2-35 2.8.3 FUEL REQUIREMENT 2-35 2.8.4 MANPOWER REQUIREMENTS 2-36 2.8.5 WATER SOURCE, UTILIZATION AND WASTE WATER 2-36 2.8.6 AIR POLLUTION 2-37 2.8.6.1 SOURCE OF FUGITIVE OR SECONDARY EMISSIONS 2-38 2.8.7 NOISE POLLUTION 2-38 2.8.8 LAND/SOIL POLLUTION 2-38 2.9 ENVIRONMENNTAL MITIGATION MEASURES 2-38 2.9.1 MITIGATION MEASURES FOR WATER POLLUTION 2-38 2.9.1.1 DETAILS OF EXISTING ETP 2-39 2.9.2 MITIGATION MEASRURES FOR AIR POLLUTION 2-40 2.9.2.1 MITIGATION MEASURES FOR FUGITIVE OR SECONDARY EMISSIONS 2-41 2.9.3 MITIGATION MEASURES FOR NOISE POLLUTION 2-41 2.9.4 MITIGATION MEASURES FOR LAND/SOIL POLLUTION 2-41

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Se. No. Title Page No.

CHAPTER-3 : BASELINE ENVIRONMENTAL STATUS

3.1 DESCRIPTION OF THE STUDY AREA 3-1 3.2 PERIOD OF MONITORING 3-1 3.3 COMPONENTS AND METHODOLOGY 3-1 3.4 BASELINE ENVIRONMENTAL DATA 3-3 3.4.1 METEOROLOGICAL ENVIRONMENT 3-3 3.4.2 AIR ENVIRONMENT 3-6 3.4.3 WATER ENVIRONMENT 3-8 3.4.3.1 PHYSICO-CHEMI CAL CHARACTERISTICS OF WATER 3-12 3.4.4 NOISE ENVIRONMENT 3-12 3.4.4.1 TRAFFIC STUDY 3-14 3.4.5 SOIL ENVIRONMENT 3-15 3.4.5.1 SOIL QUALITY INTERPRETATION 3-15 3.4.6 LANDUSE 3-16 3.4.7 SOCIO - ECONOMIC ENVIRONMENT 3-20 3.4.8 DESCRIPTION OF THE B IOLOGICAL ENVIRONMEN T 3-24 3.5 GEO HYDROLOGY 3-36 3.5.1 GENERAL GEOLOGY 3-36 3.5.2 DRAINAGE PATTERN OF THE AREA 3-38 3.5.3 GROUNDWATER DEVELOPMENT 3-38

CHAPTER-4 : ANTICIPATED ENVIRONMENTAL IMPACTS & MITIGATION MEASURES

4.1 IDENTIFICATION OF IMPACTS 4-1 4.2 PREDICTION AND EVALUATION OF IMPACTS 4-1 4.3 AIR ENVIRONMENT 4-2 4.3.1 DETAILS OF ENVIRONMENTAL IMPACTS 4-2 4.3.2 MITIGATION MEASURES 4-9 4.4 WATER ENVIRONMENT 4-10 4.4.1 CONSTRUCTION PHASE IMPACTS AND MITIGATION MEASURES 4-10 4.4.2 OPERATION PHASE IMPACTS AND MITIGATION MEASURES 4-10 4.5 SOIL ENVIRONMENT 4-10 4.5.1 CONSTRUCTION PHASE IMPACT AND MITIGATION MEASURES 4-11 4.5.2 OPERATION PHASE IMPACT AND MITIGATION MEASURES 4-11 4.6 NOISE ENVIRONMENT 4-11 4.6.1 DETAILS OF NOISE ENVIRONMENTAL IMPACTS 4-11 4.6.2 CONSTRUCTION PHASE I MPACTS 4-11 4.6.3 OPERATION PHASE IMPACT AND MITIGATION MEASURES 4-11 4.6.4 IMPACT OF THE TRANSPORTATION 4-12 4.7 ANTICIPATED ENVIRONMENTAL IMPACTS AND ITS MITIGATION 4-12 MEASURES FOR LAND USE 4.7.1 IMPACT ASSESSMENT 4-12 4.7.2 IMPACT OF LAND USE 4-12 4.7.3 MITIGATION MEASURES OF LAND USE 4-12

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Se. No. Title Page No. 4.8 ECOLOGICAL IMPACT ASSESSMENT 4-12 4.8.1 NATURAL VEGETATION 4-12 4.8.2 CROPS 4-12 4.8.3 FOREST, NATIONAL PARKS / SANCTUARIES 4-13 4.9 IMPACT ON SOCIO-ECONOMIC ASPECTS 4-13 4.10 PLACES OF ARCHAEOLOGICAL/HISTORICAL/RELIGIOUS/TOURIST 4-13 INTEREST 4.11 ENVIRONMENTAL HAZARD 4-13 4.12 MATRIX REPRESENTATION 4-16 4.12.1 CUMULATIVE IMPACT CH ART 4-16

CHAPTER-5 : ANALYSIS OF ALTERNATIVES (TECHNOLOGY & SITE)

5.1 ALTERNATIVES OF TECHNOLOGY 5-1 5.2 ALTERNATIVES OF SITE 5-1 5.2.1 DESCRIPTION 5-1 5.2.2 IDENTIFICATION OF ADVERSE IMPACT 5-1 5.2.3 MITIGATION MEASURES 5-1 5.2.4 SELECTION OF SITE 5-1 5.3 NO PROJECT ALTERNATIVE 5-2

CHAPTER-6 : ENVIRONMENTAL MONITORING PROGRAM \ 6.1 INTRODUCTION 6-1 6.2 MONITORING SCHEDULE DURING OPERATION PHASE 6-1 WORK ZONE MONITORING ARRANGEMENTS FOR HAZARDOUS 6.3 6-2 CHEMICALS

CHAPTER-7 : ADDITIONAL STUDIES

7.1 PUBLIC CONSULTATION/HEARING 7-1 7.2 RISK ASSESSMENT 7-1 7.2.1 INTRODUCTION 7-1 7.2.2 DETAILS OF MANUFACTURING PROCESS 7-2 7.2.3 STORAGE AND HANDLING 7-2 7.2.3.1 ANTIDOTES OF MAJOR PRDUCTS/RAW MATERIALS 7-5 7.2.3.2 ACTION PLAN FOR SAFETY PRECAUTIONS FOR THE STORAGE OF 7-5 MATERIALS 7.2.4 HAZARD AND ITS CONTR OL MEASURES 7-6 7.2.5 RISK IDENTIFICATION AND ANALYSIS 7-7 7.2.5.1 MAXIMUM CREDIBLE LOSS ACCIDENT SCENARIOS 7-7 7.2.5.2 DAMAGE CRITERIA 7-8 7.2.5.2.1 SOFTWARE USED FOR CALCULATIONS 7-11 7.2.5.3 VULNERABILITY ANALYS IS 7-11 7.2.5.4 MAXIMUM CREDIBLE ACCIDENT SCENARIO 7-12 7.2.6 RISK PREVENTION AND RISK MITIGATION 7-19

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Se. No. Title Page No. 7.2.6.1 PREVENTIVE MEASURES 7-19 7.2.6.2 MITIGATION MEASURES 7-22 7.2.6.3 DO’S AND DON’TS 7-26 7.2.7 DISASTER MANAGEMENT PLAN 7-27 7.2.7.1 OBJECTIVES OF EMERGENCY PROCEDURES 7-27 7.2.7.2 BASIS OF PLAN AND HANDLING OF EMERGENCY 7-27 7.2.7.3 INFORMATION ABOUT EMERGENCY AND SUBSEQUENT ACTIONS 7-28 7.2.7.4 INSTRUCTIONS TO EMPLOYEES 7-28 7.2.7.5 INSTRUCTIONS TO CONTRACTORS 7-28 7.2.7.6 MITIGATION OF CONSEQUENCES DURING MAJOR ACCIDENT 7-29 7.2.7.7 EMERGENCY CONTROL CENTRE WITH LIST OF EQUIPMENT AND 7-29 ACCESSORIES 7.2.7.8 INFORMATION REGARDING KEY PERSONS AND THEIR 7-30 RESPONSIBILITIES DURING EMERGENCY 7.2.7.9 EMERGENCY ORGANIZATION FOR IDLE HOURS 7-33 7.2.7.10 LIST OF IMPORTANT AUTHORITIES WITH THEIR ROLE IN EMERGENCY AND TELEPHONE NUMBERS 7-33 7.2.7.11 INFORMATION ABOUT EXTERNAL COMMUNICATION SYSTEM 7-33 7.2.7.12 ANNOUNCEMENT SYSTEM DETAILS 7-33 7.2.7.13 OUT SIDE IMPORTANT ADDRESSES AND PHONE NUMBERS 7-33 7.2.7.14 REHERSAL AND UPDATION OF PLAN 7-34 7.2.7.15 INFORMATION ON ASSEMBLY POINTS 7-34 7.2.8 OCCUPATIONAL HEALTH AND SAFETY PROGRAM F OR THE PROJECT 7-34

CHAPTER-8 : PROJECT BENEFITS

8.1 PHYSICAL INFRASTRUCTURE 8-1 8.2 SOCIAL INFRASTRUCTURE 8-1 8.3 EMPLOYMENT OPPORTUNITIES 8-2

CHAPTER-9: ENVIRONMENTAL COST BENEFIT ANALYSIS

9.1 ENVIRONMENTAL COST BENEFIT ANALYSIS 9-1

CHAPTER-10: ENVIRONMENTAL MANAGEMENT PLAN

10.1 DESCRIPTION OF EMP 10-1 10.1.1 AIR ENVIRONMENT 10-1 10.1.1.1 FUGITIVE EMISSION & CONTROL TECHNOLOGIES 10-2 10.1.1.2 ODOUR MANAGEMENT PLAN 10-3 10.1.2 WATER ENVIRONMENT 10-3 10.1.3 NOISE ENVIRONMENT 10-4 10.1.4 SOIL ENVIRONMENT 10-4 10.1.5 SOCIO -ECONOMIC ENVIRONMENT 10 -4 10.1.6 ECOLOGICAL ENVIRONMENT 10-5 10.1.7 HYDRO-GEOLOGICAL ENVIRONMENT 10-7

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Se. No. Title Page No. 10.2 OCCUPATIONAL HEALTH AND SAFETY 10-10 CONCEPT OF WASTE-MINIMISATION, RECYCLE/REUSE/RECOVER 10-10 10.3 TECHNIQUES, ENERGY CONSERVATION, AND NATURAL RESOURCE CONSERVATION 10.4 DESCRIPTION OF ADMINISTRATIVE ASPECTS 10-10 10.4.1 ENVIRONMENTAL MANAGEMENT CELL 10-10 10.4.2 ENVIRONMENTAL POLICY 10 -11 10.4.3 REPORTING SYSTEM TO THE DIRECTORS 10 -11 10.4.4 BUDGETORY PROVISIONS FOR EMP 10-12 10.5 OCCUPATIONAL WORK ZONE MONITORING 10-12

CHAPTER-11: SUMMARY AND CONCLUSION

CHAPTER-12 : DISCLOSURE OF CONSULTANTS ENGAGED

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LIST OF TABLES

TABLE PAGE TITLE NO. NO.

2.1 DISTANCE OF NEAREST KEY INFRASTRUCTURE FEATURES FROM SITE 2-6 2.2 BREAK UP FOR THE PROPOSED INVESTMENT 2-8 2.3 BREAK UP FOR THE PROPOSED INVESTMENT FOR THE ENVIRONMENT 2-8 POLLUTION CONTROL MEASURE (EPCM) 2.4 PROJECT IMPLEMENTATION SCHEDULE 2-9 2.5 CAPACITY OF PRODUCTS 2-9 2.6 DETAILS OF RAW MATERIALS 2-10 2.7 SOLVENT DETAILS 2-35 2.8 DETAILED LAND USE BREAKUP 2-35 2.9 FUEL REQUIREMENTS 2-35 2.10 DETAILS OF WATER CONSUMPTION 2-36 2.11 DETAILS OF WASTE WATER GENERATION 2-36 2.12 DETAILS OF STACKS 2-37 2.13 DETAILS SOLID/HAZARDOUS WASTE GENERATION 2-38 2.1 4 DETAILS SOLID/HAZARDOUS WASTE GENERATION 2-40

3.1 SITE SPECIFIC METEOROLOGICAL DATA (1ST OCT TO 31 ST DEC, 2016) 3-5 3.2 DETAILS OF AMBIENT AIR QUALITY MONITORING LOCATIONS 3-6 3.3 AMBIENT AIR QUALITY STATUS 3-7 3.4 DETAILS OF GROUND AND SURFACE WATER MONITORING 3-8 LOCATIONS 3.5 BASELINE GROUND WATER QUALITY 3-9 3.6 BASELINE SURFACE WATER QUALITY 3-10 3.7 DETAILS OF LOCATIONS FOR BACKGROUND NOISE MONITORING 3-13 STATIONS 3.8 BACKGROUND NOISE LEVELS 3-13 3.9 NOISE LEVELS DUE TO TRANSPORTATION 3-14 3.10 SAMPLING LOCATIONS OF SOIL MONITORING 3-15 3.11 PHYSICO-CHEMICALS CHARACTERISTICS OF SOIL 3-15 3.12 AREA STATISTICS OF LANDUSE/LAND COVER MAP 3-17 3.13 VILLAGE WISE DEMOGRAPHICAL DETAILS IN PIA 3-21 3.14 TREE SPECIES IN THE STUDY AREA 3-27 3.15 SHRUBS OBSEREVED IN THE STUDY AREA 3-28 3.16 HERBS OBSEREVED IN THE STUDY AREA 3-29 3.17 CLIMBERS OBSEREVED IN THE STUDY AREA 3-31 3.18 BIRDS OBSEREVED IN THE STUDY AREA 3-33 3.19 BUTTERFLIES OBSEREVED IN THE STUDY AREA 3-35 3.20 REPTILES OBSEREVED IN THE STUDY AREA 3-35 3.21 MAMMALS OBSEREVED IN THE STUDY AREA 3-35 3.22 SPECIES PROVIDED PROTECTION AS PER WILD LIFE PROTECTION ACT 3-36 1972 3.23 GROUNDWATER DEVELOPMENT OF DISTRICT 3-39

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TABLE PAGE TITLE NO. NO.

4.1 DETAILS OF STACK EMISSION DATA 4-3

4.2 MAXIMUM GROUND LEVEL CONCENTRATION OF PM, SO 2, NOx & HCl 4-4 4.3 SUMMARY OF ISCST3 MODEL OUTPUT FOR POLLUTANTS 4-9 4. 4 POTENTIAL IMPACTS & MITIGATIVE MEASURES 4-14 4.5 IMPACT IDENTIFICATION MATRIX 4-16 4.6 ENVIRONMENTAL IMPACT MATRIX 4-17 4.7 CUMULATIVE IMPACT CHART 4-17

6.1 PROPOSED SCHEDULE OF ENVIRONMENTAL MONITORING 6-1

7.1 HAZARDOUS CHARACTERISTICS & STORAGE OF RAW MATERIALS 7-2 7.2 LIST OF HAZARDOUS CHEMICALS INVENTRY & PROPERTIES 7-4 7.3 RISK ANALYSIS 7-4 7.4 ANTIDOTES OF CHEMICALS 7-5 7.5 HAZARDS AND ITS CONTROL MEASURE 7-6 7.6 DAMAGES TO HUMAN LIFE DUE TO HEAT RADIATION 7-9 7.7 EFFECTS DUE TO INCID ENT RADIATION INTENS ITY 7-9 7.8 DAMAGE DUE TO OVERPR ESSURES 7-9 7.9 WEATHER CONDITIONS 7-11 7.10 LIST OF PERSONNEL PROTECTIVE EQUIPMENT 7-22 7.11 LIST OF PROPOSED FIRE FIGHTING EQUIPMENTS 7-25 7.12 OCCUPATIONAL HEALTH MONITORING 7-34

8.1 PROPOSED CSR ACTIVITIES 8-2

10.1 RECOMMENDED PLANT SPECIES FOR GREEN BELT DEVELOPMENT 10-6 ALONG THE BOUNDARY OF AS A WIND BARRIER AS WELL AS TO PREVENT DUST POLLUTION 10.2 LIST OF SUITABLE ORNAMENTAL CLIMBERS/ SHRUBS AS 10-6 PLANTATION INSIDE THE GARDEN AND OPEN SPACES BETWEEN DIFFERENT UNITS OF PROJECT SITE 10.3 BUDGETARY OUTLETS OF GREENBELT DEVELOPMENT FOR FIVE 10-7 YEARS 10.4 WATER REQUIREMENT 10 -8 10.5 RAINWATER AVAILABLE FOR HARVESTING 10-8 10.6 WATER BALANCE 10-8 10.7 COST OF ENVIRONMENTAL PROTECTION MEASURES (RS. IN LAKHS) 10-12

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LIST OF FIGURES

Figure Page Title No. No. 2.1 DETAILED MAP OF GANDHINAGAR DISTRICT SHOWING PROJECT 2-2 LOCATION 2.2 GOOGLE IMAGE OF THE PROJECT SITE 2-3 2.3 PHOTOGRAPHS OF THE PROJECT SITE 2-4 2.4 LAYOUT OF THE PLANT 2-5 2.5 KEY INFRASTRUCTURE FEATURES AND SETTLEMENTS 2-7 2.6 WATER BALANCE DIAGRAM 2-37 2.7 SCHEMATIC FLOW DIAGRAM OF PROPOSED ETP 2-40

3.1 LOCATION MAP OF THE PROJECT SITE WITH ST UDY AREA 3-2 3.2(A) PREDOMINANT WIND DIRECTIONS (0300 UTC) 3-4 3.2(B) PREDOMINANT WIND DIRECTIONS (1200 UTC) 3-4 3.3 WIND ROSE DIAGRAM 3-5 3.4 LAND USE / LAND COVER MAP OF 10 KM RADIUS FROM STUDY AREA 3-18 3.5 SATELLITE IMAGERY OF THE STUDY AREA (10 KM RADIUS) 3-19 3.6 STUDY AREA MAP 3-26 3.7(A) GENERAL GEOLOGY OF GANDHINAGAR DISTRICT 3-37 3. 7(B) GENERAL GEOLOGY OF M AHESANA DISTRICT 3-38 3.8 WATER LEVEL MAP, GANDHINAGAR 3-39 3.9 LOCATION OF AMBIENT AIR MONITORING STATIONS 3-40 3.10 LOCATIONS OF GROUND WATER SAMPLING STATIONS 3-41 3.1 1 LOCATIONS OF SURFACE WATER SAMPLING STATIONS 3-42 3.12 LOCATIONS OF NOISE SAMPLING STATIONS 3-43 3.13 LOCATIONS OF SOIL SAMPLING STATIONS 3-44

4.1 SPATIAL DISTRIBUTION OF 24 -HOUR AVERAGE PM CONC . (µg/m 3) 4-5 3 4.2 SPATIAL DISTRIBUTION OF 24-HOUR AVERAGE SO 2 CONC. (µg/m ) 4-6 3 4.3 SPATIAL DISTRIBUTION OF 24-HOUR AVERAGE NO X CONC. (µg/m ) 4-7 4.4 SPATIAL DISTRIBUTION OF 24-HOUR AVERAGE HCl CONC. (µg/m3) 4-8

10.1 THE GENERAL DESIGN O F THE RECHARGE WELL 10 -9 10.2 AN ORGANOGRAM OF ENVIRONMENT MANAGEMENT CELL 10-11

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LIST OF ANNEXURE

Annexure Page Title No. No. I TERMS OF R EFERENCE LETTER AWAR DED BY EAC A-1 II LAND POSSESION DOCUMENT A-10 III TSDF/INCINERATION MEMBERSHIP CERTIFICATE A-14 IV CLIMATOLOGICAL DATA A-16 V RAW DATA OF AAQM A-18 VI NATIONAL AMBIENT AIR QUALITY STANDARDS (NAAQS) (2009) A-22 VII INDIAN STANDARDS/SPECIFICATIONS FOR DRIINKING WATER IS: A-234 10500 -1991 VIII CLASSIFICATION OF INLAND SURFACE WATER (CPCB STANDARDS) A-27 IX CPCB RECOMMENDATIONS FOR COMMUNITY NOISE EXPOSURE (1989) A-28 X DAMAGE RISK CRITERIA FOR HEARING LOSS OCCUPATIONAL A-29 SAFETY& HEALTH ADMINISTRATION (OSHA) XI ENVIRONMENTAL POLICY A-30 XII NOC & CCA OF EXISTING UNIT A-31 XIII COMPLIANCE REPORT A-39 XIV SAMPLE OF REGISTER FORM 32 AND FORM 33 A-43 XV ACKNOWLEDGEMENT COPY FOR GROUND WATER PERMISSION TO A-45 CGWA XVI MATERIAL SAFETY DATA SHEET FOR ALL THE CHEMICALS A-47

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COMPLIANCE OF TERMS OF REFERENCES (TOR)

TERMS OF REFERENCES (TOR) AWARDED BY: Ministry of Environment, Forests and Climate Change (MoEF&CC)

DATE OF TOR: 2nd August, 2016

TOR LETTER NO.: J-11011/115/2016-IA II (I)

TORS AND ITS COMPLIANCE

NO. TERMS OF REFERENCE COMPLIANCE SPECIFIC TOR Details on solvents to be used, measures for solvent Refer section 2.7.5 on page no. 2-35 of 1. recovery and for emissions control. Chapter-2. Details of process emissions from the proposed unit Refer section 2.8.6 on page no. 2-37 of 2. and its arrangement to control. Chapter-2. Ambient air quality data should include VOC, other Refer section 3.4.2 on page no. 3-6 of 3. process-specific pollutants* like NH *, chlorine*, 3 Chapter-3. HCI*, HBr*, H 2S*, HF*, CS 2 etc., (*-as applicable) Work zone monitoring arrangements for hazardous Refer section 6.3 on page no. 6-2 of 4. chemicals. Chapter-6. Detailed effluent treatment scheme including Refer section 2.9.1 on page no. 2-38 of 5. segregation of effluent streams for units adopting Chapter-2. 'Zero' liquid discharge. Refer section 10.1.1.2 on page no. 10-3 of 6. Action plan for odour control to be submitted. Chapter-10. A copy of the Memorandum of Understanding Not Applicable signed with cement manufacturers indicating clearly 7. that they co-process organic solid/hazardous waste

generated. Authorization/Membership for the disposal of liquid Refer section 2.9.4 on page no. 2-41 of 8. effluent in CETP and solid/hazardous waste in Chapter-2 and refer annexure-III. TSDF, if any. Material Safety Data Sheet for all the Chemicals are Refer section 7.2.3 on page no. 7-2 of 9. being used/will is used. Chapter-7 and refer annexure- XV. Authorization/Membership for the disposal of Refer section 2.9.4 on page no. 2-41 of 10. solid/hazardous waste in TSDF. Chapter-2 and refer annexure-III. There is no need to install captive incinerator as common incinerator facility 11. Details of incinerator if to be installed. is available for disposal of waste. Membership for the same will be obtained. Risk assessment for storage and handling of Refer section no. 7.2.5 on page no. 7-7 and 12. hazardous chemicals/solvents. Action plan for refer section no. 7.2.3.2 on page no. 7-5 of handling & safety system to be incorporated. chapter- 7. Arrangements for ensuring health and safety of 13. Refer 7.2.8 on page no. 7-34 of Chapter-7. workers engaged in handling of toxic materials. Details on solvents to be used, measures for solvent Refer section 2.7.5 on page no. 2-35 of 14. recovery and for emissions control. Chapter -2. ADDITIONAL TOR Public hearing to be conducted and issues raised and commitments made by the project proponent on the Refer section 7.1 on page No. 7-1 of i same should be included in EIA/EMP Report in the chapter- 7. form of tabular chart with financial budget for

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NO. TERMS OF REFERENCE COMPLIANCE complying with the commitments made. No wood or coal to be used in existing and proposed Refer section 2.8.3 on page No. 2-35 of ii boiler chapter -2. No groundwater to be extracted for proposed Refer section 2.8.5 on page No. 2-36 of iii expansion as we ll as existing plant chapter -2 and annexure -XV. Water requirement to be met from surface water Refer section 2.8.5 on page No. 2-36 of iv management/ collection and rain harvesting, etc. chapter -2 and annexure -XV. GENERIC TOR Refer executive summary of EIA report 1. EXECUTIVE SUMMARY page S-1. 2. INTRODUCTION Refer sections of Chapter - 1. Details of the EIA Consultant including NABET i. Refer section of Chapter-12. accreditation Refer section 1.2 on page no. 1-1 of ii. Information about the project proponent Chapter-1. Refer section 2.3 on page no. 2-1 of iii. Importance and benefits of the project chapter-2 and subsequent sections of Chapter-8. 3. PROJECT DESCRIPTION Refer section 2.5.1 on page no. 2-8 and i. Cost of project and time of completion. section 2.6 on page no. 2-8 and 2-9 of Chapter-2. Refer section 2.7.2 on page no 2-9 of ii. Products with capacities for the proposed project. Chapter-2. If expansion project, details of existing products Refer section 2.7.2 on page no. 2-9 and with capacities and whether adequate land is iii. refer section 2.8.1 on page no. 2-35 of available for expansion, reference of earlier EC, if Chapter-2. any. List of raw materials required and their source along Refer section 2.7.3 on page no. 2-10 of iv. with mode of transportation Chapter-2. Other chemicals and materials required with Refer section 7.2.3 on page no. 7-2 of v. quantities and storage capacities. Chapter-7. Refer section 2.8.6 on page no. 2-37, Details of Emission, effluents, hazardous waste section 2.8.5 on page no. 2-36 and section vi. generation and their management. 2.9.1 on page no. 2-38, section 2.8.8 on page no. 2-38 of Chapter-2. Refer section 2.8.5 on page no. 2-36, Requirement of water, power, with source of supply, section 2.8.2 on page no. 2-35 and 2.8.4 on vii. status of approval, water balance diagram, man- page no. 2-36 of Chapter-2. power requirement (regular and contract). Procedure for obtaining all necessary permissions is under process. Process description along with major equipments Refer section 2.7.4 on page no. 2-11 of viii. and machineries, process flow sheet (quantities) Chapter-2. from raw material to products to be provided. Hazard identification and details of proposed safety Refer section 7.2 on page no. 7-1 of ix. systems. Chapter-7. Expansion/modernization proposals: Project was established before publication a. Copy of all the Environmental Clearance(s) of EIA notification 2006. including Amendments thereto obtained for the project from MOEF/SEIAA shall be attached as CCA copy of existing unit is enclosed as x. an Annexure. A certified copy of the latest annexure-XII on page no. A-31 and CCA Monitoring Report of the Regional Office of the compliance is enclosed as annexure-XIII Ministry of Environment and Forests as per on page no. A-39. circular dated 30 th May, 2012 on the status of

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NO. TERMS OF REFERENCE COMPLIANCE compliance of conditions stipulated in all the existing environmental clearances including Amendments shall be provided. In addition, status of compliance of Consent to Operate for the ongoing existing operation of the project from SPCB shall be attached with the EIA-EMP report. b. In case the existing project has not obtained environmental clearance, reasons for not taking EC under the provisions of the EIA Notification 1994 and/or EIA Notification 2006 shall be provided. Copies of Consent to Establish/No Objection Certificate and Consent to Operate (in case of units operating prior to EIA Notification 2006, CTE and CTO of FY 2005- 2006) obtained from the SPCB shall be submitted. Further, compliance report to the conditions of consents from the SPCB shall be submitted. 4. SITE DETAILS Location of the project site covering village, Refer section 2.4 on page no. 2-1 of Taluka/Tehsil, District and State, Justification for Chapter-2 and also refer section 5.2 on i. selecting the site, whether other sites were page no. 5-1 of Chapter-5 for the selecting considered. site. A toposheet of the study area of radius of 10km and Refer section 2.4.1 on page no. 2-6 of site location on 1:50,000/1:25,000 scale on an ii. Chapter-2 and figure-2.5 on page no. 2-7 of A3/A2 sheet. (including all eco-sensitive areas and Chapter-2. environmentally sensitive places). Refer section 5.2 on page no. 5-1 of iii. Details w.r.t. option analysis for selection of site Chapter-5. Refer section 2.4 on page no. 2-1 of iv. Co-ordinates (lat-long) of all four corners of the site. Chapter -2. Refer section 2.4 on page no. 2-1 and v. Google map-Earth downloaded of the project site. figure no. 2.2 on page no. 2 -3 of Chapter -2. Layout maps indicating existing unit as well as proposed unit indicating storage area, plant area, greenbelt area, utilities etc. If located within an Refer section 2.4 on page no. 2-1 and vi. Industrial area/Estate/Complex, layout of Industrial figure no. 2.4 on page no. 2-5 of Chapter-2. Area indicating location of unit within the Industrial area/Estate. Photographs of the proposed and existing (if Refer section 2.4 on page no. 2-1 and vii. applicable) plant site. If existing, show photographs figure no. 2.3 on page no. 2-4 of Chapter-2. of plantation/greenbelt, in particular. Landuse break-up of total land of the project site (identified and acquired), government/private – Refer section 2.8.1 on page no. 2-35 of viii. agricultural, forest, wasteland, water bodies, Chapter-2. settlements, etc shall be included. (not required for industrial area). A list of major industries with name and type within Refer section 2.4 on page no. 2-1 of ix. study area (10km radius) shall be incorporated. Chapter-2. Land use details of the study area Geological features and Geo-hydrological status of Refer section 3.5 on page no. 3-36 of x. the study area shall be included. Chapter-3. Details of Drainage of the project upto 5 km radius Refer section 3.5.2 on page no. 3-38 of xi. of study area. If the site is within 1 km radius of any Chapter-3.

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NO. TERMS OF REFERENCE COMPLIANCE major river, peak and lean season river discharge as well as flood occurrence frequency based on peak rainfall data of the past 30 years. Details of Flood Level of the project site and maximum Flood Level of the river shall also be provided. (mega green field projects) Status of acquisition of land. If acquisition is not Refer section 2.8.1 on page no. 2-35 of xii. complete, stage of the acquisition process and Chapter-2. expected time of complete possession of the land. R&R details in respect of land in line with state This project does not involve rehabilitation xiii. Government policy or replacement so no R&R is required. 5. FOREST AND WILDLIFE RELATED ISSUES (IF APPLICABLE): Permission and approval for the use of forest land i. (forestry clearance), if any, and recommendations of Not Applicable the State Forest Department. (if applicable). Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineating the ii. Not Applicable forestland (in case of projects involving forest land more than 40 ha). Status of Application submitted for obtaining the iii. stage I forestry clearance along with latest status Not Applicable shall be submitted. The projects to be located within 10 km of the National Parks, Sanctuaries, Biosphere Reserves, Migratory Corridors of Wild Animals, the project proponent shall submit the map duly authenticated iv. Not Applicable by Chief Wildlife Warden showing these features vis-à-vis the project location and the recommendations or comments of the Chief Wildlife Warden-thereon. Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the State Government v. Not Applicable for conservation of Schedule I fauna, if any exists in the study area Copy of application submitted for clearance under vi. the Wildlife (Protection) Act, 1972, to the Standing Not Applicable Committee of the National Board for Wildlife 6. ENVIRONMENTAL STATUS Determination of atmospheric inversion level at the Refer section 4.3 on page no. 4-2 of project site and site-specific micro-meteorological i. Chapter- 4 and refer section 3.4.1 on page data using temperature, relative humidity, hourly no.3-3 of Chapter-3. wind speed and direction and rainfall. AAQ data (except monsoon) at 8 locations for PM 10 , PM 2.5 , SO 2, NO X, CO and other parameters relevant to the project shall be collected. The monitoring Refer section 3.4.2 on page no. 3-6 of ii. stations shall be based CPCB guidelines and take Chapter-3. into account the pre-dominant wind direction, population zone and sensitive receptors including reserved forests. Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in the NAQQM Refer section 3.4.2 on page no. 3-6 of iii. Notification of Nov. 2009 along with – min, max, Chapter-3 and Annexure-V. average and 98% values for each of the AAQ parameters from data of all AAQ stations should be

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NO. TERMS OF REFERENCE COMPLIANCE provided as an annexure to the EIA Report.

Surface water quality of nearby River (100m upstream and downstream of discharge point) and Refer section 3.4.3 on page no. 3-8 of iv. other surface drains at eight locations as per Chapter-3. CPCB/MoEF&CC guidelines. Whether the site falls near to polluted stretch of No, site does not fall near to polluted v. river identified by the CPCB/MoEF&CC, if yes stretch of river identified by the CPCB give details. /MOEF&CC. Ground water monitoring at minimum at 8 locations Refer section 3.4.3 on page no. 3-8 of vi. shall be included. Chapter-3. Noise levels monitoring at 8 locations within the Refer section 3.4.4 on page no. 3-12 of vii. study area. Chapter-3. Refer section 3.4.5 on page no. 3-15 of viii. Soil Characteristic as per CPCB guidelines. Chapter -3. Traffic study of the area, type of vehicles, frequency of vehicles for transportation of materials, additional Refer section 3.4.4.1 on page no. 3-14 of ix. traffic due to proposed project, parking arrangement Chapter-3. etc. Detailed description of flora and fauna (terrestrial and aquatic) existing in the study area shall be given with special reference to rare, endemic and Refer section 3.4.8 on page no. 3-24 of x. endangered species. If Schedule-I fauna are found Chapter-3. within the study area, a Wildlife Conservation Plan shall be prepared and furnished. Refer section 3.4.7 on page no. 3-20 of xi. Socio-economic status of the study area. Chapter-3. 7. IMPACT AND ENVIRONMENT MANAGEMENT PLAN Assessment of ground level concentration of pollutants from the stack emission based on site- specific meteorological features. In case the project is located on a hilly terrain, the AQIP Modelling shall be done using inputs of the specific terrain characteristics for determining the potential impacts of the project on the AAQ. Cumulative impact of all Refer section 4.3 on page no. 4-2 of i. sources of emissions (including transportation) on Chapter-4. the AAQ of the area shall be assessed. Details of the model used and the input data used for modelling shall also be provided. The air quality contours shall be plotted on a location map showing the location of project site, habitation nearby, sensitive receptors, if any. Water Quality modeling – in case of discharge in ii. Not applicable water body. Impact of the transport of the raw materials and end products on the surrounding environment shall be assessed and provided. In this regard, options for Refer section 4.6.4 on page no. 4-12 of iii. transport of raw materials and finished products and Chapter-4. wastes (large quantities) by rail or rail cum road transport or conveyor-cum-rail transport shall be examined. iv. A note on treatment of wastewater from different Refer section 2.9.1 on page no. 2-38 of

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NO. TERMS OF REFERENCE COMPLIANCE plant operations, extent recycled and reused for Chapter-2. different purposes shall be included. Complete scheme of effluent treatment. Characteristics of untreated and treated effluent to meet the prescribed standards of discharge under E (P) Rules. Details of stack emission and action plan for control Refer section 2.8.6 on page no. 2-37 of v. of emissions to meet standards. Chapter-2. Refer section 10.1.1.1 on page no. 10-2 of vi. Measures for fugitive emission control Chapter-10. Details of hazardous waste generation and their storage, utilization and management. Copies of Refer section 2.8.8 on page no. 2-38 of MOU regarding utilization of solid and hazardous Chapter-2. vii. waste in cement plant shall also be included. EMP shall include the concept of waste minimization, Refer section 10.3 on page no. 10-10 of recycle/reuse/recover techniques, Energy Chapter-10. conservation, and natural resource conservation. Proper utilization of fly ash shall be ensured as per Fly Ash will be sent to TSDF for disposal viii. Fly Ash Notification, 2009. A detailed plan of or sent to brick manufacturer. Refer section action shall be provided. 2.8.8 on page no. 2 -38 of Chapter -2. Action plan for the green belt development plan in 33 % area i.e. land with not less than 1,500 trees per ha. Giving details of species, width of plantation, Refer section 10.1.6 on page no. 10-5 of ix. planning schedule etc. shall be included. The green Chapter-10. belt shall be around the project boundary and a scheme for greening of the roads used for the project shall also be incorporated. Action plan for rainwater harvesting measures at plant site shall be submitted to harvest rainwater from the roof tops and storm water drains to Refer section 10.1.7 on page no. 10-7 of x. recharge the ground water and also to use for the Chapter-10. various activities at the project site to conserve fresh water and reduce the water requirement from other sources. Refer section 2.5.1 on page no. 2-8 of Total capital cost and recurring cost/annum for Chapter-2. xi. environmental pollution control measures shall be Refer section 10.4.4 on page no. 10-12 of included. Chapter-10. Action plan for post-project environmental Refer section 6.2 on page no. 6-1 of xii. monitoring shall be submitted. Chapter-6. Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency Management Plan Refer section 7.2.7 on page no. 7-27 of xiii. including Risk Assessment and damage control. Chapter-7. Disaster management plan should be linked with District Disaster Management Plan. 8. OCCUPATIONAL HEALTH For plan refer section 6.2 on page no. 6-1 of Chapter-6 and section 10.2 on page no. Plan and fund allocation to ensure the occupational i. 10-10 of Chapter-10 and for fund allocation health & safety of all contract and casual workers refer section 2.5.1 on page no. 2-8 of Chapter-2. Details of exposure specific health status evaluation Refer section 6.2 on page no. 6-1 of of worker. If the workers’ health is being evaluated ii. Chapter-6 and section 7.2.8 on page no. by pre-designed format, chest x rays, Audiometry, 7-34 of Chapter-7. Spirometry, Vision testing (Far & Near vision, M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT T-6 en-vιsι
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NO. TERMS OF REFERENCE COMPLIANCE colour vision and any other ocular defect) ECG, during pre placement and periodical examinations give the details of the same. Details regarding last month analyzed data of above mentioned parameters as per age, sex, duration of exposure and department wise. Details of existing Occupational & Safety Hazards. What are the exposure levels of hazards and whether Refer section 10.2 on page no. 10-10 they are within Permissible Exposure level (PEL). If iii. section 10.5 on page no. 10-12 and section these are not within PEL, what measures the 10.1.1.1 on page no. 10-2 of Chapter-10. company has adopted to keep them within PEL so that health of the workers can be preserved, Annual report of heath status of workers with Refer section 10.2 on page no. 10-10 of iv. special reference to Occupational Health and Safety. Chapter-10. 9. CORPORATE ENVIRONMENT POLICY Does the company have a well laid down Environment Policy approved by its Board of Refer section 10.4.2 on page no. 10-11 of i. Directors? If so, it may be detailed in the EIA Chapter-10. report. Does the Environment Policy prescribe for standard operating process / procedures to bring into focus Refer section 10.4.2 & 10.4.3 on page no. ii. any infringement / deviation / violation of the 10-11 of Chapter-10. environmental or forest norms / conditions? If so, it may be detailed in the EIA. What is the hierarchical system or Administrative order of the company to deal with the environmental Refer section 10.4 on page no. 10-10 of iii. issues and for ensuring compliance with the Chapter-10. environmental clearance conditions? Details of this system may be given. Does the company have system of reporting of non compliances / violations of environmental norms to Refer section 10.4.3 on page no. 10-11 of iv. the Board of Directors of the company and / or Chapter-10. shareholders or stakeholders at large? This reporting mechanism shall be detailed in the EIA report Details regarding infrastructure facilities such as sanitation, fuel, restroom etc. to be provided to the Refer section 2.8.4 on page no. 2-36 of v. labour force during construction as well as to the Chapter-2. casual workers including truck drivers during operation phase. Enterprise Social Commitment (ESC) 1. Adequate funds (at least 2.5 % of the project cost) shall be earmarked towards the Enterprise Refer section 8.2 on page no. 8-1 of vi. Social Commitment based on Public Hearing issues Chapter-8. and item-wise details along with time bound action plan shall be included. Socio-economic development activities need to be elaborated upon. Any litigation pending against the project and/or any direction/order passed by any Court of Law against the project, if so, details thereof shall also be included. Has the unit received any notice under the vii. Not Applicable. Section 5 of Environment (Protection) Act, 1986 or relevant Sections of Air and Water Acts? If so, details thereof and compliance/ATR to the notice(s) and present status of the case. M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT T-7 en-vιsι
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NO. TERMS OF REFERENCE COMPLIANCE A tabular chart with index for point wise Refer TOR and its Compliance of EIA/MEP viii. compliance of above TORs. Report on page no. T-1. The TORs prescribed shall be valid for a period of ix. Noted three years for submission of the EIA-EMP reports.

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INTRODUCTION

1.1 PURPOSE OF THE REPORT The purpose of the EIA study is identifying existing environmental condition, predicting environmental impacts associated with the proposed expansion project and suggesting measures to mitigate the adverse impacts and to delineate a comprehensive environment management plan along with recommendations and suggestions. The different activities that are likely to take place have been identified and mitigation measure has been proposed.

The overall objective of any EIA study is to identify and assess the adverse impacts of a project in the planning stage itself, so that necessary mitigation measures to prevent or minimize these adverse impacts can be planned early and cost-effectively. In view of this, the specific objectives of this EIA are, • To have an in-depth know-how of the project and to identify the probable sources of pollution that may arises from each stage of the process. • To review the current environmental status of the study area within 10 Km radius of the project site by collecting the baseline data on the environmental attributes including air, noise, water, land, ecological, hydro-geological climate and socio-economic environments. • To estimate the impacts of the project on the surrounding environment. • To prepare a comprehensive Environmental Management Plan to ensure that the environmental quality of the area would be preserved. • To formulate a strategy for effective monitoring and identify any deviations in the environmental quality after the project is operational, which would help in evolving measures to counter these.

1.2 IDENTIFICATION OF PROJECT & PROJECT PROPONENT Identification of Project The Environmental Impact Assessment study is carried out as a part of the process to obtain Environment Clearance for the proposed expansion of pharmaceutical manufacturing unit of M/s. Orbit Pharma Laboratories falls under Category A, of schedule 5(f), Synthetic Organic Chemicals Industry (Outside Notified Industrial Area) as per EIA Notification dated 14 th September, 2006 & its subsequent amendments. Environmental Impact Assessment (EIA) study was carried out during 01st October to 31st December, 2016 and accordingly EIA report has been prepared.

Project Proponents & their background Mr. Kunal Kikani-CEO of the company (B.E. Chemical) 07 years of experience business and Mr. N. P. Kikani (M.Sc.) 36 years of experience in business.

1.3 BRIEF DESCRIPTION OF PROJECT The proposed expansion project is Pharmaceutical Manufacturing Unit. The project is for Synthetic Organic Chemicals Industry as per EIA notification 2006. The primary purpose of the expansion is to manufacture important & some lifesaving drugs. At present, the Company is manufacturing 03 products and intends to produce 08 new products along with 02 Intermediate products within existing premises.

1.4 SCOPE OF THE STUDY The scope of the EIA study is identifying existing environmental condition as per TOR, including Baseline Monitoring of Ambient Air, Ground and Surface Water Quality, Ambient Noise Level, Soil Quality, Ecology and Biodiversity, Land Use pattern and Socio-Economic condition of the area. Predicting environmental impacts associated with the proposed project and suggesting measures to mitigate the adverse impacts and to delineate a comprehensive environment management plan along with

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1.5 STRUCTURE OF THE EIA REPORT Draft EIA and EMP Report has been prepared in line with Terms of Reference (TOR) suggested by Environmental Appraisal Committee (Industry-II) vide MoEF&CC letter No. F. No. J-11011/115/2016- IA II (I) dated, 2 nd August, 2016 attached as annexure-I.

The objective of the EIA study is a preparation of Draft Environment Impact Assessment (EIA) and Environmental Management Plan (EMP) report based on the guidelines of the Ministry of Environment and Forests (MoEF) and Central Pollution Control Board (CPCB). It incorporates the following. • Chapter 1 is an Introduction to the Industry, purpose of the report, information of project proponent and regulatory frame work. • Chapter 2 presents a Description of Project and Infrastructure facilities including industrial and environmental aspects of M/s. ORBIT PHARMA LABORATORIES during operation phase activities as well as manufacturing process details of proposed product. This chapter also gives information about project location, raw material storage and handling, water and wastewater quantitative and qualitative details, treatment of industrial and domestic effluent, details of air pollution and its control system, type and quantity of hazardous waste generation and its management, details of utilities etc. • Chapter 3 covers Baseline Environmental Status including meteorological details, Identification of baseline status of Environmental components of the surrounding area covering air, water, noise and land environment, study of land use pattern, ecological and socio-economic environment giving details about the study area. • Chapter 4 deals with Identification and Prediction of Impact, which provides quantification of significant impacts of the proposed project activities on various environmental components. Evaluation of the proposed pollution control facilities has been presented. • Chapter 5 describes the analysis of alternate technology and site. • Chapter 6 describes Environment Monitoring Plan to be adopted. • Chapter 7 gives the information of Public Hearing and additional studies like Risk Analysis and Disaster Management Plan that is adopted by the company. • Chapter 8 gives the Benefits of the projects. • Chapter 9 gives Environment cost benefit analysis. • Chapter 10 describes Environment Management Plan (EMP) to be adopted for mitigation of anticipated adverse impacts if any and to ensure acceptable impacts. • Chapter 11 gives the Summary and conclusion of the project. • Chapter 12 gives the Information of the Consultant .

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CHAPTER – 2

PROJECT DISCRIPTION

2.1 BRIEF PROJECT DISCRIPTION M/s. Orbit Pharma Laboratories was established in the year 1991 as a manufacturer and supplier of Speciality Pharmaceutical products. Manufacturing unit of the company is located at Block no. 155/1, 159, Chhatral-Kadi Road, Village Dhanot, Taluka Kalol, District Gandhinagar-382729. Orbit is managed by experienced and enthusiastic team.

2.2 TYPE OF PROJECT M/s. Orbit laboratories is planning to expand pharmaceutical unit at Block No. 155/1, 159, Chhatral-Kadi Road, Village Dhanot, Taluka Kalol, District Gandhinagar – 382 729, Gujarat. Location of project is not within notified industrial area. Thus, the project falls under Category- A of schedule 5(f), synthetic organic chemicals industry as per the EIA Notification, September 2006 and & its subsequent amendments. Total existing production capacity is 3.25 MT/Month. After proposed expansion, production capacity will be 138 MT/Month. Existing pharmaceutical manufacturing unit is having CCA valid up to 08/01/2022.

2.3 NEED OF PROJECT The market of Pharmaceutical Drugs has fast progressing growth and there is ample opportunity in indigenous as well as export market. With the ever increasing world market demand for Pharmaceutical Drugs, the management having expertise in the same field and has decided to enhance its manufacturing capacity. The project is proposed with all required infrastructural facilities.

2.4 LOCATION The proposed expansion project is going to be established in existing premises. The area is having all infrastructure facilities for ease of the smooth project functioning. Project site is near to Kalol taluka of Gandhinagar district. Proposed expansion project of Pharmaceutical Drugs manufacturing unit at Block no. 155/1, 159, Chhatral- Kadi Road, Village Dhanot, Taluka Kalol, District Gandhinagar. The project site is located adjacent to the Kadi-Chhatral highway in south direction and State Highway-41 is around 2.8 km away from the project site in east direction. National Highway-8 is around 33 km in east direction from the site. Kadi Railway station is around 9 km from the project site in west direction. Ahmedabad Airport is around 32 km in south- east direction. Nearest village habitation is around 0.8 km in south-east direction. Kadi GIDC to Chhatral is industrial corridor, many industries is developed. Figure-2.1 is showing project site in India. Figure-2.2 is showing project site in google image with surroundings. Further, figure-2.3 and figure-2.4 shows photographs of the site and layout plan of the project respectively.

List of nearby Industries are as follows: • Inter Chem. Corporation • Akshar Dyes • Subham Industries • Suzuki Synthetics • Khushboo Plywoods Pvt. Ltd. • Sun Mark Stainless Pvt. Ltd. • Kayel Syntex Ltd • Arbuda Plastochem Pvt. Ltd. • Ajay Organics and Chemicals Pvt. Ltd. • Jawahar Plywoods Pvt. Ltd. • G. R. Alloys Pvt. Ltd. • Bhole Intermediates • Virat Alloys Pvt. Ltd. • G-One Agro Products Ltd.

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• Akash Agro Industries Ltd. • Karan Paper mill and Radhe Packaging • Many more industries in Chhatral GIDC.

Details of the project location a) Village : Dhanot b) Taluka : Kalol c) District : Gandhinagar d) State : Gujarat e) Latitude : 23°16'52.50"N f) Longitude : 72°24'47.72"E

Sr. No. Particular Latitude Longitude 1 North-East Corner 23°16'55.99"N 72°24'48.89"E 2 South-East Corner 23°16'50.08"N 72°24'49.23"E 3 North -West Corner 23°16'54.97"N 72°24'47.08"E 4 South-West Corner 23°16'50.24"N 72°24'47.39"E

FIGURE-2.1 DETAILED MAP OF GANDHINAGAR DISTRICT SHOWING PROJECT LOCATION

Source: Maps of India

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FIGURE-2.2 GOOGLE IMAGE OF THE PROJECT SITE

Source: Google earth

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FIGURE-2.3 PHOTOGRAPHS OF THE PROJECT SITE

Entry Gate Factory Building

Greenbelt Storage shad

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FIGURE-2.4 LAYOUT OF THE PLANT

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2.4.1 KEY INFRASTRUCTURE FEATURES AND SETTLEMENTS Details like name, distance and direction of key infrastructure features and settlement from the project site is given in following table-2.1. As per toposheet of Survey of India (SOI) and available data, there is no defense installation, severely or critically polluted area, national park/wildlife sanctuary, ecologically sensitive area within 10 km radius of the project site. A topographical map obtained from SOI showing National Highway, State Highways, other roads with the railway lines, water bodies, etc is presented in figure-2.5. Topography of the area is plane.

TABLE-2.1 DISTANCE OF NEAREST KEY INFRASTRUCTURE FEATURES FROM SITE

No. Nearest Infrastructure Feature Distance from Project Site 1. Nearest Village Dhanot around 2.2 km in North-East direction 2. Nearest City Chhatral City is around 2.8 km in East direction 3. Nearest National Highway NH-8C around 20 km in south East direction 4. Nearest State Highway SH-41 2.40 km in East direction 5. Nearest Railway Station Kalol Railway station 10 km in South-East direction 6. River Shabarmati river 27 km East direction Ahmedabad International Airport around 32 km in South- 7. Nearest Airport West direction 8. Nearest Sea Gulf of Khambhat 138 km in South direction Naroda TSDF site , Ahmedabad around 35 km in south -south - 9. Nearest TSDF site east direction,

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FIGURE-2.5 KEY INFRASTRUCTURE FEATURES AND SETTLEMENTS

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2.5 MAGNITUDE OF OPERATION This proposed expansion project takes place from 3.25 MT/Month to total 138 MT/Month of production capacity. The process for manufacturing of the API & bulk drugs has been developed by in-house R & D. The primary purpose of the expansion is to manufacture important & life saving bulk drugs. Company is having 3 existing products and proposes new 08 products in expansion project. Addition of new products will be carried out in the existing land. Minor construction activity and some new plant machineries are required to manufacture additional products. The total project cost for the proposed expansion project would be around Rs. 5.45 Crores, so it is categorized as “Medium Scale Project” under Industrial Entrepreneurs’ Memorandum (IEM) scheme.

2.5.1 PROJECT COST The total cost of the proposed expansion project would be around Rs. 5.45 Crores. Total capital cost of pollution control measures will be Rs. 73.25 Lacs & recurring cost per annum will be 10 Lacs. The break- up of the project cost is shown in table-2.2 and table-2.3.

TABLE-2.2 BREAK UP FOR THE PROPOSED INVESTMENT No. Description Cost (Rs. In Crore) 1 Land - 2 Site development 0.15 3 Building 0.82 4 Plant & Machinery 2.0 5 Environmental protection measures 0.73 6 Preoperative expense 0.34 7 Unpredictable expense 0.05 8 Working capital margin 1.36 TOTAL 5.45

TABLE-2.3 BREAK UP FOR THE PROPOSED INVESTMENT FOR THE ENVIRONMENT POLLUTION CONTROL MEASURE (EPCM) Capital Cost Recurring Cost No. Particulars (Rs. In Lacs.) (Rs. In Lacs. Per Annum) 1. Air & Nois e Pollution Control 10 0.8 2. Water Pollution Control 55 6.8 3. Environment Monitoring & Management 1.25 1.6 4. Occupational Health 1.5 0.3 5. Green Belt 2.8 0.5 TOTAL 73.25 10

2.6 SCHEDULE OF OPERATION AND IMPLEMENTATION Implementation of project within a pre-determined time frame is an important factor for the success of a project. Timely implementation may save on various costs like interest, administrative overheads and helps to realize the goals as per pre-determined objectives. The implementation of the project will involve major activities like preparation of specification / drawings, issue of tenders, receipt of quotations, scrutiny of tenders, placing of orders, civil & structural construction, delivery & erection of equipment, test trial runs of various items of equipment and commissioning of the plant & equipment and completion of the project will take place after getting the necessary clearances from concerned authority, and the funding for the project has been tied up. A tentative schedule indicating the commencement, duration and completion of various activities, is presented as table-2.4.

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TABLE-2.4 PROJECT IMPLEMENTATION SCHEDULE Expected date of Expected date of No. Particulars Commencement Completion 1. Land Already acquired Land Development (After Necessary 2. 2 months from EC 3 months from EC clearance) 3. Civil Works 3 months from EC 15 months from EC Plant & Machinery & Other Fixed Assets 4. Placement of orders 3 months from EC 12 months from EC 5. Equipment Delivery 12 months from EC 24 months from EC 6. Erection & installation 20 months from EC 27 months from EC 7. Trial Production 28 months from EC 30 months from EC 8. Start of Commercial Production 30 months from EC

2.7 TECHNICAL AND PROJECT DESCRIPTION 2.7.1 CONSTRUCTION ACTIVITIES The proposed project site is having existing Active Pharmaceutical Ingredient (API) & Bulk Drug Manufacturing Unit. Construction activities will be only for the expansion purpose. The project site is located outside the industrial area. This aspect shall be duly considered and taken care into during the detailed engineering phase while designing the structures. Construction materials, like steel, cement, crushed stones, sand, rubble, etc. are required for the Expansion and the same shall be procured from the local market.

2.7.2 PRODUCTION ACTIVITIES List of existing and proposed products with their capacity is given in following table-2.5. The Company obtained NOC from SPCB before publication of EC notification 2006. NOC is given in Annexure-XII.

TABLE-2.5 CAPACITY OF PRODUCTS Quantity (MT/Month) No. Name of Products Existing Proposed Total 1. Diclofenac Sodium IP/BP 2.5 22.5 25.0 A. 2:6 Dichloro DIphenyl N -Acetyl Chloride 0 50 50 B. 1-(2;6-Dichloro–Phenyl)–1; 3–Dihydro– Indole–2–one 0 25 25 2. Diclofenac Potassium 0.5 4.5 5.0 3. Diclofenac Diethyl Amine 0.25 2.25 2.5 4. Chlorzoxazone 0.0 3.0 3.0 5. Fenbendazole 0.0 10.0 10.0 6. Oxfendazole 0.0 5.0 5.0 7. Triclobendazole 0.0 2.5 2.5 8. Febantel 0.0 2.0 2.0 9. Closantel Base /Sodium 0.0 5.0 5.0 10. Gabapentine 0.0 1.0 1.0 11. Ondensetronticl Dehydrate 0.0 2.0 2.0 Total 3.25 134.75 138 By Products 1 Hydrochloric Acid 0 100 100 2 Aluminum Chloride Solution 0 70 70 3 Dil. Acetic Acid 0 48 48

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4 Liquor Ammonia 0 6 6 2.7.3 RAW MATERIALS REQUIREMENTS Details of raw materials are given in following table-2.6. All major raw materials will be arranged through local vendors. Raw material for the unit will be procured from the different sources and it will be stored in separate chemical storage area.

TABLE-2.6 DETAILS OF RAW MATERIALS No. Name of Raw Material MT/Month 1. 2,6 -Dichlorophenol 69.81 2. Potassium Carbonate 31.30 3. Toluene 184.79 4. Met hyl Mono Chloro Acetate (MMCA) 48.86 5. Aniline Oil 38.39 6. Chloro Acetyl Chloride (CAC) 62.83 7. Aluminum Chloride 43.18 8. Carbon 2.68 9. Acetic acid 19.82 10. Diethyle Amine 0.72 11. Hydrochloric Acid 15.13 12. 4 Chloro -2 Aminophenol 2.73 13. Urea TG 3.28 14. Hydro Sulphide of Soda 0.03 15. Caustic Lye 23.90 16. Methanol 229.34 17. 4-Chloro -2- Nitro Aniline 12.20 18. Thiophenol 7.32 19. Ferric Chloride 0.37 20. Hydrazine Hydride 9.76 21. Hydrogen Cyanide 7.32 22. Methyl Chloro Formate 8.54 23. Dimethyl Sulxoxide 0.55 24. Hydrogen Peroxide 1.60 25. Acetone 30.94 26. N(4-5) Dicloro-2 Nitro Phenyl Acetamide 2.38 27. Dimethyl Formamide (DMF) 2.38 28. 2:3 Dichloro Phenol 2.38 29. Nitrogen Gas 0.12 30. Hydrogen Gas 0.15 31. Raneynickel 0.26 32. Hyflow 0.10 33. Potassium Hydroxide 1.79 34. Calcium Disulphide 0.86 35. Dimethyl Sulfate 1.98 36. Isopropyl Alcohol (IPA) 0.24 37. Methoxy Acetyl Chloride 0.59 38. Methylene Dichloride 16.37 39. Xylene 6.22 40. Thiourea 0.59 41. 1-Decylbromide 1.19 42. Methychloro Formate 1.33 43. 1-1 Cyclohexane Diacetic Acid 1.80 44. Liq. Bromine 1.17 45. Caustic Soda Flakes 11.78

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No. Name of Raw Material MT/Month 46. Trietylamine 0.50 47. 1,3 Cyclohexadione 0.95 48. Phenyl Hydrazine 1.01 49. Zinc Chloride 0.95 50. Phosphorous Trichloride 1.52 51. Closantel Amine 3.03 52. 3:5 DiIodosalicylic acid 4.24 53. Sodium Metal 3.18 54. Caustic Potash 1.52 55. Catalyst 0.23 56. Para Formaldehyde 1.14 57. 2-Methylimidazole 0.65 58. Liq. Ammonia 0.79

Scheme of mode of transportation: The raw materials will be purchased from the local market and transported through trucks to the project site. Approximately 60 numbers of trucks per month will be required for transportation of raw material, finished goods and hazardous wastes, etc.

2.7.4 MANUFACTURING PROCESS Manufacturing process of the products is given below; major equipments for the project are Fractional Distillation Unit, Stainless steel Reactors, Centrifuge, Dryer, etc.

1. DICLOFENAC SODIUM IP/BP Manufacturing process: Stage – I In SS reactor charge Toluene + 2,6 Dichloro Phenol + Potassium Carbonate & reflux for 12hrs & cool to room temperature & add Methyl Mono Chloro Acetate reflux for 5hrs & recover toluene. Ether is reacts with aniline in present of sodium Methoxide forms DichloroDIphenyl Aniline & Methanol to be recovered. Stage – II In a glass line reactor Dichloro diethyl amine previously drayed reacts with Chloro acetyl chloride toluene as a solvent forms N-Chloro acetyl 2:6 DichloroDIphenyl amine i.e. one of intermediates to be sale. The HCl gas generated to be scrub in water give Hydrochloric acid i.e. by product. Stage – III In a glass line reactor N-Chloroderi. Is reacts with Alluminium Chloride at boiling temperature the HCL gas is generated & scrub in water gives Hydrochloric Acid i.e. by product. After completion of reaction the mass is dumped in 2 times water then neutch filter it. The ML is alluminium chloride solution it recycle for three times i.e. by product. The product is Indolenone Intermediate & to be sales it. Stage-IV In a ss reactor in water Indolenone hydrolyzed by caustic solution & gives Crude Diclofenac Sodium filter it. The ML is waste water received. Stage-V Final Diclofenac Sodium Crude Diclofenac Sodium is dissolved in DM water, Carbon & charged reflux & filter, cool & centrifuge it. The ML is recycled in stage-IV. The products dry at 80˙c to 85˙c i.e. Diclofenac Sodium.

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Chemical Reaction

Flow Diagram

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2. DICLOFENAC POTASSIUM Manufacturing Process: Stage – I In ss reactor charge Toluene + 2,6 Dichloro Phenol + Potassium Carbonate & reflux for 12hrs & cool to room temperature & add Methyl Mono Chloro Acetate reflux for 5hrs & recover toluene. Ether is reacts with aniline in present of sodium Methoxide forms Dichloro DIphenyl Aniline & Methanol to be recovered. Stage – II In a glass line reactor Dichloro diethyl amine previously drayed reacts with Chloro acetyl chloride toluene as a solvent forms N-Chloro acetyl 2:6 Dichloro DIphenyl amine i.e. one of intermediates to be sale. The HCl gas generated to be scrub in water give Hydrochloric acid i.e. by product. Stage – III In a glass line reactor N-Chloro deri. is reacts with Alluminium Chloride at boiling temperature the HCl gas is generated & scrub in water gives Hydrochloric Acid i.e. by product. After completion of reaction the mass is dumped in 1.5 times water then neutch filter it. The ML is alluminium chloride solution it recycles for three times i.e. by product. The product is Indolenone Intermediate & to be sales it. Stage-IV In a ss reactor in water Indolenone hydrolyzed by Potassium Hydroxide solution & gives Crude Diclofenac Potassium filter it. The ML is west water received. Stage-V Final Diclofenac Potassium, Crude Diclofenac Potassium is dissolved in DM water, charge carbon & reflux & filter, cool & centrifuge it. The ML is recycled in stage-IV. The products dry at 80˙c to 85˙c i.e. Diclofenac Potassium.

Chemical Reaction

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Flow Diagram

3. DICLOFENAC DIETHYL AMINE Manufacturing Process: Stage-I: In a SS reactor charge water + Diclofenac sodium stirr for half an hour slowly, then add acetic acid & after completion of addition stir for an hour, which will produce Diclofenac Free Acid. Filter it & dry it. The ML is west water neutral. Stage-II: In SS reactor charge water and Diclofenac acid stirr well slowly add diethyl amine stirr for two hours. Cool to room temperature. Filter through centrifuge ML is neutral water. Dry the product i.e. Diclofenac Diethyl Amine dry.

Chemical Reaction:

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Flow Diagram:

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4. CHLORZOXAZONE Manufacturing Process: Stage-I: In a glass line reactor charge hydrochloric acid and 4-cap heat to reflux maintain for 4 hours. Ammonia gas generation to be scrub in water. Then charge catalyst reflux for one hour. Cool to 100˙c charge water stirr for half an hour filter & ML west water. Collect cake i.e. crude chlorzoxazone. Stage-II: In SS reactor charge methanol & crude reflux for one hour. Filter in next ss reactor adjust ph-6. Stirr for one hour & recheck it. Centrifuge it ML is west water for ETP. Collect cake of semi final product. Stage-III Purification: In ss reactor charge methanol + semi final cake & charcoal. Heat to reflux for two hrs. Filter is at 80˙c collect ML in ss reactor cool it to room temperature centrifuge it. Collect methanol dry the cake. Pulverize & pack it i.e. CHLORZOXAZONE USP.

Chemical Reaction:

Flow Diagram:

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5. FENBENDAZOLE Manufacturing Process: Stage – I (A) In a ss reactor charge Methanol & 5Chlorophenylthio- 2 -Nitro Aniline heat to reflux i.e.65˙C to 70˙C. cool to room temperature filter it. Collect crude Methanol & recover methanol from M.L. residue. The product it Nitro Thiophenyl Aniline charge Toluene & Nitrothiophenyl aniline heat to 70˙ - 80˙C start addition of Hydrazine Hydrate after completion of Hydrazine Hydrate check reduction completion test if ok cool to room temperature wash with water collect upper organic layer convert it in Hydro Chloride by adding con. HCl & water.

Stage – II (B) In glass line reactor charge water & hydrogen cynamide heat it to 50˙C. Then start addition of Methyl Chloro Formate & Caustic Flakes. After completion of addition check pH neutral. Stirr for one hour. The product is Methyl Carbono hydrogen cynamide. (B)

Stage – III Coupling (A) + (B) In a glass line reactor charge Acetone + Stage I(A) & Stage II(B) couple the both stages at room temperature stir for 5 hours below room temperature filter it. Collect cake i.e. crude Fenbendazole west water and product. Charge wet cake in SS reactor + methanol 2 times heat to reflux for one hour. Cool it filter it. Collect methanol & distilled out. Final product is FENBENDAZOLE.

Chemical Reaction:

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Flow Diagram:

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6. OXFENDAZOLE Manufacturing Process: In a dry clean glass line reactor charge acetic acid, Dimethyl Sulfoxide & Fenbendazole cool to 5˙C & add hydrogen peroxide slowly maintain 3 hours. Check TLC for reaction completion. Neutralize the mass with sodium hydroxide solution filter it & wash with acetone. Collect the cake & dry it i.e. OXFENDAZOLE dry.

Chemical Reaction:

Flow Diagram:

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7. TRICLOBENDAZOLE Manufacturing Process: Stage-I In glass line reactor charge DMF and Dinitro phenoxy Acetamide & stirr for a hour. Charge Dichloro Phenol & Potassium Carbonate. Reflux for 8 hours. Check TLC for completion of reaction. Then charge Methanol & slowly add caustic lye solution. Maintain temperature 70˙C to 75˙C for 4 hours. Check TLC for absence of Dichloro nitro phenoxy Acetamide of reaction completed add water. Stirr for half an hour. Filter & wash it by water & collect cake then dry it. Dry wet is intermediate.

Stage-II In a SS auto clave reactor charge methanol and stage-I and Raney Nickel pass first Nitrogen Gas & then hydrogen gas rise pressure & temperature 50˙C maintain for 4 hours. Check sample ok. Filter it. Charge ML in another reactor charge potassium hydroxide & carbon sulphide at low temperature. Raise the temperature & reflux for one hour. Check completion of reaction. Distilled out methanol & add water and dil. HCl to pH 6.5. Filter it wash with water dry it at 90-95˙C Product Quantity and ETP west water is received.

Stage-III In glass line reactor charge TBZ Thiol + Methanol at room temperature add slowly DMS. Raise temperature 70˙C to 75˙C & maintain 2-3 hours check reaction completion cool it. Filter it for wet cake. Charge wet cake in glass line reactor + methanol + carbon. Heats to reflux for 2 hours cool to room temperature filter it wash with acetone. Dry it.

Chemical Reaction: STAGE-I OH Cl Cl NO Cl 2 Cl O NO O 2 Cl O

2,3 dichloro phenol Cl N CH3 Cl N CH3 H H N-(4,5-dichloro-2-nitrophenyl)acetamide N-(5-chloro-4-(2,3-dichlorophenoxy)-2- Chemical Formula: C8H6Cl2N2O3 nitrophenyl)acetamide Molecular Weight: 249.1 STAGE-IIA

CS LYE Sol'n

Cl Cl Cl O NH2 1) Ra-Ni Cl O NO2

Cl NH2 Cl NH2 4-chloro-5-(2,3-dichlorophenoxy)benzene-1,2- 5-chloro-4-(2,3-dichlorophenoxy)-2-nitroaniline diamine STAGE-II Chemical Formula: C12H7Cl3N2O3 Molecular Weight: 333.6

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STAGE-III

STAGE-IV

STAGE-V

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Flow Diagram

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8. FEBANTEL Manufacturing Process: Stage-I In reactor charge 2-Nitro-5-(Phenylthio) aniline & Methelene dichloride. Stirr the reaction mass at 25 to 30˚c. Then start addition of Methoxy acetyl chloride during half an hour. Maintain for 8 hours. Check the completion of reaction. Then recover Methelene dichloride. Then add water. Stirr for 2 hours. Filter it. The wet cake i.e. 2-Methoxy-N-[2-Nitro-5(phenylthio) phenyl] Acetamide (Nitro FBT-Acetamide). Waste water is generate. Stage-II In an autoclave reactor charge methanol + Nitro FBT-Acetamide wet. Make inert atmosphere by passing Nitrogen gas & charge raney nickel. Then start pressuring hydrogen gas. Heat the reaction mass up to 70°c- 80˚c check the hydrogen pressure constant. Check TLC for completion of reaction. Cool to room temperature add water. Drain out the mass by washing methanol. Filter the catalyst. Heat the mother liquor & recover methanol. Cool to 10°C. Filter it & give water wash. Give the suspension wash by Xylene. Then again filter it. Wet cake. Recover Xylene from M.L. Dry the wet cake. Dry wt i.e. N-[2-Amino-5- (phenylthio) phenyl]-2-MethoxyAcetamide (Amino FBT-Acetamide). Stage-III In a dry & clean glass line vessel add methanol + Thiourea +1decyl bromide. Heat to reflux. Check for reaction completion by TLC. Distilled out methanol cool to room temperature add MDC + Potassium Carbonate soln + Methyl Chloro Formate slowly as the exothermic reaction maintain for 5hrs. Check for completion of reaction. Add water & separate layer. Bottom organic layer heats to reflux & recover MDC in residue add methanol & stirr for one hour & filter it. Collect ML for recovery of methanol. Wet cake. Dry it. Dry wt i.e. S-Decyl Bis Carbamate (1, 3 Bis (Methoxycaronyl)-2-decyl-2-thiopseudourea (Decyl thiopseudourea). Stage-IV In a glass line reactor charge methanol + Amino FBT Acetamide + Decyl thiopseudourea & charge hydro Chloric acid. Stirr the reaction mass at room temperature check the reaction completion test by HPLC cool to 5˚C. Filter the solid mass unload the material. Recover methanol from M.L. & wet cake dump in methelene dichloride & add water & stirr the material at room temperature. Then allow to settle & separate aqueous layer & from organic layer distilled out methelene dichloride purified the product in methanol & filter it. Recover methanol from M.L. Collect wet cake & dry wt 135kgs. The product is FEBANTAL.

Chemical Reaction:

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Flow Diagram

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9. Closantel Base /Sodium Manufacturing Process: Stage-I In a dry glass line charge toluene. Add 3:5 Dilodosalicylic acid + Closantel amine heat to reflux & then add slowly phosphorus Trichloride. Maintain for 8 hrs check the completion of reaction. Cool to room temperature. Filter it wash with toluene & followed by water. Collect cake & dry is Closantel Base.

Stage - II Charge Closantel Base in ss reactor add caustic solution. Heat to reflux & maintain for 2 hrs. Cool to room temperature check pH should be alkaline. Filter it wash with water. Collect cake & dry it.

Chemical Reaction:

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Flow Diagram

10. Gabapentine Manufacturing Process: Stage - 1 Take water and NaOH in reactor to got clear solution. And cool -5 to -10 ˚C and charge 1.1 Cyclohaxane di acitic acid monoamide. Cool -5 to -10 ˚C and charge bromine liquid in 1 hour then temp. raise 35 to 40 ˚C for 3 hours. Charge MDC at 15 ˚c stirrer for 30 min. than charge HCl bring reaction mass pH 2.0. Stirrer for 30 min. then filter the mass to take crude. Charge methanol and wet cake stirrer 30 min. and filter the reaction mass. Take the stage 1 (84).

Stage - 2 Take acetone + water in reactor charge stage - 1 then charge TEA and bring reaction mass PH 7.2 stirrer 30 min. then filter the reaction mass and take crude. Take acetone + water add crude stirrer for 1 hours cool 0 to 5 ˚C for hours filter the reaction mass take wet cake and dry at 70 ˚C finish gabapentine 60.

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Chemical Reaction: HO O HO

NH2 .HCL O NH2 Br 2/NaOH O HCL

[1-(2-amino-2-oxoethyl)cyclohexyl]acetic acid [1-(aminomethyl)cyclohexyl]acetic acid

HO HO NH2 .HCL NH2 O TEA O

[1-(aminomethyl)cyclohexyl]acetic acid [1-(aminomethyl)cyclohexyl]acetic acid

Flow Diagram

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11. Ondensetron HCl Dihydrate Manufacturing Process: Stage - I Take water charge 1, 3, Cyclohexadione in reactor charge phenyl hydrazine in 2 hours. Then temp. raise 40˚C maintain for 3 hours and cool at RT. than filter reaction mass. Wet cake dry. Finish stage I. Stage - II Charge acetic acid charge zinc chloride heat at 85˚C for 1 hour. Than charge stage I maintain 100˚C for 3 hours and cool at RT add water then filter the reaction mass. Take crud wet cake charge methanol stirrer for 1 hours cool & filter stage II dry. Stage - III Take acetone in reactor charge stage II caustic flakes and stirrer 30 min. add DMS stirrer for 3 hours cool and filter and dry. Stage - IV Take DM water in reactor charge stage III charge formaldehyde heat 100 - 105 ˚C maintain for 6 hours. Than cool RT & filter wet cake dry ETP waste. Stage - V Take DM water in reactor add stage IV cool at 15˚C and add Cons. HCl then add limidazole heat at 100 - 105˚C for 24 hours and cool 5˚C neutralise with liquor Ammonia solution filter & wash with chilled water take wet cake charge methanol add charcoal heat and reflux hot filter mother liquor cool 5˚C and stirr 1 hours and filter wet cake & dry 65˚C methanol recover from mother liquor. Stage - VI Take DM water charge stage - V add methanol add HCl stirr for 24 hours at RT then cool 5˚C filter wet cake. Methanol recover from M.L. Waste water. Dry it cake. The product is ONDANSETRON HCl DIHYDRATE IP / BP

Stage: 1 NH O 2 HN O + O HN N 1,3-cyclohexadione phenylhyadrezine Stage-1

Stage: 2

O O

ZnCL 2 Acetic acid HN N N H H Stage-1 1,2,3,9-tetrahydro-4 -carbazol-4-one

Stage: 3 O O

DMS NaOH N N H CH 1,2,3,9-tetrahydro-4 H-carbazol-4-one 3 9-methyl-1,2,3,9-tetrahydro-4 H-carbazol-4-one

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Stage: 4 O O

CH2 Paraformaldehyde

N N CH CH3 3 H 9-methyl-3-methylidene-1,2,3,9-tetrahydro-4 H-carbazol-4-one 9-methyl-1,2,3,9-tetrahydro-4 -carbazol-4-one

Stage: 5 O O CH 2 N N CH3 N N H C N H N 3

CH3 H3C 9-methyl-3-methylidene-1,2,3,9-tetrahydro-4 H-carbazol-4-one Ondansetron Base

Stage: 6 O O

N N HCL N N N H3C .HCL .2H O N H3C 2

H3C H3C Ondansetron Base Ondansetron HCL dihydrate

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Flow Diagram

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2.7.5 SOLVENT MANAGEMENT Solvents will be used for manufacturing of proposed products like Toluene, Methanol, Acetone, etc. All the spent solvent generated from the manufacturing process will be recovered and reused in the premises for the manufacturing of products. Solvent will be distilled in solvent distillation column having capacity of 10 kl. Solvent details are given in following table.

TABLE-2.7 SOLVENT DETAILS

Solvents Requirements Generation Recovered Residue MTPM Toluene 173.32 162.92 159.45 8.15 Aniline oil 38.39 36.09 35.32 1.80 Methanol Washing 35.21 33.10 32.39 1.65 Methanol 161.63 151.93 148.70 7.60 Acetone 24.44 22.97 22.48 1.15

2.8 COMPONENTS OF PROJECT 2.8.1 LAND Company is having 7066 sq. m. of private land area. No new land is required for the proposed expansion project. Detailed land use breakup of the plot area is given in following table-2.8 and plant layout shown in figure-2.4. Land documents are enclosed as annexure-II.

TABLE-2.8 DETAILED LAND USE BREAKUP Total Area No. Land Use Break Up (sq. mt.) 1 Office and Factory shed 1177.07 2 Utility area 205.9 3 Storage area 112.20 4 ETP area 81.41 5 Waste storage a rea 94.65 6 Parking area 100 7 Greenbelt (33%) 2332 8 Open area 1762.77 9 Internal road area 1200 Total 7066

2.8.2 POWER REQUIREMENT Total power requirement will be 260 KW (60 KW existing and 200 KW proposed) will be sourced from UGVCL (Uttar Gujarat Vij Company Limited). During emergency purpose one D. G. Set of 100 KVA and additional one number of D. G. Set of 250 KVA will be utilized.

2.8.3 FUEL REQUIREMENTS TABLE-2.9 FUEL REQUIREMENTS

No. Fuel Existing Proposed Total Remark 1 Wood Waste/ Agro For Boiler & Hot Air 300 Kg/Day 2,700 Kg/Day 3000 Kg/Day waste/ Coal Generator 2 Coal - 1,800 Kg/Day 1800 Kg/Day For Thermic Fluid Heater 3 Diesel 8 Lit/Day 20 Lit/Day 28 Lit/Day For DG Sets

Note: Wood waste or Agro waste will be used as a fuel in the existing and proposed boiler, however as proposed Coal shall be used only in case of non-availability of wood waste or Agro waste.

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2.8.4 MANPOWER REQUIREMENTS For proposed expansion project total 100 (existing 19 and additional 81) personnel will be required. Out of total 30 personnel will be on contract basis. Preference will be given to local people on the ground of qualification. Local people will be hired for construction work so labor colony will not be required. Existing facility will be utilized for their requirements. During operation phase rest rooms and sanitation facilities will be provided for truck drivers if required.

2.8.5 WATER SOURCE, UTILIZATION AND WASTE WATER Total water requirement will be 60 KLD. Out of 60 KLD, 6 KLD will be used only for greenbelt development & 5 KLD for domestic purpose. 49 KLD water will be required for industrial purpose (boiler, cooling tower, for process, washing & others). Area available within premises and rain fall of the region, entire water requirement cannot be met from water management/collection and rain water harvesting. Considering this fact and non-availability of any other water sources in nearby area, entire water requirement for the proposed project will be met from ground water using bore well. Application for obtaining permission from the Central Ground Water Authority (CGWA) is already submitted, acknowledgment copy is given in annexure-XV.

TABLE-2.10 DETAILS OF WATER CONSUMPTION Water Consumption (KLD) No. Purpose Existing Proposed Total (A) Domestic 0.95 4.05 5.0 Industrial (B) 1. Process 3 9.35 12.35 5 7 2. Cooling tower 2 (3 fresh + 2 reuse) (5 fresh + 2 reuse) 23 26 3. Boiler 3 (20 fresh + 3 reuse) (23 fresh + 3 reuse) 4. Washing 2 4 6 5. Others 0.15 2.5 2.65 38.85 54 (B) Total Industrial water 10.15 (38.85 fresh + 5 reuse) (49 fresh + 5 reuse) (C) Green Belt 3 3 6 45.9 65 Total 14.1 (45.9 fresh + 5 reuse) (60 fresh + 5 reuse)

TABLE-2.11 DETAILS OF WASTE WATER GENERATION Waste Water Generation (KLD) No. Purpose Existing Proposed Total (A) Domestic 0.65 3 3.65 Industrial (B) 1 Processing 2 15 17 2 Cooling Tower Blow down 0.1 0.5 0.6 3 Boiler Blow down 0.1 3 3.1 4 Washing 1.15 4 5.15 5 Others 0.1 1.7 1.8 (B) Total Industrial water 3.45 24.2 27.65 (C) Green Belt ------Total (A+B+C) 4.1 27.2 31.3

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FIGURE-2.6 WATER BALANCE DIAGRAM Fresh water 60 KLD

Domestic Process 12.35 Boiler 26 Cooling 7 Washing Others Gardening 5 KLD KLD (23+3) KLD (5+2) KLD 6 KLD 2.65 KLD 6 KLD

Domestic water Boiler Blow Waste water 3.65 KLD Down 3.1 KLD 5.15 KLD

Boiler Blow Boiler Blow Concentrate Stream Down 0.6 KLD Down 1.8 KLD 17 KLD 5 KLD Soak pit/well Condensate Dilute Stream

Send to Common ETP Single stage evaporation 10.65 KLD evaporator

2.8.6 AIR POLLUTION Air pollution is classified into point source emission and fugitive emissions. There are two main sources of point source pollution: Flue gas through utility Steam Boiler, Hot Air Generator, Thermic Fluid Heater and D.G. set & process gas emission through stack attached to reaction vessels. Emissions from point sources may include Particulate Matter (PM), Sulphur Dioxide (SO 2), Oxides of Nitrogen (NO X) & Hydrogen Chloride (HCl). Details of air pollution sources are given in the following table-2.12.

TABLE-2.12 DETAILS OF STACKS Pollution Control No. Stack Attached To Fuel Used Stack Height Final Concentration System EXISTING SCENARIO SPM ≤ 150 mg/Nm 3 1. Boiler * (1TPH) Wood Waste/ Agro 30 meter Multi Cyclone SO ≤ 100 ppm waste / 300 kg/Day 2 2. Hot Air Generator 8 meter - NO X ≤ 50 ppm SPM ≤ 150 mg/Nm 3 D.G Set (Stand By) Acoustic 3. Diesel 8 Lit/Hr 03 meter SO ≤ 100 ppm 100 KVA Enclosures 2 NO X ≤ 50 ppm PROPOSED SCENARIO SPM ≤ 150 mg/Nm 3 Boiler * Coal/ Agro waste / 1. 30 meter Multi Cyclone SO ≤ 100 ppm (2TPH) 2700 kg/Day 2 NO X ≤ 50 ppm SPM ≤ 150 mg/Nm 3 Thermic Fluid Heater Coal 2. 30 meter Multi Cyclone SO ≤ 100 ppm (2 lac Kcal) 1800 kg/day 2 NO X ≤ 50 ppm SPM ≤ 150 mg/Nm 3 D.G Set (Stand By) Diesel Acoustic 3. 09 meter SO ≤ 100 ppm 250 KVA 20 Lit/Hr Enclosures 2 NO X ≤ 50 ppm * There will be a common stack for existing and proposed boiler

PROCESS EMISSION

No. Stack Attached To Stack Height Pollution Control System Final Concentration

EXISTING SCENARIO 09 Water scrubber followed by 3 1. Reaction vessels ≤ meter Alkali Scrubber HCl 20 mg/Nm

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No. Stack Attached To Stack Height Pollution Control System Final Concentration

PROPOSED SCENARIO Water scrubber followed by 3 1. Reaction vessels 09 meter ≤ Alkali Scrubber HCl 20 mg/Nm

2.8.6.1 SOURCE OF FUGITIVE OR SECONDARY EMISSIONS The fugitive dust emissions from the proposed plant will be significant and the sources listed as under: 1. Loading unloading section 2. Material Handling Section and Transfer Points 3. Leak/ spill from storage vessels/ facilities 4. Leak from pumps, valves and pipes 5. Transportation of vehicles

2.8.7 NOISE POLLUTION The noise levels are primarily generated due to industrial activities like mechanical movement and material handling. Noise may result from loading unloading, motors, vehicular movement, generators, etc .

2.8.8 LAND/SOIL POLLUTION Details of solid/hazardous wastes generation are given in the following table-2.13.

TABLE-2.13 DETAILS SOLID/HAZARDOUS WASTE GENERATION Catego Existing Proposed Quantity No. Name of the Waste Method of Storage and Disposal ry No. (MT/M) (MT/M) (MT/M) Collection, storage and transport 1 ETP Sludge 35.3 2 13 15 to TSDF site. Collection, storage and reuse as 0.025 0.025 0.05 lubricants in the machineries 2 Used Oil 5.1 MT/Y MT/Y MT/Y within the premises only or send to authorized re-processors. Discarded Collection, storage and send to 300 300 600 3 Containers/Barrels/ 33.1 authorized recycler after nos/year nos/year nos/year plastic decontamination. Date Expired, discard What so 28.4/ After giving proper treatment will 4 and off specification ever to be 1.0 1.0 28.5 be disposed at CHWF/TSDF medicines generated Collection, storage and send to 5 Fly Ash - - 18 18 brick manufacturer or send to TSDF site. Collection, storage and sent for 6 Solvent Residue 36.1 - 20.35 20.35 incineration Collection, storage and transport 7 Evaporator salt - - 5 5 to TSDF site.

2.9 ENVIRONMENNTAL MITIGATION MEASURES 2.9.1 MITIGATION MEASURES FOR WATER POLLUTION In existing scenario 4.1 KLD waste water is generating which includes 0.65 KLD domestic waste water and remaining 3.45 KLD is industrial effluent. Domestic waste water is disposed through septic tank/soak pit. While industrial effluent is treated in ETP and after treatment it is evaporated through single stage evaporator.

After the proposed expansion, around 31.3 KLD waste water will be generated. Domestic waste water will be generated around 3.65 KLD and disposed through septic tank/soak pit. While industrial effluent around 27.65 KLD will be generated. Total effluent will be segregated into two streams i.e. concentrated stream and dilute stream. Dilute stream will be treated in proposed upgraded ETP and treated water will be

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For treating wastewater, Effluent Treatment Plant with details is given in following sections. Schematic flow diagram of existing & proposed ETP is shown in figure-2.9. Details of ETP units are given in table- 2.13 and characteristic of treated and untreated effluent is given in table-2.12.

2.9.1.1 DETAILS OF EFFLUENT TREATMENT PLANT (ETP) During the manufacturing of products, effluent is generated. From this effluent two streams are segregated, concentrated and dilute stream.

Concentrated Stream: Concentrated stream is collected separately and neutralized, if required and then it is transported through designated tankers for spray drying (Common Evaporation) facility. ETP unit details for concentrated stream are given below:

Unit Details of ETP for High COD SR. NO. UNITS DIMENSION (M 3) NOS MOC 01 Collection cum neutralization tank 2.5 m x 2.5 m x 2.5 m 2 Nos. RCC 02 Neutralization effluent holding tank 2.5 m x 2.5 m x 2.5 m 1 No. RCC 03 Filter press - 1 No -

Dilute Stream: Dilute stream is/will be treated in existing ETP where effluent is first flow to equalization cum neutralization tank where it is homogenized and neutralized, if required. Homogenized and neutralized effluent is pumped at uniform rate to flocculating channel.

Effluent at flocculating channel is mixed with lime solution and suitable coagulant solution and flock formation takes place flocked effluent then it flow to primary settling tank. Effluent is calm condition, hence settleable solids or flocks settle at bottom to form sludge and it is periodically removed and taken to sludge drying beds for sun drying. Top supernatant flows to aeration tank. The effluent is undergo aerobic biological degradation by conversion of organic matter in to micro-organisms or bio-sludge. Necessary oxygen for marinating aerobic condition is supplied with provision of surface aerator of suitable capacity. Effluent at equilibrium state of micro-organisms if flow to secondary settling tank.

Effluent here is allow micro-organisms or bio-sludge to settle at bottom which is pumped and necessary quality of bio-sludge, for marinating desired level of micro-organism, recycled to aeration tank, where as excess sludge is bled to sludge drying beds for sun drying. Top supernatant is stored in treatment effluent sump.

Unit Details of ETP for Dilute Stream SR. NO. UNITS DIMENSION (M 3) NOS MOC 1. Oil & Grease Trap 2.10 x0 1.50 x 1.00 1 RCC Collection Tank cum 2. 2.50 x 2.00 x 2.00 1 RCC Neutralization Tank 3. Flocculation Channel 2.75 x 0.40 x 0.20 1 RCC 4. Primary settling Tank 2.75 x 2.75 x 1.80 1 RCC 5. Aeration Tank 6.50 x 6.50 x 2.75 1 RCC 6. Seco ndary settling Tank 3.50 x 3.50 x 1.80 1 RCC 7. Treated Effluent Sump 2.00 x 2.0 x 2.0 1 RCC 8. Sludge drying Bed 2.00 x 2.00 x 1.10 4 RCC 9. Single stage evaporator 5 KL 1 - Proposed Scenario Single stage evaporator/ 10. 5 KL 1 - Spray Dryer

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TABLE-2.14 CHARACTERISTICS OF TREATED AND UNTREATED EFFLUENT Dilute Stream No. Parameters Untreated Parameters (mg/l) Treated Parameters (mg/l) 1 pH 7 – 7.5 6.8 – 7.2 2 BOD 1,000 <30 3 COD 2,500 <100 4 TDS 3,500 <2,100 5 Oil and Grease 2 - 2.5 Nil (Treated in ETP with single stage evaporator)

Concentrated Stream No. Parameters Untreated Parameters (mg/l) Treated Parameters (mg/l) 1 pH 7 6.8 – 7.2 2 BOD 10 ,000 <30 3 COD 22 ,000 <100 4 TDS 25 ,000 <2 ,100 5 Oil and Grease 2.5 – 3 Nil (Sent for common Evaporation Facility)

FIGURE-2.7 SCHEMATIC FLOW DIAGRAM OF ETP

Existing ETP is more than sufficient to cater the additional effluent of 24.2 KLD to treat in existing ETP. In the proposed scenario, one additional 5 KL single stage evaporator will be added to treat Dilute stream effluent. And concentrated stream effluent will be sent to common Evaporation facility to achieve zero liquid discharge.

2.9.2 MITIGATION MEASRURES FOR AIR POLLUTION Sufficient stack height & scrubbers at vent will be provided as APCM to control the air pollution. Details are given in table-2.10.

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2.9.2.1 MITIGATION MEASURES FOR FUGITIVE OR SECONDARY EMISSIONS The fugitive emissions of organic chemicals and VOCs mainly occur due to tank breathing losses, Leaking pipe fitting and valves, during maintenance operations. Though these are not expected to be significant, the following measures will be followed to ensure compliance and further reductions wherever possible. • The fugitive emissions in terms of handling losses will get reduced by proper storage and handling. • Hazardous chemicals will be stored as per standard criteria. • Periodically monitoring will be carried out as per the post project monitoring plan. • Proper ventilation in storage & production area shall be ensured and all materials must be stored in suitable packing to prevent contamination of air due to particulates & volatile emissions from storage container & area. • Enclosed system & efficient procedures for materials charging shall be ensured. • Procedures for start-up shut down, operation & maintenance procedures shall be established & maintained in all relevant area of works. • The coverage of greenbelt around the plant also acts as natural barrier to stop carrying of dust along with the wind current. • Good housekeeping will be maintained in the plant. • Risk analysis will be done at every stage to identify potential risks and install appropriate elimination / mitigation systems

2.9.3 MITIGATION MEASURES FOR NOISE POLLUTION During Construction Phase Following measures are proposed during construction period to mitigate adverse impacts: • Construction machinery and vehicles will undergo periodic maintenance to keep them in good working condition. • All machineries to be used for construction purpose will be of highest standard of reputed make and compliance of noise pollution control norms by these equipments will be emphasized by the company. • Feasibility of putting up acoustic enclosure / temporary barrier around areas with high noise levels will also be explored. • All construction workers working in high noise areas will be provided appropriate PPEs like ear muffs and made to wear them during working hours. • Possibility of raising green belt along with construction activity will also be explored so as to serve as a noise barrier.

During Operation Phase Following precautionary measures will be adopted to control the noise level: • Noise generating sources and their platforms will be maintained properly to minimize noise vibrations generated by them • Personnel working near the noisy machines in different plant locations, will be provided with well designed ear muffs / plugs (effective noise reduction 10-15 dBA) • Green belt will be improved to act as a noise barrier. • Noise barriers / shields in the form of walls, beams will be provided around the units wherever found feasible • Training to personnel will be imparted to generate awareness about effects of noise and importance of using PPEs (Personal Protective Equipments).

2.9.4 MITIGATION MEASURES FOR LAND/SOIL POLLUTION ETP Sludge will be sent to nearest TSDF site for dumping. Used Oil will be reused as lubricants in the machineries within the premises only or sent to authorize re-processors. Discarded Containers/ Barrels/ plastic will be sent to authorize recycler after decontamination. Date Expired, discard and off specification medicines, after giving proper treatment will be disposed at CHWF/TSDF. Solvent residue will be sent for incineration. Fly Ash will be sent to brick manufacturer or sent to TSDF site.

The membership of common hazardous waste treatment storage and disposal facility (TSDF) of Ecocare, Surendranagar and TSDF membership certificate is attached as Annexure-III. For further details, refer table-2.11.

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CHAPTER – 3

BASELINE ENVIRONMENTAL STATUS

3.1 DESCRIPTION OF THE STUDY AREA The baseline status of environmental quality in the vicinity of project site serves as the basis for identification, prediction and evaluation of impacts. The baseline environmental quality is assessed through field studies within the impact zone for various components. Study area for the Environmental Impact Assessment is within 10 km radius from the project site. Location map of the project site with study area is given in figure-3.1. Baseline data generation of the following environmental attributes is essential in EIA studies. I. Meteorology II. Ambient Air Quality III. Ambient Noise Quality IV. Surface and Ground Water Quality V. Soil Quality & Geological Features VI. Land use pattern VII. Biological Information VIII. Socio-economic status survey

3.2 PERIOD OF MONITORING The baseline environmental quality has been assessed during Post-Monsoon Season i.e 1st October to 31st December, 2016 in a study area of 10 km radial distance from the project site.

3.3 COMPONENTS AND METHODOLOGY In the process of Environmental Impact Assessment, baseline study is conducted for the environmental components like; air, noise, water, soil quality, land use, ecology & biodiversity and socio-economic. For the collection of baseline data of these components, primary and secondary data collection methodology is followed. The study was finalized with the TORs approved by the Ministry of Environment, Forest & Climate Change (MoEF&CC), New Delhi. Compliance of this TOR points are complied in a separate section in this report.

Primary data has been collected through field monitoring for meteorological conditions, ambient air quality, water quality, noise quality, soil quality, etc, which includes major portion of the baseline environmental studies. In addition to these important studies, further studies like land use, socio-economic studies, ecological and biodiversity studies, hydrogeology, etc. are covered during the study period. Secondary information sources and constitutes is used for these studies and remaining parts of the baseline environmental studies.

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FIGURE-3.1 LOCATION MAP OF THE PROJECT SITE WITH STUDY AREA

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3.4 BASELINE ENVIRONMENTAL DATA 3.4.1 METEOROLOGICAL ENVIRONMENT Climate of Study Area Gandhinagar has a tropical wet and dry climate with three main seasons: summer, monsoon and winter. The climate is generally dry and hot outside of the monsoon season. The weather is hot to severely hot from March to June when the maximum temperature. It is pleasant in the winter days and quite chilling in the night during December to February. The southwest monsoon brings a humid climate from mid-June to mid- September. The average annual rainfall is around 803.4 mm (31.63 in).

Meteorology Air borne pollutants is dispersed by atmospheric motion. Knowledge of these motions which range is scale from turbulent diffusion to long-range transport by weather systems. It is essential to simulate such dispersion and quality of impacts of air pollution on the environment. The purpose of EIA is to determine whether average concentrations are likely to encounter at fixed locations (Know as the receptor), due to the given sources (locations and rates of emission known), under idealized atmospheric conditions. It is imperative that one should work with idealized condition and all analysis pertaining to air turbulence and ambient air or noise pollution should be done with meteorological conditions, which can be best expected to occur. The details of measurement technique, instruments, specification of measurement standards and accuracy of instruments are adopted from the “Guidelines for micrometeorological technique in Air Pollution Studies” Care is taken to install the anemometer within a distance of six times the height of nearest vertical terrain elements (house, trees etc.) and height of 10 m from the average ground level of the fetch area. Climatological Tables of Observatories in India 1981-2010” issued by “The Director General of Meteorology, New Delhi” which is shown as annexure-IV for the station of Ahmedabad.

Temperature Details Temperature varies from season to season. Mean daily maximum temperature was recorded in the month of May at 41.6°C. Highest mean temperature in the month, recorded in May, was 44.4°C. From November to January, both day and night temperatures begin to decrease rapidly. January is generally the coldest month, with mean morning temperatures of 7.9°C. Mean daily minimum temperature of about 12.4°C is recorded in January. During the post-monsoon season, day temperatures remain between 21.4 – 35.7 ºC. In winters, i.e. January to February, day temperatures remain between 12.4 – 30.8ºC.

Relative Humidity (RH) Most humid conditions are found in the monsoon season. Thereafter, it decreases gradually during post- monsoon, winter and summer season in that order. Mornings are more humid than evenings and humidity ranges from a high of 74 to 87% in monsoon mornings to a low of 20 to 25% in summer evenings. During post-monsoon season, morning humidity remains between 57 to 65% and during the evening it remains between 36 to 41%.

Rainfall Average annual rainfall for the Ahmedabad station was observed 750.9 mm. Allocation of rainfall by season was 4.3 mm in winter (December, January, February), 10.0 mm in summer (March, April, May), 724.2 mm in monsoons (June, July, August, September) and 14.0 mm in post-monsoons (October to November).

Predominant Wind Direction Pre dominant wind direction is shown as following figure-3.2 A and figure-3.2 B.

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FIGURE-3.2 A PREDOMINANT WIND DIRECTIONS (0300 UTC) October November December

FIGURE-3.2 B PREDOMINANT WIND DIRECTIONS (1200 UTC) October November December

The annual variations in average wind speed recorded at 0300 and 1200 UTC at Ahmedabad during the period of 1971-2000. As per India Meteorological Department (IMD), Atlas of wind roses, 1971-2000 the predominant wind direction during the study period is observed to be from NE and E direction.

Site Specific Meteorological Environment Meteorological station was installed at the project site to record micrometeorological parameters on hourly basis during the study period (1st October to 31 st December, 2016) to understand the wind pattern, temperature variation, relative humidity variation, etc. Site-specific mean meteorological data is given in following table-3.1 and the wind rose diagram processed by the Industrial Source Complex – Short Term (ISCST3) software based on data collected at site is shown in figure-3.3.

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TABLE-3.1 SITE SPECIFIC METEOROLOGICAL DATA (1ST OCT TO 31 ST DEC, 2016) Month of Year 2016 Meteorological Parameter 1st Month 2nd Month 3rd Month Temperature ( 0C) Min. 23 18 13 Max. 39 36 34 Avg. 29 26 23 Relative Humidity (%) Min. 16 15 13 Max. 83 94 94 Avg. 36 43 46 Wind Speed (km/hr) Min. 00.00 00.00 00.00 Max. 06.00 05.00 05.80 Avg. 01.50 01.40 01.00 Wind Direction NE Rain Fall Nil

FIGURE-3.3 WIND ROSE DIAGRAM

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3.4.2 AIR ENVIRONMENT Design of Network for Ambient Air Quality Monitoring Locations The air quality status in the impact zone is assessed through a network of ambient air quality monitoring locations. The tropical climatic conditions mainly control the transport and dispersion of air pollutant during various seasons. The baseline studies for air environment include identification of specific air pollutants prior to implementation of the project. The EIA study requires monitoring of baseline air quality during one season. Accordingly, air quality monitoring was carried out in during 1st October to 31st December, 2016. The baseline status of the air environment is assessed through a systematic air quality surveillance programme, which is planned based on the following criteria: • Topography / terrain of the study area • Regional synoptic scale climatologically normal • Densely populated areas within the region • Location of surrounding industries • Representation of regional background • Representation of valid cross-sectional distribution in downwind direction

Reconnaissance Reconnaissance was undertaken to establish the baseline status of air environment in the study region. Eight Ambient Air Quality Monitoring (AAQM) locations were selected based on guidelines of network sitting criteria. All AAQM locations were selected within the study area of 10 km radial distance from the project site as per standard TOR.

Methodology for Ambient Air Quality Monitoring The ambient air quality monitoring was carried out in accordance with guidelines of Central Pollution Control Board (CPCB) of June 1998 and National Ambient Air Quality Standards (NAAQS) of CPCB vide G.S.R. No. 826(E) dated 18 th November, 2009. Ambient Air Quality Monitoring (AAQM) was carried out th th at eight locations during 16 March to 15 June, 2016 for parameters such as Particulate Matter (PM 10 and PM 2.5 ), Sulphur Dioxide (SO 2), Oxides of Nitrogen (NO x), Carbon monoxide (CO), Hydrogen Chloride (HCl), and Volatile Organic Compound (VOC). The monitoring was carried out 24 hours a day twice a week per location in the study area. Twenty-four numbers of observations were taken at each monitoring location. The locations of the different stations with respect to its distance and direction from project site are shown in table-3.2 and figure-3.9 respectively. Raw data of AAQM enclosed as annexure-V.

The values for mentioned concentrations of various pollutants at all the monitoring locations were processed for different statistical parameters like arithmetic mean, minimum concentration, and maximum concentration and percentile values. The existing baseline levels of PM 10 , PM 2.5 , SO 2, NO X, CO, HCl and VOC are expressed in terms of various statistical parameters as given in tables-3.3. National Ambient Air Quality Standards (NAAQS) are enclosed as an annexure-VI.

TABLE-3.2 DETAILS OF AMBIENT AIR QUALITY MONITORING LOCATIONS Bearing Approximate Radial Type of No. Name of Village W.R.T. Distance (Km) Area 1. Project site (A1) -- -- Industrial 2. Bileshvarpura (A2) NE 3.26 Residential 3. Irana (A3) NW 4.0 Residential 4. Budasan (A4) WNW 4.22 Residential 5. Rajpur (A5) N 5.3 Residential 6. Achrasan (A6) SWS 2.5 Residential 7. Lunasan (A7) SSE 3.0 Residential 8. Chhatral city (A8) E 3.4 Residential

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TABLE-3.3 AMBIENT AIR QUALITY STATUS

Parameters Sampling Unit: µg/m 3 No. - Location CO VOC PM PM SO NO HCl 10 2.5 2 X mg/m 3 (as isobutyl) Min. 67.12 30 11.17 19.27 0.1 Project site Max. 76.7 37.05 16.69 25.71 0.3 1. (A1) <1.0 <1.0 Ave. 71.52 33.63 13.91 22.43 0.2 98 th Per. 75.97 36.98 16.67 25.57 0.3 Min. 67.9 29.5 9.59 17.04 0.1 Bileshvarpur Max. 75.8 37.1 15.98 24.70 0.4 2. a (A2) <1.0 <1.0 Ave. 71.85 32.77 13.25 20.61 0.2 98 th Per. 75.43 37.08 15.94 24.58 0.4 Min. 63.6 28.8 7.89 16.93 0.1 Irana (A3) Max. 70.5 37.89 14.56 21.49 0.3 3. <1.0 <1.0 Ave. 66.85 32.60 10.7 9 18.94 0.2 98 th Per. 70.32 36.95 14.27 21.34 0.3 Min. 68.5 21.1 10.02 14.9 0.1 Budasan Max. 76.01 37.5 16.19 19.1 0.4 4. <1.0 <1.0 (A4) Ave. 72.57 32.40 13.50 17.78 0.2 98 th Per. 76.01 36.78 16.18 19.10 0.4 Min. 61.9 27.01 5.00 17.04 0.1 Rajpur (A5) Max. 70.2 34.7 12.93 22.58 0.2 5. <1.0 <1.0 Ave. 65.77 30.83 9.26 19.81 0.1 98 th Per. 70.11 34.47 12.92 22.58 0.2 Min. 66 28.46 8.03 19.05 0.1 Achrasan Max. 73.9 35.85 14.96 24.70 0.3 6. <1.0 <1.0 (A6) Ave. 70.23 31.69 11.42 21.73 0.2 98 th Per. 73.50 35.48 14.70 24.70 0.3 Min. 59.5 26.90 8.07 14.11 0.1 Lunasan Max. 66.2 33.01 12.94 21.87 0.2 7. <1.0 <1.0 (A7) Ave. 62.79 30.01 10.54 17.89 0.1 98 th Per. 66.08 33.01 12.91 21.67 0.2 Min. 69.5 31.50 3.18 15.52 0.2 Chhatral city Max. 76.01 37.27 16.62 23.99 0.5 8. <1.0 <1.0 (A8) Ave. 72.86 34.25 9.42 20.00 0.3 98 th Per. 76.01 37.15 15.69 23.99 0.5

Results & Discussion The baseline levels within the study area with respect to (PM 10 , PM 2.5 , SO 2, NO X, CO, HCl and VOC) terms of various statistical parameters are presented in tables-3.3. During baseline monitoring, the arithmetic 3 th mean values of PM 10 varied between 62.79 - 72.86 µg/m while the 98 percentile values of PM 10 ranged 3 3 between 66.08 – 76.01 µg/m . The arithmetic mean values of PM 2.5 varied between 30.01 – 34.25 µg/m while th 3 the 98 percentile values of PM 2.5 ranged between 33.01 - 37.15 µg/m . The arithmetic mean value for SO 2 3 th 3 was 9.26 – 13.91 µg/m and the 98 percentile of SO 2 was 12.91 - 17.21 µg/m . The arithmetic mean values of 3 th 3 NO x varied between 17.78 –22.43 µg/m while the 98 percentile of NO X ranged from 19.10 - 25.57 µg/m . The arithmetic mean values of CO varied between 0.1 – 0.3 mg/m 3 while the 98 th percentile of CO ranged from 0.2 – 0.5 mg/m 3. The arithmetic mean and 98 th percentile values of HCl and VOC are found below detectable limit (BDL) <1.0 µg/m 3.

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3.4.3 WATER ENVIRONMENT Methodology for Water Quality Monitoring Physico-chemical parameters have been analyzed to ascertain the baseline status existing ground water and surface water bodies. Samples were collected once during the study period. The details of ground water and surface water sampling locations are given in table-3.4 and sampling locations of water quality monitoring are shown in figure-3.10 and figure-3.11. The Indian standard specification for drinking water is given as annexure-VII and CPCB standards of classification of inland surface water is given as annexure-VIII. The physico-chemical characteristics of the different ground water samples and surface water samples are presented in the tables-3.5 and table-3.6.

TABLE-3.4 DETAILS OF GROUND AND SURFACE WATER MONITORING LOCATIONS Bearing Approximate Radial Distance No. Sampling Locations W. R. T. Project from Project Site (Km) Site GROUND WATER 1. Project site (GW1) -- -- 2. Bileshvarpura (GW2) NE 3.26 3. Irana (GW3) NW 4.0 4. Budasan (GW4) WNW 4.22 5. Rajpur (GW5) N 5.3 6. Achrasan (GW6) SSW 2.5 7. Lunasan (GW7) SSE 3.0 8. Chhatral city (GW8) E 3.4 SURFACE WATER 1. Pond Near Chhatral City (SW1) E 3.7 2. Narmada river Near Piyaj Village SSE 6.2 (SW2) 3. Narmada river Karan Nagar (SW3) SW 3.6 4. Pond Near Rangpurda Village (SW4) WSW 7.0 5. Pond Near Budasan Village (SW5) W 3.9 6. Pond Near Irana Village (SW6) NW 3.7 7. Pond Near Untva Village (SW7) NW 6.77 8. Pond Near Rajpur Village (SW8) N 5.9

GW= Ground water, SW= Surface water.

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TABLE-3.5 BASELINE GROUND WATER QUALITY Locations No. Parameters Unit Project site Bileshvarpur Budasan Rajpur Achrasan Lunasan Chhatral city Irana (GW3) (GW1) a (GW2) (GW4) (GW5) (GW6) (GW7) (GW8) 1. pH - 7.61 7.55 7.84 7.71 7.52 7.67 7.67 7.67 2. Temperature 0 C 22.3 23.1 22.8 22.4 23.5 23.6 22.1 23.0 3. Turbidity NTU 1.2 1.7 1.6 1.0 1.2 1.0 1.1 1.2 Electrical 4. ms/cm 2950 2154 875 1416 872 2852 1834 1372 Conductivity 5. Dissolved Oxygen mg/l 6.5 5.9 6.2 6.6 6.6 6.5 6.3 6.0 Total Dissolved 6. mg/l 1919 1392 608 924 560 1896 1284 888 Solids (TDS) Total Alkalinity 7. mg/l 444 340 268 288 296 280 476 320 (as CaCO 3) Total Hardness 8. mg/l 589.2 436.7 267.8 366.7 280.2 539.7 362.6 337.8 (as CaCO 3) Calcium Hardness 9. mg/l 370.8 290.5 164.8 257.5 189.5 323.4 232.8 156.6 (as CaCO 3) 10. Magnesium Hardness mg/l 218.4 146.3 103 109.2 90.7 216.3 129.8 181.3 11. Chloride mg/l 739.2 579.9 145.2 343.9 130.6 520.6 634.3 205.0 12. Sulphate mg/l 285 175 77.5 140 50 162.5 200 95 13. Phenolic Compounds mg/l NIL NIL NIL NIL NIL NIL NIL NIL 14. Ammonical Nitrogen mg/l NIL NIL NIL NIL NIL NIL NIL NIL Pt. Co. 15. Color 1.0 1.0 1.0 <1.0 1 2.0 <1.0 <1.0 Scale 16. COD mg/l N.D N.D 8 N.D N.D N.D N.D N.D 17. BOD mg/l N.D N.D N.D N.D N.D N.D N.D N.D 18. Nitrate mg/l N.D N.D N.D N.D N.D N.D N.D N.D 19. Fluoride mg/l 0.15 0.22 0.27 0.13 0.18 0.10 0.30 0.24 20. Sodium mg/l 267.3 208.6 136.5 161.2 118 242.3 193.7 130.4 21. Potassium mg/l 8 7.1 3.4 3.9 2.5 7.1 2.8 3.4 22. Salinity mg/l 755.4 840.7 529.2 610.1 233.2 1009 312.8 472.6 23. Total Phosphorus mg/l N.D N.D N.D N.D N.D N.D N.D N.D 24. Aluminum mg/l N.D N.D N.D ND N.D ND N.D ND 25. Arsenic mg/l N.D N.D N.D N.D N.D N.D N.D ND 26. Cadmium mg/l N.D N.D N.D N.D N.D N.D N.D ND 27. Chromium mg/l N.D N.D N.D N.D N.D N.D N.D ND

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Locations No. Parameters Unit Project site Bileshvarpur Budasan Rajpur Achrasan Lunasan Chhatral city Irana (GW3) (GW1) a (GW2) (GW4) (GW5) (GW6) (GW7) (GW8) 28. Copper mg/l ND N.D N.D N.D N.D N.D N.D N.D 29. Cyanide mg/l N.D N.D N.D N.D N.D N.D N.D N.D 30. Iron mg/l ND N.D N.D N.D N.D N.D N.D N.D 31. Lead mg/l N.D N.D N.D N.D N.D N.D N.D ND 32. Mercury mg/l N.D N.D N.D N.D N.D N.D N.D ND 33. Manganese mg/l N.D N.D N.D N.D N.D N.D N.D ND 34. Nickel mg/l N.D N.D N.D N.D N.D N.D N.D N.D 35. Zinc mg/l N.D N.D N.D ND N.D ND N.D ND 36. Boron mg/l N.D ND N.D N.D N.D N.D N.D ND (CFU/ 37. Total Coliform Absent Absent Absent Absent Absent Absent Absent Absent 100ml) (CFU/ 38. Faecal Coliform Absent Absent Absent Absent Absent Absent Absent Absent 100ml)

TABLE-3.6 BASELINE SURFACE WATER QUALITY Locations

Narmada Pond Near Pond Near Pond Near Pond Near Narmada Pond Near Pond Near No. Parameters Unit river Near Rangpurda Budasan Rajpur Chhatral river Karan Irana Village Untva Village Piyaj Village Village Village Village City (SW1) Nagar (SW3) (SW6) (SW7) (SW2) (SW4) (SW5) (SW8) 1. pH - 7.87 7.19 7.93 8.05 7.98 7.08 7.72 7.34 2. Temperature 0 C 25.3 24.8 25.1 25.8 25.2 25.0 26.0 24.9 3. Turbidity NTU 1.1 1.6 4.2 1.4 1.0 2.9 1.3 4.0 Electrical 851.4 4. ms/cm 967.4 1024 475.3 716.2 455.5 894.9 472.5 Conductivity 5. Dissolved Oxygen mg/l 7.4 7.8 7.9 7.1 7.0 6.6 7.2 6.8 Total Dissolved 6. mg/l 492 388 176 511 203 455 321 243 Solids (TDS) Total Alkalinity 7. mg/l 192 240 108 212 160 364 212 176 (as CaCO 3) Total Hardness 8. mg/l 123.6 107.1 57.7 90.6 76.2 135.9 92.7 80.3 (as CaCO 3) 9. Calcium Hardness mg/l 65.9 61.8 39.1 63.9 45.3 82.4 72.1 65.9 10. Magnesium mg/l 57.7 45.3 18.5 26.8 30.9 53.6 20.6 14.4 M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 3-10 en-vιsι
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Locations

Narmada Pond Near Pond Near Pond Near Pond Near Narmada Pond Near Pond Near No. Parameters Unit river Near Rangpurda Budasan Rajpur Chhatral river Karan Irana Village Untva Village Piyaj Village Village Village Village City (SW1) Nagar (SW3) (SW6) (SW7) (SW2) (SW4) (SW5) (SW8) Hardness 11. Chloride mg/l 198.6 167.6 43.2 291.9 86.0 239.4 131.6 96.2 12. Sulphate mg /l 95 80 25 100 17.5 55 77.5 40 Phenolic 13. mg/l NIL NIL 0.39 0.73 NIL NIL 0.28 NIL Compounds Ammonical 14. mg/l BDL BDL BDL BDL BDL BDL BDL BDL Nitrogen 15. Color Pt. Co. 10 9 13 11 11 5 8 9 16. COD mg/l 12 20 24 16 34 24 16 12 17. BOD mg/l N.D N.D N.D N.D N.D N.D N.D N.D 18. Nitrate mg/l N.D N.D N.D N.D N.D N.D N.D N.D 19. Fluoride mg/l 0.5 0.34 0.46 0.12 0.19 0.29 0.3 0.41 20. Sodium mg/l 68.6 54.4 38.7 86 59.2 43.3 21 35.2 21. Potassium mg/l 5.2 3.6 2.2 7.4 2.0 3.3 2.7 2.0 22. Salinity mg/l 310.8 251.2 180.3 329.1 277.5 236.2 205.6 175.6 23. Total Phosphorus mg/l N.D N.D N.D N.D N.D N.D N.D N.D 24. Aluminum mg/l N.D N.D N.D N.D N.D N.D N.D N.D 25. Arsenic mg/l N.D N.D N.D N.D N.D N.D N.D N.D 26. Cadmium mg/l N.D N.D N.D N.D N.D N.D N.D N.D 27. Chromium mg/l N.D N.D N.D N.D N.D N.D N.D N.D 28. Copper mg/l N.D N.D N.D N.D N.D N.D N.D N.D 29. Cyanide mg/l N.D N.D N.D N.D N.D N.D N.D N.D 30. Iron mg/l N.D N.D N.D N.D N.D N.D N.D N.D 31. Lead mg/l N.D N.D N.D N.D N.D N.D N.D N.D 32. Mercury mg/l N.D N.D N.D N.D N.D N.D N.D N.D 33. Manganese mg/l N.D N.D N.D N.D N.D N.D N.D N.D 34. Nickel mg/l N.D N.D N.D N.D N.D N.D N.D N.D 35. Zinc mg/l N.D N.D N.D N.D N.D N.D N.D N.D 36. Boron mg/l N.D N.D N.D N.D N.D N.D N.D N.D (CFU/ 37. Total Coliform Absent Absent Absent Absent Absent Absent Absent Absent 100ml) (CFU/ 38. Faecal Coliform Absent Absent Absent Absent Absent Absent Absent Absent 100ml) M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 3-11

3.4.3.1 PHYSICO-CHEMICAL CHARACTERISTICS OF WATER Ground Water Groundwater samples from different villages during study period was collected once during monitoring period and analyzed. The Physio-chemical characteristics of the groundwater are presented in the table-3.5. The pH varied in the range of 7.52 - 7.84, turbidity 1.0 – 1.7 NTU, total hardness 50.9 - 262.6 mg/l, dissolved solids 560 - 1919 mg/l, Sulphate 50 - 285 mg/l and Alkalinity 268 - 476 mg/l. Chloride varied from 130.6 – 739.2 mg/l. Nitrate and heavy metals concentrations were observed to be below Indian standard/specification for drinking water IS 10500-1992.

Surface Water The Physio-chemical characteristics of surface water are summarized in table-3.6. The pH varied is from 7.08 – 8.05 the turbidity varied from 1.0 – 4.2 NTU, the dissolved solids varied from 203 - 511 mg/l, total hardness varied between 57.7 – 135.9 mg/l, chloride varied from 43.2 – 291.9 mg/l, the sulphate varied from 17.5 – 100 mg/l. The nutrient values in the form of nitrate were not observed. The overall surface water quality was found to be average and the water should be treated before using it for drinking purpose.

3.4.4 NOISE ENVIRONMENT Noise is defined as unwanted sound. Noise is a disturbance to the human environment that is increasing at such a high rate that it will become a major threat to the quality of human lives. There are numerous effects on the human environment due to the increase in noise pollution. Scientists have recently found that the continuous exposure to noise with a volume more than 70 decibels can lead to permanent hearing damage. Excessive noise levels can also lead to increase of heart beat, blood pressure and blood cholesterol. It also has the potential to harm the respiratory and digestive systems. Constant noise can lead to stress disorders, which could further develop into ulcers or high blood pressure. A large amount of noise every day not only causes stress for people but also contribute to mental illness, loss of productivity. Sleep deprivation usually occurs for people at a decibel of 45 or higher at 85 decibels hearing damage occurs. People of all ages who already experience health problems are at very high risk. Noise pollution also effects the vegetation causing poor quality of crops. It also damages the nervous system of animals. Loud noise also weakens the buildings, bridges and monuments.

Reconnaissance The details of location of background noise monitoring station are given in table-3.7 and figure-3.12. Results of noise monitoring are given in table-3.8.

Equivalent Sound Levels or Equivalent Continuous Equal Energy Level (L eq ) There is large number of noise scales and rating methods based on some sort of average of weighted average quantities derived from the detailed noise characteristics. Equivalent sound levels or Equivalent continuous equal energy level (L eq ) is a statistical value of sound pressure level that can be equated to any fluctuating noise level and forms a useful measure of noise exposure and forms basis of several of the noise indices used presently.

Leq is defined as the constant noise level, which over a given time, expands the same amount of energy, as is expanded by the fluctuating level over the same time. This value is expressed by the equation: i=n Li/10 Leq = 10 log Σ (10) × ti i=1 Where, n = Total number of sound samples, Li = The noise level of any i th sample ti = Time duration of i th sample, Expressed as fraction of total sample time

Leq has gained wide spread acceptance as a scale for the measurement of long term noise exposure. Hourly equipment noise levels in the identified impact zone are monitored for day and time separately using sound level meter. All the values are reported in L eq and in case of equipment noise, Sound pressure level are monitored 1.5 m away from the machine and assessed with respect to standard prescribed in factory Act.

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Methodology for Noise Monitoring Noise standards have been designated for different types of area, i.e. residential, commercial, industrial and silence zones, as per ‘The Noise Pollution (Regulation and Control) Rules, 2000, Notified by Ministry of Environment and Forests, New Delhi, February 14, 2000. Different standards have been stipulated for day time (6 am to 10 pm) and night time (9 pm to 10 am).

Ambient noise level monitoring was done at same locations where ambient air monitoring was carried out within a study area. The locations are away from the major roads and major noise sources so as to measure ambient noise levels. One day monitoring was carried out at the locations during the study period. The frequency of monitoring was set at an interval of 15 seconds over a period of 10 minutes per hour for 24- hours. The observed Equivalent sound levels (L eq ) values in dBA are given in table-3.8 for each monitoring location in distinguished form of day time (6 am to 10 pm) and night time (10 pm to 6 am). All measurements were carried out when the ambient conditions were unlikely to adversely affect the results.

TABLE-3.7 DETAILS OF LOCATIONS FOR BACKGROUND NOISE MONITORING STATIONS Approximate Radial Type of No. Name of Village Bearing W.R.T. Distance (km) Area 1. Project site (N1) -- -- Industrial 2. Bileshvarpura (N2) NE 3.26 Residential 3. Irana (N3) NW 4.0 Residential 4. Budasan (N4) WNW 4.22 Residential 5. Rajpur (N5) N 5.3 Residential 6. Achrasan (N6) SSW 2.5 Residential 7. Lunasan (N7) SSE 3.0 Residential 8. Chhatral City (N8) E 3.4 Residential

TABLE-3.8 BACKGROUND NOISE LEVELS Category Noise Level (Leq) in dBA Noise Level (Leq) in dBA No. Location of Area (Day Time) (0600 to 2200 hrs.) (Night Time) (2200 to 0600 hrs.) 1. Project site (N1) Industrial 51.6 -77.9 45.1 -68.8 2. Bileshvarpura (N2) Residential 49.5 -65.4 39.7 -63.2 3. Irana (N3) Residential 42.3 -60.1 31.9 -58.5 4. Budasan (N4) Residential 46.7 -69.3 33.6 -60.4 5. Rajpur (N5) Residential 44.2-64.7 37.5-53.0 6. Achrasan (N6) Residential 49.3-70.5 41.4-59.3 7. Lunasan (N7) Residential 45.6-67.5 37.2-55.0 8. Chhatral City (N8) Residential 49.8 -72.3 39.5 -69.4

Baseline Noise Levels The noise level measured in study area at different locations is given in table-3.8. The noise level at the project site was found 51.6-77.9 dBA in daytime 45.1-68.8 dBA in night time. The noise levels varied in the residential area of the study area during day time [night time] in the range of 42.3-77.9 (31.9 – 69.4 ) dBA . The noise sources identified in industrial zone are vehicular traffic, industrial and commercial activities. CPCB recommendation for community noise exposure in different category of area i.e. residential, commercial, industrial and silence zone is given as annexure-IX, while Damage risk criteria for hearing loss given by occupational safety & health administration (OSHA) is given as annexure-X. The observed noise levels were below the stipulated standards of CPCB.

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Noise Levels Due to Transportation Noise levels were also measured at two different locations in November, 2016. The equivalent noise level Leq (60 min average) measured at a distance of 10 m and 20 m from the edge of the road at each of the locations are presented in table-3.9.

TABLE-3.9 NOISE LEVELS DUE TO TRANSPORTATION Noise Level in dBA No. Sampling Location Time 10 m from Edge of The Road 20 m From Edge of The Road Day 73.1 67.8 1. Kadi Chhatral Road Night 56.5 52.3 Day 53.3 52.5 2. SH-133 Near Chhatral City Night 47.2 45.0

Community Noise Levels The communities close to the project site are not exposed to major noise sources. The commercial activities and transport apart from natural sources contribute to community noise levels. The noise levels close to project site were low and within the stipulated standards of CPCB for the respective designated areas.

3.4.4.1 TRAFFIC STUDY To determine current traffic volumes on the road, the traffic studies have been accomplished. This study will give an idea about expected future traffic volumes as a part of overall impact assessment for the project. The traffic densities may vary based on working days and time, and also may vary in day and night times. This survey was conducted during normal working day to get a clear picture of traffic density.

Selection of Sampling Location The traffic density study was conducted at Chhatral which is about 2.8 km away from the project site.

Methodology Vehicular Count The vehicles moving in both the directions were counted continuously for 24 hours at one location. The vehicles were counted every hour and recorded under respective category. The maximum traffic count in an hour is termed as peak hour traffic. Categorization of Traffic The vehicles were categorized under various heads like heavy motor vehicles such as buses, trucks and tankers (10 wheelers), light motor vehicles (cars, jeeps), three wheelers (auto rickshaws, 3-wheel tempo, Bicycles etc.) two wheelers (scooters, motor cycles etc.). Results and Discussions The summary of daily traffic count for the location was monitored during the study period is summarized below and percentage of composition of the vehicles is given below. It was observed that the cars/jeeps and trucks/buses forms the major volume of the traffic. The overall total traffic PCU of this road is minimal. Presentation of Results The present level of traffic has been converted to Passenger Car Units (PCU) at this location as per the conversion factors stipulated by Indian Road Congress (IRC). The Passenger Car Unit (PCU) recorded at the selected traffic location, which is towards Chhatral is about 12385.5 PCU.

Location: Heavy vehicle Four wheel Three wheel Two wheel Chhatral 3307 1842 421 824 PCU rating as per Indian 3 1 0.5 0.5 Road Congress (IRC) PCU 9921 1842 210.5 412 TOTAL PCU 12385.5 Total Name and No. of vehicle % Composition vehicle Heavy Four Three Two Four Three Two Heavy (24 Hr.) vehicle wheel wheel wheel wheel wheel wheel 6394 3307 1842 421 824 51.72 28.81 6.58 12.89

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3.4.5 SOIL ENVIRONMENT Soil samples were collected from eight different locations within the study area in the study period. The locations selected for collection of soil samples are presented in table-3.10 & figure-3.13. The analysis results of soil samples collected from the study area given in table-3.11.

The eight soil samples collected from surrounding areas including project site were assessed for physical and chemical quality parameters. The porosity ranged from 30-74 % and WHC from 29-60 %. The EC ranged from 700 – 1078 µs/cm . The soil pH varied from 7.7-8.7. These results indicate that in general soils are saline/alkaline as EC exceeds 0.8 dS/m 800 µs/cm and pH is above 8.1. The OC varied from 1.9-3.5 % and available nitrogen from 78.2-109.2 mg/kg. The available phosphorus and potassium ranged from 1870- 2978 mg/kg and 16.5-62.5 mg/kg respectively. Among basic cations there is predominance of sodium (84.3 to 141.7 mg/kg) followed by calcium (17.8 to 41.5 mg/kg) and magnesium (8.0 to 26.2 mg/kg).

3.4.5.1 SOIL QUALITY INTERPRETATION: The soil at the proposed site is saline as EC is > 0.8 dS/m and among basic cations there is predominance of sodium which indicates that soils are likely to become alkaline, though pH is 7.73. This soil requires removal of excess salts by using rain water as ground (bore well) water is saline and providing drainage. The excess sodium could be replaced by applying gypsum and as per gypsum requirement of soil as well as application of organic manure @ 50 tons/ha for improving percolation rate of clay loam soil. The fertility status of soil indicate that nitrogen is low (>0.5% OC) to medium (0.5 to 0.75% OC). The available phosphorus and potassium are in the range of medium (28 to 56 kg P 2O5 & 140 to 280 kg/ha K 2O) to high (>56 kg P 2O5/ha & >280kg K 2O/ha). Soil at the greenbelt site should be monitored for EC, pH and ESP once in a year after cessation of monsoon and fertilized with half the recommended dose of nitrogen, phosphorus and potassium as all these nutrients are in the medium range of their availability at the site. Variations in soil porosity and water holding capacity are presented in table-3.11.

TABLE-3.10 SAMPLING LOCATIONS OF SOIL MONITORING Approximate Radial Type of No. Name of Village Bearing W.R.T. Distance (km) Area 1. Project site (S1) -- -- Industrial 2. Bileshvarpura (S2) NE 3.26 Residential 3. Irana (S3) NW 4.0 Residential 4. Budasan (S4) WNW 4.22 Residential 5. Rajpur (S5) N 5.3 Residential 6. Achrasan (S6) SWS 2.5 Residential 7. Lunasan(S7) SSE 3.0 Residential 8. Chhatral city (S8) E 3.4 Residential

TABLE-3.11 PHYSICO-CHEMICALS CHARACTERISTICS OF SOIL

Project Bileshvar Irana Budasa Rajpur Achrasa Lunasan Chhatra No Parameter Unit Site (S1) pura (S2) (S3) n (S4) (S5) n (S6) (S7) l (S8)

1 Porosity % 30 48 74 41 58 40 30 60 2 Water holding % 55 51 29 60 42 32 39 54 capacity 3 Particle size Distribution a Sand % 07 09 70 24 15 19 76 28 b Silt % 13 20 08 36 20 11 14 52 c Clay % 80 61 22 40 65 70 10 20 4 Texture - Loam Loam Sandy Loam Loam Loam Sandy Loam

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Project Bileshvar Irana Budasa Rajpur Achrasa Lunasan Chhatra No Parameter Unit Site (S1) pura (S2) (S3) n (S4) (S5) n (S6) (S7) l (S8)

5 pH - 7.73 8.29 7.90 8.21 8.52 8.70 8.20 7.88 6 Electrical µs/cm 1032 810 1050 854 700 952 1078 852 Conductivity 7 Cation meq/ Exchange 30 22 27 19 26 30 40 32 100g Capacity 8 Calcium mg/kg 17.8 28.5 51 35.6 22.5 41.5 24 39 9 Magnesium mg/kg 10 16.7 21 14.2 8 26.2 9.9 13.7 10 Sodium as Na mg/kg 84.3 129.2 133 118.2 96.4 141.7 84.2 122.4 11 potassium mg/kg 16.5 30.5 62.5 30 60 40 16.5 21 12 Phosphorus mg/kg 1870 2121 2978 2275 2700 2376 1942 2239 13 Available mg/kg 78.3 105 90.5 103.7 78.4 109.2 78.2 107 Nitrogen 14 Total Organic % 2.30 2.0 3.50 2.20 2.17 2.61 1.90 2.84 carbon (OC)

3.4.6 LANDUSE Land Use (LU) refers to man’s activities and various uses, which are carried on land. Land Cover (LC) refers to natural vegetation, water bodies, rock/soil, artificial cover and others resulting due to land transformation. Although land use is generally inferred based on the cover, yet both the terms land use and land cover are closely related and interchangeable. Knowledge about the existing land use and trends of change is essential if the nation is to tackle the problems associated with the haphazard and uncontrolled growth. A systematic framework is needed for updating the land use and land cover maps that will be timely, relatively inexpensive and appropriate for different needs at both national and state levels. The rapidly developing technology of remote sensing offers an efficient and timely approach to the mapping and collection of basic land use and land cover data over large area. It is required to carry out the land use / land cover study for the project study area (10 km radius) to obtain the necessary environmental clearances from statutory authorities. The objective of the study is to carryout land use / land cover study for the proposed project. The LU / LC study is carried out using the Satellite Imageries (IRS RS2 LISS IV FX Rabi and Khariff) in addition to Survey of India Toposheet. Appropriate guidelines are followed while preparing the LU / LC map for the project study area.

Scope of the work The LU / LC study shall be carried out for a study area of 10 km radius taking site as centre using the satellite imageries (IRS RS2 LISS III) for Rabi / Khariff season..
Procurement of latest satellite imagery (IRS RS2 III / IV 5.8m Resolution) based on availability) Rabi or Khariff seasons.
Satellite imagery processing and interpretation of land use as per land use classification covering 10 km radius of proposed Project Site.
Calculation of land use breakup w. r. t. each land use category covering 10 km of proposed Project Site.
Preparation and submission of reports, satellite imageries and maps.

Methodology The land use / land cover map is prepared by adopting the interpretation techniques of the image in conjunction with collateral data such as Survey of India topographical maps and census records. Image classification can be done by using visual interpretation techniques and digital classification using any of the image processing software. For the present study, ERDAS 9.1 version software is used for preprocessing, rectification, enhancements and classifying the satellite data for preparation of land use land

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cover map for assessing and monitoring the temporal changes in land use land cover and land developmental activities. The imagery is interpreted and ground checked for corrections. The final map is prepared after field check. Flow chart showing the methodology adopted is given in the different land use / land cover categories in the study area has been carried out based on the NRSC land use / land cover classification system. For analysis and interpretation, and preparation of LU / LC map, two types of data are needed:

1. Basic data includes Fused data of LISS IV FX Toposheets on 1:50,000 Local knowledge Area map on any scale to transfer details Reports and other literature of the study area

2. Ground data: Ground data is very much essential to verify and to increase the accuracy of the interpreted classes and also to minimize the field work.

Area under different landuse The land use classification within a distance of 10 km radius from the project location and the areas falling under the respective classifications are given as table-3.12 and Land use pattern of the study area as per satellite imagery is given as figure-3.4 & Satellite Imagery of the study area is shown as figure-3.5.

TABLE-3.12 AREA STATISTICS OF LANDUSE/LAND COVER MAP

No. Land use Area (Sq. Km) % 1. BUILT-UP LAND A. Settlements 20.096 6.4 B. Industrial area 11.932 3.8 2. WATERBODIES A. Tank/Major canal etc. 15.386 4.9 3. CROP LAND A. Single crop 217.602 69.3 B. Double crop 25.434 8.1 4. WASTELANDS A. Land with scrub 16.328 5.2 B. Land without scrub 7.222 2.3 TOTAL 314 100

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FIGURE-3.4 LAND USE / LAND COVER MAP OF 10 KM RADIUS FROM STUDY AREA

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FIGURE-3.5 SATELLITE IMAGERY OF THE STUDY AREA (10 KM RADIUS)

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3.4.7 SOCIO - ECONOMIC ENVIRONMENT An assessment of socio - economic environment forms an integral part of an EIA study. Therefore, baseline information for the same was collected during the study period. The baseline socio - economic data collected for the study region, has been identified for the four major indicators viz. demography, civic amenities, economy and social culture. The baseline status of the above indicators is compiled in forthcoming sections.

Objective of Social Impact Assessment Social Impact Assessment (SIA) is now conceived as being the process of identifying and managing the social issues of project development, and includes the effective engagement of affected communities in participatory processes of identification, assessment and management of social impacts. Although SIA is still used as an impact prediction mechanism and decision-making tool in regulatory processes to consider the social impacts in advance of a permitting or licensing decision, equally important is the role of SIA in contributing to the ongoing management of social issues throughout the whole project development cycle, from conception to post-closure. Like all other fields of practice (discourses), SIA is a community of practice with its own paradigm of theories, methods, case histories, expected understandings and values. Thus SIA includes the processes of analyzing, monitoring and managing the intended and unintended social consequences, both positive and negative, of planned interventions i.e. policies, programs, plans, projects. Its primary purpose is to bring about a more sustainable and equitable development. Social impacts examine changes in people's way of life, their culture, community, political systems, environment, health and wellbeing, their personal and property rights and their fears and aspirations. Therefore, the baseline socio - economic data was collected for the study region, has been identified in the four major indicators viz. demography, civic amenities, employment and economy and social culture. The baseline status of the above indicators is compiled in forthcoming sections.

Major Objectives of the Study • To understand the socio-economic status of the villages • To study the perceptions of people about the impact of proposed project

Stakeholders’ identification Any project usually has some negative impacts on the local population. Displacement and/or health/socioeconomic hazard are traumatic experience in spite of compensation paid and mitigation measures adopted. Therefore proper identification of stakeholders and appropriate consultation on the implementation plan and participation of affected people in decision making are of utmost importance. This helps the stakeholders in understanding the project objectives and needs; and in communicating their willingness, views and preferences. Thus it ensures increased participation of people through better acceptance of the project. Stakeholders' consultation was done during Social Impact Assessment (SIA) at the project locations and nearby villages within 10 km radius area of the proposed project. Planned Corporate Social Responsibility (CSR) activities are suggested based on findings of this social impact assessment report.

Methodology (a) A detailed desk review of reports and secondary data related to the socio-economic context of the Project was undertaken for assessing the overall existing situation. Census records are referred. (b) (i) Reconnaissance visits to the project site were made. (ii) Screening of potential social impacts in the project influence area was carried out. During the reconnaissance visit, public consultations and personal interview were conducted to gather feedback from the local people on the proposed development and perceived socio-economic impacts. Keeping this situation in view it was decided to undertake public consultations through group discussions and personal interview with local residents in the PIA (Prospective Project beneficiaries and Project Affected people).

Primary data collection: tools and techniques The survey team has used the purposive random sampling method at various stages. It was planned to gather data from various stake holders. For the purpose of this study a structured Questionnaire schedule related to socio-demographic variables and interview guide around the theme of perception of setting up the project and their expectations from the company was prepared. This assessment takes into consideration the M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 3-20

beneficial socioeconomic impact that the production unit may have on the community. It further assesses community's perception and their awareness regarding polluting components of the environment. Further it considers the impact of the proposed project on the socio-economic status of the surrounding area and their perception regarding this project. The field work duration was 01 st October - 31 th December, 2016 within the study area of 10 km radius from the project site.

Secondary Data Collection Latest available census records were referred to understand demography related to Infrastructure facilities, category of population, Economic Status, Health Status, Education Status, and Civic Amenities etc.

Data analysis and interpretation Collected data are analyzed through qualitative and quantitative method of analysis.

Limitations Study is limited to the 10 km radius with purposive sampling from the proposed project site.

The Project Influence Area The PIA for the concerned industry comprises 52 major, minor villages and urban area in 10 km radial distance from the proposed project. Demographical details as per census 2011 of the study area are given in table-3.14.

TABLE-3.13 VILLAGE WISE DEMOGRAPHICAL DETAILS IN PIA Census Population 2011 Sr. Village Taluka Population Literates Total Workers No. HH Total Male Female Male Female Male Female 1 Dingucha 732 3284 1705 1579 1370 1006 936 129 2 Pansar 1874 8438 4467 3971 3564 2693 2450 558 3 Isand 817 3881 2057 1824 1590 1216 1145 240 4 Vadavsvami 245 1186 597 589 455 359 333 21 5 Bileshvarpura 422 2071 1113 958 858 593 582 139 6 Pratappura 377 2054 1068 986 839 579 591 70 7 Piyaj 826 4342 2222 2120 1660 1065 1306 356 8 Sherisa 1183 6167 3084 3083 2272 1689 1764 757 9 Ramnagar 384 2038 1058 980 893 762 626 109 Kalol 10 Vansajada 600 3035 1502 1533 1139 778 849 248 11 Dhamasna 1022 4864 2505 2359 2099 1742 1538 394 12 Chhatral INA 766 2660 1760 900 1385 516 1337 104 13 Chhatral (CT) 2161 10215 5438 4777 4367 3190 2978 412 14 Kalol (M) 23800 113153 59839 53314 48790 39158 32424 4927 15 Dhanot (OG) 273 1299 684 615 507 357 395 129 16 Ola (OG) 394 1976 1023 953 788 563 562 194 17 Borisana (OG) 3774 17998 9449 8549 7888 6670 5165 874 18 Arsodiya (CT) 1198 5859 3088 2771 2566 1997 1661 171 Kalol Taluka 40,848 1,94,520 1,02,659 91,861 83,030 64,933 56,642 9,832 19 Dangarva 1129 5355 2797 2558 2244 1720 1551 358 20 Nandasan 2605 13440 6972 6468 5393 4483 3565 527 21 Kherpur Kadi 351 1704 862 842 700 581 509 50 Lakshmipura 22 358 1658 855 803 734 644 497 198 (Nandasan)

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Census Population 2011 Sr. Village Taluka Population Literates Total Workers No. HH Total Male Female Male Female Male Female 23 Chandarda 419 2210 1146 1064 847 579 627 255 24 Vadu 828 3909 2032 1877 1673 1273 1067 164 25 Ghumasan 951 4631 2408 2223 2002 1739 1345 252 26 Rajpur 1791 8621 4525 4096 3500 2599 2456 606 27 Sarsav 509 2486 1312 1174 1020 710 711 463 28 Aldesan 504 2423 1233 1190 925 666 718 246 29 Untva 428 2065 1081 984 840 647 559 157 30 Kundal (Part) 1984 9395 5020 4375 4022 2868 2791 294 31 Irana 717 3562 1863 1699 1379 961 1084 262 32 Jhulasan 1073 5046 2605 2441 1967 1404 1432 362 33 Ambavpura 276 1309 682 627 531 445 400 51 34 Chadasna 394 2097 1077 1020 785 541 584 123 35 Indrad 1006 4938 2665 2273 2086 1354 1445 574 36 Budasan 762 3249 1730 1519 1338 915 1015 237 37 Nani Kadi (Part) 601 2923 1481 1442 1210 1026 897 241 38 Shiyapura 221 1083 556 527 427 344 308 29 39 Rangpurda 420 1968 998 970 753 569 585 152 40 Pirojpur 230 1191 617 574 493 342 315 40 41 Karannagar 1436 6794 3489 3305 2779 2156 1969 577 42 Ankhol 389 1891 1020 871 799 521 617 32 43 Achrasan 390 2079 1034 1045 762 554 590 391 44 Lunasan 516 2522 1292 1230 1003 689 758 171 45 Vansol 388 1904 1000 904 778 521 572 487 46 Vamaj 810 3625 1895 1730 1514 1180 1144 495 47 Fuletra 616 3065 1620 1445 1128 694 974 147 48 Borisana 610 3092 1640 1452 1199 864 986 788 49 Jetpura 199 995 480 515 342 255 290 87 50 Adraj 1076 5415 2820 2595 2217 1626 1635 536 51 Vadavi 622 3146 1601 1545 1221 813 916 25 52 Kadi (M) 15344 73228 38931 34297 3230 3 25714 20617 2663 Kadi Taluka 39,953 1,93,019 1,01,339 91,680 80,914 61,997 55,529 12,040 Total 80,801 3,87,539 2,03,998 1,83,541 1,63,944 1,26,930 1,12,171 21,872 Source: Census 2011, District Gandhinagar and Mahesana, Gujarat

Findings of social impacts and community consultations The findings of the quick socioeconomic survey and various consultations at community level are presented below:

Demography: In 2011, Gandhinagar district had population of 13,91,753. Decadal growth rate during 2001-2011 is 4.29% in the population compared to population as per 2001 census. With regards to sex ratio in Gandinagar, it stood at 923 per 1000 male compared to 2001 census figure of 912. In census of India 2011, shows that density of population in Gandhinagar district is 650 people per sq. km. While other district is Mahesana, it had population of 20,35,064. Decadal growth rate during 2001-2011 is 10.73% in the population compared to population as per 2001 census. With regards to sex ratio in Mahesana, it stood at

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926 per 1000 male compared to 2001 census figure of 927. In census of India 2011, shows that density of population in Mahesana district is 462 people per sq. km. The details concerning the demographic structure of the study were collected from Census record of Gandhinagar and Mahesana district. Study area covers two taluka i.e. Kalol in Gandhinagar District and Kadi in Mahesana district. Total population density is 1234 persons per sq. km. Total population of the study area is 3,87,539 as per census 2011 from which 2,03,998 are males and 1,83,541 are females. Sex ratio of the study area as per census 2011 was 900 female population per male population.

Literacy: Average literacy rate of Gandhinagar district in 2011 census were 84.16 compared to 76.59 of 2001. Male and female literacy were 92.01 and 75.76 respectively in 2011. While in Mahesana district 2011 census were 83.16 compared to 75.22 of 2001. Male and female were 91.39 and 75.32 respectively in 2011. Literacy level in the PIA is comparatively good which is also reflected in census data. Average literacy rate of the study area was 75.05% as per census 2011.

Economic Profile- After assessment the study and observations implied that main occupations of the area are industrial jobs and small business which grows with industrial activities. Economical background of the area is general not so high.

Infrastructure Facilities: Study area is consist Kalol - Chhatral to Kadi industrial corridor. Due to this industrial development basic infrastructural facilities are available in this region. Villages in the study area are having road, water connection, electric connectivity, transportation facilities, etc.

Educational Facility- All villages are having educational facilities like angawadi and primary or middle school. While villages not having secondary, higher secondary or technical school facilities can avail the facility at Kadi, Kalol or Gandhinagar for higher education.

Water Supply: During assessment, drinking water facility is observed in the study area. Borewell and tap water facilities are available in the study area through tank water.

Sanitation: During the assessment it is observed that villages in the study area are having sanitation facility while some villages are having improper sanitation facility. Which need to be improved under Swachh Bharat Mission scheme.

Health care facility: Study area is having available basic health care facilities. These PHCs are active. Those villages not having PHC, they receive services from Aasha workers. For further, hospitals, private clinics and other healthcare centers are available at Chhatral, Kalol and Kadi.

Culture: Culture of the study area is mixed and multiculturalism seen as Kalol to Chhatral to Kadi is industrial belt. As one of the largest industrial area, multiculturalism is seen in the area while other areas of the study area are normal.

Communication and Transportation: In respect of development of transportation facilities especially in road, state has made commendable progress. Communication facilities in this region are quite good due to industrial cluster. The entire study area is connected by bus and other means of transportation facilities. Approach roads are in all forms like paved road, mud road, footpath, navigable waterway, etc.

Power Supply: Electric power is one of the basic and key infrastructures in the growing economy. It occupies a distinct role in the development of industry and agriculture. It is also a key factor in the socio- economic transformation in rural areas. All villages are electrified in the region and electricity is available for all-purpose.

Socio-Economic Survey Sampling Method Socio-economic survey was conducted with the help of predesigned tool to measure the socio-economic status of the people in the study area. In all, there are 52 villages located in all directions with reference to project site. On the basis of purposive random sampling, adult male/female from these villages were selected to collect the information related to socio-economic status. Individual interviews with the adult M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 3-23

male/female, common meetings were conducted in which heads of the villages, panchayat representatives, and other stakeholders like, school teacher, anganwadi worker, PHC incharge, gram sewak etc were present.

The salient socio-economic features observed under the study are: • Local people are having main occupation of agriculture related activities while new generation of people are intended to join jobs in industrial sector. • Most of the people in study area use LPG gas, firewood and Kerosene as the main source of fuel for cooking purpose. • Average literacy level among the people is about 75.05%. Among women in the study area, literacy level is less, as the educational facilities available in the study area. • Almost villages do not have any problem in communication and transportation facilities. Road conditions are good. There is bus facility available in the interior villages. • Medical facilities available in the area. Lack of drainage and control of mosquitoes nuisance, have resulted in higher prevalence of malaria in the area, especially during rainy season. • Electricity facility is available in villages. Nobody complained about electricity problem in the study area. Awareness and opinion of the people about the project: For the assessment of awareness about the project activities and opinion about it, following salient observations were recorded: • During survey it was observed that no awareness in villages about the proposed project as many industries are exist in the industrial belt. • People in the region expect job opportunities as their complained was outsiders are getting employment more than locals and companies should contribute for the improvement in educational, transportation and sanitation facility from project.

3.4.8 DESCRIPTION OF THE BIOLOGICAL ENVIRONMENT Introduction Biodiversity is often considered synonymous with species richness of the area. Identifying, measuring, and monitoring biodiversity is a complex exercise. The Biodiversity assessment generally concern with, conducting biodiversity inventories; for assessing existing biodiversity. This provides the information on the biodiversity richness of the area under consideration. The selection of indicators differs for biodiversity monitoring as per the output required. Various criteria have been developed for selection of indicators, taking into account biological as well as logistical aspects (Noss, 1990, UNEP, 1992).

Biodiversity of Terrestrial Environment Conference of parties to the Convention on Biological diversity (CBD) held at Curitiba, Brazil on March 20 th – 31 st , 2006 suggested biodiversity to be considered in impact assessment by providing voluntary guidelines on biodiversity inclusive Environmental Impact Assessment. CBD provides a strong international platform for applying impact assessment techniques to biodiversity conservation. It specifically calls for impact assessment measures to ensure that biodiversity is addressed in projects, plan and policy decision (Article14). An underlying justification for the application of impact assessment is also given in Article -8 which is for promoting the protection of ecosystems, natural habitats, promoting environmentally sound and sustainable development in areas next to the protected areas.

Biological Diversity The variety and variability of organisms and ecosystems is referred to as biological diversity or Bio diversity. Biodiversity is a term which has gained enormous importance in the past few years. Technically, it is a contraction of 'biological diversity'. For the purposes of the CBD (Article 2 Use of Terms), 'Biological Diversity' is "the variability among living organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this includes diversity within species, between species and of ecosystems". In practice, 'biodiversity' is most often used as a collective noun synonymous with nature or 'Life on Earth' (WCMC Biodiversity Series No 5, 1996).

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The biodiversity, we see today is the result of billions of years of evolution, shaped by natural processes. The vast array of interactions among the various components of biodiversity makes the planet habitable for all species, including humans. There is a growing recognition that, biological diversity is a global asset of tremendous value to present and future generations. At the same time, the threat to species and ecosystems has never been as great as it is today. Species extinction caused by human activities continues at an alarming rate. Protecting biodiversity is for our self-interest and also for the future generation.

Ecological Impact Assessment Ecological Impact Assessment (EcIA) is used to predict and evaluate the impacts of development activities on ecosystems and their components, thereby providing the information needed to ensure that ecological issues are given full and proper consideration in development planning. Environmental impact assessment (EIA) has emerged as a key to sustainable development by integrating social, economic and environmental issues in many countries. EcIA has a major part to play as a component of EIA but also has other potential applications in environmental planning and management. Ecological Impact Assessment provides a comprehensive review of the EcIA process and summarizes the ecological theories and tools that can be used to understand, explain and evaluate the ecological consequences of development proposals.

Environmental impact assessments have become an integral part of development projects in India ever since 1994, to formulate policies and guidelines for environmentally sound economic development. Proper assessment of biological environment and compilation of its taxonomical data is essential for the impact prediction, yet biodiversity is often inadequately addressed. There is a growing recognition of the need of biodiversity considerations in environmental impact assessments. Important barriers to the incorporation of biodiversity in impact assessment include low priority for biodiversity and limitations in one or more of the following areas: capacity to carry out the assessments; awareness of biodiversity values; adequate data; and post-project monitoring.

Consistent and regularly updated data on regional and local taxonomy and floristic and faunal diversity of the areas are almost non-existent in country as diverse as India. Instant information on biodiversity profiles of the area, where the proposed project is setting up, is an essential part of the baseline studies of EIA. In such a situation, good primary baseline biodiversity survey is a pre-requisite for the collection of reliable data. The professional ethic of the Biodiversity practitioners should be their will and skill to conduct scientific field surveys. These contributions towards biodiversity surveys may sometimes recognized as the actual value additions in terms of new records or a new data base but are more often recognized in the validation and updating of the existing information base.

Period of Study A field study for biodiversity survey was carried out during October 2016 – December 2016).

Methodology The primary objective of survey was to describe the floristic and faunal communities within the study area. Extrapolation and prediction techniques were used to limit the number of sites to be assessed. The knowledge of species habitats requirement, soil type, terrain, vegetation etc. were used to predict species occurrence. This Extrapolation Assessment Programme conducts preliminary for the assessment of biological value of poorly known area. The biological value of an area can be characterized by the species richness, degree of spices endemism, uniqueness of the ecosystem and magnitude of threats of extinction. This Rapid biodiversity assessment were undertaken by identifying potentially rich sites from satellite imaginary (Google Earth) and conducting the field survey in the potential habitats. GPS was utilized for locating field sample plots as well as gathering positional attributes of sighted flora and faunal species. For Floral survey, sample plots have been randomly distributed within the identified rich biodiversity potential habitats that falls under study area. The methodology adopted for faunal survey involved; faunal habitat assessment, random intensive survey, opportunistic observations, diurnal bird observation, active search for reptiles, active search for scats and foot prints and review of previous studies. The aim was to set baselines in order to monitor and identify trends after the commencement of production system activity. Emphasis has been placed on presence of rare, endemic, migratory and threatened species, if any present in the study area. Desktop literature review was conducted to identify the representative spectrum of M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 3-25

threatened species, population and ecological communities as listed by IUCN, ZSI, BSI and in Indian wild Life Protection act, 1972. The status of individual species was assessed using the revised IUCN category system.

FIGURE-3.6 STUDY AREA MAP

Source: Google Earth

Biodiversity of Terrestrial Environment Habitats Description of the Project Site and Its Immediate Surroundings The Project site (23°16'52.50"N, 72°24'47.72"E) is located is near to Kalol taluka of Gandhinagar district. The approach road is adjacent to the Kadi-Chhatral highway in south direction and State Highway-41 is around 2.8 km away from the project site in east direction, hence ecological impact due to this project on these human receptors is expected to be minimum. The project site is surrounded by the other industries.. There is no eco-sensitive area likes forest patches, large water bodies that attract migratory and other residential water fowls existing within the proximity of the project site, hence the direct impact due to the project on these eco-sensitive receptors are also not envisaged. Few trees mainly Azadirachta indica (Limbado), Peltophorum pterocarpum (Sonmukhi) are growing along the boundary wall of the project site.

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The tree species, herbs, shrubs, climbers and major crops, were documented during this base line study. The list of floral species documented in the study area is enlisted in

Trees Trees observed during the present survey are given in the following table-3.14. 36 trees species belong to 22 families are enumerated from the study area.

TABLE-3.14 TREE SPECIES IN THE STUDY AREA Sr. No. Family & Scientific name Vernacular name 1. Family: Anacardiaceae i. Mangifera indica L. Keri 2. Family: Annonaceae ii . Polylathia longifolia (Conn.) Thw. Asopalav 3. Family: Arecaceae iii . Cocos nucifera L. Narial 4. Family: Caesalpiniaceae iv . Delonix regia (Boj.) Raf. Gulmohar v. Delonixelata (L.) Gamble . Sandsro vi . Cassia fistula L. Garmalo vii. Peltophorum pterocarpum (DC.) Backer ex Heyne Sonmukhi viii. Tamarindus indica L. Amali 5. Family: Caricaceae ix. Carica papaya L . Papaya 6. Family: Casuarinaceae x. Casuarina equisetifolia L. Sharu 7. Family: Combretaceae xi. Terminalia catappa L. Badam 8. Family : Ehretiaceae xii. Cordia gharaf (Forsk.) E. & A. Gundi xiii. Cordia dichotoma Forst. Gunda 9. Family: Malvaceae xiv. Thespesia populnea (L.) Sol.ex Corr. Paras piplo 10 . Family: Meliaceae xv. Azadirachta indica A.Juss Limbado 11 . Family: Mimosaceae xvi. Acacia auriculiformis L. Austrianbaval xvii . Acacia leucophloea (Roxb) Willd Hermobava l

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Sr. No. Family & Scientific name Vernacular name xviii . Acacia nilotica (L.) Del.subsp.indica (Bth.) Brenan Baval xix. Albizialebbeck (L.) Bth. Siris xx . Leucaenaleucocephala (Lam.) De Pardesi Baval xxi. Pithecellobiumdulce (Roxb.) Bth. Gorasmli xxii . Prosopiscineraria (L.) Druce Khyigdo 12. Family:Moraceae xxiii . Ficus bengh alensis L. Vad xxiv. Ficus religiosa L. Piplo 13. Family:Moringaceae xxv . Moringa oleifera Lam Sargavo 14. Family:Myrtaceae xxvi . Eucalyptus sp. Nilgari 15. Family: Papilionaceae xxvii . Erythrina variegata L. Pagario 16. Family: Rutaceae xxviii . Limonia acidissima L. Kothi, Kotha 17. Family:Poaceae xxix . Dendrocalamus strictus (Roxb) Bans 18. Family:Salvadoraceae xxx. Salvadorapersica L. Piludo xxxi . Salvadora oleoides Decne Piludi 19. Family:Sapotaceae xxxii . Manilkara hexandra (Roxb.) Dub. Rayan xxxiii . Manilkara zapota (L.) Chikoo 20 . Family: Simaroubaceae xxxiv. Ailanthus excelsa Roxb. Aurdso 21 . Family: Rhamnaceae xxxv. Zizyphus glabrata Heyne ex Roth. Bor 22. Family: Verbenaceae xxxvi . Tectona grandis L.f. Sag

Shrubs Shrubs observed during the present survey are given in following table-3.15. 32 shrub species belong to 18 families are enumerated from the study area.

TABLE-3.15 SHRUBS OBSEREVED IN THE STUDY AREA Sr. No. Family & Scientific name Vernacular name 1. Family: Apocynaceae i. Nerium indicum Lalkaren ii. Thevetia peruviana Merr. Pili karan 2. Family: Asclepiadaceae iii. Calotropis gigantea (L.) R. Br Akado iv . Calotropis procera (Ait.) R. Br Akado 3. Family: Balanitaceae v. Balanites aegyptiaca Ingorio 4. Family: Caesalpiniaceae vi. Cassia auriculata L Aval vii. Cassia occidentalis L. Sundro viii. Caesalpinia crista L. Kachka

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Sr. No. Family & Scientific name Vernacular name 5. Family: Capparaceae ix. Capparis decidua (forsk.) Edgew Kerdo 6. Family: Convolvulaceae x. Ipomoea fistulosa Mart.ex Choisy Nasarmo 7. Family: Euphorbiaceae xi . Euphorbia neriifolia L. Thor xii. Jatropha curcas L. Ratanjot xiii . Ricinus communis L. Devalo 8. Family: Lythraceae xiv . Lawsonia inermis L. Mendhi 9. Family: Malvaceae xv. Abelomoschus manihot (L.) Medic. Jagali bhindi xvi . Gossypium herbaceum L. acerifolium Kapas xvii. Hibiscus rosa –sinensis Jasund 10 . Family: Musaceae xviii. Musa paradisiaca L. Kela 11 . Family: Mimosaceae xix. Prosopis juliflora DC Gando baval xx. Acacia jacquemontii Rh. Rato bjhval xxi . Dichrostachys cinerea (L.) Mor Dhundhiyu 12. Family:Nyctaginaceae xxii . Bougainvillea spectabilis Willd. Bougainvel 13. Family: Papilionaceae xxiii . Sesbania sesban (L.) Merr . Shevari 14. Family: Punicaceae xxiv. Punica granatum L. Dadam 15 . Family: Rhamnaceae xxv. Zizyphus nummularia (Burm.f.) W. &. Chanibor 16 . Family: Solanaceae xxvi. Datura metel L Daturo Solanum incanum L Ubhi ringan xxvii . Solanum indicum 17. Family: Tiliaceae xxviii . Triumfetta pentandra A. Rich.in Guill. & Perr Zipti 18. Family: Verbenaceae xxix . Clerodendrum inerme (L.) Gaertn. Madhi xxx. Lantana camara L.var.aculcata (L.) Mold. Ganthai

Herbs Herbs observed during the present survey are given the following table-3.16. 67 herbs belong to 28 families are enumerated from the study area.

TABLE-3.16 HERBS OBSEREVED IN THE STUDY AREA Sr. No. Family & Scientific name Vernacular name 1. Family Acanthaceae i. Hygrophila auriculata (Schum.) Kanatashelio,Akaro 2. Family Amaranthaceae ii . Aerva javanica (Burm .f.) Juss . Bur, Gorakhganjo iii. Celosia argentea L. Lamdi 3. Family : Aponogetonaceae iv. Aponogeton natans L. 4. Family: Asteraceae

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Sr. No. Family & Scientific name Vernacular name v. Blumea mollis Bhutaco vi. Blumea p. - vii . Echinops echinatus Roxb Shulio viii. Tridax procumbens L Pardesi Bhangro ix . Parthenium hysterophorus L x. Xanthium strumarium L. Gokhru 5. Family: Balsiminaceae xi. Impatiens balsamina L. var. coccinea 6. Family: Boraginaceae xii . Trichodesma indicum R. Br. Undha Fuli 7. Family: Commelinaceae xiii . Commelina benghalensis L xiv. C.forskalaei Vahl., Enum 8. Family: Convolvulaceae xv. Cressa cretica L. Palio, Rudanti xvi . Convolvulus arvensis L. xvii. Evolvulus alsinoides (L.) 9. Family: Cyperaceae xviii. Cyperus sp. xix. Fimbristylis dichotoma Vahl. xx . Fimbristylis sp 10. Family: Euphorbiaceae xxi . Euphorbia hirta L. 11. Family: Gentian aceae xxii . Nymphoides indicum (Roxb.) Kumudini 12. Family: Hydrocharitaceae xxiii . Hydrilla verticillata (L.f.) Royle xxiv. Ottelia alismodies L. 13. Family: Lamiaceae xxv . Basilium polystachyon Dungrau Tulsi xxvi. Ocimum gratissimum xxvii . Ocimum basilicum L xxviii . Ociumum sanctum L tulsi 14 . Family: Liliaceae xxix. Aloe barbadensis Mill. Kunvarpato 15 . Family: Malvaceae xxx. Abutilon indicum L. Khapat,Dabaliar xxxi . Hibiscus punctatus xxxii. Sida alba L Kandalo bala xxxiii . Sida sp. xxxiv . Pavonia zeylanica cav. - 16. Family : Myrtyniaceae xxxv . Martynia annua L . Vinchhudo 17. Family: Nyctaginaceae xxxvi . Boerhavia diffusa L. Satodi 18. Family: Nymphaeaceae xxxvii . Nymphaea stellate Wild Kamal

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Sr. No. Family & Scientific name Vernacular name 19 . Family: Papilionaceae xxxviii . Alysicarpus longifolious xxxix . Cortalaria prostate xl. Cortalaria juncea Shun xli . Indigofera cardifoila Heyne ex Roth xlii. Indigofera oblongifolia Forks. - xliii . Indigofera sp. xliv. Tehrosia purpurea L. Sarpankho xlv. Tephrosia sps. - xlvi . Medicago sativa L Lachko xlvii. Cacia tora Kuvandio 20 . Family: Poaceae xlviii. Aleuropus lagopoides (L) xlix . Cynodon barberi Rang. l. Cynodon dactylon (L.) li . Phragmites kara (Retz.) lii. Sorghum bicolor (L.) Jowar liii . Zea mays Makai 21. Family: Poligonaceae liv. Poligonum sp. 22 . Family: Pontederiaceae lv. Eichhornia crassipes (Mart.) Kanphutti 23 . Family: Potamogetonaceae lvi. Potomogetonsp. 24 . Family: Solanaceae lvii. Solanum nigrum L. Piludi lviii . Solanum surattense Brum. Bhoringni 25. Family: Scrophulariaceae lix. Bacopa monnieri L. 26 . Family: Tiliaceae lx. Corchorus depressus Stocks Bhuphali lxi . Corchorus aestunans L. Chunch lxii. Triumfetta rotundifolia Lam. Zipto 27 . Family: Typhaceae lxiii. Typha angustata Bory & Chaub 28 . Family: Zygophyllaceae lxiv. Tribulus terrestris L.

Climbers and Twiners Climbers observed during the present survey are given in the following table-3.17. 14 Climbers belong to 6 families are enumerated from the study area.

TABLE-3.17 CLIMBERS OBSEREVED IN THE STUDY AREA Sr. No. Family & Scientific name Vernacular name 1. Family: Asclepiadaceae i. Pentatropis spiralis (Forsk.) Decne Shingroti 2. Family: Convolvulaceae ii. Ipomea cairica (L.)

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Sr. No. Family & Scientific name Vernacular name iii . Ipomoea obscura L. iv. Ipomea aquatica Forsk. Nadanivel v. Ipomoea pes -caprae Dariani vel/Maryad vel vi. Ipomoea pes-tigrides L 3. Family: Cucurbitaceae vii. Corallocarpus epigeus (Arn.) viii . Coccinia grandis Ghiloda ix. Luffa cylindrica (L.) M. J. Roem Galku 4. Family: Cuscutaceae x. Cuscuta re flexa Roxb. Amarvel 5. Family: Menispermaceae xi . Cocculus hirsutus (L.) Diels Vevdi 6. Family: Papilionaceae xii . Mucuna prurita Hk.f. Kavach, Koyli xiii. Abrus precatorius L. Chanothi

Cultivated Plants in the Study Area The agricultural practices has occupied the majority of available the landscape. The crop practiced during the winter season in this locality is Wheat (Triticum aestivum). The crop occupying the highest percentage of the sown area of this region is taken as the major crop and all other possible alternative crops which are sown in this region either as substitutes of the base crop in the same season or as the crops which fit in the rotation in the subsequent season, are considered as minor crop.

Major Crops: Major crops in the study area are Rice (Oryza sativa L.) Cotton (Gossypium herbaceum) and Wheat (Triticum aestivum )

Minor crops: The minor crops of this region are Bajra (Pennisetum typhoides), Jowar (Sorghum bicolar ), Groundnut (Arachis hypogaea)

Rare and Endangered Flora in the Study Area The IUCN Red List is the world's most comprehensive inventory of the global conservation status of plant and animal species. It uses a set of criteria to evaluate the extinction risk of thousands of species and subspecies. These criteria are relevant to all species and all regions of the world. With its strong scientific base, the IUCN Red List is recognized as the most authoritative guide to the status of biological diversity.

Among the enumerated flora in the study area, none of them were assigned any threat category, by RED data book of Indian Plants. (Nayar and Sastry, 1990) and Red list of threatened Vascular plants (IUCN, 2010, BSI, 2003).

Endemic Plants of the Study Area De Candolle (1855) first used the concept of “Endemic”, which is defined as an area of a taxonomic unit, especially a species which has a restricted distribution or habitat, isolated from its surrounding region through geographical, ecological or temporal barriers. Among recorded plant species, during the survey period, none can be assigned the status of endemic plant of this region.

Status of Forest and Their Category in the Study Area No natural forest land was observed in the study area.

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Faunal Biodiversity in the Study Area For the documentation of the faunal biodiversity of the study area with respect to birds, reptiles, amphibians, and butterfly species, a baseline survey had been conducted.

Birds of the Study Area Systematic account of the birds in the study area with the status of occurrence is given in the table-3.18

TABLE-3.18 BIRDS OBSEREVED IN THE STUDY AREA Old Common name New Common Name Scientific Name Distribution I ORDER: APODIFORMES Family: Apodidae (swifts) House swift Little Swift Apus affinis R II ORDER: FALCONIFORMES Family: Accipitridae (vulture, Sparr ow hawk, Eagle, Harrier, Kite and Vulture) Shikra Shikra Accipiter badius R Black-winged Kite Black-winged Kite Elanus caeruleus R Common Pariakh Kite Black Kite Milvus migrans III. ORDER: : CICONIIFORMES Family: Ardeidae (heron, Egret, Bittern) Pond Heron Indian Pond-Heron Ardeola grayii R Cattle Egret Cattle Egret Bubulcus ibis R Median or Smaller Egret Intermediate Egret Mesophoyx intermedia R Egretta intermedia Little Egret Little Egret Egretta garzetta R Large Egret Great Egret Casmerodius albus Rw Family: Charadriidae (Plover, Stilt, Oystercatcher, Lapwing, Avocet ) Black-winged Stilt Black-winged Stilt Himantopus himantopus R Red -wattled Lapwing Red -wattled Lapwing Vanellus indicus R Family: Ciconiidae (Open bill, stork, Adjutant) Open bill stork Asian Open bill Anastomus oscitans R Family: Phalacrocoracidae (Cormorant) Indian Shag Indian Cormorant Phalacrocorax fuscicollis Family: Pteroclidae (Sandgrouse) Indian Sandgrouse Chestnut-bellied sandgrouse Pterocles exustus R Family: Threskiornithidae (Spoonbill and Ibis) Black Ibis Red-naped Ibis Pseudibis papillosa R White Ibis Black -headed Ibis Threskiornis melanocephalus R IV ORDER: COLUMBIFORMES Family: Columbidae (Pigeon, Dove) Blue Rock Pigeon Rock Pigeon Columba livia R Rin g Dove Eurasian Collared -Dove Streptopelia decaocto R Rufous Turtle Dove Oriental Turtle-Dove Streptopelia orientalis R V : ORDER: CORACIFORMES Family: Dacelonidae (King fishers) White breasted Kingfisher White-throated Kingfisher Halcyon smyrnensis R Family: Meropidae (Bee Eater) Chestnut-headed Bee-eater Chestnut-headed Bee-eater Merops leschenaulti R Family: Coraciidae (Roller) BlueJay or Roller Indian Roller Coracias benghalensis

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Old Common name New Common Name Scientific Name Distribution VI. ORDER: CUCULIFORMES Family: Centropodidae (Cocucal) Crow -Pheasant or Coucal Greater Coucal Centropus sinensis R Family: Cuculidae (cuckoo, Koel) Koel Asian Koel Eudynamys scolopacea R Indian Drongo Cuckoo Drongo Cuckoo Surniculus lugubris R VII. ORDER: GALLIFORMES Family: Phasianidae (Peafowl , Partridge, Quail, francolin, spur fowl, jungle fowl, Monal, ) Common Peafowl Indian Peafowl Pavo cristatus R Grey Partridge Grey Francolin Francolinus pondicerianus VIII. ORDER: GRUIFORMES Family: Rallidae (Waterhen, coot, crake water cock, Moorhen, Rail,) White-breasted Water hen White-breasted Water hen Amaurornis phoenicurus R IX. ORDER: PASSERIFORMES Family: Paridae (Tit ) Grey Tit Great Tit Parus major R Family: Cisticolidae ( Warbler or Prinia) Jungle Wern -Warbler Jungle Prinia Prinia sylvatica R Family: Corvidae Large Cuckoo-shrike Large Cuckoo-shrike Coracina macei R Coracina novaehollandiae Raven Common Raven Corvus corax R House Crow House Crow Corvus splendens R Black drongo - King Crow Black Drongo Dicrurus macrocercus R Dicrurus adsimilis Tr ee Pie Rufous Treepie Dendrocitta vagabunda R Family: Laniidae (shrike) Rufous backed Shrike Long -tailed Shrike Lanius schach R Family: Muscicapidae ( Short wing, Chat, Robin, Shama) Indian Robin Indian Robin Saxicoloides fulicata R Pied Bushchat Pied Bushchat Saxicola caprata R Family: Nectariniidae ( Sun Birds, Flower pecker, Spider hunter ) Purple Sunbird Purple Sunbird Nectarinia asiatica R Small Sunbird Crimson-backed Sunbird Nectarinia minima R Family: Passeridae ( Avadavat,Pipit, Wagtail, Munia, Snowfinch, sparrow, weaver ,Accentor) House Sparrow House Sparrow Passer domesticus R Family: Pycnonotidae (Bulbul) Red-whiskered Bulbul Red-whiskered Bulbul Pycnonotus jocosus R Red -vented Bulbul Red -vented Bulbul Pycnonotus cafer R Family: Sturnidae (Myna, Starling) Bank Myna Bank Myna Acridotheres ginginianus R Indian Myna Common Myna Acridotheres tristis R Family: Sylviidae ( Warbler, Browning, Fulvetta ,Babbler, Laughing thrash, Tailor birds) Common Babbler Common Babbler Turdoides caudat us R Jungle Babbler Jungle Babbler Turdoides striatus R Tailorbird Common Tailorbird Orthotomus sutorius R X. ORDER: PSITTACIFORMES

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Old Common name New Common Name Scientific Name Distribution Family: Psittacidae (Parrot and Parakeet) Rose-ringed Parakeet Rose-ringed Parakeet Psittacula krameri R Note: R = Widespread Resident, r= Very Local Resident, RW =Resident and winter visitor Ref WCMC, Check list of Indian Birds.

Butterflies from the Study Area Butterflies observed during the present study are documented in the table-3.19

TABLE-3.19 BUTTERFLIES OBSEREVED IN THE STUDY AREA Sr. No. Scientific name & family Common name 1 Family: Papilionidae i Papilio polytes Linnaeus Common Mormon 2 Family: Pieridae ii Eurema hecabe Linnaeus Common Grass yellow iii Ixias mariane Cramer White orange tip iv Ixias pyrene Linnaeus Yellow orange tip v Colotis danae Fabricus Crimson tip 3 Family: Nymphalidae vi Danaus chrysippus Linnaeus Plain Tiger vii Danaus genutia Cramer Stripped Tiger viii Hypolimanas misippus Linnaeus Danaid egg fly ix Mycalesis perseus Fabrici us Common bush brown

Reptiles Reptiles in the region are given in the table-3.20.

TABLE-3.20 REPTILES OBSEREVED IN THE STUDY AREA Sr. No. Scientific name & family Common name 1 Calotes versicolor (Daudin) Common garden lizard 2 Ptyas mucosus (Linn.) Common rat snake 3 Hemidactylus flaviviridis (Ruppell) House Gecko 4 Sitana ponticeriana ( Cuvier) Fan-Throated Lizard 5 Indian Cobra* Naja naja (Linn.) 6 Russell’s Viper* Daboia russelii ( Shaw and Nodder) 7 Common Indian Krait* Bungarus caeruleus ( S chneider) * Not sighted but included as per the information provided by villagers, during the interaction with them with pictorial presentation.

Mammals The wild mammals observed other than domesticated ones from study area is documented in the table-3.21

TABLE-3.21 MAMMALS OBSEREVED IN THE STUDY AREA Sr. No. Common name C Scientific name & family 1 Indian field mouse Mus booduga (Gray) 2 Common Mongoose Herpestes edwardsi (Geoffroy) 3 Hare Lepus sp. 4 Five striped Palm squirrel Funambulus pennanii ( Wroughton)

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Sr. No. Common name C Scientific name & family 5 Nilgai * Boselaphus tragocamelus (Pallas) 6 Wild Boar* Sus scrofa Linnaeus 7 Bengal Hanuman Langur Semnopithecus entellus (Dufresne

Rare and Endangered Fauna of the Study Area as Per IUCN Red (2016) List The IUCN Red List is the world's most comprehensive inventory of the global conservation status of plant and animal species. It uses a set of criteria to evaluate the extinction risk of thousands of species and subspecies. These criteria are relevant to all species and all regions of the world. With its strong scientific base, the IUCN Red List is recognized as the most authoritative guide to the status of biological diversity. Among the sighted fauna, while one bird; Black-headed Ibis ( Threskiornis melanocephalus ) is grouped under near threatened category.

As per Indian Wild Life (Protection) Act, 1972 Wild Life (Protection) Act 1972, as amended on 17th January 2003, is an Act to provide for the protection of wild animals, birds and plants and for matters connected therewith or ancillary or incidental thereto with a view to ensuring the ecological and environmental security of the country.

Some of the sighted fauna were given protection by the Indian Wild Life (Protection)Act,1972 by including them in different schedules. Among the birds in the study area, Pea fowl (Pavo cristatus), is included in schedule I of Wild life protection Act (1972), while many other birds are included in schedule IV.

Among the reptiles, Indian Cobra (Naja naja), and Common rat snake (Ptyas mucosus) were provided protection as per Schedule-II of Wild life protection act, (1972) Among mammals; (Bengal Hanuman Langur/ Northern Plains Gray Langur (Semnopithecus entellus (Dufresne) and Common Mongoose (Herpestes edwardsi), are schedule –II animals. The Indian Wild Boar (Sus scrofa) and Nilgai (Boselaphus tragocamelus) are protected as Schedule-III animal. Five stripped palm squirrel and all Hares are included in schedule IV of Wild Life Protection act 1972.

Table-3.22: Species provided Protection as per Wild Life Protection Act 1972

Group Species Schedule Birds Pea fowl (Pavo cristatus), Schedule I Most of other birds Schedule IV Reptiles Indian Cobra (Naja naja ), Schedule II Common rat snake (Ptyas mucosus) Schedule II Mammals Common Mongoose (Herpestes edwardsi ) Schedule II Five striped Palm squirrel (Funambulus pennanii) Schedule IV Hare (Lepus sp. Schedule IV Bengal Hanuman Langur, Northern Plains Gray Schedule II Langur (Semnopithecus entellus (Dufresne) The Indian Wild Boar (Sus scrofa) Schedule IV Nilgai (Boselaphus tragocamelus) Schedule III

Status of Forest and their category in the study area No natural forest land was observed in the study area except few scattered scrub cover in the barren lands and area demarcated for grazing.

3.5 GEO HYDROLOGY 3.5.1 GENERAL GEOLOGY Geologically the area is part of Cambay basin and is occupied by the quaternary alluvium comprising silt and sand.

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FIGURE- 3.7 (A) GENERAL GEOLOGY OF GANDHINAGAR DISTRICT

(Source: District Resource Map, Geological Survey of India, 2002)

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FIGURE- 3.7 (B) GENERAL GEOLOGY OF MAHESANA DISTRICT

Geomorphology Geomorphologically the district as whole has a flat planar topography.

3.5.2 DRAINAGE PATTERN OF THE AREA The study area is a part of North Gujarat Alluvial plain with neither hill features nor any prominent natural water bodies. One of the most important feature of the drainage of the study area is lack of any definite drainage system. No major river is crossing through the study area. Artificial drainage i.e. The Narmada Canal System flows through the study area.

3.5.3 GROUNDWATER DEVELOPMENT As per the GWRE, 2011 report, all the Four Talukas of the district are Over Exploited. The level of Ground Water Development varies from 102.93 % (Dehgam Taluka) to 148.46 % (Mansa Taluka). The overall development in the district is 120.05 %, and as a whole the Gandhinagar district is Over Expoited. Though, Improvement in Groundwater development is observed as a perusal of GWRE 2004, 2009 and 2011, but there is no scope for further development of groundwater resources in the district. Great need of artificial recharge and rainwater harvesting is required for efficient management of groundwater resources in the district. The details of Ground Water Resources and irrigation potential of the district is as follows which is given in table-3.23.

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TABLE-3.23 GROUNDWATER DEVELOPMENT OF DISTRICT NET STAGE OF ANNUAL EXISTING GROSS NAME OF GROUND WATER GROUND GROUND WATER DRAFT CATEGORY TALUKA DEVELOPMENT WATER FOR IRRIGATION (%) AVAILABILITY Dahegam 13408.31 13043.50 102.93 Over-exploited Gandhinagar 12165.73 13250.80 115.72 Over-exploited Kalol 10873.29 12424.00 122.90 Over-exploited Mansa 8852.73 12553.70 148.46 Over-exploited Kadi 13085.41 14688.21 119.11 Over-exploited Total 45300.05 51272.00 120.05 Over-exploited

The groundwater potential estimated by Groundwater Resource Estimation Committee is given the figure-3. 8.

FIGURE-3.8 WATER LEVEL MAP, GANDHINAGAR

Source: CGWB Report, Gandhinagar District

GROUND WATER RELATED ISSUES AND PROBLEMS The level of ground water development in Kalol taluka is 122.90%. The quality of ground water in the shallow aquifer is poor in the south western part. The fluoride content is more than permissible limit in six villages/ hamlets, whereas, in 13 villages/ hamlets the Nitrate is more the permissible limit.

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FIGURE-3.9 LOCATION OF AMBIENT AIR MONITORING STATIONS

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FIGURE-3.10 LOCATIONS OF GROUND WATER SAMPLING STATIONS

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FIGURE-3.11 LOCATIONS OF SURFACE WATER SAMPLING STATIONS

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FIGURE-3.12 LOCATIONS OF NOISE SAMPLING STATIONS

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FIGURE-3.13 LOCATIONS OF SOIL SAMPLING STATIONS

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ANTICIPATED ENVIRONMENTAL IMPACTS & MITIGATION MEASURES

4.1 IDENTIFICATION OF IMPACTS Various sources of pollution with respect to wastewater, the flue gas / process emission, hazardous waste and noise generation along with their qualitative and quantitative analysis as well as measures taken to control them are discussed herein with details. The network method was adopted to identify potential impact, which involves understanding of cause-condition-effect relationship between an activity and environmental parameters. This method involves the "Road Map" type of approach to the identification of second and third order effect. The basic idea is to account for the project activity and identify the type of impact that could initially occur followed by the identification of secondary and tertiary impacts.

4.2 PREDICTIONS AND EVALUATION OF IMPACTS Evaluation is an absolute term used for assessment and prediction by means of numerical expression or value. Assessment is the process of identifying and interpreting the environmental consequences of the significant actions . Prediction is a way of mapping the environmental consequences of the significant actions. Significant Action depicts direct adverse changes caused by the action and its effects on health of biota including flora, fauna and man, socio-economic conditions, landforms and resources, physical and cultural heritage properties and quality of bio-physics surrounds. Prediction requires scientific skill drawn from many disciplines. Prediction of ecological components is often uncertain, because their response to environmental stress cannot be predicted in absolute terms. The assessor (one who does the assessment) and decision maker (one who take the decision after adequate analysis of assessment report) is expected to be aware of the degree of uncertainty. The assessor generally uses the following methods and resources for impact assessment. ♦ Field surveys and monitoring ♦ Guideline and modeling ♦ Literature surveys and interviews ♦ Qualification and experience An impact can be defined as any change in Physical, Chemical and Biological, Cultural and Socioeconomic environment that can be attributed to activities related to alternatives under study for meeting the project needs. Impact methodology provides an organized approach for prediction and assessing these impacts.

Impact assessment is based on conceptual notions on how the universe acts that is intuitive and/or explicit assumption concerning the nature of environmental process. In most of cases the predictions consists of indicating merely whether there will be degradation, no change or enhancement of environment quality. In other cases, quantitative ranking scales are used. The selection of indicator is crucial in assessment because impacts are identifies and interpreted based on impact indicator. An impact indicator is a parameter that provides a measure (in at-least some qualitative or numerical sense) of the significance and magnitude of the impact. In India indicator is developed by the Central Pollution Control Board (CPCB) in the form of primary water quality criteria, biological water quality criteria, and national ambient quality criteria for air and noise.

The impact of the proposed expansion project on the environment has been considered based on the information provided by the proponents and data collected from the study area. The environmental impacts have been categorized as long or short term and reversible or irreversible. Primary impacts are those, which are attributed directly by the project while secondary impacts are those, which are indirectly induced. These typically include the associated investment and changed pattern of social and economical activities by the proposed action. The operational phase of the proposed project comprises several of which have been considered to assess the impact on one or another environmental parameters.

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Scientific techniques and methodologies based on mathematical modeling are available for studying impacts of various project activities on environmental parameters.

Minor and temporary impacts are expected due to the construction activities. All the impacts of construction phase will be short term only and it is very limited as minor construction work is anticipated for requirement of project. Operation of the project may potential to affect quality of life, air, noise, water, land, human and flora, fauna by increase in air, noise and water pollution, by increase in hazardous waste generation, by pollution from spillage/surface run-off, by disturbance to flora and fauna, by loss of trees resulting from increased assess, by increase in land values threatening agriculture, etc. During the operation phase, the following activities are considered as significant impact.
Air emission
Noise generation
Solid/Hazardous waste generation
Water use and waste water discharge
Employment Generation The operation of the project will involve discharge of pollutants. There may be wastewater generation, air emissions, hazardous waste generation and mechanical noise. An assessment of the quantitative changes in the various environmental components is therefore essential for predicting the impact. Operational phase activities will have impacts, either short terms or long term and reversible or irreversible on ambient air and noise, surface and ground water, land, socio-economics and cultural environment .

4.3 AIR ENVIRONMENT 4.3.1 DETAILS OF ENVIRONMENTAL IMPACTS A. During construction phase Construction phase involves site cleaning, excavation, construction, erection or installation of equipment & machinery, transportation and material handling. These activities will emit pollutants like dust, PM, SO 2 and NOx in to the air environment of the surrounding area. However, these activities will be intermittent and hence, significant adverse impact is low and for short terms only.

B. During Operation phase: Major source of air pollution during operation phase are point source i.e. stack attached to boilers, thermic fluid heater, D. G. Set, Hot air generator and Process vessels and fugitive emission. Details of which are discussed in following sections.

Details of Point source: Main pollutants from the stack attached to boilers, hot air generator, thermic fluid heater and D. G. set are PM, SO 2 and NOx, while from stack attached to process vessels is HCl.

Evaluation of Impacts using mathematical model: The impact of the concentration of air pollutants emitted from sources on the study area is evaluated using the Industrial Source Complex – Short Term (ISCST3) dispersion model, which is a steady-state Gaussian plume model. It is most widely accepted for its interpretability. It gives reasonably correct values because this obeys the equation of continuity and it also takes care of diffusion, which is a random process. The models are typically employed to determine whether the ambient air quality level due to proposed project will compliance with the National Ambient Air Quality Standards (NAAQS) or not. Over and above models also serve to assist in the design of effective control strategies to reduce emissions of harmful air pollutants. For the present study, this model is used for the prediction of maximum ground level concentration (GLC).

Following are the input data used for the modelling. 1. Micrometeorological Data : Site specific micrometeorological data i.e. ambient temperature, Relative Humidity, wind speed, wind direction, Cloud Cover, Rainfall, etc. were collected for study area. Details of micrometeorological data is presented and discussed in section 3.4.1 of Chapter-3.

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2. Mixing Height: Mixing Height (MH) is the vertical extent through which the contaminant plume can be mixed. Forecasting of mixing height is done with the aid of the vertical temperature profile. The MH is a function of stability. In unstable air the MH is higher and in stable air the MH is lower. With a lower MH, there is a smaller volume of air in which the pollutant can be dispersed, resulting in higher concentrations in the ambient environment. There is a seasonal variation of MH. During summer daylight hours, MH can be few thousand feet whereas for winter it can be a few hundred feet. It varies also in the course of a day. It is lowest at night and increases during the day. Secondary information has been used to determine the mixing height over the study region for the study period (October, 2016 to December, 2016) and it varies from 50-2500 meters (IMD).

3. Stack emission data: Details of proposed stack emission data in terms of stack height, stack diameter, flue/gas exist velocity, flue/gas exist temperature, pollutant concentration and emission rate used for the modelling purpose are given in following table-4.1.

TABLE-4.1 DETAILS OF STACK EMISSION DATA

Source of Emission (Stack Attached To) Operating Reaction No. Unit Steam Boiler (Existing + Thermic Fluid Heater Parameter Vessels Proposed) (Proposed) (Proposed) 1. Stack height Meter 30 30 09 2. Stack diameter at top Meter 0.46 1 0.15 3. Flue gas exit velocity m/s 20 3.5 1.5 4. Flue gas temp. K 473 423 333 5. Emission rate: PM g/s 0.3244 0.3000 - SO 2 g/s 0.5516 0.5101 - NOx g/s 0.2028 0.1875 - HCl g/s - - 0.0004 3 6. Emission Conc.: Utility Stacks: PM -150 mg/Nm , SO 2-100 ppm, NOx -50 ppm Process Stacks: HCl-20 mg/Nm 3

4. Model options used for computations: - The plume rise is estimated by Briggs formulae, but the final rise is always limited to that of the mixing layer. - Simple terrain. - Stack tip down-wash is not considered. - Buoyancy Induced Dispersion is used to describe the increase in plume dispersion during the ascension phase. - Calms processing routine is used by default. - It is assumed that the pollutants do not undergo any physico-chemical transformation and that there is no pollutant removal by dry deposition. - Washout by rain is not considered. - Cartesian co-ordinate system has been used for computations.

5. Model Output (Maximum Ground Level Concentration) Based on the modelling result under observed meteorological condition, 24 hourly average estimated maximum GLC along with distance and direction from the project site is presented in table-4.2.

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TABLE-4.2 MAXIMUM GROUND LEVEL CONCENTRATION OF PM, SO 2, NO X & HCl

First Maximum Ground Level Concentration (Avg. 24 Hourly) PM SO NO HCl Distance & Direction 2 X (µµµg/m 3) (µµµg/m 3) (µµµg/m 3) (µµµg/m 3) 1 km in South direction 2.45 4.17 1.53 0.03 First Maximum Ground Level Concentration (Avg. 24 Hourly) at AAQM Locations Monitoring Location Co-ordinates PM SO NO HCl No. 2 X (µµµg/m 3) (µµµg/m 3) (µµµg/m 3) (µµµg/m 3) 1. Project site (A1) (0,0) 0.00 0.00 0.00 0.0000 2. Bileshvarpura (A2) (3.105, 1.282) 0.01 0.00 0.00 0.0000 3. Irana (A3) (-2.464, 2.564) 0.24 0.41 0.15 0.0018 4. Budasan (A4) (-3.907, 0.240) 1.01 1.72 0.63 0.0035 5. Rajpur (A5) (-0.541, 4.809) 0.07 0.13 0.05 0.0001 6. Achrasan (A6) (-0.981, -1.803) 0.51 0.86 0.32 0.0041 7. Lunasan (A7) (1.903, -2.8 45) 0.04 0.07 0.02 0.0000 8. Chhatral city (A8) (3.096, -0.769) 0.06 0.11 0.06 0.0001

The spatial distribution of ground level incremental concentrations of pollutants due to proposed project operation on the impact zone area of 10 km x 10 km on modelling grid size of 1000 m x 1000 m around the proposed site is shown in figures-4.1 to 4.6 respectively. The predicted ground level concentration of pollutants is given in the table-4.3, along with resultant concentration at the monitoring location around the project site.

Modelling result envisages that incremental ground level concentrations of pollutants due to operation of proposed project during the operation phase are negligible and will remain within National Ambient Air Quality Standards published by MoEFCC, New Delhi vide G.S.R. 826 (E), dated 16/11/2009. Hence there will be no significant impact on the air environment.

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FIGURE-4.1 SPATIAL DISTRIBUTION OF 24-HOUR AVERAGE PM CONC. (µg/m3)

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3 FIGURE-4.2 SPATIAL DISTRIBUTION OF 24-HOUR AVERAGE SO 2 CONC. (µg/m )

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FIGURE-4.3 SPATIAL DISTRIBUTION OF 24-HOUR AVERAGE NOx CONC. (µg/m3)

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FIGURE-4.4 SPATIAL DISTRIBUTION OF 24-HOUR AVERAGE HCl CONC. (µg/m3)

M/s. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 4-8 en-vιsιn

TABLE-4.3 SUMMARY OF ISCST3 MODEL OUTPUT FOR POLLUTANTS

Monitoring Concentration (µµµg/m 3) NAAQM Pollutants Location Baseline Incremental Resultant Standard Project site (A1) 71.52 0.00 71.52 Bileshvarpura (A2) 71.85 0.01 71.86 Irana (A3) 66.85 0.24 67.09 Particulate Matter, Budasan (A4) 72.57 1.01 73.58 Size less than 100 µg/m 3 Rajpur (A5) 65.77 0.07 65.84 10 µm (PM 10 ) Achrasan (A6) 70.23 0.51 70.74 Lunasan (A7) 62.79 0.04 62.83 Chhatral city (A8) 72.86 0.06 72.92 Project site (A1) 13.91 0.00 13.91 Bileshvarpura (A2) 13.25 0.00 13.25 Irana (A3) 10.79 0.41 11.2 Sulphur Dioxide Budasan (A4) 13.50 1.72 15.22 3 (SO 2) 80 µg/m Rajpur (A5) 9.26 0.13 9.39 Achrasan (A6) 11.42 0.86 12.28 Lunasan (A7) 10.54 0.07 10.61 Chhatral city (A8) 9.42 0.11 9.53 Project site (A1) 22.43 0.00 22.43 Bileshvarpura (A2) 20.61 0.00 20.61 Irana (A3) 18.94 0.15 19.09 Nitrogen Oxide Budasan (A4) 20.97 0.63 21.6 (NOx) 80 µg/m 3 Rajpur (A5) 19.81 0.05 19.86 Achrasan (A6) 21.73 0.32 22.05 Lunasan (A7) 17.89 0.02 17.91 Chhatral city (A8) 20.00 0.06 20.06 Project site (A1) 0.0000 Bileshvarpura (A2) 0.0000 Irana (A3) 0.0018 Hydrochloric Budasan (A4) 0.0035 Acid (HCl) <1.0 <1.0 - Rajpur (A5) 0.0001 Achrasan (A6) 0.0041 Lunasan (A7) 0.0000 Chhatral city (A8) 0.0001

Details of fugitive emission: Looking to nature of the proposed project it may generate fugitive emissions. Sources of fugitive emissions include storage of chemicals, manufacturing activities, solvent handling, processing vessels, valves, joints, loading and unloading section, raw material handling and hazardous waste storage area, etc. Fugitive emissions will be in a small quantity but it gives continuous exposure to the workers.

4.3.2 MITIGATION MEASURES To control stack emission: Following are the mitigation measures proposed to control air emission from stack - Wood Waste/ Agro waste as fuel is being used in existing boiler and Coal/ Agro waste as fuel will be used for proposed boiler. Multi cyclone separator will be provided for common stack to control air emission. - Coal as fuel will be used in Thermic Fluid Heater, Multi cyclone separator will be provided to control air emission. - To control process emission from two stacks attached to two and four process vessels respectively, Water scrubber followed by Alkali Scrubber will be provided. - Diesel as a fuel will be used in D.G. Set, Acoustic Enclosure with adequate stack height will be provided.

M/s. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 4-9 en-vιsιn

- D. G. Set will be operated only during power failure. - Stack monitoring facility will be provided to all the stacks for regular monitoring.

To control fugitive emission: Following are the mitigation measured proposed to control fugitive emission from the proposed project. - Mechanical seals in pumps, compressors, treatment vessels, distillation vessels shall be used and maintained periodically. - LDAR programme will be implemented and followed for detection and control of fugitive emission of gases from process. - Closed unloading, conveying and packing system shall be provided. - More weightage on selection of MOC of piping shall be given to avoid leakage/spillage. - Safety devices shall be provided to workers working near the reactors. - Drip tray will be placed for each pump to collect leakages and spillages. - Breather valves, PSVs, Rupture disc, Vapor recovery system will be installed for process/storage tank vents - Proper Control of the operating parameters, mainly temperature, vacuums, cooling media circulation, during plant operation and solvent recovery - Regular monitoring of VOC concentration in work zone. - Greenbelt will be developed around the plant to arrest the fugitive emission.

4.4 WATER ENVIRONMENT With respect to water environment three aspects are generally considered in EIA, the raw water availability, consumption and wastewater generation. The first priority in water quality assessment is to maintain and restore the desirable level of water quality in general.

4.4.1 CONSTRUCTION PHASE IMPACTS AND MITIGATION MEASURES During Construction , drainage pattern and water supply system of overland water flow will be somewhat changed due to the site preparation activities. The local labor force will be deployed during construction phase and no colony is proposed as the workers will be employed from the nearby local village. During the construction phase of the project, water requirement will be mainly for construction activities, growing plants, etc. As construction labour will be from local area, minor quantity of domestic water will be required. So domestic wastewater generation will be negligible, it shall not contaminate the ground water or surface water in the nearby areas.

4.4.2 OPERATION PHASE IMPACTS AND MITIGATION MEASURES Water requirement shall be fulfilling through ground water. Daily water requirement for the existing project is 14.1 KLD, which will be increased up to 60 KLD due to proposed expansion project. Major portion of the study area is falls in semi-critical zone and rest in over exploited zone as classified by Central Ground Water Authority (CGWA). Project location is falls in over exploited zone and hence water withdrawal from ground will have significant impact on ground water availability. To reduce the impact recharging ground water through rain water harvesting within premises and nearby villages is proposed.

To maintain balance of ground water, company will construct rain water harvesting structure i.e. recharge well to recharge ground water and storage of rain water for future use as per norms specified by CGWA. There may be risk of ground water and surface water contamination due to wastewater generation and handling from the industrial activities like process, washing, cooling and boiler. Around 31.3 KLD waste water will be generated after proposed expansion project. Domestic waste water around 3.65 KLD will be treated and disposed off through septic tank/well. While industrial waste water around 28 KLD will be segregated into two streams, concentrated and diluted. Concentrated stream will be sent for common MEE facility and diluted effluent will be treated in ETP after that it will be evaporated through single stage evaporator. Detailed description of effluent treatment scheme is discussed in chapter-2.

4.5 SOIL ENVIRONMENT The main source of impact on land and soil environment will be due to solid waste generated during construction and operation activities. In addition to this accidental spillage of chemicals and effluent can also degrade the soil environment.

M/s. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 4-10 en-vιsιn

4.5.1 CONSTRUCTION PHASE IMPACT AND MITIGATION MEASURES The proposed project activities will be located on flat terrain no significant topographical change is expected due to construction activities. The construction of building will help in fixation of soil, thereby reducing the soil erosion. Some construction operations shall disturb the soil profile, but the impact will be insignificant. There will be no change in existing land use pattern, forest cover or vegetation in surrounding area. During the construction phase, various types of solid waste generated which will affect the site, all wastes from the site will be cleared with due care.

During the construction activity, municipal waste will be generated in minor quantity as local construction workers will get employed and no construction camp is proposed. The generated waste will be collected, segregated and will be disposed off suitably. Hence impacts will be insignificant, reversible and for short duration only. These impacts will be confined to the construction site only and no adverse impact on the surroundings environment is anticipated .

4.5.2 OPERATION PHASE IMPACT AND MITIGATION MEASURES Due to proposed project, hazardous/solid waste generation there will be increased. Details of existing and proposed hazardous/solid waste generation are discussed in chapter-2.

All solid/hazardous waste will be stored separately in designated area within the premises. Hazardous waste generation due to proposed expansion project will be mainly ETP sludge, used oil, Discarded Containers/ Barrels/plastic, Date Expired, discard and off specification medicines and Fly Ash. These all waste will be collected, storage designated area and disposed as per Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016. Membership of authorized common TSDF, MEE and incineration site will be obtained.

There will be risk of Soil contamination due to spillage of hazardous chemicals, solid/hazardous waste and liquid effluent during handling. To mitigate that proper handling of chemicals and hazardous waste will be done. In case of any spillage entire contaminated soil will be removed and disposed to secured landfill site. Hence, no adverse impact on soil environment due to the proposed project activities is envisaged.

4.6 NOISE ENVIRONMENT 4.6.1 DETAILS OF NOISE ENVIRONMENTAL IMPACTS The assessment of the impacts of noise on the surrounding community depends upon: • Characteristics of noise source (instantaneous, intermittent, or continuous in nature) • Time of day at which noise occurs • Location of noise source with respect to noise receptor For an approximate estimation of propagation of noise in the ambient air from the area or point source, a standard mathematical model for sound wave propagation used is as follows:

Noise (Receptor) = Noise (Source) - 20 Log [distance (Receptor) / distance (Source) ]

4.6.2 CONSTRUCTION PHASE IMPACTS Construction will be carried out within premises, so not more than industrial plant construction activities would be carried out. Like admin building, security, parking etc will not be constructed. Only Some new plant machinery will be installed for that construction work will be carried out, which will be for short period. Noise will be increased for the short period. 1. Vehicular movement for construction material transportation. 2. Operation of construction machineries So impact of construction activities on noise environment will be too much localized. Near to that factory premises no other habitation or industry so no outsiders of the company will get affected due to noise pollution. Workers near to high noise area will be provided PPEs.

4.6.3 OPERATION PHASE IMPACT AND MITIGATION MEASURES During operation phase of proposed plant prime noise emission will be expected from industrial activities like diesel generator, mechanical movement, boiler operation and material handling. Noise emission level from these sources will be expected to keep remain below the permissible limit. However, at places where M/s. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 4-11 en-vιsιn noise levels may exceed the permissible limit, acoustic enclosure will be provided (e.g. D.G. Set). Noise protection equipment will be provided to workers where high occupationally noise exposure limit envisaged. Greenbelt will be developed around the periphery of the plant to mitigate the noise levels on the ambient environment.

4.6.4 IMPACT OF THE TRANSPORTATION Total 80 numbers of trucks will be required for the transportation of raw material, finished goods and wastes after proposed expansion. Major impact on surrounding environment of this transportation will be mainly increase in noise and vibration, dust, carbon monoxide, etc. There is no alternative option available for transportation of goods other than road due to site location. And road way is feasible and easy as per location because GIDC corridor and connected to Kadi and Kalol GIDC. Nearest railway station and airport is Kalol and Ahmedabad which is around 10 km and 32 km away respectively from the site.

4.7 ANTICIPATED ENVIRONMENTAL IMPACTS AND ITS MITIGATION MEASURES FOR LAND USE 4.7.1 IMPACT ASSESSMENT To identify impact on land use of the project considering various environmental impacts, social, ecological impacts during construction and operation phases. The corresponding mitigation measures to take care of the adverse impacts are also discussed in following sections.

4.7.2 IMPACT OF LAND USE
Total land area of the project site is 7,066 m 2 & space for the proposed expansion project will be utilized from available open land.
Point to be noted that project site is situated in Kalol Taluka of Gandhinagar district and the project site is near to the district border of Gandhinagar and Mahesana, other Industries also can be found within the study area which will be cumulatively effect the environment, majorly chemical industries.
Chhtral, Kalol and Kadi are major settlement along with other smaller settlements could be affected due to air pollution, respiratory diseases.

4.7.3 MITIGATION MEASURES OF LAND USE
Seepages, percolation of project site water of the site need to be strictly controlled through constructions of peripheral the wall around the site.
All effluents whenever other pollutants must be controlled in such away leakage / seepage within the project premises or within the study area.
As project site should develop proper green belt according to requirement of CPCB norms.
Protection & Conservation measures for crop lands should take by the industries.

4.8 ECOLOGICAL IMPACT ASSESSMENT The impact due to construction phase and operation phase of the project and its activities on the ecological parameters like natural vegetation, cropping pattern, fisheries and aquatic life, forests and species diversity. There is no any sanctuary, reserve forest and national park within the 10 km area from the proposed expansion project site. Proposed expansion project will be carried out in already acquired existing land. vegetation will not be cleared. Chances of adverse effect on ecology may be occurred due to air pollution caused by flue gases emission and process emission. However, unit has proposed adequate environmental management systems and the same will be efficiently operated during the operation of project. Regular monitoring of various parameters will be carried out. Thus, there will not be any adverse impact will be occurred on surrounding ecology. Greenbelt development will have positive impact on flora and fauna.

4.8.1 NATURAL VEGETATION Industry will develop a green belt on the surrounding periphery. Since the effluents and emissions generated from the project activities shall be treated and disposed as per the EMP provisions, adverse impact over any of the ecological components of the environment is reduced to minimum.

4.8.2 CROPS The proposed expansion shall not alter the crop production of the area. The area is having cropping lands. Further, the necessary environmental protection measures have been planned under EMP e.g. air pollution control systems shall be designed to take care of even emergency releases of the gaseous pollutants like M/s. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 4-12 en-vιsιn

Particulate Matter, SO 2, and NOx. Regular environmental surveillance shall be done for the unit, so as not to have any short-term or cumulative effect on the crops and the natural vegetation of the area.

4.8.3 FOREST, NATIONAL PARKS / SANCTUARIES There is no reserved forest, national park or sanctuary within 10 km radius of the plant. There shall be no impact on the same.

4.9 IMPACT ON SOCIO-ECONOMIC ASPECTS Every development brings destruction with it, anticipated impacts and mitigations are presented here:

NEGATIVE IMPACTS
Culture : The proposed expansion project will require additional manpower around 100 (19 existing and 81 proposed). The proposed expansion project will increase the migration of skilled personnel. Additional 81 manpower are required and due to this behavior, living style, etc. of local people will change through multi-cultural. Hence, Cultural impact is envisaged.
Environmental impact: Migration may bring mental health problems. Chemical exposure during production activities may have some adverse impact on human health in the long run like skin irritation, dermatitis, erythema, and scaling, eye irritation, irritation of the respiratory tract and affect respiration.

POSITIVE IMPACTS
Employment generation: The Company recruits local people as far as possible to generate employment in local area, it will increase socio-economic status of the local society, the requirement of around additional 81 personnel as direct manpower will enhance standard of living of families. During construction period employment will be generated especially for local people. The employment opportunity created will serve as a tool for reduction of poverty.
Enhance Socio- economic status: This project will bring social change in the society with improved socio-economic life of the local people; this project will also generate indirect employment, like primary grocery requirements of residential, functional shopping, entertainment facilities, better transportation facility etc.
Rural Development: Nearby villages will get developed through CSR activities of the company. Education level will also improve among the people of local area because of two reasons, one is company will promote education under its CSR activities and secondly requirement of eligible employees for the company so students will get motivated for higher education.

4.10 PLACES OF ARCHAEOLOGICAL/HISTORICAL/RELIGIOUS/TOURIST INTEREST There is no place of archaeological, historical, religious or tourist interest within the study area i.e. 10 km radius of plant site. Hence, there shall be no impact on places of interest.

4.11 ENVIRONMENTAL HAZARD Raw material and finish products shall be transported by road and shall be stored in the plant premises. Onsite and offsite emergency plan shall be prepared for storage and handling of materials and finished goods. This report shall be prepared with the consideration of hazards associated with the materials and care should be taken for all aspects of environmental hazards. The project proponent shall consider all the safety aspects in planning, designing and operation of the plant as per standard practices. Hence, no adverse impact on this account is anticipated.

M/s. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 4-13 en-vιsιn

TABLE-4.4 POTENTIAL IMPACTS & MITIGATIVE MEASURES

Environmental Potential Source of Controls Through EMP & Potential Impacts Impact Evaluation Remedial Measures Components Impact Design Water Quality Deterioration of water Construction activity: Proper management of surface Low COD effluent will be quality Withdrawal of water for water runoff shall be made. Insignificant adverse impact evaporated after treated in construction activity and ETP and High COD stream Decrease in water domestic use for Effluent treatment plant (ETP) for will be sent to Common availability construction workers. treatment of waste water. MEE for further treatment with utmost care. Operation Activity: Rain water harvesting Water withdrawal for industrial use and domestic Green belt development use. Air Quality Emissions of dust, PM, Construction Phase: Suitable control measures will be Not significant because dust During construction Phase SO 2 and NOx All heavy construction adopted as per a dust control plan generation will be the contractors are advised activities. Transportation of and closed vehicles will be used. temporary and will settle to use dust masks for the materials. Water will be sprinkled on loose fast due to dust suppression employed labour. top soil. techniques used Operation Phase : Water sprinkling for Due to transportation of suppression of dust during raw material, wasters and Closed system adopted, due care construction phase. products. handling of chemicals

Emissions of PM, SO 2, Operation Phase : Not significant impact Efficiency of air pollution NOx and HCl Emissions from the stack Adequate stack height control equipment will be attached to steam boiler, checked on regular Hot air generator, Thermic Water scrubber followed by Alkali intervals. fluid heater and D.G.Set Scrubber attached to process stack

Emissions of HCl from Green belt to be provided with stacks attached to process specific species reducing PM vents. levels. Socio-Economic Overall growth & Project activities CSR activity is proposed Beneficial change Preference to local people development of area, for employment increased primary & secondary employment, improvement in infrastructure and growth of other industries

M/s. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 4-14 en-vιsιn

Environmental Potential Source of Controls Through EMP & Potential Impacts Impact Evaluation Remedial Measures Components Impact Design Terrestrial Ecology Minor loss of habitat -flora Project activities Green belt, P roper management of In -significant Impact - & fauna solid waste and liquid effluent

Noise Environment Noise emissions Construction Phase: Use of well-maintained equipment Residential areas are Use of Personal Protective Operation of construction fitted with silencers. located more than 800 m Equipment (PPE) like equipment and vehicles Providing noise shields near the away from the site and earmuffs and earplug during during site development. heavy construction operations hence there is no noise construction activities. Construction activity will be increase expected from the limited to daytime hours only. project activities. Also, there are no sensitive receptors located within near vicinity of site. Operation Phase: Green Belt Development In-significant - Process activity area Providing acoustic enclosures Loading and unloading Short-term exposure within area. permissible limit. Infrastructure & Improved communication, Social activities of Development has been gradual Beneficial impact - Services transport, housing, company educational & medical facilities Environmental Risk to environment & Storage of materials On site & off site Disaster Insignificant adverse impact Proper storage and handling Hazards neighboring population management plan & Safe practices of materials

M/s. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 4-15 en-vιsιn

4.12 MATRIX REPRESENTATION The parameters discussed are presented in the form of a matrix in table-4.5. The impact matrix relating to the activities during construction and operation phase is presented.

The quantification of impact is done using numerical scores 0 to 5 as per the following criteria.

Score Severity criteria 0 No impact 1 No damage 2 Slight/ Short-term effect 3 Occasional reversible effect 4 Irreversible/ Long-term effect 5 Permanent damage The scores for various parameters and activities are presented in table-4.5. Score of environmental impact matrix are given in table-4.6.

4.12.1 CUMULATIVE IMPACT CHART The total negative impact of various activities on any one parameter is represented as a cumulative score and the cumulative scores of various parameters are given in the form of a cumulative impact chart presented in table-4.7. Any particular parameter having an individual score greater than 4 or cumulative score of 20 implies serious effects due to the project and calls for suitable mitigation measures.

It is evident from the matrices that the resultant impact is beneficial to the local population and due to export (and import substitution) the resultant impact is beneficial to our country.

TABLE-4.5 IMPACT IDENTIFICATION MATRIX

Land Terres- Socio- Re- Water Requi- Env. Activities During Air Infrast- trial & Econom source Noise Qualit rement Hazar Odor Operation Phase Quality ructure Aquatic ic Deplet y & Land ds Ecology Status ion use Resource - - - Consumption Material & goods - - - - Storage/handling Utilities - - - Gaseous Emissions - - - - - Fugitive Emissions - - - - - - Solid & Hazardous - - - - - Waste Disposal Spills & Leaks - - - - - - Shutdown/ Startup - - - - Equipment Failures - - - - Plant Operations - Transportation - - - - - -

M/s. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 4-16 en-vιsιn

TABLE-4.6 ENVIRONMENTAL IMPACT MATRIX

Land Terres- Socio- Re- Water Requi- Env. Activities During Air Infrast- trial & Econom source Noise Qualit rement Hazar Odor Operation Phase Quality ructure Aquatic ic Deple- y & Land ds Ecology Status tion use Resource 1 0 2 1 0 2 1 1 3 0 Consumption Material & goods 1 2 0 2 2 1 0 0 0 1 Storage/handling Utilities 2 2 2 1 0 2 0 1 2 0 Gaseous Emissions 3 0 0 0 0 2 2 1 0 1 Fugitive Emissions 2 0 0 0 0 1 1 0 0 1 Solid & Hazardous 1 0 0 1 1 1 0 0 0 1 Waste Disposal Spills & Leaks 1 0 1 0 0 1 0 0 0 1 Shutdown/ Startup 1 1 1 0 0 0 0 2 1 1 Equipment Failures 1 1 2 0 0 1 1 0 0 1 Plant Operations 2 2 3 0 2 1 1 1 3 1 Transportation 2 2 0 0 3 1 0 0 0 0

TABLE-4.7 CUMULATIVE IMPACT CHART

Environmental Parameter Total Cumulative Score Air Quality 17 Noise 10 Water Quality 11 Land Requirement and Landuse 05 Infrastructure 08 Environmental Hazards 13 Terrestrial Aquatic Ecology 06 Socio Economic Status 06 Resource Depletion 09 Odor 08

M/s. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 4-17 en-vιsι
n CHAPTER – 5

ANALYSIS OF ALTERNATIVES

5.1 ALTERNATIVES OF TECHNOLOGY For the proposed range of products, M/s. Orbit Pharma Laboratories will use chemical synthesis methodology. All the products are well established in scientific forum of world chemical association. M/s. Orbit Pharma Laboratories will increase the efficiency of chemical synthesis, by providing proper working conditions & industrial equipments.

5.2 ALTERNATIVES OF SITE 5.2.1 DESCRIPTION • The market of Pharmaceutical Industry has fast progressing growth and there is ample opportunity in indigenous as well as export market. • Management of M/s. Orbit Pharma Laboratories has decided to come up with the new family of products. • Site selection for a project is a critical decision made by management that significantly affects their profit and loss. Decisions regarding the locations of industrial facilities influence where people work, live, and determine the life-style of a community. • For the expansion of unit, company has two options, 1. Purchase a new site. 2. Establish a new unit in existing premises. After considering adverse impact & their mitigation measures for both options, Final selection of site has been made.

5.2.2 IDENTIFICATION OF ADVERSE IMPACT (1) If company will purchase a new site 1. Enormous increase in the capital cost of the project, if land possession cost is high. 2. Water, power, raw materials, transportation and skilled labour should not be cost effective. If the site is not selected properly, it will adversely impact the project in above area.

(2) If company will establish a new unit in existing premises 1. Pollution load will be increased at existing site. 2. Fresh water requirement will be increased, thus additional burden on water source will take place. 3. More transportation will take place that will increase the traffic density of that specific region.

5.2.3 MITIGATION MEASURES (1) If company will purchase a new site 1. New site should be available within budget. 2. Site should be very well connected with road/rail for the ease of transport, with all the infrastructure facilities like availability of water, power etc. 3. Availability of man power should be there.

(2) If company will establish a new unit in existing premises 1. Proper mitigation measures to control Air, Water & Noise pollution will be provided. 2. Existing site has all the infrastructure facilities including broad roads, so that connectivity of transportation etc will easily take place. 3. Existing experience of handling raw material, plots, manpower can be a good concept for proposed expansion.

5.2.4 SELECTION OF SITE The project is having its pharmaceutical unit at the same location which is going for expansion. • All administration will be done from one stage and common facilities will have cost reduction. • Infrastructural facilities are available for the ease of project

M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 5-1 en-vιsι
n

• Easy availability of fuel, water, power, manpower, raw material, etc. • No national park or wildlife habitats fall within 10 km radial distance from proposed project site. • Hazardous waste disposal site is nearer to the project site.

Therefore, selected site is having positive benefit for the resin manufacturing unit.

So, the second option of establishing a new unit in existing premises is more convenient then to purchase a new site for the proposed project.

5.3 NO PROJECT ALTERNATIVE There is no alternatives to this project is thought of. Experience of handling similar operation of same site will anyway lead to better management of operations and an environment sound operational practice. Further the products listed are coming under life saving drugs and their production at our country will reduce the import of drugs and will increase the availability in market and hence ensuring cost control on similar products. Moreover, such projects increase resource utilizations by creating more employment and hence contributing to the nation’s economic growth.

M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 5-2 en-vιsι
n CHAPTER – 6

ENVIRONMENTAL MONITORING PROGRAM

6.1 INTRODUCTION Environmental monitoring provides feedback about the actual environmental impacts of a project. Monitoring results help judge the success of mitigation measures in protecting the environment. They are also used to ensure compliance with environmental standards, and to facilitate any needed project design or operational changes. An environmental monitoring program is important as it provides useful information and helps to:
Assist in detecting the development of any unwanted environmental situation, and thus, provides opportunities for adopting appropriate control measures, and
Define the responsibilities of the project proponents, contractors and environmental monitors and provides means of effectively communicating environmental issues among them.
Define monitoring mechanism and identify monitoring parameters.
Evaluate the performance and effectiveness of mitigation measures proposed in the Environmental Management Plan (EMP) and suggest improvements in management plan, if required.
Find out pollution level inside the plant and in nearby area.
Compile pollution related data for remedial measures.
Find out efficiency level of pollution control measures adopted.

6.2 MONITORING SCHEDULE DURING OPERATION PHASE Environmental monitoring program is a vital process of any management plan of the development project. This helps in assessing the potential problems that result from the proposed expansion project, changes in environmental conditions and effectiveness of implemented mitigation measures. Regular monitoring in a systematic and standardized manner helps in assessment of current environment and provides information on operational performance of installed pollution control facilities. Proposed schedule of environmental monitoring for the proposed project is given in following table-6.1 which will be carried out by third party.

TABLE-6.1 PROPOSED SCHEDULE OF ENVIRONMENTAL MONITORING Area of Frequency of No. Sampling Locations Parameters to be Analyzed Monitoring Sampling Air Pollution Monitoring

1. Stack Emission Each utility stack PM, SO 2, NOx , HCl Once in a month Ambient Air PM , PM , SO , NOx, VOC , 2. Three samples 10 2.5 2 Once in six month Quality CO, HCl Work Zone 3. Within premises VOC Once in a year Environment Water Pollution Monitoring pH, BOD, COD, TSS Continuous Inlet and outlet of Effluent 4. Waste water treatment plant As per consent of PCB Once in a month Ground and 5. Two sampling locations As per IS Standards Once in a year surface water Soil Pollution Monitoring Two sampling locations of 6. Soil As per consent of PCB Once in year Impact Area Noise Pollution Monitoring Noise generating units Sound Pressure Levels (Leq) Once in a month 7. Noise within Plant Sound Pressure Levels (Leq) Once in a month

M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 6-1 en-vιsι
n

Area of Frequency of No. Sampling Locations Parameters to be Analyzed Monitoring Sampling Pre-employment Check up Vision, Audiometry, Spirometry, Once after Chest Skiagram, Urine, RBCs, appointment etc. Periodical Check up Spirometry, Urine, RBCs, <30 yrs. O nce in five Anemia, etc. years 31-40 yrs. Once in Occupational four years 8. Health 41-50 yrs. Once in Monitoring two years Above >50 yrs. once every year Post employment check up Vision, Audiometry, Spirometry, Chest Skiagram, Urine, RBCs, Once before relief etc.

6.3 WORK ZONE MONITORING FOR HAZARDOUS CHEMICALS Work zone monitoring for hazardous chemicals will be carried out by third party NABL/MoEF&CC authorized laboratory. Sampling locations will be identified for the air borne concentration of hazardous chemicals. Monitoring will be carried out and records shall be kept as per Gujarat Factories Rules (GFR). List of some hazardous chemicals being used and going to be used are given as follows: Toluene, Chloro Acetyle Chloride, Acetic acid, Diethyle Amine, HCl, Acetone, Hydrogen Peroxide, IPA, MDC etc.

M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 6-2

CHAPTER – 7

ADDITIONAL STUDIES

7.1 PUBLIC CONSULTATION/HEARING Public consultation is applicable for the proposed project as per Para 7(i) III (b) of EIA Notification, 14 th September, 2006 as the project is located outside the notified industrial area. Details of the Public consultation/hearing will be incorporated after completion of public hearing.

7.2 RISK ASSESSMENT

7.2.1 INTRODUCTION Industrial activities including production, storage, handling, transportation and operational practices presents levels of hazards to workforce, population and environment at large due to accidents, spills, leaks etc. These accidents results in personal and financial loss. The assessment of the threat posed, its control and prevention through good design, management and operational controls is of primal importance. Events like the Bhopal tragedy have emphasized the need to address both on-site and off-site safety. It is against this background that the various Section and Rules under the Environment Protection Act, 1986, the Factories Act, 1948 and other Acts specify the requirements for a safe and reliable working of an industry. These require carrying out various studies and analysis to assess and mitigate hazards prevalent in the factory in line with the goal of safe and reliable working. These are more commonly known as “Risk Assessment Studies”. Risk assessment refers to the technical, scientific assessment of the nature and magnitude of risk and uses a factual base to define the health effects of exposure of individuals or populations or ecological receptors to hazardous contaminants and situations. The QRA report signifies that trained & skilled employees and supporting services can achieve improved safety & productivity levels. Together they can also achieve low maintenance cost, optimized use of Raw materials and negligible rejections/ wastes. The project is advised to equip with a well planned Disaster Management Plan as an essential Mitigation Control Measure. Substantial information is given in the chapter PREVENTIVE MEASURES of QRA, for choosing Plant and Equipment which will ensure PRODUCT SAFETY . A good Legal & Regulatory Compliance Register shall be planned and be in place. All the Rules and Regulations of the land shall be strictly followed to achieve a hindrance free operation of the plant from the statutory point of view. A good safety Manual shall be planned and be in place. All the requirements of Safety & Health of the operating plant shall be an essential part of the manual. The Safety manual will serve as a good communication medium to the employees of the plant. The systems to be complied by the operating level employees as part of their responsibilities and the operational requirements of the system will be readily available in the manual.

Risk Assessment study includes predictions of the WORST-CASE SCENARIO (catastrophic failure) and MAXIMUM CREDIBLE ACCIDENT SCENARIO along with damage distances and preparedness plan for effectively combating such situations. The report also discusses and demarcates the vulnerable zones and a detailed fire control plan for flammable substances.

No plan is complete or total of its requirements and its scope of improvement is a continuous process. Hence, the RISK ASSESSMENT REPORT is to be reviewed and updated as and when: • any expansion, alteration, or extension of the plant is planned / implemented • an incident has occurred and been dealt with, based on feedback gathered on any shortcomings in the handling of the situation • any feedback is received from the users of the report Risk Assessment is therefore defined as a continuous and integrated process of identification, evaluation, and measurement of risks, along with their potential impact on the organization .

M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 7-1

The benefits of risk assessment include the following: • Mitigation or reduction of the risk of an incident. • Mitigation of the severity and/or consequences by way of improved process techniques, fire protection systems, arrangements of storage, inventory monitoring to fit production requirements. • Confidence building in employees by improving competency. Preparedness and prompt response to deal with any accident

7.2.2 DETAILS OF MANUFACTURING PROCESS Detail of manufacturing operation is given in section 2.7.4 of chapter-2.

7.2.3 STORAGE AND HANDLING The details of storage and handling of hazardous chemicals are listed in table-7.1. This list also contains the hazardous characteristics of each Raw material. Permission for the storage of Methanol, Toluene and Acetone, etc. will be obtained from PESO (Petroleum & Explosives Safety Organization), Nagpur, if applicable.

TABLE-7.1 HAZARDOUS CHARACTERISTICS & STORAGE OF RAW MATERIALS Name of the No. of tank Possible Quantity Place of its No. Hazardous CAS No. State /drums type Stored Storage Substance /bags/carboys of Hazards 1. 2,6-Dichlorophenol 87-65-0 Solid 93 nos. Drum 23.25 MT Solid RM Store Toxic 2. Potassium Carbonate 584-08-7 Solid 417 nos. Bag 10.425 MT Solid RM Store Toxic 3. Toluene 108-88-3 Liquid 1 nos 16 KL Tank 16 KM Tank Farm Area Toxic & Fire 4. MMCA 96-34-4 Liquid 65 nos. Drum 16.25 KL Liquid RM Store Fire & Toxic 5. Aniline Oil 62-53-3 Liquid 1 nos. 20 KL 20 KL Tank Farm Area Fire & Toxic Tank 6. Sodium methoxide 124-41-4 Liquid 1 nos 20 KL Tank 20 KL Tank Farm Area Toxic, Fire & Reactive 7. Chloro Acetyle 79 -04 -9 Liquid 84 nos. Drum 21 KL Liquid RM Store Toxic Chloride 8. Alluminium Chloride 7446 -70 -0 Solid 403 nos. Bag 10.075 MT Solid RM Store Toxic 9. Caustic Soda 1310 -73 -2 Solid 105 nos. Bag 5.25 MT Solid RM Store Toxic 10 . Carbon 7440 -44 -0 Solid 30 nos. Bag 0.9 MT Solid RM Store Fire 11 . Diclofence Sodium 15307 -79 -6 Solid 22 nos. Bag 0.55 MT Solid RM Store Toxic 12. Acetic acid 64-19-7 Liquid 1 nos 20 KL Tank 20 KL Tank Farm Area Toxic 13. Diethyle Amine 109-89-7 Liquid 3 nos. Drum 0.69 KL Liquid RM Store Fire & Toxic 14. Hydrochloric Acid 7647-01-0 Liquid 18 nos. Drum 3.6 KL Liquid RM Store Toxic 15. 4 Chloro-2 95-85-2 Solid 55 nos. Bag 1.375 MT Solid RM Store Toxic Aminophenol 16. Technical Grade 57-13-6 Solid 33 nos. Bag 1.65 MT Solid RM Store Toxic, Fire Urea 17 . Hydro Sulphide of 7775 -14 -6 Solid 1 nos. Bag 50 KG Solid RM Store Fire, Toxic Soda 18 . Caustic Lye 1310 -73 -2 Liquid 1 nos 10 KL Tank 10 KL Tank Farm Area Toxic 19 . Methenol 67 -56 -1 Liquid 2 no., 20 K L 40 KL Tank Farm Area Fire, Toxic 20 . 4-Chloro -2- Nitro 89 -63 -4 Solid 163 nos. Bag 4.075 MT Solid RM Store Toxic Aniline 21 . Thiophenol 108 -98 -5 Liquid 18 nos. Drum 3.6 KL Liquid RM Store Toxic, Fire 22 . Forous Chloride 13478 -10 -9 Solid 15 nos. Bag 0.3 75 MT Solid RM Store Toxic 23 . Hydrazine Hydride 7803 -57 -8 Liquid 24 nos. Drum 4.8 KL Liquid RM Store Toxic, Fire 24 . Hydrogen Cynamide 420 -04 -2 Solid 17 nos. Drum 3.74 MT Solid RM Store Toxic, Fire 25. Methyl Formate 107-31-3 Liquid 10 nos. Drum 2 KL Liquid RM Store Fire, Toxic 26. Fenbendazole 43210-67-9 Solid 49 nos. Drum 1.225 MT Solid RM Store Fire, Toxic M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 7-2

Name of the No. of tank Possible Quantity Place of its No. Hazardous CAS No. State /drums type Stored Storage Substance /bags/carboys of Hazards 27 . Dimethyle Sulxoxide 67 -68 -5 Liquid 3 nos. Drum 0.63 KL Liquid RM Store Fire, Toxic 28 . Hydrogen Peroxide 7722 -84 -1 Liquid 27 Nos. Carboys 0.81 KL Liquid RM Store Toxic 29 . Acetone 67 -64 -1 Liquid 1 no., 20 KL 20 KL Tank Farm Area Fire, Toxic 30 . N(4 -5) Dicloro -2 5462 -30 -6 Solid 12 nos. Drum 2.4 MT Solid RM Store Toxic Nitro Phenyle Acetamide 31. DMF 68-12-2 Liquid 4 nos. Drum 0.8 KL Liquid RM Store Fire, Toxic 32. 2:3 Dichloro Phenol 576-24-9 Solid 2 nos. Drum 0.5 MT Solid RM Store Toxic, Fire 33 . Nitrogen Gas 576 -24 -9 Gas 2 nos. Cylinder 0.1 kg RM Store Toxic 34 . Hydrogen Gas 1333 -74 -0 Gas 3 nos. Cylinder 0.15 kg RM Store Fire 35 . Rancy nickel - Solid 9 nos. Drum 45 KG Solid RM Store Fire, Toxic 36 . Hyflow 68855 -54 -9 Solid 1 nos. Bag 50 KG Solid RM Store - 37 . Potassium Hydroxide 1310 -58 -3 Solid 12 nos. Bag 0.6 MT Solid RM Store Toxic 38 . Calcium Disulphide 20548 -54 -3 Solid 6 nos. Bag 0.3 MT Solid RM Store Toxic 39. Dimethyle Sulphate 77-78-1 Liquid 3 nos. Drum 0.75 KL Liquid RM Store Toxic, Fire 40. IPA 67-63-0 Liquid 1 nos. Drum 0.2 KL Liquid RM Store Fire, Toxic 41. 2 Nitro-5(Phenylethio 43156-47- Solid 2 nos. Drum 0.4 MT Solid RM Store Toxic Aniline) 44 42. Methoxy Acetyl 38870-89-2 Liquid 6 nos. Drum 0.6 KL Liquid RM Store Fire, Toxic Chloride 43 . Methylene Dichloride 75 -09 -2 Liquid 19 nos. Drum 3.8 KL Liquid RM Store Toxic, Fire 44 . Xylene 1330 -20 -7 Liquid 10 nos. Drum 2 KL Li quid RM Store Fire, Toxic 45 . Thiour 62 -56 -6 Solid 1 nos. Drum 0.1 MT Solid RM Store Toxic, Fire 46. Decyl bromide 112-29-8 Liquid 6 nos. Drum 0.3 KL Liquid RM Store 47. Methychloro Formate 79-22-1 Liquid 2 nos. Drum 0.4 KL Liquid RM Store Fire, Toxic 48. 1-1 Cyclohexane 99189-60-3 Liquid 2 nos. Drum 0.4 KL Liquid RM Store Toxic, Fire Diacetic Acid 49. Bromine 7726-95-6 Liquid 3 nos. Drum 0.3 KL Liquid RM Store Toxic 50. Caustic Flakes 1310-73-2 Solid 79 nos. Bag 3.95 MT Solid RM Store Toxic 51. Trietylamine 121-44-8 Liquid 1 nos. Drum 0.2 KL Liquid RM Store Fire, Toxic 52. 1,3 Cyclohexadione 504-02-9 Solid 10 nos. Bag 0.5 MT Solid RM Store Toxic 53. Phenyl Hydrazine 100-63-0 Liquid 3 nos. Drum 0.6 KL Liquid RM Store Toxic, Fire 54. Zinc Chloride 7646-85-7 Solid 4 nos. Bag 0.2 MT Solid RM Store Toxic 55. Phosphorous 02-12-7719 Liquid 3 nos. Drum 0.6 KL Liquid RM Store Toxic Trichloride 56. Closantel Amine 57808-65-8 Solid 61 nos. Bag 1.525 MT Solid RM Store Toxic, Fire 57. Diiodosalicycli Acid 133-91-5 Solid 85 nos. Drum 2.125 MT Solid RM Store Toxic, Fire 58. Sodium Metal 7440-23-5 Solid 7 nos. Drum 1.05 MT Solid RM Store Toxic, Fire 59. Caustic Potash 1310-58-3 Solid 15 nos. Bag 0.75 MT Solid RM Store Toxic 60 . Para Formaldehyde 30525 -89 -4 Solid 15 nos. Drum 0.375 MT Solid RM Store Toxic, Fire 61 . 2-Methylimidazole 693 -98 -1 Solid 2 nos. Drum 0.4 MT Solid RM Store Toxic 62 . Liq. Ammonia 1336 -21 -6 Liquid 4 nos. Bottle 0.2 KL Liquid RM Store Toxic

The hazardous chemicals having high risks due to storage quantity, high Flammability and acute Toxicity are analyzed labeled and separately listed in table-7.2. These Hazardous chemicals have the potential to cause the maximum damage and create a vulnerability zone in and around the company operations. They are selected and highlighted for better visibility. MSDS of chemicals to be handled is enclosed as annexure- XVI.

M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 7-3

TABLE-7.2 LIST OF MAJOR HAZARDOUS CHEMICALS INVENTRY & PROPERTIES

TPQ / No. Source Cas No. Nature of Hazards MT Highly flammable. Soluble in water. Flash Point: 52°F , B.P: 148.3°F Toxic use PPE while handling.. ERPG1: 200 ppm., ERPG2: 1000 1. Methanol 20 KL 67-56-1 ppm., ERPG3: 5000 ppm., IDLH: 6000 ppm. Regulated chemical. FLAMMABLE Aniline oil is toxic and combustible in nature. Colorless liquid having Aniline Aromatic (Amine like) ordor and Soluble in oil. B.P.: 184.1 oC, Odor 2. 20 KL 62-53-3 Oil Threshold: 2.4 ppm, TWA: 7.6 (mg/m3) from ACGIH TOXIC Flammable liquid, insoluble in water. Flash Points: 4.4°C (40°F). Flammable Limits: LOWER: 1.1% UPPER: 7.1% Boiling Point: 110.6°C (231.1°F), Odor Threshold: 1.6 ppm, AEGL-1 (60 min): 67 3. Toluene 16 KL 108-88-3 ppm AEGL-2 (60 min): 560 ppm AEGL-3 (60 min): 3700 ppm , IDLH: 500 ppm FLAMMABLE Flammable liquid, Auto-Ignition Temperature: 465°C (869°F), Flash Points: -20°C (-4°F), Flammable Limits: LOWER: 2.6% UPPER: 12.8%, Boiling Point: 56.2°C (133.2°F), Odor Threshold: 62 ppm, 4. Acetone 20 KL 67-64-1 AEGL-1 (60 min): 200 ppm AEGL-2 (60 min): 3200 ppm AEGL-3 (60 min): 5700 ppm FLAMMABLE

Hazardous scenarios for the purpose of RISK ANALYSIS which are most likely to happen during a. Storage conditions, b. during the manufacturing processes & handling are planned and listed in table-7.3. These hazardous chemicals are assessed with the scenarios, for deriving and identifying the vulnerable zones.

TABLE-7.3 RISK ANALYSIS Failure RISK Risk Rating 3 No. Source Scenarios Probability 1 Severity2 Mechanism Consequence (max = 25) 1. Acid spillage from Spillage during Puddle formation - 2 2 4 drums handling Toxic vapour 2. Leakage during Coupling fit not Leakage from the transfer of fully coupling joint. Fire 2 2 4 Hydrogen gas from established or explosion. the cylinder 3. Unloading pipe Spillage during Puddle formation coupling Loose in handling in unloading area – 3 2 6 Methanol unloading flammable vapor 4. Release of Toluene Leakage from Puddle formation – 3 2 6 from tank tank Pool fire 5. Release of Acetone Leakage from Puddle formation – 3 2 6 from tank tank Pool fire 6. Release of Aniline Leakage from Puddle formation - 2 2 4 Oil from tank tank Toxic vapour LEGEND 1PROBABILITY: 2SEVERITY: 3RISK RATING: 1 – HIGHLY UNLIKELY 1 – EXTREMELY MILD PROBABILITY x SEVERITY 2 – UNLIKELY 2 – MILD 3 – SOMEWHAT LIKELY 3 – MODERATE 4 – LIKELY 4 – SEVERE 5 – VERY LIKELY 5 – MOST SEVERE

M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 7-4

• There are few toxic severity scenario risks, on the operational and storage of chemicals. • The worst-case scenario is also well within the reach of fire protection/mitigation measures, planned for installation. • Fire protection/ control / mitigation measures are incorporated.

All the raw material will be stored within premises in Drums, Carboys, bags and cylinder except Methanol, Aniline Oil, Toluene and Acetone which will be stored in tank. Considering above rating M/s. Orbit Pharma Laboratories can be categorized as a medium hazard industry who can manage their risks through invoking On site emergency plan and actively participating in Off-site emergency plan. During the navigation of above sequence of activities, it is drawn to the understanding that the storage & handling are to be closely associated with the Threshold Planned quantities (TPQ) of hazardous chemicals. This will ensure, the associated preventive / mitigating facilities planned and installed for managing the projected risk scenarios will be serving the desired objectives . The in-house regulatory measures for implanting safety shall be appropriate to the risks, and to be handled by trained persons for the purpose. SOPs are to be documented and identified people are to be trained. Regular mock drills shall be planned and executed, as a preparation/ precaution for dealing with emergency operations.

7.2.3.1 ANTIDOTES OF MAJOR PRDUCTS/RAW MATERIALS Antidotes of major products/raw materials are shown in following table-7.4.

TABLE-7.4 ANTIDOTES OF CHEMICALS

No. Name of Chemical Antidote 1. Bromine Wash the skin plenty of water. Apply sodium bi car bonate and again wash the skin plenty of water. If gone in eye, wash plenty of water through spray up to 15 minutes. Put two or three drops of pontocane (0.5 solution) or benoxinate (novesine) 0.4%. if problem in respiration, give milk, butter milk or lemon juice or make a small cotton ball and drench with ethanol or ether solution drops and put it near victim's nose for smell. Apply pure oxygen. If go in the intestine give milk. Milk butter and milk of magnesia. Dexona, Avil 2. Phenol and derivatives Take the patient in clean air, activated charcoal and 240ml milk, if the eye or skin affected than wash with plenty of water, clean the skin with poly ethylene glycol. 3. Acetic Acid Milk of magnesia 4. Aniline Oil Methylene Blue 5. Di Methyl Amine Methylene Blue 6. Hydrochloric Acid Drink Larqe Quality of water , Milk of Maqnesia 7. Iso Propyl Alcohol Novasine Eye Drops 8. Acetic Acid Milk of maqnesia 9. Methanol Oxygen or Baking Soda in a glass of water or Ethanol, Novasine Eye Drops 10. Monochloro Ac etic Silver Sulphadiazine Acid 11. Xylene, Toluene. Wash the skin area plenty of water if affected. Fresh air or Oxygen, 0.1 mg/kg slowly through injection rest in bed. Don't apply Epinefrin, Ifridin etc. Don't apply milk, vegetable oil or alcohol.

7.2.3.2 ACTION PLAN FOR SAFETY PRECAUTIONS FOR THE STORAGE OF MATERIALS Storage in HDPE drums / Carboys or bags: - Separately stored with proper enclosures and marked, within premises in closed shed - Proper ventilation will be provided - Sufficient fire extinguishers and PPE will be provided - Flame proof fittings will be provided

M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 7-5

- Smoking will be prohibited - Bags/drums/ carboys will be stored on pallet with the suitable trap

Hazardous chemical handling, Storage, transportation and unloading: - Hazardous material will be stored away from the plant and safe distance shall be maintained - Dyke wall shall be provided to all above ground storage tank - Proper selection of MOC for tank - Fire hydrant system shall be installed - Safety shower and eye washer shall be installed near storage area - Sprinkler system shall be installed at flammable material storage area - Flame proof light fitting shall be provided at flammable storage area - Earthing/bonding shall be provided for static charges - Only authorized person shall be permitted in storage tank area - Methanol, Toluene, Acetone, Aniline Oil, etc shall be transported through road tanker - Procedure shall be prepared for loading and unloading of Methanol received through road tanker - Flame proof electric motor shall be used during loading/unloading - Personal Protective Equipments (PPEs) shall be provided - Term Card shall be provided to all transporters and shall be trained for transportation emergency of hazardous chemicals

7.2.4 HAZARD AND ITS CONTROL MEASURES Details of possible hazards or emergency at the site along with safety measures are given in following table.

TABLE-7.5 HAZARDS AND ITS CONTROL MEASURE

Name of the Its effect on person, Sr. Its souses & Place of its possible hazard or property, & Control measure provided No. reason effect emergency environment 1. BOILER Over pressure in Minor/Major injury Boiler House Lower & upper level indication 1) Burning the boiler if safety loss of human life and system provision. Safety valves for physical injury valve not working. loss of property (loss surrounding pressure control fixed temp. & explosion Water level of Main/machine places pressure indicator provided. Blow indicator not material) down & blowing system provided for working. Low cleaning tube and shell. Soft water water level used. Inter locking provided on indicator fail. High pumps, FD farm, ID fan. Periodical temp. system fail. checking & inspection maintenance done. Yearly inspection done by boiler inspector 2. ELECRICITY Loose contacts, Burning, shock, Surrounding Proper Earthing, Periodical Checking (1) Burning weak earthing short Death the accident of joints, proper insulations of (2) Fire circuit improper area Equipment, etc. flame proof fitting in (3) Shock insulation solvent storage area, bounding and jumpers to all solvent barrier lines provided 3. HOUSE Bad House keeping Physical / Chemical In all Proper handling, regular cleaning, KEEPING Thermal Burn injury surrounding Proper placement of material. (1) Physical (Major / Minor) areas i.e. (2) Burning storage plants (3) Fire (4) Chemical explosion 4. PIPELINE Leaking of pipe Physical / Chemical Plant area Proper maintenance, Proper selection LEAKAGES line to corrosion. Thermal Burn injury of material for pipe lines, immediate Spillages etc. Loose contact etc. (Major / Minor) attention, Earthing provided, flame (1) Corrosion proof fitting. (2) Toxic gas release NO SMOKING Boards displayed. 5. Fire Transformer - Electrical power Transformer - Fire Fighting Equipment's Transfer oil short failure near power - Graved bed for oil spillage or circuit etc. - Production control centre soaking hindrance M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 7-6

Name of the Its effect on person, Sr. Its souses & Place of its possible hazard or property, & Control measure provided No. reason effect emergency environment - Loss of - isolated fenced area transformer - Lightening arrestor nearby - DG set for emergency power supply 6. Fire & Toxic - Natural Disaster - Production Whole - Hydrant system chemical spillage i.e. Earthquakes, hindrance factory & - Sprinkler system in storage area population storm, - Trapping under - Lightening arrestor at buildings Lighterning nearby debris, death - First aid & ambulance available - Sabotage Fire in Chemical burn - Smoking prohibited inside the neighboring Toxic chemical factory - industries spillage - Security at all the time guarding important locations 7. Fire & smoke Solvent fire in Burns Whole - Hydrant system with water storage tank Storage tank factory & monitors catching fire population - Adequate earthing Tanker Production hindrance nearby unloading permit - Unauthorized person not allowed to enter - Breathing Apparatus for rescue operations - Alarm system for indicating unusual incidence

7.2.5 RISK IDENTIFICATION AND ANALYSIS Identification of risks is done qualitatively and quantitatively through the selection of hazardous substances and by studying the manufacturing process, to arrive at possible failures and their inherent causes. Probability of risk occurrence is also ascertained in order to determine the MAXIMUM CREDIBLE ACCIDENT SCENARIO and the WORST CASE SCENARIO . Hazardous substances have been identified as follows considering the applicable criteria laid down under the Chemical Accident (Emergency Planning, Preparedness and Response) Rules, 1996, as well as other relevant guidelines:

The risks are then analyzed quantitatively in terms of probability, and severity. The risks have also been rated according to the matrix R = Probability x Severity.

7.2.5.1 MAXIMUM CREDIBLE LOSS ACCIDENT SCENARIOS A Maximum Credible Accident (MCA) can be characterised as the worst credible accident. In other words: an accident in an activity, resulting in the maximum consequence distance that is still believed to be possible. A MCA-analysis does not include a quantification of the probability of occurrence of the accident. Another aspect, in which the pessimistic approach of MCA studies appears, is the atmospheric condition that is used for dispersion calculations. The Maximum Credible Loss (MCL) scenarios have been developed for the Facility. The MCL cases considered, attempt to include the worst “Credible” incidents- what constitutes a credible incident is always subjective. Nevertheless, guidelines have evolved over the years and based on basic engineering judgement, the cases have been found to be credible and modelling for assessing vulnerability zones is prepared accordingly. Only catastrophic cases have been considered and not partial or small failures (as is the case in Quantitative Risk Assessment where contributions from low frequency - high outcome effect as well as high frequency - low outcome events are distinguished). The objective of the study is emergency planning, hence only holistic & conservative assumptions are used for obvious reasons. Hence though the outcomes may look pessimistic, the planning for emergency concept should be borne in mind whilst interpreting the results.

M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 7-7

7.2.5.2 DAMAGE CRITERIA In consequence analysis, use is made of a number of calculation models to estimate the physical effects of an accident (spill of hazardous material) and to predict the damage (lethality, injury, material destruction) of the effects. The calculations can roughly be divided in three major groups: a) Determination of the source strength parameters; b) Determination of the consequential effects; c) Determination of the damage or damage distances. The basic physical effect models consist of the following: Source strength parameters * Calculation of the outflow of liquid, vapour or gas out of a vessel or a pipe, in case of rupture. Also two-phase outflow can be calculated. * Calculation, in case of liquid outflow, of the instantaneous flash evaporation and of the dimensions of the remaining liquid pool. * Calculation of the evaporation rate, as a function of volatility of the material, pool dimensions and wind velocity. * Source strength equals pump capacities, etc. in some cases. Consequential effects * Dispersion of gaseous material in the atmosphere as a function of source strength, relative density of the gas, weather conditions and topographical situation of the surrounding area. * Intensity of heat radiation [in kW/ m 2] due to a fire or a BLEVE, as a function of the distance to the source. * Energy of vapour cloud explosions [in N/m 2], as a function of the distance to the distance of the exploding cloud. * Concentration of gaseous material in the atmosphere, due to the dispersion of evaporated chemical. The latter can be either explosive or toxic.

It may be obvious, that the types of models that must be used in a specific risk study strongly depend upon the type of material involved: - Gas, vapour, liquid, solid - Inflammable, explosive, toxic, toxic combustion products - Stored at high/low temperatures or pressure - Controlled outflow (pump capacity) or catastrophic failure

Selection of Damage Criteria The damage criteria give the relation between extent of the physical effects (exposure) and the percentage of the people that will be killed or injured due to those effects. The knowledge about these relations depends strongly on the nature of the exposure. For instance, much more is known about the damage caused by heat radiation, than about the damage due to toxic exposure, and for these toxic effects, the knowledge differs strongly between different materials. In Consequence Analysis studies, in principle three types of exposure to hazardous effects are distinguished: 1. Heat radiation, from a jet, pool fire, a flash fire or a BLEVE. 2. Explosion 3. Toxic effects, from toxic materials or toxic combustion products. In the next three paragraphs, the chosen damage criteria are given and explained.

M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 7-8

Heat Radiation The consequence caused by exposure to heat radiation is a function of: 2 • The radiation energy onto the human body [kW/m ]; • The exposure duration [sec]; • The protection of the skin tissue (clothed or naked body). • The limits for 1% of the exposed people to be killed due to heat radiation, and for second-degree burns are given in the table-7.6 herein:

TABLE-7.6 DAMAGES TO HUMAN LIFE DUE TO HEAT RADIATION

Exposure Radiation for 1% Radiation for 2 nd Radiation for first Duration lethality (kW/m 2) degree burns(kW/m 2) degree burns, (kW/m 2) 10 Sec 21.2 16 12.5 30 Sec 9.3 7.0 4.0

• Since in practical situations, only the employees will be exposed to heat radiation in case of a fire, it is reasonable to assume the protection by clothing. It can be assumed that people would be able to find a cover or a shield against thermal radiation in 10 sec. time. Furthermore, 100% lethality may be assumed for all people suffering from direct contact with flames, such as the pool fire, a flash fire or a jet flame. The effects due to relatively lesser incident radiation intensity are given below.

TABLE-7.7 EFFECTS DUE TO INCIDENT RADIATION INTENSITY

Incident Radiation in kw/m 2 Type of Damage 0.7 Equivalent to Solar Radiation 1.6 No discomfort for long exposure 4.0 Sufficient to cause pain within 20 sec. Blistering of skin (first degree burns are likely) 9.5 Pain threshold reached after 8 sec. second degree burns after 20 sec. 12.5 Minimum energy required for piloted ignition of wood, melting plastic tubing etc.

Explosion In case of vapour cloud explosion, two physical effects may occur: * A flash fire over the whole length of the explosive gas cloud; * A blast wave, with typical peak overpressures circular around ignition source. As explained above, 100% lethality is assumed for all people who are present within the cloud proper.

For the blast wave, the lethality criterion is based on: * A peak overpressure of 0.1 bar will cause serious damage to 10% of the housing/structures. * Falling fragments will kill one of each eight persons in the destroyed buildings. The following damage criteria may be distinguished with respect to the peak overpressures resulting from a blast wave:

TABLE-7.8 DAMAGE DUE TO OVERPRESSURES

Peak Overpressure Damage Type 0.83 bar Total Destruction 0.30 bar Heavy Damage

M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 7-9

Peak Overpressure Damage Type 0.10 bar Moderate Damage 0.03 bar Significant Damage 0.01 bar Minor Damage From this it may be concluded that p = 0.17 E+5 pa corresponds approximately with 1% lethality. Furthermore, it is assumed that everyone inside an area in which the peak overpressure is greater than 0.17 E+5 pa will be wounded by mechanical damage. For the gas cloud explosion, this will be inside a circle with the ignition source as its centre.

Intoxication The consequences from inhalation of a toxic vapour/gas are determined by the toxic dose. This dose D is basically determined by: - Concentration of the vapour in air; - Exposure duration. Furthermore, of course, the breathing rates of the victim, as well as the specific toxic mechanism unto the metabolism play an important role. n The dose is defined as D = C .t, with: C = concentration of the toxic vapour, in [ppm] or [mg/m 3]; t = exposure duration, in [sec] or [min]; n = exponent, mostly > 1.0; this exponent takes into account the fact that a high concentration over a short period results in more serious injury than a low concentration over a relatively longer period of exposure. The value of n should be greater than zero but less than 5.

The given definition for D only holds if the concentration is more or less constant over the exposure time; this may be the case for a (semi) continuous source. In case of an instantaneous source, the concentration varies with time; the dose D must be calculated with an integral equation:

D = ∫ Cn.dt

For a number of toxic materials, so-called Vulnerability Models (V.M.) have been developed. The general equation for a V.M. (probit function) is:

Pr = a + b.ln (C n.t), with

Pr = probit number, being a representation of the percentage of people suffering a certain kind of damage, for instance lethality

Pr = 2.67 means 1% of the population; Pr = 5.00 means 50% of the population; a and b material dependent numbers;

Cn.t = dose D, as explained above.

The values for a and b are mostly derived from experiments with animals; occasionally, however, also human toxicity factors have been derived from accidents in past. In case only animal experiments are available, the inhalation experiments with rats seem to be best applicable for predicting the damage to people from acute intoxication. Although much research in this field have been done over the past decades, only for a limited number of toxic materials consequence models have been developed. Often only quite scarce information is available to predict the damage from an acute toxic exposition. Data transformation from oral intoxication data to inhalation toxicity criteria is sometimes necessary. Generally, in safety evaluations pessimistic assumptions are applied in these transformation calculations. The calculated damage (distance) may be regarded as a maximum. For the purposes of a response to a major incident, the IDLH value level has been chosen for the ‘wounded‘ criteria. This type of injury will require medical attention. M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 7-10

7.2.5.2.1 SOFTWARE USED FOR CALCULATIONS ALOHA (Areal Locations of Hazardous Atmospheres): Aloha is a computer program designed especially for use by people responding to chemical accidents, as well as for emergency planning and training. ALOHA can predict the rates at which chemical vapors may escape into the atmosphere from broken gas pipes, leaking tanks, and evaporating puddles. It can then predict how a hazardous gas cloud might disperse in the atmosphere after an accidental chemical release. ALOHA is an air dispersion model, which you can use as a tool for predicting the movement and dispersion of gases. It predicts pollutant concentrations downwind from the source of a spill, taking into consideration the physical characteristics of the spilled material. ALOHA also accounts for some of the physical characteristics of the release site, weather conditions, and the circumstances of the release. Like many computer programs, it can solve problems rapidly and provide results in a graphic, easy-to-use format. This can be helpful during an emergency response or planning for such a response. ALOHA provides output as amount of chemical discharged from the source as well as its concentration in air it takes in to account different levels of concentrations for a specified chemical. Different concentration levels are given below:

ERPG 1: is the maximum airborne concentration below which it is believed that nearly all individuals could be exposed for up to 1 hour without experiencing other than mild transient adverse health effects or perceiving a clearly defined, objectionable odor.

ERPG 2: is the maximum airborne concentration below which it is believed that nearly all individuals could be exposed for up to 1 hour without experiencing or developing irreversible or other serious health effects or symptoms which could impair an individual's ability to take protective action.

ERPG 3: is the maximum airborne concentration below which it is believed that nearly all individuals could be exposed for up to 1 hour without experiencing or developing life-threatening health effects.

IDLH: The Immediately Dangerous to Life or Health (IDLH) level. A chemical's IDLH is an estimate of the maximum concentration in the air to which a healthy worker could be exposed without suffering permanent or escape-impairing health effects.

7.2.5.3 VULNERABILITY ANALYSIS A vulnerability analysis is carried out on the MAXIMUM CREDIBLE ACCIDENT SCENARIO. The analysis is carried out using the help of sophisticated computer software which provides the zone of influence as well as the geographical risk contours. The calculations are complex in nature, and various parameters are defined to assist the software in simulating the risk contours. The parameters include details such as the size of the leakages / holes, quantity of materials released, duration of the release, weather and geographical conditions. The simulations are generated under standard operating conditions. Data given in the reports and manuals are taken as correct information. The weather conditions are taken as per table-7.9 for all simulations.

TABLE-7.9 WEATHER CONDITIONS

Parameters Condition A Condition B Wind Speed 10.0 m/s 3.0 m/s Pasquill Stability D F Ground Roughness Urban Forest Urban Forest Air Temperature (°C) 30 25 Surface temperature 30 25 Relative Humidity 50% 50% Cloud Cover 50% 50%

M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 7-11

7.2.5.4 MAXIMUM CREDIBLE ACCIDENT SCENARIO The MAXIMUM CREDIBLE ACCIDENT SCENARIO was analyzed based on flammable vapor and toxic vapor risks. The ALOHA simulation software was used to obtain the risk contours and the zone of influence, as well as levels of risk associated with each zone.

The calculations performed are based on Unified Dispersion Modeling and provide the foot prints of hazardous chemical dispersion and the distances of critical concentrations for flammability and toxicity. The model considers a three stage method as given in the following illustration:

POOL SPREADING AND VAPORIZATION The release containing liquid droplets forms a pool. Any evaporation from this pool will contribute to the dispersing pool.

Evaporation ↓ DISPERSION The vapor cloud disperses in the atmosphere until it has reached harmless concentration.

Calculation of the concentration profile of the cloud ↓

FLAMMABILITY AND TOXICITY

The results of the ALOHA simulation as well as the parameters used for carrying out the simulations is given below in tables. Downwind concentrations of chemicals are shown.

SCENARIOS CONSIDERED:

1. Maximum Credible Accident scenario for Toluene – “Pool Fire” - Threat Zone Evaluation :

Chemical Data: Chemical Name: TOLUENE CAS Number: 108-88-3 Molecular Weight: 92.14 g/mol AEGL-1 (60 min): 67 ppm AEGL-2 (60 min): 560 ppm AEGL-3 (60 min): 3700 ppm IDLH: 500 ppm LEL: 11000 ppm UEL: 71000 ppm Ambient Boiling Point: 110.4° C Vapor Pressure at Ambient Temperature: 0.048 atm Ambient Saturation Concentration: 48,691 ppm or 4.87%

A. For Atmospheric Stability Condition ‘D’

Source Strength: Leak from hole in horizontal cylindrical tank Flammable chemical is burning as it escapes from tank Tank Diameter: 2 meters Tank Length: 5.1 meters Tank Volume: 16.0 cubic meters Tank contains liquid Internal Temperature: 30° C Chemical Mass in Tank: 13.7 tons Tank is 90% full Circular Opening Diameter: 1 inches M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 7-12

Opening is 5 centimeters from tank bottom Max Flame Length: 5 meters Burn Duration: ALOHA limited the duration to 1 hour Max Burn Rate: 24.5 kilograms/min Total Amount Burned: 1,451 kilograms Note: The chemical escaped as a liquid and formed a burning puddle. The puddle spread to a diameter of 2.5 meters.

Threat Zone: Threat Modeled: Thermal radiation from pool fire Red : less than 10 meters(10.9 yards) --- (10.0 kW/(sq m) = potentially lethal within 60 sec) Orange: 10 meters --- (5.0 kW/(sq m) = 2nd degree burns within 60 sec) Yellow: 13 meters --- (2.0 kW/(sq m) = pain within 60 sec)

B. For Atmospheric Stability Condition ‘F’

Source Strength: Leak from hole in horizontal cylindrical tank Flammable chemical is burning as it escapes from tank Tank Diameter: 2 meters Tank Length: 5.1 meters Tank Volume: 16.0 cubic meters Tank contains liquid Internal Temperature: 25° C Chemical Mass in Tank: 13.7 tons Tank is 90% full Circular Opening Diameter: 1 inches Opening is 5 centimeters from tank bottom Max Flame Length: 7 meters Burn Duration: ALOHA limited the duration to 1 hour Max Burn Rate: 24.5 kilograms/min Total Amount Burned: 1,454 kilograms Note: The chemical escaped as a liquid and formed a burning puddle.

M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 7-13

The puddle spread to a diameter of 2.6 meters.

Threat Zone: Threat Modeled: Thermal radiation from pool fire Red : less than 10 meters(10.9 yards) --- (10.0 kW/(sq m) = potentially lethal within 60 sec) Orange: 11 meters --- (5.0 kW/(sq m) = 2nd degree burns within 60 sec) Yellow: 15 meters --- (2.0 kW/(sq m) = pain within 60 sec)

2. Maximum Credible Accident scenario for Methanol - “Pool Fire” - Threat Zone Evaluation :

Chemical Data: Chemical Name: METHANOL CAS Number: 67-56-1 Molecular Weight: 32.04 g/mol AEGL-1 (60 min): 530 ppm AEGL-2 (60 min): 2100 ppm AEGL-3 (60 min): 7200 ppm IDLH: 6000 ppm LEL: 71800 ppm UEL: 365000 ppm Ambient Boiling Point: 64.7° C Vapor Pressure at Ambient Temperature: 0.21 atm Ambient Saturation Concentration: 216,411 ppm or 21.6%

A. For Atmospheric Stability Condition ‘D’

Source Strength: Leak from hole in horizontal cylindrical tank Flammable chemical is burning as it escapes from tank Tank Diameter: 2 meters Tank Length: 7.35 meters Tank Volume: 23.1 cubic meters Tank contains liquid Internal Temperature: 30° C Chemical Mass in Tank: 19.0 tons Tank is 95% full Circular Opening Diameter: 2 inches Opening is 5 centimeters from tank bottom Max Flame Length: 5 meters Burn Duration: ALOHA limited the duration to 1 hour Max Burn Rate: 93.6 kilograms/min M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 7-14

Total Amount Burned: 5,263 kilograms Note: The chemical escaped as a liquid and formed a burning puddle. The puddle spread to a diameter of 10.9 meters.

Threat Zone: Threat Modeled: Thermal radiation from pool fire Red : 12 meters --- (10.0 kW/(sq m) = potentially lethal within 60 sec) Orange: 13 meters --- (5.0 kW/(sq m) = 2nd degree burns within 60 sec) Yellow: 16 meters --- (2.0 kW/(sq m) = pain within 60 sec)

B. For Atmospheric Stability Condition ‘F’

Source Strength: Leak from hole in horizontal cylindrical tank Flammable chemical is burning as it escapes from tank Tank Diameter: 2 meters Tank Length: 7.35 meters Tank Volume: 23.1 cubic meters Tank contains liquid Internal Temperature: 25° C Chemical Mass in Tank: 19.0 tons Tank is 95% full Circular Opening Diameter: 2 inches Opening is 5 centimeters from tank bottom Max Flame Length: 6 meters Burn Duration: ALOHA limited the duration to 1 hour Max Burn Rate: 93.8 kilograms/min Total Amount Burned: 5,274 kilograms Note: The chemical escaped as a liquid and formed a burning puddle. The puddle spread to a diameter of 11.0 meters.

M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 7-15

Threat Zone: Threat Modeled: Thermal radiation from pool fire Red : 12 meters --- (10.0 kW/(sq m) = potentially lethal within 60 sec) Orange: 15 meters --- (5.0 kW/(sq m) = 2nd degree burns within 60 sec) Yellow: 20 meters --- (2.0 kW/(sq m) = pain within 60 sec)

3. Maximum Credible Accident scenario for Acetone : “Pool Fire”- Atmospheric Stability Condition ‘D’ Chemical Data: Chemical Name: ACETONE CAS Number: 67-64-1 Molecular Weight: 58.08 g/mol AEGL-1 (60 min): 200 ppm AEGL-2 (60 min): 3200 ppm AEGL-3 (60 min): 5700 ppm LEL: 26000 ppm UEL: 130000 ppm Ambient Boiling Point: 56.3° C Vapor Pressure at Ambient Temperature: 0.37 atm Ambient Saturation Concentration: 377,520 ppm or 37.8%

A. For Atmospheric Stability Condition ‘D’

Source Strength: Leak from hole in horizontal cylindrical tank Flammable chemical is burning as it escapes from tank Tank Diameter: 2 meters Tank Length: 7.4 meters Tank Volume: 23.2 cubic meters Tank contains liquid Internal Temperature: 30° C Chemical Mass in Tank: 19.0 tons Tank is 95% full Circular Opening Diameter: 2 inches Opening is 5 centimeters from tank bottom Max Flame Length: 7 meters Burn Duration: ALOHA limited the duration to 1 hour Max Burn Rate: 93.3 kilograms/min Total Amount Burned: 5,494 kilograms

M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 7-16

Note: The chemical escaped as a liquid and formed a burning puddle. The puddle spread to a diameter of 6.3 meters.

Threat Zone: Threat Modeled: Thermal radiation from pool fire Red : 13 meters --- (10.0 kW/(sq m) = potentially lethal within 60 sec) Orange: 16 meters --- (5.0 kW/(sq m) = 2nd degree burns within 60 sec) Yellow: 21 meters --- (2.0 kW/(sq m) = pain within 60 sec)

B. For Atmospheric Stability Condition ‘F’

Source Strength: Leak from hole in horizontal cylindrical tank Flammable chemical is burning as it escapes from tank Tank Diameter: 2 meters Tank Length: 7.4 meters Tank Volume: 23.2 cubic meters Tank contains liquid Internal Temperature: 25° C Chemical Mass in Tank: 19.0 tons Tank is 94% full Circular Opening Diameter: 2 inches Opening is 5 centimeters from tank bottom Max Flame Length: 9 meters Burn Duration: ALOHA limited the duration to 1 hour Max Burn Rate: 93.7 kilograms/min Total Amount Burned: 5,511 kilograms Note: The chemical escaped as a liquid and formed a burning puddle. The puddle spread to a diameter of 6.3 meters.

Threat Zone: Threat Modeled: Thermal radiation from pool fire Red : 13 meters --- (10.0 kW/(sq m) = potentially lethal within 60 sec) Orange: 17 meters --- (5.0 kW/(sq m) = 2nd degree burns within 60 sec) Yellow: 24 meters --- (2.0 kW/(sq m) = pain within 60 sec)

M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 7-17

RISK ASSESSMENT& MANAGEMENT 1. Hazardous materials list is prepared for raw materials / intermediate products. Analyzed for possible On-site Emergency and Off site emergency conditions. 2. Threshold Planned quantities (TPQ) are planned for the plant operations. Most of the raw materials are indigenous and locally procured. Hence the storage of materials are planned max. only for 30 days. Makeup quantities shall be planned as a on-line system liking to the quantity of storage. 3. QRA analysis done for the hazardous raw materials. Vulnerability study done to assess the impact on the nearby areas / Working persons inside the plant. 4. Quantum of Raw materials / Finished products are so low that there is practically no vulnerability zone. Persons working in the plant, who are away by 10m down wind direction and 5 m on cross wind direction, are safe to work with designated PPEs. 5. It is easy to control the manpower due to less number of employees and automated systems of processes. 6. The finished products also pose less risk. The quantity of less per day, does not pose any high risk and these products are immediately shipped out in the same shift. 7. Incompatibility standards of storage of hazardous materials advised, to avoid any escalation of risk. As the storage space is limited, Vertical storage is advised with suitable design of racks.

M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 7-18

7.2.6 RISK PREVENTION AND RISK MITIGATION Accident prevention is the primary safety goal of any organization. There are risks that can be eliminated through preventive measures and those which can be reduced through mitigation measures.

7.2.6.1 PREVENTIVE MEASURES The 4 E’s for elimination of hazards and prevent accidents are as follows: • Engineering and technological innovation to improve reliability • Experience in the study of hazards and operations- Risk analysis • Enforcement of decisions on study results – Preventive mechanisms • Education, awareness, and practice in prevention of accidents (Training & drills) Various measures will be adopted at each stage of the project for ensuring safety of people, environment, and property. These measures include the following: • Site selection • Choice of technology • Equipment design incorporating domestic and international safety codes • Plant layout with utmost consideration given to operational safety aspects • Incorporation of interlocks and protection systems in plant design • Safety awareness for key management persons • Safety training of all operational , maintenance staff • Regular safety monitoring - Audits and inspections

A. Site Selection The plant is located adjacent Kadi Chhatral Highway. The site soil conditions are rigid and safe, complying with the requirements of the load bearing capacity of various installations.

B. Choice of Technology The process is carefully chosen for reducing wastes, reducing the risk to human beings and the environment. It is the proven one and acknowledged internationally.

C. Equipment Design Mechanical 1. All process equipments operating under pressure are designed as per ASME Section VIII pressure vessel code for un-fired pressure vessels. The material of construction selected is compatible with the chemicals handled to ensure minimum corrosion effects. 2. Heat exchangers are designed as per TEMA Class B and Class C standards as applicable. 3. Process tanks and vessels are sized taking into account minimum storage of intermediates and are provided with adequate instrumentation to measure temperature, pressure, level etc. 4. All process pumps are either glandless canned or provided with double mechanical seals to ensure no leakage during operation. Critical process pumps are also provided with bearing temperature monitors which will ensure timely maintenance of rotating parts. Piping 1. All pipes, fittings, and valves carrying the haz-chem are made of appropriate grade Steel, stainless steel and with PTFE (Teflon) envelop gaskets. 2. All pipes carrying haz-chem are designed to ensure non-restrictive flow from one equipment to another with minimum hold up of haz-chem in the lines. 3. All pipelines will be color coded as per the standard for easy identification of materials. 4. Pipeline sizes will be chosen such that pressure drops due to flow will be within permitted limits. Critical velocity parameters are exceeded to avoid static electricity generation. 5. Wherever required, design incorporates suitable by-pass system to carry out maintenance work during plant operations and also to enable sectional close-down during machinery break down, etc.

M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 7-19

6. Safety valves, relief valves, breather valves and rupture discs are mounted on hook-up piping to all critical equipment. 7. Moderately warm pipes carrying fluids at > 50-60 °C will be insulated from the point of personnel protection. 8. All manually operated valves will be located within easy reach of operator and at a operable height. Wherever necessary approach platforms will be provided. 9. Adequate number of flange joints shall be provided with adequate supports in long lines for easy dismantling and maintenance.

Electrical 1. Plant areas are segregated into zone areas as per the hazards present, with adequate distances to separate the two zones vide Petroleum Rules. 2. Areas designated as Zone -0,1 areas will have all electrical fixtures including lighting fixtures, switches, junction boxes, cable glands, etc. of approved make and flameproof type. 3. For stand by power diesel generator of adequate capacity will be installed with auto-start facility in case of power trip/failure. This DG set will be located far away from the processing area. 4. All tanks, pumps, tankers, and pipelines are properly earthed and bonded for electrical continuity and prevention of static electric charges. Double earthing will be provided to drain electrical charge to two independent earth pits. 5. All incomers to the electrical panels including MCCs and PCC will have air circuit breakers of adequate capacity for electrical protection of equipments connected to the outgoing feeders. 6. All feeders in MCCs and PCC will have user point identification at both termination ends for easy tracking of faults and rectification. 7. Adequate ventilation fans will be provided in electrical panels for effective heat dissipation. 8. Earthing pits locations and requirements with looping grids shall be provided as per the legal and regulatory requirements. 9. Overhead cable routing will take into account safe distances from buildings and facilities. Underground cabling shall be marked with metal markers as per the regulatory requirements. 10. All panels will have incomer earth fault relay. 11. Lightning arrestors will be provided on top of all structures. 12. All cables running on trays at elevation shall be properly dressed up and tied with clamps for rigidity. 13. All areas of plant and machinery and roads including all open operating areas are illuminated sufficiently to carry out operations round the clock.

D. Plant Layout 1. The plant is laid out in such a way that hazards are either eliminated or isolated so as to manage it effectively. 2. The location of the disaster prone areas of the plant is such that, they cause less impact to the nearby factories or inhabitations. 3. Room housing heat generating equipment or containing chemicals are well-ventilated with adequate air circulation. 4. Process plants which handles hazchem are designed as an open structure with all sides open for adequate ventilation 5. Administrative office is located away from process plants and storage tank. 6. Security office is located close to gate and away from process plants and storage area. 7. Workers’ rest area, shower, and dispensary is located close to administrative office, away from process plants. 8. Canteen is located close to administrative office and away from process plants.

M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 7-20

9. Adequate number of safety showers and eye wash fountains are provided in areas close to storage facilities and process plants and on each floor wherever necessary 10. A separate area has been provided on site in the upwind direction for emergency evacuation- Assembly Points. 11. Interconnecting roads within the plot are made circular so that more than one get-away is available at any point. 12. A second gate is provided for use in case of emergency. 13. Proper drainage and enclosures are provided to drain away storm water from unforeseen flooding. 14. Flame proof areas have been isolated from the non-flameproof areas. 15. DG room and electrical transformer located away from administrative office, process plant and storage area. 16. The storage area of hazchem is located in an isolated area, with adequate facilities for handling spills and leakages. 17. Fire hydrant system covers the entire operating area of the plant. 18. Warning boards will be put up in areas where entry is restricted 19. No Smoking boards will be put up at the entrance and at other locations throughout the plant 20. Boards showing the numbers and contact details of government / district officials as well as fire department, police department, district commissioner, etc. will be installed at security gate as well as in the operational area. 21. Battery-cum-electrically operated emergency alarms will be made available. 22. Speed breakers and speed limit signs will be displayed as required 23. Hazardous chemicals shall be stored as per compatibility and based on corrosive and reactive capabilities as per the guidelines in the MSDS. 24. MSDS of all hazardous chemicals will be kept in the areas where such materials are used and stored. 25. Waste containers will be located at appropriate locations throughout the plant, and will be coded according to the type of waste.

F. Safety Awareness for Key Management 1. Key management personnel will be made aware from the beginning of the project of the key issues regarding the safety in design and operation of the plant. 2. Project management personnel have visited several industrial plants where hazchem is used in bulk as a raw material for the production of finished products. Discussions with operational staff of the plants during these visits has given them valuable insight into the safety aspects of handling of hazchems. 3. Discussions on safe handling of hazchems have been carried out with various safety experts, technical collaborators, and with overseas suppliers through conference calls.

G. Safety Training for All Operational Staff 1. All operational staff will be given safety training as a compulsory part of their induction program. 2. Safety training will include, among other things, the following important aspects: a. awareness of hazards of individual chemicals through study of MSDS b. correct usage of Personal Protective Equipment (PPE) c. explanation of the hazards and risks present in the premises, as well as their analysis d. impact on safety, health, and environment due to improper handling of hazardous chemicals e. guidelines for safety in operations f. Do’s and Don'ts

M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 7-21

H. Safety Audits and Inspections 1. Regular safety audit will be conducted to ascertain the safety levels followed in the plant and suggestions for improvement 2. Special safety audits will be conducted whenever there are process-related equipment / operational changes made in the plant 3. Testing and inspection of high pressure equipment with periodical hydrotesting and thickness testing will be carried out during maintenance shutdown 4. Testing of pressure safety valves and setting will be carried out once in a year during maintenance shutdown 5. Calibration of control valves, instruments as and when required, but at least once in a year during maintenance shutdown 6. Testing of electrical measurements, such as earthing resistance, will be carried out every year. 7. Testing of all fire hydrant installations, fire extinguishers, fire pumps, fire water level monitors will be carried regularly.

7.2.6.2 MITIGATION MEASURES Risk mitigation involves the reduction of the likelihood of a loss occurring due to an accident and the reduction of the severity of such a loss. Several risk mitigation measures have been taken into consideration in the planning of this project: • Personal Protective Equipment • Medical facilities • Handling of leakages and spills • Firefighting system • Engineering controls • Emergency Control Centre • Disaster Management Plan

A. Personal Protective Equipment Personal protective equipment (PPE) are needed to protect individuals from injury. Several types of PPE are necessary for providing the optimum protection to individuals from the various risks. In addition to the PPE which will be used for regular plant operation, the following PPE has been selected for preservation at the plant’s Emergency Control Centre room for use in case of emergency:

TABLE-7.10 LIST OF PERSONNEL PROTECTIVE EQUIPMENT

No. List of personal protective equipment Total (nos.) 1. B. A. set 1 2. Ear Plug 50 3. Hand Gloves 50 4. Gum Boots 10 5. Goggles 50 6. Helmets 25 7. Safety Belts 5 8. Aprons 5 9. Fire Proximity Suit 4 10. Safety Shoe 20 11. Ear Muff 5 12. Face Shield 10 13. Chemical Splash Goggle 10

M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 7-22

Details of Personal Protective Equipment (PPE’s), its Care and Management System proposed by the company are given below:

Training: 1. Induction Training: All employees including contract workmen given Induction training at the time of Joining for proper use of safety equipment and PPEs with demonstration. 2. Special Training: Company will arrange Special training for types of PPEs and adequate Use of PPEs as per training calendar. 3. On Job training: During On Job training , company will cover the right Use of PPEs as hazard and work 4. Training for Self Contained Breathing Apparatus and Emergency Life Saving Apparatus: Company arranges training for Use of Self Contained Breathing Apparatus and Emergency Life Saving Apparatus for all Employee including contract workmen.

Body Protection (Non Respiratory): 1. Protecting Clothing 1. Chemical Resistant Suit: for protection against chemical other then Acid. 2. PVC Suit: for protection against Acid & Alkali other then Hydrofluoric Acid 3. Apron: for working in Laboratory, Laboratory Apron is compulsory.

2. Head Protection (Safety Helmet): Use of different color helmet for easy identification during the Emergency Situation. • Yellow Color Helmet : for the Employees of the company • Green Color Helmet : for Contract Workmen. • White Color Helmet : for Visitor • Blue Color Helmet : for Incident Controller at time of Emergency Handling.

3. Face & Eye Protection : 1. Face Shield: For working at Hazardous chemical, grinding work etc. 2. Safety Spectacles: for working in anywhere in plant side. 3. Safety Goggle: for covering of Full eye at time of certain defined job.

4. Ear Protection : Ear Muff/Ear Plug: For working in High noise area.

5. Hand Protection: 1. PVC Gloves: For Hazardous chemicals like Acid, alkali, Hydrocarbons etc. 2. Chemical Resistant Gloves (Neoprene): for Chemical where PVC gloves not suitable. 3. Leather Gloves: for protection from cuts, abrasions, flying particles mildly hot materials. 4. Rubber Gloves (Electrical): for electrical work available with different voltage ratings 5. Rubber Gloves: for chemicals, oil greases

6. Foot Protection: 1. Safety Shoes: all employees of the company should wear safety shoes compulsory. 2. Gum Boot: for working in water, deep mud or bottom sediment.

Respiratory Protection: 1. Air Purifying Type: 1. Dust Mask: for protection against dust particle use at dusting atmosphere. 2. Chemical Cartridges Respirators: for toxic gaseous area. It is used for exit from the area if any gas leakage.

M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 7-23

2. Air Supplying Type: 1. Self Contain Breathing Apparatus (SCBA): for emergency Handing. 2. Emergency Life Saving Apparatus (ELSA): as like SCBA but its capacity is low. 3. Air Hood Mask: for working in Confined space or gaseous atmosphere, there will be continue supply of Fresh air by Blower.

General Protection: 1. Safety Belt: double harness full body safety belt is compulsory for work at height. 2. Safety Net: used for work at height. 3. Safety Shower: for first aid treatment in case of chemical exposure on body 4. Eye Washer Fountains: for first aid treatment in case of eye exposure.

Care of PPE’s:
Each and every personal protective equipment should be visual checked by the user for its integrity before its use and, if any defects are observed, the concerned supervisor should be promptly informed and the defects corrected or PPE replaced.
Self-contained breathing apparatus must be inspected monthly and details of the inspection and maintenance recorded.
All employees should familiarize themselves with different types of PPEs available in the company.
When not in use, PPE should be carefully stored in a designated place. Do not put it in tool box where it is likely to be damaged or allow it to lie in an open place where it may collect dust. Store PPE in a safe place well covered, away from sunlight and dust.
Do not use the PPE’s other than its purpose or don’t temper with any PPE’s.

B. Medical Facilities Medical facilities are needed to provide immediate medical attention to people who may be exposed to certain health risks during an accident. 1. First Aid Centre will be located at the Workers’ Facility near the administrative building and canteen. 2. A doctor will visit the plant periodically. 3. First Aid Centre will be equipped with a safety shower, eye wash centre, and oxygen-administering facility, etc. 4. Medicines and antidotes for relevant hazardous chemicals will be stored for 5 persons. 5. The contact numbers of all nearby hospitals and medical facilities will be kept and put up on a board in the First Aid Centre. 6. A general agreement for immediate treatment will be made between the nearest hospital and the plant. dC. Handling of Leakages and Spills Quick and safe handling of leakages and spills is the most effective method of risk mitigation in the plant. The company will take the following steps to ensure that leakages and spills can be effectively handled: 1. Ensuring availability and provisioning of suitable PPE for handling spills and leakages. 2. Preparation of handling manuals and placement of the same at important locations. 3. Placement of sand buckets, AFFF (aqueous film forming foam) fire extinguishers, and dry chemical (potassium bicarbonate-based) fire extinguishers at high risk areas. 4. Provisioning of specially marked containers for disposal of spillages. 5. Decontamination area has been earmarked for clothing contaminated by spills. 6. Creation of dykes in the areas where likelihood of spillages and leakage is greatest. 7. Eye-wash stations and showers. In case the leakage or spill can be handled by on-site trained personnel using proper protective clothing and equipment, the incident is not considered an emergency situation. Such non-emergency situations can include malfunctioning pumps, defective pipelines or leaking valves or seals. Also small spills may occur but can generally be handled without alarm.

M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 7-24

The MAXIMUM CREDIBLE ACCIDENT SCENARIO can be suitably handled without creating an emergency situation. In the WORST CASE ACCIDENT SCENARIO, the designated incident controller will be alerted and he will ensure that the emergency is properly dealt with and mitigated with all resources available at our disposal, as per the guidelines laid out in the Disaster Management Plan.

D. Firefighting Systems Due to the handling of flammable chemicals in the plant, it is necessary to provide an effective and efficient firefighting system. A map of the firefighting installations is given in the plant site layout. Some of the salient features are described as follows: 1. Fire water tank capacity and pump capacity of are based on the number of monitors, risers, and outlets provided. 2. All firewater piping is located above ground to prevent hidden corrosion effects. 3. All fire hydrant points will have two independent ring mains for adequate water flow and safety. All fire Nozzles shall be Spray type OR Mist type suitable for surround fighting system.

M/s. Orbit Pharma Laboratories management shall take into consideration fire prevention measures at the project planning and during plant commissioning stage to avoid any outbreak of fire. But looking to the hazardous nature of manufacturing operation shall be handled and processed, the chances of outbreak of fire is however less but cannot be refuted. Hence to avoid such a scenario, a well laid fire protection system is provided in the factory which will be upgraded. List of existing and proposed firefighting equipment’s are given in table-7.10.

TABLE-7.11 LIST OF PROPOSED FIRE FIGHTING EQUIPMENTS

Firefighting Quantity No. Capacity equipment’s Existing Proposed Total 1. Fire Extinguisher 5, 8 & 10 Kgs 16 25 42 (DCP and CO 2 type) 2. Mechanical Foam 9.0 Liters 0 4 4 3. Sand Bucket Stand 3 – 4 Buckets 1 2 3 4. Sand Buckets 08 Liters 1 2 3 5. Hydrant Post - 0 15 15 6. Water Reservoir 300 KL 0 300 KL 300 KL 7. Hose rill 63 mm Día 0 10 10 8. Foam Monitor 100 mm Dia. 0 1 1 9. Foam Trolley 50 Ltr. 0 1 1 10. Smoke Detector - 0 10 10 11. Heat Detector - 0 2 2 12. Public communication - Electric Siren System 0 1 1 - Manual Siren System 0 1 1 - Public Announcement System 0 1 1 covered all Plant Area - Mega Phone 01 KM Cap. 0 1 1

Facilities of fire and safety services are also easily available in the study area.

E. Emergency Control Centre The Emergency Control Centre is a designated room that shall be occupied by the Incident Controller, the final authority to give directives, coordinate with various teams, communicate with district government agencies, and to deal with an emergency inside the plant. The following documents and equipment shall be kept here for the use of the Incident Controller during an emergency:

M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 7-25

1. Updated drawings and P&I diagrams of plant 2. Site layout plan showing raw materials and finished products storage area, security gates, assembly points, process plants, utility building and other areas of the plant 3. Disaster Management Plan 4. List of key plant operating personnel 5. Telephone numbers and contact details of key plant operating personnel 6. Telephone numbers and contact details of district government officials and emergency offices 7. Personal Protective Equipment for emergency use 8. Fire extinguishers (dry chemical powder filled)

7.2.6.3 DO’S AND DON’TS Suitable notices / boards displayed at several locations indicating appropriate hazards warning as well as DOs and DON’T for ensuring operational and personal Safety for information of workers / staff and visitors.

Do’s: 1) Check the available raw material as per the job on hand required for all stages. 2) For good physical condition, check the vessels expected to be used in the process. 3) Check the availability of utilities required till the end of the batch / job. 4) Check for proper manpower available till the entire operation in over. 5) Each and every equipment including the stand-by should be in operable condition. 6) Verify the test certificates of materials being taken for process. 7) Time schedule should prepare for material flow on basis of the process. 8) Monitor the temperature and pressure if possible during the process. 9) Use pumps for transferring the liquids to the reactor tank. 10) Familiarize the worker about what is the job on hand. 11) The worker or operator should have sufficient knowledge of the materials handling. 12) Visual instructions should properly display for characteristics of the chemicals. 13) Ensure proper training of personnel. 14) Ensure sufficient numbers of safety devices are available. 15) In view of the chemicals handled, whether required or not, please ensure availability of SCBA apparatus near every use and storage area of chemical. 16) Ensure the workers wear proper PPE of adequate grade. 17) Demarcation of the chemical storage area for chemical in test. 18) Ensure removal of used containers from workspaces. 19) Prepare and follow the safe work instruction. 20) Record every incident that led to an accident irrespective of the seriousness of the accident and analyze the same to improvise the system continuously. 21) Always check the fire water tank to be filled up to the brim to ensure availability of fire water in sufficient quantity at all times. The design of other water to be used shall be from the overflow of the fire water tank to ensure this system. 22) Never work bare foot or without safety shoes. 23) Never use mobile phones in work zones. 24) Use only proper grade PPEs and use them properly. 25) Open or use containers only on written instruction. 26) Verify the label with the instruction before use. 27) Participate wholeheartedly in all safety related exercises an keep yourself updated.

Don’ts: 1) Without checking of raw material don’t use it as per the job on hand required for all stages. 2) Don’t use the vessels expected to be used in the process without checking. 3) Don’t fail to check the availability of utilities required till the end of the batch / job 4) Don’t work without enough and proper man power. 5) Don’t use the equipments which are not in operable condition.

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6) Don’t use the materials for process without verify the test certificates. 7) Don’t use the material without Prepare time schedule of material flow on basis of the process. 8) Don’t perform without Monitoring the temperature and pressure during process. 9) Don’t handle chemicals with open hands where manual handling is a must. 10) Don’t keep the workers under wraps about what is the job on hand. 11) Don’t let the worker / operator do the work having lack of sufficient knowledge of the materials handled. 12) Don’t use the chemical with unknown characteristics or having unreadable label. 13) Don’t let the personnel do the work without giving proper training. 14) Don’t work without sufficient numbers of safety devices. 15) Don’t let the workers do work without wearing proper PPE of adequate grade. 16) Don’t use material that is under testing for production. 17) Don’t store used containers at workspaces. 18) Don’t breach the safe work instruction. 19) Don’t try to conceal information regarding missed accidents or small injuries. Remember every and any mishap can be fatal if not for yourself for others. 20) After any shutdown never start operation without having ensured the fire water tank filled up. 21) Don’t work bare foot or without safety shoes. 22) Don’t use mobile phones in work zones. 23) Do not use PPEs which are not relevant to the operational aspect that has been identified. 24) Don’t open or use containers on which instruction are not written. 25) Don’t work without Verifying the label with the instruction before use. 26) Don’t ever even thinking of evading safety instructions.

7.2.7 DISASTER MANAGEMENT PLAN

7.2.7.1 OBJECTIVES OF EMERGENCY PROCEDURES Measures those are required to be taken during emergency are co-ordination of activities with many departments/ services and outside resources. The objective of the procedure is to define role of key personnel of different services during major emergency to be effectively utilized to: 1) Safeguard lives 2) Contains of incident and bring it under control 3) Minimize damage to property & neighboring environment 4) Rescue & treatment of casualties & evacuation of persons to safe areas 5) Identification of affected persons, information to relatives and extending necessary assistance. 6) Preservation of information, records etc. which will help in investigation 7) Welfare assistance to casualties 8) Providing relevant information to police, district authorities and news media 9) Mobilizing inside resources 10) Initiating and organizing evacuation of affected persons 11) Collecting latest status, other information and requirement

7.2.7.2 BASIS OF PLAN AND HANDLING OF EMERGENCY 1) It is not possible to envisage and detail every action, which should be taken during an emergency. The basic philosophy is to get key personnel of necessary discipline who have the knowledge and background to assess the situation and give directions as per the objectives as quickly as possible. 2) The plan identifies the services/departments required to combat emergencies and also identifies the key persons to discharge the duties. 3) Key personnel have been identified for emergencies and are responsible for providing necessary assistance. 4) Any outside assistance, which company shall get, shall be co-ordinate by the main site controller on duty.

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5) Messages via telephones are restricted to key personnel only. This is required to keep the telephones free for key personnel to contact for necessary feed-back. 6) Senior person who arrives on scene is automatically in charge for the service group. He should not leave the site without entrusting the charge to his deputy. All the key personnel should be available at the main control room. All key personnel of other services will report to main site controller, who will co- ordinate between various departments and outside agencies.

7.2.7.3 INFORMATION ABOUT EMERGENCY AND SUBSEQUENT ACTIONS 1) Any person noticing fire/explosion/re lease of hazardous gases should shout FIRE, FIRE or HELP, HELP and will activate the emergency bell 2) Inform respective control rooms 3) The Executive in-charge along with the concerned Dept. Head will immediately rush to the incidence site to assess and take immediate action required to control the source of incidence. They will also inform Security and Safety personnel to come to the place of disaster/emergency and assist them. 4) If he feels that the situation is likely to escalate and may lead to emergency will communicate following minimum information to all senior persons. a) Brief description of incident. b) Status & seriousness of the situation c) Actions immediately taken. d) Immediate assistance required. e) All key personnel of respective services, depending on nature of emergency will arrive at site to take charge of positions.

7.2.7.4 INSTRUCTIONS TO EMPLOYEES The plan assumes certain discipline at site during emergency as given below; 1) Do not get panicky 2) Do not approach the scene of disaster as a spectator 3) Do not engage phones/ P.A. system unnecessarily 4) Non-essential personnel to gather at security gate after receiving instructions 5) Do not move here & there unnecessarily 6) Do not approach unnecessarily to get information or more inquiry 7) Remain at your working place unless called and be attentive to instructions 8) Ensure that all contract laborers working in the premises are immediately sent to main security gate. They will receive further instructions from main site controller All non - essential staff members should gather at safe assembly point after assessing the wind direction (from the wind sock, stack of boiler chimney) and wait for further instructions which will be communicated through PA system or by other available means.

7.2.7.5 INSTRUCTIONS TO CONTRACTORS The plan assumes certain discipline at site during emergencies as given below; 1) Do not get panicky 2) Do not approach the scene of disaster as a spectator 3) Do not engage phones/ P.A. system unnecessarily 4) Non-essential personnel to gather at security gate after receiving instructions 5) Do not move here & there unnecessarily. 6) Do not approach unnecessarily for information or more inquiry. 7) Remain at your working place unless called and be attentive to instructions 8) Ensure that all contract laborers working in the premises are immediately sent to main security gate. They will receive further instructions from main controller. All should gather at safe assembly points after assessing the wind direction (from the wind sock, stack of boiler chimney) and wait for further instructions which will be communicated through PA system or by other available means.

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9) All fabricator contractors should ensure that all welding machines are switched off and all cylinders are closed before leaving the working area. 10) All civil contractors should be gathered at assembly points after declared emergency.

7.2.7.6 MITIGATION OF CONSEQUENCES DURING MAJOR ACCIDENT No major hazard installation can ever be absolutely safe. Even if a hazard assessment has been carried out, if the hazards have been detected and appropriate measures have been taken, the possibility of an accident cannot be completely ruled out. So safely systems provide measures, which can mitigate the consequences of accident or emergency situation. In order to be able to initiate counter measures in the event of an accident, company shall install various safety systems to mitigate the consequences during Major Accident are as under: (1) Emergency Control members available round the clock in all plants (2) ECC room with full equipped with Fire Fighting Equipment (3) Fire Men available in Fire Department round the clock (4) TAC approved Fire Hydrant system with electric motor and D.G. Set and water reserved for fire fighting (5) QRA to be done by competent party (6) Alarm System and method of reporting / declaring emergency (7) Regular rehearsal of emergency preparedness (8) Training to all employees regarding emergency preparedness (9) MSDS of all hazardous chemicals are available in safety department and in concerned department.

7.2.7.7 EMERGENCY CONTROL CENTRE WITH LIST OF EQUIPMENT AND ACCESSORIES Safety Office in front of Operation Building will act as Emergency Control Center. It is equipped with all necessary accessories as mentioned below. (A) DOCUMENTS - Site Plan - Disaster Control Plan copy - List of essential telephone numbers - List firefighting equipment - Shift Schedule of Emergency Control members (B) PERSONAL PROTECTIVE EQUIPMENT - B. A. Sets (Breathing Apparatus) - Face Masks - Hand gloves - Gum boots - Goggles - Helmets - Safety belts - Aprons - Fire proximity suit (C) EQUIPMENT LIST - Internal / External Telephone - Portable alarm - Torches - Emergency Cupboard with necessary PPE - Artificial Respirator - Racer watches (STOP WATCH) - Gas Detector Tube - Static Charge Meter

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7.2.7.8 INFORMATION REGARDING KEY PERSONS AND THEIR RESPONSIBILITIES DURING EMERGENCY

A. SITE MAIN CONTROLLER After getting information of emergency, the site main controller will rushed to the Emergency Control Center immediately. 1) On reaching he will assess the magnitude of the situation in consultation with Incident Controller and decide whether inside or outside help are to be called (i.e. Fire Service, Police, Ambulance etc.). 2) Ensure that key persons are called in. 3) Give guidance and direction in vital and important activities to control the emergency situation. 4) Direct to close down and evacuation of the plants in consultation with Incident controller and key personnel. 5) If necessary arrange for evacuation of neighboring population. 6) Inform the Government authorities such as Collector, MC, Factory Inspector, Health Officer & medical Officer and request them for their help as situation demands. 7) Give prime importance to human life and guidance in organizing the rescue operations as well as ensure whether injured people getting proper medical attention in time. 8) Always be in touch with the Incident Controller to get further progress and decide further plan. 9) On completion of emergency situation declare the normalcy through Administrative Officer. 10) Control the re-occupation of the affected areas on discontinuation of emergency. 11) Do not permit to re-start the plant unless it is safe. 12) Give authentic statement of the incident to News Media & Government Authorities.

B. INCIDENT CONTROLLER 1) Take the charge of situation and assess the magnitude of the event 2) Control and guide all the operations with priorities to the Safety of Personnel, minimize pollution, loss of material and loss to the plant equipment and property. 3) Provide advice and guide to the Fire Fighting and Rescuing squad and Fire Brigade while they arrive. 4) Establish communication with emergency control center. 5) Report on all significant developments to the emergency control center through phone/Messenger. 6) Ensure that evacuation of the areas in the factory getting affected is complete. 7) After the emergency situation is brought under control, assure that the necessary evidence for further investigation in the incident is preserved and inform Site Controller regarding control of emergency.

C. TECHNICAL STAFF / DEPARTMENT HEAD 1) As soon as informed, rush to the spot and take charge of the situation till senior group arrives. 2) Ensure that emergency siren is raised which gives information to Security, Safety, Administration Staff and Technical Staff. 3) On arrival of Incident Controller, inform him about the gravity of the situation and then to work under his guidance to control the situation. 4) Ensure that only experienced and essential people remains at the location for controlling, while others to be evacuated from the scene.

D. EMPLOYEES NEAR THE SPOT (INCIDENT AREA) The employees near affected area, under the guidance of the Incident Controller shall 1) Tackle the emergency as per laid down procedures for the area bearing in mind the requirements of the situation called for by the progress of the emergency. 2) Remove all non-essential employees (who are not assigned any emergency duty) shall evacuate the area and gather at the specified assembly points. 3) Stop the operations as per the information of the Incident Controller.

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E. EMPLOYEES OF OTHER DEPARTMENTS 1) On getting information of incident, take permission of superior and confirm own plant, department, safety and then after trained and skill persons will rush to incident spot with necessary personnel protective equipment. 2) Approach the spot from up wind direction and assemble at safe place near to the spot taking in to consideration the wind direction. 3) Extend help to control the situation as per the instruction and guidance given by the senior persons controlling the operation.

F. PERSONNEL OFFICER 1) When emergency declared immediately rushed to emergency control center. 2) Basically he will work as a Liaison Officer and will stationed at emergency control center during emergency. He will work under the direction of Site Controller. 3) To ensure that the casualties receives adequate attention at first aid center, also ensure additional help if require from Government authorities or outside agencies. 4) Arrange transport facility for injured personnel to get timely medical help. 5) He will also arrange for head count at assembly points and will inform Site Controller. 6) Also be in touch with the Security and Other Departments for help. 7) Will check the Roll call from Time Office for availability of trained personnel during emergency situation at the site. 8) Determine the need to inform statutory authorities of the accident and fill the necessary forms for submission with consultation of the Site Controller. 9) When emergency is prolonged, arrange for the relief of personnel as well as inform the families of injured persons and organize refreshments / catering facility.

G. ADMINISTRATIVE OFFICER 1) When emergency declared, immediately rushed to the emergency control center and establish contact with Site Main Controller. 2) Ensure the communication between site controller and incident controller. Keep messenger for communication. 3) Make arrangement to send portable megaphone and torches to the Incident Controller if required. 4) On receiving instructions from Site Controller, organize transportation for the evacuation of people from the assembly points. 5) As per instructions from Site Controller will inform to Head Office, Insurance Surveyor, other relevant authorities and neighboring areas. 6) On getting instructions from Site Controller / Incident Controller, he will be in touch with other Industries for help in emergency. 7) Will arrange to announce necessary instructions for all personnel. 8) Ensure that telephone operator keeps the EPABX free to extend possible for in coming calls. 9) Ensure that Press and other Media do not publish unauthentic news.

H. ENGINEERING SERVICES KEY PERSONNEL 1) When emergency declared, immediately proceed to Emergency Control Center. 2) Ensure the availability of electrical wiremen, utility, maintenance employees and drivers. 3) Ensure the water supply & electric power generator in case of power failure. 4) Be in touch with the Site controller / Incident Controller to extend help as and when required. 5) Ensure availability of Light Motor Vehicles as well as Fork Lifts, JCBs etc. 6) Arrange the vehicle as per required by Administrative / Personnel Officer.

I. SECURITY & FIRE IN-CHARGE 1) When emergency declared, ensure that the Fire man in the fire station and Security guards at the main gate are sufficient. 2) On getting instruction from Site Controller/Incident controller, cordon the affected area to maintain law and order. 3) As per instruction from Site Controller/ Incident controller, arrange to start the fire hydrant pump. 4) Ensure the following duties by Security Guards;

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- Stop all vehicles and visitors entering into the factory, except any Government authorities such as Fire Brigade, Police, Factory Inspector, Medical Staff and inform the Administrative Officer on their arrival. - If any press reporter and local Leader comes at the main gate, take them to the Administration Office. - Do not allow any vehicle to park at the main gate or nearby at main road. - Assure that the entrance of the gate is clear for thorough fare. In Similar way control/ guide internal traffic for smooth operations. - Act according instructions given by Personnel and Administrative Officer. - Ensure that all essential personnel evacuated and assembled at Assembly points. - Arrange effective security nearby the incident place.

J. FIRST AID ATTENDANTS 1) As per the instructions given by the Incident Controller, arrange the supply of additional emergency related equipment to the incident place. Give necessary First Aid treatment to the affected persons immediately. 2) Inform the Personnel and Administration Officer regarding the severity of injury and advise for further medical help if necessary. 3) Ask for additional trained First-Aider, if required. 4) On arrival of Doctor, assist him to give medical treatment to the affected people.

K. SAFETY OFFICER 1) On hearing emergency siren rush to the spot and assume the position of incident controller and take care of the situation till a senior personnel arrives and on their arrival work with them in team, extending their own expertise. 2) Give instructions and guideline to the people involved in control measures. As well as help in providing required PPE. 3) Give instructions to the safety attendants. 4) Brief the Site Main Controller about the progress of control measures. 5) Advise site controller regarding type of help required from outside. 6) Give instructions to other department through internal phones /Communication Officer. 7) Make arrangement to carry out monitoring whenever necessary and appraise results to the concerned seniors

L. ESSENTIAL EMPLOYEES AND THEIRS DUTIES [a] Fireman: 1) On getting information, check the water level in emergency tanks and overhead /under ground storage tanks. Maintain the emergency tank water level to its fullest capacity. 2) Start fire hydrant pump as per the instruction from Security & Fire incharge. 3) Ensure continuous water supply to the incident place. 4) Do not leave the Fire Hydrant pump house till further instruction [b] Driver: 1) On getting information from Communication Officer remain alert and wait for further instructions along with Ambulance van to meet with emergency. 2) Extend help to shift the injured people from site of incident to First-Aid and if required to hospital through Ambulance / Other vehicle. 3) For material handling take Fork-lift / JCB to the spot if required. [c] Electrical/Utility Personnel: 1) After getting the information rush to the spot with necessary personal protective equipment and if instructed by incident controller cut off the power supply to the affected area. 2) Ensure that the D.G. Set is in running condition. 3) Extend help to the Utility Operator in maintaining adequate supply of water and others under guidance of Supervisors. 4) Water in water hydrant storage tank is in full capacity or not

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7.2.7.9 EMERGENCY ORGANIZATION FOR IDLE HOURS 1. SECURITY i) After getting information through emergency hooter inform at least two senior persons at their residence by telephone/messenger. (a) Site controller (b) Safety Officer (c) Incident controller. (d) Technical Staff/Senior Staff ii) Assure that the front side of the gate is clear for thoroughfare. iii) Act according to the instructions of Incident Controller/Senior Officers iv) Inform Emergency Control Center for emergency.

2. SAFETY/FIRST AID ATTENDANT One attendant remains present around the clock. Duties: 1) On hearing emergency hooter does not leave the Occupational Health Center. 2) As per the instructions given by the person In charge of the emergency operation or Incident Controller arrange the supply of additional emergency safety equipment to incident place. 3) Give necessary first aid to the affected person immediately. Inform the site controller about the severity of the Injury and advice for further medical help if required. On arrival of doctor, assist him for medical treatment offered to the affected people.

7.2.7.10 LIST OF IMPORTANT AUTHORITIES WITH THEIR ROLE IN EMERGENCY AND TELEPHONE NUMBERS List of important authorities with their role in emergency and telephone numbers will be prepared and listed, same will be placed/displayed at important locations.

7.2.7.11 INFORMATION ABOUT EXTERNAL COMMUNICATION SYSTEM (1) Communication will be through Emergency Central Alarm System

(2) Telephones: An EPABX unit will be installed to connect all departments internally. Company will also provide mobile connections to all important personnel at site.

(3) STD PHONE & FAX/TELEX: Will be provided at IMP places

(4) IN THE EVENT OF FAILURE OF TELEPHONE SYSTEM: Communication officer will arrange special messengers for communication Minimum one vehicle with driver/trained security personnel are available in the company premises round the clock. We will communicate through our Administration department by our vehicle to nearby community.

7.2.7.12 ANNOUNCEMENT SYSTEM DETAILS During emergency it is necessary that the alarm should be heard by all employees wherever they work, for that speakers will be placed at various locations within plant.

7.2.7.13 OUT SIDE IMPORTANT ADDRESSES AND PHONE NUMBERS List of important addresses in the nearby area such as hospitals, ambulance services, fire fighting services, Government personnel (Municipal Commissioner, district collector, zilla panchayat, police station and emergency control services and their telephone numbers will be prepared and displayed outside emergency control room.

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7.2.7.14 REHERSAL AND UPDATION OF PLAN 1) Every year mock drills will be organized. Shortfalls in actions observed during drill will be explained to participants and will be corrected accordingly. 2) Any shortcomings regarding On–Site Emergency Plan observed during such drills will be corrected and incorporated in On-Site Emergency Plan and same will be communicated to all. 3) The On-Site Emergency Plan will be updated after any significant development in factory or change in the law.

7.2.7.15 INFORMATION OF ASSEMBLY POINTS At the time of emergency, non - essential workers, casual workers, visitors and others are to be replaced to Assembly Points and separate in charge are nominated. In case of an emergency, the visitors, contract persons and factory employees will gather at nearby assembly point. Pre-designated persons will take their roll call. If needed, they can be evacuated easily through any gate in a short period as per instruction of site main controller.

7.2.8 OCCUPATIONAL HEALTH AND SAFETY PROGRAM FOR THE PROJECT Health hazards associated with the occupation are called occupational hazards. In chemical industry due to handling of toxic and hazardous chemicals there are possibilities of developing occupational diseases. Company shall carry out the following checks to curb the problem: i. Pre - employment medical checkup at the time of employment. ii. Annual medical checkup shall be done for all employees. iii. First aid training shall be given to the employees. iv. Monitoring of occupational hazards like noise, ventilation, chemical exposure shall be carried out at frequent intervals, the records of which shall be documented.

TABLE-7.12 OCCUPATIONAL HEALTH MONITORING

No. Particular Medical test Remark 1. Pre employment Vision, Audiometry, Spirometry, chest <30 yrs. Once in five years Check up Skiagram, Unrin, RBS, etc. 31-40 yrs. Once in four years 2. Periodical Check up Spirometry, Urin, RBS, etc. 41-50 yrs. Once in two years 3. Post employment Vision, Audiometry, Spirometry, chest Above >50 yrs. once every year check up Skiagram, Unrin, RBS, ec.

All precautions would be taken to avoid foreseeable accident like spillage, fire and explosion hazards and to minimize the effect of any such accident and to combat the emergency at site level in case of emergency. Some of the preventive safety measures to minimize the risk of accident with respect to Technical Safety, Organizational Safety and Personal Safety are listed below: - The factory will take all reasonably practicable measures to minimize the risk of such accident in compliance with the legal obligation under the relevant safety. - All building plans and installations are as per relevant acts and duly approved by competent government authorities. - Process and Equipment will be designed by qualified and experienced professionals and fabricated to applicable national / international codes with stage wise inspection. - Safety features such as fire extinguisher and suitable Personal Protective Equipment (PPE) shall be provided. Regular operations and testing of fire extinguishers shall be carried out. - Periodic inspection and testing of pressure vessels, equipment, machineries and equipment handling substances. - Training of workers and Staff for firefighting, work permit system, first aid, safe handling of materials and integrating safety, in all activities.

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- Accident / Incident reporting system and information of employees about the same for better awareness. - Suitable notices / boards displayed at several locations indicating appropriate hazards warning as well as DOs and DON’T for ensuring operational and personal Safety for information of workers / staff and visitors. For the safety of the workers, personal protective equipments like hand gloves, helmets, safety shoes, goggles, aprons etc. & Ear protecting devices like earplugs/earmuffs will be provided. Nose mask will be provided at places, where there is possibility of dust generation.

Company shall adequately install fire-fighting system in different sections of the plant. Some of the safeties precautionary measures shall be taken for manufacturing process are listed below: i. Safety Relief Valve, Rupture disk, temperature scanner, pressure indicator, and flow meter will be installed to vessel wherever required. ii. Cooling / Chilling water circulation arrangement will be provided to avoid abrupt increase of pressure and control heat and high temperature. iii. Auto control system (ACS) to Monitor & Control. iv. Vent will be connected with scrubber as per the requirement. v. PPE will be provided to workers during charging of various raw materials and exhaust ventilation lines will be provided as per requirement. vi. Necessary interlocking and alarm system will be installed wherever required.

MEDICAL AID SCHEME For outside help, company authority will make a mutual understanding with the following authorities to extend their help whenever an emergency occurs; (1) Doctors from Civil Hospital (2) Police Station (3) Fire Brigade Time to time company shall inform/impart training to concerned employees for awareness about chemicals and its hazards and the precautionary measures on their part.

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n CHAPTER – 8

PROJECT BENEFITS

8.1 PHYSICAL INFRASTRUCTURE The beneficial impact of proposed expansion project on the civic amenities will be substantial after the commencement of project activities. The basic requirement of the community needs will be strengthened by extending healthcare to the community, building/strengthening of existing roads in the area which will help in uplifting the living standards of local communities. The proposed project is going to come near Chhatral industrial area and the area which is engaged with industrial activities i.e. Kadi GIDC and Kalol GIDC. Infrastructure in this region is already developed and upcoming industries will make positive impacts for the development of the infrastructure.

8.2 SOCIAL INFRASTRUCTURE The proposed expansion project will bring development in the social infrastructure through CSR activities and employment generation.

Corporate Social Responsibility (CSR) The goal of CSR is to assess needs of local community and be accountable to internal and external stakeholders at all levels for smooth performance, of the organisation, transparency and social responsibility. The corporate unit has to comply with and work towards such goals. The proposed project realizes the social and environmental impacts that the proposed unit will bring about and accordingly devise ways and means to minimize the risks and maximize the opportunities/benefits associated with it.

Implementation of CSR activities is a very challenging task which M/s. Orbit Pharma Laboratories is interested to take up with consistency and determination. The Company plans the implementation of chosen initiatives and follows through with commitment across the organization to make this happen and ensures that implementation will be successful, with resources, milestones, measurement, and accountability. The Industry intends to undertake CSR activities in and around their Plant. A total amount of Rs. 13.6 Lacs would be utilized for CSR programme for five years. Total project cost is Rs. 5.45 Crores and company would to identify stake holders for the planning of CSR activities and implementation of it. All activities with its estimated cost is given in table-8.1 for benefitting the society at large and the local rural community in particular for the period of 5 years after that the company will do as per the regulations.

Plan of Actions The Company will carry out the CSR activities and collect information from the employees about their- social background, exposure to development issues, skills and ideas, etc. This will help in involving the interested employees in CSR activities. An initial assessment of current status of all programmes both for the Company as well as for the Government schemes in the area, it will also collect employees’ background and interest, funding possibilities, information regarding local Community Based Organizations (CBOs), None Governmental Organizations (NGOs), local clubs and other partners etc, CSR activities will be planned with local governing bodies ( Gram Panchayats ), NGOs and stake holders.

An annual plan or calendar will be prepared on the basis of initial assessment. Indicators for assessing the progress of initiatives and a systemic database on CSR activities shall be developed with inputs from employees. The Company shall submit a report of its activities on completion of each quarter in a year. A strategic review should follow in order to streamline the CSR programs. Basic work space and facilities will be provided by the Company at its campus. Budget for each activity should be outlined in the annual calendar/plan. The working contract shall be governed by a Terms of Reference (ToR) mutually agreed by consultant and the Company. CSR activities will have manifold practical approaches which are as follows:

1. Financing Plan The estimated budget for the planned CSR activities is as follows:

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n

In future the responsibilities for all these facilities will be handed over to the Government. A CSR cost bifurcation for 5 years is given in below table-8.1

TABLE – 8.1 PROPOSED CSR ACTIVITIES

No. Activities Details Total (Rs.) 1. Promote nutrition programme Eradicating hunger, poverty and malnutrition 68,000 2. Drainage facility Contribution in providing drainage facility 2,04 ,00 0 3. Safe Drinking Water Facility Provide facility of Safe drinking water 2,04,000 4. Health Care Facility Training, payment of bills and development of PHC 68,000 5. New techniques in Agriculture Tour and/or Training to Farmers 45,300 6. Awareness Programmes Awareness of various Govt. schemes 45,300 Construction of Rain Water Rainwater harvesting structures in nearby villages 7. 90,600 Harvesting and in premises Setting up secondary schools and vocational training 8. Promoting Education 1,26,000 centers 9. Development of village schools Donation of equipments in schools 90,700 Construction of low cost latrine for Tribal 10. Construction of Low cost latrines 1,36,000 coordinating with Government 11. Plantation Plantation on roadsides and in villages 68,000 12. Park/Playg round Development of parks/playground 68,000 13. Promote Sports Support rural sports activities 50,400 Socio-economic development and relief and welfare Contribution to the Prime Minister's 14. of the Scheduled Castes, the Scheduled Tribes, other 95,700 National Relief Fund backward classes, minorities and women TOTAL 13,60,000

8.3 EMPLOYMENT OPPORTUNITIES The project will create opportunities for direct and indirect employment for which skilled and unskilled manpower will be needed. Secondary jobs are day-to-day needs and services to the work force. This will also temporarily increase the demand for essential daily utilities in the local market.

Indirect Employment: Due to the proposed project indirect employments will be generated. Indirect employments like; Primary requirements, Grocery shops, Residential requirements, Garments requirements, Transportation facilities, Health care facilities, etc. These kinds of requirements will increase the prevailing scenario as the area is not suitable for agricultural activities so this change the employment scenario, which will generate the indirect employment.

Local villagers of the project will get its benefits more by giving preference to them in relation to direct employment associated with the various project activities. Construction and operation phase of the proposed project will involve a certain number of laborers, contractors and construction workers. There is a possibility that local people will be engaged for this purpose. The operation phase will involve a number of skilled and unskilled workers. Total employment generation for the proposed expansion project of pharmaceutical manufacturing unit shall be 100 (19 existing and 81 additional) personnel.

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CHAPTER – 9

ENVIRONMENTAL COST BENEFIT ANALYSIS

9.1 ENVIRONMENTAL COST BENEFIT ANALYSIS Environmental cost benefit analysis was not recommended at the scoping stage. Project benefits have been discussed in Chapter-5 Analysis of Alternatives and Chapter-8 Project Benefits.

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CHAPTER – 10

ENVIRONMENTAL MANAGEMENT PLAN

10.1 DESCRIPTION OF EMP Industrial development is associated with a few positive and negative impacts on the environment. The negative impacts should not hinder industrial development but they should be properly mitigated. An Environmental Management Plan (EMP) has been prepared for the proposed expansion of M/s. Orbit Pharma Laboratories to minimize negative impacts and is formed on the basis of prevailing environmental conditions and likely impacts of this project on various environmental parameters. This plan will also facilitate monitoring of environmental parameters.

This EMP includes schemes for proper scientific treatment and disposal mechanism for air, liquid and solid/hazardous pollutants. Apart from this, green belt development, safety aspect of the workers, noise control etc. is also included in it.

Purpose of Environmental Management Plan Various purposes of the environmental management plan are listed below:
To treat and dispose off all the pollutants viz. liquid, gaseous and solid waste so as to meet statutory requirements (Relevant Pollution Control Acts) with appropriate technology.
To support and implement work to achieve environmental standards and to improve the methods of environmental management.
To promote green-belt development.
To encourage good working conditions for employees.
To reduce fire and accident hazards.
Budgeting and allocation of funds for environment management system.
To adopt cleaner production technology and waste minimization program. Details of Environmental Management Plan during Construction & Operation Phase for Air, Water & Land Environment are given below.

10.1.1 AIR ENVIRONMENT During Construction Phase Construction phase will be for a short period and hence the impacts will also be for a short and temporary period. During construction activities, mainly emission of dust and gases from movement of vehicles and construction activity is expected. However, following measures will be taken to reduce/contain such emissions:

The proposed expansion project is having Active Pharmaceutical Ingredient unit so there is no need for constructing any roads.
Possibility of raising green belt along with construction activity will also be explored.
Transport vehicles and construction equipments / machineries will be properly maintained to reduce air emissions.
Vehicles and equipments will be periodically checked for pollutant emissions against stipulated norms.
Idle running of vehicles will be minimized during material loading / unloading operations.
All construction workers will be provided appropriate PPEs like dust mask, ear plug, helmet, safety belt etc. and made to wear them during working hours.
Exhaust vent of D. G. Set will be kept at proper height to ensure quick dispersal of gaseous emissions.

During Operation Phase The air pollutants in the plant may be classified broadly into particulate matter like dust, fumes etc. and gases like SO 2, NO X, HCl etc. The measure to control the air pollution will ensure the ambient air quality standards as laid down by Central Pollution Control Board (CPCB) for industrial areas.

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The system proposed for air pollution control will provide acceptable environment condition in the working areas and abate air pollution in the surrounding area of the plant. The technological equipment and processes have been selected with the above objectives. Depending on quality of emission from different sources, suitable air pollution control system like Water Scrubber, Alkali Scrubber & Acidic Scrubber will be provided. The chimney height is as per CPCB norms to ensure ground level concentration of different pollutants within permissible limit . Details for the control measures are given in section 2.8.6 of Chapter-2. Environment cell will be formed to look after the implementation of air pollution control measures.

Following measures are proposed to mitigate negative impact of operation phase of the project on the surrounding air environment.
Stack height will be provided as per statutory requirement. All the stacks will have Stack Monitoring Facility (SMF) consisting of sampling port-hole, platform and access ladder.
Online monitoring system for the pollutants from the stacks with an arrangement to reflect gaseous emission parameters on company’ server shall be provided.
Transport vehicles will be properly maintained to reduce air emissions.
Vehicles will be periodically checked for pollutant emissions against stipulated norms.
Idle running of vehicles will be minimized during material loading / unloading operations.
Water sprinkling along the haul road.
Proper maintenance air pollution control equipment.
Regular maintenance of vehicles and machinery in order to control emissions.
A good housekeeping and proper maintenance will be practiced in the industry.

10.1.1.1 FUGITIVE EMISSION & CONTROL TECHNOLOGIES • Fugitive emissions are emissions of gases or vapours from equipment due to leaks and other unintended or irregular releases of gases, mostly from industrial activities. As well as the economic cost of lost commodities, fugitive emissions contribute to air pollution and climate change. • Fugitive emissions present other risks and hazards. Emissions of volatile organic compounds pose a long term health risk to workers and local communities. In situations where large amounts of flammable liquids and gases are contained under pressure, leaks also increase the risk of fire and explosion. • Leaks from process equipment generally occur through valves, pipe connections, mechanical seals, or related equipment. Fugitive emissions also occur at evaporative sources. Though the quantities of leaked gases may be small, gases that have serious health or environmental impacts can cause a significant problem. • To minimize and control leaks at process facilities operators carry out regular leak detection and repair activities. Routine inspections of process equipment with gas detectors can be used to identify leaks and estimate the leak rate in order to decide on appropriate corrective action. Proper routine maintenance of equipment reduces the likelihood of leaks.

Sources of Secondary Emission & Control Fugitive emissions from the proposed expansion would be significant as there will be air pollution due to activities like material handling and transfer points of materials and movement of vehicles. Fugitive emissions are also likely to occur during leak from pumps, valves and pipes or leak/ spill from storage vessels/ facilities. Mainly, the loss of Toluene, Aniline Oil, Acetone etc. in form of VOCs are likely to occur as fugitive emissions from the proposed expansion project. Details of fugitive emission sources, its control and mitigation measures are given in section 2.9.2.1 of Chapter-2.

Action Plan for Fugitive Emission Control The fugitive emissions of organic chemicals and VOCs mainly occur due to tank breathing losses, Leaking pipe fitting and valves, during maintenance operations. Though these are not expected to be significant, the following measures will be followed to ensure compliance and further reductions wherever possible. • The fugitive emissions in terms of handling losses will get reduced by proper storage and handling. • Adequately designed storage area with efficient air change ratio, handling & transport facilities shall be provided for fuel, raw materials & products.

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• Raw Materials & Products will be stored in closed containers. These containers will be kept under the shade to prevent the fugitive emission at elevated temperature. • Hazardous chemicals will be stored as per standard criteria. • Periodically monitoring will be carried out as per the post project monitoring plan. • Internal concrete roads are already constructed in existing plant for the prevention of dust during vehicular movement. • Adequate air ventilation system of sufficient capacity will be provided in the entire production plant. • Proper ventilation in storage & production area shall be ensured and all materials must be stored in suitable packing to prevent contamination of air due to particulates & volatile emissions from storage container & area. • Enclosed system & efficient procedures for materials charging shall be ensured. • Procedures for start-up shut down, operation & maintenance procedures shall be established & maintained in all relevant area of works. • Proper implementation of safety procedures and efficient use of safety arrangements, facilities & equipment shall be ensured at all time of operation to prevent accidental release of materials & fuels as well as prevent fire hazard. • Safety PPEs like dust mask etc will be provided from dust protection. • The coverage of greenbelt around the plant also acts as natural barrier to stop carrying of dust along with the wind current. • Good housekeeping will be maintained in the plant. • Risk analysis will be done at every stage to identify potential risks and install appropriate elimination / mitigation systems.

10.1.1.2 Odour Management Plan Causes of odour will be Methanol, Toluene and Acetone during handling and storage. • Better management to avoid staling. • Chemicals will be stored in leak free container. • Worker will be provided by personnel protective equipments. • Avoiding the solid/hazardous waste storage inventory. • Spraying of chemicals wherever required to avoid odour. • During ETP operation, drastic change in influent COD can kill the micro-organisms & produce foul smell. To avoid this scenario, quality of influent waste water (COD, temperature, pH etc.) shall be maintained within desired limit.

10.1.2 WATER ENVIRONMENT During Construction Phase Ground water will be utilized for the construction of proposed expansion project. Small amount of water will be required for the construction. Hence, no major impact on existing water resources of the study area is envisaged. Site engineer will monitor all the activities at site and manage for resources. Proper and sufficient sanitary facilities will be provided to construction workers to maintain all hygienic conditions at site. Storm water drain compatible with the local hydrological pattern of the area, is provided to carry-off, any run-off or storm water from the premises. Care should be taken during construction work & will not create any obstruction/dips in the topography which can lead to accumulation of water within premises leading to undesirable consequences like health and hygiene problems, etc.

During Operation Phase Total water requirement for the proposed expansion project would be 65 KLD (fresh 60 KLD + 5 KLD reused) which will be sourced from ground water using bore well. Water conservation measures shall be taken to optimize the fresh water requirement. M/s. Orbit Pharma Laboratories Pvt. Ltd. While industrial effluent around 27.65 KLD will be generated. Total effluent will be segregated into two streams i.e. high COD and low COD. Which will be treated in proposed upgraded ETP and treated water will be evaporated. And High COD effluent will be sent to common MEE facility at Chhatral. Thus, company will achieve Zero Liquid Discharge (ZLD). Details of water requirement, waste water generation and its control measures are given in section 2.8.5 of Chapter-2. Environment cell will monitor for proper operation of ETP.

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10.1.3 NOISE ENVIRONMENT During Construction Phase Following measures are proposed during construction period to mitigate adverse impacts:
Construction machinery and vehicles will undergo periodic maintenance to keep them in good working condition.
All machineries to be used for construction purpose will be of highest standard of reputed make and compliance of noise pollution control norms by these equipments will be emphasized by the company.
Feasibility of putting up acoustic enclosure / temporary barrier around areas with high noise levels will also be explored.
All construction workers working in high noise areas will be provided appropriate PPEs like ear muffs and made to wear them during working hours.
Possibility of raising green belt along with construction activity will also be explored so as to serve as a noise barrier.

During Operation Phase Following precautionary measures will be adopted to control the noise level:
Noise generating sources and their platforms will be maintained properly to minimize noise vibrations generated by them.
Personnel working near the noisy machines in different plant locations, will be provided with well designed ear muffs / plugs (effective noise reduction 10-15 dBA)
Green belt will be improved to act as a noise barrier.
Noise barriers / shields in the form of walls, beams will be provided around the units wherever found feasible.
Training to personnel will be imparted to generate awareness about effects of noise and importance of using PPEs (Personal Protective Equipments).

10.1.4 SOIL ENVIRONMENT During Construction Phase Following steps are proposed to take care of impact of construction activity on project land area:
On completion of civil works, all debris etc. will be completely removed from site to avoid any incompatibility with future use.
Other materials like paints; diesel, etc. will be properly stored and handled to prevent any spillage on land.
All the wastes will be stored at a designated site within the premises to prevent scattered discharge on land.

During Operation Phase Hazardous waste ETP sludge shall be sent to TSDF site for land filling & Fly Ash to brick manufacturer or send to TSDF site. A small quantity of used lubricating oil will be generated which will be properly stored and reused/ selling to registered refiners. Discarded Container/ barrels / plastics will be sold to recycler. Date Expired, discard and off specification medicines will be disposed at CHWF/TSDF. There will be no disposal of industrial waste on land.

10.1.5 SOCIO-ECONOMIC ENVIRONMENT During Construction Phase Overall socio-economic effect of construction phase will be positive due to direct and indirect employment opportunity for the local livings.

During Operation Phase EMP for the Socio-economic aspects prepare in concern with the sustainable development, management team shall have to develop ideology to give preference local people in recruitment. Management team shall prepare an annual plan of CSR activities. All these positive contributions to the society will minimize negative effects. For the implementation of CSR activities,

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10.1.6 ECOLOGICAL ENVIRONMENT Ecology Proposed project is coming on the existing unit. Thus, no tree cutting exercise will be there and no major impact on ecology is anticipated. However, possibility of rising of green-belt along with construction activity will be explored so that greening of area can be started at the beginning of project.

Green Belt Development Greenbelts are an effective mode of control of air pollution, where green plants form a surface capable of absorbing air pollutants and forming a sink of pollutants. Leaves with their vast area in a tree crown, sorbs pollutants on their surface, thus effectively reduce pollutant concentration in the ambient air. Often the adsorbed pollutants are incorporated in the metabolic pathway and the air is purified. Plants grown to function as pollution sink are collectively referred as greenbelts. An important aspect of a greenbelt is that the plants are living organism with their varied tolerance limit towards the air pollutants. A green belt is effective as a pollutant sink only within the tolerance limit of constituent plants. Planting few, known pollutant sensitive species along with the tolerant species within a green belt however, do carry out an important function of indicator species Apart from function as pollution sink, greenbelt would provide other benefit like aesthetic improvement of the area and providing suitable habitats for birds and animals.

Selection of Plants for Greenbelts The main limitation for plants to function as scavenger of pollutants are, plant’s interaction to air pollutants, sensitivity to pollutants, climatic conditions and soil characteristics. While making choice of plants species for cultivation in green belts, due consideration has to be given to the natural factor of bio- climate. Xerophytes plants are not necessarily good for greenbelts; they with their sunken stomata can withstand pollution by avoidance but are poor absorber of pollutants. Character of plants mainly considered for affecting absorption of pollutant gases and removal of dust particle are as follows.

For absorption of Gases 1. Tolerance towards pollutants in question, at concentration, that are not too high to be instantaneously lethal 2. Longer duration of foliage 3. Freely exposed foliage 4. Adequate height of crown 5. Openness of foliage in canopy 6. Big leaves (long and broad laminar surface) 7. Large number of stomatal apertures

For Removal of Suspended Particulate matter 1. Height and spread of crown. 2. Leaves supported on firm petiole 3. Abundance of surface on bark and foliage 4. Roughness of bark 5. Abundance of axillary hairs 6. Hairs or scales on laminar surface 7. Protected Stomata

Recommended Plant Species for Green Belt Development: The following trees and shrubs are suggested for green belt development within the plant premises. The highlighted species are more suitable for plantation as well as for prevailing dust emission.

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TABLE-10.1 RECOMMENDED PLANT SPECIES FOR GREEN BELT DEVELOPMENT ALONG THE BOUNDARY OF AS A WIND BARRIER AS WELL AS TO PREVENT DUST POLLUTION TOLERANCE STOMATAL MODE OF PLANT SPECIES LOCAL NAME HABIT LIMIT INDEX REGENERATION Acacia auriculiformis Austrialanbaval Tree Tolerant 10.9 Seeds Acacia leucophloea Hermobhaval Shrub T 12.01 Seeds Ailanthus excelsa Moto Aurdso Tree T 13.01 Seeds, shoot, root cuttings Alstona scholaris Saptaparni Tree T 15.23 seeds Azadirachta indica Limbado Tree T 29.2 Seeds Bauninia recemosa Kanchner Tree T 25.68 Seeds Bougainvillea Bougainvel Shrub T 32.53 Cutting spectabilis Cassia javanica L. var. Pink Cassia Tree T - Seeds indochinensis Cordia sebastiana Scarlet Cordia Tree T - Seeds Orange Geiger tree Delonix regia Gaulmor Tree S 1438 Seeds/cuttings Kegelia Africana Tabudiyo Small T 12.90 Seeds tree Lowsonia intermis menthi Shrub T 17.0 Seeds/cuttings Mangifera indica Ambo Tree S 30.77 Seeds/ budding/grafting Melia azadirachta Bakan limdo Tree T - Seeds /stem cut ting Nerium indicum Lalkaren Shrub T 15.7 Cutting Peltophorum Sonmukhi Tree T 16.78 Seeds pterocarpum Plumeria obtuse L Chambo Tree T -- Cutting Plumeria rubra l. Champo Tree T Cutting Polyathia longifolia Asopalav Tree Sensitive 22.27 Seeds Pong amia pinnata Karanji Prosopis cineraria Khyigdo Tree T 18.1 Seeds/root suckers Salvadora oleoides Piludi Tree - Seeds/ cuttings Decne Salvadora persica L. Piludi Tree T - seeds Spathodea Scarlet-bell tree Tree T 24.84 campanulata Senna siamea Lam. Kasida Tree T 21.2 Seeds Terminalia catapppa Desi Badam Tree T 20.9 seeds Thespesia populnea L. Paras pipalo Tree T 29.81 Seeds/ cuttings Thevetia peruviana Pili karan Shrub T 27.8 Seeds T: Tolerant S- sensitive, (--) =Not available Sources: CPCB (March, 2000 ) Guidelines for developing green belts PROBES/75/1999-2000

TABLE-10.2 LIST OF SUITABLE ORNAMENTAL CLIMBERS/ SHRUBS AS PLANTATION INSIDE THE GARDEN AND OPEN SPACES BETWEEN DIFFERENT UNITS OF PROJECT SITE FAMILY SCIENTIFIC NAME COMMON ENGLISH FLOWERING NAME SEASON Bignoniaceae Bignonia ventusa Golden shower Jan-Feb Bignonia capreolata Trumpet Flower March-April Bignonia unguis –cati Cat’s claw April Bignonia speciosa Handsome flower March April Tecoma satans Yellow bell Throughout the year Tecoma radicans Trumpet vine Throughout the year Caesalpiniaceae Caesalpinia pulcherrima Peacock flower April-June Ixora coccinea Scarlet Ixora Throughout the year Ixora rosea Pink Ixora Aug-Sept

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FAMILY SCIENTIFIC NAME COMMON ENGLISH FLOWERING NAME SEASON Ixora parviflora Small Flowered Ixora March-April Rubiaceae Ixora barbata Brarded Ixora April-May Ixora lutea Yellow Ixora Throughout the year Euphorbiaceae Euphorbia pulcherrima Christmas Flower Dec-Jan Apocynaceae Thevetia peruviana Trumpet Flower Throughout the year Alemanda nerifolia - April-June Nerium Indicum Oleander Throughout the year Catharanthus roseus Periwinkle Malvaceae Hibiscus mutabilis Changeable rose September-October Hibiscus schizopetalus Coral Hibiscus April-September Hibiscus rosa –sinensis Chinese Rose Throughout the year Nyctaginaceae Bougainvillea spectabilis and Throughout the year different varieties With seasonal bloom

Guidelines for Plantation The plant species identified for greenbelt development can be planted using pitting technique. Width of the green belt in the available land area may prove difficult for many industries to attain for on eor more reasons. Hence it can be decided to have green belt in places available around the industry (source oriented plantation) as well as around the nearby habituated area (receptors oriented plantation). The choice of plats for green belt should include shrubs and trees. The intermixing of trees and shrubs should be such that the foliage area density in vertical is almost uniform. The pit size has to be either 45 cm x 45 cm x 45 cm or 60 cm x 60 cm x 60 cm. Bigger pit size will be considered at marginal and poor quality soil. Soil used for filling the pit should be mixed with well decomposed farm yard manure or sewage sludge at the rate of 2.5 kg (on dry weight basis) and 3.6 kg (on dry weight basis) for 45cm x 45 cm x 45 cm and 60 cm x 60 cm x 60 cm size pits respectively. The filling of soil has to be completed at least 5-10 days before actual plantation. Healthy sapling of identified species should be planted in each pit with the commencement of monsoon. Provision for regular and liberal watering during the summer period during the commissioning stage of the plant will be arranged from the local available resources. After the proposed plant became operational, the authorities responsible for plantation will also make adequate measures for the protection of the saplings The trees and shrubs selected from the above mention list based on its availability shall be, planted as greenbelt of 10-20 m width around the plant boundary. The plantation will be in this recommended pattern:

TABLE-10.3 BUDGETARY OUTLETS OF GREENBELT DEVELOPMENT FOR FIVE YEARS

SR. NO. YEAR NO. OF PLANTS BUDGET (RS.) 1 1st Year 190 96,000 2 2nd Year 130 64,000 3 3rd Year 130 64,000 4 4th Year 65 32,000 5 5th Year 65 32,000 TOTAL 580 2,88,000

10.1.7 HYDRO-GEOLOGICAL ENVIRONMENT Rain Water Harvesting Scheme Introduction Gandhinagar district is covered with quaternary alluvium formation of Cambay basin. Rocky area is not found in this district. The alluvial formation is made up of multi-layer sand, silt and clay formation. Alluvium thickness is more in western side of the district, while less in eastern side. Silt, clay dominates alluvium found in the northwest side while coarse-grained sand with gravels is common in the eastern part. Tertiary clay (Blue clay) occurs at different depths in the area. It demarcates the potable water boundary, below which water quality deteriorates. In the eastern part it occurs at very shallow depth i.e. at 40 to 50 mts restricting drilling depth up to that depth. Ground water occurs in semi-confined to confined and in un confined conditions. Total depth of the bore in east side is ranging from 50 to 180 Mts., while in northwest

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n side, depth of the bore varies from 200 to 350 Mts. Presently village water supply schemes are mainly based on ground water through tubewells. Water level of the district is depleting very fast due to less recharge and un-controlled withdrawal.

Water Balance The water requirement for various uses in the plant will be fulfilled by groundwater water supply extracted from bore well. The water consumption is described in table below:

TABLE-10.4 WATER REQUIREMENT WATER NO. OF DAYS SR. TOTAL PARTICULARS REQUIREMENT FOR NO. m3/year m3/DAY CONSUMPTION 1 Industrial requirement 49 300 14,700 2 Domestic requirement 5.00 300 1,500 3 Green Belt requirement 6 300 1,800 Total 18,000

The effective area available for the rainwater harvesting is tabulated in the table-10.5. The effective area is considered on the basis of rain water harvesting comes in contact with other possible contaminants.

TABLE-10.5 RAINWATER AVAILABLE FOR HARVESTING

EFFECTIVE AREA AVAILABLE AVERAGE TOTAL CONSIDERED FOR FOR SR. ANNUAL DESCRIPTION AREA RAINWATER COEFFICIENT RAINWATER NO. RAINFALL (m 2) HARVESTING HARVESTING (m) (m 2) (m 3) 1 Green belt 2332.0 2332.0 0.846 0.20 394.5 2 Paved area 1200.0 1200.0 0.846 0.60 609.1 3 Roof top area 1589.8 1589.8 0.846 0.90 1210.5 4 Open area 1762.7 1762.7 0.846 0.20 298.24 Total 2512.34

The rainwater available for harvesting is calculated 2,512.24 m3 per annum (table-10.5). The consumption of water is total 18,000 m3 per annum (table-10.4). Table-10.6 shows the water balance calculation, it is apparent that the water available for roof top rainwater harvesting is less than the water consumption per annum.

TABLE-10.6 WATER BALANCE WATER REQUIREMENT RAINWATER AVAILABLE FOR WATER BALANCE (m 3/ANNUM) HARVESTING (m 3/ANNUM) (m 3/ANNUM) 18000 2512.24 -15487.7

Total fresh water required per year 18,000 KL. As per the norms of CGWA for 200% recharge we have to recharge 36,000 KL. Studying the area & aquifer in the surrounding area and the existing bore wells, we conclude that one recharge bore well can intake 9,000 liters per hours. So considering 30 days of rainfall we can conclude one recharge bore well capacity will be 6,480 KL.

As per rainwater collection in premises 2,652 KL/Yr the unit has to be constructed one recharge Borewell in premises. Approximate seven recharge bore well has to be constructed which will recharge approximate 36,000 KL/Yr. Total volume of water to be recharge as per 200% norms for over exploited zone can be sufficed by seven recharge borewell. One in premises & six remaining in nearby village or in Village Lake. The N.O.C from required authorities of village for RWH will be obtained.

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RECOMMENDATIONS FOR RECHARGE BORE WELL. • One new recharge wells of 200 mm X150 mtrs each should be drilled by DR type of rig with heavy duty mud pump at the location as shown in the sketch map for rain water recharge. • Drilling party is instructed to collect strata samples at 06 Mtrs interval of drilling & mud water samples at 15 Mtrs depth interval of drilling for necessary verification. • Pilot hole must be electrolloged & pipe assembly should be lowered as per Electro logging results. • Casing pipe with strainer pipe of 200mm Dia should be lowered into a well reamed bore hole of 450mm Dia for recharge wells. • On the basis of the aquifer materials encountered during drilling, the size of the screen should be decided, varying from 1.0mm to 1.5 as per the grain size. • Gravel packing in the structure should strictly follow the size of screen recommended. • The tube well should be cleaned with air compressor till sand free discharge is obtained.

Recommended Specification of recharge bore well. • A trial bore of 200mmX150 mtrs depth by direct rotary rig with heavy duty mud pump is recommended as per sketch map. • Depth : 150 mtr • Diameter: 200 mm

FIGURE-10.1 THE GENERAL DESIGN OF THE RECHARGE WELL

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10.2 OCCUPATIONAL HEALTH AND SAFETY Following plan for occupational health and safety will be adopted in the plant and details for allocated fund for the same is given in section 2.5.1 of Chpater-2. Company is following as per factory rules, Form No. 32 (Health Register), Form No. 33 (Fitness Certificate) & Form No. 20 (Certify Surgeon Fitness Certificate) for health of workers and records are maintained, Samples are given in Annexure-XIV. Company is following its standard procedure. Regular work zone environmental monitoring to indentify Permissible Exposure level (PEL) of hazardous chemicals due to fugitive emission is/will be carried out.
All measures related to safety such as safety appliances, training, safety awards, posters, slogans will be undertaken.
The workers exposed to noisy sources will be provided with ear muffs/plugs.
Adequate facilities safe for drinking water and toilets will be provided to the employees.
The fire and safety equipment will be properly utilized and maintained regularly.
The health of the workers will be regularly checked by a well qualified doctor and proper records will be kept for each worker.
Restrictions ; only authorized employees permitted to enter in restricted plant areas.
Responsibility : Site appointments detailing specific responsibilities as required meeting regulatory compliance shall be completed and maintained, within the Health and Safety Management System.
Site Manager : site manager will has the overall responsibility for all occupational health and safety activities on the site, and to stop any subordinate from working on site in an unsafe manner.
Communication : All employees will be encouraged to communicate regarding hazard observed in plant to any supervisor.
Toolbox talks : supervisory staff will conduct weekly toolbox talks with employees and address the application of health and safety rules and procedure to hazards.
Site rules : site rules prepared and communicated to employees like; induction training, designated area to wear PPEs, no smoking signs, etc.
Housekeeping : dedicated area for rubbish dumping bins will be identified and established in every plant. Usage of rubbish bins will be instructed. Maintaining hygienic conditions in canteens, near drinking water source and toilets.
First aid : a first aid box will be provided and allocated to a trained, certified first aider.
Fire prevention : Flammable materials shall be stored in a suitable location and adequate firefighting equipment installed in suitable locations around the store. All operations conducted on site shall be conducted in a manner to prevent the risk of fire.
Monitoring safety: the site manager staff will monitor safety thoroughly in plant visited and if any modification observed/identified, necessary action will be taken. Incident and accident will be recorded and reported to authority.

10.3 CONCEPT OF WASTE-MINIMISATION, RECYCLE/REUSE/RECOVER TECHNIQUES, ENERGY CONSERVATION, AND NATURAL RESOURCE CONSERVATION Waste-minimisation : Process optimization can be done by using proper technology & maintenance of equipment. Recycle/reuse/recover : M/s. Orbit Pharma Laboratories Pvt. Ltd, in which low COD stream will achieve ZLD and high COD stream will be send to Common facility for MEE. Natural Resource Conservation : To conserve ground water, rain water harvesting will be carried out to store rain for future use and also to recharge ground water. Energy Conservation : To conserve energy, company will use traditional light bulbs with Compact Fluorescent Lamps (CFLs) means reduction in usage of 1/4 th of the total energy consumption.

10.4 DESCRIPTION OF ADMINISTRATIVE ASPECTS Description of different Administrative Aspects are enlisted here,

10.4.1 ENVIRONMENTAL MANAGEMENT CELL In addition to preparing an EMP, it is also necessary to have a permanent organizational set up to ensure its effective implementation. Hence, proposed plant will create a team consisting of officers from various departments to co-ordinate the activities concerned with management and implementation of the environmental control measures. This team will undertake the activity of monitoring the stack emissions,

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n ambient air quality, noise level etc. either departmentally or by appointing external agencies wherever necessary. Regular monitoring of environmental parameters will be carried out to find out any deterioration in environmental quality and also to take corrective steps, if required, through respective internal departments.

The Environmental Management Cell will also collect data about health of workers, green belt development etc. Organogram of the Environmental Management Cell is presented in figure-10.2.

FIGURE-10.2 AN ORGANOGRAM OF ENVIRONMENT MANAGEMENT CELL

Vice President – General

General Manager - Works

Manager – EHS

Executives– ETP / MEE / RO Medical Assistance – OHC Jr. Executive – F & S.

Operators – ETP / MEE / RO.

The cell will also be responsible for monitoring of the plant safety and safety related systems which include:
Checking of safety related operating conditions.
Visual inspection of safety equipments.
Preparation of a maintenance plan and documentation of maintenance work specifying different maintenance intervals and the type of work to be performed.

Other responsibilities of the cell will include:
Conduct and submit annual Environmental Audit Report. A SPCB registered agency will be retained to generate the data in respect of air, water, noise and soil and prepare the Environmental Audit Report. Timely renewal of Consolidated Consents & Authorization (CC & A) will also be taken care of.
Submitting environmental monitoring report to SPCB. Data monitored by the cell will be submitted to the Board regularly and as per the requirement of SPCB. The cell will also take mitigate or corrective measures as required or suggested by the Board.
Keeping the management updated on regular basis about the conclusions / results of monitoring activities and proposes measures to improve environment preservation and protection.
Conducting regular safety drills and training programs to educate employees on safety practices. A qualified and experienced safety officer will be responsible for the identification of the hazardous conditions and unsafe acts of workers and advise on corrective actions, organize training programs and provide professional expert advice on various issues related to occupational safety and health.
Conducting safety and health audits to ensure that recommended safety and health measures are followed.

10.4.2 ENVIRONMENTAL POLICY The Company has an environment policy approved by the Director which is attached as annexure-XI. The standard Operating procedure will be prepared after implementation of the project.

10.4.3 REPORTING SYSTEM TO THE DIRECTORS A responsible person or officer collect the Environmental and safety compliance data and submit it to their manager & he/she submit a signed Environmental and safety compliance report to the Directors. Any Environment related non compliances / violations / notices will be taken as immediate action. M/S. ORBIT PHARMA LABORATORIES, GANDHINAGAR, GUJARAT 10-11 en-vιsι
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10.4.4 BUDGETORY PROVISIONS FOR EMP Adequate budgetary provisions have been made by M/s. Orbit Pharma Laboratories Pvt. Ltd. Management for execution of environmental management plans. The details of capital and recurring (per annum) budget earmarked for pollution control / monitoring equipment; operation and maintenance of pollution control facilities, for greenbelt development and maintenance will be as given in table-10.7.

TABLE-10.7 COST OF ENVIRONMENTAL PROTECTION MEASURES (RS. IN LAKHS) RECURRING COST CAPITAL COST NO. PARTICULARS (RS. IN LACS. PER (RS. IN LACS.) ANNUM) 1. Air & Noise Pollution Control 10 0.8 2. Water Pollution Control 58 6.8 3. Environment Monitoring & 1.25 1.6 Management 4. Occupational Health 1.5 0.3 5. Green Belt 2.5 0.5 TOTAL 73.25 10

10.5 OCCUPATIONAL WORK ZONE MONITORING The Company is having its existing practice for monitoring of hazardous chemicals in work zone area. Work zone monitoring is being carried out by third party monitoring laboratory. Hazardous chemicals and sampling locations identified to monitor its concentration and records are being kept as per Gujarat Factories Rules. The Company has proposed monitoring programme to monitor the concentration of chemicals in work zone environment.

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CHAPTER – 11

SUMMARY AND CONCLUSION

11.1 INTRODUCTION M/s. Orbit Pharma Laboratories is proposed expansion project in Pharmaceutical and Bulk Drug unit at Block No. 155/1, 159, Chhatral-Kadi Road, Village Dhanot, Taluka Kalol, District Gandhinagar, Gujarat.

11.2 PROJECT DESCRIPTION 11.2.1 PROJECT DETAILS Category of the project A (Outside the Notified Industrial Area) S. No. In the schedule 5(f), Synthetic Organic Chemicals as per EIA Notification dated 14 th September, 2006 & its amendment dated 1 st December, 2009 Location of the project Block No. 155/1, 159, Chhatral-Kadi Road, Village Dhanot, Taluka Kalol, District Gandhinagar, Gujarat Project cost for proposed expansion Rs. 5.45 Crores. project Cost for EPCM (Environmental Total capital cost of pollution control measures will be Rs. 73.25 Pollution Control Measures) lacs & recurring cost per annum will be 10 lacs.

11.2.2 PROJECT REQUIREMENT

Land requirement Company is having 7066 sq. m. of private land area. N o new land is required for the proposed expansion project. Water requirement & its • Total water requirement will be 65 KLD (60.0 KLD fresh + 5.0 KLD source reused). • Out of 60 KLD, 6 KLD will be used only for greenbelt development & 5 KLD for domestic purpose. • 49 KLD water will be required for industrial purpose (boiler, cooling tower, for process, washing & others). • Entire water will be sourced from ground water using bore well & permission is under process from the Central Ground Water Authority (CGWA). Electricity requirement & • Total power requirement will be 260 KW (60 KW existing + 200 KW its source proposed) will be sourced from UGVCL (Uttar Gujarat Vij Company Limited). • During emergency purpose one .D. G. Set of 100 KVA and additional one number of .D. G. Set of 250 KVA will be utilized. Manpower requirements • For proposed expansion project total 100 (existing 19 and additional 81) personnel will be required. • Out of total 30 personnel will be on contract basis. • Preference will be given to local people on the ground of qualification. • Local people will be hired for construction work so labor colony will not be required. • Existing facility will be utilized for their requirements. During operation phase rest rooms and sanitation facilities will be pr ovided for truck drivers if required. Fuel requirement & its No. Fuel Existing Proposed Total Remark source 1 Wood Waste/ 2,700 3000 For Boiler & Hot Air 300 Kg/Day Agro waste/ Coal Kg/Day Kg/Day Generator 2 Coal - 1,800 1800 For Thermic F luid Heater Kg/Day Kg/Day 3 Diesel 8 Lit/Day 20 Lit/Day 28 Lit/Day For DG Sets

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11.2.3 RAW MATERIALS No. Name of Raw Material MT/Month 1. 2,6-Dichlorophenol 69.81 2. Potassium Carbonate 31.30 3. Toluene 184.79 4. Methyl Mono Chloro Acetate (MMCA) 48.86 5. Aniline Oil 38.39 6. Chloro Acetyl Chloride (CAC) 62.83 7. Alluminium Chloride 43.18 8. Carbon 2.68 9. Acetic acid 19.82 10. Diethyle Amine 0.72 11. Hydrochloric Acid 15.13 12. 4 Chloro -2 Aminophenol 2.73 13. Urea 3.28 14. Hydro Sulphide of Soda 0.0 3 15. Caustic Lye 23.90 16. Methanol 229.34 17. 4-Chloro -2- Nitro Aniline 12.20 18. Thiophenol 7.32 19. Ferric Chloride 0.37 20. Hydrazine Hydride 9.76 21. Hydrogen Cynamide 7.32 22. Methyl Chloro Formate 8.54 23. Dimethyl Sulxoxide 0.55 24. Hydrogen Peroxide 1.60 25. Acetone 30.94 26. N(4-5) Dicloro-2 Nitro Phenyl Acetamide 2.38 27. Dimethyl Formamide (DMF) 2.38 28. 2:3 Dichloro Phenol 2.38 29. Nitrogen Gas 0.12 30. Hydrogen Gas 0.15 31. Raneynickel 0.26 32. Hyflow 0.10 33. Potassium Hydroxide 1.79 34. Calcium Disulphide 0.86 35. Dimethyl Sulfate 1.98 36. Isopropyl Alcohol (IPA) 0.24 37. Methoxy Acetyl Chloride 0.59 38. Methylene Dichloride 16.37 39. Xylene 6.22 40. Thiourea 0.59 41. 1-Decylbromide 1.19 42. Methychloro Formate 1.33 43. 1-1 Cyclohexane Diacetic Acid 1.80 44. Liq. Bromine 1.17 45. Caustic Soda Flakes 11.78 46. Trietylamine 0.50 47. 1,3 Cyclohexadione 0.95 48. Phenyl Hydrazine 1.01 49. Zinc Chloride 0.95 50. Phosphorous Trichloride 1.52 51. Closantel Amine 3.03

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No. Name of Raw Material MT/Month 52. 3:5 DiIodosalicylic acid 4.24 53. Sodium Metal 3.18 54. Caustic Potash 1.52 55. Catalyst 0.23 56. Para Formaldehyde 1.14 57. 2-Methylimidazole 0.65 58. Liq. Ammonia 0.79

The raw materials will be purchased from the local market and transported through trucks to the project site. Approximately 80 numbers of trucks per month will be required for transportation of raw material, finished goods and hazardous wastes, etc.

11.2.4 WASTE WATER GENERATION AND MANAGEMENT In existing scenario 4.1 KLD waste water is generating which includes 0.65 KLD domestic waste water and remaining 3.45 KLD is industrial effluent. Domestic waste water is disposed through septic tank/soak pit. While industrial effluent is treated in ETP and after treatment it is evaporated through single stage evaporator. After the proposed expansion, around 31.3 KLD waste water will be generated. Domestic waste water will be generated around 3.65 KLD and disposed through septic tank/soak pit. While industrial effluent around 27.65 KLD will be generated. Total industrial effluent will be segregated into two streams i.e. high COD and low COD. Low COD stream will be treated in proposed upgraded ETP and treated water will be evaporated through single stage evaporator. High COD effluent will be sent to common MEE facility at Chhatral. Thus, company will achieve Zero Liquid Discharge (ZLD).

11.2.5 AIR EMISSION AND AIR POLLUTION CONTROL MEASURES Details of air pollution control measures given in the following. Pollution Control No. Stack Attached To Fuel Used Stack Height Final Concentration System EXISTING SCENARIO SPM ≤ 150 mg/Nm 3 1. Boiler * (1TPH) Wood Waste/ Agro 30 meter Multi Cyclone SO ≤ 100 ppm waste / 300 kg/Day 2 2. Hot Air Generator 8 meter - NO X ≤ 50 ppm SPM ≤ 150 mg/Nm 3 D.G Set (Stand By) Acoustic 3. Diesel 8 Lit/Hr 30 meter SO ≤ 100 ppm 100 KVA Enclosures 2 NO X ≤ 50 ppm PROPOSED SCENARIO SPM ≤ 150 mg/Nm 3 Boiler * Coal/ Agro waste / 1. 30 meter Multi Cyclone SO ≤ 100 ppm (2TPH) 2700 kg/Day 2 NO X ≤ 50 ppm SPM ≤ 150 mg/Nm 3 Thermic Fluid Heater Coal 2. 30 meter Multi Cyclone SO ≤ 100 ppm (2 lac Kcal) 1800 kg/day 2 NO X ≤ 50 ppm SPM ≤ 150 mg/Nm 3 D.G Set (Stand By) Diesel Acoustic 3. 09 meter SO ≤ 100 ppm 250 KVA 20 Lit/Hr Enclosures 2 NO X ≤ 50 ppm * There will be a common stack for existing and proposed boiler

PROCESS EMISSION Pollution Control No. Stack Attached To Stack Height Final Concentration System EXISTING SCENARIO 09 Water scrubber followed 3 1. Reaction vessels meter by Alkali Scrubber HCl ≤ 20 mg/Nm PROPOSED SCENARIO

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Pollution Control No. Stack Attached To Stack Height Final Concentration System

Water scrubber followed 3 1. Reaction vessels 09 meter by Alkali Scrubber HCl ≤ 20 mg/Nm

11.2.6 SOLID WASTE GENERATION & DISPOSAL Total 6 types of Solid/hazardous waste will be generated from the proposed expansion project. • Used oil (0.05 MT/Y ) will be reused as lubricants in the machineries within the premises only or send to authorized re-processors. • Discarded Containers/Barrels/plastic (600 Nos/year ) will be sent to authorized recycler after decontamination. • ETP sludge (15 MT/M) will be sent to TSDF site. • Date Expired, discard and off specification medicines (1 MT/M) will be disposed at CHWF/TSDF after giving proper treatment • Fly Ash (18 MT/M) and Evaporator salt (5 MT/M) will be collected, stored and sent to brick manufacturer or to TSDF site. • Solvent residue (20.35 MT/M) will be sent for incineration.

11.3 BASELINE ENVIRONMENT The baseline environmental quality has been assessed during Post-Monsoon Season i.e 1 st October to 31 st December, 2016 in a study area of 10 km radial distance from the project site.

11.3.1 AMBIENT AIR QUALITY The baseline levels within the study area with respect to (PM 10 , PM 2.5 , SO 2, NO X, CO, HCl and VOC) terms of various statistical parameters are presented in tables-3.3. During baseline monitoring, the arithmetic 3 th mean values of PM 10 varied between 62.79 - 72.86 µg/m while the 98 percentile values of PM 10 ranged 3 3 between 66.08 – 76.01 µg/m . The arithmetic mean values of PM 2.5 varied between 30.01 – 34.25 µg/m while th 3 the 98 percentile values of PM 2.5 ranged between 33.01 - 37.15 µg/m . The arithmetic mean value for SO 2 3 th 3 was 9.26 – 13.91 µg/m and the 98 percentile of SO 2 was 12.91 - 17.21 µg/m . The arithmetic mean values of 3 th 3 NO x varied between 17.78 –22.43 µg/m while the 98 percentile of NO X ranged from 19.10 - 25.57 µg/m . The arithmetic mean values of CO varied between 0.1 – 0.3 mg/m 3 while the 98 th percentile of CO ranged from 0.2 – 0.5 mg/m 3. The arithmetic mean and 98 th percentile values of HCl and VOC are found below detectable limit (BDL)<1.0.

11.3.2 GROUND WATER QUALITY MONITORING Groundwater samples from different villages during study period was collected once during monitoring period and analyzed. pH varied in the range of 7.52 - 7.84, turbidity 1.0 – 1.7 NTU, total hardness 50.9 - 262.6 mg/l, dissolved solids 560 - 1919 mg/l, Sulphate 50 - 285 mg/l and Alkalinity 268 - 476 mg/l. Chloride varied from 130.6 – 739.2 mg/l. Nitrate and heavy metals concentrations were observed to be below Indian standard/specification for drinking water IS 10500-1992.

11.3.3 SURFACE WATER QUALITY MONITORING pH varied is from 7.08 – 8.05 the turbidity varied from 1.0 – 4.2 NTU, the dissolved solids varied from 203 - 511 mg/l, total hardness varied between 57.7 – 135.9 mg/l, chloride varied from 43.2 – 291.9 mg/l, the sulphate varied from 17.5 – 100 mg/l. The nutrient values in the form of nitrate were not observed. The overall surface water quality was found to be average and the water should be treated before using it for drinking purpose.

11.3.4 BACKGROUND NOISE LEVEL The noise level measured in study area at different locations. The noise level at the project site was found 51.6-77.9 dBA in daytime 45.1-68.8 dBA in night time. The noise levels varied in the residential area of the study area during day time [night time] in the range of 42.3-77.9 (31.9 – 69.4 ) dBA .

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11.3.5 SOIL QUALITY The eight soil samples collected from surrounding areas including project site were assessed for physical and chemical quality parameters. The porosity ranged from 30-74 % and WHC from 29-60 %. The EC ranged from 700 – 1078 µs/cm . The soil pH varied from 7.7-8.7. These results indicate that in general soils are saline/alkaline as EC exceeds 800 µs/cm and pH is above 8.1. The OC varied from 1.9-3.5 % and available nitrogen from 78.2-109.2 mg/kg. The available phosphorus and potassium ranged from 1870-2978 mg/kg and 16.5-62.5 mg/kg respectively. Among basic cations there is predominance of sodium (84.3 to 141.7 mg/kg) followed by calcium (17.8 to 41.5 mg/kg) and magnesium (8.0 to 26.2 mg/kg).

11.3.6 LAND USE PATTERN Land use within 10 km radius of the study area has been determined with the help of satellite imagery, and broadly consists of settlements, Industrial, Tank/River/reservoir, Single crop, land with scrub, land without scrub area.

11.3.7 SOCIO-ECONOMIC STUDY The study area consist total 52 major, minor villages and urban area. Total population of the study area is 3,87,539 as per census 2011 from which 2,03,998 are males and 1,83,541 are females. Total population of Gandhinagar district was 13,91,753 having 923 female per 1000 male. While other district is Mahesana, it had population of 20,35,064. With regards to sex ratio in Mahesana, it stood at 926 per 1000 male. As per 2011 census, the total literacy rate of the Gandhinagar and Mahesana District were 84.16% and 83.16% respectively, while literacy rate in study area was 72.4%. All villages are having primary infrastructural facilities.

11.3.8 BIOLOGICAL ENVIRONMENT There is no National park, wild life sanctuary present within the study area of 10 km radius from the project site.

11.4 ANTICIPATED ENVIRONMENTAL IMPACTS & MITIGATION MEASURES 11.4.1 IMPACT ASSESSMENT An effort has been made to identify various environmental, social and ecological impacts due to proposed project during construction and operation phases considering present environmental scenario as baseline. The corresponding mitigation measures to take care of the adverse impacts are also discussed in following sections.

11.4.2 IMPACTS DURING CONSTRUCTION PHASE & ITS MITIGATION MEASURES During Construction Phase, the Fugitive Dust Emission due to civil work and vehicular movement is not expected to spread too far as water spraying will be carried out to suppress the dust emission at the site and as well as on road. The increase in noise levels due to the movement of vehicles will be taken care of by regulating the movement of vehicles and the impact on the human beings will be taken care of by providing the working people with ear plugs / ear muffs. During Construction , drainage pattern and water supply system of overland water flow will not be changed during the site preparation activities. Suspended solids can be controlled by sprinkling water and by employing enclosures to construction area to allow the particles to settle down, prior to discharge. During construction period, the project is likely to generate substantial employment and income.

11.4.3 IMPACT DURING OPERATION PHASE & MITIGATION MEASURES 11.4.3.1 AIR ENVIRONMENT The ISCST3 scientific model has been used to predict the proposed air quality on the environment. 3 The maximum 24 hourly average GLC’s for PM, SO 2, NO x and HCl is observed to be 2.45 g/m , 4.17 g/m 3, 1.53 g/m 3 and 0.03 g/m 3 respectively at a distance of 1 km in South direction. Sources of fugitive emissions include storage of chemicals, manufacturing activities, solvent handling, processing vessels, valves, joints, loading and unloading section, raw material handling and hazardous waste storage area, etc.

11.4.3.2 NOISE ENVIRONMENT The noise pollution management will be taken up in the following manner; - By providing noise barrier to the noise generating equipment, noise level will reduce below 75 dBA noise level at 1 m distance.

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- Acoustic enclosures will be provided to D. G. set to reduce the noise level. - Further, Greenbelt will help to reduce the noise level within the plant. By these measures, it is anticipated that noise levels in the plant will be maintained below 75 dBA .

11.4.3.3 WATER ENVIRONMENT Total water requirement will be 60 KLD. Out of 60 KLD, 6 KLD will be used only for greenbelt development & 5 KLD for domestic purpose. 49 KLD water will be required for industrial purpose (boiler, cooling tower, for process, washing & others) Entire water will be sourced from ground water using bore well & permission is under process from the Central Ground Water Authority (CGWA). In existing scenario 4.1 KLD waste water is generating which includes 0.65 KLD domestic waste water and remaining 3.45 KLD is industrial effluent. Domestic waste water is disposed through septic tank/soak pit. While industrial effluent is treated in ETP and after treatment it is evaporated through single stage evaporator. After the proposed expansion, around 31.3 KLD waste water will be generated. Domestic waste water will be generated around 3.65 KLD and disposed through septic tank/soak pit. While industrial effluent around 27.65 KLD will be generated. Total effluent will be segregated into two streams i.e. high COD and low COD. Low COD stream will be treated in proposed upgraded ETP and treated water will be evaporated through single stage evaporator. High COD effluent will be sent to common MEE facility at Chhatral. Thus, company will achieve Zero Liquid Discharge (ZLD).

11.4.3.4 GREEN BELT DEVELOPMENT About total 2,332 m2 (33%) area shall be developed as green belt area.

11.4.3.5 SOCIO-ECONOMIC ASPECT Impact on Socio-Economic aspect will be mainly of Population, Migration, Culture, Economic status, Health, Education, Drinking water facility, Drainage facility, Primary Infrastructure, etc. Due to this project population growth will be increased for direct and indirect employment related to this industry. With the increase of population, migration will also increase which impact will be directly on culture of the area. For the proposed expansion, total 100 (existing 19 and additional 81) personnel will be employed. Moreover indirect employment will be generated which will increase the commercial and economic status of the area. As in CSR activity of the project improvement of health facility, education facility and primary infrastructure facility will be improved which will definitely push up the socio-economic status of the area.

11.5 ENVIRONMENTAL MONITORING PROGRAMME A regular monitoring of environmental parameters like air, water, noise and soil as well as performance of pollution control facilities and safety measures in the plant are important for proper environmental management of any project. Therefore, the environment and safety cell will handle monitoring of air and water pollutants as well as the solid wastes generation as per the requirements of GPCB/CPCB.

11.6 RISK ASSESSMENT The management is very much aware of their obligation to protect all persons at work and others in the neighbourhood who may be affected by an unfortunate and unforeseen incidence occurring at the works. Any hazard either to employees or others arising from activities at the plant site shall, as far as possible, be handled by the personnel of the company and prevented from spreading any further. However in the case of eventuality the Disaster Management plan adopted may be able to control the situation.

11.7 PROJECT BENEFITS The company shall earmarks funds of Rs. 13.6 lacs i.e. 2.5% of the total project cost i.e. Rs. 545 lacs which will utilize for the CSR activities for the five years after that the company will utilize the fund as per regulations. Company will carry out the CSR activities in the field of Drinking water facility, Health care, agriculture, awareness programme, Rain water harvesting, Education, Plantation, Sports, etc.

11.8 ENVIRONMENTAL MANAGEMENT PLAN Environmental monitoring of different parameters will be done regularly and the activity will be coordinated by the Environmental Management Cell (EMC). Mitigation of environmental impact has to be implemented according to the suggestions and will be monitored regularly to prevent any lapse. The EMC will be under the overall supervision of the Manager (EHS). The cell will report on a regular basis to the

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General Manager. The EMC will prepare a formal report on environmental management and mitigation at six month intervals. The company will undertake various training programme for improving the performance of the working personnel. Special training will be arranged in regular intervals to combat emergency scenarios that may occur during the plant operation.

11 CONCLUSION It can be concluded that on positive implementation of mitigation measures and Environmental management plan during the construction & operational phase, there will be negligible impact on the environment. The project in totality may be considered environmentally safe.

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CONSULTANT ENGAGED

Environmental Impact Assessment (EIA) Study for the proposed expansion of pharmaceutical products manufacturing unit of M/s. ORBIT PHARMA LABORATORIES conducted by,

Name : Envision Enviro Technologies Pvt. Ltd. nd Address : 2 Floor, Shri Ram Complex, Above Bank of India, Surat-Dumas Road, Piplod, Surat-395 007, Gujarat. Phone : (0261) 2223003, 2224004 E-mail : [email protected] Website : www.en-vision.in Status of accreditation with : Accredited. Certificated No: NABET/EIA/1417/ IA 003 valid QCI/NABET up to December 03, 2017

Envision Enviro Technologies Pvt. Ltd. (ISO 9001:2008 certified company) is a consulting, engineering and equipment supplier firm delivering exceptional service and quality to public and private clients in India. Envision is working with zeal in the field of environmental engineering for more than 20 years. Envision has a vision of supporting and being a part of development that is sustainable to our environment.

Envision is one of the leading companies as Environmental Consultants providing the EIA study required for Environmental Clearance from MoEF&CC/SEIAA and NOC (Consent to Establish), CCA (Consent to Operate) from Pollution Control Board. Envision has a well established laboratory with environmental monitoring and analysis of environmental parameters (Air & Water monitoring, Waste Water analysis, Stack analysis).

Envision is also working as consultants, turnkey project executors and equipment suppliers in the field of Pollution Control (Environmental) Engineering and deals with turnkey projects in Incineration System for Solid and Hazardous waste. Envision also does the design, construction, erection and commission of Water Treatment Facility (Effluent treatment plants, Sewage treatment plants, etc.) and Secured Landfill sites. Envision is the first organization in India that holds Common Plastic Waste Management Facility.

Envision is enlisted contractor with PWD, Goa as Class-I-A (One-A) in the category of Water Supply & Waste Water Disposal. Envision is recognized as Environmental Auditors and enlisted as consultants and pollution control equipment suppliers with Gujarat Pollution Control Board. Provide Services in the field of Structural Engineering, Water Supply Engineering and Civil Engineering. It has national cliental from state of Gujarat, Chhattisgarh, Assam, Haryana, Madhya Pradesh, Andhra Pradesh, Rajasthan, Goa, Kerala, etc and international cliental from Dubai and Egypt.

EETPL is Member of Consulting Engineers Association of India, Indo-German Chamber of Commerce, Society of Environmental Auditors and Consultants, Ahmedabad and Member of CII. EETPL is operated by Mr. Nihar Doctor and Mrs. Nimisha Doctor, who are actively involved in achieving their vision to be a significant contributor in the development sustainable by Environment using collective technical acumen to provide services & equipments and be a part of movement of building Modern India with better environment and safety aim.

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ACCREDITATION CERIFICATE BY QCI NABET

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Functional area experts and assistance to FAE involved in the EIA study for M/s. Orbit Pharma Laboratories Gandhinagar, Gujarat is as follow:

FUNCTIONAL AREA EXPERTS INVOLVED IN THE EIA Name of EIA Functional area experts involved Coordinator / Assignment Head Functional area Name/s involved Dr. Y. Rama Mohan LU (Land Use) Ms. Smitha Rajesh Associate: Mayur Harsora AQM (Meteorology, Air Quality Nihar Doctor Associate: Modeling & Prediction) Associate: Smitha Rajesh, Krunal Patel Arif Shaikh AP (Air Pollution Monitoring, Nihar Doctor Prevention & Control) Associate: Krunal Patel, Vaibhavi Kanani Nihar Doctor WP (Water Pollution Monitoring, Associate: Smitha Rajesh, Mayur Harsora, Prakash Prevention, & Control) Vaghela Dr. Manoj Eledath EB (Ecology & Biodiversity) Associate: Satyendra Singh Dr. Rumjhum Ray Chaudhuri SE (Socio-Economy) Associate: Arif Shaikh Haneesh Panicker N (Noise) Associate: Mayur Harsora, Vaibhavi Kanani HG (Hydrology, Ground Water & Naresh Gor Water Conservation) Associate: Apoorva Ghantiwala Sundararajulu Chinnikrishna Amidala RH (Risk Assessment & Hazard Associate: Smitha Rajesh Jignesh Patel, Krunal Management) Patel SHW (Solid & Hazardous Waste Nihar Doctor Management) Associate: Smitha Rajesh, Jatin Wadia

LABORATORY INVOLVED FOR BASELINE MONITORING & OTHER ANALYSIS

No. Name of laboratory NABL registration status Role

1. En-Tech Laboratory Certificate No. T-3750 Monitoring and Analysis

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ANNEXURES

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TERMS OF REFERENCE LETTER AWARDED BY EAC

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ANNEXURE-II

LAND DOCUMENT

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LAND DOCUMENT

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LAND DOCUMENT

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LAND DOCUMENT

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TSDF/INCINERATION MEMBERSHIP CERTIFICATE

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TSDF/INCINERATION MEMBERSHIP CERTIFICATE

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CLIMATOLOGICAL DATA

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CLIMATOLOGICAL DATA

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RAW DATA OF AAQM

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RAW DATA OF AAQM

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RAW DATA OF AAQM

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ANNEXURE-V (CONTD.)

RAW DATA OF AAQM

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ANNEXURE-VI

NATIONAL AMBIENT AIR QUALITY STANDARDS (NAAQS) (2009)

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n ANNEXURE-VI (CONT.)

NATIONAL AMBIENT AIR QUALITY STANDARDS (NAAQS) (2009)

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n ANNEXURE-VII

INDIAN STANDARDS/SPECIFICATIONS FOR DRIINKING WATER IS: 10500-1991

Sr Substances or Requireme- Undesirable Effects Permissible Limit Method of Remarks No. Charcter- Nt Out-Side The In Absence of Test Ci Ref Istics (Desirable Desirable Limit Alternate Source of Max Limit) Is: 3025 ESSENTIAL CHARACTERISTICS 1 Colour, Hazen 5 Above this, 25 4 of 3025, Extended upto 25 only unit consumer 1983 if toxic substances are acceptance not suspected in decreases absence of alternate Source. 2 Odour Unobjectionable - 5 of a. Test cold and when 3025,198 heated 3 b. Test at several dilutions 3 Taste Agreeable - - Test to be conducted only after safety has been established 4 Turbidity, NTU 5 Above this, 10 8 Test to be conducted consumer only after safety has acceptance been established decreases 5 pH Value 6.5-8.5 Beyond this range No relaxation 8 - the water will affect the mucous membrane and/or water supply system 6 Total Hardness 300 Encrustation on 600 - - mg/L (as CaCO 3) water supply structure and adverse effects on domestic use 7 Iron (as Fe), 0.3 Beyond this limit,, 1.0 32 of - mg/L taste/appearance are 3025, affected has adverse 1964 effect on domestic uses and water supply structures & promotes iron bacteria 8 Chlorides 250 Beyond this limit 1000 32 of - (as Cl -) mg/L taste, corrosion and 3025 palatability are affected 9 Residual free 0.2 - - 26 of To be applicable only chlorine, mg/L 3025, when water is 1986 chlorinated tested at consumer end, when protection against viral infection is required it should be min 0.5 mg/L 10 Dissolved Solids, 500 Beyond this 2000 16 of - mg/L palatability decrease 3025 and may cause gastrointestinal irritation 11 Calcium (as Ca) 75 - 200 40 of - mg/L 3025, 1984

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n ANNEXURE-VII (CONT.)

INDIAN STANDARDS/SPECIFICATIONS FOR DRIINKING WATER IS: 10500-1991

Substances or Requireme- Method of Undesirable Effects Permissible Limit Sr. Charcter- Nt Test Ci Out-Side The In Absence of Remarks No. Istics (Desirable Ref of Desirable Limit Alternate Source Max Limit) Is: 3025

DESIRABLE CHARACTERISTICS 12 Copper (as Cu), 0.05 Astringent,taste 1.5 36 of mg/L discoloration of 3025, pipes, fittings and 1964 utensils will be caused beyond this 13 Manganese (as 0.1 Astringent ,taste 0.3 35 of Mn), mg/L discoloration of 3025,196 pipes, fittings and 4 utensils will be caused beyond this 14 Sulphate (as 200 Beyond this 400 24 of May be extended -2 SO 4 ), mg/L causes 3025, upto 400 provided gastrointestinal 1986 (as Mg) does not irritation when exceed 30 mg/l magnesium or sodium are present - 15 Nitrate (as NO 3 45 Beyond this 100 - - ), mg/L methaemoglo- binemia 16 Fluoride (as F -), 1.0 Fluoride may be 1. 5 23 of - mg/L kept as low as 3025, possible. High 1964 fluoride may cause fluorosis 17 Phenolic 0.001 Beyond this, it 0.002 54 of substances may cause 3025 mg/L (as objectionable taste C6H5OH) and odour 18 Mercury (as 0.01 Beyond this, the No relaxation See note To be tested when Hg), mg/L water becomes mercury pollution is toxic ion suspected analyzer 19 Cadmium (as 0.01 Beyond this the No relaxation See note To be tested when Cd), mg/L water becomes mercury pollution is toxic ion suspected analyser 20 Selenium (as 0.01 Beyond this the No relaxation 28 of To be tested when Se) mg/L water becomes 3025, pollution is toxic 1964 suspected 21 Arsenic (As), 0.05 Beyond this the No relaxation 37 of To be tested when mg/L water becomes 3025, pollution is toxic 1988 suspected

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n ANNEXURE-VII (CONT.)

INDIAN STANDARDS/SPECIFICATIONS FOR DRIINKING WATER IS: 10500-1991

Permissible Substances or Requireme- Undesirable Effects Limit In Method of Sr. Charcter- Nt Out-Side The Absence of Test Ci Ref of Remarks No. Istics (Desirable Desirable Limit Alternate Is: 3025 Max Limit) Source 22 Cyanide (CN -), 0.05 Beyond this the water No relaxation 27 of 3025, To be tested mg/L becomes toxic 1986 when pollution is suspected 23 Lead (Pb), 0.05 Beyond this the water No relaxation See note 86 To be tested mg/L becomes toxic when pollution plumbosolvenc y is suspected 24 Zinc (as Zn), 5 Beyond this limit it 15 39 of To be tested mg/L can cause astringent 3025,1964 when pollution taste and an is suspected opalescence in water 25 Anionic 0.2 Beyond this limit 1.0 Methylene To be tested detergents mg/L undesirable taste and blue when pollution (as MBAS) odour after extraction is suspected Chlorination takes method place 26 Chromium (as 0.01 May be carcinogenic 0.05 28 0f 3025 To be tested Cr +6 ), mg/L above this limit when pollution is suspected 27 Polynuclear - May be carcinogenic - 28 of To be tested aromatic 3025,1964 when pollution hydrocarbons, is suspected mg/L 28 Mineral Oil, 0.01 Beyond this limit 0.03 Gas To be tested mg/L undesirable taste and chromatogra when pollution odour after phic method is suspected Chlorination takes place 29 Pesticides Absent Toxic 0.001 58 of 3025, - mg/L 1964 30 Radioactive materials a. Alpha - - 0.1 - - emitters Bq/L b. Beta emitters - - 1.0 - - pci/L 31 Alkalinity (as 200 Beyond this limit 600 13 of - CaCO 3), mg/L taste becomes 3025,1964 unpleasant 32 Aluminum (as 0.03 Cumulative effect is 0.2 31 0f - Al), mg/L reported to cause 3025,1964 dementia 33 Boron (as B), 1 - 5 29 of - mg/L 3025,1964 Note: Atomic absorption spectrophotometric method may be used.

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n ANNEXURE-VIII

CLASSIFICATION OF INLAND SURFACE WATER (CPCB STANDARDS)

SR CHARACTERISTICS A@ B@ C@ D@ E@ NO.

1 Dissolved Oxygen (mg/L), Min 6 5 4 4 -

2 Biochemical Oxygen Demand (mg/L), 2 3 3 - - Min

3 Total Coliform Organisms, MPN/100 50 500 5000 - - ml, Max.

4 Total Dissolved Solids (mg/L), Max 500 - 1500 - 2100

5 Chlorides (as Cl -), mg/L, Max. 250 - 600 - 600

6 Colour, Hazen units, Max 10 300 300 - -

7 Sodium absorption ratio, Max - - - - 26

8 Boron (as B), mg/L, Max - - - - 2

-2 9 Sulphates (as SO 4 ), mg/L, Max. 400 - 400 - 1000

- 10 Nitrates (as NO 3 ), mg/L, Max 20 - 50 - -

11 Free Ammonia (as N), mg/L, Max - - - 1.2 -

12 Conductivity at 25°C, micromhos/cm, - - - 1.0 2.25 Max

13 pH value 6.5-8.5 6.5-8.5 6.5-8.5 6.5-8.5 6.0-8.0

14 Arsenic (as As), mg/L, Max 0.05 0.2 0.2 - -

15 Iron (as Fe), mg/L, Max 0.3 - 50 - -

16 Fluorides (as F), mg/L, Max 1.5 1.5 1.5 - -

17 Lead (as Pb), mg/L, Max 0.1 - 0.1 - -

18 Copper (as Cu), mg/L, Max 1.5 - 1.5 - -

19 Zinc (as Zn), mg/L, Max 15 - 15 - -

* If the Coliform count is found to be more than the prescribed tolerance limits, the criteria for coliforms shall be satisfied if not more than 20 percent of samples show more than the tolerance limits specified, and not more than 5 percent of samples show values more than 4 times the tolerance limit. Further, the feacal coliform should not be more than 20 percent of the coliform.

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n ANNEXURE-IX

CPCB RECOMMENDATIONS FOR COMMUNITY NOISE EXPOSURE (1989)

Leq (dBA) Ldn (dBA) CATEGORY (DAYTIME) (NIGHT TIME) OF AREA (0600 TO 2100 HRS) (2100 TO 0600 HRS)

Industrial Area 75 70

Commercial Area 65 55

Residential Area 55 45

Silence Zone 50 40

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n ANNEXURE-X

DAMAGE RISK CRITERIA FOR HEARING LOSS OCCUPATIONAL SAFETY& HEALTH ADMINISTRATION (OSHA)

MAXIMUM ALLOWABLE NOISE LEVEL DURATION PER DAY (SLOW RESPONSE ) (HOURS) dBA

8 90 6 92

4 95 3 97 2 100 1.5 102 1 105 0.5 110 0.25 or Less 115

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n ANNEXURE-XI

ENVIRONMENTAL POLICY

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NOC & CCA OF EXISTING UNIT

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ANNEXURE-XII (CONTD.)

NOC & CCA OF EXISTING UNIT

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ANNEXURE-XII (CONTD.)

NOC & CCA OF EXISTING UNIT

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ANNEXURE-XII (CONTD.)

NOC & CCA OF EXISTING UNIT

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ANNEXURE-XII (CONTD.)

NOC & CCA OF EXISTING UNIT

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n ANNEXURE-XII (CONTD.)

NOC & CCA OF EXISTING UNIT

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ANNEXURE-XII (CONTD.)

NOC & CCA OF EXISTING UNIT

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ANNEXURE-XII (CONTD.)

NOC & CCA OF EXISTING UNIT

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ANNEXURE-XIII

COMPLIANCE REPORT

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ANNEXURE-XIII (CONTD.)

COMPLIANCE REPORT

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n ANNEXURE-XIII (CONTD.)

COMPLIANCE REPORT

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n ANNEXURE-XIII (CONTD.)

COMPLIANCE REPORT

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n ANNEXURE-XIV

SAMPLE OF REGISTER FORM 32 AND FORM 33

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n ANNEXURE-XIV

SAMPLE OF REGISTER FORM 32 AND FORM 33

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n ANNEXURE-XV

ACKNOWLEDGEMENT COPY FOR GROUND WATER PERMISSION TO CGWA

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n ANNEXURE-XV (CONTI…)

ACKNOWLEDGEMENT COPY FOR GROUND WATER PERMISSION TO CGWA

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n ANNEXURE-XVI

MATERIAL SAFETY DATA SHEET FOR ALL THE CHEMICALS

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