Concord Biotech Ltd - Welcome to Environment Envirotech Pvt. Ltd., Ahmedabad EIA Report of Concord...

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Final Environmental Impact Assessment Report of Concord Biotech Ltd. Plot No. 1482-1486, Trasad Road, Tal: Dholka, Dist. Ahmedabad, Gujarat for Proposed expansion of Bulk Drugs manufacturing Project Activity: 5(f), Category: A Prepared by San Envirotech Pvt. Ltd. 424, Medicine Market, Paldi Cross Road, Ahmedabad Email: [email protected] (February, 2017)

Transcript of Concord Biotech Ltd - Welcome to Environment Envirotech Pvt. Ltd., Ahmedabad EIA Report of Concord...

Final Environmental Impact Assessment Report

of

Concord Biotech Ltd. Plot No. 1482-1486, Trasad Road,

Tal: Dholka, Dist. Ahmedabad, Gujarat

for

Proposed expansion of Bulk Drugs manufacturing

Project Activity: 5(f), Category: A

Prepared by

San Envirotech Pvt. Ltd. 424, Medicine Market, Paldi Cross Road,

Ahmedabad Email: [email protected]

(February, 2017)

Declaration by experts contributing to the EIA of Concord Biotech Ltd.

I, hereby, certify that I was a part of the EIA team in the following capacity

that developed the above EIA.

EIA Coordinator:

Name: Dr. Mahendra Sadaria

Signature & Date:

Period of involvement July, 2015

Contact Information: 079-26583077

Functional Area Experts

Functional Areas

Name of the Expert

Involvement (Period and Task)

Signature & date

Air Pollution Monitoring & Control (AP)

Dr. Mahendra Sadaria

Planning of meteorological AAQM baseline monitoring, site visit/ survey, select monitoring locations, data verification & approval, interpretation of baseline condition of air environment. Evaluation of results of Ambient Air Quality Monitoring (AAQM). Contribution in EIA documentation.

Air Quality Modeling and Prediction (AQ)

Dr. Mahendra Sadaria

Meteorology file generation, Air quality model (ISCST-3) run using meteorology data, identifying source & receptor. Prediction of GLC & plotting isopleths. Study of GLCs obtained & calculating cumulative concentration of pollutants. Contribution in EIA documentation.

Water Pollution (WP)

Dr. Mahendra Sadaria

Site visit, selection of sampling locations, review & interpret baseline water quality, water balance calculation for the project, prediction of impacts & proposed mitigation measures, contribution in EIA documentation.

Ecology and Bio-diversity Conservation (EB)

Dr. Khyati Thacker

Site visit/survey for ecology study, review of Greenbelt development requirement of the project-suggestion for species, type of plantation and contribution in EIA documentation.

Solid and Hazardous Waste Management (SHW)

Dr. Mahendra Sadaria & Dr. Khyati Thacker

Identified source of generation of Hazardous waste & disposal methods, studying adequacy of mitigation measures for management of hazardous waste.

Socio Economy (SE)

Shobhana Sadaria

Site visit, data collection, evaluation of Socio-Economic status of the study area, assessment of the possible chances to socio-economic issues arising out of the proposed activity & contribution in EIA documentation.

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EIA Report of Concord Biotech Ltd. 1

Index Particulars Page No.

Contents 1-9

List of Tables 10-12

List of Figures 13-14

List of Annexures 15

Contents CHAPTER CONTENT PAGE NO.

Chapter 1 Introduction

1.1 Preface 1-1

1.2 Purpose of the report 1-1

1.3 Identification of project & project proponent 1-2

1.3.1 Identification of project site with site specific criteria 1-2

1.3.2 Screening category 1-3

1.3.3 Project Proponent 1-3

1.4 Brief description of project 1-4

1.4.1 Nature of project 1-4

1.4.2 Size of the project 1-4

1.4.3 Location of the project 1-5

1.5 Applicable environmental regulatory framework 1-6

1.6 Scope of the study 1-6

1.7 Compliance to terms of reference 1-7

1.8 Objective of EIA 1-23

1.9 Methodology for EIA 1-23

1.10 Details of industries surrounding the unit 1-25

1.11 Structure of EIA Report 1-25

Chapter 2 Project Description

2.1 Introduction 2-1

2.2 Type of Project 2-1

2.3 Importance & Benefits of the Project 2-2

2.3.1 Importance of the Project 2-2

2.3.2 Benefits of the project 2-2

2.4 Capital Investment 2-2

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2.5 Land Requirement 2-2

2.6 Location 2-3

2.7 Production and size of the Unit 2-4

2.8 Proposed Schedule for Approval and Implementation

2-5

2.9 Infrastructure Facilities of the Plant (Major Machineries)

2-5

2.10 Manufacturing Process Description 2-11

2.11 Project Components 2-11

2.12 Input Requirements 2-12

2.13 Utilities Requirements 2-13

2.14 Generation of Pollutants 2-14

2.14.1 Wastewater Generation 2-14

2.14.2 Air Pollution 2-14

2.14.3 Hazardous waste generation 2-15

2.14.4 Noise Generation 2-15

2.15 Pollution Control Strategy 2-15

2.15.1 Effluent Management 2-15

2.15.2 Air pollution Control Measures 2-17

2.15.3 Hazardous Waste Management 2-17

2.15.4 Type of microbes in extraction and its disposal 2-18

2.15.5 Noise Pollution Control 2-19

2.16 Rain Water Harvesting 2-20

2.17 Green Belt Development 2-22

2.18 Occupational Health & Safety 2-22

Chapter 3 Description of Environment

3.1 General 3-1

3.2 Study area 3-1

3.3 Study Period 3-2

3.4 Source of Environmental data generation 3-2

3.5 Methodology 3-2

3.6 Land environment 3-3

3.6.1 Land use pattern of the Study Area 3-3

3.6.2 Objective of Land Use Studies 3-4

3.6.3 Topography 3-4

3.6.4 Seismicity of the area 3-4

3.7 Meteorology 3-4

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3.7.1 IMD meteorological data 3-5

3.7.2 Site specific micro-meteorological data 3-6

3.7.2.1 Wind Rose 3-6

3.8 Ambient Air Quality 3-7

3.8.1 Introduction 3-7

3.8.2 Design Network for Ambient Air Quality Monitoring Stations

3-8

3.8.3 Reconnaissance 3-8

3.8.4 Parameters, Frequency and monitoring Methodology 3-8

3.8.5 Interpretation of result 3-9

3.9 Water Environment 3-10

3.9.1 Hydro-Geology of the Study Area 3-10

3.10 Water Quality 3-11

3.10.1 Introduction 3-11

3.10.2 Sampling Frequency, Techniques & Methodology 3-12

3.10.3 Surface Water Quality (Primary data) 3-13

3.10.4 Ground Water Quality 3-13

3.10.5 Interpretation 3-13

3.10.6 Conclusion 3-14

3.11 Noise Environment 3-14

3.11.1 Instrument used for Sampling and Monitoring 3-15

3.11.2 Noise Quality Monitoring Locations 3-15

3.11.3 Ambient Noise Standards 3-15

3.11.4 Results 3-15

3.11.5 Conclusion 3-16

3.12 Soil Environment 3-16

3.12.1 Soil sampling locations 3-16

3.12.2 Methodology 3-16

3.12.3 Corollaries 3-17

3.12.4 Conclusion 3-18

3.13 Biological Environment 3-18

3.13.1 Period of the study 3-19

3.13.2 Study methodology 3-19

3.13.3 Floral species in the study area 3-20

3.13.4 Fauna in the study area 3-20

3.14 Socio-economic Environment 3-20

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3.14.1 Objective of the study 3-20

3.14.2 Land use pattern and infrastructure 3-21

3.14.3 Demographic and Socio-Economic Environment 3-21

3.14.4 Living Standard and Infrastructure 3-22

Chapter 4 Anticipated Environment Impact & Mitigation Measures

4.1 General 4-1

4.2 Identification of Impact 4-2

4.2.1 Identification of Impacting Activities 4-2

4.2.2 Identification of Environment Attributes 4-3

4.3 Impact on topography 4-3

4.4 Impact on Air environment 4-3

4.4.1 Air Pollution Dispersion Modeling of Stack 4-4

4.4.2 Micrometeorology 4-5

4.4.3 Input Data 4-6

4.4.4 Receptor Network 4-6

4.4.5 Output of model (24-hourly GLCs) 4-6

4.4.6 Incremental & cumulative concentration of pollutants

4-7

4.4.7 Conclusion 4-7

4.5 Impact on Water Environment 4-7

4.6 Impact on Noise Environment 4-8

4.7 Impact on Land Environment 4-9

4.8 Impact on Biological Environment 4-10

4.9 Impact on Socio-Economic Environment 4-11

4.10 Impact on Occupational Health & Safety 4-12

Chapter 5 Analysis of Alternatives

5.1 Prologue 5-1

5.2 Site Alternative 5-1

5.3 Process Alternative 5-1

Chapter 6 Environmental Monitoring Programme

6.1 Prelude 6-1

6.2 Environment Monitoring Program 6-1

6.3 Objective of monitoring plan 6-1

6.4 Schedule for environment monitoring 6-2

6.5 Ambient air quality monitoring 6-2

Chapter 7 Additional Studies

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(A) Hazards Analysis & Risk Assessment 7-1

7.1 Introduction 7-1

7.2 Risk Assessment-Identification of Hazard 7-1

7.3 Hazardous Materials Storage 7-3

7.4 Risk Screening Approach 7-4

7.4.1 Acute Exposure Guideline Levels (AEGLS) 7-9

7.4.2 Emergency Response Planning Guidelines (ERPGs) 7-9

7.4.3 Temporary Emergency Exposure Limits (TEELs) 7-10

7.5 QAR Approach 7-11

7.6 Thermal Hazards 7-11

7.7 Damage Due to Explosion 7-13

7.8 Toxic Release 7-13

7.8.1 Acid/Alkali Hazards 7-14

7.9 Data Limitations 7-14

7.10 Likely Failure Scenarios 7-15

(B) Quantitative Risk Assessment & Consequence Analysis

7-15

7.11 Preamble 7-15

7.11.1 Weather Effect 7-16

7.12 Incidents Impacts 7-16

7.13 Consequential Impacts 7-20

7.13.1 Thermal and Explosion Hazards 7-21

7.13.2 Toxic Hazards 7-21

7.13.3 Other Hazards 7-21

7.13.4 Other Toxic Hazards 7-21

7.14 Occupational Health 7-21

7.14.1.1 Treatment of workers affected by accidental spillage of chemicals

7-22

7.15 Conclusion & Recommendations 7-23

7.16 Action plan for handling & safety system 7-24

7.16.1 Safety Measures for Transportation and Unloading

of Hazardous Chemicals

7-25

7.16.2 Safety Measures for Storage/Handling of Hazardous Chemicals

7-25

7.16.3 Safety Measures for Process Units 7-25

7.16.4 Safety Measures for Preventive Maintenance 7-26

7.16.5 Safety measures to prevent spillage/leakage of toxic chemicals

7-27

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7.17 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials

7-27

7.18 Disaster Management Plan (DMP) 7-29

7.18.1 Definitions 7-30

7.18.2 Objective of the Disaster Management Plan 7-31

7.19 Onsite Emergency Plan 7-32

7.19.1 Incident Controller 7-32

7.19.1.1 Duties of Incident Controller 7-32

7.19.2 Site Main Controller 7-33

7.19.2.1 Duties of Site Main Controller 7-33

7.19.3 Other Key Personnel 7-34

7.19.3.1 Emergency Response Team 7-34

7.19.3.2 Emergency Personnel’s responsibilities Outside Normal Working Hours of the Factory

7-34

7.19.3.3 Assembly Points 7-35

7.19.4 Emergency Control Centre 7-35

7.19.4.1 Role of Emergency Control Centre 7-35

7.19.5 Fire & Toxicity Control Arrangements 7-36

7.19.6 Medical Arrangements 7-36

7.19.7 Transport & Evacuation, Mutual Aid Arrangements 7-36

7.20 Communication System 7-36

7.20.1 Declaring the Emergency 7-36

7.20.1.1 Types of Sirens 7-36

7.20.1.2 Location of Siren 7-37

7.201.3 Raising Alarm 7-37

7.20.2 Internal Communication 7.38

7.20.2.1 Availability of Key Personnel outside Normal Working Hours

7-38

7.20.2.2 To the Outside Emergency Services 7-38

7.20.3 Communication to the Authorities 7-38

7.20.3.1 To Neighboring Firms & the General Public 7-39

7.21 Pre-emergency activities 7-39

7.22 Post-Emergency Activities 7-39

7.22.1 Evacuation and Transportation 7-39

7.22.2 Safe Close Down 7-40

7.22.3 Use of Mutual Aid 7-40

7.22.4 Use of External Authorities 7-40

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7.22.5 Medical Treatment 7-40

7.22.6 Accounting for Personnel 7-40

7.22.7 Access to Records 7-40

7.22.8 Public Relation 7-40

7.22.9 Rehabilitation 7-40

7.23 Causes of Emergency 7-41

7.23.1 Risk 7-41

7.23.1.1 Nature 7-41

7.23.1.2 Various Emergency Action 7-41

7.23.1.3 Response Time-Minutes 7-42

7.24 Off-Site Emergency Plan 7-42

7.24.1 Need of the Site Emergency Plan 7-42

7.24.2 Structure of the Off-Site Emergency Plan 7-43

7.24.3 Role of the Factory Management 7-43

7.24.4 Role of Emergency Co-ordination Office (ECO) 7-43

7.24.5 Role of Local Authority 7-43

7.24.6 Role of Fire Authorities 7-43

7.24.7 Role of the Police and Evacuation Authorities 7-43

7.24.8 Role of Health Authorities 7-43

7.24.9 Role of Mutual Aid Agencies 7-44

7.24.10 Role of Factory Inspectorate 7-44

7.25 Mock Drills and Records 7-44

7.25.1 Need of Rehearsal & Training 7-44

7.25.2 Some Check Points 7-44

7.25.3 Records and Updating the Plan 7-44

(C) Social Impact Assessment 7-45

(D) Public Consultation 7-45

Chapter 8 Project Benefits

8.1 Introduction 8-1

8.2 Improvement in physical infrastructure 8-1

8.3 Improvement in social infrastructure 8-1

8.4 Employment potential 8-2

8.5 Other tangible benefits 8-2

Chapter 9 Environmental Cost Benefit Analysis

Chapter 10 Environment Management Plan

10.1 Introduction 10-1

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10.2 Objective of environment management plan 10-1

10.3 Components of EMP 10-2

10.4 Environmental Management systems (EMS) 10-2

10.5 Environmental Management Cell 10-2

10.5.1 Hierarchical Structure of Environmental Management Cell

10-3

10.5.2 Record Keeping and Reporting 10-3

10.6 Environmental Management During Construction Phase

10-4

10.7 Environmental Management During the Operational Phase

10-5

10.7.1 Air Pollution Management 10-5

10.7.1.1 Source of air pollution and control measures 10-5

10.7.1.2 Solvent Management Plan 10-6

10.7.1.3 Action plan for Odour control 10-8

10.7.2 Water Environment 10-9

10.7.3 Hazardous/Solid Waste Management 10-12

10.7.4 Noise Control 10-13

10.8 Green belt development Plan 10-14

10.9 Resource Conservation/Waste Minimization, Recycling, Reuse & Cleaner Production Option

10-16

10.10 Occupational health & safety plan 10-17

10.11 Plans for periodic medical checkup 10-18

10.12 Socio-economic activities 10-19

10.13 Post-project environmental monitoring 10-21

10.13.1 Details of Work Place Air Quality Monitoring Plan 10-21

10.14 Environment management budget allocation 10-22

10.15 Reporting system of non-compliances/violations of environmental norms

10-22

Chapter 11 Summary & Conclusion

11.1 Project Description 11-1

11.1.1 General Introduction 11-1

11.1.2 Brief project description 11-1

11.1.3 Location of Project 11-1

11.1.4 Investment of the project 11-2

11.1.5 List of products 11-2

11.2 Description of Environment 11-3

11.2.1 Baseline Environmental Study 11-3

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11.2.2 Air Environment 11-3

11.2.3 Water Environment 11-4

11.2.4 Noise Environment 11-6

11.2.5 Soil Quality 11-6

11.2.6 Biological Environment 11-6

11.2.7 Socio-economic Environment 11-6

11.3 Anticipated environmental impacts and mitigation

measures

11-7

11.3.1 Summary of impacts on Air Environment 11-7

11.3.2 Summary of impacts on Water Environment: 11-8

11.3.3 Impacts on Noise quality & Mitigation measures 11-8

11.3.4 Summary of Impacts on Land Environment 11-9

11.3.5 Summary of impact on Socio Economy 11-9

11.3.6 Summary of impact on Ecology 11-9

11.4 Environment Monitoring Programme 11-10

11.5 Additional studies 11-10

11.5.1 Risk Assessment 11-10

11.6 Project benefits 11-10

11.7 Environmental Management Plan 11-11

11.8 Conclusion 11-12

Chapter12 Disclosure of Consultant engaged

12.1 Details Of EIA Consultant Organization 12-1

12.2 List of Exerts involved in EIA study 12-2

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List of Tables Table No. Name Page No.

1.1 Product details 1-4

1.2 Four corner co-ordinates of site 1-6

2.1 Land break up 2-2

2.2 Location Details 2-3

2.3 List of existing & proposed products with quantity 2-4

2.4 Plant machineries (Existing & Proposed) 2-5

2.5 Utilities 2-13

2.6 Raw Material Consumption, Source & transportation details

2-23

2.7 Details of water consumption &wastewater generation 2-31

2.8 Size and dimension of Effluent Treatment Plant 2-32

2.9 Characteristics of untreated and treated effluent 2-33

2.10 Technical specification of MVRE/crystallizer 2-34

2.11 Technical specification of Sludge Dryer 2-36

2.12 Details of stacks 2-37

2.13 Existing/Estimated Air emission Quality 2-38

2.14 Source of Fuel 2-39

2.14(a) Fuel Analysis 2-39

2.15 Technical specification of Boiler 2-40

2.16 Details of Hazardous Waste 2-41

2.17 Estimated Characteristics of Hazardous waste 2-42

3.1 Environmental setting of the study area 3-2

3.2 Land use statistics work out based on satellite imaginary

3-3

3.3 Predominant Month-wise Wind Directions at IMD Ahmedabad

3-5

3.4 Average Meteorological Condition at IMD Ahmedabad 3-5

3.5 Monitoring Methodology of Meteorological Data 3-6

3.6 Meteorological Data for the Monitoring Period (Mar-2016 to May-2016)

3-6

3.7 Frequency Distribution Chart (%) (Mar-16 to May-16) 3-7

3.8 Methodology of Ambient Air Monitoring 3-8

3.9 Monitored Parameters and Frequency of Sampling 3-9

3.10 Sampling locations with source & date of sampling 3-12

3.11 Monitoring Methodology of Noise 3-15

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3.12 Location of soil sampling 3-16

3.13 Methodology of Soil Sample analysis 3-17

3.14 Methods used for sampling of flora and fauna 3-19

3.15 Ambient Air Quality Monitoring Locations 3-24

3.16 Ambient Air Quality Status 3-25

3.17 Ambient Air Quality Status (PM10) 3-26

3.18 Ambient Air Quality Status (PM2.5) 3-27

3.19 Ambient Air Quality Status (SO2) 3-28

3.20 Ambient Air Quality Status (NOx) 3-29

3.21 Ambient Air Quality Status (CO, HC (Methane & non-Methane), VOC)

3-30

3.22 National Ambient Air Quality Standards 3-31

3.23 Results of Groundwater Quality in the Study Area 3-33

3.24 Surface Water analysis of study area 3-34

3.25 Indian Standard Specification for Drinking Water 3-35

3.26 Ambient Noise Levels in the Study Area 3-36

3.27 Ambient Air Quality Standards with respect to Noise 3-36

3.28 Soil Analysis of Study area 3-37

3.29 Floral Diversity 3-38

3.30 Faunal Biodiversity 3-40

3.31 Traffic Survey 3-42

3.32 Land Use Pattern 3-43

3.33 Summary of Socio-economic status of Study area (Demography)

3-44

3.34 Summary of Socio-economic status of Study area (Amenities)

3-46

4.1 Input data for air quality modeling 4-14

4.2 Cumulative Concentrations at various locations 4-15

4.3 The 24-hourly average GLC Concentration Values for SPM

4-16

4.4 The 24-hourly average GLC Concentration Values for SO2

4-17

4.5 The 24-hourly average GLC Concentration Values for NOx

4-18

6.1 Environment Monitoring Plan 6-4

6.2 Budget for implementation of Environmental Monitoring Plan

6-5

7.1 Bulk Storage of Hazardous Chemicals 7-4

7.2 Hazards Analysis – Raw materials (stored in Bulk) 7-5

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7.3 Fuels Hazards Classification 7-8

7.4 Risk Classification 7-11

7.5 Effects due to Incident Radiation Intensity 7-12

7.6 Thermal Radiation Impact to Human 7-12

7.7 Tolerable Intensities for Various Objects 7-12

7.8 Damage due to Overpressure 7-13

7.9 Different Failure Scenarios 7-15

7.10 Hazards Scenario Impact 7-16

7.11 Points raised during public hearing 7-45

10.1 Size and dimension of Effluent Treatment Plant 10-10

10.2 Budgetary provisions for the social upliftment 10-20

10.3 Budget Allocation for Environment Management 10-22

10.4 Environment Monitoring Plan 10-24

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List of Figures Figure No. Name Page No.

1.1 Location of the project site 1-28

1.2 Google map of 10 km radius 1-29

1.3 Image showing all four boundaries coordinates of the site

1-30

2.1 Water Balance Diagram (Existing) 2-43

2.2 Water Balance Diagram (after expansion) 2-44

2.3 ETP flow Diagram 2-45

2.4 Schematic Diagram of Solvent Recovery System 2-46

2.5 Plant Layout 2-47

3.1 Seismic Zone map of Gujarat 3-4

3.2 Graphical representation of Ambient Air Quality 3-25

3.3 Graphical representations for PM10 3-26

3.4 Graphical representations for PM2.5 3-27

3.5 Graphical representations for SO2 3-28

3.6 Graphical representations for NOx 3-29

3.7 Location of AAQM Station 3-50

3.8 Wind Rose Diagram 3-51

3.9 Water Sampling Locations 3-52

3.10 Noise monitoring locations 3-53

3.11 Soil Sampling Locations 3-54

3.12 LULC map (10 km radius) 3-55

3.13 Topo sheet of location with site location map of 10 km radius (1:25,000 scale)

3-56

3.14 Topo sheet of location with site location map of 10 km radius (1:50,000 scale)

3-57

4.1 Isopleths for Ground Level Concentrations for SPM 4-19

4.2 Isopleths for Ground Level Concentrations for SO2 4-20

4.3 Isopleths for Ground Level Concentrations for NOx 4-21

7.1 Acetone Tank spillage-Thermal Impact Zone 7-17

7.2 Acetonitrile Spillage- Toxic Impact Zone 7-17

7.3 Ammonia Spillage/leakage- Toxic Impact Zone 7-18

7.4 Cyclohexane Spillage- Thermal Impact Zone 7-18

7.5 Ethyl Acetate Spillage-Thermal Impact Zone 7-19

7.6 Iso-Butanol Spillage–Thermal Impact Zone 7-19

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7.7 Methanol Spillage- Thermal Impact Zone 7-20

7.8 Toluene Spillage- Thermal Impact Zone 7-20

10.1 Environment Management Cell 10-3

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List of Annexures Annexure

No. Name Page No.

I Manufacturing Process, Chemical Reaction & Mass Balance of all products

A-1

II MoU from Ambuja Cement Ltd. for co-processing of waste

A-65

III Membership certificate for disposal of hazardous waste at TSDF & CHWIF

A-84

IV Material Safety Data Sheet of Hazardous chemicals A-86

V Certified Compliance report of existing EC byRO, MoEF&CC

A-168

VI NABET/QCI Certificate A-180

VII Copy of Environmental Clearance A-182

VIII Photographs of existing site, proposed expansion area

& Plantation/Greenbelt

A-192

IX Land Documents A-196

X Health record of workers A-202

XI EHS policy A-210

XII Copy of Terms of Reference (TOR) A-211

XIII Undertaking from Consultant & PP A-221

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EIA Report of Concord Biotech Ltd. 1-1

Chapter-1 Introduction

1.1 PREFACE

An Environmental Impact Assessment (EIA) is an assessment of the

possible positive or negative impact that a proposed project may have on

the environment, together consisting of the environmental, social and

economic aspects. It is an assessment and management tool that

evaluates the possible positive or negative impact that a proposed project

may have on the environment. EIA systematically examines both

beneficial and adverse consequences of the project and ensures that

these effects are taken into account during project design. The purpose of

the assessment is to ensure that decision makers consider the ensuing

environmental impacts when deciding to proceed with a project.

As India is a developing country, lots of industrialization has been came

in focus since last few decades that ultimately leads the bigger issues

related the environmental quality of the country. Hence, it is needful for

Government of India to control the haphazard industrial development by

providing sustainable development under the legislation.

In India, Ministry of Environment and Forests has defined elaborated

“Environmental Clearance (EC)” framework along with requirements for

preparing Environmental Impact Assessment (EIA) under the

Environmental (Protection) Act, 1986 (Environmental Impact Assessment

Notification, 2006) for establishing/expanding and industry/development

projects although it supports development but only if the development

does not hamper the environment over a defined threshold limit.

1.2 PURPOSE OF THE REPORT

Industrial development in India has increased economic growth and

improved living standards of people. These growths are achieved through

industrialization, infrastructure development. Industrialization has played

a major role in development of the country. It also has many other

benefits. Although the industrial development leads to rapid consumption

of natural resources, fuel etc. in day to day operational activity. These

will deteriorating resources and increase emissions of waste in terms of

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EIA Report of Concord Biotech Ltd. 1-2

solid, liquid& gaseous. To control the pollutions from industrial activity,

government has framed regulations which are governed by Ministry of

Environment, Forest & Climate change in India.Environment Impact

analysis is mandatory as per the Environment Impact Assessment (EIA)

Notification issued by Ministry of Environment, Forest & Climate change

(MoEF&CC), New Delhi dated 14th September, 2006 and its subsequent

amendment; for setting up a new projects or activities, or expansion or

modernization of existing projects or activities based on their potential

environmental impacts as indicated in the Schedule to the notification,

being undertaken in any part of India, unless prior environmental

clearance has been accorded.

Proposed expansion activity of M/s. Concord Biotech Ltd. falls under

the schedule of 5(f) of schedule of EIA Notification, 2006 “Synthetic

Organic Chemical Industries” and categorized under “A”. Therefore, unit

requires prior Environmental Clearance for proposed expansion project.

EIA Consultant

In view of the above, legal aspect and monitoring work has been carried

out for all the environmental attributes by M/s. San Envirotech Pvt. Ltd.,

Ahmedabad. Draft Environment Impact Assessment (EIA) and

Environmental Management Plan (EMP) have been prepared after

obtaining Terms of References (TORs) from Ministry of Environment,

Forests & Climate Change (MoEF&CC), New Delhi. The public hearing was

held on the basis of the draft EIA/EMP incorporating the Terms of

References. Final EIA/EMP Report after incorporating the comments of

public during public hearing will be submitted to MoEF&CC for

Environment Clearance.

1.3 IDENTIFICATION OF PROJECT &PROJECT PROPONENT

1.3.1 Identification of project site with site specific criteria

Unit exists at Plot No. 1482-1486, Trasad Road, Taluka: Dholka, Dist.:

Ahmedabad and now proposed to expand production capacity of existing

products with addition of some new products. Expansion will be done in

same plant premises. Required infrastructure and resources are readily

available.

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EIA Report of Concord Biotech Ltd. 1-3

Other salient features are summarized below:

• The existing open area of plot is sufficient for further expansion

activities.

• Availability of all essential facilities like infrastructure,

communication, medical facilities, fuel, water, power, unskilled &

skilled manpower, raw materials, road network etc.

• As the proposed expansion will be done in existing premises, no

Rehabilitation and Resettlement involved.

• Nearest city Ahmedabad is @ 38.0 km away from the site, which is

having connectivity with other parts of the country by road, rail &

air.

Therefore, no other optional site or area was considered for expansion

activity.

1.3.2 Screening category

As per the EIA Notification, 2006 and amendment thereof; proposed

activity is covered under 5(f) category- Synthetic organic chemicals

industry (dyes & dye intermediates; bulk drugs and intermediates

excluding drug formulations; synthetic rubbers; basic organic chemicals,

other synthetic organic chemicals and chemical intermediates).

1.3.3 Project proponent

Concord Biotech Ltd. is well known and leading manufacturing company

of bulk drugs based on biotechnology process. The unit is established in

the year 2000. The management of the organization is in the hands of -

Mr. Sudhir Vaid (Chairman & Managing Director)

Mr. Sudhir Vaid began his career in 1975 as a biotechnologist and went

on to work with several leading biotechnology companies in India and

abroad, before eventually becoming an entrepreneur in the year 2000.

Backed by 30 years of rich experience in Corporate R&D and Consultancy,

Mr. Vaid has further expanded his knowledge horizons by working along

with the leading global API companies in the area of Biotechnology

encompassing vitamins, statins, hormones and antibiotics.

As the brains behind Concord Biotech Limited, Mr. Vaid has helped the

company grow by leaps and bounds, revolutionizing it from a single

product company to a global leader in the area of fermentation based

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EIA Report of Concord Biotech Ltd. 1-4

products providing key strategic direction to the organization. He has also

played a crucial role in building profitable alliances and a strong and

prestigious customer base for Concord. By recognizing and supporting the

talent pool, he has instilled a positive work culture in Concord that is

based on Quality, Cost and Deliverables.

Mr. Ankur Vaid(CEO)

The CEO of Concord, Mr. Ankur Vaid is a big influence in developing the

R&D division, contributing to the market strategy and at the same time,

spearheading the entire organization towards its goals and objectives. Mr.

Vaid is a MBA with bachelor’s degree in chemical engineering. Playing a

vital role in the promoter group, he has performed tremendously across

various business verticals and brought about operational efficiencies thus

providing a major boost to the growth of the company.

1.4 BRIEF DESCRIPTION OF PROJECT

1.4.1 Nature of project

Unit is proposed to expand production capacity of bulk drugs within the

same plant premises. Proposed expansion activity covered under

project/activity 5(f) -Synthetic Organic Chemicals Industry of EIA

Notification-2006 and its amendment thereof. List of raw materials to be

used are given in Table 2.6of chapter-2. Generated wastewater will be

treated in ETP and then it will be passed through RO. Reject of RO will be

sent to MEE/MVRE. RO permeate will be utilized for greenbelt

development. There will be no effluent discharge outside premises.

Hazardous waste generation & its management are given in Table 2.16.

1.4.2 Size of the project

Unit proposed to expands capacity of existing products with addition of

new products. Production details are given in table below:

Table 1.1 Product details

Sr. No.

Name of Product Quantity (MTPA) Existing Proposed Total

A Enzyme – 25.0 MTPA 1 Penicillin G Amidase Enzyme 15.00 10.00 25.00 B Antibiotic – 23.1 MTPA 2 Vancomycin 3.00 1.0 4.0 3 Teicoplanin 1.00 1.0 2.0 4 Daptomycin 0.50 0.0 0.50

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5 Fidaxomycin 3.00 0.0 3.0 6 Mupirocin& salts 6.00 2.50 8.50 7 Fosfomycin 1.00 0.0 1.0 8 Dalbavancin 0.50 0.0 0.50 9 Telavancin 0.50 0.0 0.50 10 Capreomycin 0.10 0.0 0.10 11 Tobramycin sulphate 2.50 0.0 2.50 12 Oritavancin 0.0 0.50 0.50 C Antiparasitic – 1.90 MTPA 13 Milbemycinoxime 1.00 0.9 1.90 D Antifungal- 1.98 MTPA 14 Pneumocandin Bo 0.20 0.0 0.20 15 Caspofungin 0.20 0.0 0.20 16 Micafungin 0.93 0.0 0.93 17 Anidulafungin 0.65 0.0 0.65 E Immunosuppressant-122 MTPA 18 Tacrolimus 1.00 0.0 1.00 19 Mycophenolic Acid 0.50 0.0 0.50 20 Cyclosporine 7.00 0.0 7.00 21 Rapamycin 0.30 0.20 0.50 22 MycophenolateMofetill&Mycophenolate

sodium 45.00 68.00 113.00

F Onco products-4.05 MTPA 23 Ixabepilone 0.10 0.0 0.10 24 Romidepsin 0.10 0.0 0.10 25 Temsirolimus 0.05 0.0 0.05 26 Everolimus 0.60 0.40 1.0 27 Ridaforolimus 0.05 0.0 0.05 28 Pimecrolimus 0.50 0.0 0.50 29 Doxorubicin 0.60 0.25 0.85 30 Daunorubicin 0.45 0.15 0.60 31 Epirubicin 0.20 0.0 0.20 32 Idarubicin 0.10 0.0 0.10 33 Bleomycin 0.10 0.0 0.10 34 Geldanamycin 0.10 0.0 0.10 35 Mitomycin 0.0 0.10 0.10 36 Dactinomycin 0.0 0.10 0.10 37 Trabectedin 0.0 0.10 0.10 G Statin – 9 MTPA 38 Lovastatin 7.00 -1.0 6.00 39 Pravastatin 1.00 0.0 1.00 40 Orlistatin 2.00 0.0 2.00 H R & D Products 1.00 1.0 2.00

Total 103.83 85.20 189.03

1.4.3 Location of the project

The unit is located in Dholka Taluka of Ahmedabad District of Gujarat

State. The geographical co-ordinates of the site are 22041’59.55” N

Latitude and 72026’48.63” E Longitude. The location map showing project

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site is given in Figure 1.1 and satellite image/Google earth image is

shown in Figure 1.2. Boundary co-ordinates latitude and longitude of all

four corners of the site are given in Table 1.2 and shown in Figure 1.3.

Table 1.2Four corner co-ordinates of site

Corner Latitude Longitude A 22°41'58.74"N 72°26'43.58"E B 22°41'53.19"N 72°26'53.21"E C 22°41'58.18"N 72°26'56.85"E D 22°42'09.44"N 72°26'48.41"E

1.5 APPLICABLE ENVIRONMENTAL REGULATORY FRAMEWORK

The proposed project will abide and function under the purview of the

following Rules, Acts & Regulations which are formulated by the Govt. of

India to protect the environment and development in a sustainable way.

• The Water (Prevention & Control of Pollution) Act, 1974

• The Air (Prevention & Control of Pollution) Act, 1981

• The Environmental (Protection) Act, 1986

• Environmental Impact Assessment Notification dated 14th September

2006 and subsequent amendments

• The Hazardous & Other Waste (Management and Transboundary

Movement) Rules, 2016

• Noise Pollution (Regulation and Control) Rules, 2000 and its

amendments

• The Public Liability Insurance Act, 1991

1.6 SCOPE OF THE STUDY

The scope of the EIA study is based on the guideline provided by

MoEF&CC, Government of India for structure of Environmental Impact

Assessment document. The scope of the study broadly includes:

Field sampling of environmental attributes at various representative

locations in the study area to establish the baseline status;

Collect & compile secondary data including socio-economic data;

Identification, assessment and evaluation of the beneficial and adverse

impacts on surrounding environment due to proposed project activities

considering the existing baseline status along with compilation of other

information.

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Analysis of project proposal and data analysis.

Assessment of pollution potential due to proposed project.

Predict the incremental levels of pollutants in the study area;

Evaluate the predicted impacts on the various environmental

attributes by using scientifically developed and widely accepted

models.

Identification and assessment of risks associated with the proposed

project and their appropriate management through proper Risk

Assessment (RA) and Disaster Management Plan (DMP).

Prepare an Environmental Management Plan (EMP) to mitigate the

predicted impacts; and

Identify critical environmental attributes required to be monitored

during the project execution and to suggest post project monitoring.

The scope also includes all the conditions outlined in the TOR issued by

MoEF&CC and the compliance to the TOR is given below.

1.7 COMPLIANCE TO TERMS OF REFERENCE

Based on the presentation made before 2nd Expert Appraisal Committee

(Industry-2) on 16th – 17th December, 2015; Terms of Reference (TOR)

was issued by MoEF&CC; vide letter no. J-11011/268/2015-IA II (I),

dated 28.01.2016 and directed to prepare detailed EIA/EMP including

terms of reference. Compliance of TORs is as below:

Sr. No.

Conditions Compliance

A. Specific TOR

1. Details on solvents to be used, measures for solvent recovery and for emissions control.

Pls. refer sec. 10.7.1.2, page no. 10.6 for list of solvent &its recovery. Schematic Diagram of solvent recovery system is given in figure 2.4, page no. 2-46.

2. Details of process emissions from the proposed unit and its arrangement to control.

There will be no process emission anticipated from the unit.

3. Ambient air quality data should include VOC, etc.

Pls. refer table 3.21, page no. 3-30 of chapter-3 for ambient air quality details (VOCs).

4. Work zone monitoring arrangements for hazardous chemicals.

How to select locations for work zone monitoring is summarized in section 10.13.1, page no. 10-21 of chapter-10.

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Sr. No.

Conditions Compliance

Monitoring programme of work area is summarized in Table 6.1, page no. 6-4.

5. Details effluent treatment scheme including segregation of effluent streams for units adopting ‘Zero’ liquid discharge.

Pls. refer sec. 2.15.1 and Table 2.8, page no. 2-15 and 2-32 respectively of chapter-2 for ETP scheme. No effluentwill bedischarged outside the plant premises.

6. Action plan for odor control to be submitted.

Pls. refer sec. 10.7.1.3, page no. 10-8 for action plan for odor control.

7. Details of incinerator along with pollution control device to be provided.

We are not going to install incinerator, hence not applicable in our case.

8. A copy of the memorandum of Understanding signed with cement manufacturers indicating clearly that they co-process organic solid/ hazardous waste generated.

Copy of MoU made with Ambuja Cement indicating that they co-process generated organic solid/ hazardous waste is enclosed as Annexure-II.

9. Authorization/Membership for the disposal of liquid effluent in CETP and solid/hazardous waste in TSDF, if any.

Unit is not going to discharge effluent in CETP so membership of CTEP is not required. Membership certificate of approved TSDF & CHWIF site is enclosed as Annexure-III.

10. Action plan for utilization of MEE/dryers salts.

We have explored the possibility for utilization of MEE/dryer salt and currently not any industry is utilizing MEE/dryer salt. We continuous try to explore the possibility to utilize salt of MEE/dryer by any actual users.

11. Material Safety Data Sheet for all the Chemicals are being used/will be used.

MSDS of Haz. chemicals are attached as Annexure-IV.

12. Authorization/Membership for the disposal of solid/hazardous waste in TSDF is being used/will be used.

Membership certificate for the disposal of Hazardous waste in TSDF & CHWIF site is enclosed as Annexure-III.

13. Authorization/Membership for the disposal of solid/hazardous waste in TSDF.

Membership certificate for the disposal of Hazardous waste in TSDF & CHWIF site is enclosed as Annexure-III.

14. Risk assessment for storage and handling of hazardous chemicals/ solvents. Action plan for handling & safety system to be incorporated.

Separate chapter-7 ‘Additional Studies’ is cover risk assessment study.

15. Arrangement for ensuring health and safety of workers engaged in handling of toxic materials.

There is no use of any toxic material because processes itself biotechnology based and

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Sr. No.

Conditions Compliance

even trace toxicity can destroy the biotechnology process.

B. Additional TOR i. Public hearing to be conducted and

issues raised and commitments made by the project proponent on the same should be included in EIA/EMP Report in the form of tabular chart with financial budget for complying with the commitments made.

Public hearing was held on 27.04.2017. Issues raised and its replied by the project proponentis tabulated below.

ii. A separate chapter on status of compliance of Environmental Conditions granted by State/Centre to be provided. As per circular dated 30th May, 2012 issued by MoEF, a certified report by RO, MoEF on status of compliance of conditions on existing unit to be provided in EIA-EMP report.

A certified report by RO, MoEF&CC is enclosed as Annexure-V.

iii. To analyze/enlist microbes in extraction and disposal.

Pls. refer sec. 2.15.4, page no. 2-18 of chapter-2.

3.0 These ‘TORs’ should be considered for the preparation of EIA/EMP for expansion of bulk drug manufacturing unit (from 103.83 MTPA to 189.03 MTPA) at plot no. 1482-1486, Trasad Road, Taluka Dholka, District Ahmedabad, Gujarat by M/s Concord Biotech Ltd. in addition to all the relevant information as per the ‘General Structure of EIA’ given in Appendix III and IIIA in the EIA Notification, 2006. The EIA/EMP as per TORs should be submitted to the Chairman, Gujarat Pollution Control Board, for public consultation. The SPCB shall conduct the public hearing/public consultation as per the provisions of EIA Notification, 2006.

Agreed, We have prepared EIA report based on TOR & generic structure of EIA.

4.0 You are requested to kindly submit the final EIA/EMP prepared as per TORs and incorporating all the issues raised during Public Hearing/Public Consultation to the Ministry for considering the proposal for environmental clearance within 3 years as per the MoEF O.M. No. J-11013/41/2006-IA.II (I) dated 8th October, 2014.

Public Hearing was conducted on 27.04.2017 and final EIA/EMP after public hearing is submitted within a due course i.e. within validity of TOR.

5.0 The consultants involved in the preparation of EIA/EMP report after accreditation with Quality Council of India/National Accreditation Board of

QCI/NABET accreditation certificate of the consultant is attached as Annexure-VI in EIA report.

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Sr. No.

Conditions Compliance

Education and Training (QCI/NABET) would need to include a certificate in this regard in the EIA/EMP reports prepared by them and data provided by other Organization(s)/Laboratories including their status of approvals etc.

Generic Terms of Reference (TOR) in respect of Industry Sector 1. Executive Summary Executive summary of the

project is given in Chapter-11 of EIA report.

2. Introduction i. Details of the EIA Consultant including

NABET accreditation. Details of EIA consultant is given in chapter-12 ‘Disclosure of Consultant engaged’. NABET accreditation certificate is enclosed as Annexure-VI.

ii. Information about the project proponent

Pls. refer sec. 1.3.3, page no. 1-3 of chapert-1 for details of project proponent.

iii. Importance and benefits of the project.

It is described in chapter-8 of EIA report.

3. Project Description i. Cost of project and time of

completion. Cost of the project is given in sec. 2.4, page no. 2-2. Time of completion of project: Around 8-10 months after accordance of EC.

ii. Products with capacities for the proposed project.

Pls. refer table 2.3, page no. 2-4 of chapter-2 for product details with capacity.

iii. If expansion project, details of existing products with capacities and whether adequate land is available for expansion, reference of earlier EC if any.

Pls. refer table 2.3, page no. 2-4 of chapter-2 for existing product details with capacity. Unit has total land of 112302m2 which is adequate for the existing as well as proposed expansion. Earlier EC is attached as Annexure-VII.

iv. List of raw materials required and their source along with mode of transportation.

Pls. refer table 2.6, page no. 2-23 for list of raw material required, its source along with mode of transportation.

v. Other chemicals and materials required with quantities and storage capacities.

Pls. refer table 7.1, page no. 7-4 for bulk storage details of other chemicals.

vi. Details of Emission, effluents, hazardous waste generation and their management.

Emission: Pls. refer table 2.12 on page no. 2-37 for sources of air emission. Effluent: Pls. refer table 2.8& figure2.3 on page no. 2-32&2-

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Sr. No.

Conditions Compliance

45 respectively for effluent treatment details. Hazardous waste: Pls. refer table 2.16 on page no. 2-41 for Haz. waste generation & its management.

vii. Requirement of water, power, with source of supply, status of approval, water balance diagram, man-power requirement (regular and contract).

Pls. refer sec. 2.12, page no. 2-12 of chapter-2 for all the details.

viii. Process description along with major equipments and machineries, process flow sheet (quantities) from raw material to products to be provided.

Pls. refer Annexure-I for process description, process flow diagram. Pls. refer table 2.4, page no. 2-5 of chapter-2 for major equipment & machineries.

ix. Hazard identification and details of proposed safety systems.

Pls. refer sec. 7.2, page no. 7-1. Its safety system is given in sec. 7.16, page no. 7-24.

x. Expansion/modernization proposals: a. Copy of all the Environmental

Clearance(s) including Amendments thereto obtained for the project from MoEF/SEIAA shall be attached as an Annexure. A certified copy of the latest Monitoring Report of the Regional Office of the Ministry of Environment and Forests as per circular dated 30th May, 2012 on the status of 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.

Copy of all Environmental Clearance is enclosed as Annexure-VII. A certified copy of the latest Monitoring Report of the RO MoEF&CC is enclose as Annexure-V.

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,

Unit has obtained EC for its existing set up and it is enclosed asAnnexure-VII.

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Sr. No.

Conditions Compliance

compliance report to the conditions of consents from the SPCB shall be submitted.

4. Site Details: i. Location of the project site covering

village, Taluka/ Tehsil, District and State, Justification for selecting the site, whether other sites were considered.

Location of the project site covering village, Taluka/Tehsil, District and State on Indian map is attached as figure 1.1, page no. 1-24 of chapter-1.

ii. A toposheet of the study area of radius of 10km and site location on 1:50,000/1:25,000 scale on an A3/A2 sheet. (Including all eco-sensitive areas and environmentally sensitive places).

Topo sheet of study area with site location on 1:25,000 scale followed by 1:50,000 scale of a circle of a radius of 10 kms is incorporated in EIA/EMP report. Pls. refer figure no. 3.13& 3.14 on page no. 3-56& 3-57.

iii. Details w.r.t. option analysis for selection of site.

Expansion project is in the existing premises so no option analyze for alternate site.

iv. Co-ordinates (lat-long) of all four corners of the site.

Coordinates (Lat long) of all four corners of the site is given in sec. 1.4.3 & figure 1.3, on page no. 1-6 & 1-26 of chapter-1.

v. Google map-Earth downloaded of the project site.

Google map of 10 km radius is attached as figure 1.2 on page no. 1-25 of chapter-1.

vi. Layout maps indicating existing unit as well as proposed unit indicating storage area, plant area, greenbelt area, utilities etc. If located within an Industrial area/Estate/Complex, layout of Industrial Area indicating location of unit within the Industrial area/Estate.

Layout map indicating existing set up as well as storage area, plant area, greenbelt area, utilities etc. are given as figure 2.5, page no. 2-47 of chapter-2.

vii. Photographs of the proposed and existing (if applicable) plant site. If existing, show photographs of plantation/greenbelt, in particular.

Photographs of existing & proposed plant site along with Plantation/Greenbelt are attached as Annexure-VIII.

viii. Land use break-up of total land of the project site (identified and acquired), government/private - agricultural, forest, wasteland, water bodies, settlements, etc. shall be included. (not required for industrial area).

Details of total land & its breakup are given in table 2.1, page no. 2-2 of chapter-2.

ix. A list of major industries with name and type within study area (10km radius) shall be incorporated. Land use details of the study area.

List of industries (name and type of industries)located within 10 km radius is mentioned in sec. 1.10, page no. 1-21 of chapter-1. Land use details of the study area based on satellite

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Sr. No.

Conditions Compliance

imaginary is given in Table 3.2, page no. 3-3.

x. Geological features and Geo-hydrological status of the study area shall be included.

Hydrogeological status of the study area is given in sec. 3.9.1, page no. 3-10 of chapter-3.

xi. Details of Drainage of the project upto 5km radius of study area. If the site is within 1 km radius of any 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).

There is not any river & flood Hazard zone within 1 km radius from the site hence this point is not applicable.

xii. Status of acquisition of land. If acquisition is not complete, stage of the acquisition process and expected time of complete possession of the land.

Unit is already in existence and land is owned by the company. Land documents are enclosed as Annexure-IX. Hence no need of mutual agreement for land acquisition. Proposed expansion will be done in existing premises.

xiii. R&R details in respect of land in line with state Government policy.

Proposal is for expansion of plant in the plant premisesso no R&R is required.

5. Forest and wildlife related issues (if applicable): i. Permission and approval for the use of

forest land (forestry clearance), if any, and recommendations of the State Forest Department. (if applicable)

No forest land is involved hence permission from State Forest Department is not required.

ii. Land use map based on High resolution satellite imagery (GPS) of the proposed site delineating the forest land (in case of projects involving forest land more than 40 ha).

Not applicable as no forest land is involved.

iii. Status of Application submitted for obtaining the stage I forestry clearance along with latest status shall be submitted.

Not applicable

iv. 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 by Chief Wildlife Warden showing these features vis-à-vis the project location and the recommendations or comments of the

Not applicable as no forest land is involved.

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Sr. No.

Conditions Compliance

Chief Wildlife Warden-thereon. v. Wildlife Conservation Plan duly

authenticated by the Chief Wildlife Warden of the State Government for conservation of Schedule I fauna, if any exists in the study area.

Not applicable

vi. Copy of application submitted for clearance under the Wildlife (Protection) Act, 1972, to the Standing Committee of the National Board for Wildlife.

Not applicable

6. Environmental Status i. Determination of atmospheric

inversion level at the project site and' site-specific micro-meteorological data using temperature, relative humidity, hourly wind speed and direction and rainfall.

One season site-specific micro- meteorological data are given in sec. 3.7.2 & table 3.6 on page no. 3-6.

ii. AAQ data (except monsoon) at 8 locations for PM10, PM2.5, SO2, NOX, CO and other parameters relevant to the project shall be collected. The monitoring stations shall be based CPCB guidelines and take into account the pre-dominant wind direction, population zone and sensitive receptors including reserved forests.

AAQ data at 8 locations are tabulated in table no. 3.17 to 3.21 on page no. 3-26 to 3-30. Figure 3.7 shows Air monitoring stations on page no. 3-50.

iii. Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in the NAQQM Notification of Nov. 2009 along with - min., max., average and 98% values for each of the AAQ parameters from data of all AAQ stations should be provided as an annexure to the EIA Report.

AAQM of all station is summarized in table no. 3.17 to 3.21 on page no. 3-26 to 3-30 of EIA report.

iv. Surface water quality of nearby River (100m upstream and downstream of discharge point) and other surface drains at eight locations as per CPCB / MoEF&CC guidelines.

This point is not applicable in our case because no river is passing in the vicinity and no w/w disposal outside of factory premises.Pls. refer table 3.24, page no. 3-34 of chapter-3 for surface water quality.

v. Whether the site falls near to polluted stretch of river identified by the CPCB/ MoEF&CC, if yes give details.

Not applicable

vi. Ground water monitoring at minimum at 8 locations shall be included.

Ground water monitoring at 8 locations is given in Table 3.23, page no. 3-33 of chapter-3.

vii. Noise levels monitoring at 8 locations within the study area.

Noise level monitoring is given in Table 3.26, page no. 3-36 of

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Sr. No.

Conditions Compliance

chapter-3. viii. Soil Characteristic as per CPCB

guidelines. Soil Characteristic is given in Table 3.28, page no. 3-37 of chapter-3.

ix. Traffic study of the area, type of vehicles, frequency of vehicles for transportation of materials, additional traffic due to proposed project, parking arrangement etc.

Traffic study of the area is given in Table 3.31, page no. 3-42 of chapter-3.

x. Detailed description of flora and fauna (terrestrial and aquatic) existing in the study area shall be given with special reference to rare, endemic and endangered species. If Schedule-I fauna are found within the study area, a Wildlife Conservation Plan shall be prepared and furnished.

Description of flora is given in Table 3.29, page no. 3-38 and fauna is given in table 3.30, page no. 3-40 of chapter-3.

xi. Socio-economic status of the study area.

Pls. refer sec. 3.14, page no. 3-20 of chapter-3 for socio-economic status of the study area.

7. Impact and Environment Management Plan i. 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 Modeling 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 sources of emissions (including transportation) on the AAQ of the area shall be assessed. Details of the model used and the input data used for modeling 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.

All the points mentioned are covered in cheapter-4 of EIA report. Cumulative impact of all sources of emissions on AAQ of the area is given in table 4.2, page no. 4-15. Pls. refer figure 4.1 to 4.3, page no. 4-19 to 4-21 for Isoplethsplotted on location map.

ii. Water Quality modeling - in case of discharge in water body.

Unit is not disposing w/w in water body so this point is not applicable.

iii. 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 transport of raw materials and finished products and wastes (large quantities) by rail or rail-cum

The road transport system will be utilized for this project is nearby village road, which is open at state highway (Dholka-Vataman) and is sufficient to accommodate the proposed expansion project. Rail or

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EIA Report of Concord Biotech Ltd. 1-16

Sr. No.

Conditions Compliance

road transport or conveyor-cum-rail transport shall be examined.

conveyor transport system is not proposed in present scenario of development.

iv. A note on treatment of wastewater from different plant operations, extent recycled and reused for 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.

Pls. refer sec. 2.15.1, page no. 2-16 for effluent treatment process. Refer figure 2.2, page no. 2-44 for recycle/reuse details of treated effluent. Pls. refer table 2.9, page no. 2-33 for characteristics of untreated and treated effluent.

v. Details of stack emission and action plan for control of emissions to meet standards.

Pls. refer table 2.12, page no. 2-37 for stack emission and APCM details.

vi. Measures for fugitive emission control.

Pl. refer sec. 10.7.1.1, page no. 10-6 for fugitive emission control details.

vii. Details of hazardous waste generation and their storage, utilization and management.Copies of MOU regarding utilization of solid and hazardous waste in cement plant shall also be included.EMPshall include the concept of waste-minimization, recycle/reuse/recover techniques, Energy conservation,and natural resource conservation.

Pls. refer table 2.16, page no. 2-41 for hazardous waste generation & management. Copy of MOU with Ambuja Cement is attached as Annexure-II. Concept of waste-minimization, recycle/ reuse/ Energy conservation is given in sec. 10-9, page no. 10-16 of chapter-10.

viii. Proper utilization of fly ash shall be ensured as per Fly Ash Notification, 2009. A detailed plan of action shall be provided.

No generation of fly ash as FO is used as fuel.

ix. 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, planning schedule etc. shall be included. The green belt shall be around the project boundary and a scheme for greening of the roads used for the project shall also be incorporated.

Detailed greenbelt development plan is given in sec. 10.8, page no. 10-14 of chapter-10.

x. Action plan for rainwater harvesting measures at plant site shall be submitted to harvest rainwater from the roof tops and storm, water drains to recharge the ground water and also to use for the various activities at the project site to conserve fresh water and reduce the water requirement from other sources.

Rainwater harvesting details are given in sec. 2.16; page no. 2-20 of chapter-2.

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Sr. No.

Conditions Compliance

xi. Total capital cost and recurring cost/ annum for environmental pollution control measures shall be included.

Total capital cost and recurring cost/annum for environmental pollution control measures is given in sec. 2.4, page no. 2-2 for chapter-2.

xii. Action plan for post-project environmental monitoring shall be submitted.

Post-project environmental monitoring is given in Table 10.13, page no. 10-21.

xiii. Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency Management Plan including Risk Assessment and damage control. Disaster management plan should be linked with District Disaster Management Plan.

Pls. refer sec. 7.19, page no. 7-32& sec. 7.24, page no. 7-42 for onsite& offsite emergency plan.

8. Occupational health: i. Plan and fund allocation to ensure the

occupational health & safety of all contract and casual workers.

It is covered in fund for EMS Table 10.3, page no. 10-22.

ii. Details of exposure specific health status evaluation of worker. If the workers' health is being evaluated by pre designed format, chest x rays, Audiometry, Spirometry, Vision testing (Far & Near vision, colour vision and any other ocular defect) ECG, during pre-placement and periodical examinations gives 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.

Pls. refer sec. 10.11, page no. 10-18 of chapter-10.

iii. Details of existing Occupational & Safety Hazards. What are the exposure levels of hazards and whether they are within Permissible Exposure Level (PEL)? If these are not within PEL, what measures the company has adopted to keep them within PEL so that health of the workers can be preserved.

Unit has done periodical medical checkup of its workers. As per the medical record, no adverse impact observed till date.

iv. Annual report of health status of workers with special reference to Occupational Health and Safety.

Unit maintains health record of workers. Health report of 2 workers is attached as Annexure-X.

9. Corporate Environment Policy i. Does the company have a well laid

down Environment Policy approved by its Board of Directors? If so, it may be detailed in the EIA report.

Yes, Environment policy of the unit is attached as Annexure-XI.

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Conditions Compliance

ii. Does the Environment Policy prescribe for standard operating process/ procedures to bring into focus any infringement/deviation/ violation of the environmental or forest norms / conditions? If so, it may be detailed in the EIA.

Yes

iii. What is the hierarchical system or Administrative order of the company to deal with the environmental issues and for ensuring compliance with the environmental clearance conditions? Details of this system may be given.

Details are given in Environment management cell sec. 10.5, page no. 10-2. Hierarchical system of the unit is given in figure 10.1, page no. 10-3.

iv. Does the company have system of reporting of non-compliances / violations of environmental norms to the Board of Directors of the company and / or shareholders or stakeholders at large? This reporting mechanism shall be detailed in the EIA report.

Pls. refer sec. 10.14, page no. 10-19 of chapter-10.

10. Details regarding infrastructure facilities such as sanitation, fuel, restroom etc. to be provided to the labor force during construction as well as to the casual workers including truck drivers during operation phase.

All facilities like sanitation, fuel, restroom etc. to be provided to the labor force during construction as well as to the casual workers including truck drivers during the operation phase.

11. Enterprise Social Commitment (ESC) i. Adequate funds (at least 2.5% of the

project cost) shall be earmarked towards the Enterprise Social Commitment based on Public Hearing issues and item-wise detailsalong with time bound action plan shall be included. Socio-economic development activities need to be elaborated upon.

Covered in sec. 10.12, on page no. 10-19 of EIA report.

12. 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 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.

No

13. A tabular chart with index for point wise compliance of above TORs.

Done

14. The TORs prescribed shall be valid for Noted the point

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Sr. No.

Conditions Compliance

a period of three years for submission of the EIA-EMP reports.

The following general points shall be noted: i. All documents shall be properly

indexed, page numbered. Noted and complied

ii. Period/date of data collection shall be clearly indicated.

Noted and complied

iii. Authenticated English Translation of all material in Regional languages shall be provided.

Noted and complied

iv. The letter/application for environmental clearance shall quote the MoEF file no. and also attach a copy of the letter.

Noted and complied

v. The copy of the letter received from Ministry shall be also attached as an annexure to the final EIA-EMP Report.

Complied ToR letter received from MoEFCC is attached as Annexure-XII.

vi. The index of the final EIA-EMP report must indicate the specific chapter and page no. of the EIA-EMP Report.

Noted and complied

vii. While preparing the EIA report, the instructions for the proponents and instructions for the consultants issued by MOEF vide O.M. No. J-11013/41/2006-IA.II (I) dated 4th August, 2009, which are available on the website of this Ministry shall also be followed.

Undertaking of proponent & consultant is enclosed as Annexure-XIII.

viii. The consultants involved in the preparation of EIA-EMP report after accreditation with Quality Council of India (QCI)/ National Accreditation Board of Education and Training (NABET) would need to include a certificate in this regard in the EIA-EMP reports prepared by them and data provided by other organization/ Laboratories including their status of approvals etc. Name of the Consultant and the Accreditation details shall be posted on the EIA-EMP Report as well as on the cover of the Hard Copy of the Presentation material for EC presentation.

NABET/QCI certificate is enclosed as Annexure-VI.

Issues/objections raised by the participants and responded to by the representative of the applicant during the Public Hearing: Sr. No.

Name and Address

Point Represented Reply from Project Proponent

1. Name: Hasmukhbhai B

• He expressed the gratitude of the company and said that

---

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EIA Report of Concord Biotech Ltd. 1-20

Patel Vill: Dholka

expansion in this company will create employment opportunities. This unit does not seem to consider highly polluting industry and it will create better development opportunity of Dholka and its surrounding area.

2. Name: Rajnikant Manilal Thakkar Vill: Dholka

• We have a business of ginning mill next to Concord biotech and we are residing close to the factory. We also have two ginning factories on the Trasad road and we are regularly passing through this area. For 20 years, we have not felt that there is any pollution or odor in the air. We have not seen pollution even when we go for Picnic with our family at a temple of BootBhavani Maata, which is near to factory. Water flowing nearby which is also not seem to polluted. We have no any kind of damage in terms of health due to this company till date. Expansion will generate employment. Educated people will get job, so the village of Dholka will be developed and benefitted.

---

3. Name: Govind Dodiya Vill: Dholka

• Surrounding villages get benefits from Concord Biotech. We get benefit for expansion. There is no noticeable water or air pollution.

---

4. Name: Snehlatta Patel Vill: Dholka

• How to dispose of waste water from this unit?

• Representative of the company's informed that, the main source of waste water generation is from the fermentation process; the second source is the Cooling bleed off and the Boiler Blow Down. The unit has a primary, secondary and tertiary unit treatment plant. Then it will be passed through RO, permeate is reused and reject is evaporated in MVR/MEE and condensate is recover and reuse. Hence at the end of process, no effluent is released outside the factory premises.

5. Name: Ranachhodbhai Maljibhai

• Our land is surrounding the Concord Biotech and unit is emitting Gas (air pollution)

---

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EIA Report of Concord Biotech Ltd. 1-21

Rabari Vill: Dholka

after 9 pm. In this regard, we have 2 times made application. 2 times negative report comes from Gujarat Pollution Control Board that they are generating pollution. I have copy of this report. 3rd time they said that, close this case. So 4th time I have taken online action to central level. We cannot live in our farm after 9 pm and we have threatened by saying that do whatever you want to. I have written papers of Gujarat Pollution Control Board in which it is mention that, there is an odour issue. Same papers I have submitted to Gandhinagar also. Now, if you wish, then we will migrate from here and leave this place.

6. Name: Hasmukhbhai Modi Vill: Dholka

• I have been working as the Secretary of GIDC industrial estate for last 17 years and if there is any question, we will immediately resolve mutually. We are doing any kind of work for the development of Dholka. Some elements are always objectionable & against the development. And if any new factory comes or expands in this area, their objections are immediately come in front. If they are facing any problem, then represent it, so we can resolve the problem. But we do not tolerate false objections against the development of our area.

---

7. Name: Parimal H Rabari Vill: Dholka

• I have submitted complain in writing to stop toxic pollution generated by Concord Biotech. We cannot live in our farm which is adjoining to the unit, after 9 pm. Our workers cannot work after 9 pm in our farm. In this regard, I am giving you written application. Take strict action against this unit in this matter.

• Reply of written representation is attached with Minutes.

8. Name: Paresh Rathod Vill: Dadusar

• There is no noticeable pollution from Concord Biotech. No harm by this unit and around 700 to 800 people are getting employment since its inception. Due to closure of Kenco Overseas near Valthera, the employment of around 500-700 people was snatched off.

---

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EIA Report of Concord Biotech Ltd. 1-22

These workers have get employment in Concord Biotech. This unit is giving salary around Rs. 9000 to 10000 salary and PF. Apart from this, Concord Biotech provide free ambulance service along with free diagnosis & medicines. It is my opinion that, this company has progressed further. My personal request is to free develop Concord Biotech.

9. Name: Mahammad Yunus Ahemad Malik Vill: Renvad, Dholka

• My farm is adjacent to Concord Biotech in Survey No. 1491-1492. We are not against of development but we are against of spread of pollution.

---

10. Name: Dhiren Patel Vill: Dholka

• It is true that Concord Biotech gives employment to everyone, but takes appropriate measures to control pollution along with employment.

---

11. Name: Ashwin D Jamod Vill: Jalalpur Godhaneshwar

• What steps will you take to control Air pollution?

• Representative of the company’s informed that, no air emission during process because this is a biotechnology process and if any poisonous substance present, then product cannot produce. This process is complete after 8 to 9 days once it starts and this process is done in closed reactor. Once it starts then it cannot be stopped in between and restarted again. So there is no air pollution until the process is over. This process is like the same process of fermentation we are doing at home.

12. Name: Vikram Makawana Vill: Jalalpur Godhaneshwar

• Chemical water comes out from the unit, so what safety measures will you take to avoid any harm to people?

• Representative of the company’s informed that, this process is fermentation based process, in which mainly edible substances like Soybean flour, Sucrose, Dextrose and edible oil are used and no inedible substance are used in it. If any inadequate substance is used, then the fermentation process does not go forward. w/w generated at the end of

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EIA Report of Concord Biotech Ltd. 1-23

this process has little TDS and high COD, which is bio degradable. It is treated in existing ETP and reuse after treatment. Not any w/w discharge outside the premises.

13. Name: Budhabhai Makawana Vill: Jalalpur Godhaneshwar

• What steps will you take to ensure that the people of the surrounding villages get jobs after its expansion?

• Representative of the company’s informed that, at present local people are preferred for employment and after expansion also local people will be given priority for employment.

14. Name: Janki Patel Vill: Dholka

• Explain briefly about the manufacturing of medicine from biotechnology.

• Representative of the company's informed that, this is a fermentation process in which certain types of Enzymes are used in specific types of medicine. It produces 1 to 2% of the drug. The process lasts for 8 to 10 days. The medicine made at the end of this process is extracted and purified. Fermentation is the main part of the process.

1.8 OBJECTIVE OF EIA

EIA is a policy and management tool for both planning and

decisionmaking. EIA assists in identification, prediction and evaluation of

theforeseeable environmental consequences of proposed developmental

andindustrial projects.

The objectives of the present EIA Study is to assess the impacts

onvarious environmental components due to the proposed project

activity, identify potential source of pollution, evaluate impact on

environment andto recommend appropriate environmental management

system andenvironment management plan for the unit to ensure that the

adverseimpacts if any will be minimized. Moreover, to prepare an

EnvironmentalStatement to indicate conclusively if the overall impacts

are positive ornegative.

1.9 METHODOLOGY FOR EIA

Environmental Assessment (EA), another term used in the

environmentalstudies, refers to an understanding of the present status of

environmentand a study of how to manage them. Keeping in view the

nature and sizeof the proposed project and industrial area and various

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EIA Report of Concord Biotech Ltd. 1-24

guidelinesavailable, it was decided to cover an area of 10-km radius from

thecenter of proposed plant site for the purpose of environmental

impactassessment study. The methodology is briefly reported below and

hasbeen described in this section.

Baseline data collection

The baseline data for the impact zone have been generated for the

following environmental parameters.

• Ambient Air Quality

• Micrometeorology

• Noise Level

• Surface &Ground Water Quality

• Soil Quality

• Ecology &Biodiversity

• Land use pattern

• Socio-Economics

The baseline status of the above environmental parameters has been

worked out based on the rapid monitoring/analysis carried out during the

study period of March, 2016 to May, 2016 supplemented by data

collected from various Government Departments, census publications etc.

The data is collected and analyzed as per the standard methods for

establishing the baseline data and so determine the impact of proposed

activity on the same.

Evaluation of Impact from Project Activities

The Environmental Impact resulting from the various project activities,

have been identified, predicted and evaluated based on the study of

manufacturing process and other project related activities as well as

correlating the same with existing baseline status.

Preparation of Environmental Management Plan

Environmental Management Plan has been prepared covering pollution

prevention measures at source in terms of air and water pollution control

measures, solid waste/hazardous waste management, safety

management, greenbelt development, environmental surveillance and

environmental surveillance and environmental management team.

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EIA Report of Concord Biotech Ltd. 1-25

Finally, the detailed assessment of the resultant environmental impacts

have been made based on the impacts identification and evaluated from

the activities over the baseline status of various environmental

components to reduce the pollution and to delineate a comprehensive

environment management plan along with recommendations and

suggestions to improve environment management system.

1.10 DETAILS OF INDUSTRIES SURROUNDING THE UNIT

Sr. No.

Name of Industries Activities

1 ShriJagdamba Polymers Ltd. Woven PP/PE Fabrics

2 Cadila Pharmaceuticals Ltd Pharma Products

3 Astral Pipes Ltd CPVC Pipes

4 WaghBakri Ltd Tea Processing unit

5 Shakti Polyweave Pvt. Ltd. Polymer product

6 Global Energy Food Industries Rice Processing unit

7 Gimatex Industries Pvt. Ltd. Viscose Vortex Fabric

8 Shree Hans Alloys Ltd. Steel & stainless castings

9 Deep Care Health Pvt. Ltd. Pharma Products

10 Jay Shakti Engineering Engineering Unit

11 Jay Laxmi Poly Plast HDPE Woven Bags

12 Kikani Exports Pvt Ltd Cotton Yarn

13 Atlantis Products Pvt. Ltd. Woven Sacks

14 Raj Gum Industries Gaur Gum Powder

15 Global Energy Food Biscuits & Confectionary

16 Gimatex Industries Ltd. Ginning, Spinning mill

17 Punit Packaging Industries Packaging

18 Shri Ram Texspin Industries Spindles for textile Industries

1.11 STRUCTURE OF EIA REPORT

The overall contents of the EIA report is in line with generic structure of

EIA report as per the Appendix III of the EIA Notification, 2006. The

report consists of twelve chapters and the content is briefly described in

this section.

• Chapter 1: Introduction

The chapter gives brief outline of the project and its proponent, brief

description nature, size and location of the project, purpose of the EIA

study including the scope of the study, TORs compliance etc. and work

to be covered under each Environmental component.

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EIA Report of Concord Biotech Ltd. 1-26

• Chapter 2: Project Description

This chapter includes project details and Infrastructure facilities

including all industrial & environmental aspects of the unit as well as

manufacturing process details. It also gives information about utilities,

raw material, water & wastewater quantitative details, stack details,

hazardous waste generation, storage & disposal facility.

• Chapter 3: Description of the Environment

This chapter covers data of existing condition of Valued Environmental

Components like air, water, noise, soil, biological environment and

socio-economic aspects, basic amenities land use pattern. It also gives

details of study area, period of study, component of environment & its

methodology. Various sections of the chapter discuss the existing land

use and drainage pattern, climate and meteorological parameters.

Both primary and secondary data collected for the study are depicted

in this chapter.

• Chapter 4: Anticipated Environmental Impacts and Mitigation

Measures

This chapter describes the overall impacts of the project activities on

various environmental components. It predicts the overall impact of

the project activities on different components of the environment viz.

Air, Water, Land, Noise, Biological and Socio-Economic and its

mitigation measures.

• Chapter 5: Analysis of Alternatives

This chapter gives details of analysis of alternatives in terms of

technology & site.

• Chapter 6: Environmental Monitoring Programme

This chapter describes technical aspects of monitoring (including

measurement methodologies, frequency, location and data analysis,

reporting schedules, emergency procedures, detailed budget and

procurement schedules.

• Chapter 7: Additional Studies

This chapter describes Risk assessment and on-site, off-site

emergency plan and occupational health & safety programme.

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EIA Report of Concord Biotech Ltd. 1-27

• Chapter 8: Project Benefits

This chapter focuses on benefits of project on improvement in physical

infrastructure, social infrastructure & other tangible benefits.

• Chapter 9: Environmental Cost Benefit Analysis

• Chapter 10: Environmental Management Plan

This chapter describes Environment Management Plan (EMP) to be

adopted for mitigation of anticipated adverse impacts if any and to

ensure acceptable impacts.

• Chapter 11: Summary & Conclusion

It gives brief of the EIA Report and chapters there in. It also describes

about overall justification for implementation of the project and

explanation on various mitigation measures.

• Chapter 12: Disclosure of Consultants engaged

This chapter describes the name of the consultant engaged with their

brief nature of consultancy activities.

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EIA Report of Concord Biotech Ltd. 1-28

Figure 1.1

Location of the project site

Project Location Ahmedabad

District

Gujarat state

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EIA Report of Concord Biotech Ltd. 1-29

Figure 1.2

Google map of 10 km radius

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EIA Report of Concord Biotech Ltd. 1-30

Figure 1.3

Image showing all four boundaries coordinates of the site

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EIA Report of Concord Biotech Ltd. 2-1

Chapter-2 Project Description

2.1 INTRODUCTION

Concord Biotech Ltd. manufacturespharmaceuticalbulk drugs based on

biotechnology(through the process of Fermentation, Semi-synthetic

&synthetic processes). Concord has founded in the year 2000 and

emerged from a single-product company into a broad spectrum solution

provider dealing in diverse therapeutic segments. Today, Concord has a

commanding presence in more than 50 countries worldwide with efficient

distribution infrastructure in markets like North America, Europe, Japan,

Central & Latin America, Africa, Australia, New Zealand, Asia - Pacific as

well as CIS and MENA countries.Unit is located at Plot no. 1482-1486,

Trasad Road, Taluka: Dholka, Dist. Ahmedabad, Gujarat.Existing capacity

ofthe unit is 103.83 MTPA.

Now, looking to the market demand, unit wishes to enhance its

production capacity of existing products with addition of four new

products. So after expansion, total capacity of the unit will increase from

103.83 MTPA to 189.03 MTPA. Expansion will be done in existing

premises. Existing and proposed products with respective capacities are

given in Table 2.3.Unit has obtained EC from MoEF&CC for its existing

activities and has valid Consent to operateissued by GPCB vide order no.

AWH-67254 valid up to 13.08.2019.

2.2 TYPE OF PROJECT

Unit proposed to expand production capacity of bulk drugs. Said activities

fall under activity 5(f) “Synthetic Organic Chemical Industries (dyes &

dye intermediates; bulk drugs and intermediates excluding drug

formulations; synthetic rubbers; basic organic chemicals, other synthetic

organic chemicals and chemical intermediates)” of EIA Notification, 2006,

dated 14th September, 2006 and its subsequent amendment. Considering

the project location and its capacity, as per the EIA Notification, it falls

under category ‘A’ project. Hence, it is necessary to obtain the

Environmental Clearance from central level before start the expansion

activities.

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EIA Report of Concord Biotech Ltd. 2-2

2.3 IMPORTANCE &BENEFITS OF THE PROJECT

2.3.1 Importance of the project

Unit manufacturers pharmaceuticalbulk drugs based on biotechnology.

Now, proposed to expand manufacturing of products by considering

present market scenario &expertise of same products in terms of

technical with good market exposure. Unit is having a very good

expertise for the manufacturing of Enzyme, Antibiotic,

Antiparasitic,Antifungal, Immunosuppressant, Onco products, Statin with

different kind of R&D Products. There is ample market for National &

International of these products. In view of the availability of scientific

staff that able to develop sustainable process at relatively low cost, and

demand of product in market; company has decided to expand its

manufacturing capacity.

2.3.2 Benefits of the project

• High quality products supply to the international as well as domestic

market &reduce the demand and supply gap within the market.

• No additional land purchase is required for expansion activities.

• Economical growth of the country by selling maximum products in

international market.

• CSR activities to develop social environment.

• Secondary employment will generate after expansion of the project.

2.4 CAPITAL INVESTMENT

Total cost of the existing project is Rs. 172.0crores. Estimated cost of the

proposed expansion will be around Rs. 20.0 crores. Out of this, around

Rs. 3.0 crore will be earmarked as capital investment for additional EMS

and Rs. 3.25 crorewill be recurring/operating cost per annum.

2.5 LAND REQUIREMENT

Proposed expansion will be carried out in the existing plant premises

admeasuring total area of 112302 m2.Detailed breakup of the land is

given in Table 2.1 below:

Table 2.1 Land break up

Sr. No.

Particular Area in m2 Existing Proposed Total after

expansion 1. Manufacturing area 5793 1948 7741

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EIA Report of Concord Biotech Ltd. 2-3

2. Utility block 653 450 1103

3. RM & finished product storage

546 200 746

4. R & D building 543 0 543

5. Solvent storage area (Tank farm)

2032 0 2032

6. Solvent recovery system 196 0 196

7. Haz. Waste storage area 132 100 232

8. ETP 644 0 644

9. Admin block& canteen 635 0 635

10. Toilet block 38 0 38

12. Greenbelt 23653 61347 85000

13. Parking 100 50 150

14. Internal road 6096 3100 9196

15. Security office 115 0 115

16. Open area 71125 - 3930

Total 112302 67195 112302

(Source: Concord Biotech Ltd.)

2.6 LOCATION

The unit is located in Dholka Taluka of Ahmedabad District. Other salient

featuresof the project site are given in following table:

Table 2.2 Location details

Sr. No.

Particulars Details

1 Plant location Plot No. 1482-1486

Taluka Dholka

District Ahmedabad

State Gujarat

2 Site Coordinates

Latitude 22°41'59.55" N

Longitude 72°26'48.63" E

3 Nearest Village Trasad(2.3 km)

4 Nearest Railway Station Dholka (3.85 km)

5 Nearest Airport Ahmedabad(45.0 km)

6 Nearest City Ahmedabad (38.0 km)

7 Nearest Highway SH (Dholka-Vataman) – 1.3 km NH 8A (A’bad-Rajkot) - 15.0 km

8 Sanctuary/National park None within 10 km radius

Note: Aerial distances are given in above table.

(Source: Google earth& verified by site visit)

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EIA Report of Concord Biotech Ltd. 2-4

2.7 PRODUCT AND SIZE OF THE UNIT

Existing production capacity of the unit is 103.83 MTPA, which will be

increase upto 189.03 MTPA. Product details with its capacity are given in

table below.

Table 2.3 List of existing & proposed products with quantity

Sr. No.

Name of Products Quantity (MTPA) Existing Proposed Total

A Enzyme – 25.0 MTPA 1 Penicillin G Amidase Enzyme 15.00 10.00 25.00 B Antibiotic – 23.1 MTPA 2 Vancomycin 3.00 1.0 4.0 3 Teicoplanin 1.00 1.0 2.0 4 Daptomycin 0.50 0.0 0.50 5 Fidaxomycin 3.00 0.0 3.0 6 Mupirocin& salts 6.00 2.50 8.50 7 Fosfomycin 1.00 0.0 1.0 8 Dalbavancin 0.50 0.0 0.50 9 Telavancin 0.50 0.0 0.50 10 Capreomycin 0.10 0.0 0.10 11 Tobramycin sulphate 2.50 0.0 2.50 12 Oritavancin 0.0 0.50 0.50 C Antiparasitic – 1.90 MTPA 13 Milbemycinoxime 1.00 0.9 1.90 D Antifungal- 1.98 MTPA 14 Pneumocandin Bo 0.20 0.0 0.20 15 Caspofungin 0.20 0.0 0.20 16 Micafungin 0.93 0.0 0.93 17 Anidulafungin 0.65 0.0 0.65 E Immunosuppressant-122 MTPA 18 Tacrolimus 1.00 0.0 1.00 19 Mycophenolic Acid 0.50 0.0 0.50 20 Cyclosporine 7.00 0.0 7.00 21 Rapamycin 0.30 0.20 0.50 22 MycophenolateMofetill&Mycophenolate

sodium 45.00 68.00 113.00

F Onco products-4.05 MTPA 23 Ixabepilone 0.10 0.0 0.10 24 Romidepsin 0.10 0.0 0.10 25 Temsirolimus 0.05 0.0 0.05 26 Everolimus 0.60 0.40 1.0 27 Ridaforolimus 0.05 0.0 0.05 28 Pimecrolimus 0.50 0.0 0.50

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 2-5

29 Doxorubicin 0.60 0.25 0.85 30 Daunorubicin 0.45 0.15 0.60 31 Epirubicin 0.20 0.0 0.20 32 Idarubicin 0.10 0.0 0.10 33 Bleomycin 0.10 0.0 0.10 34 Geldanamycin 0.10 0.0 0.10 35 Mitomycin 0.0 0.10 0.10 36 Dactinomycin 0.0 0.10 0.10 37 Trabectedin 0.0 0.10 0.10 G Statin – 9 MTPA 38 Lovastatin 7.00 -1.0 6.00 39 Pravastatin 1.00 0.0 1.00 40 Orlistatin 2.00 0.0 2.00 H R & D Products 1.00 1.0 2.00

Total 103.83 85.20 189.03

2.8 PROPOSED SCHEDULE FOR APPROVAL AND IMPLEMENTATION

Specifics Applied under the Act

Specifics for approval or legal

procedure

Related recent Status

Implementation

EC for Expansion Project

Under Environment Protection Act, 1986

Environment Clearance for the expansion project from MoEF&CC as per the guideline of EIA Notification-2006

Submitted Form I, TOR presentation, TORs awarded on 28.01.2016

Project will executed after the obtaining EC obtain from MoEF&CC.

Operation of the expansion project

Under Air, Water & Environment (Protection) Act, 1986.

CTE & CTO/CCA from GPCB.

Shortly apply for CTE/CCA to GPCB.

Establishment after obtaining EC/CTE and operate after obtaining CC&A.

2.9 INFRASTRUCTURE FACILITIES OF THE PLANT (MAJOR

MACHINERIES)

The proposed expansion activities will be carried out in the existing plant

premises. Building construction will be done as per requirement. For the

manufacturing of the products, required raw materials are available

nearby and can be transported to the project site with ease because of

good road connectivity. The details about existing and proposed

infrastructural facilities & plant machineries are given in Table 2.4 below.

Table 2.4 Plant machineries (Existing & Proposed)

Sr. No.

Name of the equipment/machinery

Qty. Capacity

Production Plant – 2 (Fermentation) 1 Fermenter 6 nos. 15 KL each

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 2-6

Sr. No.

Name of the equipment/machinery

Qty. Capacity

2 Seed Tank 2 nos. 1.5 KL each 3 Dosing Tank 1 no. 0.5 KL each

2 nos. 1.5 KL each Production Plant – 2 (Recovery) 1 Harvester 1 no. 18 KL

1 no. 20 KL 2 Pieralisi Decanter 2 nos. 3000 Lit/hr. each 3 Solvent Receiver 1 no. 13 KL 4 Distillation Kettle 1 no. 1.6 KL

1 no. 2.5 KL 5 Centrifuge 3 nos. 36” each 6 RotaconeVaccum Dryer 3 nos. 300 Ltr. each 7 Crystallizer 3 nos. 600 Ltr. each 8 Sparkler Filter 1 no. 12 Plates 9 Sifter 1 no. 30 Kg/hr. 10 Multimill 1 no. 25-175 Kg/hr. 11 Micronizer 1 no. 20-40 Kg/hr. 12 Blender 1 no. 1000 Ltr. Production Plant – 3 (Recovery) 1 Reactor 3 nos. 2.5 KL each

2 nos. 3.0 KL each 3 nos. 0.6 KL each 1 no. 0.25 KL

2 Centrifuge 2 nos. 36” each 3 RotoconeVaccum Dryer 2 nos. 300 Ltr. each 4 Blender 1 no. 500 Ltr. 5 SparKLer Filter 1 no. 100 Ltr.

1 no. 20 Ltr. 1 no. 120 Ltr.

6 Sifter 1 no. 50-150 Kg/hr. 7 Micronizer 1 no. 20-60 Kg/hr. 8 Multi Mill 1 no. 150-200 Kg/hr.

Production Plant – 4 (Recover) 1 Reactor 2 nos. 1.2 KL each

1 no. 0.5 KL 1 no. 250 KL 4 nos. 50 KL each 1 no. 2 KL

2 Column 4 nos. 365 Ltr. each 3 Nutsch Filter 1 no. 50 Ltr.

3 nos. 5 Ltr. each 4 Vacuum Tray Dryer 3 nos. 2 tray in each

1 no. 12 Tray 5 Multi Mill 1 no. 5-70 kg/hr. 6 Sifter 1 no. 10-20 kg/hr. 7 Rotavapour 1 no. 20 Ltr.

Production Plant – 4A (Recovery)

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 2-7

Sr. No.

Name of the equipment/machinery

Qty. Capacity

1 Rota evaporator 3 nos. 20 Ltr. each 2 Vacuum Tray Dryer 2 nos. 2 Tray each 3 Multi mill 1 no. 5-25 Kg/hr. 4 Sifter 2 nos. 20 Kg/hr each 5 Blender 1 no. 20 Ltr.

Production Plant – 5 (Fermentation) 1 Media Preparation Reactor 1 no. 10 KL 2 Inoculum Tank 1 no. 100 Ltr 3 Seed Tank 2 nos. 1.5 KL each 4 Fermenter 4 nos. 20 KL each 5 Dosing Tank 2 nos. 3.0 KL each

2 nos. 2.0 KL each Production Plant – 5 (Recovery) 1 Harvester 1 no. 30 KL 2 Pieralisi 1 no. 3000 LPH 3 Solvent Reactor 1 no. 20 KL 4 Distillation Kettle 1 no. 1.6 KL 5 Reactor 2 nos. 1.0 KL each

1 no. 500 Ltr. 2 nos. 3.0 KL each 1 no. 750 Ltr. 1 no. 1.6 KL 1 no. 6.0 KL

6 Centrifuge 4 nos. 36” each 7 SparKLer Filter 2 nos. 200 Ltr. each

1 no. 25 Ltr. 8 Rotocone Vacuum Dryer 1 no. 300 Ltr. 9 Vacuum Tray Dryer 1 no. 36 tray

1 no. 24 tray 10 Blender 1 no. 200 Ltr 11 Sifter 1 no. 30-300 Kg/hr. 12 Multi Mill 1 no. 50-200 Kg/hr. Production Plant – 5 (Recovery) 1 Harvester 1 no. 30 KL 2 Pieralisi 1 no. 3000 LPH 3 Solvent Reactor 1 no. 20 KL 4 Distillation Kettle 1 no. 1.6 KL 5 Reactor 2 nos. 1.0 KL each

2 nos. 3.0 KL each 1 no. 500 Ltr. 1 no. 750 Ltr. 1 no. 1.6 KL 1 no. 6.0 KL

6 Centrifuge 4 nos. 36” each 7 SparKLer Filter 2 nos. 200 Ltr. each

1 no. 25 Ltr. 8 Rotocone Vacuum Dryer 1 no. 300 Ltr.

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 2-8

Sr. No.

Name of the equipment/machinery

Qty. Capacity

9 Vacuum Tray Dryer 1 no. 36 Tray 1 no. 24 Tray

10 Multi Mill 1 no. 500-200 Kg/hr. 11 Sifter 1 no. 30-300 Kg/hr. 12 Blender 1 no. 200 Ltr. Production Plant – 6 (Fermentation) 1 Media Preparation reactor 1 no. 10 KL 2 Inoculums Tank 1 no. 75 Ltr. 3 Seed Tank 2 nos. 1.5 KL each 4 Fermenter 2 nos. 20 KL each 5 Dosing Tank 1 no. 3.0 KL

Production Plant – 7 (Fermentation) 1 Inoculum Tank 1 no. 50 Ltr. 2 Seed tank 2 nos. 2.0 KL each

2 nos. 2.5 KL each 3 Fermenter 3 nos. 20 KL each

Production Plant – 7 (Recovery) 1 Reactor 3 nos. 5.0 KL each

2 nos. 10 KL each 1 no. 1.5 KL 1 no. 3.0 KL 1 no. 50 L

2 Harvester 2 nos. 10 KL each 3 Column 2 nos. 8.0 KL each

4 nos. 4.0 KL each 2 nos. 2.5 KL each

4 Micro Filtration 1 no. - 5 Nano Filtration 1 no. - 6 SparKLer Filter 1 no. 86 Ltr.

1 no. 4.8 Ltr. 7 Distillation Kettle 1 no. 86 Ltr. 8 Centrifuge 2 nos. 260 Kg each 9 Depyrogen Filter 1 no. - 10 Rotacone Vacuum Dryer 1 no. 260 Kg 11 Vacuum Tray Dryer 2 nos. 34 tray in each 12 Fluid Bed Dryer 1 no. 100 Kg/hr 13 Sifter 1 no. 30-300 Kg/hr 14 Multi Mill 1 no. 50-200 Kg/hr 15 Micronizer 1 no. - Production Plant – 8 (Recovery) 1 Reactor 2 nos. 1.6 KL each 2 Column 2 nos. 212 Ltr each 3 Rotacon Vacuum Dryer 1 no. 300 Ltr 4 Centrifuge 1 no. 36” 5 Star Filter 1 no. 200 Ltr

Production Plant – 11 (Recovery) 1 Harvester 1 no. 30 KL

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 2-9

Sr. No.

Name of the equipment/machinery

Qty. Capacity

2 Solvent Receiver 1 no. 20 KL 3 Distillation Kettle 2 nos. 1.5 KL each 4

Reactor 1 no. 1.0 KL 1 no. 2.0 KL 1 no. 6.0 KL

5 Decanter 1 no. 3000 LPH 6 Centrifuge 1 no. 36” 7 Nutsch Filter 1 no. 60 Ltr. 8 SparKLer Filter 1 no. 27.5 Ltr. 9 Rotacone Vacuum Dryer 1 no. 300 Ltr. 10 Vacuum Tray Dryer 1 no. 2 Tray Production Plant – 12 (Recovery) 1 Column 2 nos. 2.4 KL each

2 nos. 4.8 KL each 2 Reactor 2 nos. 3.0 KL each

3 nos. 250 KL each 1 no. 3000 KL each

3 Star Filter 1 no. 200 Ltr. 4 SparKLer Filter 1 no. 4.8 Ltr. 5 Nutsch Filter 1 no. 60 Ltr. 6 Centrifuge 1 no. 36” 7 Vacuum Tray Dryer 1 no. 24 tray 8 Sifter 1 no. 75-300 Kg/hr. 9 Multimill 1 no. 200-300 Kg/hr. 10 Blender 1 no. 200 Ltr. Production Plant – 14 (Fermentation) 1 Fermenter 3 nos. 15 KL each 2 Seed Tank 4 nos. 1.5 KL each 3 Media Preparation Reactor 1 no. 5.0 KL

Production Plant – 15 (Fermentation) 1 Fermenter 3 nos. 15 KL each 2 Seed Tank 4 nos. 1.5 KL each 3 Media Preparation Tank 1 no. 5.0 KL 4 Inoculum Tank 3 nos. 100 Ltr. each

Production Plant – 16 (Recovery) 1 Reactor 4 no. 500 Ltr. each

3 nos. 250 Ltr. each 3 nos. 25 Ltr. each 1 no. 100 Ltr. 1 no. 35 Ltr. 1 no. 5 Ltr.

2 Nutsch Filter 1 no. 25 Ltr. 3 nos. 15 Ltr. each

3 Sifter 1 no. 10-20 Kg/hr. 4 Multi Mill 1 no. 5 Kg/hr. 5 Vacuum Tray Dryer 2 nos. 2 Tray each 6 Preparative HPLC 1 no. -

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 2-10

Sr. No.

Name of the equipment/machinery

Qty. Capacity

7 Rotavapour 2 nos. 20 Ltr. each 8 Column 2 nos. 25 Ltr. each

1 no. 100 Ltr. Production plant – 17 Lyophilizer 1 Reactor 2 nos. 500 Ltr. each 2 Multi effect Distillation still 1 no. 300 Ltr/hr. 3 WFI storage tank 1 no. 2500 Ltr 4 Pure steam generator 1 no. 500 Kg/hr. 5 Dry heat sterilizer 1 no. 33 tray 6 Lyophilizer 1 no. 400 Kg ice

capacity 7 High pressure high vacuum steam

sterilizer 1 no. --

8 Purified water system 1 no. 1.0 KL/hr. 9 Purified water storage tank 1 no. 1200 Ltr. 10 Multimill 1 no. 70 Kg/hr. Production Plant – 19 (Recovery) 1 Reactor 1 no. 63 Ltr.

2 nos. 150 Ltr each 4 nos. 250 Ltr each 3 nos. 500 Ltr each 1 no. 100 Ltr 1 no. 2.0 KL

2 Nutsch Filter 3 nos. 16” each 1 no. 36”

3 Prep HPLC 1 no. - 4 Column 1 no. 200 Ltr.

1 no. 400 Ltr. 5 Isolator 3 nos. -

Production Plant – 20 (Recovery) 1 Harvester 1 no. 30.0 KL 2 Solvent Receiver 1 no. 20.0 KL 3 Decanter 1 no. 4000 LPH 4 Distillation Kettle 2 nos. 1.5 KL each 5 Reactor 1 no. 6.0 KL

2 nos. 1.0 KL each 6 Centrifuge 1 no. 150 Kg 7 SparKLer filter 1 no. 12 plates 8 Micro filter 1 no. - 9 Rotocone Vacuum Dryer 1 no. 300 Ltr. 10 Nutsch filter 1 no. 10 Ltr. Production Plant - 21 1 Reactor 2 nos. 3.0 KL each

1 no. 250 Ltr. 2 Vacuum Tray Dryer 1 no. 36 Tray 3 Rotocone Vacuum Dryer 1 no. 300 Ltr. 4 Centrifuge 1 no. 150 kg 5 SparKLer Filter 1 no. 12 Plates

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 2-11

Sr. No.

Name of the equipment/machinery

Qty. Capacity

6 Agitated Nutsch Filter 1 no. - 7 WestFalia 1 no. 4000 Ltr/hr. 8 Column 1 no. 800 Ltr.

2 nos. 1200 Ltr each Production Plant – 22 (Fermentation) 1 Inoculum Tank 3 nos. 100 Ltr. each 2 Seed Tank 4 nos. 500 Ltr. each 3 Fermenter 2 nos. 5 KL each 4 Media preparation reactor 1 no. 1 KL 5 Tubular Centrifuge 1 no. -

Production Plant – 22 Recovery Section 1 Harvester 1 no. 7.5 KL 2 Solvent Reactor 1 no. 7.5 KL 3 Wastfalia Decanter 1 no. - 4 Centrifuge 1 no. 24” 5 Vacuum Tray Dryer 2 nos. 12 tray each 6 Distillation Kettle 2 nos. 1 KL each 7 Reactor 1 no. 35 Ltr.

1 no. 25 Ltr. 1 no. 100 Ltr.

8 Crystallizer 1 no. 500 Ltr. 9 Micro filtration 1 no. - 10 Ultra filtration 1 no. - 11 Nano filtration 2 nos. - 12 Nutsch filter 1 no. 24”

1 no. 12” 13 Lyophilizer 1 no. 36 Ltr. 14 Column 2 nos. 420 mm each 15 HPLC Skid 1 no. - 16 Preparative HPLC column 1 no. -

(Source: Concord Biotech Ltd.)

2.10 MANUFACTURING PROCESS DESCRIPTION

Manufacturing process, chemical reaction & mass balance of all products

are given as Annexure-I of EIA report.

2.11 PROJECT COMPONENTS

Components of the project include all facilities required for the operation

of the project with legal necessity.

a) Input requirements: Raw materials, Water, Fuel, Power etc.

b) Utility requirement: Boiler, Cooling tower, Chillers, D.G. Set etc.

c) Treatment Facilities:

Water Treatment facilities: ETP with RO treatment along with

MVR/MEE

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 2-12

Air Pollution Control Facilities: No APCM

Hazardous/solid waste facilities: It includes separate storage area.

d) Other facilities: Rain water harvesting system

2.12 INPUT REQUIREMENTS

(a) Raw Material Requirement:

Raw material required along with quantity, its source & mode of

transportation is given in Table 2.6. The transportation of raw materials

will be done by road complying with all safety requirements. The raw

materials will be stored/inventory will be maintained as per market

requirement of the products and production schedule. Most of the raw

materials are indigenously available.

(b) Water:

At present, total water requirement is (Industrial + Domestic +

Greenbelt) 589.5 KLD. Out of which; 349.5 KLD is fresh water

requirement and 240.0 KLD is recycle water. After expansion; water

requirement will be increase up to 955.0KLD; Out of which, 556.0 KLD

will be fresh water requirement. Unit has its own borewell within the plant

premises to satisfy its fresh water requirement and after proposed

expansion;source of water requirement will remain same. Water balance

diagram showing existing and after expansion scenario is given in Figure

2.2.

(c) Power:

Electricity is supplied from Uttar Gujarat Vij Company Ltd. (UGVCL). After

expansion, total power requirement will be tune around 4000

kVA(Existing: 3400 kVA &proposed addition: 600 kVA). Unit has installed

2 stand by D.G.sets and has proposed to install 3 stand-by D.G. sets with

capacity of 1000 kVAeach to meet the power requirement of plant in case

of power failure. D.G.setswill be operated only during failure of power

supply by state grid.

(d) Fuel:

At present, Furnace Oil (FO)-820 kg/hr. is used as a fuel in boiler. After

expansion, consumption of FO will increase up to 1100 kg/hr. HSD will be

used as fuel in stand by D.G. set.

Details of fuel consumption are given below.

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 2-13

Sr. No.

Equipment Name of fuel

Fuel consumption Existing Proposed

(Additional) Total

1 Boiler FO 820 kg/hr. 280 kg/hr. 1100 kg/hr.

2 Stand by D. G. Set

HSD 115 lit/hr. 250 lit/hr. 365 lit/hr.

(Source: Concord Biotech Ltd.)

(e) Manpower:

After expansion, total manpower will be 719; i.e. existing 619 nos. and

proposed 100 nos. which include manpower at all levels i.e. manager,

supervisor & chemist, skilled workers and unskilled workers.

2.13 UTILITIES REQUIREMENTS

Details of utility are tabulated below:

Table 2.5 Utilities

Sr. No.

Particulars Qty. Capacity Remark (Existing/Proposed)

1 Boiler 1 8000 Kg/hr. Existing 1 3000 Kg/hr./

8000 Kg/hr. after

modification/ replacement

Existing

2 Chiller 1 7 TR Existing 1 24 TR Existing 1 52 TR Existing 1 80 TR Existing 1 250 TR Existing 1 337 TR Proposed 1 365 TR Proposed 

3 Chiller (Brine) 1 15 TR Existing 4 Air Compressor 1 114 CFM Existing 

1 500 CFM Existing 1 472 CFM Existing 1 3050 CFM Proposed 1 7029 CFM Proposed 1 4054 CFM Proposed 

5 D.G. Set 1 1000 KVA Existing 3 1000 KVA each Proposed

6 RO Water Plant 1 5.0 m3/hr. Existing 2 10.0 m3/hr. Proposed

7 RO Recovery Plant 1 6.0 m3/hr. Existing 8 Soft Water Plant 1 5.0 m3/hr. Existing 9 Cooling Tower 5 800 TR each Existing 10 Nitrogen Plant 1 6 m3/hr. Existing

1 20 m3/hr. Existing

(Source: Concord Biotech Ltd.)

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EIA Report of Concord Biotech Ltd. 2-14

2.14 GENERATION OF POLLUTANTS

The sources of pollution will be as below:

2.14.1 Wastewater Generation

After proposed expansion, total wastewater generation will be increased

from 210.0 KLD to 399.0 KLD which include effluent from process,

washing, utilities, reject from water treatment & sewage effluent. Total

wastewater generation will be 399.0 KLD (including industrial and non-

industrial sources), out of which 351.0 KLD will be industrial wastewater

and 48.0 KLD will be domestic w/w. The breakup of wastewater

generation (existing & after proposed expansion) are given in Table

2.7.Water balance diagram showing existing and after expansion scenario

is given in Figure 2.1 & 2.2.

2.14.2 Air Pollution

Main source of air emission will be point source & fugitive emission. There

will be no process gas emission. At present, flue gas emission is from one

common stack of 2 nos. of steam boiler, furnace Oil (FO)is used as fuel.

After expansion, one boiler will be modified/replace in terms of capacity

from 3 TPH to 8 TPH. Therefore,FO consumption will also increase from

820 kg/hr. to 1100 kg/hr. Most probable emitted pollutants from flue gas

stacks will be SPM, SO2and NOx.

Unit has installed D. G. Sets with capacity of 1000 kVA& 680 kVA. After

expansion, one D. G. set of 680 kVA will be dismantled and 3 new stand-

by D.G. sets with capacity of 1000 kVA each will be installed to fulfill

power requirement in case of non-availability of power/emergency. HSD

will be used as a fuel. Probable pollutants likely to emit will be SPM,

SO2&NOx, but it will not the constant source of emission as it will be used

in case of power failure only. Details of the stacks are given in Table

2.12.

Sources of fugitive emission:

The fugitive emission such as VOCs & Dust (PM) is likely to be emitted

from material handling area, process area, solvent storage area.

Solvent use and recycle

Solvents are used for extraction of products. Used solvents are recovered

by distillation system and reuse in next process of extraction of products.

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EIA Report of Concord Biotech Ltd. 2-15

The solvent residues which are mainly organic in nature and contain

significant calorific value are sent for co-processing.Schematic diagram of

solvent recovery system is presented in Figure 2.4.

2.14.3 Hazardous waste generation

Hazardous wastesare generated from process, solvent distillation,

wastewater treatment& utilities. The effluent treatment system generates

ETP sludge & MEE salts and process operations generate spent carbon.

Distillation of solvents generates solvent residue. D.G. sets generate

waste oil. Other waste is discarded containers/bags/liners. After

expansion, sources of Haz. Waste generation will remain same and there

will be increase in the quantity of the hazardous waste generation.The

details of hazardous waste generation with its category as per HWM

Rules, 2016are given in Table 2.16.

2.14.4 Noise Generation

Main source of noise generation is boiler, reactor, process plant, vehicular

transportation & other machineries.There will be slight increase in noise

level due to proposed manufacturing activities, due to installation of some

new additional mechanical equipment required for the proposed

expansion. The noise level in the unit is well within the prescribed limit.

2.15 POLLUTION CONTROL STRATEGY

The details of pollution control strategy for various parameters are given

hereunder,

2.15.1 Effluent Management

The industry is manufacturing pharmaceutical products using

biotechnology process. The manufacturing activities of these products

generate wastewater from the process, washing and utilities. After

proposed expansion, total wastewater generation will be increased from

210.0 KLD to 399.0 KLD.Wastewater generated from process, washing

&utility is directly sent to ETP having primary & secondary treatment

units.Domestic effluent is also sent to ETP along with industrial

wastewater. Reject from first stage RO will be sent to second stage RO.

Reject fromsecond stage RO will be sent to MVR/MEE. Condensate of

MVR/MEE & permeate of second stage ROwill be used in Cooling.Entire

quantity of treated water from ETP is utilized for greenbelt

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EIA Report of Concord Biotech Ltd. 2-16

development.To treat the wastewater generated from the production

activities as well as domestic usage, the industry have full-fledge effluent

treatment plant with the designed capacity of 400 m3/day.After

expansion, unit will treat its effluent in exiting ETP.Design details of ETP

are given in Table 2.8and flow diagram of ETP is given as Figure 2.3.

Details of the Effluent Treatment scheme are described below.

Effluent treatment scheme:

To considering high suspended solids due to microbes (broth) in industrial

effluent, unit has installed decanter as a pre-treatment to remove it

before primary treatment.Effluent from collection tank flows to Oil &

Grease trap. The oil and grease are removed in this unit. The effluent

then flows to the equalization cum neutralization tanks. Adding the

chemicals viz. lime, alum and poly electrolyte depending upon the quality

of incoming effluent, neutralizes the effluent here. For air requirement

diffused aeration system is provided in this unit. The neutralized effluent

is flows to the primary clarifier where quiescent condition is provided for

settlement of settable solids. The sludge settled in the primary clarifier

taken to the sludge drying bed or decanter collection tank while the

supernatant is subjected to the biological treatment.

The supernatant from the clarifier is taken to the aeration tank. Biological

degradation of the organic matter occurs in the aeration tank in presence

of the oxygen. Effluent containing biomass from aeration tank flows to

the secondary Clarifier. Here the settlement of the biomass takes place

under quiescent condition. Settled biomass is either recycled in to the

aeration tank to maintain the MLSS concentration or can be taken in to

the sludge drying bed or decanter collection tank.

Biologically treated effluent will be passed through two stageRO. Reject

from first stage RO will be sent to second stage RO. Reject fromsecond

stage RO will be sent to MVR/MEE. Condensate of MVR/MEE & permeate

of second stage ROwill be used in Cooling.Entire quantity of treated water

from ETP is utilized for greenbelt development.

The decanter feed pump transfer to the decanter where the solid and

liquid are segregate. The solids are collected or dried in sludge dryer and

then after packedinto the HDPE bag. The liquid from decanteris transferto

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EIA Report of Concord Biotech Ltd. 2-17

collection tank or equalization tank. Sludge bags are stored in Hazardous

waste storage area.

2.15.2 Air Pollution Control Measures

The industry has two boilers (out which 1 is stand-by) to generate steam

required for different process activities, Furnace Oil is used as fuel in both

the boilers. After expansion, one boiler will be modified/replace in terms

of capacity from 3 TPH to 8 TPH. Air pollution is caused due to emissions

from the boilers due to combustion of fuel. Due to use of liquid fuel i.e.

FO, no need of APCM except appropriate stack height as per CPCB

guideline. There will be no process emission from the unit.

Unit has installed D.G. Sets with capacity of 1000 kVA & 680 kVA. After

expansion, D.G. set of 680 kVA will be dismantled and 3 new stand-by

D.G.sets with capacity of 1000 kVA each will be installed to fulfill power

requirement in case of non-availability of power/emergency. HSD will be

used as a fuel. Probable pollutants likely to emit will be SPM, SO2 and

NOx, but it will not the constant source of emission as it will be used in

case of power failure only. Details of the stacks with height are given in

Table 2.12.

Fugitive Emission Control

To control fugitive emission, following steps will be implemented:

• Entire process will be carried out in closed reactors.

• Pneumatically transfer of liquid raw material in rector.

• Regular maintenance of valves, pipes

• PPEs will be provided to the workers.

• Frequent work area monitoring will be done ensure fugitive

emissions level.

• Greenbelt will be developed in and around the plant to capture the

fugitive emission.

2.15.3 HazardousWaste Management

Entire quantity of hazardous waste will be handled and disposed as per

Hazardous & Other waste (Managementand Transboundary Movement)

Rules, 2016.Currently unit is disposed its ETP sludge at TSDF site, SEPPL.

ETP sludge generation is mainly from biological treatment and source of

effluent is also from biotechnology process. It has good NPK value and no

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EIA Report of Concord Biotech Ltd. 2-18

hazardousness primarily found in sludge analysis. So unit proposed to use

it as manure and will obtain necessary permission from concerned

department. Distillation residue is sent to SEPPL for incineration or to

RSPL for co-processing, spent carbon is sent to SEPPL for incineration or

to RSPL for co-processing or for co-processing at Ambuja Cement

Limited,used lubricating oil is used within premises as a lubricant and in

case of excess; disposed by selling to registered re-refiners. Whereas

discarded drums/containers are reuse or incase of excess,disposed off by

selling to registered recyclers. Off specific products will be disposed to

CHWIF for incineration/sent for co-processing. Unit has provided isolated

area with impervious flooring for the storage of hazardous waste. Thus,

hazardous waste management system provided by the unit will be

adequate and there will not be any major impact on the environment due

to hazardous waste management. The details of hazardous waste

generation are given in Table2.16.

2.15.4 Type of microbes in extraction and its disposal

The source of vegetative microbesculturesis from microbiology laboratory

is amplified in fermentation at plant level. The broth is treatedby aerobic

biological treatment and it is not hazardous in nature. The extraction

process is given in each process and for disposal; the waste is

deactivated and deactivated broth are dewatered along with ETP sludge

in in-house decanter and finally disposed at TSDF site and proposed to

use as manure in agriculture farm. List of microbes used in fermentation

process are summarized below.

S.No.

Products Microbes name

1 Penicilling G Amidase Enzyme E.coli 2 Vancomycin Amycolatopsisorientalis 3 Teicoplanin Streptomyces tsukaenbiasis 4 Daptomycin Streptomyces roseosporus 5 Fidaxomycin Actinoplanesdeccanensis 6 Mupirocin& salts Pseudomonas fluorescens 7 Fosfomycin Streptomyces fradiae 8 Dalbavancin ActinomycetesNonomureaea

species 9 Telavancin Amycolatopsisorientalis 10 Capreomycin Streptomyces capreolus

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EIA Report of Concord Biotech Ltd. 2-19

11 Tobramycin sulphate Streptomyces tenebrarius 12 Milbemycinoxime Streptomyces hygroscopicus

subsp. Auriolacrimosus 13 Oritavancin Nocardiaorientalis 14 Pneumocandin Bo ZalerionArboricola 15 Caspofungin ZalerionArboricola 16 Micafungin Coleophomaempetri 17 Anidulafungin Aspergilusnidulans 18 Tacrolimus Streptomyces tsukubaensis 19 Mycophenolic Acid Penicilliumbrevicompactum 20 Cyclosporine Beauverianivea 21 Rapamycin Streptomyces hygroscopicus sub

spp. Hygroscopicus 22 MycophenolateMofetill&Mycop

henolate sodium Penicilliumbrevicompactum

23 Ixabepilone SorangiumCellulosum 24 Romidepsin Chromobacteriumviolaceum 25 Temsirolimus Streptomyces hygroscopicus sub

spp. Hygroscopicus 26 Everolimus Streptomyces hygroscopicus sub

spp. Hygroscopicus 27 Ridaforolimus Streptomyces hygroscopicus sub

spp. Hygroscopicus 28 Pimecrolimus Streptomyces hygroscopicus

subsp. Ascomyceticus 29 Doxorubicin streptomycescoeruleorubidus 30 Daunorubicin streptomycescoeruleorubidus 31 Epirubicin streptomycescoeruleorubidus 32 Idarubicin streptomycescoeruleorubidus 33 Bleomycin streptomycesmobaraensis 34 Geldanamycin Streptomyces hygroscopicus sp. 35 Mitomycin streptomycescaespitosus 36 Dactinomycin Streptomyces purvulus 37 Trabectedin Pseudomonas fluorescens 38 Lovastatin Aspergilusterrus 39 Pravastatin Streptomyces carbophillus 40 Orlistatin Streptomyces toxytricini

2.15.5 Noise Pollution Control

Noise is anticipated from boilers, machineries, D. G. set, reactors etc. The

D. G. set shall be kept in a separate room with acoustic enclosure. The

motors and compressors shall be mounted properly to ensure the

reduction of noise and vibration. The employees working in noise

generating areas shall be provided with appropriate Personnel Protective

Equipments (PPEs). The greenbelt area will be developed within industrial

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EIA Report of Concord Biotech Ltd. 2-20

premises and around the periphery to prevent the noise pollution in

surrounding area.

2.16 RAIN WATER HARVESTING

Rainwater harvesting is the accumulation and deposition of rainwater for

reuse on-site, rather than allowing it to run off. It is widely used system

throughout the world. Rain water from terraces/rooftop areas shall be

collected through rain water down-take pipes & collected to catch basins

or stored in rain water tanks. However, the rain water from plant area

and parking area may contaminated and not advise to collect directly to

catch basins. Rain water harvesting pits shall be provided wherever

feasible so that maximum rain water recharged into the ground before it

reaches the storm water mains.

In designing any Rainwater harvesting structure, capturing rainfall and

runoff for local use is the key concept. Hard surface such as roof

pavements and roads that decrease groundwater percolation constitute

catchments and generate the high runoff which has to be diverted into

the storage tank & recharged into ground water regime through simple

filtration & injection well system for subsequent extraction by service

wells. To improve water availability, rainwater harvesting is the most

imminent & short-term solution.In view of above, rainwater harvesting

structures at this point can serve the purpose of arresting roof top

rainwater and runoff generated through roads in the area. The design is

based on average annual rainfall and its intensity and the intake capacity

of the water by the aquifers.

Design of Rain Water Harvesting:

For good design of rainwater harvesting, following points are to be kept

under consideration:

• Ideal location with good ground slope

• The location has adequate subsurface permeability of the aquifer to

accommodate maximum recharge of rainwater through injection

well.

• Rate of filtration should exceed average rainfall intensity.

• Clogging of filtration media should be cleaned periodically.

• Ground water pollution does not take place.

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EIA Report of Concord Biotech Ltd. 2-21

Schematic design of rooftop rainwater harvesting structure at Concord Biotech Ltd. plant premises

Schematic design of road and open area rainwater harvesting structure at Concord Biotech Ltd. Plant premises

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 2-22

2.17 GREEN BELT DEVELOPMENT

The unit has done extensive plantation in 23653 m2 in its existing unit

and some more area of about 61347m2 will be added for greenbelt

development. After expansion, total area of greenbelt area will be 85000

m2which will be more than 33% of total land area.

2.18 OCCUPATIONAL HEALTH & SAFETY

The company is concerned with the health, safety and environment

protection. The company will formulate and develop an ‘Occupational

Health & Safety Policy’ to ensure good health and safety of its employees.

Following key safety measures shall be a part of the Health & Safety

policy of the company and shall be followed after the project

implementation.

• Safety Training shall be provided to the employees.

• Safety Sirens with Alarm System in case of emergency shall be

provided.

• Fire Hydrant System shall be installed.

• Fire Extinguishers shall be provided.

• Mock drills shall be periodically conducted and factors like response

time shall be evaluated.

• First Aid Facility and training shall be provided.

• Personnel protective Equipment shall be provided to the employees.

• Health check-ups shall be organized at regular intervals.

• Safety/Health records and MSDS shall be maintained.

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EIA Report of Concord Biotech Ltd. 2-23

Table 2.6

Raw Material Consumption, Source & transportation details

Sr. No.

Name of Product Quantity (MTPA) Source Transportation Existing Proposed Total

A Enzyme 1 Penicillin G Amidase Enzyme - 25.0 MTPA 1 Constip liquor 0.214 0.143 0.357 Local By road 2 Ammo solution 42.857 28.572 71.429 Local By road 3 Potassium Phosphate 2.143 1.428 3.571 Local By road 4 Sodium Phosphate 2.143 1.428 3.571 Local By road 5 MgSO4 0.214 0.143 0.357 Local By road 6 CaCl2 0.043 0.028 0.071 Local By road 7 Sugar 32.143 21.428 53.571 Local By road 8 NaCl 8.571 5.715 14.286 Local By road 9 Glutar 2.143 1.428 3.571 Local By road 10 Polymin 2.143 1.428 3.571 Local By road 11 Ammonia 3.214 2.143 5.357 Local By road 12 NaOH 0.857 0.572 1.429 Local By road B Antibiotic 2 Vancomycin - 4.0 MTPA 1 Dextrose 0.252 0.084 0.336 Local By road 2 Dextrine 15.126 5.042 20.168 Local By road 3 Potato Protein 3.630 1.21 4.840 Local By road 4 CaCO3 0.227 0.076 0.303 Local By road 5 Soya flour 3.630 1.21 4.840 Local By road 6 Salt minerals 0.252 0.084 0.336 Local By road 7 Ethanol 0.378 0.126 0.504 Local By road 8 IPA 0.378 0.126 0.504 Local By road 3 Teicoplanin - 2.0 MTPA 1 Dextrose 14.857 14.857 29.714 Local By road 2 Dextrine 48.571 48.572 97.143 Local By road 3 Cotton seed flour 22.714 22.715 45.429 Local By road 4 CaCO3 1.786 1.785 3.571 Local By road 5 Soya flour 22.714 22.715 45.429 Local By road 6 Salt minerals 3.571 3.572 7.143 Local By road 7 Ethanol 1.429 1.428 2.857 Local By road 4 Daptomycin - 0.5 MTPA 1 Dextrose 1.833 0.0 1.833 Local By road 2 Dextrine 12.500 0.0 12.500 Local By road 3 CaCO3 0.156 0.0 0.156 Local By road 4 Soya flour 0.292 0.0 0.292 Local By road 5 Salt minerals 0.156 0.0 0.156 Local By road 6 IPA 0.417 0.0 0.417 Local By road 5 Fidaxomycin - 3.0 MTPA 1 Dextrose 7.364 0.0 7.364 Local By road 2 Tapioca Starch 21.545 0.0 21.545 Local By road 3 Soybean flour 8.018 0.0 8.018 Local By road 4 Veg Peptone 4.364 0.0 4.364 Local By road 5 Yeast Extract 6.000 0.0 6.000 Local By road 6 Minerals 2.182 0.0 2.182 Local By road 7 Ethyl acetate 0.927 0.0 0.927 Local By road 8 Isopropyl alcohol 0.655 0.0 0.655 Local By road 9 Methanol 3.273 0.0 3.273 Local By road

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EIA Report of Concord Biotech Ltd. 2-24

6 Mupirocin& salts - 8.5 MTPA 1 Dextrose Monohydrate 15.714 6.548 22.262 Local By road 2 Soybean meal 16.057 6.691 22.748 Local By road 3 Wheat Gluten meal 4.857 2.024 6.881 Local By road 4 Corn Syrup powder 4.571 1.905 6.476 Local By road 5 Salt & minerals 2.000 0.833 2.833 Local By road 6 Antifoam (Silicon) 0.286 0.119 0.405 Local By road 7 Ethyl acetate 0.103 0.043 0.146 Local By road 8 Sulphuric acid 0.686 0.285 0.971 Local By road 9 Sodium bicarbonate 2.857 1.191 4.048 Local By road 10 n-heptane 0.286 0.119 0.405 Local By road 7 Fosfomycin - 1.0 MTPA 1 Fosfomycinphenylethyl amine 1.600 0.0 1.600 Local By road 2 25 % sodium hydroxide

solution 1.250

0.0 1.250

Local By road

3 MIBK - Methyl isobutyl ketone 0.500 0.0 0.500 Local By road 4 Activated carbon 0.050 0.0 0.050 Local By road 5 Hyflow 0.050 0.0 0.050 Local By road 8 Dalbavancin - 0.5 MTPA 1 Yeast Extract 1.667 0.0 1.667 Local By road 2 Yeast autolysate 1.667 0.0 1.667 Local By road 3 Peptone 1.667 0.0 1.667 Local By road 4 Dextrose Monohydrate 1.667 0.0 1.667 Local By road 5 Sodium chloride 0.500 0.0 0.500 Local By road 6 Calcium carbonate 0.667 0.0 0.667 Local By road 7 n-butanol 1.000 0.0 1.000 Local By road 8 Ethyl acetate 0.833 0.0 0.833 Local By road 9 Telavancin - 0.5 MTPA 1 Soya flour 2.500 0.0 2.500 Local By road 2 Potato protein 2.500 0.0 2.500 Local By road 3 Calcium Chloride 2.500 0.0 2.500 Local By road 4 Sodium Chloride 1.500 0.0 1.500 Local By road 5 Maltodextrin 1.000 0.0 1.000 Local By road 6 Mineral salts 1.500 0.0 1.500 Local By road 7 Isobutyl acetate 1.500 0.0 1.500 Local By road

10 Capreomycin - 0.1 MTPA 1 Bacto Peptone 0.417 0.0 0.417 Imported Sea 2 Casamino acid 0.208 0.0 0.208 Imported Sea 3 Cerelose 1.250 0.0 1.250 Local By road 4 Magnesium sulphate 0.250 0.0 0.250 Local By road 5 Ferrous sulphate 0.000 0.0 0.000 Local By road 6 Calcium Chloride 0.021 0.0 0.021 Local By road 7 Ethyl acetate 2.917 0.0 2.917 Local By road 8 n-Heptane 0.075 0.0 0.075 Local By road

11 Tobramycin Sulphate - 2.5 MTPA 1 Starch 8.102 0.0 8.102 Local By road 2 Soya peptone 20.833 0.0 20.833 Local By road 3 Dextrose 23.380 0.0 23.380 Local By road 4 Corn Gluten 13.889 0.0 13.889 Local By road 5 Soya flour 19.676 0.0 19.676 Local By road 6 Soyabean Oil 2.315 0.0 2.315 Local By road 7 Calcium Carbonate 1.111 0.0 1.111 Local By road 8 Magnesium Sulphate 0.278 0.0 0.278 Local By road 9 Ammonium Chloride 0.278 0.0 0.278 Local By road

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EIA Report of Concord Biotech Ltd. 2-25

10 Zinc Sulphate 0.056 0.0 0.056 Local By road 11 Ethyl acetate 6.944 0.0 6.944 Local By road 12 Oritavancin - 0.5 MTPA 1 Dextrose 7.500 0.0 7.500 Local By road 2 soyabean Flour 4.500 0.0 4.500 Local By road 3 Potato Protin 9.000 0.0 9.000 Local By road 4 CaCO3 0.750 0.0 0.750 Local By road 5 Corn Steep Liquid 0.900 0.0 0.900 Local By road 6 PPG 2000 0.900 0.0 0.900 Local By road 7 Soya Peptone 1.500 0.0 1.500 Local By road 8 Antifoam 0.600 0.0 0.600 Local By road 9 Methanol 3.000 0.0 3.000 Local By road 10 Isopropyl alcohol 0.050 0.0 0.050 Local By road 11 Chlorobiphenylcarboxaldehyde 0.900 0.0 0.900 Local By road C Antiparasitic

13 Milbemycinoxime - 1.9 MTPA 1 Sucrose 10.000 9.000 19.000 Local By road 2 Yeast extract 7.000 6.300 13.300 Local By road 3 Soya flour 5.000 4.500 9.500 Local By road 4 Magnesium sulphate 1.000 0.900 1.900 Local By road 5 Di-potassium hydrogen

phosphate 0.300 0.270 0.570 Local By road

6 Calcium carbonate 2.000 1.800 3.800 Local By road 7 Ferrous sulphate 0.030 0.027 0.057 Local By road 8 Ethyl acetate 22.500 20.250 42.750 Local By road 9 Isopropyl alcohal 1.750 1.575 3.325 Local By road D Antifungal 14 Pneumocandin Bo - 0.2 MTPA 1 Dextrose 0.536 0.0 0.536 Local By road 2 KH2PO4 0.518 0.0 0.518 Local By road 3 Corn Steep Liquor 0.054 0.0 0.054 Local By road 4 Trace Salt Solution 0.007 0.0 0.007 Local By road 5 L-Proline 0.893 0.0 0.893 Local By road 6 Antifoam 0.001 0.0 0.001 Local By road 7 Methanol 0.071 0.0 0.071 Local By road 8 Acetonitrile 0.357 0.0 0.357 Local By road 9 Salts and Minerals 0.054 0.0 0.054 Local By road 10 IBA 3.036 0.0 3.036 Local By road 11 Acetonitrile 0.036 0.0 0.036 Local By road 15 Caspofungin - 0.2 MTPA 1 PnBo 0.318 0.0 0.318 Local By road 2 DMF 0.318 0.0 0.318 Local By road 3 CyCl2 0.064 0.0 0.064 Local By road 4 Ammonium acetate 0.229 0.0 0.229 Local By road 5 Catalyst 0.032 0.0 0.032 Local By road 6 Acetonitrile 21.975 0.0 21.975 Local By road

16 Micafungin - 0.93 MTPA 1 FR 901379 Nucleus 7.440 0.0 7.440 Local By road 2 Side Chain 5.580 0.0 5.580 Imported Sea 3 DMAP 6.045 0.0 6.045 Local By road 4 DMF 0.465 0.0 0.465 Local By road 5 Ethyl acetate 0.223 0.0 0.223 Local By road

17 Anidulafungin - 0.65 MTPA 1 Echinocandin Nucleus 0.975 0.0 0.975 Local By road

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EIA Report of Concord Biotech Ltd. 2-26

2 Side Chain 0.429 0.0 0.429 Imported Sea 3 KH2PO4 0.163 0.0 0.163 Local By road 4 Acetone 0.910 0.0 0.910 Local By road E Immunosuppressant

18 Tacrolimus - 1.0 MTPA 1 Dextrose 143.542 0.0 143.542 Local By road 2 Dextrin 229.167 0.0 229.167 Local By road 3 Milk 0.313 0.0 0.313 Local By road 4 CaCO3 2.396 0.0 2.396 Local By road 5 Soya Peptone 15.625 0.0 15.625 Local By road 6 Yeast extract 10.417 0.0 10.417 Local By road 7 Proteose peptone 0.313 0.0 0.313 Imported Sea 8 Sodium acetate 11.875 0.0 11.875 Local By road 9 PEG 400 5.938 0.0 5.938 Local By road 10 Citric acid 24.063 0.0 24.063 Local By road 11 Salt & minerals 4.167 0.0 4.167 Local By road 12 Toluene 208.333 0.0 208.333 Local By road 13 Acetone 2.083 0.0 2.083 Local By road 14 Ethyl acetate 2.083 0.0 2.083 Local By road 19 Mycophenolic Acid - 0.5 MTPA 1 Dextrose 9.444 0.0 9.444 Local By road 2 Glycine 0.611 0.0 0.611 Local By road 3 Methionone 0.024 0.0 0.024 Local By road 4 Salts and minerals 0.556 0.0 0.556 Local By road 5 IBA 1.250 0.0 1.250 Local By road 6 Activated carbon 0.025 0.0 0.025 Local By road

20 Cyclosporine - 7.0 MTPA 1 Dextrose 4.00 0.0 4.000 Local By road 2 Fructose 480.00 0.0 480.000 Local By road 3 Soyaflour 4.00 0.0 4.000 Local By road 4 L-valine 50.00 0.0 50.000 Local By road 5 L-leucine 40.00 0.0 40.000 Local By road 6 Corn steep liquor 0.70 0.0 0.700 Local By road 7 Salt & minerals 30.00 0.0 30.000 Local By road 8 Toluene 160.00 0.0 160.000 Local By road 9 Acetone 2.00 0.0 2.000 Local By road 10 Methanol 2.00 0.0 2.000 Local By road 11 Cyclohexane 2.00 0.0 2.000 Local By road 21 Rapamycin - 0.5 MTPA 1 Dextrose 7.50 5.000 12.500 Local By road 2 Dextrin 420.00 280.000 700.000 Local By road 3 Soyaflour 243.75 162.500 406.250 Local By road 4 CaCO3 5.63 3.745 9.375 Local By road 5 Soyapeptone 28.13 18.745 46.875 Local By road 6 Yeast Extract 0.75 0.500 1.250 Local By road 7 Proteose peptone 0.75 0.500 1.250 Local By road 8 NaCl 22.50 15.000 37.500 Local By road 9 Citric acid 18.75 12.500 31.250 Local By road 10 PEG 400 15.00 10.000 25.000 Local By road 11 Salts minerals 7.50 5.000 12.500 Local By road 12 Toluene 300.00 200.000 500.000 Local By road 13 Acetone 3.75 2.500 6.250 Local By road 14 Ethyl acetate 3.75 2.500 6.250 Local By road 22 MycophenolateMofetill&Mycophenolate sodium - 113.0 MTPA

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EIA Report of Concord Biotech Ltd. 2-27

(a) MycophenolateMofetil 1 IBA 48.000 72.533 120.533 Local By road 2 Xylene 36.000 54.400 90.400 Local By road 3 Dipyridyl carbonate 6.000 9.067 15.067 Local By road 4 Sodium bicarbonate 5 %sol 3.900 5.893 9.793 Local By road 5 Acetone 9.000 13.600 22.600 Local By road 6 Activated Carbon 3.000 4.533 7.533 Local By road Or (b) Mycophenolate Sodium 1 Acetone 20.833 31.482 52.315 Local By road 2 Sodium 2 Ethyl Hexanoic acid 25.000 37.778 62.778 Local By road F Oncology

23 Ixabepilone - 0.1 MTPA 1 Epothilone B 0.20 0.0 0.200 Imported Sea 2 Tetrabis (TPP) Palladium 0.001 0.0 0.001 Imported Sea 3 Sodium azide 0.038 0.0 0.038 Local By road 4 Triphenyl phosphine 0.10 0.0 0.100 Local By road 5 Diphenylphosphorylazide 0.03 0.0 0.030 Local By road 6 Ethyl acetate 0.50 0.0 0.500 Local By road

24 Romidepsin - 0.1 MTPA 1 Dextrose 1.000 0.0 1.000 Local By road 2 Glycerol 0.083 0.0 0.083 Local By road 3 Yeast extract 0.250 0.0 0.250 Local By road 4 Corn starch 0.200 0.0 0.200 Local By road 5 Ammonium Sulphate 0.008 0.0 0.008 Local By road 6 Magnesium sulphate 0.005 0.0 0.005 Local By road 7 Potassium Di Hydrogen

phosphate 0.042 0.0 0.042 Local By road

8 Sodium Chloride 0.050 0.0 0.050 Local By road 9 Isobutyl acetate 0.250 0.0 0.250 Local By road

25 Temsirolimus - 0.05 MTPA 1 Sirolimus 0.060 0.0 0.060 Local By road 2 Dichloromethane 0.064 0.0 0.064 Local By road 3 Side Chain 0.080 0.0 0.080 Imported Sea 4 DMAP 0.020 0.0 0.020 Local By road 5 Hydrochloric acid 0.010 0.0 0.010 Local By road 6 Tetrahydro furan 0.024 0.0 0.024 Local By road 7 n-Heptane 0.024 0.0 0.024 Local By road

26 Everolimus - 1.0 MTPA 1 Sirolimus 0.720 0.480 1.200 Local By road 2 Toluene 0.384 0.256 0.640 Local By road 3 2-(t-butyldimethylsilyl)

oxyethyltriflate) 0.480 0.320 0.800 Local By road

4 2,6-lutidine 0.300 0.200 0.500 Local By road 5 Methanol 0.156 0.104 0.260 Local By road 6 Formic acid 0.060 0.040 0.100 Local By road 7 Dichloromethane 0.480 0.320 0.800 Local By road 8 n-Heptane 0.210 0.140 0.350 Local By road

27 Ridaforolimus - 0.05 MTPA 1 Sirolimus 0.063 0.0 0.063 Local By road 2 Dimethyl PhosphonicChloride 0.019 0.0 0.019 Local By road 3 Pyridine 0.006 0.0 0.006 Local By road 4 Dichloromethane 0.063 0.0 0.063 Local By road 5 N-Hexane 0.035 0.0 0.035 Local By road 6 Sodium bicarbonate 0.025 0.0 0.025 Local By road

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EIA Report of Concord Biotech Ltd. 2-28

28 Pimecrolimus - 0.5 MTPA 1 Ascomycin 0.750 0.0 0.750 Local By road 2 Toluene 1.000 0.0 1.000 Local By road 3 Acetonitrile 0.675 0.0 0.675 Local By road 4 Trifloromethane sulfonic

anhydride 0.325

0.0 0.325

Local By road

5 Ethyldiisopropylamine 0.250 0.0 0.250 Local By road 6 Benzenetriethylammonim

chloride 1.000

0.0 1.000

Local By road

7 Acetone 0.675 0.0 0.675 Local By road 29 Doxorubicin - 0.85 MTPA 1 Bromodunarubicin 6.000 2.500 8.500 Imported Sea 2 Acetone 4.500 1.875 6.375 Local By road 3 Dichromethane 3.600 1.500 5.100 Local By road 4 Hydrobromic acid 0.750 0.313 1.063 Local By road

30 Daunorubicin - 0.6 MTPA 1 Yeast powder 2.592 0.864 3.456 Local By road 2 Soluble starch 1.800 0.6 2.400 Local By road 3 Yeast extract 0.540 0.18 0.720 Local By road 4 Sodium Chloride 0.360 0.12 0.480 Local By road 5 Calcium carbonate 0.540 0.18 0.720 Local By road 6 Mineral salt 0.216 0.072 0.288 Local By road 7 Oxalic acid 0.360 0.12 0.480 Local By road 8 Acetone 0.216 0.072 0.288 Local By road 9 Methanol 0.405 0.135 0.540 Local By road

31 Epirubicin - 0.2 MTPA 1 Epi-TFA daunorubicin 0.300 0.0 0.300 Imported Sea 2 Sodium hydroxide 0.040 0.0 0.040 Local By road 3 Dichloromethane 0.400 0.0 0.400 Local By road 4 n-Hexane 0.200 0.0 0.200 Local By road

32 Idarubicin - 0.1 MTPA 1 Corn Gluten 0.740 0.0 0.740 Local By road 2 Cotton seed meal 0.490 0.0 0.490 Local By road 3 Glucose 0.750 0.0 0.750 Local By road 4 Glycerol 0.750 0.0 0.750 Local By road 5 Yeast Extract 0.500 0.0 0.500 Local By road 6 Calcium Carbonate 0.200 0.0 0.200 Local By road 7 MIBK - Methyl isobutyl ketone 0.675 0.0 0.675 Local By road 8 Actonitrile 0.090 0.0 0.090 Local By road

33 Bleomycin - 0.1 MTPA 1 Starch 1.250 0.0 1.250 Local By road 2 Glucose 0.833 0.0 0.833 Local By road 3 Soyameal 1.250 0.0 1.250 Local By road 4 Di potassium hydrogen

phosphate 0.167

0.0 0.167

Local By road

5 Zinc Sulphate 0.083 0.0 0.083 Local By road 6 Copper sulphate 0.167 0.0 0.167 Local By road 7 Corn steep liquor 0.500 0.0 0.500 Local By road 8 Ethyl acetate 2.083 0.0 2.083 Local By road

34 Geldanamycin - 0.1 MTPA 1 Starch 1.667 0.0 1.667 Local By road 2 Cotton seed meal 0.417 0.0 0.417 Local By road 3 Glucose 0.417 0.0 0.417 Local By road 4 Corn steep liquor 0.833 0.0 0.833 Local By road

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EIA Report of Concord Biotech Ltd. 2-29

5 Yeast Extract 0.417 0.0 0.417 Local By road 6 Calcium Carbonate 0.167 0.0 0.167 Local By road 7 MIBK 0.208 0.0 0.208 Local By road 8 Ethyl acetate 0.125 0.0 0.125 Local By road

35 Mitomycin - 0.1 MTPA 1 Dextrose 0.0 0.900 0.900 Local By road 2 Starch 0.0 2.250 2.250 Local By road 3 Soyabean Flour 0.0 1.350 1.350 Local By road 4 Dry Yeast 0.0 0.225 0.225 Local By road 5 CaCO3 0.0 0.675 0.675 Local By road 6 Corn Steep Liquid 0.0 0.450 0.450 Local By road 7 Yeast Extarct 0.0 0.270 0.270 Local By road 8 K2HPO4 0.0 0.900 0.900 Local By road 9 MgSO4.7H2O 0.0 0.045 0.045 Local By road 10 Antifoam 0.0 0.045 0.045 Local By road 11 Phosphoric acid 0.0 0.050 0.050 Local By road 12 Ethyl acetate 0.0 0.400 0.400 Local By road 13 Methanol 0.0 0.550 0.550 Local By road 36 Dactinomycin - 0.1 MTPA 1 Dextrose 0.0 1.000 1.000 Local By road 2 Starch 0.0 1.750 1.750 Local By road 3 Soyabean Powder 0.0 1.000 1.000 Local By road 4 Dry Yeast 0.0 0.500 0.500 Local By road 5 CaCO3 0.0 0.250 0.250 Local By road 6 (NH4)2SO4 0.0 0.250 0.250 Local By road 7 Yeast Extract 0.0 0.250 0.250 Local By road 8 K2HPO4 0.0 0.050 0.050 Local By road 9 Antifoam 0.0 0.050 0.050 Local By road 10 Toluene 0.0 0.350 0.350 Local By road 11 Acetone 0.0 0.040 0.040 Local By road 12 Diisopropylether 0.0 0.010 0.010 Local By road 37 Trabectedin - 0.1 MTPA 1 Dextrose 0.0 1.200 1.200 Local By road 2 Manitol 0.0 2.400 2.400 Local By road 3 Yeast Extract 0.0 1.200 1.200 Local By road 4 (NH4)2SO4 0.0 0.600 0.600 Local By road 5 K2HPO4 0.0 0.240 0.240 Local By road 6 KCl 0.0 0.480 0.480 Local By road 7 FeCl3 0.0 0.001 0.001 Local By road 8 L-Glycine 0.0 0.060 0.060 Local By road 9 CaCO3 0.0 0.480 0.480 Local By road 10 PPG 2000 0.0 0.030 0.030 Local By road 11 Antifoam 0.0 0.120 0.120 Local By road 12 Sodium Hydroxide 0.0 0.010 0.010 Local By road 13 Ethyl acetate 0.0 0.400 0.400 Local By road 14 Methanol 0.0 0.040 0.040 Local By road 15 Acetonitrile 0.0 0.010 0.010 Local By road 16 Silver Nitrate 0.0 0.120 0.120 Local By road G Statin 38 Lovastatin - 6.0 MTPA 1 Dextrose 182.609 -26.087 156.522 Local By road 2 Sucrose 0.350 -0.05 0.300 Local By road 3 Milk 29.217 -4.174 25.043 Local By road 4 CaCO3 3.652 -0.522 3.130 Local By road

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EIA Report of Concord Biotech Ltd. 2-30

5 Soyabean flour 12.783 -1.826 10.957 Local By road 6 Yeast Extract 0.091 -0.013 0.078 Local By road 7 Preotease peptone 0.091 -0.013 0.078 Local By road 8 Sodium acetate 3.652 -0.522 3.130 Local By road 9 PEG 400 1.522 -0.218 1.304 Local By road 10 Citric acid 6.087 -0.87 5.217 Local By road 11 Salt & minerals 1.522 -0.218 1.304 Local By road 12 Toluene 41.391 -5.913 35.478 Local By road 13 IPA 1.217 -0.174 1.043 Local By road 14 Activated Carbon 0.335 -0.048 0.287 Local By road 39 Pravastatin - 1.0 MTPA 1 Dextrose 7.738 0.0 7.738 Local By road 2 Cotton seed meal 0.818 0.0 0.818 Local By road 3 NaCl 1.563 0.0 1.563 Local By road 4 CaCO3 0.744 0.0 0.744 Local By road 5 Soyabean flour 7.887 0.0 7.887 Local By road 6 Corn steep liquor 1.563 0.0 1.563 Local By road 7 Salt & minerals 0.372 0.0 0.372 Local By road 8 IBA 17.113 0.0 17.113 Local By road 9 IPA 0.372 0.0 0.372 Local By road 10 Acetonitrile 0.744 0.0 0.744 Local By road 11 Activated Carbon 0.104 0.0 0.104 Local By road 40 Orlistat - 2.0 MTPA 1 Glycerol 3.810 0.0 3.810 Local By road 2 Soya Floor 7.619 0.0 7.619 Local By road 3 Yeast Extract Powder 0.060 0.0 0.060 Local By road 4 Gluten Flour 1.667 0.0 1.667 Local By road 5 Sun Flower Oil 1.905 0.0 1.905 Local By road 6 ZnSO4 0.024 0.0 0.024 Local By road 7 Calcium Carbonate 0.024 0.0 0.024 Local By road 8 Vitamin C 0.030 0.0 0.030 Imported Sea 9 Vitamin E 0.030 0.0 0.030 Imported Sea 10 Catalyst 0.060 0.0 0.060 Imported Sea 11 n-Haptane 13.333 0.0 13.333 Local By road

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 2-31

Table 2.7

Details of water consumption &wastewater generation

Water consumption

Sr. No.

Usage Existing Water Consumption

(KLD)

Total Water Consumption after expansion (KLD)

1 Domestic 25 60

2 Gardening 190* 399*

3 Industrial i) Water treatment 90 08

ii) Process 60 125

iii) R & D 4.5 10

iv) Washing 50** 50

v) Cooling 40 168

vi) Boiler 130 135

Total Industrial 374.5 496 Total (I+II+III) 589.5 955

Less recycle 240 399 Actual fresh water

requirement 349.5 556

Source of water supply: Borewell

* Treated water utilize for greenbelt

** Reject from water treatment utilize for washing

Wastewater Generation

Sr. No.

Usage Existing wastewater Generation

(KLD)

Total w/w generation after

expansion (KLD)

1 Domestic 20 48

2 Industrial i) Water treatment 40 03

ii) Process 55 240

iii) R & D 04 08

iv) Washing 50 50

v) Cooling 20 40

vi) Boiler 21 10

Total Industrial 190 351 Total (I+II) 210 399

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 2-32

Table 2.8

Size and dimension of Effluent Treatment Plant

Sr. No.

Name of Unit MOC Capacity (m3)

Size Dimension (m)

Quantity

1 Collection Tank (01 No.) RCC 20.83 Dia.6.0 x 2.0 1

2 Oil & Grease Trap (01 No.) RCC 18.75 8.0 x 2.0 x 1.2 1

3 Chemical Storage Tank (01 No.)

RCC -- 6.0 x 6.0 1

4 Equalization cum Neutralization Tank (02 Nos.)

RCC 750 10 x 10 x 3.5 2

5 Equalization cum Neutralization Tank (02 Nos.)

RCC 300 7 x 7 x 3.5 2

6 Primary Clarifier (01 No.) RCC 140 Dia.8.0 x 3.0 1

7 Aeration Tank-1 RCC 2060 Dia.27 x 3.5 1

8 Aeration Tank-2 RCC 2000 Dia.20.5 x 5.5 1

9 Secondary Clarifier-1 RCC 70.65 Dia.6.0 x 2.5 1

10 Secondary Clarifier-2 RCC 70.65 Dia.6.0 x 2.5 1

11 Holding Tank (01 No.) RCC 31.40 Dia.4.0 x 25 1

12 Sand Filter (01 No.) MS -- Dia.1.5 x 2.0 1

13 Sludge Drying Beds (14 Nos.)

RCC -- 8.0 x 8.0 14

14 Sludge Storage Area Brick work

-- 15.0 x 4.0 -

15 Chemical Solution tank RCC - 2 x 2 x 1.25 3

16 Chemical Solution tank RCC - 2 x 2 x 1.25 3

17 Chemical Store room RCC - 3 x 5 1

18 Decanter 1 Standard supply

- 300 kg/hr. 1

19 Decanter 2 Standard supply

- 450 kg/hr. 1

20 Sludge Dryer Standard supply

- 500 kg/hr. 1

21 Mechanical Vapor Recompression Evaporation

Standard supply

- 100 kl/d 1

22 Crystallizer Standard supply

10 KL/day 1

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EIA Report of Concord Biotech Ltd. 2-33

Table 2.9

Characteristics of untreated and treated effluent

Sr.

No.

Parameters Characteristics

Before treatment

After treatment

1 pH 7.1 7.6

2 TDS (mg/L) 4295 2051

3 SS (mg/L) 237 62

4 COD (mg/L) 6249 242

5 BOD (mg/L) 3492 94

6 O&G (mg/L) 20.2 5.2

7 Sulphate (mg/L) 1083 529

8 Chloride (mg/L) 798 567

9 Phenolic Compound (mg/L) 0.9 0.37

10 Ammonical Nitrogen (mg/L) 81.7 36.2

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 2-34

Table 2.10

Technical specification of MVRE/crystallizer

Sr. No. Details Specification

Polymeric Film Evaporation System (PFET) (100 m3/Day) 1 PFET FEED PUMP

Quantity 2 No. (1W+1S)

Capacity 4.2 M3/Hr.

Head 2.5 Kg/cm2

Type Centrifugal

MOC Casing CI/Impeller SS 316

2 PRE HEAT EXCHANGER

Quantity 1 No.

Type Plate Heat Exchanger

MOC SS 316

3 EVAPORATOR VESSEL

Quantity 1 No.

Diameter DDE

Length DDE

MOC MSEP

Polymeric H.E. Provided

4 PFET CIRCULATION PUMP

Quantity 1 No.

Capacity 240 m3/hr.

Type Centrifugal

MOC Casing CI/Impeller SS 316

5 CONDENSER

Quantity 1 No.

Type Plate Heat Exchanger

MOC SS 304 (plates)

6 CONDENSATE TANK Quantity 1 No.

Diameter 0.7 m

Height 2.0 m

MOC MSEP

7 CONDENSATE PUMP

Quantity 2 No. (1W+1S)

Capacity 3.8 m3/hr.

Head 2.5 Kg/cm2

Type Centrifugal (Low NPSH)

MOC Casing CI/Impeller SS 316

8 CONCENTRATE PUMP

Quantity 2 No. (1W+1S)

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 2-35

Capacity 0.7 m3/hr.

Head 2.5 Kg/cm2

Type Centrifugal (Low NPSH)

MOC Casing CI / Impeller SS 316

9 QUENCH PUMP

Quantity 2 No. (1W+1S)

Capacity 2 m3/Hr.

Type Centrifugal

10 QUENCH WATER STORAGE TANK

Quantity 1 No.

MOC HDPE

11 VACUUM PUMP

Quantity 2 No. (1W+1S)

Type Water Ring

MOC CI / SS 304 wetted parts

12 PFET FAN

Quantity 1 No.

Type Centrifugal

Capacity DDE

Head 300 mm of water column

CRYSTALLIZER SYSTEM (10 M3/DAY)

1 Quantity 1 No.

2 Type Single Effect

3 MOC of Wetted Part SS 316

4 Feed Flow 10 KLD

5 Operating hrs. 20

 

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 2-36

Table 2.11

Technical specification of Sludge Dryer

Sr. No.

Specification Details

1. Specification of Feed & Product

a) Material ETP-Sludge b) Nature Wet Cake c) Feed Rate 500 Kg/hr d) Feed temperature 30 oC e) Solvent Evaporated Water f) Moisture Content in Feed 85% (w/b) g) Moisture Content in Product 20% (w/b) h) Product Rate 94 kg/hr (From Dryer Outlet) i) Evaporation Load 406 kg/hr j) Bulk Density 1,000 Kg/m3 (Assumed) k) Specific Heat 0.40 kcal/kg oC (Assumed) l) Product Temperature ~105 oC

2. Utilities

a) Supply Characteristics Power: 415 V, 3 Phase, 50 Hz 4 wire connection

b) Area classification Control: 110 V; 1 Phase: 50 Hz Safe

c) Steam Inlet Pressure @ 7 bar (g), Temperature: 170oC

Consumption: 610 kg/hr. d) Make up water/Treated ETP water Temperature: 30- 40 oC

Consumption: 1-2 m3/hr. (max)

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EIA Report of Concord Biotech Ltd. 2-37

Table 2.12

Details of stacks

Sr. No.

Stack attached to

Stack Height

(m)

Fuel used

Fuel consumption rate

APC measure

Probable Pollutants

Existing After expansion

Existing 1 Steam Boiler

(2 nos.- one stand by)

45 Furnace oil

820 kg/hr.

1100 kg/hr.

-- PM<150 mg/NM3

SO2<100 ppm

NOx<50 ppm 2 D.G. Set

(1000 kVA) 30 HSD 65 lit/hr. 65 lit/hr. Acoustic

enclosure

3 D.G. Set (680 kVA)*

HSD 50 lit/hr. 50 lit/hr.

Proposed 1 D.G.Set

(1000 kVA x 3 nos.)

30 HSD -- 250 lit/ltr. each

Acoustic enclosure

PM<150 mg/NM3

SO2<100 ppm

NOx<50 ppm

* D G set of 680 kVA will be dismantled after expansion.

Note:There will be no additional flue gas stack, except stack of stand by D. G. Set.

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 2-38

Table 2.13

Existing/Estimated Air emission Quality

Sr. No.

Stack attached to

Stack Temp. (0K)

Velocity (m/s)

Stack Height

(m)

Dia. (m)

Fuel Used

SPM mg/ Nm3

SO2

mg/ Nm3

NOX

mg/ Nm3

Existing performance of air emission 1 Steam Boiler

(2 nos.- one stand by)

448 7.9 45 0.8 Furnace Oil

78 32.0 28.2

2 D.G. Set (1000 kVA)

468 15.5 30 0.4 HSD 72 27.4 32.5

Estimated air emission of proposed stacks 1 DG set (1000

kVA x 3 nos.) 470 16.0 30 0.4 HSD 75 30.0 35.0

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 2-39

Table 2.14

Source of Fuel

Name of Fuel

Source Distance from plant site

Mode of transportation

Furnace oil Reliance Industries Ltd.

Within 293 km from plant site

Road Tanker transport

HSD IN DRUM HSD Local Supplier Within 5.4 km from plant site

Table 2.14(a)

Fuel Analysis

Furnace Oil (RFO MVG-1)

Parameters Characteristics

Ash content (%) 0.038

G.C.V (kcal/kg) 10077

Density at 150C (kg/m3) 1009

Flash Point (PMCC) (0C) 114

Total Sulphur (%) 2.1

Water content (% vol) 0.1

Kinetic Viscosity at 500C (cSt) 133.0

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 2-40

Table 2.15

Technical specification of Boiler

Sr. No.

Description Unit Specifications

1 Capacity kg/hr. 8000

2 Design Pressure kg/cm2g 10.54/17.5

3 Efficiency

a) Furnace Oil % 89 (without HRU) 92 (with APH)

4 Fuel - Furnace oil

5 Fuel firing system Pressure Jet, Dual block

6 Fuel Consumption - Without HRU/With HRU

a) Furnace oil kg/hr. 503/487

7 Connected Electrical Load – Furnace oil (With APH)

kW 50/59

8 Chimney Top Diameter mm 700

9 Dry weight (10.54/17.5) Tonne 15/19

10 Flooded weight (10.54/17.5) Tonne 30.8/34.5

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 2-41

Table 2.16

Details of Hazardous Waste

Sr. No.

Type of Solid

Waste

As per HWM Rules, 2016

Quantity (MTPM) Disposal method Existing Proposed Total

1 ETP Sludge& MEE salt

35.3 60.0

50.0 + 27.0 (MEE

salt)

137.0 Collection, Storage, decontamination, Transportation, Disposal at SEPPL-TSDF site Kutch.

2 Distillation residue

20.3 12.00 8.0 20.0 Collection, Storage, decontamination, Transportation, Disposal by Incineration at CHWIF of SEPPL-Kutch. Or Co-process at RSPL-Panoli

3 Spent Carbon

28.3 7.234 4.766 12.0 Collection, Storage, decontamination, Transportation, Disposal by Incineration at CHWIP of SEPPL-Kutch Or Co-process at RSPL-Panoli/Co-processing at Ambuja Cement Ltd.

4 Discarded Container

33.1 3000 Nos./ month

2000 Nos./mon

th

5000 Nos./ month

Collection, Storage, decontamination, Transportation, Disposal by selling to authorized recycler or reuse.

5 Used oil -- 1.596 MT/yr.

1.404 MT/yr.

3.00 MT/yr.

Collection, storage, transportation, disposal by selling registered recycler.

6 Off specification Product & date expire product

28.4 & 28.5

-- Whatever generated

Whatever generated

Collection, Storage, decontamination, Transportation, Disposal of SEPPL-Kutch or Co-process at RSPL-Panoli.

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 2-42

Table 2.17

Estimated Characteristics of Hazardous waste

S. No.

Parameters Unit Result (ETP Sludge)

AS IS BASIS 1. Moisture (%) - 20.4

2. Ether Soluble gm/Kg 0.96

3. TIS at 5500C gm/Kg 655

WATER LEACHATE (10% Solution in Distilled Water) 1. pH pH Unit 7.5

2. Sulphate gm/Kg 11.3

3. Chloride gm/Kg 10.5

4. Total Alkalinity gm/Kg 6.8

5. Total Dissolved Solid gm/Kg 27.1

6. COD gm/Kg 5.9

7. Iron gm/Kg 1.12

8. Total Chromium gm/Kg <0.01

9. Hexavalent Chromium gm/Kg <0.01

10. Total Nitrogen (as N) % 5.42

11. Total Phosphate (as P2O5) % 4.29

ACID LEACHATE 1. Iron gm/Kg 41.3

2. Total Chromium gm/Kg <0.01

3. Hexavalent Chromium gm/Kg <0.01

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EIA Report of Concord Biotech Ltd. 2-43

Figure 2.1

Water Balance Diagram (Existing)

Total Water Consumption = 589.5 KLD (fresh water - 349.5 KLD + Recycle water – 240 KLD)

Industrial 324.5

Domestic 25

Soak pit 20

Water treatment 324.5

Reject 90

Water used 234.5

Washing 50

Process 60

Boiler 130

Cooling 40

ETP 55+4+21+20+40+50 = 190

Bleed off 20

50

55

R & D 4.5

4.0

21

40

50

Used for Greenbelt development within

premises

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 2-44

Figure 2.2 Water Balance Diagram (after expansion)

Total Water Consumption – 955 KLD (fresh water - 556 KLD + Recycle water – 399 KLD)

Industrial 496

Domestic 60

Process 125

Boiler 135

ETP 48+240+8+10+50+40+3 = 399

240

R & D 10

8.0

Water treatment (DM/softener) 43

48

Direct steam inject 120

Indirect heating

10

Greenbelt (total greenbelt area 85000 sqm)

Water treatment (1st stage RO) 453

Reject (2st stage RO) 133

Product water 320

Permeate 80

Reject 53

Blow down

Washing 50

50

MVR/MEE 53

Condensate 48

Salt 0.9

Loss 4.1

Cooling 80+48+40

= 168

40

Blow down Bleed off 40

3

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 2-45

Figure 2.3

ETP flow Diagram

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 2-46

Figure 2.4

Schematic Diagram of Solvent Recovery System

 

Addition Tank 

  

 

Reaction Vessel 

 

Distillation Colum 

 

   

 

Receiving Tank 

Chillcondenser 

Chillcondenser 

Spent Solvent  

Aquarius Layer   

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EIA Report of Concord Biotech Ltd. 2-47

Figure 2.5 Plant Layout

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EIA Report of Concord Biotech Ltd. 3-1

Chapter-3 Description of Environment

3.1 GENERAL

To assess environmental impacts from proposed project at a specific

location, it is essential to monitor the existing environmental quality

prevailing in the surrounding area prior to implementation of the project.

The environmental status within the impact zone could be used for

identification of significant environmental issues to be addressed in the

impact assessment study. Baseline data generation forms a part of the

Environmental Impact Assessment (EIA) study and helps to evaluate the

predicted impacts on the various environmental attributes in the study

area by using scientifically developed and widely accepted impact

assessment methodologies.

This section contains the description of baseline studies of 10 km radius

surrounding the project site. The baseline study was carried out to

understand following environmental parameters.

• Land Environment

• Meteorology

• Air Environment

• Water Environment

• Soil Environment

• Noise Environment

• Biological Environment

• Socio-economic Environment

The data collected has been used to understand the existing environment

scenario around the project site against which the potential impacts of

the proposed project can be assessed.

3.2 STUDY AREA

The unit is located at Plot No. 1482-1486, Trasad Road, Taluka: Dholka,

Dist.: Ahmedabad, Gujarat. An area of 10 km radius from the boundary

of the project site is considered as study area for the EIA study as per the

TOR issued by MoEF&CC.

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EIA Report of Concord Biotech Ltd. 3-2

Table 3.1 Environmental setting of the study area

1. General Particular i) Latitude 22°41'59.55" N ii) Longitude 72°26'48.63" E iii) Taluka Dholka iv) District Ahmedabad

2. Site specific details i) Nearest village Trasad (2.3 km) ii) Nearest City Ahmedabad (38.0 km) iii) National Highway/

State Highway SH (Dholka-Vataman) – 1.3 km NH 8A (A’bad-Rajkot) - 15.0 km

iv) Nearest Railway Station Dholka (3.85 km) v) Sanctuary/National park None within 10 km radius

3.3 STUDY PERIOD

Baseline environmental quality represents the background scenario of

various environmental components. As part of EIA study, baseline

environmental monitoring was done over a radial distance of 10 km

around the project site during the period of Mar, 2016 to May, 2016.

3.4 SOURCE OF ENVIRONMENTAL DATA GENERATION

Baseline information on micrometeorology, ambient air quality, water

quality, noise level, soil quality and ecology (flora-fauna) are generated

by M/s. San Envirotech Pvt. Ltd., an Environment Consultants,

Ahmedabad. Apart from these, secondary data have been collected from

census book, revenue records, soil survey and forest department,

meteorological department etc. The generation of primary as well as

collection of secondary data &information from the site and surrounding

was carried out during the period of Mar, 2016 to May,2016.

3.5 METHODOLOGY

The process & methodology adopted for various environmental attributes

in the study is as follows:

To assess the Air environment in the study area, monitoring of the Air

quality was done by setting up reconnaissance. The samples were

collected by installation of Respirable Dust Sampler (RDS) Sampler

(with gaseous attachment & FPS facility) at different locations for

monitoring of primary air pollutants to work out the existing status of

air quality.

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EIA Report of Concord Biotech Ltd. 3-3

Ground water samples& surface water samples were analyzed for the

parameters necessary to determine water quality (based on IS:

10500-2012 criteria) and those which are relevant from the point of

view of environmental impacts of the project site.

Soil samples were collected using an Auger and analyzed for relevant

physico-chemical characteristics in order to assess the impact on soil.

The noise level monitoring was done at various locations at different

intervals of time with the help of sound level meter.

Socio-economic data was collected from field studies and secondary

sources like Census of India 2011, Revenue record, etc.

3.6 LAND ENVIRONMENT

Land Cover is the physical material at the surface of the earth (includes

grass, trees, bare ground, water etc.); whereas Land use is the human

use of land. Studies on land use aspects of eco-system play an important

role in identifying susceptible issues and to take appropriate action to

uphold ecological equilibrium in the region. Main objective is to provide a

baseline status of the study area so that temporal changes due to the

proposed activities on the surroundings can be assessed in future.

3.6.1 Land use pattern of the Study Area

The study area of 10-km around the project site is considered in the land

use pattern study. The term land-use indicates the way in which the land

is utilized for different purposes. The land-use distribution of the study

area is given in Table 3.2.Land-use map is given in Figure 3.12.

Table 3.2 Land use statistics work out based on satellite imaginary

Sr. No.

Level 1 Level 2 Area (Sq. km.)

Area in %

1 Built-up Land Residential/Commercial 18.655 5.938 Industrial

2 Agricultural Land

Crop Lands 260.360 82.88 Fallow Land Plantations

3 Vegetation Cover

Scrub 23.090 7.35 Open vegetation Close vegetation

4 Wastelands Salt-Affected Land 8.410 2.677 Waterlogged Land Marshy/Mud Land Area

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EIA Report of Concord Biotech Ltd. 3-4

Land without Scrub Sandy Area

5 Water Bodies Reservoir/Lakes/Ponds 3.628 1.155 River Beds

Total 314.143 100 3.6.2 Objective of Land Use Studies

The objectives of land use studies are:

• To develop land use & land cover map using land coordinates of the

project area.

• To identify and mark important basic features according primary

and secondary data.

• To suggest measures for conservation and sustainable use of land.

3.6.3 Topography

The site area is plain with little undulating at few places. Agriculture and

allied activities are most predominant in this area. Fallow land and barren

lands were less observed near project site. There was no any Eco Fragile

Zone or Natural Forest near project site in study area.

3.6.4 Seismicity of the area

The project site falls under seismic zone III which is a moderate damage

corresponding toMSK intensity VII. The Seismic Zone Map of Gujarat is

given below Figure 3.1.

Figure 3.1 Seismic zone map of Gujarat

3.7 METEOROLOGY

Meteorology is the key to understand the air quality. Wind fluctuations

over a very wide range of time, accomplish dispersion and strongly

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EIA Report of Concord Biotech Ltd. 3-5

influence other processes associated with them. The micrometeorological

conditions at the project site will be regulating the transport and diffusion

of air pollutants released into the atmosphere.

3.7.1 IMD meteorological data

Wind data generated at site were also compared with the climatological

data obtained from the closest Indian Meteorological Department (IMD)

station at Ahmedabad. Predominant month wise wind directions recorded

at IMD Ahmedabad is given in Table 3.3 & average meteorological

condition recorded at IMD Ahmedabad is given in Table 3.4.

Table 3.3 Predominant Month-wise Wind Directions at IMD Ahmedabad

Month Predominant Wind First Second Third

Morning Evening Morning Evening Morning Evening January E N NE NW N NE February E/NE NW NW N N W March NW NW W W NNW SW April NW NW W W NNW SW May W W NW SW SW NW June SW SW W S S W July SW SW W W S S August SW SW W W NW S September NW SW W W SW NW October NW NW E N N NE November E N NE E N NE December E N NE E N NE/NW

Table 3.4 Average Meteorological Condition at IMD Ahmedabad

Month Mean Daily Temperature

Rainfall (mm)

Monthly Total

No. of Rainy days

Relative Humidity

(%), (Morning)

Relative Humidity

(%), (Evening)

Max Min

January 28.3 11.9 1.8 0.2 59 32 February 30.9 14.0 1.1 0.1 53 25 March 35.8 18.9 1.0 0.1 49 20 April 39.8 23.5 2.7 0.2 54 20 May 41.7 26.2 7.1 0.7 65 23 June 38.5 27.1 98.7 4.2 74 45 July 33.4 25.6 262.3 11.2 85 67 August 31.9 24.7 239.6 11.2 85 67 September 33.7 24.2 108.9 5.3 82 58 October 36.0 21.0 16.2 0.4 64 37 November 33.1 16.6 11.5 0.6 55 35 December 29.6 13.2 3.8 0.2 60 35

Total -- -- 762.7 34.0 -- -- Average 34.4 20.6 - - 66 39

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EIA Report of Concord Biotech Ltd. 3-6

3.7.2 Site specific micro-meteorological data

The data on surface meteorological parameters in the study area were

collected from Mar, 2016 toMay, 2016, by setting up portable weather

monitoring station placed at project site. The sensor of the equipment

was kept at sufficient height (about 10 m) from ground level with free

exposure to the atmosphere. The monitoring methodology is given in

Table 3.5 &data collected are presented in Table 3.6. The following

parameters were recorded at hourly intervals during monitoring period:

• Wind speed & Wind direction

• Temperature

• Relative humidity

• Rainfall

Table 3.5: Monitoring Methodology of Meteorological Data

S. No.

Sampling Parameters

Sample Collection Total Sampling

Period

Sampling Frequency

Methodology Sampling

Equipment Sensitivity/ Detection

Limit 1 Wind Speed Anemometer

cup counter (0 to 65 m/s)

0.25 m/s March to May,2016

Hourly As per manufacturer’s manual, Instruments are Calibrated

2 Wind Direction

Wind vane (0° to 357°)

10

3 Temperature Thermometer (-40° to 60°)

0.10C

4 Humidity Thermometer (-40° to 60°)

3%

5 Rainfall Rain gauge 0.5 mm 6 Cloud Cover -- -- 4 Hourly Visual

Inspection by the observer

Table 3.6: Meteorological Data for the Monitoring Period (Mar, 2016 to May, 2016)

Month Wind speed (km/hr.)

Pre dominant wind

direction

Temp. (0C)

Relative Humidity

(%)

Rain fall (mm)

Max Min Max Min Max Min 24 hrs. highest

No. of rainy days

Mar, 16 27.37 0 WNW 46 23 65 4 No rainfall during the study period April, 16 28.98 3.22 WNW 45 25 61 2

May, 16 33.81 4.83 SW 48 29 70 9 Average 15.02 WNW 35.46 28.65 --

3.7.2.1 Wind Rose

Wind rose is the diagrammatic representation of wind speed in a specified

direction with its arms representing sixteen directions, each arms give a

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EIA Report of Concord Biotech Ltd. 3-7

clear frequency distribution of wind speed in a particular direction for a

given period of time. It is one of the most important meteorological

parameters and governs dispersion, diffusion & transportation of

pollutants.The % frequencies of wind in 16 directions have been

computed from the recorded data during the study period for 24-hourly

intervals to plot wind rose. The predominant wind direction during the

study period is observed to be blowing from WNW to ESE. Calm wind

during this period is 7.43%. The summary of wind frequency distribution

is given in below table. Wind rose diagram is shown as Figure 3.8.

Table 3.7 Frequency Distribution Chart (%) (Mar-16 to May-16)

Sr. No.

Direction Wind speed (km/hr.) From 1 - 5 6 - 10 11 - 15 16 - 20 21-25 26-30

1 N 0 27 21 0 0 0

2 NNE 3 22 12 0 0 0

3 NE 6 6 18 6 3 0

4 ENE 0 0 9 3 3 0

5 E 0 0 0 9 0 0

6 ESE 0 3 3 0 0 0

7 SE 0 0 0 0 0 0

8 SSE 0 0 0 0 0 0

9 S 0 3 9 9 8 1

10 SSW 0 9 21 36 54 3

11 SW 0 38 75 86 64 0

12 WSW 9 54 90 96 60 0

13 W 11 82 123 72 21 0

14 WNW 6 134 154 111 18 0

15 NW 6 63 128 64 9 0

16 NNW 7 54 75 24 3 0

Total (%) 2.17 22.42 33.42 23.37 11.01 0.18

Calm 7.43%

3.8 AMBIENT AIR QUALITY

3.8.1 Introduction

To quantify the impact of the proposed project on the ambient air quality,

it is necessary to evaluate the existing ambient air quality of the area.

The ambient air quality monitoring with respect to the study area of 10

km radius around the project site was done for the baseline information.

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3.8.2 Design Network for Ambient Air Quality Monitoring Stations

The baseline status of the ambient air quality has been assessed through

a scientifically designed ambient air quality monitoring network. The

design of monitoring network is based on the following considerations:

Topography/Terrain of the study area

Populated areas within the region

Prediction of maximum concentrations and distances of their likely

occurrence under prevailing meteorological conditions

Representation of regional background

Representatives of likely impact areas

Ambient Air Quality Monitoring (AAQM) stations were placed at eight

locations with due consideration to the above mentioned points.

3.8.3 Reconnaissance

Reconnaissance was undertaken to establish the baseline status of air

environment in the study region. The prime objective of the NAAQ

survey, within 10 km radial study area around the proposed project, was

to establish the existing ambient air quality levels. The monitoring

locations (relative directions and distances) are given in Table 3.15&

shown in Figure 3.7and results are given in Table 3.16 to 3.21.

3.8.4 Parameters, Frequency and monitoring Methodology

The existing ambient air quality, in terms of Particulate Matter-10 (PM10),

Particulate Matter-2.5 (PM2.5), Sulphur Dioxide (SO2), Oxides of Nitrogen

(NOx), CarbonMonoxide (CO), Hydro Carbon (HCs)& Volatile Organic

Compound (VOC) has been measured. It was ensured that, the

equipment was placed at open space free from any obstacles at a height

of at least 3 to 4 m above the ground level at each monitoring station to

avoid the effects of wind-blown ground dust. Monitoring has been carried

out as per the latest CPCB and MoEF&CC guidelines and notifications.

Details of methodology are given in Table 3.8.

Table 3.8 Methodology of Ambient Air Monitoring

Sampling Parameters

Instrument used

Analytical equipment

Sensitivity/ DetectionLimit

Test method

PM10 RDS (Respirable Dust Sampler)

Electronic Balance

1 μg/m3 Gravimetric IS: 5182 (Part 23) 2006

PM2.5 FPM (Fine Electronic 1 μg/m3 Gravimetric

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Particulate Sampler) APM 550

Balance CPCB Guidelines for Ambient Air Monitoring

SO2 Gaseous flow attachment with RDS sampler

Spectro Photometer

1.7 μg/m3 Colorimetric IS: 5182: (Part II) 2001

NOx Gaseous flow attachment with RDS sampler

Spectro Photometer

0.5 μg/m3 Colorimetric IS: 5182: (Part VI) 2006

CO CO Analyzer/ GC

Bladder & Pump

1145 μg/m3 Sensor/GC method(IS: 5182: Part 10)

HC GC Bladder & Pump

1 ppm Gas Chromatography

VOC GC Bladder & Pump

0.01 ppm Gas Chromatography

The duration of sampling of PM2.5, PM10, SO2& NOx was 24-hourly

continuous sampling per day and CO, HCs& VOC was sampled for 8-hours

duration. The monitoring was done for twice a week for three months.

Parameters and frequency of sampling is giveninTable 3.9.

Table 3.9 Monitored Parameters and Frequency of Sampling

Parameters Sampling frequency Fine Particulate Matter (PM2.5) 24 hourly sample twice a week for three

months

Respirable Particulate Matter (PM10) 24 hourly sample twice a week for three months

Sulphur dioxide (SO2) 24 hourly sample twice a week for three months

Oxides of Nitrogen (NOx) 24 hourly sample twice a week for three months

Carbon Monoxide (CO) 8 hourly sampling

Hydro Carbon (HC) 8 hourly sampling

Volatile Organic Compound (VOC) 8 hourly sampling

3.8.5 Interpretation of result

The existing baseline levels with respect to PM10, PM2.5, SO2,NOXare

tabulated in Tables 3.17 to 3.20& chart is given as figure 3.3 to 3.6.

Particulate Matter (PM10)

An average and 98th percentile value of 24-hourly PM10 values at all the

locations are found from 58.9-70.0μg/m3 and 65.4-73.0μg/m3. The results

were found well within the National Ambient Air Quality Standards

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(NAAQS-CPCB) of 100 μg/m3 and have negligible adverse impact by

proposed project activities.

Particulate Matter (PM2.5)

An average and 98th percentile value of 24-hourly PM2.5 values at all the

locations ranges from 35.1-42.8μg/m3 and 39.5-47.9μg/m3. The values are

well within National Ambient Air Quality Standards (NAAQS-CPCB) of 60

μg/m3 and have negligible adverse impact by proposed project activities.

Sulphur Dioxide (SO2)

An average and 98th percentile value of 24-hourly SO2 value of arithmetic

mean at all the locations ranged from 16.5-22.1μg/m3 and 19.8-

28.3μg/m3 respectively, which are well below National Ambient Air

Quality Standards (NAAQS-CPCB) of 80 μg/m3 and have negligible

adverse impact by proposed project activities.

Oxides of Nitrogen (NOx)

An average and 98th percentile value of 24 hourly NOx value of arithmetic

mean at all the locations ranged from 19.3-25.1μg/m3 and 23.2-

30.7μg/m3 respectively, which are well below the National Ambient Air

Quality Standards (NAAQS-CPCB) of 80 μg/m3 and have negligible

adverse impact by proposed project activities.

3.9 WATER ENVIRONMENT

3.9.1 Hydro-Geology of the Study Area

Geology of study area

Geologically the area consists of Quaternary alluvium with a few sporadic

outcrops of Deccan Trap and Limestone toward the southern parts of

region. The geological set up of the area is somewhat similar to that of

Cambay Basin. The south west area viz. Part of Barvada, Ranpur and

Dhandhuka is made up of Basalt Rock. While rest area of the district is

consist of alluvial formation. This is made up of alternate beds of Clay

and Sand.

Hydrogeology of study area

Geohydrologically, major parts of the district consist of alluvial

formation.Alluvial formation is made up of Sand, clay, kankers, silt and

gravels. In thisformation water is available under confined and

unconfined conditions.Remaining area is made up of Basalt. This is very

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poor in ground wateravailability and yield. Sufficient discharge is available

from alluvial formation.Thickness of Alluvium in north- west part of the

area is more. Average depth oftube-well in eastern part ranges from 90-

120 mts and in north- west part it is350 to 400 Mts.Generally water

supply schemes of Ahmedabad district are based on deep tubewells.Due

to heavy drilling activity and over extraction of ground water sincelast

two decades, there is a sharp decline in water levels and in the quality

ofwater.From the observation and study of the relevant information of

GWRDC Tube Wells in and around the study area it is inferred that

In and around the study area ground water occurs in Alluvium aquifers

which comprises of alternate beds of sand, clay, kankar mixed with

clay are occurring in this area.

The thickness and extent of this aquifer vary with respect to space and

depth.

In this area ground water occurs in the zone of primary porosity. The

quantity of ground water stored in the aquifer depends on the grain

size of the aquifer material, its hydraulic characteristics and thickness.

Ground water is mainly occurring under unconfined shallow confined,

deep confined or more precisely semi-confined conditions.

From the above observations, of GWRDC tube well data it is observed that

Ground water occursunder confined or more precisely semi-confined

conditions.

3.10 WATER QUALITY

3.10.1 Introduction

Water quality assessment is one of the essential components of EIA

study. Such assessment helps in evaluating the existing health of water

body and suggesting appropriate mitigation measures to minimize the

potential impact from development projects. The water quality at the site

and other locations within the 10-km impact zone was monitored during

the study period.The purpose of the study is to:

• Assess the water quality characteristics for critical parameters;

• Evaluate the impact on agricultural productivity, habitat conditions

recreational resources and aesthetics in the vicinity; and

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• Predict the likely impacts on water quality due to the project and

related activities.

Reconnaissance survey was undertaken and monitoring locations were

finalized based on:

• Location of residential areas representing different activities/likely

impact areas; and

• Likely areas, which can represent baseline conditions.

3.10.2 Sampling Frequency, Techniques & Methodology

Five surface water and eight groundwater samples were collected during

the study period. Ground water samples were collected from the existing

bore wells, while surface water was collected from ponds/river by surface

water sampler. These samples were taken as grab samples.Necessary

precautions were taken for preservation of samples.Sampling locations

with source & date of sampling is given in Table 3.10.

The samples collection procedure was adopted from ‘Standard Methods’

for the examination of Water and Wastewater published by American

Public Health Association (APHA) and IS 10500-2012.The samples were

analyzed for Physico-chemical parameters to assess the existing water

quality of the area (based on IS: 10500-2012&APHA/AWWA, 22nd

edition). The water sampling locations marked within the study area and

the result of the analysis (ground water and surface water) is presented

in the Figure 3.9&Table 3.23 &3.24 respectively.

Table 3.10 Sampling locations with source & date of sampling

Ground Water Sampling Locations

Sample Code

Location Date of Sampling

Source Taluka District

GW1 Project site 25/04/16 Bore well Dholka Ahmedabad

GW2 Khanpur 25/04/16 Bore well Dholka Ahmedabad

GW3 Lana 25/04/16 Bore well Dholka Ahmedabad

GW4 Mujpur 25/04/16 Bore well Dholka Ahmedabad

GW5 Rampur 26/04/16 Bore well Dholka Ahmedabad

GW6 Andhari 26/04/16 Bore well Dholka Ahmedabad

GW7 Sathal 26/04/16 Bore well Dholka Ahmedabad

GW8 Paldi 27/04/16 Bore well Dholka Ahmedabad

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Surface Water Sampling Locations

Sample Code

Location Date of Sampling

Source Taluka District

SW1 Nesda 25/04/16 Pond Dholka Ahmedabad

SW2 Dholka 26/04/16 Pond Dholka Ahmedabad

SW3 Sabarmati 26/04/16 River Dholka Ahmedabad

SW4 Sathal 26/04/16 Pond Dholka Ahmedabad

SW5 Paldi 27/04/16 Pond Dholka Ahmedabad

3.10.3 Surface Water Quality (Primary data)

Surface water samples were collected from ponds of Dholka, Paldi,

Nesda, Sathal&River Sabarmati. Analysis of the same is given in Table

3.24.The results have been compared with the drinking water quality

standards specified in IS: 10500-2012. It was observed that all the

physico chemical parameters and heavy metals from surface water

samples are below stipulated drinking water standards& it is suitable for

drinking and other purposes.

3.10.4 Ground Water Quality

Groundwater is one of the sources of drinking water in the area. Besides,

it is an important source of water for the agricultural and the industrial

sector. The results of the ground water quality monitored during the

study period are given in Table 3.23.

3.10.5 Interpretation

The samples were taken as grab samples and analyzed for various

parameters of ground water. Sampling location is shown in Figure

3.9.The results are shown in Table 3.23.

Color: All the samples were found color less meeting desirable norms.

pH: All the samples meet the desirable standards (pH ranges from 7.54

to 7.92).

Total Dissolved Solids (TDS):TDS in samples ranges from 985 mg/L

(Lana) to 1659 mg/L (Project Site). All the samples meet the permissible

limit of 2000 mg/L, (If alternate sources of potable water are not

available).

Calcium: Calcium contents in the water ranges from 69 mg/L (Lana) to

189 mg/L (Project Site), all the samples meet the permissible limit of 200

mg/L, (If alternate sources of potable water is not available).

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Magnesium: Magnesium content in the water ranges from 53 mg/L

(Paldi) to 98 mg/L (Project Site). All the samples meet the permissible

limit of 100 mg/L (if alternate source of potable water in not available).

Sulfate: Sulfate content in the water ranges from 82 mg/L (Lana) to 259

mg/L (Paldi). All the samples meet the permissible limit of 400 mg/L for

drinking water (if alternate source of potable water in not available).

Fluoride: Fluoride content in the water ranges from 0.69 mg/L (Andhari)

to 0.97 mg/L (Mujpur). All the samples meet the permissible limit (1.5

mg/L).

Total Alkalinity: Total alkalinity in the water samples ranges from 161

mg/L (Sathal) to 294 mg/L (Project Site). All the samples are within the

permissible limit of drinking water (600 mg/L) (if alternate source of

portable water is not available).

Other Parameters: Potassium (ranges from 43 mg/L to 160 mg/L),

Sodium (ranges from 158 mg/L to 358 mg/L) and Chloride (ranges from

399 mg/L to 753 mg/L).

Heavy metals like copper, lead, chromium and zinc are well below the

limit in all samples.

3.10.6 Conclusion

The results have been compared with the drinking water quality

standards specified in IS: 10500-2012 & meet the permissible limit set by

the authority (BIS). Indian Standard specification for drinking water is

given in Table 3.25.All the ground water samples analyzed can be

considered fit for drinking purpose.

3.11 NOISE ENVIRONMENT

Noise can be defined as an unwanted sound. The definition of noise as

unwanted sound implies that it has an adverse effect on human beings

and their environment. The noise level variation can be temporal, spatial.

It interferes with speech and hearing and is intense enough to damage

hearing or is otherwise annoying. Noise can also disturb natural wildlife

and ecological system. It is therefore, necessary to measure both the

quality as well as the quantity of noise in and around the proposed site.

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3.11.1 Instrument used for Sampling and Monitoring

The intensity of sound energy in the environment is measured in a

logarithmic scale and is expressed in a decibel, dB(A) scale. Sound Level

Meter (SLM) is used for the collection of data related to noise at an

interval of one hour. The day noise levels have been monitored during

6:00 am to 10:00 pm and night noise levels during 10:00 pm to 6:00 am

at all the eight locations. Noise levels recorded at each station are

computed for equivalent noise levels. Noise monitoring methodology is

given in Table 3.11.

Table 3.11 Monitoring Methodology of Noise

Environment Component

Sampling Location

Test method Instrument used

Make

Ambient Noise level

08 Locations

As per manufacturers Manual

Sound Level Meter

Mextech-SL-4012

3.11.2 Noise Quality Monitoring Locations

The noise survey was conducted to assess the background noise levels in

different zones. Noise level measurements have been made at 8 locations

within the study area using Sound Level Meter. Based on theGazettes

Notification (S.O. 123(E)) of MoEF dated February 14, 2000 on ambient

air quality standards, 8 monitoring locations were selected; 7 in the

residential area & one at project site.The noise monitoring locations & its

results are given in Figure-3.10& Table 3.26 respectively.

3.11.3 Ambient Noise Standards

Ministry of Environment & Forests (MoEF) has notified the noise

standards vide Gazette Notification dated February 14, 2000 for different

zones viz. industrial, commercial, residentialand silence zones under the

Environment Protection Act (1986). These standards are given in Table-

3.27.

3.11.4 Results

The noise levels of various locations are given in Table 3.26. The

monitored noise level in the day time Leq (Ld) varies from 51.7 to

61.2dB(A) and the night time Leq (Ln) varies from 42.5 to 54.5 dB(A)

within the study area. Higher noise value of 61.2dB(A) was recorded

during day time at project site & lower noise value of 42.5 dB(A) was

recorded during night time in village Khanpur.

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3.11.5 Conclusion

Based on the observations made during the studies, it is concluded that;

the noise levels recorded at various locations in the study area show

considerable fluctuations because of changes in traffic movement,

commercial and other domestic activities in the study area.Overall the

ambient noise level in the monitored locations was found to be within the

permissible limits stipulated for residential and industrial areas.

3.12 SOIL ENVIRONMENT

Soils may be defined as a thin layer of earth’s crust that serves as a

natural medium for the growth of plants. It is the unconsolidated mineral

matter that has been subjected to and influenced by genetic and

environmental factors. Soils serve as a reservoir of nutrients for plants

and crops and also provide mechanical anchorage and favorable tilth.

The objective of the soil sampling is:

• To determine the baseline soil characteristics;

• To monitor the impact on soil (pollutant deposition/other) in long

run.

3.12.1 Soil sampling locations

Soil quality of the study area is one of the important components for

environment impact assessment. The composite soil samples were

collected from the study area from six locations (Project site, village

Khanpur, village Mujpur, village Rampur, village Paldi, village Sathal) and

were analyzed for different parameters. The locations of the monitoring &

results are given in Table 3.28 and depictedin Figure 3.11.

Table 3.12 Location of soil sampling Sample Code

Locations Date of sampling

Tehsil District

S1 Project site 25/04/16 Dholka Ahmedabad

S2 Khanpur 25/04/16 Dholka Ahmedabad

S3 Mujpur 25/04/16 Dholka Ahmedabad

S4 Rampur 26/04/16 Dholka Ahmedabad

S5 Sathal 26/04/16 Dholka Ahmedabad

S6 Paldi 27/04/16 Dholka Ahmedabad

3.12.2 Methodology

To understand the soil quality of the study area, analysis of all six

locations including the project site was conducted by making suspension

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of soil sample. The samples were examined forvarious physical and

chemical characteristics in order to assess the impact on soil. Analysis

was done by using following methodology.

Table 3.13 Methodology of Soil Sample analysis

Sampling Parameters

Sample collection

Analytical Equipment

Methodology Remarks

Porosity

Manual sample

Collection in polyethylene bags using an Auger

- IS: 2720 Part 7 Trial pit method

for topsoil sample

collection; disturbed samples

Water holding capacity

- -

Permeability - IS: 2720 Part 17 Moisture content

Electronic Balance

IS: 2720 Part 2

Texture - IS: 2720 Part 4 Particle size Distribution

Glass wares

IS: 2720 Part 4

5% Leachate to be made and

analyzed as per APHA,

“Standard Methods”

All method numbers are as

per APHA “Standard Methods”

(22nd edition)

Cation Exchange Capacity

Centrifuge IS: 2720 Part 24 (1976)

SAR

F. Photometer (Na, K) Titration

(Ca & Mg)

Calculation

pH pH Meter 4500 H+B Electrical Conductivity

Conductivity Meter

As per IS 14767 -2000

Calcium Glass wares 3500 Ca B Magnesium Glass wares 3500 Mg B Sodium (Na) Flame

Photometer 3500 Na B

Potassium

Flame Photometer

3500 K B

3.12.3 Corollaries

Physical Parameters

Particle Size: A Particle size of the different constituents (clay, silt, sand

and gravel) controls the porosity and water holding characteristic of the

soil. Clay (size<0.002 mm) amount in the soil samples ranges from 17%

to 24%; Silt (size 0.002 to 0.075 mm) in the soil samples is 29% to 36%

and Sand (size 0.075 to 0.475 mm) in the soil samples is 31% to 40%,

while Gravel (size>4.75 mm) in the soil samples is 10% to 16%. Analysis

shows that the soil has moderate water holding capacity.

Porosity: Porosity is a measure of space in between soil particles caused

by structural conditions and determined under identical conditions.

Porosity of soil samples of the study area ranges from 41.4% to 44.5%.

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Water Holding Capacity (WHC): Water Holding Capacity (WHC) of soil

samples of the study area ranges between 36% to 41%.

Bulk Density: Bulk Density of soils in the study area is found to be in the

range from 1.34 to 1.39 g/cm3.

Chemical Parameters

pH: pH of soils in the study area is found to be in the range of 7.7 to 8.1.

Chloride: Chloride content in soils of the study area is found to be in the

range of 129 to 192 mg/kg.

Soluble Calcium: The soluble calcium as CaCO3 in soil samples is found

to be in the range of 45 to 109 mg/kg.

Magnesium: Magnesium content in soil samples of the study area ranges

from 35 to 53 mg/kg.

Total Phosphorus: Available Phosphorus content in soil samples of the

study area ranges from 21 to 28 mg/kg.

Total Nitrogen: Available nitrogen content in soil samples of the study

area is found to be in the range from 139 to 152 mg/kg.

Potassium: Potassium content in soil samples of the study area is found

to be in the range from 31 to 71 mg/kg.

Sodium: Sodium content in soil samples of the study area is found to be

in the range from 108 to 192 mg/kg.

Total Organic Matter (TOM): Total organic matter content in soil

samples of the study area is found to be in the range of 1.36 to 1.43

mg/kg.

3.12.4 Conclusion

In the study area, variations in the pH value ranging from 7.7 to 8.1

which shows that the soil is slightly alkaline in nature. Organic Matter

ranges from 1.36 to 1.43 mg/kg in the soil samples. Soil of the study

area is known to be good for cultivation. Generally, soils with low bulk

density have favorable physical conditions (porosity and permeability)

whereas those with high bulk density exhibit poor physical conditions for

agriculture crops.

3.13 BIOLOGICAL ENVIRONMENT

An ecological study of the ecosystem is essential to understand the

impact of industrialization and urbanization on existing flora and fauna of

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the study area.The biological study was undertaken as a part of the EIA

study report to:

• Understand the present status of ecosystem prevailing in the study

area.

• Compare it with past condition with the help of available data.

• Predict changes in the biological environment as a result of present

activities and to suggest measures for maintaining its health.

The survey was conducted to study the flora & fauna in 10 km radius.

Some of the information was gathered from the local habitants. All the

collected data were classified to interpret the impact of pollution on the

flora and fauna of the region.

3.13.1 Period of the study

The baseline study, for the assessment of the floral and faunal

biodiversity of the terrestrial environment, within 10 km radius from the

site was conducted during Mar, 2016 to May, 2016.

3.13.2 Study methodology

Survey methodology was based on the flora and fauna species

identification in personal and recently recorded and found in the region by

the localities. Sampling of grass species was carried out by quadrat

sampling method to examine the species distribution and its frequency in

the region.

Table 3.14 Methods used for sampling of flora and fauna

Taxa Sampling Methods Plants Quadrate sampling and enumeration

Amphibians Visual encounter survey

Reptiles Visual encounter survey

Birds Point count, opportunistic observation

Mammals Tracks and signs and visual encounter survey

• Quadrat Sampling Method:

A quadrat (or plot-based) survey is a quantitative examination of species

distribution & abundance. Quadrats are more likely to detect

inconspicuous species because a smaller area is sampled in a

concentrated search. The survey was carried out for the vegetation

ground cover found in the road edges by 1 m2 quadrat and study on the

edge effect due to rapid industrialization and urbanization.

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3.13.3 Floral species in the study area

Flora is basically the plant life that is present in a particular region or

habitat at a particular time. List of flora found in the study area is

tabulated in Table 3.29.

3.13.4 Fauna in the study area

Fauna is the animal life that is present in a particular region or habitat at

a particular time. Irrespective of its unfriendly terrain, Gujarat gives

shelter to a variety of animals and birds. They live in smaller herds and

thrive mainly on wild grasses and various types of shrubs.

Faunal biodiversity with their scientific names and common names is

presented in Table 3.30.

3.14 SOCIO-ECONOMIC ENVIRONMENT

An essential part of environmental study is socio-economic environment

incorporating various facts related to socio-economic conditions in the

area, which deals with the total environment. Socio economic study

includes demographic structure of the area, provision of basic amenities

viz., housing, education, health and medical services, occupation, water

supply, sanitation, communication, transportation as well as feature of

aesthetic significance such as temples, historical monuments etc. at the

baseline level. This would help in visualizing and predicting the possible

impact depending upon the nature and magnitude of the project.Socio-

economic study of an area provides a good opportunity to assess the

socioeconomic conditions of an area. This study will possibly make a

change in living and social standards of the particular area benefitted due

to the project. The gross economic production of the area will be

increased substantially due to the existence of this project. It can

undoubtedly be said that this plant will provide direct and indirect

employment and improve the infrastructural facilities and standards of

living of the area.

3.14.1 Objective of the study

The objectives of this socio-economic report consist of:

• To conduct socio-economic assessment study in lease Area

• To help in providing better living standards.

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• To know the current socio-economic situation in the region to cover

the sub sectors of education, health, sanitation, water and food

security.

• To provide employment opportunities.

3.14.2 Land use pattern and infrastructure

The land use pattern indicates the manner in which different parts of land

in an area is being utilized or non-utilized. It is an important indicator of

environmental health; human activity and a degree of inter play between

these two. Even though the soil quality, water availability and climate

have strong influence on agriculture and vegetation, the human activity

may alter the natural environment to a large extent to suit human needs.

Unnatural land use often triggers rapid environmental deterioration and

disturbs ecological balance. In census records, major land use

classifications are; Forests, Cultivable land, Cultivable wasteland and area

not available for cultivation. Cultivable land is further classified as:

irrigated and un-irrigated. Area not available for cultivation includes lands

put to non-agriculture uses as well as barren and uncultivable lands.

The main land use in area is for dwellings, infrastructure and related

activities. However, the land use pattern for rural areas is discussed

below. The information is preliminary based on 2011 Census as depicting

in Table 3.32.Total land area is 37024 ha, out of that Irrigated area is

11225.4 ha. It constitutes 30.31% of the total land area. Land has got

irrigation facilities from tube well with electricity. 14146.1 ha are un-

irrigated by source and it constitutes 38.20% of total land area. The

study area consist of Cultivable wasteland is 2057.2 ha (5.55%). Area not

available for cultivation is 9595.3 ha & it constitute 25.91%.

3.14.3 Demographic and Socio-Economic Environment

The demographic and Socio-economic details of the study area are

discussed below. These are primarily based on census data of 2011. Data

on number of households, population as well as literacy and employment

pattern in the study area have been presented in Table3.33. The

employment pattern in the area is indicator of number of persons

employed in various sectors. It also indicates the various categories of

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employment flourishing in the area. The study area in 10 km radius has

33 villages including project site.

The total no. of household in the villages are 14126 and the total

population is 69186 (52.14% men & 47.86% women). 66.31% of are

literate while literacy rate among women & men is 27.16% & 39.15%

respectively. 27.86% of male population is part of main worker, while

only 5.29% of female population is a part of main workers. 3.16% of

male workers are marginal workers, while 9.76% of female workers are

engaged in such type of activities. 21.11% of male population and

32.81% of female population are non-workers.

3.14.4 Living Standard and Infrastructure

In India it is not possible to setup a primary standard of living because of

wide variations in terms of income, economic conditions, social custom,

employment opportunity, pattern of spending, etc. However, availability

of amenities like education, medical, water supply, communication, road

network, electricity, etc. significantly reflects the level of development of

the area. Information on available amenities in the study area has been

extracted from census record of 2011. Total numbers of village in study

area are 33. On the basis of data presented in the Table 3.34, the status

of available amenities is discussed in following sub-sections:

Educational Facilities: As per 2011 census, there are Primary schools,

5 Higher Secondary schools, 1College, 1 Higher Secondary/ Intermediate/

Pre-University/ Junior College or Senior Secondary center and 2 Adult

Literacy Class/Centre in all 33 villages.

Medical Facilities: 33 villages in the study area have 2 Allopathic

Hospitals, 5 Maternity and Child Welfare Centre, 3 Primary Health Centre,

7 Primary Health Sub Centers, 6 Registered Private Medical Practitioner, 3

Child Welfare Centre, 9 Community Health Worker/Health Worker, 2

Dispensary, 4 Family Welfare Centre, 2 Subsidized Medical Practitioner

and 1 Nursing Home in study area of 10 km.

Drinking Water Supply: All the villages in the study area have two or

more sources of drinking water. Most of the villages in study area have

tap water supply in addition to Tube well water (almost all). Moreover 6

villages have well water facility, 10 villages have tank water facility, 2

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 3-23

have river facility, 2 have hand pump facility and 3 villages have other

facility.

Communication and Transport: The main mode of public transport

available in the study area is by bus service. All villages have approach to

railway station as western railway meter gauge line is passing through

nearby. Majority of villages in the study area is connected with pucca

road.

Post and Telegraph: As per 2011 census record out of 33 villages in

study area, almost all the villages have post office facility at doorstep &

phone facility.

Power Supply: As per 2011 census record almost all the villages are

getting power supply for all purposes.

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 3-24

Table 3.15: Ambient Air Quality Monitoring Locations

(Period of Monitoring: March, 2016 to May, 2016)

Sr. No.

Sampling Location

Direction w.r.t.

center of Industry

Distance (km)

Type of Area

1 Project site(A1) - -- Industrial

2 Khanpur(A2) W 5.0 Residential

3 Mujpur(A3) N 2.4 Residential

4 Dholka(A4) WSW 2.8 Residential

5 Rampur(A5) ENE 3.7 Residential

6 Paldi(A6) SSW 5.6 Residential

7 Andhari(A7) ESE 5.5 Residential

8 Sathal(A8) ENE 6.7 Residential

Sr. No.

1

2

3

4

5

6

7

8

F

(Peri

SampLocat

Project site(A1)

Khanpur

Mujpur(A

Dholka(A

Rampur(

Paldi(A6)

Andhari(

Sathal(A

Stan

Figure 3.2

0

20

40

60

80

100

Concen

tration in m

icrogram

/m3

Table 3.

od of Mo

ling tion

(6

(A2) (6

A3) (5

A4) (5

(A5) (5

) (5

A7) (5

A8) (6

ndard

2 Graphic

7066.4

42.838

20.81

23.3

.16: Amb

onitoring:

PM10

A

70.0 5.2-73.1)

66.4 1.7-71.2)

63.6 4.8-69.8)

64.0 6.4-70.1)

63.7 5.9-69.1)

62.4 3.9-72.5)

58.9 1.2-65.4)

65.0 0.3-69.3)

100

cal repre

4 63.6

8.1 37.9

16.522.119.925.1

Ambie

San

bient Air Q

: March, 2

PM2.5

Average (

42.8 (37.8-48

38.1 (34.8-41

37.9 (35.2-41

35.1 (30.2-39

36.5 (31.0-40

35.8 (29.7-40

36.1 (30.8-42

37.6 (32.8-40

60

sentation

64 63.7

35.1 36.5

21.816.

24.52

Location

ent Air Q

Envirotec

Quality S

2016 to M

S

Min-Max)

.1) 2

(17.6

.6) 1

(13.6

.3) 2

(19.2

.7) 2

(16.9

.8) 1

(12.9

.9) 1

(14.5

.0) 1

(14.5

.7) 1

(13.28

n of Amb

62.458.

35.8 3

.8 17.720 20.7

n

Quality 

ch Pvt. Ltd

Status

May, 201

SO2

- µg/m3

0.8 6-25.6) (

6.5 6-20.1) (2.1

2-25.4) (1.8

9-28.3) (6.8

9-26.1) (7.7

5-22.2) (9.0

5-26.9) (6.5

2-20.7) (80

bient Air Q

.965

6.1 37.6

19 16.521.7 19.3

status

d., Ahmed

6)

NOx

23.3 19.9-28.3)

19.9 15.6-23.9)

25.1 21.3-28.6)

24.5 19.8-31.2)

20.0 16.1-28.2)

20.7 17.5-25.2)

21.7 18.2-29.1)

19.3 15.7-23.2)

80

Quality

3

PM10

PM2.5

SO2

NOx

dabad

)

)

)

)

)

)

)

)

Average-2

StatioName

Project site(A1)

Khanpur(A

Mujpur(A3

Dholka(A4

Rampur(A

Paldi(A6)

Andhari(A

Sathal(A8

Tab

(Peri

24 Hours

on e

Max

73.1

A2) 71.2

3) 69.8

4) 70.1

A5) 69.1

72.5

A7) 65.4

8) 69.3

Fig

2

4

6

8

10

Concen

tration in m

icrogram

/m3

ble 3.17:

od of Mo

x Min P

1 65.2

2 61.7

8 54.8

1 56.4

1 55.9

5 53.9

4 51.2

3 60.3

gure 3.3

70

0

20

40

60

80

00

Graph

Ambient

onitoring:

98th Percentile

73.0

71.2

69.5

70.0

69.1

71.0

65.4

69.3

Graphica

66.4 63.6

hical repr

San

t Air Qua

: March, 2

75th Percentile

71.5

68.9

66.9

67.4

66.3

65.5

61.5

66.8

al represe

64 63

resentat

Envirotec

lity Statu

2016 to M

Unit-μg/m

e 50th

Percent70.3

65.7

64.2

63.9

63.7

62.8

59.3

65.3

entation

3.7 62.4

tion for 

ch Pvt. Ltd

us (PM10)

May, 201

m3

tile

25t

Perce68.

64.

60.

61.

61.

59.

55.

63.

for PM10

58.965

PM10

d., Ahmed

)

6)

th ntile

Avg

.7 70.0

.4 66.4

.9 63.6

.7 64.0

.1 63.7

.4 62.4

.5 58.9

.1 65.0

5

dabad

SD

0 2.2

4 2.9

6 4.0

0 3.9

7 3.8

4 4.7

9 4.3

0 2.5

Average-2

Station Name Project site(A1) Khanpur(A

Mujpur(A3

Dholka(A4

Rampur(A

Paldi(A6)

Andhari(A

Sathal(A8

Tab

(Peri

24 Hours

Max

48.1

A2) 41.6

3) 41.3

4) 39.7

A5) 40.8

40.9

A7) 42.0

8) 40.7

Fig

4

Concen

tration in m

icrogram

/m3

ble 3.18:

od of Mo

x Min P

1 37.8

6 34.8

3 35.2

7 30.2

8 31.0

9 29.7

0 30.8

7 32.8

gure 3.4 G

42.8

0

20

40

60

Grap

Ambient

onitoring:

98th ercentile

47.9

41.4

40.6

39.5

40.7

40.5

41.7

40.7

Graphica

38.1 37.9

phical re

San

t Air Qual

: March, 2

75th Percentile

45.4

39.3

39.0

37.0

38.3

38.5

38.7

39.2

al represe

35.1 36

presenta

Envirotec

lity Statu

2016 to M

Unit-μg/m

e 50th

Percent42.0

38.0

38.0

34.9

36.5

36.1

36.5

37.8

entation f

6.5 35.8

ation for

ch Pvt. Ltd

us (PM2.5)

May, 201

m3

ile

25t

Percen40.

36.

36.

33.

34.

33.

33.

36.

for PM2.5

36.1 37.6

 PM2.5

d., Ahmed

)

6)

th ntile

Avg.

5 42.8

8 38.1

8 37.9

3 35.1

6 36.5

0 35.8

7 36.1

6 37.6

6

dabad

. SD

2.8

1.9

1.6

2.4

2.7

3.3

3.3

2.1

Average-2

Station Name Project site(A1)

Khanpur(A

Mujpur(A3

Dholka(A4

Rampur(A

Paldi(A6)

Andhari(A

Sathal(A8

Ta

(Peri

24 Hours

Max

25.6

A2) 20.1

3) 25.4

4) 28.3

A5) 26.1

22.2

A7) 26.9

8) 20.7

Fig

2

4

6

8

Concen

tration in m

icrogram

/m3

ble 3.19:

od of Mo

x Min P

6 17.6

1 13.6

4 19.2

3 16.9

1 12.9

2 14.5

9 14.5

7 13.2

gure 3.5

20.81

0

20

40

60

80

Grap

: Ambien

onitoring:

98th Percentile

25.4

19.8

25.3

28.3

24.1

21.9

25.5

20.4

Graphica

16.522.1

phical re

San

t Air Qua

: March, 2

75th Percentile

21.9

18.1

23.9

23.1

18.0

20.0

20.2

18.3

al represe

21.816

epresent

Envirotec

ality Statu

2016 to M

Unit-μg/m

e 50th

Percent20.9

16.1

21.6

21.3

16.1

17.1

18.6

16.2

entations

6.8 17.7

tation fo

ch Pvt. Ltd

us (SO2)

May, 201

m3

tile

25t

Perce19.

15.

20.

19.

14.

15.

16.

14.

s for SO2

19 16.

or SO2

d., Ahmed

6)

th ntile

Avg

.2 20.8

.1 16.5

.7 22.1

.7 21.8

.6 16.8

.9 17.7

.7 19.0

.7 16.5

.5

dabad

SD

8 2.1

5 1.9

1 2.0

8 3.0

8 3.1

7 2.4

0 2.8

5 2.2

Average-

Station Name Project site(A1)

Khanpur(A

Mujpur(A3

Dholka(A4

Rampur(A

Paldi(A6)

Andhari(A

Sathal(A8

Tab

(Peri

-24 Hours

Max

28.3

A2) 23.9

3) 28.6

4) 31.2

A5) 28.2

25.2

A7) 29.1

8) 23.2

Fig

4

8

Concen

tration in m

icrogram

/m3

ble 3.20:

od of Mo

x Min P

3 19.9

9 15.6

6 21.3

2 19.8

2 16.1

2 17.5

1 18.2

2 15.7

gure 3.6 G

23.3

0

20

40

60

80

Grap

Ambient

onitoring:

98th Percentile

28.3

23.8

28.5

30.7

26.3

24.7

27.4

23.2

Graphica

19.925.1

phical re

San

t Air Qua

: March, 2

75th Percentile

24.6

21.6

26.8

26.4

21.4

23.2

23.6

20.7

l represe

24.52

epresent

Envirotec

ality Statu

2016 to M

Unit-μg/m

e 50th

Percent23.1

19.7

25.1

24.5

21.1

19.7

21.3

18.9

entations

20 20.7

tation fo

ch Pvt. Ltd

us (NOx)

May, 201

m3

tile

25t

Perce21.

18.

22.

22.

18.

18.

19.

17.

s for NOx

21.7 19.3

or NOx

d., Ahmed

6)

th ntile

Avg

.0 23.3

.7 19.9

.1 25.1

.1 24.5

.1 20.0

.9 20.7

.6 21.7

.8 19.3

3

dabad

SD

3 4.8

9 2.2

1 2.1

5 3.1

0 3.0

7 2.4

7 2.7

3 2.1

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 3-30

Table 3.21: Ambient Air Quality Status (CO, HC (Methane & non-Methane), VOC)

(Period: March, 2016 to May, 2016)

Station Name CO (μg/m3)

Hydro Carbon (μg/m3) VOC (μg/m3) Methane Non-

Methane Benzene Toluene Xylene

Project site(A1) 1180 53.8 1064.6 BDL 29.2 BDL

Khanpur(A2) 1096 41.6 966.7 BDL BDL BDL

Mujpur(A3) 1040 37.0 946.6 BDL BDL BDL

Dholka(A4) 1372 38.3 1058.9 BDL 1.26 2.19

Rampur(A5) 985 25.1 982.1 BDL BDL BDL

Paldi(A6) 1064 30.4 1016.6 BDL BDL BDL

Andhari(A7) 967 28.4 1088.6 BDL BDL BDL

Sathal(A8) 925 35.0 1061.8 BDL BDL BDL

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 3-31

Table 3.22: National Ambient Air Quality Standards (EP, 7th amendment rules-2009)

Pollutants Time-weighted average

Concentration in ambient air Industrial,

Residential, Rural and

others area

Ecologically Sensitive

area (Notified by

Central Government)

Method of Measurement

Sulphur Dioxide (SO2), µg/m3

Annual Average*

50 20 Improved west and Gaeke

Ultraviolet fluorescence

24 hours** 80 80

Oxides of Nitrogen as (NO2), µg/m3

Annual Average*

40 30 Modified Jacob &Hochheiser

(Na-Arsenate) Chemiluminescence

24 hours** 80 80

Particulate Matter (Size less than 10 µm or PM10, µg/m3

Annual Average*

60 60 Gravimetric TOEM Beta attenuation 24 hours** 100 100

Particulate Matter(Size less than 2.5 µm or PM2.5, µg/m3

Annual Average*

40 40 Gravimetric TOEM Beta attenuation 24 hours** 60 60

Ozone (O3) µg/m3

8 hours ** 100 100 UV photometric Chemiluminescence Chemical Method

1hours** 180 180

Lead (Pb) µg/m3

Annual Average*

0.50 0.50 AAS/ICP method after sampling on EPM 2000 or equivalent filter paper

ED-XRF using Teflon filter

24 hours** 1.0 1.0

CarbonMonoxide (CO) mg/m3

8 hours** 02 02 Non Dispersive Infra Red (NDIR) spectroscopy

1 hour** 04 04

Ammonia (NH3) µg/m3

Annual Average*

100 100 Chemiluminescence Indophenol Blue Method 24 hours** 400 400

Benzene (C6H6) µg/m3

Annual* 05 05 Gas chromatography based continuous analyzer

Adsorption and desorption followed by GC analysis

Benzo(a)Pyrine (BaP)-particulate phase only,µg/m3

Annual* 01 01 Solvent extraction followed by HPLC/GC analysis

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 3-32

Arsenic (As), µg/m3

Annual* 06 06 AAS/ICP method after sampling on EPM 2000 or equivalent filter paper

Nickel (Ni) µg/m3

Annual* 20 20 AAS/ICP method after sampling on EPM 2000 or equivalent filter paper

* Annual Arithmetic mean of minimum 104 measurements in a year taken twice a week 24 hourly at uniform interval.

** 24 hourly/8 hourly or 01 hourly values, as applicable, shall be complied with 98% of the time in a year. 2% of the time, they may exceed the limits but not two consecutive days of monitoring.

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 3-33

Table 3.23: Results of Groundwater Quality in the Study Area (Date of Sampling: 25/04/16 to 27/04/16)

Sr. No.

Parameters Unit Result Project site

(GW1) Khanpur (GW2)

Lana (GW3)

Mujpur (GW4)

Rampur (GW5)

Andhari (GW6)

Sathal (GW7)

Paldi (GW8)

1 pH pH Unit 7.54 7.71 7.65 7.79 7.79 7.92 7.77 7.81 2 Color Co-Ptunit Colorless Colorless Colorless Colorless Colorless Colorless Colorless Colorless 3 Odour -- Unobjectio-

nable Unobjectio-

nableUnobjectio-nable

Unobjecti-onable 

Unobjecti-onable

Unobjecti-onable

Unobjecti-onable

Unobjecti-onable

4 Taste -- Agreeable Agreeable Agreeable Agreeable Agreeable Agreeable Agreeable Agreeable

5 Turbidity NTU 4.6 2.1 4.1 3.3 1.9 4.1 3.7 2.3 6 Total Hardness mg/L 875 470 436 449 487 497 442 440 7 Alkalinity mg/L 294 186 197 167 172 182 161 184 8 Chlorides mg/L 753 412 418 423 437 465 399 480 9 Sulphate mg/L 101 187 82 240 246 252 204 259 10 TDS mg/L 1659 1043 985 1114 1139 1189 1015 1242 11 Sodium mg/L 358 197 198 193 182 191 158 249 12 Potassium mg/L 160 99 43 116 119 123 114 112 13 Calcium mg/L 189 86 69 84 91 95 83 89 14 Magnesium mg/L 98 62 64 58 63 63 57 53 15 Nitrate mg/L 3.2 2.3 4.1 1.2 2.1 2.1 1.6 1.7 16 Fluoride mg/L 0.83 0.94 0.71 0.97 0.76 0.69 0.91 0.82 17 Phenol as C6H5OH mg/L <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 18 Arsenic as As mg/L <0.002 <0.002 <0.002 <0.002 <0.002 <0.002 <0.002 <0.002 19 Cadmium as Cd mg/L <0.003 <0.003 <0.003 <0.003 <0.003 <0.003 <0.003 <0.003 20 Copper as Cu mg/L <0.05 <0.05 <0.05 <0.05 <0.05 <0.05 <0.05 <0.05 21 Lead as Pb mg/L <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 22 Manganese as Mn mg/L <0.04 <0.04 <0.04 <0.04 <0.04 <0.04 <0.04 <0.04 23 Iron as Fe mg/L 0.96 0.72 0.59 0.81 0.69 0.82 0.91 0.71 24 Total Chromium mg/L <0.003 <0.003 <0.003 <0.003 <0.003 <0.003 <0.003 <0.003 25 Zinc as Zn mg/L <0.08 <0.08 <0.08 <0.08 <0.08 <0.08 <0.08 <0.08 26 Nickle as Ni mg/L <0.02 <0.02 <0.02 <0.02 <0.02 <0.02 <0.02 <0.02

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 3-34

Table 3.24: Surface Water analysis of study area (Date of Sampling: 25/04/16 to 27/04/16)

Sr. No

Parameters Unit Result

Nesda Pond

(SW1)

Dholka Pond

(SW2)

Sabarmati River

(SW3)

Sathal Pond

(SW4)

Paldi Pond

(SW5) 1 pH pH Unit 8.1 7.7 7.9 7.8 7.8 2 Color Co-Pt

Units Colorless Colorless Colorless Colorles

s Colorless

3 Odour -- Unobjecti-onable

Unobjectionable

Unobjectio-nable

Unobjecti-onable

Unobjectio-nable

4 Taste -- Agreeable Agreeable Agreeable Agreeable

Agreeable

5 Turbidity NTU 9.7 8.9 5.4 6.8 7.2 6 Total Hardness mg/L 166 130 161 152 135 Alkalinity mg/L 172 144 164 198 218 7 Chlorides mg/L 123 115 154 95 91 8 Sulphate mg/L 82 92 112 69 93 9 TDS mg/L 410 402 523 337 394 10 Sodium mg/L 112 109 135 93 126 11 Potassium mg/L 29 25 27 26 21 12 Calcium mg/L 32 29 30 28 26 13 Magnesium mg/L 21 14 21 20 17 14 Nitrate mg/L 3.97 3.41 5.74 2.63 3.46 15 Fluoride mg/L 0.40 0.49 0.43 0.34 0.57 16 Phenol as C6H5OH mg/L <0.001 <0.001 <0.001 <0.001 <0.001 17 Arsenic as As mg/L <0.002 <0.002 <0.002 <0.002 <0.002 18 Cadmium as Cd mg/L <0.003 <0.003 <0.003 <0.003 <0.003 19 Copper as Cu mg/L <0.05 <0.05 <0.05 <0.05 <0.05 20 Lead as Pb mg/L <0.01 <0.01 <0.01 <0.01 <0.01 21 Manganese as Mn mg/L <0.04 <0.04 <0.04 <0.04 <0.04 22 Iron as Fe mg/L 0.27 0.26 0.19 0.31 0.22 23 Total Chromium mg/L <0.003 <0.003 <0.003 <0.003 <0.003 24 Zinc as Zn mg/L <0.08 <0.08 <0.08 <0.08 <0.08 25 Nickle as Ni mg/L <0.02 <0.02 <0.02 <0.02 <0.02 26 Coliform Bacteria MPN/

100 ml 7 11 11 11 7

27 Total Bacterial Count

- 55 62 59 62 58

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 3-35

Table 3.25: Indian Standard Specification for Drinking Water

Sr. No.

Parameters Desirable Limit

Permissible Limit in the Absence of Alternate

Source I Essential Characteristics 1. Colour, Hazen Units, Max. 5 25 2. Odour Unobjectionable - 3. Taste Agreeable - 4. Turbidity, NTU, Max. 5 10 5. pH 6.5-8.5 No Relaxation 6. Total Hardness (as CaCO3) mg/l, Max. 300 600 7. Iron (as Fe) mg/l, Max. 0.3 1.0 8. Chlorides (as Cl) mg/l, Max. 250 1000 9. Residual Free Chlorine, mg/l, Min. 0.20* - II Desirable Characteristics 10. Dissolved Solids, mg/l, Max. 500 2000 11. Alkalinity (as CaCO3), mg/l, Max. 200 600 12. Sulphate (as SO4) mg/l, Max. 200 400 13. Nitrate (as NO3) 45 100 14. Fluoride (as F) mg/l, Max. 1.0 1.5 15. Calcium (as Ca) mg/l, Max. 75 200 16. Magnesium (as Mg) mg/l, Max. 30 100 17. Copper (as Cu) mg/l, Max. 0.05 1.5 18. Manganese (as Mn) mg/l, Max. 0.1 0.3 19. Mercury (as Hg) mg/l, Max. 0.001 No Relaxation 20. Cadmium (as Cd) mg/l, Max. 0.01 No Relaxation 21. Selenium (as Se) mg/l, Max. 0.01 No Relaxation 22. Arsenic (As As) mg/l, Max. 0.05 No Relaxation 23. Cyanide (as CN) mg/l, Max. 0.05 No Relaxation 24. Lead (as Pb) mg/l, Max. 0.05 No Relaxation 25. Zinc (as Zn) mg/l, Max. 5 15 26. Aluminium (as Al) mg/l, Max. 0.03 0.2 27. Boron (as B) mg/l, Max. 1 5 28. Chromium (as Cr) mg/l, Max. 0.05 No Relaxation 29. Phenolic Compounds (as C6H5OH) mg/l,

Max. 0.001 0.002

30. Anionic Detergents (as MBAS) mg/l, Max. mg/l, Max.

0.2 1.0

31. Mineral Oil mg/l, Max. 0.01 0.03 32. Pesticides Absent 0.001 33. Radioactive Materials

a. Alpha Emitters, Bq/I, Max. b. Beta Emitters, Pci/I, Max

- -

0.1

0.037 Note: * Applicable only when water is chlorinated

Source: IS: 10500, 2012

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 3-36

Table 3.26: Ambient Noise Levels in the Study Area (Date of Monitoring: 25/04/16 to 27/04/16)

Sr. No.

Noise Monitoring Locations

Date of Monitoring

CPCB Limits dB (A)

Average Noise levels in dB (A)

Leq (Day) dB A

Leq (Night)

dB A

Leq (Day) dB A

Leq (Night)

dB A

1. Nr. Project site(N1) 25/04/16 75 70 61.2 54.5

2. Village Khanpur (N2) 25/04/16 55 45 53.0 42.5

3. Village Mujpur (N3) 25/04/16 55 45 53.6 42.9

4. Village Rampur (N4) 26/04/16 55 45 52.4 42.8

5. Bus stop, Andhari (N5) 26/04/16 65 55 53.9 42.8

6. Village Santhal (N6) 26/04/16 55 45 53.8 44.1

7. Trasad Cross road Dholka (N7)

27/04/16 65 55 52.8 44.2

8. Village Paldi (N8) 27/04/16 55 45 51.7 43.6

Table 3.27

Ambient Air Quality Standards with respect to Noise

Zone  Limits Leq, dB(A) 

Day Time Night Time

Industrial 75 70

Commercial 65 55

Residential 55 45

Silence 50 40

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 3-37

Table 3.28: Soil Analysis of Study area

(Date of Sampling: 25/04/16 to 27/04/16)

S. No.

Parameters Unit Project site

(S1)

Khanpur (S2)

Mujpur (S3)

Rampur (S4)

Sathal (S5)

Paldi (S6)

1. pH (5%) Solution - 7.7 8.1 7.8 7.7 7.9 8.1

2. Loss of Ignition % 5.2 5.1 6.0 6.0 5.2 5.7

3. Particle Size

Clay (<0.002 mm) % 22 17 18 24 20 17

Silt (0.002 to 0.075 mm)

% 36 33 35 34 29 33

Sand (0.075-0.475 mm

% 32 34 32 31 39 40

gravel (size >4.75 mm)

% 10 16 15 11 12 10

4. Water Holding Capacity

% 36 40 41 39 36 36

5. Permeability cm/hr 3.12 3.00 2.86 2.98 3.05 2.95

6. Bulk Density g/cm3 1.38 1.35 1.34 1.39 1.36 1.34

7. Porosity % 42.5 43.0 41.4 41.8 44.5 43.8

8. Sodium Absorption Ratio

- 2.31 2.21 4.07 2.97 2.0 2.01

9. Sodium mg/kg 111 108 153 129 192 156

10. Potassium mg/kg 31 41 39 36 71 51

11. Calcium mg/kg 109 105 45 64 102 99

12. Magnesium mg/kg 39 45 37 53 35 42

13. Chlorides mg/kg 186 192 161 185 129 133

14. Sulphates mg/kg 79 84 79 75 37 40

15. Organic Matter mg/kg 1.41 1.36 1.39 1.43 1.41 1.39

16. Available Nitrogen mg/kg 150 152 149 152 144 139

17. Available Phosphorus mg/kg 23 28 22 25 21 25

18. Iron mg/kg 1.5 1.4 1.3 1.5 1.4 1.6

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 3-38

Table 3.29

Floral Diversity

(A) Trees

Sr. No.

Scientific Name

Family

Vernacular Name

1 Acacia auriculiformis Mimosaceae Australian Baval

2 Acacia caiehu Mimosaceae Khair

3 Acacia niloticaSubsp.Indica Mimosaceae Baval

4 Albizziaindica Mimosaceae Siris

5 Azadirachta indica Meliaceae Limdo

6 Eucalytus globules Myrtaceae Nilgiri

7 Ficusvirens Moraceae Pipli

8 Leucenaleucocephala Mimosaceae PardesiBaval

9 Parkinsonia aculeate Caesalpiniaceae Ram Baval

10 Peltophorumpterocarpum Caesalpiniaceae Tamarafali

11 Pongamia pinnata fabaceae Karanj

12 Prosopisjuliflora Mimosaceae GandoBaval

13 Prosopisspicigera Mimosaceae Khijado

14 Roystonearegia Arecaceae Royal Palm

15 Salvadoraaleoides Salvadoraceae Pilvo

16 Salvadorapersica Salvadoraceae Pilvo

17 Samaneasaman Mimosaceae Rate Saeasdo

(B) Shrubs

Sr. No.

Scientific Name

Family

Vernacular Name

1 Cadabaindica Capparidaceae Teliohemkand

2 Calotropis gigantean Asclepiadaceae Akado

3 Calotropisprocera Asclepiadaceae Akado

4 Capparissepiaria Capparidaceae Kerdo

5 Capparissepiaria Capparidaceae Kanthar

6 Euphorbia nerifolia Euphorbiaceae Thor

7 Ipomoea fistulosa Convolvulaceae Nafatio

8 Nerium indicum Apocynaceae LalKarne

9 Zizyphusrotundifolia Rhamnaceae ChaniBor

(C) Herbs

Sr. No.

Scientific Name

Family

Vernacular Name

1 Abutilon indicum Malvaceae Khapat

2 Amaranthusviridis Amarathaceae -

3 Cassis pumpila Caesalpiniaceae Nani Chimed

4 Cenchrussetigerus Poaceae DhamanGhas

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EIA Report of Concord Biotech Ltd. 3-39

5 Chenopodium album Chenopodiaceae Chil

6 Chlorisbarbata Poaceae Mindadin

7 Clitoriatematea Fabaceae Gokern

8 Cynodoncretica Convolvulaceae Rudanti

9 Cynodondoctylon Poaceae Darbh

10 Cyperuscompressus Cyperraceae -

11 Daemiaextensa Asclepiadaceae ChamarDudheli

12 Echinopusechinatus Asteraceae Shulio

13 HeliotropiumSupinum Borginaceae GhedioOKharad

14 Heteropogencontortus Poaceae Dabhsuliu

15 Ipomphasestelata Convolvulaceae Nali Ni Bhaji

16 Nymphaeastelata Nymphaeaceae Poyana

17 Triumfeittarotundifolia Tiliaceae GolZipti

18 Typhaangustata Typhaceae Ramban

19 Xanthium strumarium Asteraceae Gokhuru

(D) Agricultural Crops

Sr. No.

Scientific Name

Family

Vernacular Name

1 Triticumaestivum Poaceae Gehu

2 Oryza sativa Poaceae Chokha

3 Sorghum vulgare Poaceae Barja

4 Gossypiumherbaceum Malvaceae Kapas

5 Cuminum Apiaceae Jiru

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 3-40

Table 3.30

Faunal Biodiversity

(A) Amphibia

Sr. No.

Common Name Scientific Name

1 Skipper Frog Euphlyctiscyanophlytis

2 Common India Toad Bufomelanostictus

(B) Reptilia

Sr.No. Common Name

Scientific Name

1 Calotes CalotesVersicolor

2 Skink Mabuyacaninata

3 Wall Lizard Hemidoctylusflaviviridis

4 Wall Lizard Ptyas mucous

5 Cobra Najanaja

(C) Birds

Sr.No. Common Name

Scientific Name

1 Pond Heron ArdeolaGrayli 2 Cattle Egret Bulbulcus ibis 3 Pariah Kite Milvusmigrans 4 Red Wattled Lapwing Vanellusindicus 5 Blackwinged stilt HimanatopusHimantopus 6 Common Sandpiper Tringahypoleucos 7 Spotted dove StreptopeliaChinensis 8 Red turtle Dove Streptopliatrenquebarica 9 Blue Rock pigeon Columbia livia 10 Common Kingfisher Alcedoathis 11 White Breasted Kingfisher Halcyon smyrensis 12 Small Green Bee-Eater Meropsorientalis 13 Indian Roller Corvussplendens 14 House Crow Corvussplendens 15 Common myna Aceredotherestristis 16 Red Vented Bulbal Pycnontuscafer 17 Jungle babbler Turdoidesstriatus 18 Indian Robin SaxicoloidesFulicata 19 House Sparrow Passardomesticus

(D) Mammals

Sr.No. Common Name

Scientific Name

1 Palm Squirre Funambuluspennati 2 Mongoose Herpestesedwardsii 3 Common Langur Presbytis entellus

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EIA Report of Concord Biotech Ltd. 3-41

(E) Annelida

Sr.No. Common Name

Scientific Name

1 House Cricket Achetadomesticus 2 cockroach Blattagermanica 3 House fly Muscadomestica 4 Mosquito Anopheles sp. 5 Striped tiger Danausgenutiagenutia 6 Mosquito Culex Sp. 7 Common Grass Yellow Euremahecabe simulate 8 Common Crow Euploea core core 9 Black Ant Pheidole sp. 10 Red Ant Oecophyllasmar 11 Wasp Vespa sp. 12 Bumble Bee Bombus sp. 13 Social Spider Stegodyphusarasinorum 14 Jumping spider Phidippuspunjabensis 15 Lynx Spider Oxyopesshweta 16 Funnel Web spider Hippasa sp. 17 Wolf spider Pardosemukundi 18 Wolf Spider Lycosa sp. 19 Garden Spider Argiopeanasuja

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 3-42

Table 3.31 Traffic Survey

TRAFFIC SHEET

LOCATION Near plant site Dholka-Trasad Road TIME 09.00 to 10.00 DATE 25/04/2016

TOTAL PCU calculation Total PCU/hr BUSES* 19 PCU x 3 57 CARS/VANS 95 PCU x 1 95 MOTORCYCLES / BICYCLES 172 PCU x0.5 86

Total 238

TIME 18.00 to 19.00 DATE 24/04/2016

TOTAL PCU calculation Total PCU/hr BUSES* 27 PCU x 3 81 CARS/VANS 117 PCU x 1 117 MOTORCYCLES / BICYCLES 218 PCU x0.5 109

Total 307 Note: *Mini-bus, Chartered Bus, School Bus, have been collectively classified as Buses.

Additional traffic from our project will be estimated 60 PCU/day [20 trucks/tankers (in & out) x 3] and 100 PCU/day from car and motorcycle, which have insignificant impact on existing traffic load. Existing Traffic Scenario and Level of Services

The road from Dholka-Trasadis double track road, all types of vehicles move on the

road.

Capacity of road as per IRC = 1500 PCU’s/hr

Total Volume during Peak Hours = 307

Existing Volume/Capacity ratio = 307/1500= 0.205

The level of service is “B” that is Very Good LEVEL OF SERVICE

Sr. No.

Existing Volume/Capacity Ratio

Level of Services

1. 0.0 to 0.2 “A” (Excellent) 2. 0.2 to 0.4 “B” (Very Good) 3. 0.4 to 0.6 “C” (Good) 4. 0.6 to 0.8 “D” (Fair) 5. 0.8 to 1.0 “E” (Poor)

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 3-43

Table 3.32

Land Use Pattern

Name of Village Total Area of the

Village(ha)

Irrigated by source

(ha)

Un-irrigated

(ha)

cultivable waste (ha)

Area not available for cultivation

(ha) Juvalrupavati 847.6 692.6 45.8 41.7 67.5

VasnaKeliya 821.4 500.0 203.4 69.6 48.4

Shekhdi 219.9 201.6 - 8.3 10.0

Sindhraj 2013.3 834.9 620.9 92.9 464.6

Lana 678.1 437.3 205.2 16.6 19.0

Sakodara 1105.2 218.2 887.0 - -

Dholka (Rural) 9607.1 1521.0 1780.0 125.4 6180.7

Ranoda 971.8 772.3 65.1 6.2 128.2

Rajpur 193.1 140.0 39.5 4.9 8.7

Ambaliyara 1081.6 925.6 - 110.1 45.9

Sathal 1761.4 1033.1 170.3 371.4 186.6

JalalpurVazifa 662 209.8 220.8 60.3 171.1

Mujpur 316.1 - 300.8 11.5 3.8

Ambareli 1210.1 400.0 615.8 70.3 124.0

Kadipur 195 - 187.7 4.4 2.9

Kaliyapura 216.2 - 195.8 5.9 14.5

Virpur 666.6 170.2 453.9 40.3 2.2

Andhari 304.8 5.0 263.8 13.7 22.3

Paldi 1425.4 561.6 276.0 142.8 445.0

Sahij 1157.1 431.6 385.0 198.6 141.9

Rampur 403.6 202.3 150.9 48.1 2.3

Khanpur 526.7 9.0 301.0 66.7 150.0

Nesda 645.4 7.5 581.8 43.6 12.5

Dadusar 805.8 209.2 509.2 45.9 41.5

Transad 630.6 246.8 310.2 37.7 35.9

Khatripur 315.1 80.9 205.6 1.7 26.9

Pisawada 2168.6 91.0 1797.2 138.5 141.9

Sarandi 1512.7 2.0 1168.0 94.3 248.4

Vautha 1034.7 486.5 169.8 70.9 307.5

JalalpurGodhaneshwer 707.2 290.3 174.7 54.7 187.5

Ambethi 475.6 246.8 155.2 37.7 35.9

Bhetawada 403.9 298.3 25.0 14.7 65.9

Kauka 1940.3 - 1680.7 7.8 251.8

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 3-44

Table: 3.33 Summary of Socio-economic status of Study area (Demography)

Name of the Village/

Town/Ward

No. of Occupied

Residential House

Total Population (Including

institutional and houseless

population)

Literates Total main Workers

Cultivators Agricultural Laborer

Marginal Workers

Non-Worker

P M F M F M F M F M F M F M F VasnaKeliya 1220 5776 2977 2799 2429 1826 1727 572 435 12 859 455 68 417 1182 1810 Shekhdi 136 672 351 321 262 162 199 21 40 2 107 15 19 204 133 96 Sindhraj 558 2577 1313 1264 963 709 721 56 123 1 458 39 57 157 535 1051 Ranoda 443 2122 1097 1025 849 609 568 98 93 5 205 70 11 75 518 852 JalalpurVazifa 846 4071 2129 1942 1588 1017 1211 251 252 6 564 147 121 518 797 1173 Rajpur 214 897 482 415 379 237 286 41 51 1 55 13 10 3 186 371 Ambaliyara 751 3567 1861 1706 1509 1033 996 204 247 4 406 43 196 646 669 856 Sathal 855 4303 2203 2100 1680 1207 1161 77 336 3 678 59 114 646 928 1377 Lana 267 1522 794 728 549 402 372 126 163 25 116 76 90 43 332 559 JalalpurGodhaneshwar

194 906 480 426 354 217 238 31 68 2 67 12 37 130 205 265

Khanpur 271 1451 751 700 440 325 255 17 94 6 82 4 122 68 374 615 Mujpur 87 460 242 218 155 76 143 5 32 1 79 1 5 126 94 87 Dholka (Rural) 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Rampur 479 2266 1204 1062 963 686 590 28 175 4 61 7 202 576 412 458 Khatripur 205 1152 569 583 446 454 352 125 38 2 301 120 1 1 216 457 Sahij 754 3499 1837 1662 1479 1028 1022 89 278 14 557 58 72 289 743 1284 Ambethi 233 1210 619 591 482 335 334 25 109 4 174 16 21 217 264 349 Transad 563 2724 1419 1305 1113 786 778 284 146 6 325 186 85 245 556 776 Bhetawada 462 2496 1315 1181 988 619 663 63 227 3 283 38 64 520 588 598 Nesda 373 1956 1031 925 778 520 502 261 188 10 168 162 121 239 408 425 Dadusar 373 1914 1008 906 723 550 563 72 97 3 375 27 15 194 430 640 Sarandi 520 2374 1323 1051 993 540 800 192 181 7 257 141 10 111 513 748 Kadipur 162 764 384 380 306 193 212 14 102 2 76 12 0 0 172 366 Ambareli 653 3169 1646 1523 1223 838 765 108 316 29 265 46 234 404 647 1011 Paldi 291 1469 767 702 541 340 442 113 178 9 173 73 11 16 314 573 Pisawada 760 3689 1933 1756 1343 993 1110 332 323 42 483 135 57 110 766 1314 Andhari 109 515 265 250 202 113 59 6 24 4 4 1 113 109 93 135 Virpur 303 1612 834 778 575 412 410 48 169 5 136 11 94 209 330 521

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EIA Report of Concord Biotech Ltd. 3-45

Name of the Village/

Town/Ward

No. of Occupied

Residential House

Total Population (Including

institutional and houseless

population)

Literates Total main Workers

Cultivators Agricultural Laborer

Marginal Workers

Non-Worker

P M F M F M F M F M F M F M F Vautha 427 2056 1083 973 864 578 502 89 148 5 172 60 184 220 397 664 Kauka 785 3834 1999 1835 1331 960 1145 102 222 5 673 67 6 55 848 1678 Kaliyapura 111 673 351 322 213 123 170 5 60 1 55 3 0 1 181 316 Juvalrupavati 322 1566 810 756 606 429 406 124 77 1 163 63 24 77 380 555 Sakodara 399 1924 995 929 757 477 576 84 58 5 362 69 24 128 395 717  

   

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 3-46

Table 3.34: Summary of Socio-economic status of Study area (Amenities)

Name of Village

Educational Facility

Medical Facility

Drinking Water Facility

Communication (Post

or Telegraph)

Transportation Facility

(Bus etc.)

Approach to

Village

Nearest town and Distance (Kms.)

Power Supply

Juvalrupavati P, C(5-10) H(5-10),MCW(5-10), PHC(<5)

T,W PO,PH(5-10) BS,RS(<5) PR,MR,FP Bavla(10) EA

VasnaKeliya P(5), S, PUC, C(5-

10)

PHS, RMP(2), H(5-10), MCW(5-10),

PHC(<5)

T,TW PO,PH(256) BS,RS(5-10) PR Dholka(9) EA

Shekhdi P, C(5-10) H(5-10), MCW(5-10), PHC(<5)

T, W, TK PO, PH(8) BS, RS(5-10) PR, MR, FP Dholka(8) EA

Sindhraj P(3), C(5-10)

CWC,RMP, H(5-10),MCW(5-10),

PHC(5-10)

T,TW PO,PH(18) BS,RS(5-10) PR Dholka(5) EA

Lana P(3), C(5-10)

CHW(2),H(5-10), MCW(5-10),PHC(5-10)

T,TW PO,PH(7) BS(5-10), RS(5-10)

PR Dholka(5) EA

Sakodara P, C(+10)

H(+10),MCW(5-10), PHC(5-10)

T,TW PO(<5),PH(10+) BS,RS(10+) PR,MR,FP Bavla(15) EA

Dholka(Rural) P(<5), C(<5)

H(<5),MCW(<5), PHC(10+)

TW,TW PO(<5),PH(<5) BS,RS PR,MR Dholka(4) EA

Ranoda P(2), C(5-10)

H(5-10),MCW(5-10), PHC(5-10)

T,TW PO,PH(21) BS,RS(5-10) PR

Dholka(5) EA

Rajpur P,C(5-10) CHW(2),H(5-10), MCW(5-10),PHC(10+)

T,TW,W, TK

PH(29),PO(10+) BS,RS(5-10) PR Dholka(5) EA

Ambaliyara P(3),S, C(5-10)

PHC,FWC, RMP(2),H(5-10),

MCW(5-10)

T,TW PO,PH(225) BS,RS(5-10) PR Dholka(9) EA

Sathal P(2), C(5-10)

RMP,CHW(2), H(5-10),MCW(5-10),

PHC(5-10)

T,TW,R PO,PH(38) BS,RS(5-10) PR Dholka(10) EA

JalalpurVazifa P(4), C(5-10)

HA(2),SMP(2),CHW(3),H(5-10),MCW(5-10),PHC(10+)

T,TW PO,PH(48) BS,RS(5-10) PR Dholka(5) EA

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 3-47

Name of Village

Educational Facility

Medical Facility

Drinking Water Facility

Communication (Post

or Telegraph)

Transportation Facility

(Bus etc.)

Approach to

Village

Nearest town and Distance (Kms.)

Power Supply

Mujpur P,C(<5) CHW,H(<5),MCW(<5) PHC(<5)

T,TK PO(<5),PH(<5) BS,RS(<5) PR Dholka(3) EA

Ambareli P(2),S, C(5-10)

PHS,CHW(3),H(5-10), MCW(5-10),PHC(10+)

T,TW,W,TK

PO,PH(13) BS,RS(5-10) PR,MR,FP Dholka(9) EA

Kadipur P,C(10+) H(10+), MCW(10+),PHC(10+)

T,TW,W,TK

PH(16), PO(5-10)

BS,RS(5-10) PR,MR,FP Dholka(11) EA

Kaliyapura P,C(10+) CHW,H(10+), MCW(10+),PHC(10+)

T,TW,O PO,PH(5) BS,RS(10+) PR Dholka(16) EA

Virpur P,C(10+) H(10+),MCW(10+), PHC(5-10)

T,TW PH(5),PO(5-10) BS,RS(10+) PR Dholka(14) EA

Andhari P,C(10+) H(10+),MCW(10+), PHC(5-10)

T,TW PH(3),PO(<5) BS,RS(10+) PR Dholka(12) EA

Paldi P,S,AC, C(10+)

CWC(3),PHS,RMP(2), SMP,CHW,H(5-10),

MCW(5-10),PHC(5-10)

T,TW,W, TK,R,O

PO,PH(15)

BS,RS(10+) PR,MR

Ahmedabad(14)

EA

Sahij P(2), C(5-10)

PHS,RMP,CHW,H(5-10),MCW(5-10),PHC(5-

10)

T,TW,O PO,PH(49) BS,RS(10+) PR Dholka(10) EA

Rampur P(2), C(5-10)

RMP,CHW,H(5-10), MCW(5-10),PHC(5-10)

T,TW PO,PH(108) BS,RS(5-10) PR Dholka(5) EA

Khanpur P(2), C(5-10)

H(5-10),MCW(5-10), PHC(5-10)

T,TW,K PO,PH(5-10) BS,RS(10+) PR Dholka(5) EA

Nesda P(2), C(5-10)

H(5-10),MCW(5-10) PHC(5-10)

T,HP,TW, W,TK

PO,PH(10) BS,RS(5-10) PR,MR Dholka(5) EA

Dadusar P,C(5-10) CHW,H(5-10), MCW(5-10)

T,TK PO,PH(13) BS,RS(5-10) PR Dholka(6) EA

Transad P, S, C(5-10)

PHC,RMP,CHW(2), H(5-10),MCW(5-10)

T,TW PO,PH(35) BS,RS(5-10) PR Dholka(7) EA

Khatripur P(2) C(5-10)

CHW,H(5-10), MCW(5-10),PHC(5-10)

T,TW PH(3),PO(5-10) BS,RS(5-10) PR Dholka(7) EA

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 3-48

Name of Village

Educational Facility

Medical Facility

Drinking Water Facility

Communication (Post

or Telegraph)

Transportation Facility

(Bus etc.)

Approach to

Village

Nearest town and Distance (Kms.)

Power Supply

Pisawada P(3) C(10+)

PHS,RMP,CHW(2), H(10+),MCW(10+),

PHC(<5)

T,TW PO,PH(49) BS,RS PR Dholka(11) EA

Sarandi P(3) C(5-10)

PHS,CHW,H(5-10), MCW(5-10),PHC(5-10)

T,HP,TW, TK

PO,PH(22) BS,RS PR Dholka(10) EA

Vautha P(2) C(10+)

PHS,RMP,SMP,H(10+), MCW(10+)

T,TW PO,PH(54) BS,RS(10+) PR,MR,FP Dholka(15) EA

JalalpurGodhaneshwer

P, C(10+)

CHW(2), H(10+), MCW(10+), PHC(10+)

T PO, PH(13) BS, RS PR Dholka(12) EA

Ambethi P, C(5-10)

CHW(2), H(5-10), MCW(5-10), PHC(5-10)

T, TW PH(12), PO(5-10)

BS, RS(5-10)

PR Dholka (5)

EA

Bhetawada P(2), C(5-10)

CHW(2), H(5-10), MCW(5-10), PHC(< 5)

T, TW PH(19), PO(<5)

BS, RS(5-10)

PR Dholka (7)

EA

Kauka P(3), S, AC, C(10+)

NH, D, MCW, CWC, PHS, RMP(2), H(10+),

PHC(10+)

T, TW, W, TK

PO, PTO, PH(119)

BS, RS(10+)

PR

Dholka (18)

EA

   

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 3-49

Abbreviations: Educational P - Primary School C - College, Any college (Graduate level & above) like Arts, Science,

Commerce Ac - Adult Literacy Class/Centre S - Higher Secondary schools PUC - Higher Secondary/Intermediate/Pre-University/Junior College or Senior Secondary

Medical Facility

H - Hospitals MCW - Maternity & Child welfare Centre PHC - Primary Health Centre PHS - Primary Health Sub-Centre RMP - Registered Private Medical Practitioner CWC - Child Welfare Centre CHW - Common Health Worker D - Dispensary FWC - Family Welfare Centre SMP - Subsidized Medical Practitioner NH - Nursing Home

Drinking Water T - Tap Water W - Well Water TW - Tube well Water TK - Tank Water R - River HP - Hand pump O - Other facility

Post and Telegraph PO - Post Office PH - Telephone Connection PTO - Post & Telegraph Office

Transportation BS - Bus RS - Railway Station

Approach to Village PR - Paved Road MR - Mud Road FP - Foot Path

Power Supply EA - Electricity for all Purposes

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 3-50

Figure3.7

Location of AAQM station

Indicating AAQM stations

Project site 

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 3-51

Figure 3.8

Wind Rose diagram

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 3-52

Figure 3.9

Water sampling Locations

Indicating Ground Water sampling location

IndicatingSurface Water Sampling location

Project site 

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 3-53

Figure 3.10

Noisemonitoring locations

Indicating Noise Monitoring location 

Project site 

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 3-54

Figure 3.11

Soil Sampling Locations

Indicating locations of Soil sampling

Project site

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 3-55

Figure 3.12

LULC map (10 km radius) 

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 3-56

Figure 3.13

Topo sheet of location with site location map of 10 km radius

(1:25,000 scale)

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 3-57

Figure 3.14

Topo sheet of location with site location map of 10 km radius

(1:50,000 scale)

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 4-1

Chapter-4 Anticipated Environmental Impacts&

Mitigation Measures

4.1 GENERAL

Environmental Impact can be defined as any change in environmental

conditions which may be adverse or beneficial; occurred due to action or

set of actions under consideration.

It can be assessed by identifying the sources of the impact and predicting

the same. The identification of environmental impacts has been made by

co-relating the relationship between project activity and environmental

parameters. As a part of present EIA study, anticipated environmental

impacts associated with the project activity of the unit have been

identified. The project activities are usually divided into two phases:

Construction Phase and Operation Phase. For evaluation of impacts due

to proposed activities, baseline data has been utilized. Changes in the

environmental parameters & their impact in terms of short term or long

term, positive or negative, reversible & irreversible are identified &

predicted.

The next step is prediction of impacts, which is an important component

in environmental impact assessment process. Several techniques and

methodologies are in vogue for predicting the impacts due to proposed

industrial development on physical, chemical, biological and socio-

economic components of environment. Such predictions delineate

contribution in existing baseline condition for the proposed project. The

additional impacts due to proposed activities are analyzed by keeping in

mind the baseline status. This helps to assess the assimilative capacity of

the environment and in turn the gravity of the impacts. Based on the

identification & prediction of the nature of impact, it can be evaluated

qualitatively and quantitatively.

In this chapter, the effect due to construction & operational activity of the

proposed expansion project is explained.

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EIA Report of Concord Biotech Ltd. 4-2

4.2 IDENTIFICATION OF IMPACT

This chapter deals with the assessment of project impacts on

environment. Mitigation measures are suggested to minimize the likely

negative impacts. The network method (Cause - effect) was adopted to

identify potential impact of the proposed expansion activity. It includes

stepwise study of relationship between an activity and its environmental

parameters. This method involves in the “Road Map” type of approach to

the identification of second&third order effect. The basic idea is to

account for the project activity & identify the type of impact that could

initially occur followed by the identification of secondary and tertiary

impact.

The project will have impacts of varying magnitude on different

environmental components. These impacts could be categorized as -

• Primary impacts, i.e. impacts which occur as a direct result of the

project activities.

• Secondary and tertiary impacts, i.e. impacts that occur as a result

of primary impacts.

4.2.1 Identification of Impacting Activities

Various activities involved in the project are divided viz.:

A. Construction phase activities: impacts are immediate, in the vicinity

and sporadic

B. Operation phase activities: impacts are long term, in wide area and

continuous

The activities identified for the project under each phase are:

Construction phase

• Excavation

• Foundation & Civil work

• Transportation of construction materials, equipments & machineries

• Installation of equipments & machineries

Operation phase

• Plant operation

• Material storage & handling

• Utilities and services

• Green belt development

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EIA Report of Concord Biotech Ltd. 4-3

4.2.2 Identification of Environment Attributes

There are various types of impacts arise due to the proposed expansion

activities which will be evaluated considering the following environment

parameters in construction and operational phase,

• Impact on Topography

• Impact on Air Environment

• Impact on Water Environment

• Impact on Noise Environment

• Impact on Land Environment (Hazardous/solid waste generation)

• Impact on Biological Environment

• Impact on Socio-Economic Environment

• Impact on Occupational Health & Safety

4.3 IMPACT ON TOPOGRAPHY

Proposed expansion will be carried out in the existing premises. During

the construction, excavated soil will be restored to its original shape.

Thus, the impact during the construction is reversible, for short terms

and insignificant. Construction of plant & building will be carried out for

proposed expansion. During the operational phase of the project being an

existing unit, no major impact is envisaged on the topography.

4.4 IMPACT ON AIR ENVIRONMENT

a. Construction Phase impact & mitigation measures

Proposed expansion will be done in the existing premises wherein the

construction activities will be carried out as per the plant design. So,

there will be chances of dust generation. It will be limited up to working

area only and not likely to spread in wider area. To mitigate the impact,

regular sprinkling of the water will be done.Vehicular traffic lead to

increased concentration pollutants through exhaust gases, affecting the

ambient air quality of surrounding areas. Vehicles only with PUC

certificates will be allowed. However, this effect remains localized near to

the plant site during the time of vehicular movement only. So this impact

is envisaged as short term negative &reversible in nature. Hence, looking

to the overall facts described above, it can be concluded that, the impacts

on air due to the construction & erection activities will be minimum or

negligible.

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EIA Report of Concord Biotech Ltd. 4-4

b. Operational phase impact & mitigation measures

Long term impacts on the air quality are anticipated due to operational

activities. It depends on various factors like process technology,

operation&maintenance, raw material, fuel, air pollution control

measures. For the study of impact assessment for air environment, all

probable emissions are studied including fugitive emission. The sources

and expected emission level are described in below section.

Emission from the project

Main source of air emission will be point source & fugitive emission. There

will be no process gas emission. At present, flue gas emission is from one

common stack of 2 nos. of steam Boilers. FO is used as fuel. After

expansion, one boiler will be modified/replace in terms of capacity from 3

TPH to 8 TPH. Therefore, consumption of FO will be increased.Emitted

pollutants will be SPM, SO2 and NOx.Unit has installed D.G. Sets with

capacity of 1000 kVA & 680 kVA. After expansion, D. G. set of 680 kVA

will be dismantled and 3 new stand-by D. G. Sets with capacity of 1000

kVA each will be installed to fulfill power requirement in case of non-

availability of power/emergency. HSD will be used as a fuel.

Mitigation measures

Due to use of liquid fuel i.e. FO, no need of APCM. Adequate stack height

and facility for sampling such as ladder &sampling point is provided as

per the SPCB guidelines for proper dispersion of pollutants.

4.4.1 Air Pollution Dispersion Modeling of stack

Following sub-section give air dispersion modeling details for prediction of

changes in GLC of pollutants emitted from the above stacks.

Objective: The objective of dispersion modeling is to predict the ground

level concentration during the operation of the project and its impact on

ambient air quality of the area concentrations and compare with

applicable NAAQS.

Model used: The impact on air quality due to emissions from single

source or group of sources is evaluated by use of mathematical models.

The impacts of air pollutants were predicted usingGaussian air dispersion

model, which is selected on the basis of existence of multiple point

sources within the industrial complex and the plain terrain at the project

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site. In order to predict the impact of air pollutants on ambient air

quality, ISCST3 model (Industrial Source Complex – Short Term

(ISCST3) dispersion model) of United State Environmental Protection

Agency (USEPA) was used by considering guidelines stipulated by CPCB

for air pollution dispersion modeling. The Gaussian model provides

estimates of pollutant concentrations at various receptor locations.

It is an hour-by-hour steady state Gaussian model which takes into

account the following:

• Terrain adjustments

• Stack-tip downwash

• Gradual plume rise

• Buoyancy-induced dispersion, and

• Complex terrain treatment and consideration of partial reflection

• Plume reflection off elevated terrain

• Building down wash

• Partial penetration of elevated inversions is accounted for Hourly

source emission rates, exit velocity and stack gas temperature

Only two stability conditions based on the meteorology aspects were used

to calculate the theoretical maximum ground level concentration is

comparing the actual data and data generated from mathematical

modeling, it highlights that the stability condition E & A-Bwere

predominant in the region.

Following are the assumptions made while using the model:

- No dry and wet depletion of pollutants

- Receptors are on flat terrain

The key emitted pollutants will be SPM, SO2 and NOx.

4.4.2 Micrometeorology

Hourly micrometeorological data collected during the study period

(March, 2016 to May, 2016) have been used for modeling. The hourly

wind speed, solar insolation & total cloudiness during day time and wind

speed & total cloudiness during night time were used to determine the

hourly atmospheric stability classes (defined by Pasquill and Gifford as A

to F, A being most unstable and F being most stable). The hourly stability

classes were determined based on the technique suggested by Turner.

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EIA Report of Concord Biotech Ltd. 4-6

Turner’s system used for determining the stability classes is as follows:

- For day or night: If total cloud cover (TC) = 10/10 and ceiling

<7000 ft (2134 m), NR=0

- For night-time (defined as period from one hour before sunset to

one hour after sunrise):

a) If TC<4/10, use NR = -2

b) If TC>4/10, use NR = -1

- For daytime: determine isolation class number (IN)

a) If TC<5/10, use NR=IN

b) If TC>5/10, modify IN by the sum of the following applicable

criteria

If ceiling<7000 ft (2134 m), modification = -2

If ceiling>7000 ft but <16000 ft (4877 m), modification = -1

- If TC=10/10 and ceiling>7000 ft, modification = -1 and let modified

value of IN=NR, except for day-time NR cannot be <+1.

During the study period, stability calculated based on above-mentioned

Turner method gives average stability as A-B class during Day time and E

class during Night time.

4.4.3 Input data

Stack emissions data have been used for prediction of incremental GLC

values of PM, SO2, NOx using one season meteorological data during

March, 2016 to May, 2016. Input data includesquantitative expected

emission levels, temperature, mixing height from the stack. Input data is

given in Table 4.1.

4.4.4 Receptor Network

Uniform polar grid and ambient air monitoring locations are considered as

discrete Cartesian receptor network for entire study area of 10 km radius.

4.4.5 Output of model (24-hourly GLCs)

The 24-hourly average Ground Level Concentration (GLC) values from

proposed project have been computed for PM, SO2, NOx considering

topographical features around the plant & applicable stability classes. The

maximum 50 (24-hr) average concentration values for PM, SO2, NOx are

given in Table 4.3 to 4.5. Corresponding Isopleths for 24-hourly

predicted value is generated which is shown in Figure 4.1 to 4.3.

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EIA Report of Concord Biotech Ltd. 4-7

It may be noted from the computed result for the proposed scenario that,

the highest 24-hourly average GLCs value of PM, SO2, NOx from the

proposed expansion activity are 0.434 μg/m3, 0.173 μg/m3, 0.182μg/m3,

respectively. These GLCs are expected to occur at a distance of 1.0 km

from the source in E direction for PM, SO2& NOx. With this marginal

contribution due to the proposal of the project, the levels of PM10, SO2&

NOx will remain well below the 24-hourly ambient air quality standards

for SO2& NOx (80 μg/m3), PM10 (100 μg/m3), PM2.5 (60 μg/m3) prescribed

by CPCB.

4.4.6 Incremental & cumulative concentration of pollutants

The maximum incremental GLCs due to project for SPM, SO2, NOx is

superimposed on the baseline concentrations recorded during the study

period to arrive at the likely resultant concentrations after

implementation of the proposed plant. The cumulative concentrations

(baseline + incremental) of the project is tabulated below at Table 4.2.

4.4.7 Conclusion

The modeling study proved that, the air emissions from the proposed

expansion activities would not likely to cause any significant impact on

the ambient air quality of the study area. The ambient air quality around

project site will remain within the National Ambient Air Quality Standards

(NAAQS) prescribed for residential area.

4.5 IMPACT ON WATER ENVIRONMENT

The main sources of impact on water environment will be due to

withdrawal of fresh water from the ground during construction and

operation phase. These are discussed below.

a. Construction Phase impacts & mitigation measures

The water requirement for various purposes will be met from own bore

well. During construction work, water requirement is estimated to be

about 15-20 KLD depending upon nature of construction work. In addition

to this, about 2-3 KLD fresh water will be required for domestic activities

of the construction staff which will also be met through the same

source.There will be no wastewater generation from the construction

work. Hence, it can be concluded that there will be no adverse impact

during construction phase.

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EIA Report of Concord Biotech Ltd. 4-8

b. Operational Phase impacts & mitigation measures

Raw water requirement for the project will be met from own bore well.

After expansion, total fresh water requirement will be increased up to 556

KLD, which will have impact on ground water.

c. Impact Assessment

As fresh water will be extracted from ground, there will be some impact

on the ground water table. However, it will be balanced by recharging

ground water during the monsoon season. For that, industry has

developed rain water harvesting structure. Thus, by recharging the

ground water during the rain, unit will contribute to balance groundwater.

So, there will not be any major impact on the water environment due to

proposed expansion activities.

Additionally, generated w/w will be treated in in-house ETP. Reject from

first stage RO will be sent to second stage RO. Reject from second stage

RO will be sent to MVR/MEE. Condensate of MVR/MEE & permeate of

second stage RO will be used in Cooling. Entire quantity of treated water

from ETP is utilized for greenbelt development. Domestic w/w is also

treated in ETP along with industrial effluent. Proper, effective planning

will be implemented to minimize the temporary effect on water resources.

Mitigation Measures:

• Minimum use of water will be done for construction phase.

• Regular maintenance of rain water harvesting structures shall be

undertaken to have effective recharge.

• Condensate of MVR/MEE & permeate of second stage RO will be used

in coolingto reduce burden on fresh water resources.

4.6 IMPACT ON NOISE ENVIRONMENT

Any unwanted sound that creates disturbance in hearing is termed as

Noise. Hence, it is important to assess the present noise quality of the

area in order to predict the potential impact of future noise levels due to

the project.

a. Construction Phase Impact & mitigation measures

During the construction phase, impacts on noise level will occur due to

the noise generation from new equipments/machineries as well as some

impact due to transportation. Mainly the impacts of increased noise levels

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EIA Report of Concord Biotech Ltd. 4-9

during construction are likely to occur due to increase movement of

trucks &other diesel powered material handling equipment. The impacts

of noise during the construction would be restricted to the site only and

will be temporary. PPEs like ear muff/ear plug will be provided to the

workers. Regular maintenance & lubrication of construction equipment &

machineries will be undertaken to reduce the noise generation. Thus, it is

envisaged that the impacts on noise during the construction phase would

be insignificant after mitigation measure.

b. Operational Phase Impact & mitigation measures

During operation of the project, noise levels will increase considerably

due to operation of boiler, generators, reactors etc. The noise anticipated

from the project will be confined only within plant boundary. Adequate

greenbelt is developed for prevention of noise propagation outside plant

premises.Oiling/lubrication & preventive maintenance will be done to

reduce noise generation at source to the permissible limit. However, at

places where noise levels may exceed the limit, PPEs will be provided to

workers. Adequate noise control measures such as silencers, anti-

vibration pad etc. will be provided. All the equipment will be

designed/operated in such a way that the noise level in work place shall

not exceed 85 dB(A) as per the OSHA Standard. During operation, the

protective measures like PPEs (ear muff, ear plug) will be provided & the

exposure duration of workers/other personnel to noise will be managed

as per OSHA standard.The results of baseline monitoring carried out in

the region are presented in Chapter-3. The results are below the

standards prescribed for Industrial environment. It can be concluded

that, the impact on noise environment will be long term but insignificant.

4.7 IMPACT ON LAND ENVIRONMENT

The main source of impact on land and soil environment will be due to

construction activities and hazardous waste disposal.

a. Construction Phase Impact & mitigation measures

Since the proposed expansion activities will be carried out in the existing

premises leveling would not be required. There will be no change in land

use as the land is already been converted for use of industrial

purpose.The construction activities like excavation, clearing, leveling &

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EIA Report of Concord Biotech Ltd. 4-10

vehicular movements will entail change in the landscape, which are

expected to be of short duration and insignificant. Unit will provide

sanitation facilities for the staff engaged in construction work which will

prevent the impacts on land. Thus, there will not be any issue of impacts

on land during the construction phase.

b. Operational Phase impact (Solid/Hazardous Waste)

During the operation phase, it is identified that the impacts on land would

occur due to the contamination by Solid/Hazardous wastes. The

hazardous wastes are the major source of impacts on land. Hazardous

waste generation from project must be considered to identify the

potential impacts. There will be increase in the quantity of generation of

hazardous waste. Total qty. after proposed expansion is given below.

Details of Hazardous Wastes

a) ETP Sludge + MEE salt – 137.0MT/month

b) Distillation Residue – 20.0 MT/month

c) Spent Carbon – 12.0 MT/month

d) Discarded containers/ liners – 5000 nos./month

e) Used Oil – 3.0 kl/yr.

f) Off specific products/date expire product – whatever generated

Entire quantity of the hazardous waste will be stored in the isolated

hazardous waste storage area within premises having impervious

platform having RCC floor, leachate collection system & roof cover and

disposed as per the scientific method. No adverse impact on the land

environment is likely to occur. Hence, no significant negative impact is

envisaged on the surrounding soil quality.

4.8 IMPACT ON BIOLOGICAL ENVIRONMENT

a. Construction phase impact & mitigation measures

Unit is already in existence, so there will not be any cutting of natural

vegetation. Thus, it is envisaged that there will not be any adverse

impacts on the ecology/biological environment in construction phase.

b. Operational phase impact & mitigation measures

There are no protected areas like national park/wildlife sanctuary within

the 10 km radial of the project site so there will not be any significant

impact on ecology. No endangered floral or faunal species has been

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recorded within the study area. Further, unit already has developed

greenbelt&proposed to make it denser to enhance the biological feature

of the site. Also, the trees are identified for their sensitivity & pollution

tolerance capacity.Following is the list of trees which are helpful as

pollution absorber and at the same time pollution sensitive.

Family Name Botanical Name Common Name

Sensitive Tolerant

Anacardiaceae Mangiferaindica Mango Cement dust, Coal dust, SO2

Dust collector

Anonaceae Polyalthialongifolia Asopalav SO2 Dust collector

Caesalpini-aceae

Cassia fistula Garmalo Cement dust, Poor Dust collector, SO2

N.A

Delonixregia Gulmohar SO2, Fly ash, Cement dust

N.A

Meliaceae Azadirachtaindica Neem Cement dust SO2

Mimosaceae Pithecellobiumdulce Gorasamli N.A Better Dust collector, SO2

There will not be any discharge of effluent from the plant into any water

body; hence there will not be any impact on aquatic ecology of the

surrounding area. GLCs of air pollutants will remain low and hence no

significant impact on terrestrial ecology is expected. Thus, there will not

be any significant impact on ecological environment due to proposed

expansion activities.

4.9 IMPACT ON SOCIO-ECONOMIC ENVIRONMENT

a. Construction Phase Impacts & mitigation measures

During the peak construction phase, construction manpower including

construction workers will be employed.However, to the maximum extent

possible, construction workers will be employed from within the study

area. Since the construction phase of this project will be for short time

period, the socio-economic impact due to construction of this project is

going to be temporary.Around 25-30 workers will be employed in the

construction work. This will increase construction employment in the

study area. As the construction phase for the proposed project will be few

months, the impact would be temporary.

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EIA Report of Concord Biotech Ltd. 4-12

b. Operation Phase Impacts & mitigation measures

The proposed expansion activities will be carried out in the existing plant

premises. Therefore, no displacement of person is envisaged. Unit will

provide employment opportunity to locally available skilled and un-skilled

labours at different level as per the requirement, which in turn result into

a positive impact on prevailing socio-economic environment. For the

proposed expansion, additional 100 nos. of workers will be employed. In

addition, employment will be generated by the secondary supporting

activities e.g. transportation, communication, daily utility services.

Surrounding area has got good educational facilities and most of

employees will come from the surrounding area. Thus, overall impacts on

socio-economic environment are long term and positive in nature.

4.10 IMPACT ON OCCUPATIONAL HEALTH & SAFETY

a. Construction Phase Impacts & mitigation measures

In the Construction phase, some effects on occupational health &safety of

the employees working in the site are envisaged. Major health issues

encountered will be physical hazards & accidental Hazard. All plans and

construction schedule will be followed as per relevant laws approved by

competent authority, so as to minimize the occupational health hazards.

Sr. No.

Environmental Attribute

Mitigation Measures

1 Safety & Health • Necessary PPEs like helmets, ear plug/ear muff, safety shoes, goggles etc. will be provided to workers.

• Incident/accident reporting system will be developed and all the employees will be made aware for the same.

• Periodic inspection & testing of equipments & machineries will be done.

b. Operational Phase Impacts & mitigation measures

In operational phase, various effects on occupational health and safety of

the employees working in the plant are envisaged. Major health and

safety issues encountered will be physical hazards, respiratory hazards,

electrical hazards, noise, fire hazards associated while working within the

plant.

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Preventive safety measures shall be taken to minimize the risk of

accident with respect to chemical handling.

Sr. No.

Environmental Attribute

Mitigation Measures

1 Safety & Health Emergency preparedness plan should be implemented. First aid/other emergency treatment should be provided. Workers shall be well equipped with personal protective equipments. Only authorized persons will be allowed inside the plant. A health monitoring program shall be in place to monitor the health of the persons working on the site to ensure the health status of all concerned. Fire hydrant system, fire extinguishers will be installed at different locations within premises. Sign boards will be displayed at designated locations indicating appropriate hazard warnings. Good house-keeping will be ensured within the factory premises.

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EIA Report of Concord Biotech Ltd. 4-14

Table 4.1

Input data for air quality modeling

Sr. No.

Stack attached to

Stack Temp. (0K)

Velocity (m/s)

Stack Height

(m)

Dia. (m)

Fuel Used

SPM mg/ Nm3

SO2 mg/ Nm3

NOX mg/ Nm3

Existing performance of air emission 1 Steam Boiler

(2 nos.- one stand by)

448 7.9 45 0.8 Furnace Oil

78 32.0 28.2

2 D.G. Set (1000 kVA)

468 15.5 30 0.4 HSD 72 27.4 32.5

Estimated air emission of proposed stacks 1 DG set (1000

kVA x 3 nos.) 470 16.0 30 0.4 HSD 75 30.0 35.0

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Table 4.2

Cumulative Concentrations at various locations

Station Direction Dist.

(Km)

Baseline Concentration

(µg/m3)

Predicted GLCs (µg/m3)

Cumulative Concentration

(µg/m3) PM SO2

NOx PM SO2 NOx PM SO2

NOx

Project site

- -- 70.0 20.8 23.3 0.1 0.03 0.03 70.1 20.8 23.3

Khanpur W 5.0 66.4 16.5 19.9 0.0 0.0 0.0 66.4 16.5 19.9

Mujpur N 2.4 63.6 22.1 25.1 0.04 0.02 0.02 63.6 22.1 25.1

Dholka WSW 2.8 64.0 21.8 24.5 0.04 0.02 0.02 64.0 21.8 24.5

Rampur ENE 3.7 63.7 16.8 20.0 0.04 0.02 0.02 63.7 16.8 20.0

Paldi SSW 5.6 62.4 17.7 20.7 0.02 0.01 0.01 62.4 17.7 20.7

Andhari ESE 5.5 58.9 19.0 21.7 0.08 0.03 0.03 59.0 19.0 21.7

Sathal ENE 6.7 65.0 16.5 19.3 0.02 0.01 0.01 65.02 16.51 19.31

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Table 4.3

The 24-hourly average GLC Concentration Values for SPM RANK CONC RECEPTOR (XR,YR) TYPE RANK CONC RECEPTOR (XR,YR) TYPE

1 0.434 ( 1000.00, .00) GC 26 0.205 ( 1000.00, 1000.00) GC

2 0.314 ( 1000.00, .00) GC 27 0.205 ( 1000.00, -1000.00) GC

3 0.313 ( 1000.00, .00) GC 28 0.204 ( 2000.00, 2000.00) GC

4 0.276 ( -1000.00, -1000.00) GC 29 0.204 ( 3000.00, .00) GC

5 0.261 ( 1000.00, .00) GC 30 0.202 ( 1000.00, 1000.00) GC

6 0.259 ( .00, -1000.00) GC 31 0.202 ( 1000.00, .00) GC

7 0.259 ( 1000.00, .00) GC 32 0.198 ( .00, -1000.00) GC

8 0.258 ( .00, -2000.00) GC 33 0.197 ( 4000.00, .00) GC

9 0.248 ( 2000.00, 2000.00) GC 34 0.197 ( 2000.00, 2000.00) GC

10 0.246 ( 2000.00, .00) GC 35 0.196 ( 3000.00, .00) GC

11 0.241 ( 2000.00, .00) GC 36 0.195 ( 3000.00, .00) GC

12 0.238 ( 5000.00, -2000.00) GC 37 0.195 ( .00, -4000.00) GC

13 0.228 ( .00, -3000.00) GC 38 0.192 ( 2000.00, -2000.00) GC

14 0.224 ( 1000.00, 1000.00) GC 39 0.190 ( 2000.00, 2000.00) GC

15 0.224 ( 2000.00, -5000.00) GC 40 0.187 ( 2000.00, .00) GC

16 0.219 ( 3000.00, .00) GC 41 0.187 ( 4000.00, .00) GC

17 0.218 ( 1000.00, -1000.00) GC 42 0.187 ( 2000.00, .00) GC

18 0.217 ( 3000.00, .00) GC 43 0.185 ( 2000.00, 2000.00) GC

19 0.216 ( 2000.00, .00) GC 44 0.185 ( 1000.00, 1000.00) GC

20 0.214 ( 5000.00, -2000.00) GC 45 0.183 ( 3000.00, -7000.00) GC

21 0.211 ( 2000.00, .00) GC 46 0.182 ( 1000.00, .00) GC

22 0.210 ( 3000.00, 3000.00) GC 47 0.182 ( 2000.00, .00) GC

23 0.210 ( 2000.00, -2000.00) GC 48 0.182 ( 1000.00, -2000.00) GC

24 0.207 ( 2000.00, .00) GC 49 0.181 ( 2000.00, -2000.00) GC

25 0.205 ( 1000.00, -2000.00) GC 50 0.181 ( 5000.00, 2000.00) GC

Note: Receptor Types: GC = Grid cart, Concentration in µg/m3

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Table 4.4

The 24-hourly average GLC Concentration Values for SO2 RANK CONC RECEPTOR (XR,YR) TYPE RANK CONC RECEPTOR (XR,YR) TYPE

1 0.173 ( 1000.00, .00) GC 26 0.081 ( 3000.00, .00) GC

2 0.125 ( 1000.00, .00) GC 27 0.080 ( 1000.00, 1000.00) GC

3 0.124 ( 1000.00, .00) GC 28 0.080 ( 1000.00, -2000.00) GC

4 0.110 ( -1000.00, -1000.00) GC 29 0.080 ( 2000.00, 2000.00) GC

5 0.104 ( 1000.00, .00) GC 30 0.080 ( 1000.00, .00) GC

6 0.103 ( 1000.00, .00) GC 31 0.080 ( 1000.00, 1000.00) GC

7 0.103 ( .00, -1000.00) GC 32 0.079 ( .00, -1000.00) GC

8 0.102 ( .00, -2000.00) GC 33 0.078 ( 4000.00, .00) GC

9 0.098 ( 2000.00, 2000.00) GC 34 0.078 ( 2000.00, 2000.00) GC

10 0.097 ( 2000.00, .00) GC 35 0.077 ( 3000.00, .00) GC

11 0.095 ( 2000.00, .00) GC 36 0.077 ( .00, -4000.00) GC

12 0.094 ( 5000.00, -2000.00) GC 37 0.077 ( 3000.00, .00) GC

13 0.090 ( .00, -3000.00) GC 38 0.076 ( 2000.00, -2000.00) GC

14 0.089 ( 2000.00, -5000.00) GC 39 0.075 ( 2000.00, 2000.00) GC

15 0.088 ( 1000.00, 1000.00) GC 40 0.074 ( 2000.00, .00) GC

16 0.086 ( 1000.00, -1000.00) GC 41 0.074 ( 4000.00, .00) GC

17 0.086 ( 3000.00, .00) GC 42 0.074 ( 2000.00, .00) GC

18 0.086 ( 3000.00, .00) GC 43 0.073 ( 2000.00, 2000.00) GC

19 0.085 ( 5000.00, -2000.00) GC 44 0.073 ( 1000.00, .00) GC

20 0.085 ( 2000.00, .00) GC 45 0.073 ( 3000.00, -7000.00) GC

21 0.083 ( 3000.00, 3000.00) GC 46 0.072 ( 1000.00, 1000.00) GC

22 0.083 ( 2000.00, .00) GC 47 0.072 ( 5000.00, 2000.00) GC

23 0.083 ( 2000.00, -2000.00) GC 48 0.072 ( 1000.00, -1000.00) GC

24 0.081 ( 1000.00, -1000.00) GC 49 0.071 ( 2000.00, 2000.00) GC

25 0.081 ( 2000.00, .00) GC 50 0.071 ( 2000.00, -2000.00) GC

Note: Receptor Types: GC = Grid cart, Concentration in µg/m3

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EIA Report of Concord Biotech Ltd. 4-18

Table 4.5

The 24-hourly average GLC Concentration Values for NOx RANK CONC RECEPTOR (XR,YR) TYPE RANK CONC RECEPTOR (XR,YR) TYPE

1 0.182 ( 1000.00, .00) GC 26 0.089 ( 1000.00, 1000.00) GC

2 0.133 ( 1000.00, .00) GC 27 0.088 ( 2000.00, 2000.00) GC

3 0.132 ( 1000.00, .00) GC 28 0.087 ( 1000.00, 1000.00) GC

4 0.117 ( -1000.00, -1000.00) GC 29 0.087 ( 3000.00, .00) GC

5 0.111 ( 1000.00, .00) GC 30 0.086 ( 1000.00, .00) GC

6 0.111 ( .00, -2000.00) GC 31 0.086 ( 1000.00, -1000.00) GC

7 0.110 ( .00, -1000.00) GC 32 0.085 ( 2000.00, 2000.00) GC

8 0.108 ( 1000.00, .00) GC 33 0.085 ( 4000.00, .00) GC

9 0.108 ( 2000.00, 2000.00) GC 34 0.085 ( 3000.00, .00) GC

10 0.106 ( 2000.00, .00) GC 35 0.084 ( 3000.00, .00) GC

11 0.104 ( 2000.00, .00) GC 36 0.083 ( .00, -4000.00) GC

12 0.101 ( 5000.00, -2000.00) GC 37 0.083 ( 2000.00, 2000.00) GC

13 0.097 ( .00, -3000.00) GC 38 0.083 ( 1000.00, 1000.00) GC

14 0.097 ( 1000.00, 1000.00) GC 39 0.082 ( .00, -1000.00) GC

15 0.095 ( 3000.00, .00) GC 40 0.082 ( 2000.00, -2000.00) GC

16 0.095 ( 2000.00, -5000.00) GC 41 0.081 ( 1000.00, -2000.00) GC

17 0.095 ( 2000.00, .00) GC 42 0.080 ( 2000.00, .00) GC

18 0.093 ( 3000.00, .00) GC 43 0.080 ( 2000.00, 2000.00) GC

19 0.093 ( 1000.00, -1000.00) GC 44 0.080 ( 1000.00, 1000.00) GC

20 0.092 ( 2000.00, .00) GC 45 0.080 ( 4000.00, .00) GC

21 0.091 ( 5000.00, -2000.00) GC 46 0.079 ( 2000.00, .00) GC

22 0.090 ( 1000.00, -2000.00) GC 47 0.079 ( 2000.00, .00) GC

23 0.090 ( 2000.00, -2000.00) GC 48 0.078 ( 2000.00, -2000.00) GC

24 0.090 ( 3000.00, 3000.00) GC 49 0.078 ( 2000.00, 2000.00) GC

25 0.090 ( 2000.00, .00) GC 50 0.078 ( 3000.00, -7000.00) GC

Note: Receptor Types: GC = Grid cart, Concentration in µg/m3

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EIA Report of Concord Biotech Ltd. 4-19

Figure 4.1: Isopleths for Ground Level Concentrations for SPM

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EIA Report of Concord Biotech Ltd. 4-20

Figure 4.2: Isopleths for Ground Level Concentrations for SO2

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EIA Report of Concord Biotech Ltd. 4-21

Figure 4.3: Isopleths for Ground Level Concentrations for NOx

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EIA Report of Concord Biotech Ltd. 5-1

Chapter-5 Analysis of Alternatives

5.1 PROLOGUE

Alternative analysis is the process of analyzing the proposed locating for

suitability for basic necessities to operate the plant safely, this analysis

also covers the environmental aspect of pollution prevention and

improvement in quality of life nearby the project vicinity. The project

alternative is the course of action in pace of another, that would meet the

same purpose and need, but which would avoid or minimize negative

impacts and enhance project benefits.

Such projects may result in specific impacts which can be avoided or

mitigated by adherence to certain predetermined performance standards,

guidelines or design criteria. Alternative approaches may therefore be

more effective in integrating environmental and social concerns into the

project planning process.

5.2 SITE ALTERNATIVE

Concord Biotech Ltd. is an existing unit and proposed expansion will be

carried out in existing premises. The existing open area of the plot is

sufficient for further expansion activities. Therefore, no other site or area

was considered for expansion activities.

5.3 PROCESS ALTERNATIVE

The unit is manufacturing Pharmaceutical Bulk Drugs andit involves

fermentation process and physical operations like filtration, separation,

extraction,pulverization, sieving and drying. The unit has adopted latest

and best technologyavailable so far in the market for the manufacturing

of such products. The unit intendsto do expansion with the same category

of products and hence technology finalized forthe proposed expansion

project is similar kind that of existing one.

Moreover, the unit is very concerns and conscious about the product

quality andequally about the environmental protection and resource

conservation; and hence theyput their efforts for upgrading their existing

process time totime with the best available technology for the

biotechnology based pharmaceutical industry.Unit has own R&D

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EIA Report of Concord Biotech Ltd. 5-2

centrewhich work on process modification to achieve best technology for

respective products.

The existing technology used by Concord Biotech Ltd. for manufacturing

of Bulk Drugs is one of the best and proven technologies available in the

market; hence no alternative process technology has been analysed.

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EIA Report of Concord Biotech Ltd. 6-1

Chapter-6 Environmental Monitoring Programme

6.1 PRELUDE

Environment monitoring is the sampling and analysis tool to know the

environment conditions at particular time. The record of environmental

monitoring is most important as the environmental changes are slow in

nature and impact appears after many years. Environmental Monitoring is

the technical heart of assessment of environmental and social impacts

arising due to implementation of the proposed project. An equally

essential element of this process is to develop measures to eliminate,

offset or reduce impacts to acceptable levels during implementation and

operation of projects. The integration of such measures into project

implementation and operation is supported by clearly defining the

environmental requirements within an Environmental Management Plan.

Concord Biotech Ltd. proposed to expand capacity of bulk drugs

manufacturing in the same plant premises. It has adequate

environmental monitoring programme.

6.2 ENVIRONMENT MONITORING PROGRAM

The continuous monitoring of Environmental parameters like air, water,

noise, soil and performance of pollution control facilities and safety

measures in the plant are vital for proper Environmental management of

any industrial project. Therefore, the company shall create environmental

monitoring facilities by the environmental and safety department to

monitor air and water pollutants as per the guideline of GPCB & CPCB.

Moreover, air and water shall be monitored by outside agencies

authorized by GPCB at regular frequencies. This department shall also

carry out periodical checkup of fire and safety equipments.

6.3 OBJECTIVE OF MONITORING PLAN

The basic objective of implementing a monitoring plan on a regular basis

is as follows:

To know the pollution status within the plant and its vicinity.

Generate data for corrective action in respect of pollution.

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EIA Report of Concord Biotech Ltd. 6-2

Correlate the production operations with emission & control

mechanism.

Examine the performance of pollution control system.

Assess the Environmental impacts.

Remedial measures and environment management plant to reverse

the impacts.

6.4 SCHEDULE FOR ENVIRONMENT MONITORING

The environmental monitoring will be scheduled on regular interval to

assess the conditions. The record of these monitoring will be compared

with the baseline study to know the changes in environmental conditions.

The post-project environmental monitoring suggested herewith should be

as per the following guideline.

The highlights of the integrated environmental monitoring plan are:

• The stack monitoring facilities like ladder, platform and porthole at

all the stacks will be maintained in good condition.

• Regular monitoring of all gaseous emissions from stacks/vents.

• The performance of air pollution control equipment evaluated based

on these monitoring results.

• Water consumption will be recorded daily.

• As far as possible, noise curbed at its source, with the help of

acoustic hoods and other such noise reducing equipment. Regular

noise level monitoring will be carried out.

• Greenbelt will be properly maintained and new plantation

programmes will be undertaken frequently.

• Continuous environmental awareness programmes will be carried

out for the employees and also in the surrounding villages.

6.5 AMBIENT AIR QUALITY MONITORING

Scheme for monitoring ambient air quality, stack emissions and fugitive

emissions are proposed. The ambient air quality monitoring systems are

recommended for monitoring the ground level concentrations and fugitive

emissions around the plant. Unit should install three monitoring stations

around its battery limit (at 1200 as per guideline) for monitoring PM, SO2

and NOx. The combined data will provide overall characteristic and

emission from the industry. For this, the following equipment is

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EIA Report of Concord Biotech Ltd. 6-3

recommended to be procured or can higher the services from

Environmental consultant by the project proponent for implementing the

above mentioned monitoring schemes:

Respirable Dust Sampler

Blower - 1.0-1.5 m3/min capacity with adapter for uniform suction

through filter and a properly calibrated manometer assembly for the

determination of flow rate through filter paper.

Rota meter - For gaseous sampling, calibrated Rota meter (0-5 LPM) for

maintaining flow rate should be provided.

Main housing - The main housing should be rectangular with a stand of

about 1.25 m height.

Besides this, stack emissions monitoring as per SPCB guidelines shall be

carried out.

Water Environment:

Entire quantity of wastewater will be sent to ETP. Domestic effluent is

also sent to ETP along with industrial wastewater. Reject from first stage

RO will be sent to second stage RO. Reject from second stage RO will be

sent to MVR/MEE. Condensate of MVR/MEE & permeate of second stage

RO will be used in Cooling. Treated water from ETP is utilized for

greenbelt development.

Noise Environment:

Monitoring of noise levels is essential to assess the efficacy of

maintenance schedules undertaken to reduce noise levels and noise

protection measures. A good quality digital sound pressure level meter is

essential for this purpose.

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EIA Report of Concord Biotech Ltd. 6-4

Table: 6.1 Environment Monitoring Plan

Nature of Analysis Frequency of analysis with

its analyzer

Parameters

Wastewater analysis Monthly by external agency pH, TDS, SS, Oil &

Grease, etc.

Stack Monitoring of

each stack

Monthly by external agency PM, SO2, NOX

Ambient Air Quality

Monitoring

Monthly for 24 hours or as

per the statutory conditions

by external agency

PM10, PM2.5, SO2, NOX

Noise level Monthly as per the statutory

conditions by external agency

Nr. Main gate, Nr. boiler, Nr. D. G. Set, Process area etc.

Work zone fugitive

monitoring

Monthly by external agency RPM, VOCs, acid mist

Health check-up of

workers

As per the statutory guideline All workers

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EIA Report of Concord Biotech Ltd. 6-5

Table: 6.2 Budget for implementation of Environmental Monitoring Plan

Particulars No. of location

Parameters Methodologies

Method of Monitoring

Method of Analysis

Stack Monitoring of each stack

All stacks PM, SO2, NOx Stack monitoring

kit

PM: IS 11255: part-1: 1985 SO2: IS 11255: part-2: 1985 NOx: IS 11255: part-7: 2005

Ambient Air Quality Monitoring

3 locations PM2.5, PM10, SO2, NOx

RDS, Fine particulate sampler

PM2.5: IS 5182: part-23: 2006 PM10: IS 5182: part-23: 2006 SO2: IS 5182: part-2: 2001 NOx: IS 5182: part-6: 2006

Waste water Analysis

1 sample pH, TDS, SS, Oil & Grease,

etc.

-- APHA-AWWA 22nd edition

Work zone fugitive monitoring

2 to 3 locations

RPM, VOCs, Acid mist

Personal sampler,

VOC sampler

Gravimetric, GC, Colorimetric

Noise Pollution 6 to 8 locations

Sound Level Meter

Sound Level Meter

Sound Level Meter

Health status of workers

All workers As suggested by panel doctor

-- --

Budgetary provision for environment & safety management system has been

made in the project planning with Rs. 3.0crore as capital cost for additional EMS

and Rs. 3.25 crorerecurring cost per annum.

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EIA report of Concord Biotech Ltd. 7-1

Chapter-7 Additional Studies

(A) Hazards Analysis & Risk Assessment

7.1 INTRODUCTION

Industrial plants deal with materials, which are generally hazardous in

nature by virtue of their intrinsic chemical properties or their operating

temperatures or pressures or a combination of these. Fire, explosion,

toxic release or combinations of these are the hazards associated with

industrial plants using hazardous chemicals. More comprehensive,

systematic and sophisticated methods of Safety Engineering, such as,

Hazard Analysis and Quantitative Risk Assessment have now been

developed to improve upon the integrity, reliability and safety of

industrial plants. The primary emphasis in safety engineering is to reduce

risk to human life, property and environment. Some of the more

important methods used to achieve this are:

Quantitative Risk Analysis: Provides a relative measure of the

likelihood and severity of various possible hazardous events by

critically examining the plant process and design.

Work Safety Analysis: The technique discerns whether the plant

layout and operating procedures in practice have any inherent

infirmities.

Safety Audit: Takes a careful look at plant operating conditions, work

practices and work environments to detect unsafe conditions.

Together, these three broad tools attempt to minimize the chances of

accidents occurring. Yet, there always exists, no matter how remote,

probability of occurrence of a major accident. If the accident involves

highly hazardous chemicals in sufficiently large quantities, the

consequences may be serious to the plant, to surrounding areas and the

populations residing therein.

7.2 RISK ASSESSMENT-Identification of Hazard

A three ‘levels’ risk assessment approach has been adopted for the M/s.

Concord Biotech Ltd. (Henceforth Concord) for its expansion project

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EIA report of Concord Biotech Ltd. 7-2

located at Plot No. 1482-1486, Trasad Road, Taluka: Dholka, Dist.

Ahmedabad, Gujarat. The risk assessment levels are generally consistent

with the practices encountered through various assignments for medium

and large chemical complexes. The brief outline of the three tier approach

is given below:

Level 1 – Risk Screening

This is top-down review of worst- case potential hazards/risks, aimed

primarily at identifying plant sites or areas within plant, which pose the

highest risk. Various screening factors considered include:

• Inventory of hazardous materials;

• Hazardous Materials properties;

• Storage conditions (e.g. temperature and pressure);

• Location sensitivity (distance to residential areas/populace).

The data/information is obtained from plant. The results provide a

relative indication of the extent of hazards and potential for risk

exposure.

Level 2 – Major Risk Survey (Semi - Quantitative)

The survey approach combines the site inspection with established risk

assessment techniques applied both qualitative as well quantitative

mode. The primary objective is to identify and select major risks at a

specific location in the plant considering possible soft spots/weak links

during operation/maintenance. Aspects covered in the risk usually

include:

• Process Hazards;

• Process Safety Management Systems;

• Fire Protection and Emergency response equipment and programs.

• Security Vulnerability;

• Impact of hazards consequences (equipment damage, business

interruption, injury, fatalities);

• Qualitative risk identification of scenarios involving hazardous

materials;

• Risk reduction measures.

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EIA report of Concord Biotech Ltd. 7-3

Selection of critical scenarios and their potential of damage provide

means of prioritising mitigative measures and allocate the resources to

the areas with highest risks.

Level 3 – Quantitative Risk Assessment (Deterministic)

This is the stage of assessment of risks associated with all credible

hazards (scenarios) with potential to cause an undesirable outcome such

as human injury, fatality or destruction of property. The four basic

elements include:

• Hazards identification utilizing formal approach (Level 2, HAZOP etc.);

• Frequency Analysis. Based on past safety data (incidents / accidents);

Identifying likely pathway of failures and quantifying the toxic /

inflammable material release;

• Hazards analysis to quantify the consequences of various hazards

scenarios (fire, explosion, BLEVE, toxic vapour release etc.).Establish

minimum value for damage (e.g. IDLH, over pressure, radiation flux)

to assess the impact on environment.

• Risk Quantification: Quantitative techniques are used considering

effect/impact due to weather data, population data, and frequency of

occurrences and likely hood of ignition/toxic release. Data are

analyzed considering likely damage (in terms of injury/fatality,

property damage) each scenarios is likely to cause.

QRA provides a means to determine the relative significance of a number

of undesired events, allowing analyst and the team to focus their risk

reduction efforts where they will be beneficial most.

Concord Biotech Ltd. project is hazardous in nature. The QRA for this

plant is based on Level 1 and Level 2. Table 2.3 in Chapter 2 gives the

list of products (and their monthly production capacity) to be

manufactured in the proposed project. Table below gives the bulk

storages of liquid and gaseous raw materials and their consumption.

7.3 HAZARDOUS MATERIALS STORAGE

The solid materials will be kept in bags or drums and will be stored in

chemicals godowns. The products (liquid or solid) will be packed in drums

and stored in product godowns as per market demand. The bulk storages

of liquid hazardous materials are given in below Table 7.1.

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EIA report of Concord Biotech Ltd. 7-4

In addition, CONCORD will store fuels mainly FO for boiler (15 KL x 3

tanks) and HSD for D G Set (in drums; during power failure only.)

The solid material powder or granules spillage can results in polluting

small area only. The damage to personnel can be through ingress- dermal

(if individual come in contact), oral (if individual food gets infected

through fugitive dust) or inhalation (fugitive dust). The main route is

fugitive dust which in covered area will move to short distance only. The

risk is through liquid materials which are volatile material. The toxic

vapours due to spillage of such material can travel to some distance (as

they are stored in covered godowns) and cause damage.

Table 7.1: Bulk Storage of Hazardous Chemicals

Sr. No.

Name of Hazardous chemicals

Physical form

Maximum Storage at a time (MT)

Type of container

1 Acetone Liquid 28.0 Tank

2 Acetonitrile Liquid 14.0 Tank

3 Ammonia Liquid 1.0 Carboys

4 Cyclohexane Liquid 5.0 Drum

5 DMF Liquid 1.0 Drum

6 Ethanol Liquid 0.4 Drum

7 Ethyl Acetate Liquid 30.0 Tank

8 IBA Liquid 18.0 Tank

9 IPA Liquid 14.0 Tank

10 Methanol Liquid 25.0 Tank

11 N-Heptane Liquid 6.0 Drum

12 Sulphuric acid Liquid 5.0 Tank

13 Toluene Liquid 30.0 Tank

14 Xylene Liquid 5.0 Drum

Drums capacity ~ 200 liters

7.4 Risk Screening Approach

Proposed Plant: Risk screening of Concord Biotech Ltd. plant was

undertaken through process study and study of data/information

provided by unit. Data of major/bulk storages of raw materials,

intermediates and other chemicals were collected. MSDS of hazardous

chemicals were studied vis a vis their inventories and mode of storage.

Concord plant will be using number of hazardous chemicals and also

producing organic chemicals – hazardous in nature. The chemicals stored

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EIA report of Concord Biotech Ltd. 7-5

in bulk (liquid or gaseous) and defined under MSHIC Rule will be

considered for detailed analysis:

Bulk Drugs Products: Concord is manufacturer of Active Pharmaceutical

Ingredients through the process of Fermentation, Semi-synthetic and

synthetic processes. The existing production of the unit is 103.83 MTPA,

which will be increased to 189.03 MTPA after expansion of the unit.

Currently, company is manufacturing around 36 nos. of products, which

will get increased to 40 nos. with increase in production capacity of

existing products and addition of 4 new products. Product details with its

capacity are given in Table 2.3. The products are drugs and not

hazardous if used in limited quantity as per medical doctor’s prescription.

Many of the Concord raw materials/chemicals are hazardous in nature.

However, hazards potential (for damage) of chemicals and other

materials to plant personnel, environment and off-site area is different for

different materials. Concord will be using a number of raw materials but

only 14 are stored in bulk and are listed under “List of hazardous and

Toxic Chemicals” category under MSIHC Rules, 1989. The raw materials

coming under hazardous category as specified by MSIHC Rules, 1989

(including subsequent amendments) is given in Table 7.2 below.

Table 7.2: Hazards Analysis – Raw materials (stored in Bulk) S.

No. Raw Material S. No & Threshold

Quantity (TQ in MT) as per

MSHIC Rules

Chemicals Hazards Potential Remarks

Schedule- 1,

Part-II

Schedule-2, Part-I

Schedule-3, Part-I

Hazards Toxic

1 Acetone [C3H6O] CAS No: 67-64-1 Colourless liquid; Pleasant Etheral odour BP-56.2 0C

4 -- -- Hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation. Slightly hazardous in case of skin contact (permeator). Flammable: Limits- Lower-2.6%; Upper- 12.8%

ORAL (LD50): Acute: 5800 mg/kg [Rat]. VAPOR (LC50): Acute: 50100 mg/m 8 hours [Rat].

2 Acetonitrile CAS No:75-05-8 UN No:1648 A colourless limpid liquid with an aromatic odour. Flash point 42°F

7 --- -- Highly flammable; toxic vapours (HCN /NOX) are generated when heated; Vapor heavier than air and may travel a considerable distance to a source of ignition and flash back. Health Hazards: Exposure

TEEL-1: 13 ppm TEEL-2: 320 ppm TEEL-3: 670 ppm IDLH 500 ppm

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EIA report of Concord Biotech Ltd. 7-6

to 160 ppm for 4 hours causes flushing of the face and a feeling of constriction in the chest; 500 ppm for brief periods is irritating to the nose and throat.

3 Ammonia 31 2 TQ-1: 60 MT TQ-2: 600 MT

105 TQ-1: 50 MT TQ-2: 500 MT

Fire Hazards: (Gas); Mixing of ammonia with several chemicals can cause fire hazards, / or explosions; vapours are toxic- irritation to eyes and respiratory tract.

ERPG-1: 25 ppm ERPG-2: 150 ppm IDLH: 300 ppm

Contact with liquid may cause frost bite.

4 Cyclo Hexane CAS No: 110-82-7 Liquid. with: Chloroform-like odor; LFL: 1.3% UFL:8.4% BP: 80.70C FP: -18 0C

161 --- Slightly hazardous in case of skin contact (irritant, permeator), of eye contact (irritant), of ingestion, of inhalation

ORAL (LD50): Acute: 12705 mg/kg [Rat]. 813 mg/kg [Mouse]. DERMAL (LD): Acute: & gt; 18000 mg/kg [Rabbit].

Flammable

5 DMF Dimethyl formamide CAS No:68-12-2 UN No: 2265 A water-white liquid with a faint fishy odour. Flash point 136°F. Slightly less dense than water

--- Flammable. Water soluble. Fire Hazard Special Hazards of Combustion Products: Vapors are irritating (USCG, 1999) Health Hazard Irritation of eyes, skin and nose. May cause nausea.

6 Ethanol Ethyl Alcohol CAS No:64-17-5 (200 Proof) (Pure DMA) Liquid with alcohol/wine like odour BP: 78.50C FP(CC):18.50C LFL:3.3%; UFL: 19%

248 ----

---- Hazardous in case of skin contact (irritant), of eye contact (irritant). Slightly hazardous in case of skin contact (permeator), of ingestion. Non-corrosive for skin. Non-corrosive to the eyes. Non-corrosive for lungs

Oral (LD50): 7060 [Rat]. 3450 [Mouse]. Vapor (LC50): 20000 ppm 8 hours [Rat]. 39000 4 hours [Mouse].

Flammable. NFPA: Health: 2 Flammability: 3 Reactivity: 0

7 Ethyl Acetate (C4H8O2) CAS No: 141-78-6 Colourless liquid; Pleasant Etheral odour BP-77 0C

247 --- --- Hazardous in case of ingestion, of inhalation. Slightly hazardous in case of skin contact (irritant, permeator), of eye contact (irritant). FLAMMABLE: FP (Closed Cup)- -4.4 0C Flammable Limits_ Lower 2.2%; Upper-9%

(LD50): Acute: 5620 mg/kg [Rat]. 4100 mg/kg [Mouse]. VAPOR (LC50): 16000 ppm 6 hours [Rat].

8 IBA (Isobutyl alcohol) CAS No: 78-83-1 Colourless Liquid with Sweety and slightly

328 -- -- Highly flammable in presence of open flames and sparks, of heat. Slightly flammable to flammable in presence of oxidizing materials. Non-

ORAL (LD50): Acute: 2460 mg/kg [Rat.]. DERMAL (LD50): Acute: 3400 mg/kg [Rabbit.].

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suffocating odour; BP-108 0C

flammable in presence of shocks. Auto Ignition Temp-415.56 0C Hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation. Slightly hazardous in case of skin contact (permeator).

9 Isopropyl Alcohols CAS No: 67-63-0

334 --- --- Flash Pt: 55.00 F Method Used: TCC Explosive Limits: LEL: 2.5% UEL: 12.1% LD 50/ LC 50: Acute dermal Rabbit 1300 mg/kg; Acute inhalation Rat (8 hours) 12000 ppm.

10 Methanol CAS No:67-56-1 UN No:1230

377 -- --- A colorless fairly volatile liquid with a faintly sweet pungent odor like that of ethyl alcohol. Highly Flammable; Behaviour in Fire: Containers may explode.

ERPG-1: 200 ppm ERPG-2: 1000 ppm ERPG-3: 5000 ppm IDLH: 6000 ppm

Health Hazards: Exposure to excessive vapor causes eye irritation, head- ache, fatigue and drowsiness. 50,000 ppm will probably cause death in 1 to 2 hrs. Swallowing may cause death or eye damage.

11 N-Heptane[C7 H16] CAS No:142-82-5 Liquid with Gasoline like odour; BP-98.4 0C

-- -- -- Flammable; Auto Ignition Temp-203.89 0C; Risks of explosion of the product in presence of mechanical impact:

VAPOR (LC50): Acute: 103000 mg/m 4 hours [Rat].

Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation.

12 Sulphuric Acid CAS No: 7664-93-9 UN No: 1830

591 --- -- --- ERPG-1: 2.0 mg/m3 ERPG-2: 10 mg/m3 ERPG-3: 30 mg/m3 IDLH: 15 mg/m3

13 Toluene CAS No: 108-88-3 UN No: 1294 A clear colourless liquid with a characteristic aromatic odour. Flash point 40°F

628 -- --- Flammability: Ignites at normal temperatures; Vapor is heavier than air and may travel a considerable distance to a source of ignition and flash back; Health Hazard Vapors irritate eyes and upper respiratory tract; cause dizziness, headache, nesthesia, respiratory arrest. Liquid irritates eyes and causes drying of skin. If aspirated, causes coughing, gagging, distress, and rapidly developing pulmonary edema. If

ERPG-1: 50 ppm ERPG-2: 300 ppm ERPG-3: 1000 ppm IDLH: 500 ppm

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EIA report of Concord Biotech Ltd. 7-8

ingested causes vomiting, griping, diarrhea, depressed respiration.

14 Xylene 442 Highly Flammable: Will be easily ignited by heat, sparks or flames. Vapors may form explosive mixtures with air. Vapors may travel to source of ignition and flash back. Health Hazards: Fire will produce irritating, corrosive and/or toxic gases. Vapors may cause dizziness or suffocation.

TEEL-1: 130 ppm

O-Xylene May cause toxic effects if inhaled or absorbed through skin. Inhalation or contact with material may irritate or burn skin and eyes. Fire will produce irritating, corrosive and/or toxic gases. Vapors may cause dizziness or suffocation. Cause toxic effects if inhaled or absorbed through skin. Inhalation or contact with material may irritate or burn skin and eyes.

Table 7.3: Fuels Hazards Classification

Item Physical Impact on Man, Animal & Eco-System Physical Chemical

HSD UN No.-1202 Flammable Liquid-Class-3 Hazardous Waste ID No.-17 Hazchem Code-3Y* NFPA Hazards Signal Health-0 Flammability-2 Reactivity/Stabilty-0

BP- 150 – 400°C Vapour Pressure (35°C)- <1 mm at 38°C Specific Gravity-0.81 – 0.91 at 20°C

LEL - 0.6% (V/V) UEL - 7.5% (V/V) Flash Point>32° C Auto ignition Temp.-256° C Stable compound Incompatible with oxidizing agents

Entry through inhalation, ingestion and skin; Inhalation Effects: Dizziness and headache, Aspiration – Rapidly developing, potential fatal chemical pneumonities Ingestion Effect: Nausea and Vomiting; Contact Effects: Irritation, Eyes- Irritation; Dermatitis may develop on prolonged contact.

LD50 (oral rat)- 2800 mg/kg; LD50 -200;TLV (ACGIH)- 5 mg/kg; STEL- 10 mg/kg

LSHS/FO UN No.-1270 Flammable Liquid-Class-3 Hazardous Waste ID No.-17 Hazchem Code-3Y*E NFPA Hazards Signals Health-0 Flammability-2 Reactivity/Stabilty-0

BP- 185 – 5000C Vapour Pressure (350C)- <1 mm at 200C Specific Gravity-0.8 – 0.9 -- 1.05 at 15.50C

LEL - 1% (V/V) UEL - 5% (V/V) Flash Point > 660C Auto ignition Temp.-2630 C Stable Compound

Entry through inhalation, and skin; Inhalation: Dizziness and headache. Ingestion: Nausea and Vomiting Contact: Irritation, Eyes: Irritation. Dermatitis may result from prolonged contact.

Solubility in water- Insoluble in water

Incompatible with oxidizing agents.

Vapour Density (Air-1)-3 - 5

Note: 1. TQ-I: Threshold quantity (for application of rules 4,5,7 to 9 and 13 to 15)

TQ-II: Threshold quantity (for application of rules 10 to 12)

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EIA report of Concord Biotech Ltd. 7-9

S. No.

Toxicity Oral toxicity LD50

(mg/kg)

Dermal toxicity

LD50 (mg/kg)

Inhalation toxicity

LC50 (mg/l) 1. Extremely toxic >5 <40 <0.5 2. Highly toxic >5-50 >40-200 <0.5-2.0 3. Toxic >50-200 >200-1000 >2-10

As detailed in the above table out of 14 liquid bulk raw materials (stored)

twelve are listed in MSIHC list. None of them are Toxic, highly toxic or

extremely toxic or inflammable as per Schedule I of MSIHC Rules.

Note:

1. Oral Toxicity (OT) in LD50 (mg/kg)

2. Dermal Toxicity (DT) in LD50 (mg/kg)

3. Inhalation Toxicity in LC50 (mg/l) [4 hrs.]

7.4.1 Acute Exposure Guideline Levels (AEGLS)

• AEGL-3 is "the airborne concentration of a substance above which it is

predicted that the general population, including susceptible individuals,

could experience life-threatening adverse health effects or death."

• AEGL-2 is "the airborne concentration of a substance above which it is

predicted that the general population, including susceptible individuals,

could experience irreversible or other serious, long-lasting adverse

health effects or an impaired ability to escape."

• AEGL-1 is "the airborne concentration of a substance above which it is

predicted that the general population, including susceptible individuals,

could experience notable discomfort, irritation, or certain asymptomatic

no sensory effects.

7.4.2 Emergency Response Planning Guidelines (ERPGs)

The 3 ERPG tiers are defined as follows:

• 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."

• 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."

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EIA report of Concord Biotech Ltd. 7-10

• 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 health effects or

perceiving a clearly defined, objectionable odor."

7.4.3 Temporary Emergency Exposure Limits (TEELs)

TEELs are used in similar situations as the 60-minute AEGLs and ERPGs.

However, in situations where the concentration varies over time, the

TEEL developers recommend using a conservative 15-minute time-

weighted average concentration. A chemical may have up to 4 TEEL

values, each of which corresponds to a specific tier of health effects.

The 4 TEEL tiers are defined as follows:

• TEEL-3 is "the maximum concentration in air below which it is believed

nearly all individuals could be exposed without experiencing or

developing life-threatening health effects."

• TEEL-2 is "the maximum concentration in air below which it is believed

nearly all individuals could be exposed without experiencing or

developing irreversible or other serious health effects or symptoms that

could impair their abilities to take protective action."

• TEEL-1 is "the maximum concentration in air below which it is believed

nearly all individuals could be exposed without experiencing other than

mild transient health effects or perceiving a clearly defined

objectionable odor."

• TEEL-0 is "the threshold concentration below which most people will

experience no appreciable risk of health effects."

• The National Institute of Occupational Safety and Health (NIOSH)

defines an immediately dangerous to life or health condition as a

situation "that poses a threat of exposure to airborne contaminants

when that exposure is likely to cause death or immediate or delayed

permanent adverse health effects or prevent escape from such an

environment."

• The IDLH limit represents the concentration of a chemical in the air to

which healthy adult workers could be exposed (if their respirators fail)

without suffering permanent or escape-impairing health effects.

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EIA report of Concord Biotech Ltd. 7-11

7.5 QRA APPROACH

Identification of hazards and likely scenarios (based on Level-1 and

Level-2 activities) calls for detailed analysis of each scenario for potential

of damage, impact area (may vary with weather conditions/wind

direction) and safety system in place. Subsequently each incident is

classified according to relative risk classifications provided in Table 7.4.

Table 7.4: Risk Classification

Stage Description

High (> 10-2/yr.)

A failure which could reasonably be expected to occur within the expected life time of the plant. Examples of high failure likelihood are process leaks or single instrument or valve failures or a human error which could result in releases of hazardous materials.

Moderate (10-2 --10-4/yr.)

A failure or sequence of failures which has a low probability of occurrence within the expected lifetime of the plant. Examples of moderate likelihood are dual instrument or valve failures, combination of instrument failures and human errors, or single failures of small process lines or fittings.

Low (<10-4)

A failure or series of failures which have a very low probability of occurrence within the expected lifetime of plant. Examples of ‘low’ likelihood are multiple instruments or valve failures or multiple human errors, or single spontaneous failures of tanks or process vessels.

Minor Incidents Impact limited to the local area of the event with potent for ‘knock – on- events’

Serious Incident One that could cause: Any serious injury or fatality on/off site; Property damage of $ 1 million offsite or $ 5 million

onsite. Extensive Incident

One that is five or more times worse than a serious incident.

Assigning a relative risk to each scenario provides a means of prioritising

associated risk mitigation measures and planned actions.

7.6 THERMAL HAZARDS

In order to understand the damages produced by various scenarios, it is

appropriate to understand the physiological/physical effects of thermal

radiation intensities. The thermal radiation due to tank fire usually results

in burn on the human body. Furthermore, inanimate objects like

equipment, piping, cables, etc. may also be affected and also need to be

evaluated for damages. Table 7.5, Table 7.6 and Table 7.7 (below),

respectively give tolerable intensities of various objects and desirable

escape time for thermal radiation. Thermal hazards could be from fires or

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EIA report of Concord Biotech Ltd. 7-12

explosion. Fire releases energy slowly while explosion release energy very

rapidly (typically in micro seconds). Explosion is rapid expansion of gases

resulting in rapidly moving shock wave. Explosion can be confined (within

a vessel or building) or unconfined (due to release of flammable gases).

BLEVE (boiling liquid expanding vapour explosion) occurs if a vessel

containing a liquid at a temperature above its atmospheric boiling point

ruptures. The subsequent BLEVE is the explosive vaporization of large

fraction of its vapour contents; possibly followed by combustion or

explosion of the vaporized cloud if it is combustible. Thermal hazards

have been considered for various scenarios including: Fire in inflammable

chemicals storage tanks.

Table 7.5: Effects due to Incident Radiation Intensity

Incident Radiation kW/m2

Damage Type

0.7 Equivalent to Solar Radiation 1.6 No discomfort on long duration 4.0 Sufficient to cause pain within 20 sec.

Blistering of skin (first degree burn are likely). 9.5 Pain threshold reached after 8 sec. Second

degree burn after 20 sec. 12.5 Minimum energy required for piloted ignition

of wood, melting of plastic tubing etc. 25

Minimum Energy required for piloted ignition of wood, melting, plastic tubing etc.

37.5 Sufficient to cause damage to process equipment.

62.0 Spontaneous ignition of wood.

Table 7.6: Thermal Radiation Impact to Human

Exposure Duration

Radiation Energy {1% lethality;

kW/m2}

Radiation Energy for 2nd degree burns;

kW/m2

Radiation Energy for 1st degree burns;

kW/m2 10 sec 21.2 16 12.5

30 9.3 7.0 4.0

Table 7.7: Tolerable Intensities for Various Objects

Sl. No.

Objects Tolerable Intensities (kw/m2)

1 Drenched Tank 38 2 Special Buildings

(No window, fire proof doors) 25

3 Normal Buildings 14 4 Vegetation 10-12

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5 Escape Route 6 (up to 30 secs.) 6 Personnel in Emergencies 3 (up to 30 secs.) 7 Plastic Cables 2 8 Stationary Personnel 1.5

7.7 DAMAGE DUE TO EXPLOSION

The explosion of a dust or gas (either as a deflagration or detonation)

results in a reaction front moving outwards from the ignition source

preceded by a shock wave or pressure front. After the combustible

material is consumed the reaction front terminates but the pressure wave

continues its outward movement. Blast damage is based on the

determination of the peak overpressure resulting from the pressure wave

impacting on the object or structure. Damage estimates based on

overpressure are given in Table 7.8 below:

Table 7.8: Damage due to Overpressure

Sr. No.

Overpressure (psig/bar)

Damage

1. 0.04 Loud Noise/sonic boom glass failure 2. 0.15 Typical pressure for glass failure 3. 0.5 - 1 Large and small windows usually shattered 4. 0.7 Minor damage to house structure 5. 1 Partial demolition of houses, made uninhabitable 6. 2.3 Lower limit of serious structure damage 7. 5 - 7 Nearly complete destruction of houses 8. 9 Loaded train box wagons completely demolished 9. 10 Probable total destruction of houses 10. 200 Limits of crater lip

In Concord case explosion probability is remote.

7.8 TOXIC RELEASE

Hazardous materials handled and stored in bulk in CONCORD complex are

hazardous materials (as detailed in Table 7.1) as defined in MSHIC rules

and indicated in Table 7.2 and Table 7.3. Some of these chemicals are

stored in bulk (in tank farm).

Damage criteria: For toxic release the damage criteria considered is IDLH

concentration (if data are available). In the absence of non-availability of

IDLH, ‘Inhalation Toxicity (IT) data for rats’ are considered. ‘IT’ data are

used for such chemicals for whom IDLH are not available for these

chemicals.

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7.8.1 Acid/Alkali Hazards

Various hazards that can occur due to the acid and alkali incidents are -

• Skin irritation and corrosive effects after spillage

• Spill pool evaporation of acid or Caustic lye storage tanks catastrophic

failure are limited only

• Catastrophic failure giving rise to spill pool evaporation dispersion up

to LC50, IDLH and TLV level

The more hazardous scenario likely is if spilled acid comes in contact with

metal and hydrogen is generated resulting in fire/explosion hazards.

Based on the outcome of the risk assessment, following recommendation

has been made to avoid any risk associated with the storage and use of

acids in the plant:

• Double drain valve will be provided to sulphuric acid storage tank.

• Full body protection will be provided to operator.

• Caution note and emergency first aid will be displayed.

• All employees will be trained for use of emergency first aid.

• Safety shower and eye wash will be provided in storage tank area and

plant area.

• Total close process will be adopted for Sulphuric acid handling.

• Dyke wall will be provided to storage tank.

• Tanker unloading procedure will be prepared.

• SOP will be prepared for acid handling.

• Training programme will be conducted for safe handling and

emergency handling of Sulphuric Acid.

• In Storage Tank Area, reaction with water generating fumes should be

displayed and avoided.

• Suitable extinguishing media-Extinguish with dry powder/sand. DO

NOT USE WATER.

7.9 DATA LIMITATIONS

Concord is handling various toxic raw materials. The main use of the

products is for human consumption to kill bacteria’s in the human body

system directly or indirectly. It is also observed that very little data or

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EIA report of Concord Biotech Ltd. 7-15

information (regarding physical properties required for modeling) is

available about these drugs and modeling cannot be done for these.

7.10 LIKELY FAILURE SCENARIOS

Few likely failure scenarios have been selected after critical appraisal of

raw materials and storage inventories. Failure scenarios selected are as

given in Table 7.9 below:

Table 7.9: Different Failure Scenarios

S. No. Scenario Remark Raw materials RM-1 Acetone Inflammable RM-2 Acetonitrile Toxic RM-3 Ammonia Toxic RM-4 Cyclohexane Inflammable RM-5 Ethyl Acetate Toxic RM-6 IBA Inflammable RM-7 Methanol Toxic RM-8 Toluene Toxic

(B) QUANTITATIVE Risk ASSESSMENT & CONSEQUENCE ANALYSIS

7.11 PREAMBLE

In the previous chapter, we have carried out the hazards analysis of the

CONCORD proposed expansion project considering various aspects

including bulk storages of hazardous chemicals, plant process system,

plant incidents/ accidents records, critical appraisal and discussion at site

for soft spots in the plant etc. Based on the hazards analysis few critical

scenarios have been selected for QRA and consequence analysis. QRA

quantifies vulnerable zones for a conceived incident with various levels of

severity. Consequence calculations for risk assessment are invariably in

terms of percentage of fatalities but for emergency handling, fatalities are

of no interest saving lives is the main objectives then. The injury criteria

have to be agreed in terms of thermal load or toxic concentration versus

exposure duration in the first instance. In consequence calculation, 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, and other property damage). The

risk assessment modeling can be roughly divided into three groups:

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EIA report of Concord Biotech Ltd. 7-16

• Determination of source strength parameters;

• Determination of consequential effects;

• Determination of damage or damage distances (with specific severity

rates)

7.11.1 Weather Effect

The effect of ambient conditions on the impact of fire/heat radiation and

GLC of hazardous/toxic material can be beneficial as well as harmful. A

high wind (turbulence) can dilute the toxic material while stable

environment can extend the reach of IDLH or IT (inhalation LC50 rats for

products) concentration to long distance. Any inflammable gas/vapour

release in turbulent weather will soon dilute the hazardous gases below

LEL and thus save the disaster.

7.12 INCIDENTS IMPACTS

The identified failure scenarios (Table 7.9) have been analysed (Using

ALOHA and EFFECT Modules) for the impact zones considering damage

due to thermal and toxic impacts. Similar impacts are considered for

expansion units. Each incident will have Impact on the surrounding

environment which in extreme case may cross plant boundary. The

impact zones for various scenarios are given in Table 7.10.

Table 7.10: Hazards Scenario Impact

Scenario No.

Scenario Impact Zone (m)

Remarks

Scenario Raw Material RM-1 Acetone-Puddle Fire 18 1st degree burn

Figure 7.1 RM-2 Acetonitrile Tank

Leakage 14 Stability Class D (IDLH)

Figure 7.2 RM-3 Ammonia

Spillage/leakage 1600 Stability Class D (IDLH)

Figure 7.3 RM-4 Cyclohexane Puddle fire 15 1st degree burn

Figure 7.4 RM-5 Ethyl Acetate Puddle

Fire 17 1st degree burn

Figure 7.5 RM-6 IBA Puddle Fire 12 1st degree burn

Figure 7.6 RM-7 Methanol Tank Leakage <10

<10 Stability Class D 1st degree burn Figure 7.7

RM-8 Toluene Tank Leakage 14 29

Stability Class D 1st degree burn Figure 7.8

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Figure 7.1 Acetone Tank spillage-Thermal Impact Zone

Figure 7.2 Acetonitrile Spillage - Toxic Impact Zone

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EIA report of Concord Biotech Ltd. 7-18

Figure 7.3: Ammonia Spillage/leakage- Toxic Impact Zone

Figure 7.4: Cyclohexane Spillage- Thermal Impact Zone

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EIA report of Concord Biotech Ltd. 7-19

Figure 7.5: Ethyl Acetate Spillage-Thermal Impact Zone

Figure 7.6: Iso-Butanol Spillage –Thermal Impact Zone

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Figure 7.7: Methanol Spillage - Thermal Impact Zone

Figure 7.8: Toluene Spillage- Thermal Impact Zone

7.13 CONSEQUENTIAL IMPACTS

The consequential impacts from each incident scenarios can be though

thermal and toxic route. The damage can be on plant personnel (and

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EIA report of Concord Biotech Ltd. 7-21

neighboring residents in case incident crosses boundary), property and

also loss in production.

7.13.1 Thermal and Explosion Hazards

Incidents involving thermal hazards are mainly due to raw material fire

(in tank farms). The impact (1st degree burn) is limited to 29 m only (i.e.

within plant boundary). However the consequences can go to worse if the

incidents lead to domino effect to other tanks.

7.13.2 Toxic Hazards

Toxic hazards are mainly due to Ammonia tank leakage spillage and other

chemicals leakage and their impact can cross the plant boundary (if not

controlled in time). The impact due to Ammonia (IDLH) tank leakage can

go as far as 1.6 km i.e. crossing the plant boundary.

7.13.3 Other Hazards

The other hazards in the plant include (but not limited to):

• Other toxic hazards due to acids / other toxic spillages (mainly limited

to spillage area only.).

• Mechanical hazards due to machines/equipment.

• Hazards due to individual soft spots like walking casually and noticing

a pit and falling or colliding/stumbling or slipping (not noticing a wet

place etc.).

7.13.4 Other Toxic Hazards

Acid spillage-its impact will be limited to spillage area. The spillage if

comes in contact with metal parts will produce hydrogen which is highly

flammable gas. Any person moving in area and getting splash will get the

injury. In addition the spillage will cause pollution problem. The spillage is

to be collected and neutralized for toxic contents before disposal.

7.14 OCCUPATIONAL HEALTH

Concord has a well-equipped first aid post and other HSE infrastructure.

It will also have staff personnel trained in first aid. Injured personnel will

be immediately rushed to hospital after giving first aid. All employees will

have regular medical checkup as per norms. An emergency

vehicle/ambulance will always (round the clock) available for meeting any

eventuality.

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EIA report of Concord Biotech Ltd. 7-22

7.14.1.1 Treatment of workers affected by accidental spillage of chemicals

There is wide range of chemicals present in the Chemical plants. The safe

cleanup of a chemical spill requires some knowledge of the properties and

hazards posed by the chemical & any added dangers posed by the

location of the spill. Employees must notify their immediate supervisor of

injury by spillage of chemicals or exposure to hazardous materials. All

injuries must be reported. Supervisor is responsible for reporting any

injuries or occupational illnesses to the management.

Following steps will be immediate taken by the Supervisor.

Identify spillage/leakages of hazardous chemicals

Chemical Exposure to Skin:

Immediately flush with cool water for at least 15 minutes. If there are no

visible burns, remove the cloth from burning part of body. Seek medical

attention if exposure/spillages occur major possible problems.

Chemical Exposure to Skin – Serious:

Remove all contaminated clothing. Locate the nearest emergency shower

and soak for at least 15 minutes. Have someone contact the Hospital for

immediate medical attention.

Chemicals in Eyes:

Irrigate eyes for at least 15 minutes with tempered water from

emergency eyewash station. Remove contact lenses if there is. Notify the

management and immediate medical attention.

Acid Fumes:

Anyone overcome by fumes should be removed by fresh air. Never

attempt to enter a location where potentially dangerous fumes might

place you at risk. If someone is down, contact emergency personnel and

let them enter. Self-breathing apparatus is requiring to whom enter in the

acidic fumes area. Seek medical attention for exposure as soon as

possible.

Chemical Spills:

The safe clean-up of an acid spill requires some knowledge of the

properties and hazards posed by the acid and any added dangers posed

by the location of the spill. If you believe a spill is beyond your capacity

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EIA report of Concord Biotech Ltd. 7-23

to clean up, do not attempt to do so by your own, immediately contact to

nearest fire/emergency station. Spill kits with instructions, absorbents,

neutralizing agents if applicable, protective equipment, and sealable

waste buckets should be present in plant area.

Following Steps to be taken for ensuring health and safety of

workers engaged in handling of Hazardous materials

• Identify chemicals to be used, amounts required, condition followed as

per the MSDS guideline.

• Evaluate the hazards posed by the chemicals and the process

conditions. The evaluation should cover toxic, physical, reactive,

flammable, explosive as well as any other potential hazards posed by

the respective chemicals.

• Select appropriate controls to minimize risk, including use of

engineering controls, administrative controls, and personal protective

equipment (PPE) to protect workers from hazards. The controls must

ensure that OSHA’s Permissible Exposure Limits (PELs).

• Avoid Underestimation of Risk of handling and its reaction.

• Before working with chemicals, know the facility’s policies and

procedures for how to handle an accidental spill or fire. Emergency

telephone numbers should be posted in a prominent area. Know the

location of all safety equipment and the nearest fire alarm and

telephone.

• Provide popper Ventilation in the plant/process area.

• Corrosive chemicals that require vented storage should be stored in

vented cabinets instead of in a chemical hood.

• Local exhaust ventilation devices should be appropriate to the

operations in the plant.

• Chemicals should be separated and stored according to hazard

category and compatibility.

7.15 CONCLUSION & RECOMMENDATIONS

The hazard analysis and risk assessment of few possible selected incident

scenarios indicates that such incidents mostly are not limited to plant

battery limits and have impact on adjoining plants. Only one scenario

(specifically toxic hazards scenario due to Ammonia leakage) is crossing

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EIA report of Concord Biotech Ltd. 7-24

the CONCORD plant boundaries. The direction of impact will be in down

wind direction (wind direction and speed varies with season). Some of the

recommendations for Tank farm storage system are as given below:

• Provision of flame detectors/ thermal sensors at strategic locations in

the tank farm area.

• Auto water deluge system on each bulk storage tank for inflammable

liquids. The system should automatically start taking signal from flame

detectors or thermal relay.

• Fixed foam system with adequate capacity.

Toxic Hazards are due to methanol and Toluene. Regular ‘Hazard Survey’

ensures the detection of leakage in the plant.

In house ‘capability building’ to attend hazardous scenarios is to be taken

up through mock drills.

• Train staff in attending such scenarios.

Human Factors: CONCORD should have well equipped Toxic and fire

handling system and also safety department – safety practices. Human

factors role in safety cannot be ignored. Odd hours working and over/long

hours work can drain out individual. It shows in lack of efficiency and also

the lack of apt attention the modern chemical complex demand. They are

to be closely looked into and avoided.

Safety’ has unique features:

a. If no accident has happened so far probability of incident/accident

occurring increases.

b. ‘No accident’ / good safety record develops complacency inertia/ over

confidence in the team. This attitude gives rise to gaps/soft spots in

the system giving chances to incidents / accidents.

c. Safety requires novelty. Routine training practices get stale with no

positive results. Look for novel scheme of training/ safety practices to

build up fresh impetus in safety. Involvement of employees with

refreshed outlook for safety is to be achieved.

7.16 ACTION PLAN FOR HANDLING & SAFETY SYSTEM

Flammable chemicals will be stored in open area outside the process

plant with all the safety measures. Hazardous chemicals will be stored

and handle in dispensing room for taking out sample from the container

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for quality check-up purpose or for the partial use. This activity for

Hazardous material handling will be carried out by using all PPEs with

proper ventilation & under supervision.

7.16.1 Safety Measures for Transportation and Unloading of Hazardous

Chemicals

• Solvent unloading standard procedure will in place and will be

implemented for safe unloading of road tanker.

• Static earthing provision will be made for tanker unloading.

• Drum handling trolleys will be used for transportation of drums up to

plant and internal handling from storage to process area.

• Display Boards will be provided on all storage tanks which include the

name of the chemicals and its major hazardous characteristics.

• Fire extinguishers will be provided as required.

• First aids boxes will also be provided at different places wherever

required.

• Water showering system will be provided to the flammable chemicals

storage area.

• Area will be declared as “NO SMOKE ZONE”.

7.16.2 Safety Measures for Storage/Handling of Hazardous Chemicals

All Hazardous and flammable chemicals will store separately and away

from the strong oxidant & kept it in well ventilated room. Adequate

firefighting system will be installed. Safety shower and eye washer will be

installed near storage area. Flame proof light fitting will be provided at

storage area. Sprinkler system will be installed near storage area. Safety

permit system will be followed for loading and unloading. Isolate storage

will be provided with wire fencing under lock and key. Caution note,

hazardous identification board will be provided. Only authorized person

will be permitted in storage area and register will be maintained. “NO

SMOKING” board will be displayed and Wind Indicator and siren will be

provided.

7.16.3 Safety Measures for Process Units

Safety measures are the most important aspect of selection of process

technology to ensure safety in production unit. For the safety in

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production area some important critical safety measures will be provided

within the process technology/equipment itself & will put continue efforts

for developing new technology/equipment. Company will ensure such

provision in the technology/equipment/machineries at time of purchase.

The details of the critical safety measures for process unit are as below;

any reaction upsets will be confined to the reaction vessel itself as

defined quantity of raw materials will be issued to the reaction vessel by

metering pumps/load cells. Process parameters control will be provided

as per SOP- Standard Operating Procedures. Materials will be transferred

by pumping through pipeline or by vacuum from drums. All reaction vents

will be connected to vapor condensers system. Hazardous materials will

be transferred by pipelines and in control manners. Trained person will be

engaged for handling of hazardous materials. Proper safety precautions

will be taken during handling of hazardous materials. All solvents and

flammable material with required quantity will be charge in reactor by

pump or by gravity. All the vessels will be examined periodically by a

recognized competent person. All the vessels and equipments will be well

earthed appropriately and well protected against Static Electricity.

Temperature indicators will be provided near all reactor and distillation

systems. Flame proof light fittings will be installed in the plant. All the

Plant Personnel will be provided with Personal Protection Equipments to

protect against any adverse health effect during operations, leakage,

spillages or splash. PPE like Helmets, Safety Shoes and Safety Glasses

will be provided to the employees.

7.16.4 Safety Measures for Preventive Maintenance

The safety measures in the form of the general Do's & Don'ts for safety in

process & other plant area are as below:

• Do not work on equipments without permission from plant head and

maintenance head.

• Make sure equipment is empty and fluxed with nitrogen and air.

• Check VOC content for flammable and make sure that no flammable

vapour contents.

• Keep proper and adequate fire extinguisher near work area.

• Use proper PPE.

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EIA report of Concord Biotech Ltd. 7-27

• Do not allow any employment without pre-medical check-up or without

checking fitness.

• Work in any equipment must be conducted in presence of supervisor.

• Additional safety measures in form of the checklist covering Do's &

Don'ts of preventive maintenance, strengthening of HSE,

manufacturing utility staff for safety related measures will be updated

timely and will be made available to all concern department &

personnel.

7.16.5 Safety measures to prevent spillage/leakage of toxic chemicals

The preventive maintenance will be planned and carried out as per plan

to avoid the failure of valve, pipelines and other component of

transferring line. The spillage will be confined to the dyke area

underneath the vessel. The resultant splash of such chemicals will result

in exposure of toxic chemicals to employees. Decontamination facilities

(Safety shower and eye wash fountains) will be provided in the plant

area, which can be used to decontaminate the affected employees.

Suitable decontamination procedure will be used to decontaminate the

spilled or leaked material. The SOP for decontamination will be available

with all related department.

7.17 ARRANGEMENTS FOR ENSURING HEALTH AND SAFETY OF

WORKERS ENGAGED IN HANDLING OF TOXIC MATERIALS

The significance of Safety & Health in plant has been a vital issue in

achieving productivity and quality standard. Following is an effort for

safety & health of workers working in the plant. Numbers of chemicals

are used in plant have specific health hazards in nature. Following are

basic fundamental principles properly underlie all the workers working in

the plant. Occupational health and safety is about preventing people from

being harmed by work or becoming ill from work by taking adequate

precautions and providing a safe and healthy work environment.

Consideration of each should be encouraged before beginning work as

part of the culture of safety within the plant.

• Plan ahead. Determine the potential hazards associated with

production.

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EIA report of Concord Biotech Ltd. 7-28

• Minimize exposure to chemicals. Do not allow toxic chemicals to

come in contact with skin. Provide proper ventilation devices to

prevent/minimize airborne.

• Do not underestimate hazards or risks. Assume that any mixture

of chemicals will be more toxic than its most toxic component. Treat

all the chemicals as toxic substances.

• Be prepared for accidents. Before beginning of any batch reaction,

know what specific steps to take which cause to accident if any

hazardous substance release accidently. Proper follow SOP- Standard

Operating procedure to take batch reaction.

Unit will assess is careful examination of what, at work, could cause harm

to workers, accidents and ill health. All risks in the workplace must be

identified and assessed for control measures to be put in place.

Follow the five steps of hazard identification will be taken by unit namely;

• Identify the hazards

• Decide who might be harmed and how

• Evaluate the risks and decide on precaution

• Record your findings and implement them

• Review your assessment and update if necessary

Following Information workers should know regarding hazardous

chemicals

We shall ensure that the employee is adequately trained with regard to:

• The contents of the hazardous chemical substances

• Potential source exposure to chemicals

• Measures taken by the employer to protect employees against any risk

from exposure

• Precautions to be taken by an employee to protect himself against the

health risks associated exposure

• Correct use, maintenance of safety equipment, facilities and

engineering controls

• Importance of good housekeeping at the workplace and personal

hygiene

• Safe working procedures

• Procedures to be followed in the event of spillages or leakages.

San Envirotech Pvt. Ltd., Ahmedabad

EIA report of Concord Biotech Ltd. 7-29

7.18 DISASTER MANAGEMENT PLAN (DMP)

Disaster/Emergency Management Plan is essential for a chemical plant as

the processes adopted for manufacturing are classified under Factory Act

as Hazardous due to handling and storage of toxic, flammable and

explosive hazardous materials. Over the years, the chemical process

plant has created adequate infrastructure and adopted risk mitigation

measures to tackle any emergency that may arise during the

manufacturing process. The important aspect in emergency planning is to

control an emergency by technical and organizational means, minimize

accidents and consequent losses. Emergency planning also brings to light

deficiencies, such as, lack of resources necessary for effective emergency

response. It also demonstrates the organization's commitment to safety

of employees and physical property as well as increases the awareness

among management and employees. Disaster Management Plan for the

plant is necessarily a combination of various actions which are to be

taken in a very short time but in a pre-set sequence to deal effectively

and efficiently with any disaster, emergency or major accident with an

aim to keep the loss of men, material, plant/machinery etc. to the

minimum. A major emergency in a hazardous chemical plant is one,

which has the potential to cause serious injury or loss of life. It may

cause extensive damage to property and serious disruption of both inside

and outside the plant. Sometimes, it would require the assistance of

outside emergency services to handle it effectively. Although the

emergency at the plant may be caused by a number of different factors,

e.g. leakage of toxic and flammable materials from piping/tanks,

total/partial power failure, earthquake or sabotage, it will normally

manifest itself in fire/toxic release.

Primarily, DMP is prepared to furnish details which may require at the

time of the emergency, to delegate responsibility, to estimate the

consequences in advance and to prepare ourselves to control any type of

emergency. The plan explains basic requirements as follows:

• Definition,

• Objectives,

• Organization set up,

San Envirotech Pvt. Ltd., Ahmedabad

EIA report of Concord Biotech Ltd. 7-30

• Communication System,

• Action on site,

• Link with Off-site Emergency Plan,

• Training rehearsal and record aspect.

7.18.1 Definitions

Various definitions on different analogy used on On-site & Off-site

Emergency Plan are as follows:

Accident: An accident may be defined as “an undesirable and unplanned

event with or without or major damage consequence of life and /or

property.

Major Accident: It is a sudden, unexpected, unplanned event resulting

from uncontrolled developments during an industrial activity, which

causes or has the potential to cause, death or hospitalization to a number

of people, damage to environment, evacuation of local population or any

combination of above effects.

Emergency: This can be defined as any situation, which presents a

threat to safety of person's or/and property. It may require outside help

also.

Major Emergency: Occurring at a work is one that may affect several

departments within and/or may cause serious injuries, loss of life,

extensive damage to properly or serious disruption outside the works. It

will require the use of outside resources to handle it effectively.

Disaster: Disaster is a sudden calamitous event, bringing great damage,

loss or destruction.

Hazards: Hazard may be defined as “the potential of an accident”.

Hazard exists in man and the system of materials and machines.

Chemical Hazards: It is a hazard due to chemical(s) (including its

storage, process, handling, etc.) and it is realized by fire, explosion,

toxicity, corrosively, radiation, etc.

Risk: Risk may be defined as the combination of consequence and

probability or likelihood of an accident being caused in a given man-

material – machine system.

San Envirotech Pvt. Ltd., Ahmedabad

EIA report of Concord Biotech Ltd. 7-31

On-Site Emergency plan: It deals with measures to prevent and control

emergencies within the factory and not affecting outside public or

environment.

Off-Site Emergency plan: It deals with measures to prevent and

control emergencies affecting public and the environment outside the

premises.

7.18.2 Objective of the Disaster Management Plan

The primary purpose of this Disaster Management Plan is to equip the

Plant with required resources and information for prompt implementation

of the set of actions to be undertaken in the event of an accident posing

hazards to the people and community after commissioning of the plant.

The objective of Disaster Management Plan (DMP), for the plant is to be

in a state of perceptual readiness through training, development and

mock drills, to immediately control and arrest any emergency situation so

as to avert a full fledge disaster and the consequence of human and

property damage and in the event of a disaster still occurring, to manage

the same to that the risk of the damage consequences to life and

property are minimized and thereafter, proper rehabilitation, review and

revisions of the DMP to overcome the shortcomings noticed are

undertaken. The DMP document is prepared keeping in view and to

confirm the requirements of the provisions of The Factories Act, 1948

under section 41 B (4), Guidelines issued by the Ministry of Environment

and Forests, Govt. of India and Manufacture, Import and Storage of

Hazardous Chemicals Rules, 1989 amended in 2000, Schedule 11 under

Environmental Protection Act, 1986.

Following are the main objectives of the plan to:

• Defined and assess emergencies, including hazards and risk

• Control and contain incidents.

• Safeguard employees and people in vicinity.

• Minimize damage to property and/or the environment.

• Minimization of risk and impact of event accident.

• Preparation of action plan to handle disasters and to contain damage.

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EIA report of Concord Biotech Ltd. 7-32

• Inform employees, the general public and the authority about the

hazards/risk assessed and to provide safeguard, and the role to be

played by them in the event of emergency.

• Be ready for 'mutual aid' if need arises to help neighbouring unit.

• Inform authorities and mutual aid centres to come for help.

• Effect rescue and treatment of casualties.

• Effective rehabilitation of the affected persons and prevention of

damage to the property.

• Identify and list any fatalities.

• Inform and help relatives.

• Secure the safe rehabilitation of affected areas and to restore

normalcy.

• Provide authoritative information to the news media.

7.19 ONSITE EMERGENCY PLAN

7.19.1 Incident Controller

Incident Controller’s role is to control the emergency at the incident site.

7.19.1.1 Duties of Incident Controller

Incident Controller will proceed to the place of emergency after hearing

siren/announcement. He will:

• Assess the scale of emergency and decide if a major emergency exists

or is likely, accordingly activate emergency procedure.

• Immediately give his feedback to Emergency Control Centre (ECC)

regarding emergency.

• Direct all operations within the area with following priorities.

o Secure the safety of personnel

o Minimize damage to plant property and environment.

o Minimize loss of material.

• Direct rescue and firefighting operations till the arrival of the outside

Fire Brigade, he will relinquish control to Sr. Officer of Fire Brigade.

• Ensure that the affected area is searched for causalities.

• Ensure that all non-essential workers in the affected area evacuate to

the appropriate assembly point.

• Set up communication point to establish Radio/Telephone/Messenger

contact as with emergency control centre.

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EIA report of Concord Biotech Ltd. 7-33

• Pending arrival of works site controller, assume the duties of the post

in particular to:

o Direct the shutting down and evacuation of plant and areas likely to

be threatened by emergency.

o Ensure that the outside emergency services have been called in.

• Ensure that the key personnel have been called in.

• Report all significant development to the Site Main Controller.

• Provide advice and information, as required to the Senior Officer of the

Fire Brigade.

• Preserve evidence that would facilitate any subsequent inquiry into the

cause and circumstances of emergency.

Dy. Incident Controller will carry out above said duties in absence of

Incident Controller.

7.19.2 Site Main Controller

Site Main Controller will be overall in-charge of emergency organization

7.19.2.1 Duties of Site Main Controller:

• Relieve the Incident Controller of responsibility of overall main control.

• Co-ordinate ECC or if required, security for raising evacuation siren

and also all clear siren, in case emergency is over.

• Declaration of major emergency ensures that outside emergency

services will be called and when required nearby firms will be

informed.

• Ensure that key personnel will be called in.

• Exercise direct operational control on parts of the works outside the

affected area.

• Maintain a speculative continuous review of possible development and

assess these to determine most possible cause of events.

• Direct the shutting down and evacuation of plants in consultation with

key personnel.

• Ensure causalities are receiving adequate attention; arrange for

additional help if required. Ensure relatives are advised.

• Liaison with Chief Officers of the Fire and Police services for providing

assistance in tackling the emergency.

• Ensure the accounting of personnel.

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EIA report of Concord Biotech Ltd. 7-34

• Control traffic movement within the work.

• Arrange for a chronological record of the emergency to be maintained.

• During prolonged emergency, arrange for the relief of the personnel

and provision of catering facilities.

• Contact the local office to receive early notification of impending

changes in weather conditions, in case of prolonged emergency.

• Issue authorized statements to the news media and informs H.O.

• Ensure that proper consideration is given to the preservation of

evidence.

• Control rehabilitation of affected areas after control of the emergency.

7.19.3 Other Key Personnel

The key personnel required for taking decision about further action for

shutting down the plant, evacuate the personnel, and carry out

emergency engineering works in consultation with Site Main Controller in

light of the information received.

HOD’s /Senior Managers/ Section Heads will be responsible for safety,

security, fire, gas and pollution control, spillage control, communication

system including telephone, wireless etc. Also medical services,

transport, engineering, production, technical services, will form part of

advising team.

7.19.3.1 Emergency Response Team

The role of Emergency Response Team members is to actually combat

the emergency at the site and control the emergency situation and carry

out rescue operations. All team members will be thoroughly trained to

deal with fires, explosions, chemical spills and atmospheric releases, first

aid. As per priority list during emergency, the activities will be carried

out as per emergency control plan.

7.19.3.2 Emergency Personnel’s responsibilities Outside Normal

Working Hours of the Factory.

The duties of Shift In-charge & team members have been brought out

in emergency control plan. All team members after evacuating the area

shall report to ECC/ Incident Place. The non-essential workers shall be

evacuated from the plants if need arises and this will be determined with

San Envirotech Pvt. Ltd., Ahmedabad

EIA report of Concord Biotech Ltd. 7-35

the forcible rate with which incident may escalate. Non-essential workers

shall assemble at the earmarked/specified point of assembly.

7.19.3.3 Assembly Points

At the proposed plan, at least 2 assembly points will be identified and

marked properly.

7.19.4 Emergency Control Centre

It will be headed by Site Main Controller, HOD – PD, HOD- P&A and it is

sited in Office of Site Main Controller in Admin Building & New

security office (after office hours), which is readily accessible & with

minimum risk, equipped with telephone facilities and other

announcements extra communications facilities needed. It has enough

means to receive and transmit information and directions from site main

controller to incident controller and other areas. In emergency control

centre due to its safer location and advantage of easier accessibility, all

necessary personnel protective equipment’s fire-fighting extinguishers

will be stocked in sufficient quantity.

7.19.4.1 Role of Emergency Control Centre

In case of mishap or accident like fire, toxic gas leakage, explosion in the

factory, The Emergency Control Centre will be Office of Head- Operations.

• The plot plan indicating all the activities in the factory premises

including that of storage’s utility services, production area,

administration, will be kept for ready reference, showing the location

of fire hydrant and fire-fighting aids.

• Normal roll of employees, work permits, gate entries and documents

for head count, employees blood group, other information and

addresses will be available and the person, who will handle this

operation will HOD P & A.

• Stationery required is available in the Control Centre (ECC) and HOD

(P & A) looks after it.

• The requirement of personnel protective equipment and other

material, like torches, have been worked out and the quantity required

during emergency will be kept in the Control Room (ECC). The

responsible person for maintaining the said requirement/inventory will

be HOD-HSE.

San Envirotech Pvt. Ltd., Ahmedabad

EIA report of Concord Biotech Ltd. 7-36

7.19.5 Fire & Toxicity Control Arrangements

The plant will be well equipped with suitable numbers of fire-fighting and

personnel protective equipment. The staff will be trained regularly to

handle the various emergency situations.

7.19.6 Medical Arrangements

Availability of first aid facilities in sufficient quantity will be always

ensured. In case of emergency arrangements will be made to avail

outside medical help immediately. Emergency transport facility will be

available.

7.19.7 Transport & Evacuation, Mutual Aid Arrangements

Transport & Evacuation and Mutual Aid arrangements will be available in

the factory.

7.20 COMMUNICATION SYSTEM

7.20.1 Declaring the Emergency

In case of any emergency in the plant, speedy and effective

communication of the same to all concerned in least possible time is the

most important aspect of any emergency-handling plan. An early

communication increases the chances of control of emergency in the bud

stage. Blowing siren will be adopted as method of communication of

emergency, to all employees in the plant.

7.20.1.1 Types of Sirens

Three different types of sirens have been identified for communication of

emergency.

Alert Siren: Single Continuous Siren for One Minute. This indicates

that there is some accidental happening in the plant. All have to become

alert. Incident controller will be rush to the site of emergency. Plant area

people have to start safe shut down. Rescue team and other emergency

control teams have to reach at the site of emergency.

Siren for evacuation: wailing & waning siren for three minutes.

This siren indicates that emergency is of serious proportion and

everybody has to leave his work place. All people having their role in

emergency control have to assume their assigned role. All non-essential

workers have to proceed immediately to assembly area and wait for

further instruction.

San Envirotech Pvt. Ltd., Ahmedabad

EIA report of Concord Biotech Ltd. 7-37

All clear siren: Long continuous siren for two minutes. This is a sign

of return of normalcy. On hearing this siren everybody should go back to

his or her respective workplace.

7.20.1.2 Location of Siren

Siren will be located in centre of the pant for wide coverage of the whole

campus. Switch for siren will be provided at security gate. The switch at

Security gate should be operated only as a general rule.

Emergency manual call bell will be installed which will be used in case of

total failure of electricity. It is responsibility of HOD (HSE) to maintain the

upkeep of electric call bell and HOD- Security and administration to

maintain manual and Hand operated siren.

7.20.1.3 Raising Alarm

Any person noticing any emergency situation in the plant should

immediately call security gate with following information:

• Identify oneself

• State briefly the type of emergency i.e. whether fire, explosion, toxic

gas release etc.

• Give the location of the incident

• Estimated severity of the incident.

Security personnel after ensuring genuineness of the call shall raise the

ALERT SIREN. At the same time he will also contact the incident

controller and ECC in order and inform about the incident. He will keep

the gate open and rush his two security personnel at the site of

emergency. ECC will be located at the office of Head- Operations on

normal working hours and at Security gate after normal working hours

(during night). ECC shall be immediately manned on hearing alert siren.

If the authorized people to handle ECC are not available, any senior most

people out of the available person nearby shall occupy ECC till authorized

person comes. Incident controller, on hearing alert siren or by any other

way of information of the emergency, will immediately reach at the site of

incident and assess the situation. He will immediately give his feed back

to ECC. ECC shall direct security gate to raise evacuation siren, if the

need arise. SIREN FOR EVACUATION shall be raised on instruction from

Site Main Controller or any Manager of the plant in the ECC. Security gate

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EIA report of Concord Biotech Ltd. 7-38

person will be authorized to raise ALL CLEAR SIREN on instruction from

Site Main Controller or ECC, after the emergency is over. Incident

controller shall assume the responsibility of site main controller in his

absence.

7.20.2 Internal Communication

It shall be responsibility of ECC to communicate to all employees in the

plant. They may take help of telephone operator for such communication.

However, telephone operator can directly communicate information about

emergency to all internal departments, if such message comes from

incident controller or site main controller. Telephone operator will

continue to operate the switchboard advising the callers that staffs are

not available and pass all calls connected with the incident to ECC.

7.20.2.1 Availability of Key Personnel outside Normal Working Hours

The details of key personnel availability after working hours will be made

available at Security Gate, ECC, telephone operator as well as production

units. Security personnel shall call required key personnel from their

residence in case emergency occurs outside normal working hours.

Availability of emergency vehicle/Ambulance will be ensured to fetch the

key personnel residing outside. It will be the responsibility of HOD (P & A)

to maintain it.

7.20.2.2 To the Outside Emergency Services

Decision to call outside help to deal with emergency like fire brigade,

ambulance, police, etc., shall be taken by Site Main Controller. However,

in absence of Site Main Controller, if the incident controller realizes the

situation going out of control, he may ask for immediate help from

outside. ECC will be responsible for calling help from outside. A list of

emergency services available in the area with their telephone numbers

will be provided at ECC, at Security gate and with telephone operator.

Facilities such as phones, emergency vehicle, and security personnel will

be available to help calling outside emergency services and authorities.

7.20.3 Communication to the Authorities

The emergency will be immediately communicated to the government

officers and other authorities such as SPCB, police, district emergency

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EIA report of Concord Biotech Ltd. 7-39

authority, Factory Inspectorate, hospital etc. by Emergency Control

Centre.

7.20.3.1 To Neighboring Firms & the General Public

In case of emergency having its outside impact, public will be cautioned

regarding the same. Co-ordination of police will be sought for speedy

action. This is to be ensured by ECC.

7.21 Pre-emergency activities

Internal Safety survey with regard to identification of hazards, availability

of protective equipment’s, checking for proper installation of safety

devices will be carried out periodically.

• Periodic pressure testing of equipment

• Periodic pressure testing of lines

• Periodic safety/relief valve testing

• Periodic fire hydrant system testing

• Mock drill to check up level of confidence, extent of preparedness of

personnel to face emergency is being contemplated

• Regular training is being imparted to all personnel to create awareness

• Adequate safety equipment will be made available

• Periodic check-up of emergency lights

• Safer assembly points will be identified

• Storage of adequate first aid treatment facilities

7.22 POST-EMERGENCY ACTIVITIES

Following post emergency actions will be carried out to study in detail and

preventive measures to be taken

• Collection of records

• Inquiries

• Insurance claims

• Preparation of reports comprising suggestion and modification

• Rehabilitation of affected personnel

• Normalization of plant

7.22.1 Evacuation and Transportation

In case of emergency, evacuation and transportation of non-essential

workers will be carried out immediately. The affected personnel will be

transported for medical aid.

San Envirotech Pvt. Ltd., Ahmedabad

EIA report of Concord Biotech Ltd. 7-40

7.22.2 Safe Close Down

During emergency plant shut down will be carried out if situation

warrants. This will be as per the instruction of site main controller under

guidance of incident controller.

7.22.3 Use of Mutual Aid

Mutual aid agreement with nearby industries will be ensures to provide

help to each other in the emergency,

7.22.4 Use of External Authorities

As and when necessary, statutory authorities, police, pollution control

personnel, medical aid/center, ambulance etc. will be contacted.

7.22.5 Medical Treatment

The affected personnel will be brought to safer place immediately to give

them first aid. Immediate medical attention will be sought.

7.22.6 Accounting for Personnel

Proper accounting for personnel will be laid down in all the shifts. The

number of persons present inside the plant premises, their duty etc. will

be available with the P & A. This record will be regularly updated and will

be made available.

7.22.7 Access to Records

The relatives of affected personnel will be informed. The details regarding

all employees will be made available to Administration building.

7.22.8 Public Relations

In case of emergency, Manager P & A will be available for official release

of information pertaining to the incident.

7.22.9 Rehabilitation

The affected area will be cleared from emergency activities only after

positive ascertaining of the system in all respects. The entry to affected

area will have to be restricted until statutory authorities visit and inspect

the spot of incident. Nothing should be disturbed from the area till their

clearance. The site main controller will be in charge of the activities to be

undertaken. The plan will cover emergencies, which can be brought under

control by the works with the help of emergency team/fire services. The

DISASTER CONTROL PLAN for gas leak and fire will be prepared for entire

factory.

San Envirotech Pvt. Ltd., Ahmedabad

EIA report of Concord Biotech Ltd. 7-41

7.23 CAUSES OF EMERGENCY

7.23.1 Risk

7.23.1.1 Nature

In the plant, the nature of dangerous events could be of the following:

• Fire : Chemical/Electrical

• Toxic Release : From chemicals

• Leakages : Equipment, pipe lines, valves, etc.

7.23.1.2 Various Emergency Actions

a) Onsite

• Safe shut down of the plant and utilities

• Emergency control measures.

• To attempt with the help of trained crew in firefighting to contain the

fire spread up/gas emission and limit within limited space.

• To cut off source of oxygen by use of firefighting appliances/to cut off

source of gas emission.

• Cut off fall sources of ignition like electrical gadgets.

• To protect fire prone area from the fire.

• To remove material which can catch fire to the extent possible from

fire prone area.

• Evacuation of non-essential persons.

b) Medical Facilities/Treatment

• The Plant will have a Health centre which is manned with trained male

nurse on continuous basis who can render medical first aid. Doctor

will visit two times a week for two hour each time. The Plant is

searching for a full time medical officer and will appoint as and when

available.

• Depending on seriousness the injured person shall be shifted to any

other hospital.

• Vehicle will be available round the clock for transportation. Ambulance

will be also made available in the campus on regular basis.

c) In the event of Fatal Accidents

The information shall be given to following authorities:

• Inspector of Police

• Inspector of Factories

San Envirotech Pvt. Ltd., Ahmedabad

EIA report of Concord Biotech Ltd. 7-42

• Mamlatdar

• Corporate Office

• Regd. Office

• Insurance the plant

• Regional Officer, SPCB

d) Emergency Siren

Emergency siren shall be blown for announcing the emergency which

shall have different sound for identification/differentiation than the

normally used for commencement of factory working etc.

• Location of Siren Above Plant

• Type of Siren Industrial Siren

• Position of siren switch Located at Main Gate

e) Seeking help from neighboring industries/sources for fire engine

f) Advise for vacation of other areas

• Since the effect of fire/gas emission shall be contained within the area

of the plant advice of vacation of other areas is not necessary

7.23.1.3 Response Time-Minutes

Hazard Fire Fighting Police Medical Services

Fire & Explosion

Immediate with whatever facilities available with the plant

10 min.

10 minutes

External Help within 15 minutes

7.24 OFF-SITE EMERGENCY PLAN

7.24.1 Need of the Site Emergency Plan

Depending upon the wind direction and velocity of the effects of accident

in factory may spread to outside its premises. To avert major disaster it

is essential to seek guidance/assistance of statutory authorities, police

and health department. The movement of traffic may have to be

restricted. Required information will be given to the authority and

consultation will be sought for remedial measures.

A purpose of the off-site emergency plan is:

• To provide the local/district authorities, police, fire, brigade, doctors,

surrounding industries and public the basic information of risk and

environmental impact assessment and appraise them of the

consequences and the protection/prevention measures and to seek

their help to communicate with public in case of major emergency.

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EIA report of Concord Biotech Ltd. 7-43

• To assist district authorities for preparing the off-site emergency plan

for district or particular area and to organize rehearsals from time to

time and initiate corrective actions on experience.

7.24.2 Structure of the Off-Site Emergency Plan

Available with concerned authorities.

7.24.3 Role of the Factory Management

The site main controller will provide a copy of action plan to the statutory

authorities in order to facilitate preparedness of district/area off-site

emergency plan.

7.24.4 Role of Emergency Co-ordination Office (ECO)

He will be a senior police or fire officer co-ordination with site main

controller. He will utilize emergency control centre.

7.24.5 Role of Local Authority

Preparation of Off Site Plan lies with local authorities. An emergency-

planning officer (EPO) works to obtain relevant information for preparing

basis for the plan and ensures that all those organization involved in

offsite emergency and to know their role and responsibilities.

7.24.6 Role of Fire Authorities

The fire authorities will take over the site responsibility from incident

controller after arrival. They will be familiarized with site of flammable

materials, water and foam applies points, fire-fighting equipment.

7.24.7 Role of the Police and Evacuation Authorities

Senior Police Officer designed, as emergency co-ordination officer shall

take over all control of an emergency. The duties include protection of

life, property and control of traffic movement.

Their functions include controlling standards, evacuating public and

identifying dead and dealing with casualties and informing relatives of

dead or injured. There may be separate authorities/agencies to carry out

evacuation and transportation work. Evacuation depends upon the nature

of accident, in case of fire only neighboring localities shall be alerted.

Whole areas have to be evacuated in case of toxic release.

7.24.8 Role of Health Authorities

After assessing the extent of effect caused to a person the health

authorities will treat them.

San Envirotech Pvt. Ltd., Ahmedabad

EIA report of Concord Biotech Ltd. 7-44

7.24.9 Role of Mutual Aid Agencies

Various types of mutual aid available from the surrounding factories and

other agencies will be utilized.

7.24.10 Role of Factory Inspectorate

In the event of an accident, the Factory Inspector will assist the District

Emergency Authority for information and helping in getting Neighbouring

Industries/mutual aid from surrounding factories. In the aftermath,

Factory Inspector may wish to ensure that the affected areas are

rehabilitated safely.

7.25 MOCK DRILLS AND RECORDS

7.25.1 Need of Rehearsal & Training

Regular training and rehearsal program of emergency procedures shall be

conducted with elaborate discussions and testing of action plan with mock

drill. If necessary, the co-operation/guidance of outside agencies will be

sought.

7.25.2 Some Check Points

• The extent of realistic nature of incidents.

• Adequate assessment of consequences of various incidents.

• Availability of sufficient resources such as water, fire-fighting aids,

personnel.

• The assessment of time scales.

• Logical sequences of actions.

• The involvement of key personnel in the preparation of plan.

• At least 24 hours covers to take account of absences due to sickness

and holiday, minimum shift manning.

• Satisfactory co-operation with local emergency services and district or

regional emergency planning offices.

• Adequacy of Site.

7.25.3 Records and Updating the Plan

All records of various on-site and off-site emergency plans of the factory

will be useful alone with those of the factors by which statutory

authorities draw a detailed plan for the whole area/district. The records of

the activity will be updated regularly.

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EIA report of Concord Biotech Ltd. 7-45

(B) Social Impact Assessment

There will be no R & R require as proposed expansion will be done in the

existing premises. No any negative Social Impact envisaged from the

proposed expansion project activities. In fact, positive social impact will

occur as necessity of unskilled and skilled person will increase for

proposed activities and unit will give opportunity to the local people.

(C) Public Consultation

The public hearing was held on 27.04.2017 on the basis of the draft

EIA/EMP incorporating the Terms of References. Report is finalized after

incorporating the comments and suggestions by the public during pubic

consultation is given below.

Table 7.11 Points raised during public hearing

Issues/objections raised by the participants and responded to by the representative of the applicant during the Public Hearing: Sr. No.

Name and Address

Point Represented Reply from Project Proponent

1. Name: Hasmukhbhai B Patel Vill: Dholka

• He expressed the gratitude of the company and said that expansion in this company will create employment opportunities. This unit does not seem to consider highly polluting industry and it will create better development opportunity of Dholka and its surrounding area.

---

2. Name: Rajnikant Manilal Thakkar Vill: Dholka

• We have a business of ginning mill next to Concord biotech and we are residing close to the factory. We also have two ginning factories on the Trasad road and we are regularly passing through this area. For 20 years, we have not felt that there is any pollution or odor in the air. We have not seen pollution even when we go for Picnic with our family at a temple of BootBhavani Maata, which is near to factory. Water flowing nearby which is also not seem to polluted. We have no any kind of damage in terms of health due to this company till date. Expansion will generate employment. Educated people will get job, so the village of Dholka will be developed and benefitted.

---

3. Name: Govind • Surrounding villages get ---

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EIA report of Concord Biotech Ltd. 7-46

Dodiya Vill: Dholka

benefits from Concord Biotech. We get benefit for expansion. There is no noticeable water or air pollution.

4. Name: Snehlatta Patel Vill: Dholka

• How to dispose of waste water from this unit?

• Representative of the company's informed that, the main source of waste water generation is from the fermentation process; the second source is the Cooling bleed off and the Boiler Blow Down. The unit has a primary, secondary and tertiary unit treatment plant. Then it will be passed through RO, permeate is reused and reject is evaporated in MVR/MEE and condensate is recover and reuse. Hence at the end of process, no effluent is released outside the factory premises.

5. Name: Ranachhodbhai Maljibhai Rabari Vill: Dholka

• Our land is surrounding the Concord Biotech and unit is emitting Gas (air pollution) after 9 pm. In this regard, we have 2 times made application. 2 times negative report comes from Gujarat Pollution Control Board that they are generating pollution. I have copy of this report. 3rd time they said that, close this case. So 4th time I have taken online action to central level. We cannot live in our farm after 9 pm and we have threatened by saying that do whatever you want to. I have written papers of Gujarat Pollution Control Board in which it is mention that, there is an odour issue. Same papers I have submitted to Gandhinagar also. Now, if you wish, then we will migrate from here and leave this place.

---

6. Name: Hasmukhbhai Modi Vill: Dholka

• I have been working as the Secretary of GIDC industrial estate for last 17 years and if there is any question, we will immediately resolve mutually. We are doing any kind of work for the development of Dholka. Some elements are always objectionable & against the development. And if any new factory comes or expands in

---

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EIA report of Concord Biotech Ltd. 7-47

this area, their objections are immediately come in front. If they are facing any problem, then represent it, so we can resolve the problem. But we do not tolerate false objections against the development of our area.

7. Name: Parimal H Rabari Vill: Dholka

• I have submitted complain in writing to stop toxic pollution generated by Concord Biotech. We cannot live in our farm which is adjoining to the unit, after 9 pm. Our workers cannot work after 9 pm in our farm. In this regard, I am giving you written application. Take strict action against this unit in this matter.

• Reply of written representation is attached with Minutes.

8. Name: Paresh Rathod Vill: Dadusar

• There is no noticeable pollution from Concord Biotech. No harm by this unit and around 700 to 800 people are getting employment since its inception. Due to closure of Kenco Overseas near Valthera, the employment of around 500-700 people was snatched off. These workers have get employment in Concord Biotech. This unit is giving salary around Rs. 9000 to 10000 salary and PF. Apart from this, Concord Biotech provide free ambulance service along with free diagnosis & medicines. It is my opinion that, this company has progressed further. My personal request is to free develop Concord Biotech.

---

9. Name: Mahammad Yunus Ahemad Malik Vill: Renvad, Dholka

• My farm is adjacent to Concord Biotech in Survey No. 1491-1492. We are not against of development but we are against of spread of pollution.

---

10. Name: Dhiren Patel Vill: Dholka

• It is true that Concord Biotech gives employment to everyone, but takes appropriate measures to control pollution along with employment.

---

11. Name: Ashwin D Jamod Vill: Jalalpur Godhaneshwar

• What steps will you take to control Air pollution?

• Representative of the company’s informed that, no air emission during process because this is a biotechnology process and if any poisonous substance present, then product cannot produce. This process is complete

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EIA report of Concord Biotech Ltd. 7-48

after 8 to 9 days once it starts and this process is done in closed reactor. Once it starts then it cannot be stopped in between and restarted again. So there is no air pollution until the process is over. This process is like the same process of fermentation we are doing at home.

12. Name: Vikram Makawana Vill: Jalalpur Godhaneshwar

• Chemical water comes out from the unit, so what safety measures will you take to avoid any harm to people?

• Representative of the company’s informed that, this process is fermentation based process, in which mainly edible substances like Soybean flour, Sucrose, Dextrose and edible oil are used and no inedible substance are used in it. If any inadequate substance is used, then the fermentation process does not go forward. w/w generated at the end of this process has little TDS and high COD, which is bio degradable. It is treated in existing ETP and reuse after treatment. Not any w/w discharge outside the premises.

13. Name: Budhabhai Makawana Vill: Jalalpur Godhaneshwar

• What steps will you take to ensure that the people of the surrounding villages get jobs after its expansion?

• Representative of the company’s informed that, at present local people are preferred for employment and after expansion also local people will be given priority for employment.

14. Name: Janki Patel Vill: Dholka

• Explain briefly about the manufacturing of medicine from biotechnology.

• Representative of the company's informed that, this is a fermentation process in which certain types of Enzymes are used in specific types of medicine. It produces 1 to 2% of the drug. The process lasts for 8 to 10 days. The medicine made at the end of this process is extracted and purified. Fermentation is the main part of the process.

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EIA Report of Concord Biotech Ltd. 8-1

Chapter-8 Project Benefits

8.1 INTRODUCTION

Project benefit focus on those points which will become beneficial to the

surrounding area or community in terms of infrastructural development,

social development, employment and other tangible benefits due to the

project. Proposed expansion project has a potential for employment of

skilled, semi-skilled and unskilled employees during construction phase as

well as operational phase.

8.2 IMPROVEMENT IN PHYSICAL INFRASTRUCTURE

Unit has proposed to expand manufacturing capacity in the same plant

premises. Project will have requirement of an additional infrastructure

and so direct benefit of infrastructures development is anticipated. The

project proposes to employ local people which will help to increase the

income of local people & improve their standard of living.

The construction and commissioning phase will require a substantial man-

power and resources. The unit has proposed to employ local contractual

services for this. Hence, with the growth in the economic conditions, the

project may lead to growth in the social stature & improvement of the

quality of life in the surrounding area. It will also help in improvement in

local amenities. Thus, the project will have considerable indirect benefits

to the public physical infrastructures.

8.3 IMPROVEMENT IN SOCIAL INFRASTRUCTURE

The company will conduct social welfare activities which include the

funding & contribution for public infrastructure/facilities development,

maintenance & improvement on basis of as & when required.

Due to proposed project activity, social infrastructure will improve by

means of civilization, vocational training and basic amenities.

Civilization: Due to the project, employment and other infrastructural

facilities will boost up income of surrounding people and improve

qualityof life. This will indirectly boost up the civilization of the

surrounding people.

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Vocational Training: Moreover, unit will provide vocational training

opportunity to the surrounding people and greed for employment will

motivate the education activities that will lead the change in life style of

the surrounding and affected people hence social infrastructure will be

improved.

Basic Amenities: Better education facilities, proper healthcare, road

infrastructure and drinking water facilities are basic social amenities for

better living standard of any human being which will further increase the

above amenities directly/indirectly either by providing or by improving

the facilities in the area, which will help in uplifting the living standards of

local communities.

8.4 EMPLOYMENT POTENTIAL

In the construction phase, direct and indirect manpower will be involved.

Thus temporary and permanent employment will be generated during

construction phase. The proposed manpower requirement during

construction will be 20-25 nos. During the operation phase, additional

100 nos. of skilled and unskilled manpower will be required for proposed

expansion activities. Moreover, unit will provide first priority to local

workers for the employment.

Further, the indirect employment via increased transportation, ancillary

units & local economic activities will also add in the employment potential

of the project. Thus, project will result in considerable benefits in terms of

employment.

8.5 OTHER TANGIBLE BENEFITS

As mentioned above, the project will have many employment & trade

opportunities with the inception of the construction activities. Thus, these

will eventually result in appreciable economic benefits to the local people

& businesses/contractors. Indirectly, the project will help the Government

by paying different taxes from time to time, which is a part of revenue

and thus, will help in developing the area.

The CSR activities planned by the company will be considerably beneficial

to the surrounding area. These all together with the economic benefits of

the proposed project will result in further benefits in terms of the literacy

level, primary and middle level education and on health facilities.

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EIA Report of Concord Biotech Ltd. 9-1

Chapter-9 Environmental Cost Benefit Analysis

As per EIA Notification 2006, this Chapter of the ‘Environmental Cost Benefit

Analysis’ is applicable only if it is recommended at the Scoping stage. As per

the ToR points issued by MoEF&CC, New Delhi vide File No. J-

11011/268/2015-IA II (I) & ToR letter dated 28th January, 2016; the

Environmental Cost Benefit Analysis is not applicable and hence has not

been prepared.

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EIA Report of Concord Biotech Ltd. 10-1

Chapter-10 Environment Management Plan

10.1 INTRODUCTION

Environmental Management Plan (EMP) includes the protection,

mitigation and environmental enhancement measures to be implemented

to nullify the adverse impact on the environment. This plan will also

facilitate monitoring of environmental parameters.

Assessment of environmental and social impacts arising due to

implementation of the project activities is the technical heart of EIA

process. An equally essential element of this process is to develop

measures to eliminate, offset or reduce impacts to acceptable levels

during implementation and operation of projects. The integration of such

measures into project implementation and operation is supported by

clearly defining the environmental requirements within an Environmental

Management Plan (EMP). The EMPhas been formulated considering all

necessary mitigation measures to prevent/minimize/eliminate

environmental impacts as well assignment of implementation stage&

responsibilities. Unit, being anexisting unit has already formed an

Environment Management Cellin order to keep a close watch on the

performance of the pollution control equipment, emissions from the

sources and the quality of surrounding environment in accordance with

the monitoring program. EMP will be modified/upgraded as per

requirement after the proposed expansion.

10.2 OBJECTIVE OF ENVIRONMENT MANAGEMENT PLAN

The EMP is prepared with the main objective of enlisting all the

requirements to ensure effective mitigation of adverse impacts for all the

components of the proposed project. The objective of the Environmental

Management Plan is summarized hereunder,

To comply with the stipulated enviro-legal requirements & standards.

To limit/reduce the degree, extent, magnitude or duration of adverse

impacts.

To treat all the pollutants i.e. liquid effluent, air emissions and

hazardous waste with adoption of adequate and efficient technology.

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To create good working conditions.

To reduce any risk hazards and design the disaster management

plan.

Continuous development and search for innovative technologies for a

cleaner and better environment.

To make budgetary provision and allocation of funds for environment

management system and for timely revision of budgetary provisions.

To contribute significantly for sustainable development by resource

conservation, waste minimization/recycling/reuse and approaching to

Cleaner Production practices.

10.3 COMPONENTS OF EMP

EMP for the proposed expansion project covers following aspects:

Description of mitigation measures for operation phase only

Description of monitoring program

Institutional arrangements

Implementation schedule and reporting procedures

10.4 ENVIRONMENTAL MANAGEMENT SYSTEMS (EMS)

For the effective implementation of the mitigation measures and

consistent functioning of theproposed expansion project, an

Environmental Management System (EMS) has been proposed. The

EMSwill include the following:

• Environmental Management Cell

• Environmental Monitoring Program

• Personnel Training

• Regular Environmental Audits and Corrective Action Plan

• Documentation – SOPs of Environmental Management

• Plans and other records

10.5 ENVIRONMENTAL MANAGEMENT CELL

Unit, being anexisting unit has already set up separate Environment

Management Cell (EMC). The major duties andresponsibilities of

Environmental Management Cell are as follows:

• To implement the Environmental Management Plan

• To ensure regular operation and maintenance of pollution control

devices

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• To assure regulatory compliance with all relevant rules and regulations

• To minimize environmental impacts of operations by strict adherence

to the EMP.

• To initiate environmental monitoring as per approved schedule.

• Review &interpretation of monitored results and corrective measures

in case monitored results are above the specified limit.

• Maintain documentation of good environmental practices and

applicable environmental laws as ready reference.

• Maintain environmental related records.

• Coordination with regulatory agencies, external consultants and

monitoring laboratories.

• Maintaining log of public complaints and the action taken.

10.5.1 Hierarchical Structure of Environmental Management Cell

EMP cell is supervised by a dedicated person who reports to theSite

Manager. The hierarchical structure is given below in Figure 10.1.

Figure 10.1: Environment Management Cell

10.5.2 Record Keeping and Reporting

Record keeping and reporting of performance is an important

management tool for ensuring sustainable operation of the proposed

ETP in-charge

Safety officer

Senior Manager

ETP Operator

Director

Manager

Executive

MVRE in-charge

Fireman MVRE operator

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EIA Report of Concord Biotech Ltd. 10-4

manufacturing unit. Records will be maintained for regulatory, monitoring

and operational issues.

10.6 ENVIRONMENTAL MANAGEMENT DURING CONSTRUCTION PHASE

Construction phase results in temporary environmental pollution except

for the permanent change in local land use pattern &aesthetics in certain

cases. Such pollution is mainly due to site preparation, civil works,

transportation, storage & handling of construction materials, construction

worker’s sanitation etc. These are usually short-term impacts.

During construction work, air pollution is expected in the form of

increased suspended particulate matter concentration. Installation work

will generate noise and dust but it will within working areas. To mitigate

the adverse environment impact due to the construction phase, following

measures will be taken:

• Regular sprinkling of the water will be done along with the

construction activities.

• Regular preventing maintenance of machinery and transportation of

vehicles during construction to reduce noise pollution.

• Provision of silencer, to modulate the noise generated by the machine,

if required.

• Reduce the exposure time of workers to the higher noise level by job

rotation.

• To protect workers working in noisy area, personal protective

equipments like earmuffs/earplugs will be provided.

• Tree plantation will be proposed periphery of plant premises and along

the roads.

Water Environment

During construction phase, provision for infrastructural services including

water supply, sewage and electrification will be made. The construction

site would be provided with suitable toilet facilities for the workers to

allow proper standards of hygiene.

Safety and Health during Construction Phase

Adequate space will be provided for construction of temporary sheds for

construction workers mobilized by the contractors. Unit will also supply

potable water for the construction workers. The safety department will

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EIA Report of Concord Biotech Ltd. 10-5

supervise the safe working of the contractor and their employees. Work

spots will be maintained clean, provided with optimum lighting and

enough ventilation to eliminate dust/fumes.

Socio-economic Environment

Management will give preference to local people through both direct and

indirect employment.

10.7 ENVIRONMENTAL MANAGEMENT DURING THE OPERATIONAL

PHASE

EMP proposed for implementation is detailed under the following heads:

♦ Air Pollution Control

♦ Wastewater Management

♦ Solid/Hazardous Waste Management

♦ Noise Management

♦ Greenbelt Development

♦ Occupational Safety and Health

10.7.1 Air Pollution Management

10.7.1.1 Source of air pollution and control measures There is no process gas emission from the plant. At present, flue gas

emission is from one common stack of 2 nos. of steam boilers, furnace

Oil (FO) is used as fuel. After expansion, one boiler will be

modified/replace in terms of capacity from 3 TPH to 8 TPH. Therefore, FO

consumption will increase from 820 kg/hr. to 1100 kg/hr. Due to use of

liquid fuel i.e. FO, no need of APCM except appropriate stack height as

per CPCB guideline. Most probable emitted pollutants will be SPM, SO2

and NOx.

Unit has installed D.G. Sets with capacity of 1000 kVA & 680 kVA. After

expansion, D.G. set of 680 kVA will be dismantled and unit will install 3

new stand by D.G. sets with capacity of 1000 kVA each to fulfill power

requirement in case of non-availability of power/emergency. D. G. Set

will not the constant source of emission as it will be used in case of power

failure only so adequate stack height is provided.

In order to minimize the air pollution the unit will develop greenbelt on

and around its premises considering the following guidelines,

i) Green cover should be created at all the available open spaces.

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ii) Strict surveillance is made to increase the survival rate of the trees.

iii) Plants with higher height, medium and low height should be planted

to ensure thick belt for attenuation of fugitive emission. This activity

demands expert advice and guidance.

Measures for fugitive emission

Following measures will be adopted to prevent and control fugitive

emissions:

• Regular maintenance of valves, pumps and other equipment will be

done to prevent leakages and thus minimizing the fugitive emissions

of VOCs.

• Entire process is carried out in the closed reactors with proper

maintenance of pressure and temperature.

• The ventilation system provided will reduce the health impact on

employees by way of dilution of work room air and also dispersion of

contaminated air.

• Care will be taken to store construction material properly to prevent

fugitive emissions, if any.

• Regular periodic monitoring of work area to check the fugitive

emission.

• To eliminate chances of leakages from glands of pumps, mechanical

seal will be provided at all solvent pumps.

• During transfer of material, steps shall be taken to reduce and prevent

splashes and spills. Any liquid or dry material spilled shall be cleaned

as expeditiously as possible.

• Good housekeeping, proper maintenance and continuous observation

will prevent the chances of any fugitive emission from the process

plant.

10.7.1.2 Solvent Management Plan Resource optimization/recycling and reuse is envisaged for the project as

follows:

The raw materials will be stored in closed containers and will be

handled through closedsystem to avoid the handling losses.

The solvent distillation system is designed so as to achieve minimum

95% - 98% recovery of solvent.

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Wherever required, the solvents shall be directly pumped into day

tanks from the storage tanks and shall be charged into the reactors

without involving any manual handling.

Total of 40 numbers of API bulk drugs produce by biotechnology root

with maximum capacity of 189.03 MT/year.

All the products shall be recovered from aqueous solution to dissolve

into solvent. Solvents shall be collected & re-processor for distillation

and recovered solvent will be ruse in process.

The Reactors shall be connected to an efficient condenser system with

cooling/chilling water circulation.

Reactor and solvent handling pumps shall have mechanical seals to

prevent leakages. Also provide with breather valve to prevent losses.

Solvent will be taken from storage tank to reactors through closed

pipe line. Storage tank shall be vented through trap receiver &

condenser operated on cooling water.

The condensers shall be provided with sufficient HTA and residence

time so as to any loss of solvent.

All necessary firefighting systems shall be provided with alarm

system.

Flameproof wiring and flame proof electrical accessories shall be

provided to avoid any mishap.

Residue generated from the distillation will be incinerated sent to

common incinerator site.

Solvents shall be stored as per statutory requirement.

Solvents shall be kept at a separate specified area with all the safety

measures.

Multipurpose Distillation System-MS Column

There will be a multipurpose batch distillation system consisting of

distillation column with structured packed column, kettle, distillation

column, water condenser, child condenser and distillate receivers.

Entire systems are in closed loop with vacuum pump and feed &

recovered solvent storage tanks. The system is designed as

multipurpose and can separate most of the known solvent mixtures.

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The whole system is designed for vacuum and can handle both

vacuum distillation and atmospheric distillation.

Name of Solvent

Quantity use Mt/Month

Solvent Recovery Mt/Month

Loss of Solvent Residue/ with effluent

Mt/Month Acetone 93.5 88.8 4.7

DMF 0.8 0.8 0.0

Ethanol 3.5 3.3 0.2

Ethyl acetate 66.5 64.8 1.7

IBA 144 138.2 5.8

IPA 6.33 6.0 0.4

Methanol 10 9.5 0.5

Toluene 697 676.1 20.9

Solvents are used for extraction of products. Used solvents are recovered

by distillation system and reuse. The solvent residues which are mainly

organic in nature and contain significant calorific value are sent for co-

processing. Total solvent balance is given in above table. Schematic

diagram of solvent recovery system is presented in Figure 2.4of chapter-

2.

10.7.1.3 Action plan for odour control Early detection and response is a key consideration in the management of

potential odors. Potential odors are at the wastewater treatment plant and

the surrounding areas. Fermentation process for Biotechnology based

medicine is taking more focus for fermentation hence no chances of odor

nuisance. The API fermentation systems generate carbon dioxide (CO2)

that contains some volatile organic compounds (VOC) which can have a

sweet fermented smell. Non-condensable gases from the facility distillation

system contain some solvent and other VOCs which can have a slightly

astringent alcohol odor.

Second source of odour problems is ETP and sludge handling systems.

During nominal operations, wastewater flows through the basin quickly,

does not become septic, and does not generate odors. Odors could occur

during periods of operational downtime. If wastewater would be allowed to

stagnate in the clarifier for days, septic water and sludge could be fanned,

and, as a result, excessive odors potentially could be generated. To

minimize the generation of odors during periods of operational downtime,

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efforts are taken to prevent water from being held in the ETP for extended

periods. Corrective measures could reduce the retention time for primary

treatment and removing the water and solids from the clarifier in due time

cycle.

Other source of odour problems in ETP is biological treatment. in the

Activated Sludge process is to provide which microorganisms can

consume organic materials in wastewater. These microorganisms, called

mixed liquor, are live single-celled organisms typically found in aquatic and

moist environments. Oxygen is added to this basin to support the growth

of these organisms and prevent the basin from becoming septic. Excessive

odors could occur during periods of low dissolved oxygen (DO) values. To

minimize the generation of excessive odors from the ETP, efforts are taken

to manage the causes of the low DO. Maintain the aeration system to

maintain the DO level in effluent. Increase recycles of waste activated

sludge. Remove excess sludge from secondary clarifier. Minimize the

holding of sludge slurry and dewatered in with minimum time to avoid

odour problems.

10.7.2 Water Environment

At present, total water requirement (industrial + domestic+ greenbelt) is

589.5 KLD. Out of which; 349.5 KLD is fresh water requirement and

240.0 KLD is recycle water. After expansion; it will be increased up to

955.0 KLD; out of which 556.0 KLD will be fresh water requirement. Raw

water is satisfied from own bore well.

After proposed expansion, total industrial wastewater generation will be

increased from 210.0 KLD to 399.0 KLD.Domestic effluent is also sent to

ETP along with industrial wastewater. Wastewater generated from

process, washing & utility is directly sent to ETP having primary &

secondary treatment units. Unit has full-fledge Effluent Treatment Plant

with capacity of 400 m3/day. After expansion, unit will treat its effluent in

exiting ETP.

Effluent treatment scheme:

To considering high suspended solids due to microbes (broth) in industrial

effluent, unit has installed decanter as a pre-treatment to remove it

before primary treatment. Effluent from collection tank flows to Oil

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&Grease trap. The oil and grease are removed in this unit. The effluent

then flows to the equalization cum neutralization tanks. Adding the

chemicals viz. lime, alum and poly electrolyte depending upon the quality

of incoming effluent, neutralizes the effluent here. For air requirement

diffused aeration system is provided in this unit. The neutralized effluent

is flows to the primary clarifier where quiescent condition is provided for

settlement of settable solids. The sludge settled in the primary clarifier

taken to the sludge drying bed or decanter collection tank while the

supernatant is subjected to the biological treatment.

The supernatant from the clarifier is taken to the aeration tank. Biological

degradation of the organic matter occurs in the aeration tank in presence

of the oxygen. Effluent containing biomass from aeration tank flows to

the secondary Clarifier. Here the settlement of the biomass takes place

under quiescent condition. Settled biomass is either recycled in to the

aeration tank to maintain the MLSS concentration or can be taken in to

the sludge drying bed or decanter collection tank. Biologically treated

effluent will be passed through two stage RO. Reject from first stage RO

will be sent to second stage RO. Reject from second stage RO will be sent

to MVR/MEE. Condensate of MVR/MEE & permeate of second stage RO

will be used in Cooling. Entire quantity of treated water from ETP is

utilized for greenbelt development.The decanter feed pump transfer to

the decanter where the solid and liquid are segregate. The solids are

collected or dried in sludge dryer and then after packedinto the HDPE

bag. The liquid from decanteris transfer to collection tank or equalization

tank. Sludge bags are stored in Hazardous waste storage area.

Table 10.1 Size and dimension of Effluent Treatment Plant

Sr. No.

Name of Unit MOC Capacity (m3)

Size Dimension (m)

Qty.

1 Collection Tank (01 No.) RCC 20.83 Dia.6.0 x 2.0 1

2 Oil & Grease Trap (01 No.)

RCC 18.75 8.0 x 2.0 x 1.2 1

3 Chemical Storage Tank (01 No.)

RCC -- 6.0 x 6.0 1

4 Equalization cum Neutralization Tank (02 Nos.)

RCC 750 10 x 10 x 3.5 2

5 Equalization cum Neutralization Tank

RCC 300 7 x 7 x 3.5 2

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(02 Nos.) 6 Primary Clarifier (01 No.) RCC 140 Dia.8.0 x 3.0 1

7 Aeration Tank-1 RCC 2060 Dia.27 x 3.5 1

8 Aeration Tank-2 RCC 2000 Dia.20.5 x 5.5 1

9 Secondary Clarifier-1 RCC 70.65 Dia.6.0 x 2.5 1

10 Secondary Clarifier-2 RCC 70.65 Dia.6.0 x 2.5 1

11 Holding Tank (01 No.) RCC 31.40 Dia.4.0 x 25 1

12 Sand Filter (01 No.) MS -- Dia.1.5 x 2.0 1

13 Sludge Drying Beds (14 Nos.)

RCC -- 8.0 x 8.0 14

14 Sludge Storage Area Brick work

-- 15.0 x 4.0 -

15 Chemical Solution tank RCC - 2 x 2 x 1.25 3

16 Chemical Solution tank RCC - 2 x 2 x 1.25 3

17 Chemical Store room RCC - 3 x 5 1

18 Decanter 1 Standard supply

- 300 kg/hr. 1

19 Decanter 2 Standard supply

- 450 kg/hr. 1

20 Sludge Dryer Standard supply

- 500 kg/hr. 1

21 Mechanical Vapor Recompression Evaporation

Standard supply

- 100 kl/d 1

22 Crystallizer Standard supply

10 KL/day 1

Water Management

The unit maintains records for the total water consumption at various

sources.

Domestic effluent will be treated in ETP along with other effluent.

Unit is doing rain water harvesting to balance the ground water.

The mitigation measures for minimizing the impacts on water

environment in general includes following:

Minimization of water use

Segregation and collection philosophy for effluent to minimize waste

generation and facilitate treatment as well as recycle.

Treatment philosophy to achieve mandated standards

Reuse/recycle

Some of the measures, which are to be implemented, include:

Use of high-pressure hoses for cleaning the floor to reduce the

amount of wastewater generated.

Ensuring proper operation and maintenance schedule for the ETP.

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EIA Report of Concord Biotech Ltd. 10-12

10.7.3 Hazardous/Solid Waste Management

Main source of hazardous waste generation is ETP sludge & MEE salts,

distillation residue, spent carbon, used oil, discarded bags/containers, off

specific products. After expansion, there will be increase in the quantity

of all the existing hazardous waste. Storage & Disposal mode is as per

Hazardous & other Waste (Management & Transboundary Movement)

Rules, 2016.

Storage of Solid/Hazardous Waste:

• Proper Hazardous waste storage area with impervious flooring and

covered shed is provided for storage of solid/hazardous waste.

• Entire quantity of the hazardous waste is stored in the isolated hazardous

waste storage area within premises having leachate collection system and

roof cover. The storage yard shall be properly labeled for identification of

wastes.

• Hazardous waste shall not be stored for a period more than 90 days.

Records of the same shall be maintained and make them available for

inspection.

Transportation of Solid/Hazardous Waste:

• Properly packed & labeled waste shall be transported through dedicated

vehicle with GPS system to authorized TSDF facility.

Disposal of Hazardous Waste:

• Currently unit is disposed its ETP sludge at TSDF site, SEPPL. ETP sludge

generation is mainly from biological treatment and source of effluent is

also from biotechnology process. It has good NPK value and no

hazardousness primarily found in sludge analysis. So unit proposed to use

it as manure and will obtain necessary permission from concerned

department.

• Distillation residue & spent carbon is sent to SEPPL for incineration or to

RSPL for co-processing, Spent Carbon is sent for Co-process at Ambuja

Cement Limited, used lubricating oil is used within premises as a

lubricant and in case of excess; disposed by selling to registered re-

refiners. Whereas discarded drums/containers are reuse or incase of

excess, disposed off by selling to registered recyclers. Off specific

products will be disposed to CHWIF for incineration/sent for co-

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EIA Report of Concord Biotech Ltd. 10-13

processing. Unit has provided isolated area with impervious flooring for

the storage of hazardous waste.

10.7.4 Noise Control

The main sources of noise generation will be from installation of

additional machineries and equipments, D.G. set. However, these impacts

will be very minor and temporary in nature. The impact on the

environment during the operational phase will be long term but of

insignificant. However, to minimize the noise pollution the unit proposes

the following noise control measures,

• Noise suppression measures such as enclosures, buffers and/or

protective measures should be provided, if required (wherever noise

level is more than 90 dB (A)).

• Extensive oiling, lubrication and preventive maintenance will be carried

out for the machineries and equipments to reduce noise generation.

• Use of PPE like ear plugs and ear muffs is made compulsory near the

high noise generating machines.

• Moreover, the personnel shall be provided breaks in their working

hours, with the continuous exposure not increasing three hours.

• The transportation contractor shall be informed to avoid unnecessary

speeding of the vehicles inside the premises.

• Acoustic enclosure shall be provided for D.G. set and similar provisions

like noise attenuator wherever suitable/possible.

• The selection of any new plant equipment will be made with

specification of low noise levels.

• Areas with high noise levels will be identified and segregated where

possible and will include prominently displayed caution boards.

• Adequate Greenbelt will be developed within industrial premises and

around the periphery to prevent the noise pollution.

• Periodic monitoring of noise levels as per post-project monitoring plan

shall be done on regular basis.

By taking measures as mentioned above, it is anticipated that noise

levels in the plant will be maintained below the permissible limit.

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EIA Report of Concord Biotech Ltd. 10-14

10.8 GREEN BELT DEVELOPMENT PLAN

Tree plantation is one of the effective remedial measures to control the

air pollution and noise pollution. It also causes aesthetics improvement of

the area as well as sustains and supports the biosphere.

The unit has done extensive plantation in 23653 m2 in its existing unit

and some more area of about 61347m2 will be added for greenbelt

development. After expansion, total area of greenbelt area will be 85000

m2which will be more than 33% of total land area.

Design of Green Belt

As far as possible, following guidelines will be considered in greenbelt

development.

• The spacing between the trees will be maintained as per SPCB

guideline i.e. 1 tree/4 sqm.

• Spaces, so that the trees may grow vertically and slightly increase

the effective height of the greenbelt.

• Planting of trees in each row will be in staggered orientation.

• The short trees (< 10 m height) will be planted in the first two rows

(towards plant side) of the green belt. The tall trees (> 10 m height)

will be planted in the outer three rows (away from plant side).

Planting methodology

The plantation shall be done in pits. The pit shall be refilled with soil after

the planting. The sampling of healthy, nursery raised, seedlings in

polythene containers shall be transported in baskets. Planting shall be

done after first monsoon showers.The level of soil is about 10 cm above

of ground level. The soil around the plant shall be pressed to form a low

through. About 25 gm chemical fertilizers shall be added. Watering shall

be continued after plantation if any dry spells follows. Planted area shall

be inspected and mortality rate ensured for each species. The dead and

drying plant shall be replaced by fresh seedlings.

Selection of species for greenbelt

For the development of greenbelt, plants having simple big leaves and

native species are preferred to the plants.The plants are suitable for

greenbelt development based on gaseous exchange capacity of foliage

which is ascertained by the following characteristics:

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EIA Report of Concord Biotech Ltd. 10-15

- The plant should be fast growing.

- It should have thick canopy cover.

- It should be perennial and evergreen.

- It should have large leaf area index.

- It should be indigenous.

- It should be efficient in absorbing pollutants without significant effects

on plant growth.

The objectives of the industrial greenbelt are to improve the micro-

environment. The success depends on the type of land available and

selection of suitable tree species for pollution control. Selection of tree

species for industrial areas is influenced by the nature of industry. The

objective should be to ensure a green cover tolerating pollutant gases

and solid particulates present in the atmosphere. It is also advisable to

select suitable tree species and adopt simple techniques which require

minimum investment and care.

Plantation Programme

Plantation of trees in and around the company are meant mainly to

reduce air pollution caused by factory emissions, to absorb sound, to

prevent soil erosion and to maintain aesthetic value for healthy living.

Floral species recommended for greenbelt

Following list of trees are suggested for the greenbelt development with

respect to this particular area. They are mostly deciduous and evergreen

tree types suitable to be grown in the area.

Botanical Name Common Name

Mangiferaindica L. Mango, Aambo, Keri

Annonasquamosa Sitaphal

Polyalthialongifolia (Sonn.) Thw. Asopalav

Nerium oleander L. The Oleander, Kanher, Lal Karen

Cassia fistula Garmalo

Delonixregia Gulmohar

Tamarindusindica L. Tamarind Tree, Amli

Phyllanthusemblica L. Indian Goose Berry, Amla

Jatrophacurcas L. Ratanjyot

Lawsoniainermis L. Hennah, Mehndi

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EIA Report of Concord Biotech Ltd. 10-16

Azadirachtaindica Limbdo

Acacia Nilotica DesiBaval

Acacia senegal (L.) Wild GoradiyoBaval

Survival rate of trees and post plantation care

Considering the availability of water and general survey of surrounding

area, the survival rate is expected to be around 70-75%. Moreover, the

wire net guards will be provided to protect the saplings. The same will be

properly manure and watered so that it can grow well.

Budgetary Expenditure:

Unit has already developed greenbelt in and around of our plant

premises. Unit will dense the greenbelt at demarcated greenbelt area in

plant premises. Estimated maintenance cost of greenbelt is tune around

15-17 lakhs/annum.

Protection of plantation site:

• Protection from grazing will be done by erecting tree guards a rounded

planted sapling.

• Though the tree suggested for plantation will require very less water,

however during the first year watering will be done twice in a day.

There after watering will be done twice in a week.

• The ETP sludge and treated water content high nutrient value including

nitrogen & phosphorus, so watering the plant can take up the plant

easily. No other manuring is required.

• Damaged plants will be replaced with new plants.

10.9 RESOURCE CONSERVATION/WASTE MINIMIZATION, RECYCLING,

REUSE&CLEANER PRODUCTION OPTION

Steps that are undertaken by the industry are given below:

• Housekeeping will be regularly maintained.

• Solid wastes e.g. powders, spills, etc. in process and packaging are

to be separately collected and disposed off instead of allowing these

to effluent streams. This will reduce load and increase the efficiency

of treatment system.

• Liquid raw material will be charged by pumping and closed loops ad

dosing by metering to avoid fugitive emissions.

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EIA Report of Concord Biotech Ltd. 10-17

• Mechanical seals will be provided to the process vessels having

agitator for reduction of fugitive emissions and leakages.

• Storage for raw material and finished products will be fitted with

appropriate control devices to avoid possible leakages.

• Condensate of MVR/MEE & permeate of second stage RO will be used

in cooling.

• Treated water from ETP will be utilized for greenbelt development to

reduce the fresh water consumption.

• Recovered solvents will be recycled back to the process.

• CFLs or LED lights will be used in plant premises.

• Rain water harvesting system will be adopted to reduce the fresh

water requirement.

10.10 OCCUPATIONAL HEALTH & SAFETY PLAN

To maintain high standard in Health, Safety and Environment, necessary

key mitigation measures & action plan as EMP has been suggested as

described below.

• Post-employment health check-up programs will be carried out on

annually and all records & documents related with employee health

check-up program will be maintained.

• As per RA report, all risk control & prevention measures in the unit will

be implemented.

• Necessary PPEs, safety equipments/materials to ensure healthy & safe

work conditions will be provided to employees.

• The project does not envisage conditions that could lead to excess

heating. Consequently, special requirements for protection against

heat stress are not anticipated. However, ventilation for heat

evacuation, suitable PPEs such as heat for occasional handling of

heated equipment or materials.

• All employees will be provided with required set of PPEs like ear plug,

ear muff etc. where noise levels in excess of 80 dB(A) are regularly

generated.

• Regular inspection for the safety procedures and use of PPEs & Safety

equipment/material is done by the management/safety cell.

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EIA Report of Concord Biotech Ltd. 10-18

• It is recommend that Pre-employment health check-up programs shall

be carried out for every new employee and all records & documents

related with employee health check-up program shall be maintained

by the proponent.

• Safety documents, procedures, guidelines along with MSDS shall be

provided to the associated/concerned personnel engaged in respective

operational activities.

• Training programs & safety audit shall be done on regular basis to

prevent impacts of the operational activities on occupational health as

well as to improve workplace condition & safe work system.

• The proponent shall ensure implementation of emergency

management plan with provision of fire-fighting equipment/facilities,

first aid & medical facilities, evacuation procedures etc.

• Proponent shall also ensure proper implementation & functioning as

well as assess effectiveness of this safety & emergency system on

regular basis throughout the project operation phase.

10.11 PLANS FOR PERIODIC MEDICAL CHECKUP

• Part time doctor isperiodically visited the plant for health check-up of

each employee.

• Pre-employment health check-up will be followed by periodical health

check-up with special attention to occupational health.

• Medical records of each employee will be maintained in prescribed

format as per Factory Act.

• The health check-up will be conducted as per the pre-designed format

which will include chest X-rays, Audiometry, Spirometry, Vision

Testing, ECG, Blood and urine test etc.

• The work zone monitoring will be conducted on regular basis.

The following precautions shall 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.

• Various emergency spots in plant area will be identified and kept in

sharp and alert watch.

• Protective equipments will be regularly checked and will be kept easily

accessible and easily workable during emergency.

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EIA Report of Concord Biotech Ltd. 10-19

• Safety installations like available quantity of running water will be

regularly watched.

• Fire bucket and hose reels will be provided to withstand the fire or

explosion conditions.

• Various types of fire extinguishers such as (Foam type, water CO2

type, CO2 type) will be provided inside the factory premises.

• Every pressure vessel will be provided with minimum one or more

pressure relief devices. The design of the valve is made in such a way

that the breakage of any part will not obstruct force discharge of the

liquid under pressure. Moreover, relief valves are tested and a periodic

schedule for their testing shall be maintained. The defective valves will

be removed if found unsafe for the operation.

10.12 SOCIO-ECONOMIC ACTIVITIES

Corporate Social Responsibility (CSR) refers to voluntary actions

undertaken by company/organization to either improve the living

conditions (economically, socially, environmentally) of local communities

or to reduce the negative effects of the project. By definition, voluntary

actions are those that go beyond legal obligations, contracts, and license

agreements. Socio-economic development activities is a concept of

organization whereby organizations serve the interests of society by

taking responsibility for the impact of their activities on customers,

employees, shareholders, communities and the environment in all aspects

of their operations.

Unit has done many CSR activities so far. List of CSR activities carried

outin current financial year i.e. 2016-17 is summarized below.

Sr. No.

List of activities Year Rs. utilize

1. Organ Donation Awareness FY 2016-17 1 crore 2. Mobile Medical Unit – Providing

free consultation and medication to the people residing in the villages near Dholka and Valthera

FY 2016-17

3. Blood Donation Camp FY 2016-17 4. Scholarships to the economically

backward children to encourage them to take up further studies

Ongoing activity for every year

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EIA Report of Concord Biotech Ltd. 10-20

The identified activities under CSR program are as follows:

Scholarships to meritorious students

Health and Family Welfare including support to primary health center

Supporting education through distribution of stationary, science kits,

etc.

Rural infrastructure development by construction of rainwater

harvesting ponds, check dams etc.

Following activities will be under taken as a part of CSR under

different heads:

Education

• Awarding meritorious school students in SSC & HSC

• Providing utensils to schools and anganwadi for Mid-Day Meal

preparation

• Science Lab - Equipment & books in libraries for schools

• Supports for sport & cultural competitions in schools

Health and family welfare

• Malaria eradication camps (collection of blood sample & detection of

virus & free medicine distribution, blood donation camp)

• General Health camp for men, women & kids

• Contribution towards primary Health Services depending on local

needs.

• Dental & Eye checkup camp

Preservation of the Environment and to Sustainable Development

• Water harvesting systems in nearby villages.

• Landscaping and greenbelt development in & around the project site.

• Provide sanitation facilities to villagers.

Unit has committed to spend about Rs. 100 Lakhstowards various CSR

activities.

Table: 10.2 Budgetary provisions for the social upliftment

Sr. No.

Activity Budgetary provision (Rs. in Lakhs)

1 Educational activities 20

2 Drinking water and sanitation facilities

14

3 Public Health and family welfare 32

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EIA Report of Concord Biotech Ltd. 10-21

4 Women Empowerment & children Development activities

09

5 Preservation of the Environment and Sustainable Development

14

6 Miscellaneous as per the demand of surrounding villages

11

Total 100

10.13 POST-PROJECT ENVIRONMENTAL MONITORING

Post - project environmental monitoring suggested herewith should be as

per the guideline. The highlights of the integrated environmental

monitoring plan are:

• The stack monitoring facilities like ladder, platform and port-hole of all

the stacks maintained in good condition.

• Regular monitoring of all gaseous emissions from stacks &fugitive

emissions in the process areas.

• The performance of air pollution control equipment evaluated based on

these monitoring results.

• Water consumption in the unit recorded daily.

• Analysis of untreated and treated effluent will be carried out regularly.

• Performance of effluent treatment plant units evaluated based on

these analysis results.

• As far as possible, noise curbed at its source, with the help of acoustic

hoods and other such noise reducing equipment. Regular noise level

monitoring carried out.

• Green belt properly maintained and new plantation programmes

undertaken frequently.

• Continued environmental awareness programmes carried out within

the employees and also in the surrounding villages.

• Rain water harvesting ponds will be developed within the industrial

premises and encouraged in the surrounding villages too.

10.13.1 Details of Work Place Air Quality Monitoring Plan

Work zone monitoring will be carried out by independent competent third

party every month. Records will be kept in Form No. 37 as per Gujarat

Factories Rules. Location for samplings will be identified. Following

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EIA Report of Concord Biotech Ltd. 10-22

information will be incorporated in the format for maintaining records of

work zone monitoring:

• Location/Operation monitored

• Identified contaminant

• Sampling instrument used

• Number of Samples

• Range of contaminant concentration as measured in sample

• Average concentration

• TWA concentration of contaminant (As given in Second Schedule of

Factories Act)

• Reference method used for analysis

• Number of workers exposed at the location being monitored

• Signature of the person taking samples

• Other relevant details

10.14 ENVIRONMENT MANAGEMENT BUDGET ALLOCATION

Total capital cost and recurring cost/annum earmarked for environment

pollution control measures will be as under.

Table 10.3: Budget Allocation for Environment Management

S. No.

Particulars Additional Capital

Cost (Rs. in Lakhs)

Recurring Cost per annum

(Rs. in Lakh)

1 Air Pollution Control 10 5

2 Water Pollution Control 120 105

3 Noise Pollution Control 2 2

4 Solid/Hazardous waste management

98 150

5 Environment Monitoring and Management

3 10

6 Occupational Health& safety 12 22

7 Green Belt Development 30 20

8 Rain water harvesting system

25 11

Total 300 325

10.15 REPORTING SYSTEM OF NON COMPLIANCES/VIOLATIONS OF

ENVIRONMENTAL NORMS

Company will develop reporting systems of non-compliances/violations

of environmental norms to the Board of Directors.

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EIA Report of Concord Biotech Ltd. 10-23

The mechanism is summarized below:

1. Identify deviation/non-compliance/violation of environmental norms

as lay down in consent to operate and letter of Environmental

clearance. Record to communication/complain received from

plausible stake holder.

2. The EHS manager will identify deviation/non-compliance/violation

from failure to comply with statutory requirements.

3. Respond from EHS manager within reasonable time limit to concern

authorities with c/c mark to Technical head.

4. Technical head will take it in action and give necessary guideline to

comply this deviation/non-compliance/violation of environmental

norms. Parallel arrange budget for necessary action to comply the

condition.

5. Communication received from the EHS manager will be discussed in

technical management meeting.

6. Board discussion, Decision and Action

• The chairperson will review the information available and take a

decision depending on the seriousness of the violation.

• The decision will be taken to ensure the compliance of non-

compliance/violation of environmental norms and it’s safeguarded.

The decision will be taken by consensus and if no consensus is

arrived at, voting will be conducted.

• Enlist measures that would undertake to ensure that deviations/

non-compliance/violations of Environmental norms and take care

not to occur same violation in future.

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EIA Report of Concord Biotech Ltd. 10-24

Table: 10.4 Environment Monitoring Plan

Nature of Analysis

Frequency of analysis with its analyzer

Parameters

Wastewater Monthly by external agency pH, COD, BOD, NH3-N,

TDS, SS, Oil & Grease, etc.

Stack Monitoring

of each stack

Monthly by external agency PM, SO2, NOX

Ambient Air

Quality Monitoring

Monthly for 24 hours or as

per the statutory conditions

by external agency

PM10, PM2.5, SO2, NOX

Noise level Monthly as per the statutory

conditions by external agency

Nr. main gate, Nr. boiler,

Process area, Nr. ETP, Nr.

D.G. etc.

Work area

monitoring

Monthly by external agency RPM, VOC, Acid mist

Health checkup of

workers

As per the statutory guideline All workers

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EIA Report of Concord Biotech Ltd. 11-1

Chapter-11 Summary & Conclusion

11.1 PROJECT DESCRIPTION

11.1.1 General Introduction

Concord Biotech Limited is one of the most recognized names in the

biopharmaceutical sector today. It manufactures Bulk Drugs through the

process of fermentation, semi-synthetic &synthetic processes. Unit was

established in the year 2000 with single facility of an enzyme and today,

it has a commanding presence in more than 50 countries worldwide. Unit

is having a very good expertise for the manufacturing of Enzyme,

Antibiotic, Antiparasitic, Antifungal, Immunosuppressant, Onco products,

Statin with different kind of R&D Products.

Now, unit proposed to expand manufacturing capacity from 103.83

MT/annum to 189.03 MT/annum in the same plant premisesby

considering present market scenario and expertise of same products.

11.1.2 Brief project description

1. Name & Address Concord Biotech Ltd. Plot No. 1482-1486, Trasad Road, Tal: Dholka, Dist. Ahmedabad, Gujarat

2. Total plot area 112302 m2 3. Production capacity 189.03 MT/annum

(total after expansion) 4. Power requirement 4000 kVA, Source: UGVCL

5. Water requirement 955 KLD (total after expansion)

6. Wastewater generation 399 KLD (total after expansion)

7. Fuel requirement FO: 1100 kg/hr. HSD: 365 lit/hr.

8. Source of Air emission Existing: Boiler & D. G. set Proposed: D. G. set

9. Haz. waste generation ETP sludge, spent carbon, distillation residue, used oil, discarded containers, off specific product

10. Total Manpower 719 nos.

11.1.3 Location of Project

The unit is located in Dholka Taluka of Ahmedabad District.

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EIA Report of Concord Biotech Ltd. 11-2

Details of the project site are given in following table:

Sr. No. Particulars Details 1 Plant location

Plot No. 1482-1486 Taluka Dholka District Ahmedabad State Gujarat

2 Site Co-ordinates Latitude 22°41'59.55" N Longitude 72°26'48.63" E

3 Nearest Village Trasad (2.3 km) 4 Nearest Railway Station Dholka (3.85 km) 5 Nearest Airport Ahmedabad(45.0 km) 6 Nearest City Ahmedabad (38.0 km) 7 Nearest Highway SH (Dholka-Vataman) – 1.3 km

NH 8A (A’bad-Rajkot) - 15.0 km 8 Wildlife

sanctuary/National park

None within 10 km radius

Note: Aerial distances are given in above table.

11.1.4 Investment of the project

Total cost of the existing project is Rs. 172.0crores. Estimated cost of the

proposed expansion will be around Rs. 20.0 crores. Out of this, Rs. 3.0

crore will be earmarked as capital investment for additional EMS and Rs.

3.25 crorewill be recurring/operating cost per annum.

11.1.5 List of products

Product details with its capacity are given in table below.

Sr. No.

Name of Products Quantity (MTPA) Existing Proposed Total

A Enzyme - 25.0 MTPA 1 Penicillin G Amidase Enzyme 15.00 10.00 25.00 B Antibiotic - 23.1 MTPA 2 Vancomycin 3.00 1.0 4.0 3 Teicoplanin 1.00 1.0 2.0 4 Daptomycin 0.50 0.0 0.50 5 Fidaxomycin 3.00 0.0 3.0 6 Mupirocin&salts 6.00 2.50 8.50 7 Fosfomycin 1.00 0.0 1.0 8 Dalbavancin 0.50 0.0 0.50 9 Telavancin 0.50 0.0 0.50 10 Capreomycin 0.10 0.0 0.10 11 Tobramycin sulphate 2.50 0.0 2.50 12 Oritavancin 0.0 0.50 0.50 C Antiparasitic- 1.90 MTPA

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13 Milbemycinoxime 1.00 0.9 1.90 D Antifungal- 1.98 MTPA 14 Pneumocandin Bo 0.20 0.0 0.20 15 Caspofungin 0.20 0.0 0.20 16 Micafungin 0.93 0.0 0.93 17 Anidulafungin 0.65 0.0 0.65 E Immunosuppressant-122 MTPA 18 Tacrolimus 1.00 0.0 1.00 19 Mycophenolic Acid 0.50 0.0 0.50 20 Cyclosporine 7.00 0.0 7.00 21 Rapamycin 0.30 0.20 0.50 22 MycophenolateMofetill&Mycophenolate

sodium 45.00 68.00 113.00

F Onco products-4.05 MTPA 23 Ixabepilone 0.10 0.0 0.10 24 Romidepsin 0.10 0.0 0.10 25 Temsirolimus 0.05 0.0 0.05 26 Everolimus 0.60 0.40 1.0 27 Ridaforolimus 0.05 0.0 0.05 28 Pimecrolimus 0.50 0.0 0.50 29 Doxorubicin 0.60 0.25 0.85 30 Daunorubicin 0.45 0.15 0.60 31 Epirubicin 0.20 0.0 0.20 32 Idarubicin 0.10 0.0 0.10 33 Bleomycin 0.10 0.0 0.10 34 Geldanamycin 0.10 0.0 0.10 35 Mitomycin 0.0 0.10 0.10 36 Dactinomycin 0.0 0.10 0.10 37 Trabectedin 0.0 0.10 0.10 G Statin – 9 MTPA 38 Lovastatin 7.00 -1.0 6.00 39 Pravastatin 1.00 0.0 1.00 40 Orlistatin 2.00 0.0 2.00 H R & D Products 1.00 1.0 2.00

Total 103.83 85.20 189.03

11.2 DESCRIPTION OF ENVIRONMENT

11.2.1 Baseline EnvironmentalStudy

To predict the impact of the project on the surrounding environment, the

current baseline environmental status was studied by collecting the data

and carrying out monitoring during March, 2016 to May, 2016 in the

study area of 10 km radius from project site as per the TOR.

11.2.2 Air Environment

The ambient air quality monitoring was carried out at8 AAQM locations,

with a frequency of twice a week, to assess the existing sub-regional air

quality status during the period of March, 2016 to May, 2016.

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EIA Report of Concord Biotech Ltd. 11-4

Respirable Dust Sampler&Fine Particular Sampler along with the

analytical methods, prescribed by CPCB was used for carrying out air

quality monitoring. At all these sampling locations; PM10, PM2.5, SO2 and

NOx were monitored on 24-hourly basis to enable the comparison with

ambient air quality standards prescribed by the CPCB. The data on

concentrations of various pollutants were processed for different

statistical parameters like arithmetic mean, standard deviation, minimum

and maximum concentration and various percentile values.

The results are summarized below:

Particulate Matter (PM10) An average and 98th percentile value of 24-hourly PM10 values at all the

locations varied between 58.9-70.0 μg/m3 and 65.4-73.0 μg/m3, which

are well within the stipulated standard of CPCB, 100 μg/m3.

Particulate Matter (PM2.5)

An average and 98th percentile value of 24-hourly PM2.5 values at all the

locations variedbetween 35.1-42.8 μg/m3 and 39.5-47.9 μg/m3, which

arewell within the stipulated standard of CPCB, 60 μg/m3.

Sulphur Dioxide (SO2)

An average and 98th percentile value of 24-hourly SO2 value of arithmetic

mean at all the locations ranged between 16.5-22.1μg/m3 and 19.8-

28.3μg/m3 respectively, which are well within the stipulated standards of

80 μg/m3.

Oxides of Nitrogen (NOx)

An average and 98th percentile value of 24-hourly NOx value of arithmetic

mean at all the locations ranged between 19.3-25.1μg/m3 and 23.2-

30.7μg/m3 respectively, which are much lower than the standards

stipulated by CPCB, i.e. 80 μg/m3.

Conclusion:

The quality of ambient air in the study area is compared with AAQM

Standards prescribed by CPCB & found below the prescribed standards.

11.2.3 Water Environment

Five surface water &eight ground water samples were collected during

the study period.

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EIA Report of Concord Biotech Ltd. 11-5

Surface Water Quality

Surface water samples were collected from Nesda Pond, Dholka Pond,

Sabarmati River,Sathal Pond and Paldi Pond. Results of the same are

given in Chapter-3 of EIA report.

Conclusion:

It was observed that, results of all the physico-chemical parameters and

heavy metals from surface water samples are below stipulated drinking

water standards IS: 10500-2012 & it is suitable for drinking and other

purposes.

Ground Water Quality

Ground water samples have been collected from project site, Khanpur,

Lana, Mujpur, Rampur, Andhari, Sathal&Paldivillages.

The summary of the analysis is as below:

Color: All the samples were colorless meeting desirable norms.

pH: All the samples meet the desirable standards (pH ranges from 7.54

to 7.92).

Total Dissolved Solids (TDS):TDS in samples ranges from 985 mg/L

(Lana) to 1659 mg/L (Project Site). All the samples meet the permissible

limit of 2000 mg/L, (If alternate sources of potable water are not

available).

Calcium: Calcium contents in the water ranges from 69 mg/L (Lana) to

189 mg/L (Project Site), all the samples meet the permissible limit of 200

mg/L, (If alternate sources of potable water is not available).

Magnesium: Magnesium content in the water ranges from 53 mg/L

(Paldi) to 98 mg/L (Project Site). All the samples meet the permissible

limit of 100 mg/L (if alternate source of potable water in not available).

Sulfate: Sulfate content in the water ranges from 82 mg/L (Lana) to 259

mg/L (Paldi). All the samples meet the permissible limit of 400 mg/L for

drinking water (if alternate source of potable water in not available).

Fluoride: Fluoride content in the water ranges from 0.69 mg/L (Andhari)

to 0.97 mg/L (Mujpur). All the samples meet the permissible limit (1.5

mg/L).

Total Alkalinity: Total alkalinity in the water samples ranges from 161

mg/L (Sathal) to 294 mg/L (Project Site). All the samples are within the

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EIA Report of Concord Biotech Ltd. 11-6

permissible limit of drinking water (600 mg/L) (if alternate source of

portable water is not available).

Other Parameters: Potassium (ranges from 43 mg/L to 160 mg/L),

Sodium (ranges from 158 mg/L to 358 mg/L) and Chloride (ranges from

399 mg/L to 753 mg/L).

Heavy metalslike copper, lead, chromium and zinc are found below

detectable limit in all samples.

Conclusions:

Ground water samples from villages meet the permissible limit set by the

authority (BIS).

11.2.4 Noise Environment

Noise monitoring has been conducted at eight locations in the study area.

The Leq(Ld) values of noise levels during day-time varied from 51.7 to

61.2 dB(A) and the night time Leq (Ln) varied from 42.5 to 54.5 dB(A)

within the study area. Higher noise value of 61.2 dB(A) was recorded

during day time at project site & lower noise value of 42.5 dB(A) was

recorded during night time in village Khanpur.

11.2.5 Soil Quality

Soil samples were collected from 6 different locations and analyzed to

assess the soil quality prevailing in the study area. Physical

characteristics of soil have been delineated through specific parameters,

viz. particle size distribution (grain size analysis), porosity, water holding

capacity and permeability whereas data for chemical characterization of

soil, viz. pH, electrical conductivity, cation exchange capacity and sodium

absorption ratio have been analyzed.

11.2.6 BIOLOGICAL ENVIRONMENT

Baseline data for flora & fauna has been collectedwith its family. It was

found that, none of the species of conservation importance exists in the

study area andno endangered species found in the study area.

11.2.7 SOCIO-ECONOMIC ENVIRONMENT

Socio-economic study includes description of demography, available basic

amenities like housing, health care services,transportation, education

facilities. Information on the above saidparameters has been collected to

define the socio-economic profile of the study area(10-km radius).

San Envirotech Pvt. Ltd., Ahmedabad

EIA Report of Concord Biotech Ltd. 11-7

11.3 ANTICIPATED ENVIRONMENTAL IMPACTS AND MITIGATION

MEASURES

Impact identification has been carried out for various activities involved in

construction as well as operational phase of the project and prediction

has been done for significant impacts. The summary of anticipated

adverse environmental impacts due to proposed expansion project and

mitigation measures is given below.

11.3.1 Summary of impacts on Air Environment:

(a) During construction phase &Mitigation measures

Main sources of impact during construction phase are due to movementof

vehicles &construction equipment at site, foundation works,

transportation of construction material etc.Water sprinkling in the vicinity

of the construction areawill be done to control dust. PUC certified vehicles

will be used.Temporary barricades will be provided to reduce spreading

ofparticulates from construction area.

(b) During operation phase&Mitigation measures

There is no process gas emission anticipated from the process. At

present, flue gas emission is from one common stack of 2 nos. of steam

boilers, where furnace Oil (FO) is used as fuel. After expansion, one boiler

will be modified/replace in terms of capacity from 3 TPH to 8 TPH.

Therefore, FO consumption will also increase.Flue gas emission is also

from stack attached with D. G. Set (1000 kVA & 680 kVA); after

expansion, D. G. set of 680 kVA will be dismantled and 3 new stand-by

D.G. sets of 1000 kVA each will be added. HSD will be used as a fuel. The

impact on air quality is assessed based on emissions of the boilers& D.

G.set in the plant.

Prediction of impacts on air environment is quantified using ISCST3

model. Maximum Ground level concentrationsof 24-hr averagefor PM,

SO2, NOx were found 0.434 μg/m3, 0.173 μg/m3, 0.182 μg/m3

respectively. The point of maximum concentration by unit would be 1.0

km from centre of industry in E direction.The obtained GLCs are well

within the24-hourly ambient air quality standards stipulated by CPCB.

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EIA Report of Concord Biotech Ltd. 11-8

However, to mitigate the impact due to the proposed expansion, unit will

provide adequate stack height for proper atmospheric dispersion as per

the norms.

11.3.2 Summary of impacts on Water Environment

(a) Impacts during construction phase & Mitigation measures:

Temporary impacts are likely to occur due to water

consumption&sewagegeneration. It will not be significant as water

requirement would be temporaryduring construction phase. Proper

sanitation facilities with adequate disposal system are already exists

within the operational plant.

(b) Impacts during operation phase & Mitigation measures:

Fresh water requirement of the unit is satisfy from own bore well. At

present, total water requirement is 589.5 KLD. Out of which; 349.5 KLD

is fresh water & 240 KLD is recycle water. After expansion; water

requirement will be increase up to 955 KLD; Out of which, 556 KLD will

be fresh water requirement.

Total w/w generation will be 399.0 KLD. Currently, the effluent is treated

in an adequate Effluent Treatment Plant having primary & secondary

treatment units followed by RO &MVR/MEE. Condensate of MVR/MEE &

permeate of second stage RO is used in Cooling. Treated effluent from

ETP is utilizedfor greenbelt development. After expansion, unit will treat

its effluent in exiting ETP. Hence, no impact on the water environment is

envisaged.

11.3.3 Impacts on Noise quality & Mitigation measures

(a) Impacts during construction phase & Mitigation measures:

During construction phase, major sourcesof noise are vehicle’s

movement&construction activities.High noiseproducing activities will be

restricted to daytime only.Well maintained equipment will be used to

prevent noise generation. Usage ofPPE by workers&proper maintenance

of machineries will be done to reduce impact of noise.

(b) Impacts during operation phase & Mitigation measures:

During the operation phase, the noise levels may increase due to the

operation of boiler, reactors, D. G. set and other machineries. The impact

is found to be insignificant outside the premises. Unit will provide

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EIA Report of Concord Biotech Ltd. 11-9

necessary PPEs like earplugs or earmuffs to all workers where exposure is

85 dB(A) or more and selection of any new plant equipment will be made

with specification of low noise levels.

11.3.4 Summary of Impacts on Land Environment

(a) Impacts during construction phase &Mitigation measures:

The construction activities like excavation, leveling & vehicular

movements will change the landscape, which are expected to be of short

duration and insignificant. Preliminary activities like proper storage of

construction materials& proper management will be done within the

project area. Therefore, impact will be negligible. Unit will provide

sanitation facilities for the staff engaged in construction work which will

prevent the impacts on land.

(b) Impacts during operation phase &Mitigation measures:

Hazardous wastes havesignificant negative impacts if disposed

unsystematically. Unithas provided all required structural facilities like

separate hazardouswaste storage room with RCC floor, leachate collection

system, concretefloors within premises. Hence, no significant negative

impact is envisaged on the land environment.

11.3.5 Summary of impact on Socio Economy

(a) Impacts during construction phase &Mitigation measures:

As the proposed expansion will be in the existing unit, no R&R is required.

Local contractors to be employed for construction, so no other issues like,

social conflict are envisaged.Temporary employment generated during

construction of project will have beneficial impacts on economic

environment.

(b) Impacts during operation phase &Mitigation measures:

Expansion project will require about 100additional persons forits

operation, which result into a positive impact on prevailing socio-

economic environment. Project will also have potential ofindirect

employment due to the increase transportation activities, contractual

worksas well as opportunity of trade.Thus, overall impacts on socio-

economic environment are long term and positive in nature.

11.3.6 Summary of impact onEcology

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EIA Report of Concord Biotech Ltd. 11-10

Unit is under operation and proposed expansion will bedone in the

existing premises only. There are no protected areas like National

Park/Wildlife Sanctuary within the 10 km radial periphery of the project

site so there will not be any significant impact on ecology.

11.4 ENVIRONMENT MONITORING PROGRAMME:

The unit has a dedicated Environment Management Cell to monitor and

evaluate the environmental performanceand to supervise the

environment management measures. Budgetaryprovision for environment

& safety management system has been made in the projectplanning with

additional Rs. 3.0croreof capital cost and 3.25 crorerecurring cost per

annum. BelowPost-project monitoring programmewill be followed.

Environment Monitoring Program

Nature of Analysis Frequency of analysis with its analyzer

Parameters

Wastewater analysis Monthly by external agency pH, TDS, SS, Oil & Grease, etc.

Stack Monitoring of each stack

Monthly by external agency PM, SO2, NOX

Ambient Air Quality Monitoring

Monthly for 24 hours or as per the statutory conditions by external agency

PM10, PM2.5, SO2, NOX

Noise level Monthly as per the statutory conditions by external agency

Nr. main gate, Nr. boiler, Nr. D. G. Set, Process area etc.

Work zone fugitive monitoring

Monthly by external agency RPM, VOCs, acid mist

Health check-up of workers

As per the statutory guideline All workers

11.5 ADDITIONAL STUDIES

11.5.1 Risk Assessment

Risk analysis and study have been carried out for identification of

accident hazards, selection of credible scenarios, Risk Mitigation

measures etc. All the hazardous chemicals will be stored and handled as

per MSDS guidelines. The detail study is prescribed in Chapter-7.

11.6 PROJECT BENEFITS

Proposed expansion project has apotential for employment of skilled,

semi-skilled & unskilled employees. The direct employment potential after

proposed expansion is estimated as 719 personsand many other willbe

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EIA Report of Concord Biotech Ltd. 11-11

indirectly employed.Indirectly, the proposed expansion will help the

Government by payingdifferent taxes (sales tax, excise duty, etc.) from

time to time, which is a part of revenue and thus, will helpin developing

the area.The company has allocated a budget of 1.0 crorefor CSR

activities, which can lead to improve social infrastructure.

11.7 ENVIRONMENTAL MANAGEMENT PLAN

EMP includes the protection & mitigation measures to be implemented to

reduce the adverse impact on the environment. Management plan of

impacts identified is detailed below:

Air Pollution Management

There is no process gas emissions envisage from the process. Flue gas

emission is from FO fired boilers. Due to use of liquid fuel i.e. FO, no need

of APCM. Appropriate stack height and SMF is provided as per the

guideline.To control the fugitive emissions,unit will adopt following

mitigation measures.

• Regular maintenance of valves, pumps and other equipment will be

done to prevent leakages.

• Mechanical seals will be provided toall the reactors.

• Regular periodic monitoring of work area to check the fugitive

emission.

Water Pollution Management

• Industrial wastewater will be treated in adequate in-house ETP.

• Treated effluent from ETP water will be utilized for plantation.

• Sewage will be treated in ETPalong with industrial effluent.

• Regular monitoring of working of ETP.

• Condensate of MVR/MEE & permeate of second stage RO will be used

in Cooling.

• Unit will maintain the records for the total water consumption.

• Rain water harvesting structure is installed in the unit.

Hazardous Waste Management

Entire quantity of hazardous waste will be handled and disposed as per

Hazardous & Other Waste (Management & Transboundary Movement)

Rules, 2016. ETP sludge is disposed off at approved TSDF site.There is

possibility to use ETP sludge as organic manure as it is having good

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EIA Report of Concord Biotech Ltd. 11-12

nutrient value and primarily no hazardous characteristics found because

its major source is from biotechnology based fermentation. Distillation

residue is sent to SEPPL for incineration or to RSPL for co-processing,

spent carbon is sent to SEPPL for incineration or to RSPL for co-

processing or for co-processing at Ambuja Cement Ltd., used lubricating

oil is used within premises as a lubricant and in case of excess; disposed

by selling to registered re-refiners. Whereas discarded drums/containers

are disposed off by selling to registered recyclers. Off specific products

will be disposed to CHWIF or for co-processing/sent for co-processing.

The unit has provided isolated area with impervious flooring for the

storage of hazardous waste. Thus, hazardous waste management system

proposed by the unit is adequate. There will not be any major impact on

the environment due to hazardous waste management.

Noise Pollution Management

• Extensive oiling, lubrication and Regular maintenance will be carried

out for the machineries and equipments to reduce noise generation.

• PPEs will be provided to the workers working in high noise area.

• Noise control equipments are provided for D.G. set.

• Greenbelt will be increased within industrial premises to prevent the

noise pollution.

• Periodic monitoring of noise levels will be done.

Green Belt Development

The unit has done extensive plantation in 23653m2 in its existing unit and

some more area of about 61347m2 will be added. After expansion, total

greenbelt area will be 85000 m2and it will be more than 33% of total land

area.

11.8 CONCLUSION

Based on the study it is concluded that-

• There will be no major impact on water environment as effluent will

be treated in ETP followed by RO &MVR/MEE and treated effluent will

be utilize for greenbelt development.

• Condensate of MVR/MEE will be reuse/recycled.

• Due to use of liquid fuel i.e. FO, no need to install APCM.

• No process emission from the unit.

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EIA Report of Concord Biotech Ltd. 11-13

• To prevent fugitive emission various step will be taken like regular

sprinkling of water and paved road.

• Adequate arrangement for handling and disposal of Hazardous solid

waste is made as per regulatory norms.

• Fire protection and safety measures will be provided to take care of

fire hazard.

• Direct and indirect employment opportunities will have positive

impact.

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EIA Report of Concord Biotech Ltd. 12-1

Chapter-12 Disclosure of Consultant engaged

12.1 DETAILS OF EIA CONSULTANT ORGANIZATION

a) Introduction San Envirotech Pvt. Ltd. (An ISO 9001:2008, 14001:2008 and OHSAS

18001 certified company) is a leading multi-disciplinary testing laboratory

in Gujarat. SEPL provides testing services in the areas of environmental

assessment and analytical testing.

SAN Envirotech Pvt. Ltd. (henceforth SEPL) has started its work in 1990

to serve the environment as a trustee of a next generation with a small

infrastructure under the dynamic leadership of Dr. Mahendra Sadaria.

During last two decade, SEPL has been taking care of client’s unique

problems and concerns in order to develop cost effective strategies to

meet their regulatory obligations. We focus on strategic planning and

comprehensive solutions to address both the short and long term needs

of the clients. Consequently we have developed long-term relationship

with our clients to provide them the services necessary to meet their

changing needs.

To protect and preserve the natural resources on earth for future

generation, it offers extensive consultancy services in the field of

environment. With its rich experience, multidisciplinary expertise and

with the support of its state-of the-art analytical equipments, the services

offered by the division are wide ranging and encompasses entire scope of

environment management and monitoring services. With its emphasis on

quality services over the years, it has evolved itself into a single

reference point in India for comprehensive environmental services.

We conduct analytical works pertaining to various Environmental

Parameters. We perform effluent treatability studies also. To conduct the

analysis work, we follow National & International Quality Standard and

update our process regularly.

“Quality Assurance Team” always welcomes any suggestion and

feedback, to improve the Quality, Performance and Standards of the

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EIA Report of Concord Biotech Ltd. 12-2

services. These suggestion and feedback are considered for reviewing of

the services and complied immediately.

b) Major Milestones and Accreditation

SEPL is a recognize schedule-II Environmental Auditor appointed by

Gujarat Pollution Control Board as per the directives of the Honorable

High Court of Gujarat. Recognize laboratory under Environment

Protection (EP) Act, 1986 by Government of India (GOI). SEPL has listed

as accredited EIA consultant organization by NABET/QCI for EIA report

preparation.

12.2 List of Exerts involved in EIA study

SEPL has necessary manpower and expertise in various fields and also

the required infrastructure facilities to carry out work related to EIA. SEPL

team consists of qualified & experienced personnel. Experts involved in

the preparation of this EIA/EMP report are given in EIA report as

‘declaration by experts’.

Annexure-I

Manufacturing Process, chemical reaction & Mass

Balance of all products

Concord Biotech Limited A-1

Manufacturing Process, chemical reaction & Mass Balance

A. Enzyme

1. Penicillin G Amidase Enzyme

Process Description

Penicillin G Amidase Enzyme is produced in two parts–Fermentation and Recovery.

Fermentation – Penicillin G Amidase Enzyme is produced by E. Coil strain through a fed

batch fermentation process. The microorganism is grown up in a shake flask, then

seeds fermenter and finally transferred to main fermenter. The total fermentation time

is 72 hr under strictly controlled parameter like sterility, pH, temperature, aeration and

Dissolved Oxygen. During fermentation productivity is measured by taking sample at

different intervals.

Recovery-After completion of fermentation the harvested broth is transferred to the

broth–holding vessel and biomass is separated by using high-speed centrifuge. The

biomass is immobilized with specific polymer and processed through basket centrifuge.

The cake is taken in granulation form, dried and washed with water. The enzyme is

finally stored at 40C in airtight containers for sale. The total time cycle for fermentation

and recovery will be 8 days.

Flow Diagram

Concord Biotech Limited A-2

B. Antibiotic

2. Vancomycin

Process Description

Vancomycin is produced in a single stage fermentation process. The spores of

microorganisms are activated from dormant state to vegetative state in microbiological

laboratory. The vegetative state microorganisms are further germinated to seed stage

in the seed tank (for 36-48 hours) where sterile air, nutrients and controlled friendly

environment (pH and temperature 27oC) for the microorganisms is maintained. When

sufficient seed has been developed, it is transferred to the fermenter.

Fermenter is a large vessel with agitator and cooling coils. Raw Material, nutrient,

sterilized air, microorganisms etc. are fed in the vessel. Suitable environment that is,

temperature, pH, dissolved oxygen and agitation are maintained in the fermenter for

production of the desired product. The fermentation continues for nearly 240 hrs.

The fermentation product is recovered in the harvester through ware and passed in the

micro filter lead to rich aqueous layer which is followed nano-filteration and

subsequent resign column. The concentrated mass is then dried. The dried product is

further purified by crystallization, drying and analyzed and if found meeting the

desired specification is packed and sent to warehouse.

The recovery and purification steps are operated carefully for the safety of the system.

After each campaign the total plant is thoroughly cleaned, washed, sterilized and

recalibrate. After each pass the column is regenerated by washing. Water used for

regeneration of column and washing of vessels goes to ETP for the treatment.

Concord Biotech Limited A-3

Process flow diagram

Concord Biotech Limited A-4

3. Teicoplanin

Process Description

Teicoplanin is produced in a single stage fermentation process. The spores of

microorganisms are activated from dormant state to vegetative state in microbiological

laboratory. The vegetative state microorganisms are further germinated to seed stage

in the seed tank (for 36-48 hr) where sterile air, nutrients and controlled friendly

environment (pH and temperature 27oC) for the microorganisms is maintained. When

sufficient seed has been developed, it is transferred to the fermenter.

Fermenter is a large vessel with agitator and cooling coils. Raw Material, nutrient,

sterilized air, microorganism’s etc. are fed in the vessel. Suitable environment that is,

temperature, pH, dissolved oxygen and agitation are maintained in the fermenter for

production of the desired product. The fermentation continues for nearly 240 hrs.

The fermentation product is recovered in the harvester through ware and passed in the

micro filter lead to rich aqueous layer which is followed nano-filteration and

subsequent resign column. The concentrated mass is then dried. The dried product is

further purified by crystallization, drying and analyzed and if found meeting the

desired specification is packed and sent to warehouse.

The recovery and purification steps are operated carefully for the safety of the system.

After each campaign the total plant is thoroughly cleaned, washed, sterilized and

recalibrate. After each pass the column is regenerated by washing. Water used for

regeneration of column and washing of vessels goes to ETP for the treatment.

Process Flow Diagram

Concord Biotech Limited A-5

4. Daptomycin

Process Description

Daptomycin is cyclic lipopeptide antibacterial agent produced by Streptomyces

roseoporus through fermentation process. Daptomycin is recovered from fermentation

broth through different steps of recovery. Manufacturing of Daptomycin is carried out

in three different stages:

Preparation of Seed: Laboratory inoculum comprises of Vegetative growth (2000-

3000 ml).Vegetative growth is developed by inoculating 100/200 ml of seed media

contained in 500/1000 ml conical flasks with spore suspensions from working cell

bank. The inoculated flasks are incubated on rotary shaker at 30 ± 3 ºC and 250 ± 10

RPM. The matured vegetative growth from different flasks is collected in sterilized

inoculation assembly under aseptic condition on laminar air flow work bench. This

matured vegetative growth is used to inoculate seed fermenter. Seed fermenter is

prepared by sterilizing 500 – 1000 Liters seed medium at 123 ± 3 ºC for 40 to 50

minutes and inoculated with laboratory inoculum under aseptic conditions. The seed is

incubated at 27–33 ºC for 40–90 hrs and checked periodically for purity, pH and PMV

(%). After achieving desired criteria seed culture is being transferred to main

fermenter.

Fermentation: Daptomycin production is carried out in production fermenter by

aseptically transferring the seed (5–7%) to production medium (8 to 14 KL) sterilized

at 123 ± 3 ºC for 40 to 50 minutes. The fermenter is incubated at 27–33 ºC. During

the fermentation cycle the appropriate culture conditions like aeration, agitation and

back pressure are maintained. Methyl oleate & cupric acid are added as precursors

from 20 hrs onwards. pH are maintained in the range of 6.3 to 6.9 throughout

fermentation cycle with 50 % Dextrose solution. Foaming is controlled by addition of

the mixture of antifoaming agent and Soya oil. The fermentation broth samples are

checked periodically for pH, PMV (%), purity and activity. The fermentation batch is

harvested at around 150–200 hrs when there is no significant increase in Daptomycin

concentration as is ascertained by HPLC analysis.

Recovery: After completion of fermentation the harvested broth is transferred to the

broth-holding vessels and biomass is removed by micro-filtration and concentration by

neon filtration. And purification by multiple resign reaction and ppt out with addition of

anti-solvent addition.

The dried product is further purified by crystallization, drying and analysed and if

found meeting the desired specification is packed and sent to warehouse.

Concord Biotech Limited A-6

Process Flow diagram

Concord Biotech Limited A-7

5. Fidaxomycin

Process description

Fidaxomycin is produced in a single stage fermentation process. The microorganisms

are activated from dormant state to vegetative state in microbiological Laboratory. The

vegetative state microorganisms are further germinated to seed stage in the seed tank

where optimum environmental condition like sterile air, nutrients and controlled

friendly environment for the microorganisms is maintained. When sufficient seed has

been developed, it is transferred to fermenter. Fermenter is a large vessel with

agitator and cooling coils. Raw materials, nutrients, sterilized air, microorganisms etc.

are fed in the vessel. Suitable process parameters i.e. Temperature, pH, dissolved

oxygen and agitation are maintained in the fermenter for production of the desired

product.

The broth is filtered and washes the cake with RO water and the wet cake is extracted

with methanol and then concentrate up to last drop under vacuum. The residue mass

is further extracted with ethyl acetate. The organic layer is concentrate under vacuum.

Isopropyl is added and stir to get required crystallized product. The wet cake is

suspended in Isopropyl alcohol and filter to get the pure Fidaxomycin. The recovered

solvents are stored in the respective solvent tanks for reused and the residue mass

send to incinerator.

Concord Biotech Limited A-8

Process flow diagram

Concord Biotech Limited A-9

6. Mupirocin & salts

Process description

Mupirocin is produced in a single stage fermentation process. The microorganisms are

activated from dormant state to vegetative state in microbiological Laboratory. The

vegetative state microorganisms are further germinated to seed stage in the seed tank

where sterile air, nutrients and controlled friendly environment for the microorganisms

is maintained. When sufficient seed has been developed, it is transferred to fermenter.

Fermenter is a large vessel with agitator and cooling coils. Raw materials, nutrients,

sterilized air, microorganisms etc. are fed in the vessel. Suitable process parameters

i.e. Temperature, pH, dissolved oxygen and agitation are maintained in the fermenter

for production of the desired product.

The fermentation broth containing active mupirocin is harvested and the pH of the

broth is adjusted to about 4.0-4.5 by slow addition of aqueous sulphuric acid solution.

The fermentation broth is then extracted with Ethyl acetate by adding ethyl acetate

under stirring. The ethyl acetate is then separated from the broth using decanter and

rich ethyl acetate obtained. Rich ethyl acetate is then washed with water and the 2%

solution of sodium bicarbonate is added to it, stirred and allowed to settle. The rich

aqueous layer is then separated and organic layer is again treated with 2% sodium

bicarbonate solution. Both the aqueous layers are combined together and ethyl acetate

is added to it. The pH of the solution mixture is adjusted to about 4.0-4.5 by slow

addition of aqueous sulphuric acid solution so that Mupirocin get transferred in ethyl

acetate as a free acid. After adjusting the pH and stirring, the solvent mixture is

passed through decanter to separate the organic layer and aqueous layer. The organic

layer of ethyl acetate thus obtained treated with charcoal and filtered. The filtered

clear solution treated with anhydrous sodium Sulphate to dry the organic layer and

again filtered. The rich ethyl acetate thus obtained is concentrated at 25-30°C till the

required concentration of Mupirocin. The ambient amount of n-Heptane is added to this

solution and allowed to stir for about 20-72 hrs to crystallize the Mupirocin crude. It is

filtered and dried under vacuum till its LOD is less than 1.0% to get the Mupirocin

crude.

Take the Mupirocin crude and dissolve in the ethyl acetate so that the concentration of

mupirocin is 150-200 g/L. Heat the solution to 40-45°C so that mupirocin crude get

dissolved completely. Filter the solution to get the clear solution. This clear solution is

taken in a reactor and required quantity of n-Heptane is added. The turbid solution

kept on stirring till crystallization of mupirocin started. The stirring continued for 20-24

hrs and then at 10-15°C for further 5-10 hrs. The crystallized Mupirocin is filtered on a

nutch filter to get the wet cake of Mupirocin pure. Wet cake is washed with cold (10-

Concord Biotech Limited A-10

15°C) ethyl acetate and dried under vacuum at 30-35°C. After drying the material is

packed and analyzed for Mupirocin purr.

Process flow diagram

Concord Biotech Limited A-11

7. Fosfomycin

Process Description

Charge RO water, Fosfomycin phenyl ethyl amine and MIBK under stirring at room

temperature. Cool the reaction mass and add sodium hydroxide solution under cooling.

Maintain the stirring for 1 hour and then separate the layer. The rich aqueous layer is

taken for carbon treatment and then loads the aqueous layer for lypophillization.

Unload the required product after 65 hours and packed after analysis. The organic

layer is taken for solvent recovery and phenyl ethyl amine as byproduct which can be

sold in market. The residue is sent for incineration.

Process flow diagram

Concord Biotech Limited A-12

8. Dalbavancin

Process Description

Dalbavancin is produced by a single stage fermentation process. The microorganisms

are activated from dormant state to vegetative state in microbiological Laboratory. The

vegetative state microorganisms are further germinated to seed stage in the seed tank

where sterile air, nutrients and controlled friendly environment for the microorganisms

is maintained. When sufficient seed has been developed, it is transferred to fermenter.

Fermenter is a large vessel with mixing device and cooling coils. Raw materials,

nutrients, sterilized air, microorganisms etc. are fed in the vessel. Suitable process

parameters i.e. Temperature, pH, dissolved oxygen and agitation are maintained in the

fermenter for production of the desired product.

The harvested broth is filter and filtrate is taken for nano filtration while mycelia send

to ETP. The product is extracted with n-butanol from retentant and spent aqueous

mass along with permeate is send to ETP. The n-butanol layer is concentrate up to last

drop under vacuum and residue is precipitate with ethyl acetate. Filter the required

product and dry. The mother liquor send for solvent recovery and residue send for

incineration.

Concord Biotech Limited A-13

Process flow chart: Dalbavancin

Concord Biotech Limited A-14

9. Telavancin

Process Description

Telavancin is produced by a single stage fermentation process. The microorganisms

are activated from dormant state to vegetative state in microbiological Laboratory. The

vegetative state microorganisms are further germinated to seed stage in the seed tank

where sterile air, nutrients and controlled friendly environment for the microorganisms

is maintained. When sufficient seed has been developed, it is transferred to fermenter.

Fermenter is a large vessel with mixing device and cooling coils. Raw materials,

nutrients, sterilized air, microorganisms etc. are fed in the vessel. Suitable process

parameters i.e. Temperature, pH, dissolved oxygen and agitation are maintained in the

fermenter for production of the desired product.

Process flow diagram

Concord Biotech Limited A-15

10. Capreomycin

Process Description

Capreomycin is produced by a single stage fermentation process. The microorganisms

are activated from dormant state to vegetative state in microbiological Laboratory. The

vegetative state microorganisms are further germinated to seed stage in the seed tank

where sterile air, nutrients and controlled friendly environment for the microorganisms

is maintained. When sufficient seed has been developed, it is transferred to fermenter.

Fermenter is a large vessel with mixing device and cooling coils. Raw materials,

nutrients, sterilized air, microorganisms etc. are fed in the vessel. Suitable process

parameters i.e. Temperature, pH, dissolved oxygen and agitation are maintained in the

fermenter for production of the desired product.

The Harvested broth is extracted with ethyl acetate and spent broth is sent for ETP.

While rich ethyl acetate is concentrated under vacuum. The residual mass is

crystallized with n-heptane at lower temperature. The wet cake of the required product

is taken for drying. The filtrate is taken and sends for solvent recovery for reused and

residual mass is sent for incineration.

Process flow diagram

Concord Biotech Limited A-16

11. Tobramycin Sulphate

Process Description

Tobramycin Sulphate is produced by a single stage fermentation process. The

microorganisms are activated from dormant state to vegetative state in microbiological

Laboratory. The vegetative state microorganisms are further germinated to seed stage

in the seed tank where sterile air, nutrients and controlled friendly environment for the

microorganisms is maintained. When sufficient seed has been developed, it is

transferred to fermenter.

Fermenter is a large vessel with mixing device and cooling coils. Raw materials,

nutrients, sterilized air, microorganisms etc. are fed in the vessel. Suitable process

parameters i.e. Temperature, pH, dissolved oxygen and agitation are maintained in the

fermenter for production of the desired product.

The harvested broth is filter and filtrate is pass from resin while mycelia send to ETP.

The product is extracted with Ethyl Acetate and spent aqueous mass along with

permeate is send to ETP. The Ethyl acetate layer is concentrate up to last drop under

vacuum and residue is precipitate with ethyl acetate. Filter the required product and

dry. The mother liquor send for solvent recovery and residue send for incineration.

Concord Biotech Limited A-17

Process flow diagram

Concord Biotech Limited A-18

12. Oritavancin

Process Description

Oritavancin is produced by a single stage fermentation process. The microorganisms

are activated from dormant state to vegetative state in microbiology Laboratory. The

vegetative state microorganisms are further germinated to seed stage in the seed tank

where sterile air, suitable raw materials and controlled environment for the growth of

microorganisms is maintained. When sufficient growth of microorganism in form of

seed has been developed, it is transferred to main fermenter for the production.

Fermenter is a large vessel having mixing device and heating/cooling coils. Raw

materials, nutrients, sterilized air, microorganisms in form of seed etc. are fed in the

vessel. Appropriate process parameters i.e. Temperature, pH, dissolved oxygen,

agitation etc. are maintained in the fermenter which helps in desired growth of

microorganisms as well as for the production of desired product.

Oritavancin is fermentation and synthesis product. Oritavancin is two step products,

first Isolate intermediate A82846B by fermentation and second single step synthesis.

Filter the broth of A82846B and wash the cake with RO water, load the filtrate in to

resin and elute with mix solvent (water + isopropyl alcohol), distil out pool fraction and

pure with preparative HPLC to give pure A82846B. Take pure A82846B and add chloro

biphenyl carboxaldehyde with methanol to reflux it and concentrate the mass to give

oily mass. Crystallisation the oily mass with Isopropyl alcohol to give pure Oritavancin.

The recovered solvents are stored in the respective solvent tanks for reused and the

residue mass send to incinerator.

Concord Biotech Limited A-19

Process Flow Diagram

Concord Biotech Limited A-20

C. Antiparasitic

13. Milbemycin oxime

Process Description

Milbemycin is produced by a single stage fermentation process. The microorganisms

are active ted from dormant state to vegetative state in microbiological Laboratory.

The vegetative state microorganisms are further germinated to seed stage in the seed

tank where sterile air, nutrients and controlled friendly environment for the

microorganisms is maintained. When sufficient seed has been developed, it is

transferred to fermenter. Fermenter is a large vessel with mixing device and cooling

coils. Raw materials, nutrients, sterilized air, microorganisms etc. are fed in the vessel.

Suitable process parameters i.e. Temperature, pH, dissolved oxygen and agitation are

maintained in the fermenter for production of the desired product.

Extract the broth with Ethyl acetate and spent broth is transfer to ETP. The rich Ethyl

acetate is filtered to remove the suspension mass. The filtrate is concentrate up to last

drop under vaccum at room temperature. Charge isopropyl alcohal to oily mass under

stirring. Stir the mass to get clear solution then cool slowly. Chill the mass and

maintain for 5 hrs to crystallized the required product. Filtered and then unload the

material for drying. Packed the final product after analysis. Filtrate is sent for solvent

recovery and the residual mass is sent for incineration.

Concord Biotech Limited A-21

Process flow diagram

Concord Biotech Limited A-22

D. Antifungal

14. Pneumocandin B0

Process Description

Pneumocandin B0 is intermediate for the Caspofungin which is an antifungal drug.

Pneumocandin B0 is produced by the fungal strain Zalerion arboricola through

fermentation process. Pneumocandin B0 is recovered from fermentation broth through

different steps of recovery. Manufacturing of Pneumocandin B0 is carried out in three

different stages:

Preparation of Seed: Laboratory inoculums comprises of Vegetative growth (2000-

3000 ml).Vegetative growth is developed by inoculating 100/200 ml of seed media

contained in 500/1000 ml conical flasks with spore suspensions from working cell

bank. The inoculated flasks are incubated on rotary shaker at 22-28ºC and 250 ± 10

RPM. The matured vegetative growth from different flasks is collected in sterilized

inoculation assembly under aseptic condition on Laminar air flow work bench. This

matured vegetative growth is used to inoculate seed fermenter. Seed fermenter is

prepared by sterilizing 500-1000 Liters seed medium at 123 ± 3 ºC for 40 to 50

minutes and inoculated with laboratory inoculum under aseptic conditions. The seed is

incubated at 22-28ºC for 40-120 hrs and checked periodically for purity, pH and PMV

(%). After achieving desired criteria seed culture is being transferred to Main

fermenter.

Fermentation: Pneumocandin production is carried out in production fermenter by

aseptically transferring the seed (5-7%) to production medium (8 to 14 KL) sterilized

at 123 ± 3 ºC for 40 to 50 minutes. The fermenter is incubated at 22-28 ºC. During

the fermentation cycle the appropriate culture conditions like aeration, agitation and

back pressure are maintained. L-Proline is added as a precursor from 90 hrs onwards.

D-Mannitol is used as feed from 180 hrs onwards. It serves the dual purpose as energy

source and also maintains the pH of fermenter broth in the range of 6.5 to 8.0.

Foaming is controlled by addition of the mixture of antifoaming agent and soya oil. The

fermentation broth samples are checked periodically for pH, PMV (%), purity and

activity. The fermentation batch is harvested at around 250-360 hrs when there is no

significant increase in Pneumocandin B0 concentration as is ascertained by HPLC

analysis.

Recovery: The fermentation broth is harvested and extracted with Iso-butyl acetate.

The rich isobutyl acetate is then concentrated to get the concentrated mass. A binder

is prepared from Calcium chloride and Potassium phosphate which is then added to the

concentrate mass. Stirred well and filtered and dried to get the Pneumocandin B0

crude. The filter is then washed with methanol. The methanol containing

Concord Biotech Limited A-23

Pneumocandin B0 is concentrated and crystallized by adding Acetonitrile. Precipitated

product is then filtered and dried to get the Pneumocandin B0 pure.

Process Flow Diagram

Concord Biotech Limited A-24

15. Caspofungin

Process Description

Caspofungin is a semisynthetic API manufactured from Pneumocandin B0 by multistep

synthetic process. The pneumocandin B0 is treated with Cyanuric chloride in Dimethyl

formamide at -30°C for 20-30 hrs. After the reaction is complete it is decomposed by

addition of water and the product 1 is isolated in liquid solution by solid phase

extraction technique. To this solution a catalyst is added and catalytic hydrogenataion

is carried out in the presence of Ammonium acetate and acetic acid. After complete

hydrogenation the solution is filtered using hyflo and the product 2 (An amine

intermediate) is obtained again by solid phase extraction.

This amine intermediate is taken in acetonitrile and treated with tetrazole at -10°C in

presence of Phenyl Boronic acid and Triflic acid. After completion of the reaction

monitored by HPLC, the reaction is quenched by addition of methanol. The resultant

solution containing product 3 is allowed to react with 1,2-diaminoethane in presence of

ethyl acetate for 2-3 days. Once the reaction completes, the caspofungin formed is

purified by SPXL resin using ethanol water mixture. The rich cuts are taken together

and the repurified on preparative HPLC using acetonitrile as a mobile phase. The pure

fractions are taken together and precipitated out by addition of 10% aq. NaCl solution.

The precipitated solid is filtered and again recrystallized using ethanol, acetic acid and

ethyl acetate mixture. The crystallized material is filtered and dried under nitrogen to

get the Caspofung in diacetate as the final drug substance.

Concord Biotech Limited A-25

Process Flow Diagram

Concord Biotech Limited A-26

16. Micafungin

Process Description

Mixture of Nucleus FR901379, [4-[5-(4-pentyloxyphenyl) isoxazol-3-yl] benzoyloxy]-

1H-1, 2, 3-benzotriazole (Side chain) in N, N-dimethylformamide, DMF and 4-(N,N-

dimethylamino) pyridine (DMAP) are stirred for 12 hours at ambient temperature. The

reaction mass is then diluted with ethyl acetate and further wet cake is obtained by

filtration. Mother liquor send for the solvent recovery. Wet cake is suspended in the

mixture of acetone and ethyl acetate. Stir and filter the material, after drying white

color solid powder of micafungin is obtained. Mother liquor is sent to solvent recovery.

Process flow chart

Concord Biotech Limited A-27

17. Anidulafungin

Process description

Mixture of Echinocandin Nucleus, Side chain (TOBt), KH2PO4, acetone and water are

stirred for 3 hours at 55°C. Cool the reaction mixture at room temperature and filter it.

Wet cake is suspended in RO water and stir for 1 hour. Filter the product, after drying

solid powder of Anidulafungin is obtained. The aqueous filtrate is send to ETP while

aqueous acetone filtrate is distilled to recover the solvent and aqueous residual mass

is also send for incineration.

Process flow diagram

Concord Biotech Limited A-28

E. Immunosuppressant

18. Tacrolimus

Process Description

Tacrolimus is produced in a single stage fermentation process. The spores of

microorganisms are activated from dormant state to vegetative state in microbiological

laboratory. The vegetative state microorganisms are further germinated to seed stage

in the seed tank (for 36-48 hr) where sterile air, nutrients and controlled friendly

environment (pH and temperature 27oC) for the microorganisms is maintained. When

sufficient seed has been developed, it is transferred to the fermenter.

Fermenter is a large vessel with agitator and cooling coils. Raw Material, nutrient,

sterilized air, microorganism’s etc. are fed in the vessel. Suitable environment that is,

temperature, pH, dissolved oxygen and agitation are maintained in the fermenter for

production of the desired product. The fermentation continues for nearly 240 hrs.

The fermentation product is recovered in the harvester through solvent (Toluene)

extraction and purified through multiple solvent washing, concentration in vacuum and

dried. The dried product is further purified by crystallization, drying and analyzed and

if found meeting the desired specification is packed and sent to warehouse. Spent

solvent are recovered in the solvent recovery units. The recovery and purification steps

are operated carefully for safety of the system. After each campaign total plant is

thoroughly cleaned, washed, sterilized and recalibrate.

The solvent residue from the solvent distillation column is sent for incineration. Figure

shows the process flow diagram detailing the important step and raw material

requirement for each batch.

Concord Biotech Limited A-29

Process Flow Diagram

Concord Biotech Limited A-30

19. Mycophenolic Acid

Process Description

MPA is produced in a single stage fermentation process. The spores of microorganisms

are activated from dormant state to vegetative state in microbiological laboratory. The

vegetative state microorganisms are further germinated to seed stage in the seed tank

(for 36 - 48 hr) where sterile air, nutrients and controlled friendly environment (pH

and temperature 27oC) for the microorganisms is maintained. When sufficient seed has

been developed, it is transferred to the fermenter.

Fermenter is a large vessel with agitator and cooling coils. Raw Material, nutrient,

sterilized air, microorganism’s etc. are fed in the vessel. Suitable environment that is,

temperature, pH, dissolved oxygen and agitation are maintained in the fermenter for

production of the desired product. The fermentation continues for nearly 240 hrs.

The fermentation product is recovered in the harvester through solvent (IBA)

extraction and purified through multiple solvent washing, concentration in vacuum and

dried. The dried product is further purified by crystallization, drying and analyzed and

if found meeting the desired specification is packed and sent to warehouse.

Spent solvent are recovered in the solvent recovery units. The recovery and

purification steps are operated carefully for safety of the system. After each campaign

total plant is thoroughly cleaned, washed, sterilized and recalibrate.

The solvent residue from the solvent distillation column is sent for incineration. Figure

shows the process flow diagram detailing the important step and raw material

requirement for each batch.

Concord Biotech Limited A-31

Process Flow Diagram

Concord Biotech Limited A-32

20. Cyclosporine

Process Description

Cyclosporine is produced in a single stage fermentation process. The spores of

microorganisms are activated from dormant state to vegetative state in microbiological

laboratory. The vegetative state microorganisms are further germinated to seed stage

in the seed tank (for 36-48 hours) where sterile air, nutrients and controlled friendly

environment (pH and temperature 27oC) for the microorganisms is maintained. When

sufficient seed has been developed, it is transferred to the fermenter.

Fermenter is a large vessel with agitator and cooling coils. Raw materials, nutrients,

sterilized air, microorganisms etc. are fed in the vessel. Suitable environment that is,

temperature, pH, dissolved oxygen and agitation are maintained in the fermenter for

production of the desired product. The fermentation continues for nearly 240 hours.

The fermentation product is recovered in the harvester through solvent (Toluene)

extraction and purified through multiple solvent washing, concentration in vacuum and

dried. The dried product is further purified by crystallization, drying and analyzed and

if found meeting the desired specification is packed and sent to warehouse.

Spent solvent are recovered in the solvent recovery units. The recovery and

purification steps are operated carefully for safety of the system. After each campaign

total plant is thoroughly cleaned, washed, sterilized and recalibrate.

The solvent residue from the solvent distillation column is sent for incineration. Figure

shows the process flow diagram detailing the important step and raw material

requirement for each batch.

Concord Biotech Limited A-33

Process Flow Diagram

Concord Biotech Limited A-34

21. Rapamycin

Process Description

Rapamycin is produced in a single stage fermentation process. The spores of

microorganisms are activated from dormant state to vegetation state in microbiological

laboratory. The vegetative state microorganisms are further germinated to seed stage

in the seed tank (for 36 - 48 hours) where sterile air, nutrients and controlled friendly

environment (pH and temperature 27oC) for the microorganisms is maintained. When

sufficient seed has been developed, it is transferred to the fermenter.

Fermenter is a large vessel with agitator and cooling coils. Raw Material, nutrient,

sterilized air, microorganisms etc. are fed in the vessel. Suitable environment that is,

temperature, pH, dissolved oxygen and agitation are maintained in the fermenter for

production of the desired product. The fermentation continues for nearly 240 hrs.

The fermentation product is recovered in the harvester through solvent (IBA)

extraction and purified through multiple solvent washing, concentration in vacuum and

dried. The dried product is further purified by crystallization, drying and analyzed and

if found meeting the desired specification is packed and sent to warehouse.

Spent solvent are recovered in the solvent recovery units. The recovery and

purification steps are operated carefully for safety of the system. After each campaign

total plant is thoroughly cleaned, washed, sterilized and recalibrate.

The solvent residue from the solvent distillation column is sent for incineration. Figure

shows the process flow diagram detailing the important step and raw material

requirement for each batch.

Concord Biotech Limited A-35

Process Flow Diagram

Concord Biotech Limited A-36

22. Mycophenolate Mofetill & Mycophenolate sodium

Manufacturing Process Description of Mycophenolate mofetil:

It is single stage reaction involving the condensation of Mycophenolic Acid with

Morphonline -2- ethanol in Xylene to give crude Mycophenolate Mofetil, which is then

purified through multiple solvent washing, drying and analysed and if found meeting

the desired specification is packed and send to finished goods.

Manufacturing Process Description of Mycophenolate sodium:

It is single stage reaction involving the reaction between Mycophenolic Acid with

Sodium 2 Ethyl Hexaunic acid. After this it is centrifuge, drying and analyzed and if

found meeting the desired specification is packed and send to finished goods.

Process Flow Diagram

Concord Biotech Limited A-37

F. Onco Products

23. Ixabepilone

Process description

Charge Ethyl acetate, Epothilone B, tetrabis (TPP) palladium and sodium azide in the

reactor under dry condition. Stir the mass for four hours and quinch in water and then

extract with ethyl acetate. The aqueous layer is send to ETP and organic layer distill up

to last drop under vacuum at room temperature. Charge ethyl acetate in the oily mass

then charge trihenyl phosphine and diphylphoryl azide. Heat the reaction to 50 - 55°C

and maintain for 2 hours. Cool the reaction and quinch with water. Extract the mass

with ethyl acetate and taken for distillation under vacuum to isolate the require

product. The distilled solvent is send to solvent tank. The aqueous layer sends to ETP.

The colorless oil which is product is pack after analysis.

Process flow diagram

Concord Biotech Limited A-38

24. Romidepsin

Process description

Romidepsin is produced by a single stage fermentation process. The microorganisms

are activated from dormant state to vegetative state in microbiological Laboratory. The

vegetative state microorganisms are further germinated to seed stage in the seed tank

where sterile air, nutrients and controlled friendly environment for the microorganisms

is maintained. When sufficient seed has been developed, it is transferred to fermenter.

Fermenter is a large vessel with mixing device and cooling coils. Raw materials,

nutrients, sterilized air, microorganisms etc. are fed in the vessel. Suitable process

parameters i.e. Temperature, pH, dissolved oxygen and agitation are maintained in the

fermenter for production of the desired product.

The harvested broth is filter and the filtrate is taken for nano filtration while mycilia

cake is send to ETP. The permeate from nano filter is send to ETP while retentate is

loaded on HP-20 resin and elute the product with 1 % hydrochloric acid. Pool the

fraction and extract with iso butyl acetate at basic pH. The spent aqueous is send to

ETP. The iso butyl acetate is concentrate and the residual mass is cool and chill to

crystallize the required product. The mother liquor is taken for solvent recovery and

residue send for incineration. The final product is packed after drying.

Concord Biotech Limited A-39

Process flow diagram

Concord Biotech Limited A-40

25. Temsirolimus

Process Description

Charge dichloromethane, sirolimus and DMAP in the reaction. Cool the mass and then

add mixed anhydride drop wise within two hours. Once the reaction is completed, add

water and stir. Separate the layers. The aqueous layer is send to ETP and organic layer

is distilled up to the last drop under vacuum. Add terahydro furan to oily mass and

hydrolyzed with hydrochloric acid to convert intermediate crude temsirolimus. Distilled

off tetra hydro furan and residue is crystallized with n-heptane. Filter the required

product and dry under vacuum then pack after analysis. Distil filtrate to remove the

solvent and send residue for incineration.

Process flow diagram

Concord Biotech Limited A-41

26. Everolimus

Process Description

Charge toluene, 2, 6 lutidine and sirolimus. Stir the mass and heat to 50 - 60°C and

then add triflate within one hour. Maintain the reaction for four hour. Once the reaction

is completed, cool the reaction mass and then add water. Stir and separate the layer.

Aqueous layer send to ETP while organic layer is distil up to last drop under vacuum.

Charge methanol to the residue under stirring and hydrolyse with formic acid to

convert intermediate everolimus. Distill off methanol up to last drop and residue is

taken in dichloromethane. Wash the organic layer with water and then distill off

dichloromethane under vacuum. Residue is crystallized with n-heptane. Filter and dry

the product and pack after analysis. The filtrate is distilled off to recover n-heptane

and residue is sent for incineration.

Process flow diagram

Concord Biotech Limited A-42

27. Ridaforolimus

Process Description

Charge in the reactor followed by the addition of siroliums under stirring. Add pyridine

then chill the reaction mass to 0°C and then start the addition of dimethyl phophoric

chloride drop wise with in 1hr. Once reaction is completed then quench in water under

chilling condition. Separate the organic layer and wash layer with bicorbonate solution.

Distil the organic layer up to last drop under vacuum and residue is crystallizing with

n-Hexane. Filter the mass and dry the product under vacuum. Unload the product and

pack after analysis while the filtrate is distilled to recover the solvent and residue is

send to incinerator.

Process flow diagram

Concord Biotech Limited A-43

28. Pimecrolimus

Process Description

Ascomycin is dried using Toluene then dissolved in toluene and acetonitrile. Then add

of triflic anhydirde followed by addition of Diisopropulamine in the reaction mass and

then add trific anhydride followed by addition of Diisopropyl amine in the reaction

mass and then add benzen .Once reaction is over added water washed with water and

separate organic layer. Organic phase is distilled under vacuum to obtain crude

Pimecrolimus as oily mass which is purified by aqueous acetone. Final product is

packed after analysis and collects the filtrate and send for solvent recovery and

residue send for incineration.

Process flow diagram

Concord Biotech Limited A-44

29. Doxorubicin

Process Description

Charge the RO water in the reactor followed by the addition of Bromo daunorubicin.

Stir the mass after addition of hydro-bromic acid then extract the product in

dichloromethane. Concentrate the organic layer under vacuum and the residue is

loaded on HP- 20 column for purification. Elute the residue product with 50% aqueous

acetone. Pool the fractions and concentrate. The aqueous residual portion is cool &

chill to crystallize the product. Filter, dry under vacuum and pack after analysis.

Mother liquor is send for solvent recovery.

Process flow diagram

Concord Biotech Limited A-45

30. Daunorubicin

Process Description

Daunorubicin is produced by a single stage fermentation process. The microorganisms

are activated from dormant state to vegetative state in microbiological Laboratory. The

vegetative state microorganisms are further germinated to seed stage in the seed tank

where sterile air, nutrients and controlled friendly environment for the microorganisms

is maintained. When sufficient seed has been developed, it is transferred to fermenter.

Fermenter is a large vessel with mixing device and cooling coils. Raw materials,

nutrients, sterilized air, microorganisms etc. are fed in the vessel. Suitable process

parameters i.e. Temperature, pH, dissolved oxygen and agitation are maintained in the

fermenter for production of the desired product.

Take broth which is containing Duanorubicin and adjust pH 1 to 3 with oxalic acid.

Remove mycelia from Microfiltration and then take Aq. Layer for nano-filtration. Take

Retentate and pure with resin column with elute Water: Methanol. Pool the fractions

and distillation. Add Acetone in residual mass and filter and dry to give daunarubicin

red-orange color and packaged the final material. Mother liquor send for solvent

recovery and residue send for incineration.

Concord Biotech Limited A-46

Process flow diagram

Concord Biotech Limited A-47

31. Epirubicin

Process Description

Charge RO water and sodium hydroxide under stirring & cooling. Charge EPi-TFA

daunorubicin and maintain the reaction mass under stirring for 1 hr. Extract the

reaction mass with dichromethane. Concentrate the organic layer and the residual is

precipitate with n-Hexane. Filtered the mass, unload the wet cake and dry under

vacuum and then packed after analysis. Filtrate is taken for solvent recovery. The

residual mass is sent for incineration.

Process flow diagram

Concord Biotech Limited A-48

32. Idarubicin

Process Description

Idarubicin is produced by a single stage fermentation process. The microorganisms are

activated from dormant state to vegetative state in microbiological Laboratory. The

vegetative state microorganisms are further germinated to seed stage in the seed tank

where sterile air, nutrients and controlled friendly environment for the microorganisms

is maintained. When sufficient seed has been developed, it is transferred to fermenter.

Fermenter is a large vessel with mixing device and cooling coils. Raw materials,

nutrients, sterilized air, microorganisms etc. are fed in the vessel. Suitable process

parameters i.e. Temperature, pH, dissolved oxygen and agitation are maintained in the

fermenter for production of the desired product.

The harvested broth is filtered and filtrate is send to ETP. While solid mass is

suspended in MIBK, stir for 2 hr. then filter. The spent solid mass is send for

incineration and organic phase is taken for distillation up to last drop under vaccum.

The recovered solvent is send to respective solvent tank. The residual oilish mass is

crystallizing with acetonitrile and then filter. The require product is dried and packed

after analysis and filtrate is taken for solvent recovery and corresponding residue is

send for incineration.

Concord Biotech Limited A-49

Process flow diagram

Concord Biotech Limited A-50

33. Bleomycin

Process Description

Bleomycin is produced by a single stage fermentation process. The microorganisms are

activated from dormant state to vegetative state in microbiological Laboratory. The

vegetative state microorganisms are further germinated to seed stage in the seed tank

where sterile air, nutrients and controlled friendly environment for the microorganisms

is maintained. When sufficient seed has been developed, it is transferred to fermenter.

Fermenter is a large vessel with mixing device and cooling coils. Raw materials,

nutrients, sterilized air, microorganisms etc. are fed in the vessel. Suitable process

parameters i.e. Temperature, pH, dissolved oxygen and agitation are maintained in the

fermenter for production of the desired product.

The harvested broth is filter and the filtrate is taken for nano filtration while mycilia

cake is send to ETP. The permeate from nano filter is send to ETP while retentate is

loaded on HP-20 resin and elute the product with 1% hydrochloric acid. Pool the

fraction and extract with ethyl acetate at basic pH. The spent aqueous is send to ETP.

The rich ethyl acetate is concentrate and the residual mass is cool and chill to

crystallize the required product. The mother liquor is taken for solvent recovery and

residue send for incineration. The final product is packed after drying.

Concord Biotech Limited A-51

Process flow diagram

Concord Biotech Limited A-52

34. Geldanamycin

Process Description

Geldanamycin is produced by a single stage fermentation process. The microorganisms

are activated from dormant state to vegetative state in microbiological Laboratory. The

vegetative state microorganisms are further germinated to seed stage in the seed tank

where sterile air, nutrients and controlled friendly environment for the microorganisms

is maintained. When sufficient seed has been developed, it is transferred to fermenter.

Fermenter is a large vessel with mixing device and cooling coils. Raw materials,

nutrients, sterilized air, microorganisms etc. are fed in the vessel. Suitable process

parameters i.e. Temperature, pH, dissolved oxygen and agitation are maintained in the

fermenter for production of the desired product.

The harvested broth is filter and filtrate is taken for nano filtration while mycelia send

to ETP. The product is extracted with MIBK from retentate and spent aqueous mass

along with permeate is send to ETP. The MIBK layer is concentrate upto last drop

under vacuum and residue is precipitate with ethyl acetate. Filter the required product

and dry. The mother liquor send for solvent recovery and residue send for incineration.

Concord Biotech Limited A-53

Process flow diagram

Concord Biotech Limited A-54

35. Mitomycin

Process description

Mitomycin is produced by a single stage fermentation process. The microorganisms are

activated from dormant state to vegetative state in microbiology Laboratory. The

vegetative state microorganisms are further germinated to seed stage in the seed tank

where sterile air, suitable raw materials and controlled environment for the growth of

microorganisms is maintained. When sufficient growth of microorganism in form of

seed has been developed, it is transferred to main fermenter for the production.

Fermenter is a large vessel having mixing device and heating/cooling coils. Raw

materials, nutrients, sterilized air, microorganisms in form of seed etc. are fed in the

vessel. Appropriate process parameters i.e. Temperature, pH, dissolved oxygen,

agitation etc. are maintained in the fermenter which helps in desired growth of

microorganisms as well as for the production of desired product.

Mitomycin is produced in a single stage fermentation process. Filter the broth and

wash the cake with RO water, pass the filtrate with Resin and distil out pool fraction.

Crystallisation mass with methanol and dry in oven to give pure Mitomycin. The

recovered solvents are stored in the respective solvent tanks for reused and the

residue mass send to incinerator.

Concord Biotech Limited A-55

Process flow diagram

Concord Biotech Limited A-56

36. Dactinomycin

Process description

Dactinomycin is produced by a single stage fermentation process. The microorganisms

are activated from dormant state to vegetative state in microbiology Laboratory. The

vegetative state microorganisms are further germinated to seed stage in the seed tank

where sterile air, suitable raw materials and controlled environment for the growth of

microorganisms is maintained. When sufficient growth of microorganism in form of

seed has been developed, it is transferred to main fermenter for the production.

Fermenter is a large vessel having mixing device and heating/cooling coils. Raw

materials, nutrients, sterilized air; microorganisms in form of seed etc. are fed in the

vessel. Appropriate process parameters i.e. Temperature, pH, dissolved oxygen,

agitation etc. are maintained in the fermenter which helps in desired growth of

microorganisms as well as for the production of desired product.

Dactinomycin is produced in a single stage fermentation process. Add toluene in to

broth and filter it, take filtrate and concentrate up to oily mass. Purified oily mass with

column chromatography and pool fraction. Crystallisation in diisopropylether solvent to

give Pure Dactinomycin. The recovered solvents are stored in the respective solvent

tanks for reused and the residue mass send to incinerator.

Concord Biotech Limited A-57

Process flow diagram

Concord Biotech Limited A-58

37. Trabectedin

Process description

Trabectedin is produced by a single stage fermentation process. The microorganisms

are activated from dormant state to vegetative state in microbiology Laboratory. The

vegetative state microorganisms are further germinated to seed stage in the seed tank

where sterile air, nutrients and controlled friendly environment for the microorganisms

is maintained. When sufficient seed has been developed, it is transferred to main

fermenter for the production.

Fermenter is a large vessel with mixing device and heating/cooling coils. Raw

materials, nutrients, sterilized air, microorganisms etc. are fed in the vessel. Suitable

process parameters i.e. Temperature, pH, dissolved oxygen and agitation are

maintained in the fermenter which helps in desired growth of microorganism as well as

for the production of desired product.

Trabectedin is Fermentation and Semi synthesis Product. Extract the broth with ethyl

acetate, and concentrate the rich ethyl acetate to give oily mass. Load the mass in to

silica gel column, elute the material with mix solvent of ethyl acetate + methanol,

concentrate the pool fraction to give Safracin-B, to be proceed chemically synthesis

and extract it with solvent and distill out solvent completely under vacuum, wet

product dry under vacuum to give pure Trabectedin. The recovered solvents are stored

in the respective solvent tanks for reused and the residue mass send to incinerator.

Concord Biotech Limited A-59

Process Flow diagram

Concord Biotech Limited A-60

G. Statin

38. Lovastatin

Process Description

Lovastatin is produced in a single stage fermentation process. The spores of

microorganisms are activated from dormant state to vegetative state in microbiological

laboratory. The vegetative state microorganisms are further germinated to seed stage

in the seed tank (for 36-48 hr at 27oC) where sterile air, food and controlled friendly

environment (pH and temperature) for the microorganisms is maintained. When

sufficient seed has been developed, it is transferred to the fermenter.

Fermenter is a large vessel with agitator and cooling coils. Raw Materials, nutrient,

sterilized air, microorganism’s etc. are fed in the vessel. Suitable environment that is

temperature, pH, dissolved oxygen and agitation are maintained in the fermenter for

production of the desired product. The fermentation continues for nearly 240 hrs.

The fermentation product is recovered in the harvester through solvent (Toluene)

extraction and purified through multiple solvent washing, concentration in vaccum and

dried. The dried product is further purified by crystallization, drying and analysed and

if found meeting the desired specification is packed and sent to warehouse.

Spent solvent is recovered in the solvent recovery units. The recovery and purification

steps are total plant is thoroughly cleaned, washed, sterilized and recalibrate.

The solvent residue from the solvent distillation column is sent for incineration. Figure

shows the process flow diagram detailing the important step and raw material

requirement for each batch.

Concord Biotech Limited A-61

Process Flow Diagram

Concord Biotech Limited A-62

39. Pravastatin

Process Description

Pravastatin is produced in two – stage fermentation process. The spores of

microorganisms are activated from dormant state to vegetative state in microbiological

laboratory. The vegetative state microorganisms are further germinated to seed stage

in the seed tank (for about 36-48 hours) where sterile air, food and controlled friendly

environment (pH and temperature 27oC) for the microorganisms are maintained. When

sufficient seed has been developed, it is transferred to the fermenter.

Fermenter is a large vessel with agitator and cooling coils. Raw materials, nutrients,

sterilized air, microorganism etc. are fed in the vessel. Suitable environment that is,

temperature, pH, dissolved oxygen and agitation are maintained in the fermenter for

production of the desired product. The fermentation continues about 120 hrs.

The fermentation product is recovered in the harvester through solvent (IBA)

extraction and purified through multiple solvent washing, concentration in vacuum and

dried. The dried product is further purified by crystallization, drying and analyzed and

if found meeting the desired specification is packed and sent to warehouse.

Spent solvent are recovered in the solvent recovery units. The recovery and

purification steps are operated carefully for safety of the system. After each campaign

total plant is thoroughly cleaned, washed, sterilized and recalibrate.

The solvent residue from the solvent distillation column is sent for incineration. Figure

shows the process flow diagram detailing the important step and raw material

requirement for each batch.

Concord Biotech Limited A-63

Process Flow Diagram

Concord Biotech Limited A-64

40. Orlistatin

Process Description

Orlistatin is produced in a single stage fermentation process. The spores of

microorganisms are activated from dormant state to vegetative state in microbiological

laboratory. The vegetative state microorganisms are further germinated to seed stage

in the seed tank (for 36-48 hrs at 270C) where sterile air, food, and controlled friendly

environment (pH and temperature) for the microorganisms is maintained. When

sufficient seed has been developed, it is transferred to the fermenter.

Fermenter is a large vessel with agitator and cooling coils. Raw material, nutrient,

sterilized air, microorganism’s etc. are fed in the vessel. Suitable environment that is,

temperature, pH, DO and agitation are maintained in the fermenter for production of

the desired product. The fermenter continues for nearly 240 hrs.

The fermentation product is recovered in the harvester through solvent (N- Heptane)

extraction followed by hydrogenation reaction and purified through multiple solvent

washing, concentration in vacuum and dried. The dried product is further purified by

crystallization, drying and analysed and if found meeting the desired specification is

packed and sent to warehouse. Spent solvent are recovered in the solvent recovery

units. The recovery and purification steps are operated carefully for the safety of the

system. After each campaign the total plant is thoroughly cleaned, washed, sterilized

and recalibrate. The mycelium, organics residue form the solvent distillation column,

vessel washing, etc. are all sent to ETP for treatment or incinerator for safe disposal.

Process Flow Diagram

Annexure-II

MoU from Ambuja Cement Ltd. for co-processing of

waste

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This service agreement ("this agreement") is made at Ahmedabad o n e ~ a ~ of S E P ~ E ~ B B ~ ? 2016.

BETWEEN

Ambuja Cements Limited (CIN : L26942GJl981PLC004717), a company incorporated and registered under the provisions of the companies Act, 1956 and having its registered-office and factory at P.O. Ambuja'nagar, Taluka Kodinar, Dist. Gir Somnath, Gujarat 362 715 (India), having its division/ unit/ section as 'Geocycle" that provides specialized services for thermal destruction or recovery of hazardous/ non Hazardous waste material etc in cement. kilns (hereinafter referred to as "the First. Party" or "the Service Provider" which expression shall, unless repugnant to the context or meaning thereof, be deemed to mean and include its successors and assigns ) represented herein by Mr S Ramarao who is authorized to do so on behalf of company of the FIRST PART.

AND Concord ~ io tech Ltd (~1~:~24230~~1984~~~007440), a company incorporated under the provisions of the Companies Act, 1956' and having its registered office .and manufacturing facility. at 'Plot No.1482/1486, Village Trasad Rs, Tal- Dholka, Dist.- Ahmedabad, PIN- 382225, Gujarat (hereinafter referred to as "the Second Party" or 'the Generator' which expression shall, unless repugnant to the context of. meaning thereof, be deemed to mean a'nd include its successors in business and assigns) represented herein by R J Modi, who is authorized to do. so through the ',' resolution passed by its Board of directors of the SECOND PART. The Service Providerand Generator are individually referred to as Party and collectively as Parties. WHEREAS:

a) Ambuja Cements Ltd. ('the Service Provider') is in the business of manufacturing and selling Ambuja branded cement through its distributors/dealers throughout India.

b) Geocycle is a business unit of the Service Provider that provides specialized services for thermal destruction or recovery of hazardous/non hazardous waste material etc, in cement kilns.

c) The Generator, who is in the business of manufacturing of Pharmaceutical products desires to dispose of its waste and has requested the Service Provider to co-process the Spent Carbon (Category - 28.2) ("Material") and the Service Provider has agreed with the Generator to preprocess and/or transport and/or store and co-process the waste generated by the Generatdr upon the ,.-,, following terms and conditions.

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&a,& Signature \ * .,' i? (Second Party) .~ , , . ... : .. .: . .

A\ A-65

NOW THIS AGREEMENT WITNESSTH AS FOLLOWS:

1. DEF:[NITIONS AND INTERPRETATIONS

I . "FACILITY" means 'Cement Kilns having capability to Co- process the waste generated by th'e Second Party'.

1.2 "SERVICES" means the providing waste management solutions through co-processing as defined below:-

1.3 "Co-processing" means treatment of Hazardous/Non Hazardous waste in Cement Kilns,

1.4 "Pre-processing" means pre-treatment of Hazardous/Non Hazardous waste making it suitable for co-processing,

1.5 "Hazardous Waste" means 'Hazardous Wastef as specified in Hazardous Wastes (Management, Handling and Trans- boundary Movement) Rules, 2016.

1.6 "Rules" means Hazardous Wastes (Management, Handling and Trans-boundary Movement) Rules, 2016

1.7 "SPCBff means 'State ~ollution Control Board' (a state pollution control board).

1.8 "CPCB" means 'Central Pollution Control Board'. 1.9 "Total Fees" means invoice amount raised by service provider

which contains Co-processing charges, applicable taxes, transportation charges if any.

1.10 The headings of or title to the Clauses in this Agreement shall not be deemed to be a part thereof or be taken into consideration in the interpretation or construction thereof of the agreement.

1.11 Words imparting the singular only also include the plural and vice versa where the context so require.

1.12 The present agreement is entered into by the Service Provider for Co-processing of Hazardous/Non' Hazardous Waste a

generated by the Generator. 2. 2 2.1 This Agreement shall be in force for the period of Two (2)

years & I1 (eleven) months commencing on the day of September 2016 and will end on day of July 2019.

2.2 Upon expiration of the term of this Agreement, both the parties hereto may mutually agree for renewal on terms and conditions as decided by the parties mutually.

2.3 The agreement shall be valid until all outstanding amounts are paid in full by the Generator even following the initial term of 2 years & eleven months are over.

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3. SPECIFICATIONS '

Material requiring treatment will have certain specifications as stated in Annexure-A. Material that meets all of the Specifications stated in Annexure-A and Special Instructions, stated in Clause 3A, will be considered as "Conforming Material". Material will be considered 'Non-Conforming Material" if it fails to meet any one of the Specifications or Special Instructions. a) The Generator will ensure all Hazardous Waste sent for

treatment to the Service Provider shall, under all circumstances, conform to the norms specified by SPCB and as prescribed under the provisions of law in force at the relevant time.

b) At no time the Generator shall send Hazardous Waste containing toxic materials exceeding the limits of concentration as specified or that may be notified by the Service Provider / SPCB from time to time.

c) Subject to the availability of space with the Service Provider, the Generator agrees to send material requiring treatment on a regular basis to the Service Provider. Such quantity shall not be less than 10 MT annually and shall be called the "contracted minimum quantity".

d) The Generator shall send a t its costs and risks the contracted quantity to the site of the Service Provider.

4. NON-CONFORMING MATERIAL

At any time after receiving delivery of Material, if the Service Provider finds that some or all are Non-Conforming Material, the Service Provider may charge applicable.surcharges or, at sole cost of the Generator, may bring the Non-Conforming Material into conformance with the specifications or notify the Generator and require the Generator to arrange for immediate removal' of the Non-Conforming Material from the Service Provider's property ("Rejection"). The Service Provider will send written confirmation to the Generator of all such Rejections along with an estimated cost of whatsoever nature, which is likely to be incurred for the Non-Conforming Material. The Service Provider reserves the right, after waiting three (3) days from date the Generator receives notice of the Rejection, to transport such Non-Conforming Material to the Generator for proper disposal. The Service Provider shall be entitled to collect from the Generator any costs and expenses it incurs, including but not limited to transport, storage or disposal costs. The Generator designates the in-fact and authorizes it to sign any transport the Non-Conforming accordance with this Paragraph.

.i;.

0 A-67

Unless otherwise agreed to by the Service Provider, the title, risk of loss and spillage to Conforming Material shall be transferred to the Service Provider upon receipt of the Material and Confirmation of Conformity by the authorized personnel of the Service Provider. Unless otherwise agreed to by the Service Provider in writing, title to IVon-Conforming Material shall remain with the Generator even after the same is delivered to the Service Provider and Generator shall continue to be liable for all the risks. CO-PROCESSING CHARGES AND SURCHARGES:

Co-processing Charges ('the price applicable to the Conforming Material") is stated in Annexure- B I n addition to its right of rejection. The Generator agrees that the charges for the Co-processing of its HazardousjNon ~azaldous Waste as notified by +," d Service Provider shall be subject to revision during the validity of this Agreement. Such Revision shall be called for on the . grounds of escalation of Fuel cost and the cost of other major parameters including but not limited to Power tariff, Change in the disposal/ Co-processing technology/ pre-processing requirements, Hike in wages etc. The Service Provider shall inform the Generator in advance the revised'charges for the service and the same will only be applicable on a mutual agreement between the Service Provider and the Generator. The rates for co-processing services provided by the Service Provider have been duly approved and agreed by the Generator and the Generator undertakes and agrees to pay as .

per the rate prescribed in commercial offer. The Generator will submit 50% amount of annual Co- processing fees with service provider before commencement of actual Co-processing. The said amount will be considered as sec~~r i ty deposit and the same is refundable or adjustable against any dues pending with Generator. However Service Provider will not pay any interest for such Security Deposit amount lying with it during tenure of this agreement. Ambiguity or dispute about any irlvoice amount, the Generator shall be entitled to dispute the invoice amount within 3 business days after receipt of the invoice. I f the Generator does not raise any dispute, it is presumed that the same is acceptable and the Generator sl~all be liable to make the payment in respect of the same within a period of 30 days from the date of the invoice.

S eal & Signature '

(First Partyl

A-68

The Service Provider will carry out Finger Print analysis atbits own cost for every consignment of the waste received from the Generator to confirm the basic parameters in corrlparison to the Corliprehensive analysis. I n case of the discrepancy between Finger Print and Comprehensive analysis, the Service Provider will have the right to carry out a Compreliensive analysis for that consignment; charges of the same shall be borne by the Generator. If the Generator wishes to cross check the results of the analysis, the sample can be sent to a third party lab for analysis mutually agreed by both the parties. However, the cost for the same shall be borne by the Generator. I n case a discrepancy is found between the two analysis, tlie Service Provider will have the right either refuse the waste or revise the charges for the co processing based 011 the characteristics of the waste as per the latest comprehensive analysis, in this case the Generator shall be liable, as per the estimates provided by the ~erGice Provider and agreed to by the Generator to pay the revised charges for co-processing. However, the Generator shall always be liable for any injury to persons or damage to properties arising from any accident or exposure till the time both the parties arrive at some solution for safe disposal through Co-processing. 'The Service Provider shall charge the Generator on the basis of Weight (as per the weight slip of the weight bridge a t the Service Provider's Site) at the rates as per agreed commercial offer annexed as Annexure-B and Annexure - C to this Agreement. I f the Weigh Bridge at Co-processing site is not working, it will be weighed at outside Weigh Bridge approved by both parties l1

The Generator covenants that the charges for the Co- processing of its Hazardous Waste as notified by the Service Provider shall be subject to revision during the validity of this Agreement and as and when the revision is called for on the grounds of escalation of Fuel cost, on other major price escalation namely Power tariff, Change in the disposal/ Co- processing technology/ pre-processing requirements, Hike in wages etc. The Service Provider shall inform the Generator in advance the revised charges for the service and the same will orrly be applicable on a mutual agreement between the Service Provider and Generator. The Generator shall immediately, upon the receipt of the bill from the Service Provider, make the payment on or before the due date i.e. 7 days from the date of receipt of invoice.

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Seal & Signature (First ~ a r t y l (Second Partyl Z

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6.12 It is hereby agreed by and between the parties hereto that delayed payment means any payment not received within the stipulated due date of any invoice raised on the Generator by the Service Provider. The Service Provider reserves its right to discontinue the arrangement under this Agreement on account of non-payment of an.y of its outstanding amounts in due course and the Service Provider shall have a right to refuse to accept any Material sent by the Generator

6.13 I n case of default / dishonor in payment and subsequent settlement of outstanding dues, the Service Provider shall restart the performance of the facilities under this Agreement to the Generator only on receipt of Undisputed outstanding dues/ DEMAND DRAFT of the said amount within 24 hours

7. TOTALFEE.

The Total Waste Fee charged by the Service Provider shall include any amount that the Service Provider is required to pay to any government or agency by virtue of tax, tariff. fee or other charge. whether presently or future. Any such increase will be included as a separate item on invoices su brnitted to the Generator.

8.

8.1 The Service Provider reserves the right: to accept or refuse waste, in the event of the Generator committing any breach/violation of the condition of the present Agreement or any provision of Law/Act/Rules for the time being in force. -the Service Provider reserves its right to suspend/terminate this Agreement for such period with an intimation of the breach to the Generator.

8.2 The suspension / termination shall be revbked only a t the sole ,, discretion of the Service provider after it is satisfied that breach of the terms have been rectified by the Generator.

9. SUPPLY SCHEDULE

9.1 The Generator will deliver Material as specifled in Annexure-A to a storage location designated by the Service Provider at no cost t o the Service Provider. The Generator shall be responsible for all costs and risk related t o the preparation, loading, delivery, handling and transportation of the Conforming Materials as specified in Annexure-A

9.2 The Generator shall pay to the Service Provider the charges calculated according t o the rates listed in Annexure-B. for all hazardous Waste, the Generator shall arrange for delivery of the waste t o the location designated by the Service Provider as per Hazardous and Other Wastes (Management & Transboundary Movement) Rules 2016. It shall undertake this activity under its own risk and responsibility. 48 hours prior notice shall be given by the Generator subject to the Service Provider cif the intention to transport the ~aza rdous Wastes and shall always availability of storage space at the designated location

.'P :, ,5 ! (Fzrst Party)

(3 9, t . . A-70

The Service Provider may provide Dumpers, Trucks or other form of transport duly authorized by 'SPCB' to the Generator for transporting its Hazardous Waste to the co-processing site of the Service Provider at the cost of the Generator. The Generator will provide details of all hazardous waste to the Service Provider by filling Form 8 as may be prescribed as per Hazardous and other Wastes (Management and Trans- boundary Movement) Rules 2016 and amended thereafter. The Generator will provide details of the Hazardous Waste in the manifest Form 10 as may be prescribed as per the Hazardous and other Wastes (Management and Trans- bol-~ndary Movement) Rules 2016 & Guidelines on Co- processing in Cement industry and amended thereafter. The Generator shall not in any case send waste specified in negative list for Co-processing as per the Annexure E attached herewith. 'The Generator will provide the TREM Card i.e. Form 6 - Contents as per the ~azardous and other Wastes (Management and Trans-boundary Movement) Rules 2016 and Guidelines on Co-processing in Cement industry and amended thereafter to be duly filled and handed over to the Transporter. I n case of any false information provided by the Generator, liabilities will lie on them as per the Hazardous and other Wastes (Management and Tran boundary Movement) Rules 2016 and Guidelines on Co-processing in Cement industry and amendments thereafter. I f the ~ e n e r a t & wishes to use transportation facilities of the Service Provider, the Generator will be required to intimate the Service Provider with a t least 48 hours prior notice. Due to the extensive a~ialytical requirements to comply with internal accepta~ice criteria, the Service Provider may require an unloading time of eight hours. The Service Provider assumes no responsibility for transportation demurrage or the time required for resolving analytical or manifest discrepancies and such costs will be the sole responsibility of the Generator OBLIGATION OF THE GENERATORS

The Generator shall provide the Service Provider the different categories of Hazardous Waste that it desires to dispose. These categories of Waste shall be as per the parameters specified in the Schedule of Hazardous and other Wastes (Management and Tran boundary Movement) Rules 2016, as amended from time to time. The Generator shall also give true and correct information related to the 'description, amount, nature and toxicitv of Hazardous Waste Substance.

Seal & Signature (First Party)

Seal & Signature \vJ &/' (Second Par@)

A-71

10.2 The Generator shall take all Primary Treatment arrangement at its premises prior to transportation to the Service Provider of any waste material that may be notified by the Service Provider or SPCB or any other Authority prescribed under the relevant provisions of law in this behalf for the time being in force

10.3 The Generator shall comply with the provisions of Environment (Protection) Act, 1986 and the Rules and all other applicable laws as amended from time to time as also with the condition of the present agreement and that any breach of this Agreement committed by the Generator will allow the Service Provider to terminate this Agreement.

10.4 Packaging, Labeling and Loading:- 10.4.1 Before Hazardous Waste is loaded in the transportation

facilities, the Generator shall ensure that the said waste is packed in a manner suitable for transportation (so that no leakage/Seepage shall occur during the transit and after reaching the Service Provideras Site). The packing cost will be borne by the Generator.

I INSURANCE, TAXES

The Generator and the Service Provider sliall maintain all insurances as per the applicable laws and regulations. Upon req~~est , a party shall provide certificates or other documentary evidence of the above insurance. These policies will remain in effect during the initial term and any renewal terms of this Agreement.

12. INSPECTIONS

The Generator shall allow the Service provider to conduct inspections of any delivery of Material tendered to the Service Provider prior to loading at the Generator site or unloading at the Service Provider's site.

13. TRANSFER OF RIGHTS

The Service Provider may at any time transfer or assign its rights and obligations under this Agreement to any other company or business concern by giving intimation in writing to the Generator. Upon such transfer or assignment, only the transferee or assignee shall be liable for the obligations herein contained.

14. GOVERNING LAW AND DISPUTE RESOLUTION

a. Governing Law: This Agreement shall be governed by and interpreted under the laws of India and both the parties hereby submit to the Jurisdiction of the court in Ahmedabad, Gujarat State subject to the clause no.14.b mentioned below.

% ' Seal & Signature

. . ~jsd.: (First Party) .I

(Second Party)

A-72

b. Dispute Resolution: All disputes in connection with this agreement or the execution thereof shall be settled by friendly negotiation between the parties. Should the parties fail to resolve any controversy or claim within 30 days, arising out of or relating to the interpretation or application of any term or provision set forth herein, or the alleged breach thereof, such controversy or claim shall be resolved by arbitration of law in accordance with the Rules of Conciliation and Arbitration under the Arbitration and Conciliation Act, 1996. Any award rendered pursuant to the terms and conditions set forth herein shall be final and binding. 'The Parties expressly agree to abide by the arbitration award. Any arbitration held pursuant to this Agreement shall be held in Ahmedabad, Gyjarat State, IIVDIA. The language for conducting the arbitration proceedings shall be English.

AMENDMENTS:

Both the parties can a t any point of t ime make suitable changes in the present Agreement after serving a notice to the other party and after mutually agreeing to the amendments. The modification, amendment, or waiver of any provision of this Agreement shall be effective only i f it is in writing and signed in person or by an authorized representative of each Party.

16. TERMINATION OF AGREEMENT

16.1 Either party hereto may terrr~inate this Agreement forthwith in the event of: (1) the other Party committing a breach of any of the terms and

conditions of this Agreement, including non-payment of dues. (2) if a creditor takes possession of or a Receiver is appointed on the

whole or a substantial part of the undertaking or assets of the other party; or

(3) if the other party becomes insolvent or is taken into liquidation or an effective resolution for its winding up is passed by its shareholders;

(4) if either party commits any criminal offence with respect to the business connected with this Agreement and cognizance of the same is taken by any statutory authority.

(5) the other party, for any reason whatsoever, prevented or prohibited by virtue of any law from performing its part of obligations as mentioned herein.

(6) Expiration or termination of this Agreement shall be without prejudice to any right which has accrued to the Parties hereto with respect of any antecedent breach of any provision of this Agreement or any obligation undertaken by any Party hereto before termination.

3 t A . - - 8 I ' Seal & Signature 2' uM'+ - (First Party) 3 q 1 . r

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16.2 Both the Parties hereto agree that the present Agreement shall automatically come to an end if the Authorization for Co- processing given t o the Service Provider by relevant authorities is cancelled/refused or not granted by SPCB. I n such case the Service Provider will inform the Generator immediately and then this Agreement will come to end.

16.3 l lotwithstanding anything contained in this Agreement, either of the parties shall have the right to terminate this Agreement, with or without any reason by serving the other party a prior notice o f 30 days RELATIONSHIP

Nothing contained herein shall be deemed to constitute a partnership, joint venture or agency by and between the Parties hereto. Accordingly the parties herein shall have and maintain exclusive control and direction over all of its employees, agents and contractors and assumes full and exclusive responsibility for payment of all compensation, ,benefits, premiums, contributions, payroll taxes and other taxes now or hereafter imposed by any law or regulation as to its employees, agents and contractors.

'

18. CONFIDENTIALITY The Parties hereto agrees that he/they/it shall not, at any time or in any manner, either directly or indirectly, divulge, disclose or communicate to any third party, any information concerning the business affairs of the other Party without prior written permission of the other Partv.

The OH&S Policy of the Service Provider Company relating tp safety measures and-occupational health to be obsetved by the Generator Company and his/their/its employees / workers / agents / representatives during the subsistence of this Agreement is attached herewith as Annexure-D (OH&S Policy). 'The Generator Company shall regularly provide necessary training on safety to all his/their/its employees/ workers/ agents/ representatives engaged for performing the work covered under this Agreement.

20. Ethical View Reporting Policy and Anti-Briberv & Corruption

Directives (ABCD) of the Company

The Generator Company is aware that the Service provider Company has instituted a ~histleblower policy viz. Ethical View Reporting Policy and an Anti-Bribery & Corruption Directives (ABCD), which is a part of the Code of Conduct initiated by the Company to promote the highest standards of professionalism, honesty, integrity and ethical behavior within its organization. 'The Generator Company declare(s) that he/they/it haslhave not paid or agreed to pay any favour either in cash or kind to any of the officials of the Service Provider Company either directly or indirectly to secure this Contract and further undertake(s) to promptly inform the Service Provider Company if any such demand'is made in future by any officials of the Service Provider Company either directly or&F-1 indirectly.

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The Generator Company is also aware that if it is found indulged in any of fraudulent, unfair or unethical practices, the Generator Company shall be liable for such action at the sole discretion of the Service Provider Company including termination of this Agreement by concurrent notice and the decision of the Service Provider Company in this regard shall be final and binding on the Generator Company. The Generator Compa~iy further undertakes not to directly or indirectly indulge in any corruption with Government officials or otherwise in any manner at any time and in case of such breach, violation, the Generator themselves shall wholly liable for all consequences.

The Generator represents and warrants that any Materials provided to the Service provider will be Conforming Material, unless otherwise agreed to by The Service provider in writing.

22. COMPLIANCE WITH LAWS

The Generator and the Service provider shall comply with all applicable laws, rules, rulings, brders, ordinances, permits and regulations affecting or related to their respective obligations under this Agreement.

23. INDEMNITY

23.1 First Party shall indemnify, defend and hold harmless Second Party and its directors, employees and agents from and against any and all ~claims, demands, fines, losses, damages, costs, penalties, expenses, actions, suits or proceedings, injuries, monetary liability on account of death of any person, costs 6f response to any governmental inquiry, liability for loss of or damage to property or for loss or damage arising from attachments, liens or claims of materials, men or laborers, and reasonable attorney and consulting fees and costs relating to any of the foregoing ("Claims"), arising

r.

from First Party's performance of the Agreement or resulting from First Party's negligence, acts or omissions or from First Party's tender of Waste Material or from First Party 's breach of the terms and conditions of this Agreement. The foregoing indemnification shall not apply to the extent such Claims are the result of Second Party's gross negligence or willful default.

23.2 Second Party shall indemnify, defend and hold harmless First Party and its directors, employees and agents from and against any and all claims, demands, fines, losses, damages, costs, penalties, expenses, actions, suits or proceedings, injuries, monetary liability on account of death of any person, costs of response to any governmental inquiry, liability for loss of or damage to property or for loss or damage arising from attachments, liens or claims of materials, men or laborers, and reasonable attorney and consulting fees and costs relating to any of the foregoing ("Claims"), arising from Second Party's performance of the Agreement or resulting from Second Party's negligence, acts or omissions or from Second Party's breach of the terms and conditions of this A'greement. The foregoing indemnification shall not apply to the extent such Claims are the result of First Party's gross negligence or willful default.

s- , h t i i> 'r t , r uf,? @ Seal & Signature 5' . ,f-)zi (First Party) ! h

' . \. : '. :yt :.: \ . A-75

24. FORCE MAJURE

24.1 Any failure or omission by either Party to perform its obligations shall not be deemed to be a breach of this Agreement, if the same is caused by reasons or circumstances constituting Force Majeure which shall include acts of God, acts of any Government or any agency thereof, law, order, decree or regulation, both present and future, of any Government or any agency thereof, fire, war, riots, civil, commotion, strikes, lockouts, embargoes, disasters or any other cause beyond the control of the party affected.

24.2 The Party claiming Force Majeure shall, as soon as possible, notify the other Party by post, courier, registered letter or fax of the conditions constituting Force Majeure which affect the execution of the Agreement together with expected duration thereof, and send at the earljest by registered mall a detailed report of the Force IYajeure circumstances.

24.3 When the cause of Force Majeure has ceased to exist, the Party affected thereby shall immediately inform the other Party by post, courier or fax about the same and confirm it by registered mail. Further, the performance of obligations of the Party invoking Force Majeure shall, to the extent affected by it, remain suspended during the subsistence of such Force Majeure and the period for the performance thereof shall stand extended by the period(s) of delay on account of it.

24.4 I f the Force-Majeure condition continues for a period of three months, both the parties shall meet and decide the future course of action, including termination of.this Agreement.

25. SEVERABILITY.

I n case any one or more of the provisions contained .in this Agreement shall for any reason be held invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provision hereof, and this Agreement shall be construed as if such invalid, illegal, unenforceable provision had never been contained.

26. INTEGRATION, MODIFICATION.

This Agreement constitutes the entire agreement between the parties and supersedes all other agreements and understandings between the parties. No modification or any claimed waiver of any of the provisions of this Agreement shall be binding

Seal & Signature '

(First Party)

. . . unless in writing- and signed . by all parties.

. Seal & Signature :,,.. ,... - : .,. ;. .. ,:

(Second Parv) >...

A-76

NOTICE

Any notice, demand, request or report to be given or made under this Agreement shall be given or made in the English language in writing by letter or facsirr~ile transceiver and shall be deemed to have been given, in the case of a letter ten [ l o ] days after posting and in the case of a facsimile transceiver, twenty four [24] hours after dispatch, provided always that if the deemed delivery date is not a normal business day at the address of the address then the delivery shall be deemed to take place on the first normal business day then following. The notice, demand, request or report shall be given or made to Mr R 3 Modi, at the address stated at the commencement of this agreement or at such other address as such Party shall have designated by notice in writing to the other Party hereto. Notices to be given he,reunder shall be in writing and except where provided otherwise herein shall be deemed delivered in case of registered mail or personal delivery on receipt and in case of fax 12 hours after confirmed transmission. Any notice communication or invoice to be given under this agreement shall be in writing and deemed to have sufficiently given when delivered in person or by registered post or confirmed facsimile transmission to the address of the respective party set out in this agreement. BINDING EFFECT The agreement shall be binding upon the successor in title, legal representatives and permitted assigns of the parties hereto. NON EXCLUSIVE ENGAGEMENT

The Generator -hereby grants to the Service Provider a non- exclusive right, on the terms and conditions contained herein, to provide the Services. Nothing herein contained shall prevent or prohibit the Generator from engaging other Parties for the provision of the Services once the committed quantities are sent for co-processing to the Service Provider in this Agreement. It is clearly agreed and understood between the parties heretothat the Service Provider shall also on their part be at liberty to be engaged by other Industries who generate waste material for the provision of the Services. The Parties hereby agree t o procure all the required permissions and sanctions to deal with the material and to dispose off the same in accordance with the Laws. The Signatories of the parties here are competent and authorized to agree to the terms and execute this presents. This Agreement may be executed in two counter parts each of which when so executed will be deemed an original and such counter parts together shall constitute one and the same instrument. fl . .

. :

. . . ,

(Second Party) . .. .< ., . .

. . .- > . -<.

,;, h! Lh>'), , , Seal & Signature ..,. i ; d 4 ~ . . , ~ , - . ,\ , -3i, !%,,,," .? !; (First Partyl

A-77

The addressees of the, parties hereto unless changed by written

notification to be given at least 15 days in advance by registered

letter prior to proposed date of change, shall be as follows:

I I Site/Unit Address I

Concord Biotech Ltd

Service Provider

Ambuja Cements Ltd

Second Party

Plot No. 1482-1486,Village- Trasad Rd, Tal-

Dholka, Dist.- Ahmedabad, PIN-382225

Gujarat .

First Party

Post-Ambujanagar, Tal- Kodinar, Dist- Gi

Sonmath- 3627i5, Gujarat

Second Party

Sea2 & Signature .. .. (Second Partyl

A-78

IN WI'TIVESS WHEREOF the parties hereto acting through their properly constituted representatives have set their hands to cause this AGREEMENT signed and executed in their respective names and on their behalf.

SIGNED AND DELIVERED by the

Within named Service Provider,

AMBUJA CEMENTS LIMITED

through its Authorised Signatory )

Mr. S Ramarao- Unit Head 1 in the presence of

SIGNED AND DELIVERED by the . . Within named Generator For, Corrcnrd Biotech Limited

i l 1

Concord Biotech Ltd ) 'F. through its Authorised Signatory . . . ,. ..

Mr R J Modi- Factory Manager

in the presence of 1

Seal & Signature (First Party)

seal & Signature (Second Party)

A-79

Charges (Per Ton'). Spent Carbon

No.

1

I

Co-processing Charges Rs. . Rs. 55001MT + Taxes '

To be borne by Concord Transportation Charges Rs.

HDPE bags or Non PVC 1

PARAMETERS

Moisture O/O

Packaging Mode

Limits

< 20%

3

4

5

material bags-

(preferably jumbo type) ~

CI O/o

S O/o

PH

, " . LG': . % ,.. Seal & Signature

! I I (First Par&)

1.5O/o

1.5OIo

4 - 8

A-80

ACL (Service Provider's) OCCUPATIONAL HEALTH & SAFETY V IS ION

'NO HARM ANYWHERE TO ANYONE ASSOCIATED W I T H ACL"

'NO HARM" means:

IVo fatalities

IVo disabling Injuries

IVo Lost Time Injuries

IVo Medical treatment Injuries

No First Aid Injuries

No Occupational Illness

"ANYONE" means:

Employees, Contractors personnel on site, Ready-mix drivers on

job, Third party contractors on site, Visitors to ACL site

ACL OCCUPATIONAL HEALTH & SAFETY POLICY

We manage our activities in a responsible manner to avoid causing any harm to the health and safety of our employees, contract personnel and visitors. We apply OH&S standards and guidelines; provide the necessary resources, training and education and measure performance for continuous improvement.

ACL OH&S PRINCIPLES

All injuries, occupational illnesses a ~ d diseases are preventable. It is good business to prevent injuries and illness. Working safely is a condition of en-~ployment. Everyone is responsible for health & Safety performance. Line Managers / Supervisors are accountable. All Line Managers / Supervisors must do safety observations and they must ensure all problenis are noted and corrected. All unsafe practices / incidents must be recorded. Unsafe practices must be corrected; incidents must be investigated, root causes found & corrected.

Training is essential to have a healthy and safe working environment. promote off the job safety for employees. . ,

8

r Seal & Signature

(Second Partyl

A-81

FIVE CARDINAL RULES FOR SAFETY

I. I assess and control risks before starting any task.

2. I only perform activities for which I am authorized.

3. I never override or misuse health & safety devices.

4. I do not work under the influence of alcohol or

drugs.

5. I report all incidents. . .

CORPORATE SOCIAL RESPONSIBILITY . .

a. Labor conditions

Without prejudice to the Warranties, Representations and Covenants on the part of Generator in this Agreement, Generator represents and warrants. to Service Provider that Generator comply with the Standard of Social Accountability SA8000. i.e. I. No child labor. 2. No forced labor. 3. Respect local occupational health and safety regulations. 4. Freedom of Association and collective bargaining. 5. No Discrimination 6. No corporal punishment, mental or physical coercion or verbal abuse. 7. Respect legally mandated work hours. 8. Guarantee of a fair compensation to its employees. (This standard is available at: http://www.sa-intl.org) Service Provider makes the same representations'and warranties to ., Generator under these Clauses.

b. Occupational Health & Safety

Generator represents warrants and agrees with the Service Provider that:

1. It is the policy of the Service Provider to secure the health and safety of all personnel (own, and Generator s') as well as the integrity and reliability of all property and equipment. Hence, the Generator also recognizes its responsibility and accountability for the protection of all employees and preservation of the Service Provider's property and equipment.

2. To comply with this policy, the Generator will use properly qualified personnel and incorporate safeguards, rules and procedures which will rr~inin~ize the risk of any personal injury to Service Provider's people and loss of, or damage to, Service Provider's property and equipmgnt during the performance of the service provided.

$1 Seal [,J di Signature \ 0 ii ' (Second Parlyl

$ L _ ; I - '

' r

($3 A-82

3. Generator's persohnel must comply with Service Provider3 established OH&S rules, practices and procedures, use OH&S equipment, Personal Protective equipment (PPE), tools and any devices that are required / provided, and conduct themselves in a way which assures the health and safety of themselves, their fellow employees and/or any other persons.

4. Generator's personnel are responsible for providing and maintaining a safe and healthy workplace where all hazards, unsafe acts and/or conditions are identified and analysed before being controlled o r eliminated. Generator must document this in a (mandatory) health and safety program.

5. When working, all Generator's personnel will conduct themselves in accordance with Service Provider's OH&S standards, including having a proper OH&S plan for the work, work instructions, training and testing as needed, inspection and audit programs as well as recording and reporting of all accidents, unsafe actions and/or conditions.

6. Generator represents and warrants to Service Provider, that they have accident/workers compensation insurance.

7. Service Provider is entitled to inspect and audit the corrrpliance of Generator with Clauses 1 to 6.

8. Non-compliance with Clauses 1 - 6 is a serious offence and may result in immediate termination of the contract with ACL. Any direct o r consequential damage resulting out of non-compliance is in the full liability of the Generator.

Annexure-E

The wastes listed below are not recommended f& Co-processing

till otherwise provided for:

a) Radioactive waste b) Asbestos-containing waste c) Explosives and ammunition / weapons d) Anatomical medical waste e) Electronic fraction of electrical and electronic waste (e-waste) f) Whole batteries as a targeted material stream g) Waste of unknown or unpredictable composition, including unsorted m~~nicipal waste

Seal & Signature (First Partyl

f.. Seal & Signature

(Second Par@)

A-83

Annexure-III

Membership certificate for disposal of hazardous waste

at TSDF & CHWIF

Snunlshrnn Envino Pnojtcrs Pvr. Lrd.Integrated Common Hazardous Waste Management Facility

Site : R S No. 415 417 & 418, Village : Juna Kataliya. B/h. Gail Pump Sialion,

Samakhiya iRandhanpo Highway. Teluk€ : Bh8chau, Disl - Kuhh.

Ph.r+91.261-2351248 2346181,6452205 Fax:+91-26t2354068 E.mai r [email protected] Websiie : vvvl]\'.seppllndia.com

DT - 11,04'2014

TO WIIOMSOEVER CONCENRED

CERTIFICATE

This is to certify that M/s Concord Biotech Ltd situated at 1482'1486' T€sad Road Dholka'' Disl

Ahmedabad is valid member of our Integrated Common Hazardous Waste Management Facility

(ICHWMF) though membership No CSC032.

Details of$aste type along with quantity proposed by the member unit are as follows:-

SrNo.

1

Ilazardous waste

ETP Sludge

Distillation Residue

Spent Catalyst

Cat. No.

34.3

20.3

28.2

9!s4!!

100 MVMonth

15 Kl^r'ear

7 Mvlronth

N4/s Saurashtra Enviro Projects P!'t.Ltd Sho\ts its readiness to accept thg above waste proposed by

th" .".b"r unit after successful completion of all rnembership fomalities and undefaking

comprehensit e analysis of the *ast" confitmittg disposal pathway for safe disposal of Hazardous

waste.

For Saurashtra Enviro Projects Pvt. Ltd.

vY,,/

Amit Renose(Sr. Mgr - Business Developmeut)

Resd.off.€ |3rd Floor, K.G. chamb€6, Udhna Da /aja, Rlnt Road, Sunt - 395 002.

A-84

A-85

Annexure-IV

Material Safety Data Sheet of Hazardous chemicals

SIGMA-ALDRICH MATERIAL SAFETY DATA SHEET Date Printed: 10/01/2009 Date Updated: 01/31/2006 Version 1.4 Section 1 - Product and Company Information Product Name ACETONE-1,3-13C2, 99 ATOM % 13C Product Number 299189 Brand ALDRICH Company Sigma-Aldrich Address 3050 Spruce Street SAINT LOUIS MO 63103 US Technical Phone: 800-325-5832 Fax: 800-325-5052 Emergency Phone: 314-776-6555 Section 2 - Composition/Information on Ingredient Substance Name CAS # SARA 313 ACETONE-1,3-13C2, 98 ATOM % 13C 7217-25-6 No Formula C3H6O Section 3 - Hazards Identification EMERGENCY OVERVIEW Flammable (USA) Highly Flammable (EU). Irritant. Irritating to respiratory system and skin. Risk of serious damage to eyes. Target organ(s): Liver. Kidneys. HMIS RATING HEALTH: 1 FLAMMABILITY: 4 REACTIVITY: 1 NFPA RATING HEALTH: 1 FLAMMABILITY: 4 REACTIVITY: 1 For additional information on toxicity, please refer to Section 11. Section 4 - First Aid Measures ORAL EXPOSURE If swallowed, wash out mouth with water provided person is conscious. Call a physician. INHALATION EXPOSURE If inhaled, remove to fresh air. If not breathing give artificial respiration. If breathing is difficult, give oxygen. DERMAL EXPOSURE In case of contact, immediately wash skin with soap and copious amounts of water.

A-86

EYE EXPOSURE In case of contact, immediately flush eyes with copious amounts of water for at least 15 minutes. Section 5 - Fire Fighting Measures FLAMMABLE HAZARDS Flammable Hazards: Yes EXPLOSION HAZARDS Vapor may travel considerable distance to source of ignition and flash back. Container explosion may occur under fire conditions. FLASH POINT 1 °F - 17.0 °C Method: closed cup EXPLOSION LIMITS Lower: 2.15 % Upper: 13.2 % AUTOIGNITION TEMP N/A FLAMMABILITY N/A EXTINGUISHING MEDIA Suitable: For small (incipient) fires, use media such as "alcohol" foam, dry chemical, or carbon dioxide. For large fires, apply water from as far as possible. Use very large quantities (flooding) of water applied as a mist or spray; solid streams of water may be ineffective. Cool all affected containers with flooding quantities of water. FIREFIGHTING Protective Equipment: Wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes. Specific Hazard(s): Extremely flammable. Vapor may travel considerable distance to source of ignition and flash back. Emits toxic fumes under fire conditions. Section 6 - Accidental Release Measures PROCEDURE TO BE FOLLOWED IN CASE OF LEAK OR SPILL Evacuate area. Shut off all sources of ignition. PROCEDURE(S) OF PERSONAL PRECAUTION(S) Wear respirator, chemical safety goggles, rubber boots, and heavy rubber gloves. METHODS FOR CLEANING UP Cover with dry-lime, sand, or soda ash. Place in covered containers using non-sparking tools and transport outdoors. Ventilate area and wash spill site after material pickup is complete. Section 7 - Handling and Storage HANDLING User Exposure: Avoid breathing vapor. Avoid contact with eyes, skin, and clothing. Avoid prolonged or repeated exposure. ALDRICH - 299189 www.sigma-aldrich.com Page 2

A-87

STORAGE Suitable: Keep container closed. Keep away from heat, sparks, and open flame. Section 8 - Exposure Controls / PPE ENGINEERING CONTROLS Safety shower and eye bath. Use nonsparking tools. Mechanical exhaust required. PERSONAL PROTECTIVE EQUIPMENT Respiratory: Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU). Where risk assessment shows air-purifying respirators are appropriate use a full-face respirator with multi-purpose combination (US) or type AXBEK (EN 14387) respirator cartridges as a backup to engineering controls. If the respirator is the sole means of protection, use a full-face supplied air respirator. Hand: Compatible chemical-resistant gloves. Eye: Chemical safety goggles. GENERAL HYGIENE MEASURES Wash thoroughly after handling. Wash contaminated clothing before reuse. SPECIAL PRECAUTIONS The material may slowly penetrate protective gloves; therefore in case of spills, discard gloves after use. Section 9 - Physical/Chemical Properties Appearance Physical State: Liquid Property Value At Temperature or Pressure Molecular Weight 60.06 AMU pH N/A BP/BP Range 56.5 °C 760 mmHg MP/MP Range - 94.0 °C Freezing Point N/A Vapor Pressure 184 mmHg 20 °C Vapor Density 2 g/l Saturated Vapor Conc. N/A SG/Density 0.818 g/cm3 Bulk Density N/A Odor Threshold N/A Volatile% N/A VOC Content N/A Water Content N/A Solvent Content N/A Evaporation Rate N/A Viscosity N/A Surface Tension N/A Partition Coefficient N/A Decomposition Temp. N/A Flash Point 1 °F - 17.0 °C Method: closed cup Explosion Limits Lower: 2.15 % Upper: 13.2 % Flammability N/A Autoignition Temp N/A Refractive Index 1.359 Optical Rotation N/A ALDRICH - 299189 www.sigma-aldrich.com Page 3

A-88

Miscellaneous Data N/A Solubility N/A N/A = not available Section 10 - Stability and Reactivity STABILITY Conditions of Instability: Moisture. Conditions to Avoid: Moisture. Materials to Avoid: Bases, Oxidizing agents, Reducing agents. HAZARDOUS DECOMPOSITION PRODUCTS Hazardous Decomposition Products: Carbon monoxide, Carbon dioxide. HAZARDOUS POLYMERIZATION Hazardous Polymerization: Will not occur Section 11 - Toxicological Information ROUTE OF EXPOSURE Skin Contact: Causes skin irritation. Skin Absorption: May be harmful if absorbed through the skin. Eye Contact: Causes severe eye irritation. Inhalation: Material is irritating to mucous membranes and upper respiratory tract. May be harmful if inhaled. Ingestion: May be harmful if swallowed. SENSITIZATION Sensitization: Causes dermatitis. TARGET ORGAN(S) OR SYSTEM(S) Liver. Kidneys. SIGNS AND SYMPTOMS OF EXPOSURE To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated. Section 12 - Ecological Information No data available. Section 13 - Disposal Considerations APPROPRIATE METHOD OF DISPOSAL OF SUBSTANCE OR PREPARATION Contact a licensed professional waste disposal service to dispose of this material. Burn in a chemical incinerator equipped with an afterburner and scrubber but exert extra care in igniting as this material is highly flammable. Observe all federal, state, and local environmental regulations. Section 14 - Transport Information DOT Proper Shipping Name: Acetone UN#: 1090 Class: 3 Packing Group: Packing Group II Hazard Label: Flammable liquid PIH: Not PIH IATA ALDRICH - 299189 www.sigma-aldrich.com Page 4

A-89

Proper Shipping Name: Acetone IATA UN Number: 1090 Hazard Class: 3 Packing Group: II Section 15 - Regulatory Information EU ADDITIONAL CLASSIFICATION Symbol of Danger: F Indication of Danger: Highly Flammable. R: 11 Risk Statements: Highly flammable. S: 9-16-23-33 Safety Statements: Keep container in a well-ventilated place. Keep away from sources of ignition - no smoking. Do not breathe vapor. Take precautionary measures against static discharges. US CLASSIFICATION AND LABEL TEXT Indication of Danger: Flammable (USA) Highly Flammable (EU). Irritant. Risk Statements: Irritating to respiratory system and skin. Risk of serious damage to eyes. Safety Statements: Keep container tightly closed in a cool place. Keep away from sources of ignition - no smoking. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. Wear suitable protective clothing. US Statements: Target organ(s): Liver. Kidneys. UNITED STATES REGULATORY INFORMATION SARA LISTED: No CANADA REGULATORY INFORMATION WHMIS Classification: This product has been classified in accordance with the hazard criteria of the CPR, and the MSDS contains all the information required by the CPR. DSL: No NDSL: No Section 16 - Other Information DISCLAIMER For R&D use only. Not for drug, household or other uses. WARRANTY The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. The information in this document is based on the present state of our knowledge and is applicable to the product with regard to appropriate safety precautions. It does not represent any guarantee of the properties of the product. Sigma-Aldrich Inc., shall not be held liable for any damage resulting from handling or from contact with the above product. See reverse side of invoice or packing slip for additional terms and conditions of sale. Copyright 2009 Sigma-Aldrich Co. License granted to make unlimited paper copies for internal use only. ALDRICH - 299189 www.sigma-aldrich.com Page 5

A-90

REVISION DATE: 04/04/2005

ACETONITRILE MSDS

ACETONITRILE

1 IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND COMPANY/UNDERTAKING

PRODUCT NAME ACETONITRILE

PRODUCT NO. A007

Abbey ChemicalsSUPPLIER

27-30 North River Road

Great Yarmouth, Norfolk, NR30 1SH

Tel: +44 1493 850303

Fax: +44 1493 330909

www.abbey-chemicals.co.uk

EMERGENCY TELEPHONE +44 (0) 1493 850303

2 COMPOSITION/INFORMATION ON INGREDIENTS

EU INDEX NO. 608-001-00-3

EC (EINECS) NO. 200-835-2

CAS-NO. 75-05-8

3 HAZARDS IDENTIFICATION

Highly flammable. Harmful by inhalation, in contact with skin and if swallowed. Irritating to eyes.

CLASSIFICATION Xn;R20/21/22. Xi;R36. F;R11.

4 FIRST-AID MEASURES

GENERAL INFORMATION

In case of accident or if you feel unwell, seek medical advice immediately (show label where possible).

INHALATION

Move the exposed person to fresh air at once. Keep the affected person warm and at rest. Get prompt medical attention.

INGESTION

Immediately rinse mouth and provide fresh air. Drink plenty of water. Do not induce vomiting. NEVER MAKE AN UNCONSCIOUS PERSON

VOMIT OR DRINK FLUIDS! Get medical attention if any discomfort continues.

SKIN CONTACT

Remove affected person from source of contamination. Promptly wash contaminated skin with soap or mild detergent and water. Promptly remove

clothing if soaked through and wash as above. Contact physician if irritation persists.

EYE CONTACT

Remove victim immediately from source of exposure. Promptly wash eyes with plenty of water while lifting the eye lids. Continue to rinse for at least

15 minutes. Get medical attention promptly if symptoms occur after washing.

5 FIRE-FIGHTING MEASURES

EXTINGUISHING MEDIA

Fire can be extinguished using: Do not use water as an extinguisher. Water spray, fog or mist. Foam, carbon dioxide or dry powder.

SPECIAL FIRE FIGHTING PROCEDURES

Standard procedure for chemical fires Cool containers exposed to flames with water until well after the fire is out.

SPECIFIC HAZARDS

In case of fire, toxic gases may be formed.

PROTECTIVE MEASURES IN FIRE

Self contained breathing apparatus and full protective clothing must be worn in case of fire.

6 ACCIDENTAL RELEASE MEASURES

41 /

A-91

REVISION DATE: 04/04/2005

ACETONITRILE

PERSONAL PRECAUTIONS

Warn everybody of potential hazards and evacuate if necessary. Extinguish all ignition sources. Avoid sparks, flames, heat and smoking.

Ventilate. In case of inadequate ventilation, use respiratory protection. Wear protective clothing as described in Section 8 of this safety data sheet.

ENVIRONMENTAL PRECAUTIONS

Collect and dispose of spillage as indicated in section 13. Do not discharge into drains, water courses or onto the ground. Spillages or

uncontrolled discharges into watercourses must be IMMEDIATELY alerted to the Environmental Agency or other appropriate regulatory body.

SPILL CLEAN UP METHODS

Absorb with sand or other inert absorbent. Collect in containers and seal securely. Remove containers and flush area with water. Ensure that

waste and contaminated materials are collected and removed from the work area as soon as possible in a suitably labelled container

7 HANDLING AND STORAGE

USAGE PRECAUTIONS

Keep away from sources of ignition - No smoking. Take precautionary measures against static discharges. Avoid contact with skin and eyes. Wear

full protective clothing for prolonged exposure and/or high concentrations. Provide adequate ventilation, including appropriate local extraction,

to ensure that the defined occupational exposure limit is not exceeded. If ventilation is insufficient, suitable respiratory protection must be

provided. Good personal hygiene is necessary. Wash hands and contaminated areas with water and soap before leaving the work site.

STORAGE PRECAUTIONS

Keep away from food, drink and animal feeding stuffs. Keep away from sources of ignition - No smoking. Store in tightly closed original

container in a cool, dry well-ventilated place. Do not store near heat sources or expose to high temperatures. Protect from freezing and direct

sunlight.

8 EXPOSURE CONTROLS/PERSONAL PROTECTION

Std ST - ppmLT - ppm LT - mg/m3 ST - mg/m3Name

40 ppm 68 mg/m3OES 60 ppm 102 mg/m3ACETONITRILE

40 ppm 68 mg/m3OES 60 ppm 102 mg/m3ACETONITRILE

PROTECTIVE EQUIPMENT

ENGINEERING MEASURES

No specific ventilation requirements noted, except this product must not be used in a confined space without good ventilation.

RESPIRATORY EQUIPMENT

If ventilation is insufficient, suitable respiratory protection must be provided.

HAND PROTECTION

Chemical resistant gloves required for prolonged or repeated contact.

EYE PROTECTION

If risk of splashing, wear safety goggles or face shield.

OTHER PROTECTION

Chemical resistant apron, lightweight protective clothing or suit & heavy duty work shoes.

HYGIENE MEASURES

When using do not eat, drink or smoke. Wash promptly if skin becomes wet or contaminated. Wash at the end of each work shift and before

eating, smoking and using the toilet.

9 PHYSICAL AND CHEMICAL PROPERTIES

APPEARANCE Liquid

COLOUR Colourless

ODOUR Pungent

BOILING POINT (°C) 81.6 @ 760 mm Hg MELTING POINT (°C) -45.7

RELATIVE DENSITY 0.782 20 FLASH POINT (°C) 2

AUTO IGNITION TEMPERATURE

(°C)

524 FLAMMABILITY LIMIT - LOWER(%) 4.4

FLAMMABILITY LIMIT - UPPER(%) 16

42 /

A-92

REVISION DATE: 04/04/2005

ACETONITRILE

10 STABILITY AND REACTIVITY

STABILITY

Stable under normal temperature conditions and recommended use.

MATERIALS TO AVOID

Oxidising materials. Strong acids. Strong bases.

HAZARDOUS DECOMPOSITION PRODUCTS

Fire or high temperatures create: Vapours/gases/fumes of: Carbon monoxide (CO). Carbon dioxide (CO2). Sulphurous gases (SOx). Nitrous

gases (NOx).

11 TOXICOLOGICAL INFORMATION

INHALATION

Harmful by inhalation.

EYE CONTACT

Irritating to eyes.

12 ECOLOGICAL INFORMATION

13 DISPOSAL CONSIDERATIONS

GENERAL INFORMATION

Do not reuse empty containers. Dispose of contaminated packaging in accordance with local Environmental Protection Agency requirements.

DISPOSAL METHODS

Dispose of waste and residues in accordance with local authority requirements. Incinerate with provision for removal of effluent gases by scrubber.

14 TRANSPORT INFORMATION

UK ROAD CLASS 3

PROPER SHIPPING NAME ACETONITRILE

1648UN NO. ROAD UK ROAD PACK GR.

3ADR CLASS NO. Class 3: Flammable liquids.ADR CLASS

IIADR PACK GROUP 3ADR LABEL NO.

2YEHAZCHEM CODE 30GF1-I+IICEFIC TEC(R) NO.

3RID CLASS NO. RID PACK GROUP

1648UN NO. SEA 3IMDG CLASS

IIIMDG PACK GR. F-E, S-DEMS

See GuideMFAG No.MARINE POLLUTANT

1648UN NO. AIR 3ICAO CLASS

IIAIR PACK GR.

15 REGULATORY INFORMATION

LABELLING

Highly Flammable Harmful

RISK PHRASES

R11 Highly flammable.

R20/21/22 Harmful by inhalation, in contact with skin and if swallowed. 4

3 /

II

II

A-93

REVISION DATE: 04/04/2005

ACETONITRILE

R36 Irritating to eyes.

SAFETY PHRASES

S1/2 Keep locked up and out of the reach of children.

S16 Keep away from sources of ignition - No smoking.

S36/37 Wear suitable protective clothing and gloves.

STATUTORY INSTRUMENTS

Chemicals (Hazard Information and Packaging) Regulations.

16 OTHER INFORMATION

REVISION DATE 04/04/2005

REV. NO./REPL. SDS GENERATED 5

DATE 28/03/2002

DISCLAIMER

This information relates only to the specific material designated and may not be valid for such material used in combination with any

other materials or in any process. Such information is, to the best of the company's knowledge and belief, accurate and reliable as of

the date indicated. However, no warranty guarantee or representation is made to its accuracy, reliability or completeness. It is the

user's responsibility to satisfy himself as to the suitability of such information for his own particular use.

44 /

A-94

p. 1

0 2 0

He a lt h

Fire

Re a c t iv it y

Pe rs o n a lPro t e c t io n

3

0

0

Material Safety Data SheetAmmonium hydroxide MSDS

Section 1: Chemical Product and Company Identification

Product Name: Ammonium hydroxide

Catalog Codes: SLA3667, SLA3490, SLA1144

CAS#: 1336-21-6

RTECS: BQ9625000

TSCA: TSCA 8(b) inventory: Ammonium hydroxide

CI#: Not applicable.

Synonym: Aqueous Ammonia; Strong Ammonia Solution;Stronger Ammonia Water

Chemical Name: Not applicable.

Chemical Formula: Not applicable.

Contact Information:

Sciencelab.com, Inc.14025 Smith Rd.Houston, Texas 77396

US Sales: 1-800-901-7247International Sales: 1-281-441-4400

Order Online: ScienceLab.com

CHEMTREC (24HR Emergency Telephone), call:1-800-424-9300

International CHEMTREC, call: 1-703-527-3887

For non-emergency assistance, call: 1-281-441-4400

Section 2: Composition and Information on Ingredients

Composition:

Name CAS # % by Weight

Ammonia, anhydrous 7664-41-7 27-31

Water 7732-18-5 69-73

Toxicological Data on Ingredients: Ammonia, anhydrous: GAS (LC50): Acute: 2000 ppm 4 hours [Rat]. 4230 ppm 1 hours[Mouse].

Section 3: Hazards Identification

Potential Acute Health Effects:Very hazardous in case of skin contact (corrosive, irritant, permeator), of eye contact (irritant), of ingestion, . Non-corrosiveto the eyes. Non-corrosive for lungs. Liquid or spray mist may produce tissue damage particularly on mucous membranes ofeyes, mouth and respiratory tract. Skin contact may produce burns. Inhalation of the spray mist may produce severe irritationof respiratory tract, characterized by coughing, choking, or shortness of breath. Severe over-exposure can result in death.Inflammation of the eye is characterized by redness, watering, and itching. Skin inflammation is characterized by itching,scaling, reddening, or, occasionally, blistering.

Potential Chronic Health Effects:CARCINOGENIC EFFECTS: Not available. MUTAGENIC EFFECTS: Mutagenic for bacteria and/or yeast. [Ammonia,anhydrous]. TERATOGENIC EFFECTS: Not available. DEVELOPMENTAL TOXICITY: Not available. The substance is toxic

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to upper respiratory tract, skin, eyes. Repeated or prolonged exposure to the substance can produce target organs damage.Repeated or prolonged contact with spray mist may produce chronic eye irritation and severe skin irritation. Repeated orprolonged exposure to spray mist may produce respiratory tract irritation leading to frequent attacks of bronchial infection.Repeated exposure to a highly toxic material may produce general deterioration of health by an accumulation in one or manyhuman organs.

Section 4: First Aid Measures

Eye Contact:Check for and remove any contact lenses. Immediately flush eyes with running water for at least 15 minutes, keeping eyelidsopen. Cold water may be used. Get medical attention immediately. Finish by rinsing thoroughly with running water to avoid apossible infection.

Skin Contact:In case of contact, immediately flush skin with plenty of water for at least 15 minutes while removing contaminated clothingand shoes. Cover the irritated skin with an emollient. Cold water may be used.Wash clothing before reuse. Thoroughly cleanshoes before reuse. Get medical attention immediately.

Serious Skin Contact:Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek immediate medicalattention.

Inhalation:If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medicalattention immediately.

Serious Inhalation:Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. Ifbreathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. WARNING: It maybe hazardous to the person providing aid to give mouth-to-mouth resuscitation when the inhaled material is toxic, infectious orcorrosive. Seek medical attention.

Ingestion:If swallowed, do not induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to anunconscious person. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention immediately.

Serious Ingestion: Not available.

Section 5: Fire and Explosion Data

Flammability of the Product: Non-flammable.

Auto-Ignition Temperature: Not applicable.

Flash Points: Not applicable.

Flammable Limits: Not applicable.

Products of Combustion: Hazardous decomposition include Nitric oxide, and ammonia fumes

Fire Hazards in Presence of Various Substances: Not applicable.

Explosion Hazards in Presence of Various Substances: Non-explosive in presence of open flames and sparks, of shocks.

Fire Fighting Media and Instructions: Not applicable.

Special Remarks on Fire Hazards: Not available.

Special Remarks on Explosion Hazards:Forms explosive compounds with many heavy metals such as silver, lead, zinc and their halide salts. It can form shocksensitive compounds with halogens, mercury oxide, and siliver oxide.

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Section 6: Accidental Release Measures

Small Spill:Dilute with water and mop up, or absorb with an inert dry material and place in an appropriate waste disposal container. Ifnecessary: Neutralize the residue with a dilute solution of acetic acid.

Large Spill:Corrosive liquid. Poisonous liquid. Stop leak if without risk. Absorb with DRY earth, sand or other non-combustible material.Do not get water inside container. Do not touch spilled material. Use water spray curtain to divert vapor drift. Use water sprayto reduce vapors. Prevent entry into sewers, basements or confined areas; dike if needed. Call for assistance on disposal.Neutralize the residue with a dilute solution of acetic acid. Be careful that the product is not present at a concentration levelabove TLV. Check TLV on the MSDS and with local authorities.

Section 7: Handling and Storage

Precautions:Keep locked up.. Keep container dry. Do not ingest. Do not breathe gas/fumes/ vapor/spray. Never add water to this product.In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and showthe container or the label. Avoid contact with skin and eyes. Keep away from incompatibles such as metals, acids.

Storage: Keep container tightly closed. Keep container in a cool, well-ventilated area. Do not store above 25°C (77°F).

Section 8: Exposure Controls/Personal Protection

Engineering Controls:Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their respectivethreshold limit value. Ensure that eyewash stations and safety showers are proximal to the work-station location.

Personal Protection:Face shield. Full suit. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Gloves. Boots.

Personal Protection in Case of a Large Spill:Splash goggles. Full suit. Vapor respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoidinhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling thisproduct.

Exposure Limits:TWA: 25 (ppm) from ACGIH (TLV) [United States] TWA: 50 STEL: 35 (ppm) from OSHA (PEL) [United States] TWA: 25 STEL:35 from NIOSH Consult local authorities for acceptable exposure limits.

Section 9: Physical and Chemical Properties

Physical state and appearance: Liquid.

Odor: Ammonia-like (Strong.)

Taste: Acrid.

Molecular Weight: 35.05

Color: Colorless.

pH (1% soln/water): 11.6 [Basic.] This is the actual pH in a 1 N solution.

Boiling Point: Not available

Melting Point: -69.2°C (-92.6°F)

Critical Temperature: Not available.

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Specific Gravity: 0.898 (Water = 1)

Vapor Pressure: 287.9 kPa (@ 20°C)

Vapor Density: Not available

Volatility: Not available.

Odor Threshold: 5 - 50 ppm as ammonia

Water/Oil Dist. Coeff.: Not available.

Ionicity (in Water): Not available.

Dispersion Properties: See solubility in water

Solubility: Easily soluble in cold water.

Section 10: Stability and Reactivity Data

Stability: The product is stable.

Instability Temperature: Not available.

Conditions of Instability: Incompatible materials, high temperatures

Incompatibility with various substances:Highly reactive with metals. Reactive with acids. Slightly reactive to reactive with oxidizing agents.

Corrosivity:Extremely corrosive in presence of zinc, of copper. Corrosive in presence of aluminum. Non-corrosive in presence of glass, ofstainless steel(304), of stainless steel(316).

Special Remarks on Reactivity:Incompatible with the following: Organic acids, amides, organic anhydrides, isocyanates, vinyl acetate, epichlorhydrin,aldehydes, Acrolein, Acrylic acid, chlorosulfonic acid, dimethyl sulfate, fluorine, gold + aqua regia, hydrochloric acid,hydrofluoric acid, hydrogen peroxide, iodine, nitric acid, olelum, propiolactone, propylene oxide, silver nitrate, silver oxide,silver oxide + ethyl alcohol, nitromethane, silver permanganate, sulfuric acid, halogens. Forms explosive compounds withmany heavy metals (silver, lead, zinc) and halide salts.

Special Remarks on Corrosivity:Dissolves copper and zinc. Corrosive to aluminum and its alloys. Corrosive to galvanized surfaces. Severe corrosive effect onbrass and bronze

Polymerization: Will not occur.

Section 11: Toxicological Information

Routes of Entry: Absorbed through skin. Dermal contact. Eye contact. Inhalation. Ingestion.

Toxicity to Animals: Acute oral toxicity (LD50): 350 mg/kg [Rat].

Chronic Effects on Humans:MUTAGENIC EFFECTS: Mutagenic for bacteria and/or yeast. [Ammonium hydroxide]. May cause damage to the followingorgans: mucous membranes, skin, eyes.

Other Toxic Effects on Humans:Very hazardous in case of skin contact (corrosive, irritant, permeator), of ingestion, . Hazardous in case of eye contact(corrosive), of inhalation (lung corrosive).

Special Remarks on Toxicity to Animals: Highly toxic to aquatic organisms

Special Remarks on Chronic Effects on Humans:May affect genetic material based on tests with microorganisms and animals. May cause cancer (tumorigenic) based onanimal data. No human data found at this time. (Ammonia, anhydrous)

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Special Remarks on other Toxic Effects on Humans:Acute Potential Health Effects: Skin: Causes severe irritation. Causes skin burns. May cause deep, penetrating ulcers of theskin. Contact with skin may cause staining, inflammation, and thickening of the skin. Eye: Contact with liquid or vapor causessevere burns and possible irreversible eye damage including corneal injury and cataracts. Inhalation: Causes severe irritationof the upper respiratory tract with coughing, burns, breathing difficulty. May cause acute pulmonary edema, pneumoconiosis,fibrosis, and even coma. It is a respiratory stimulant when inhaled at lower concentrations. It may also affect behavior/central nervous system (convulsions, seizures, ataxia, tremor), cardiovascular system (increase in blood pressure and pulserate). Ingestion: Harmful if swallowed. Affects the Gastrointestinal tract (burns, swelling of the lips, mouth, and larynx, throatconstriction, nausea, vomiting, convulsions, shock, and may cause severe and permanent damage), liver, and urinary system(kidneys) May affect behavior (convulsions, seizures, ataxia, excitement). Chronic Potential Health Effects: Ingestion: Maycause effects similar to those of acute ingestion. Inhalation: Repeated exposure to low concentrations may cause bronchitiswith cough, phlegm, and/or shortness of breath. May also cause liver and kidney damage, and affect the brain, and blood.Eye: May cause corneal damage and the development of cataracts and glaucoma. Skin: Repeated skin contact to lowconcentrations may cause dryness, itching, and redness (dermatitis)

Section 12: Ecological Information

Ecotoxicity:Ecotoxicity in water (LC50): 0.1 ppm 24 hours [Rainbow trout]. 8.2mg/l 96 hours [Fathead minnow]. 0.1 ppm 48 hours[Bluegill].

BOD5 and COD: Not available.

Products of Biodegradation:Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise.

Toxicity of the Products of Biodegradation: The products of degradation are less toxic than the product itself.

Special Remarks on the Products of Biodegradation: Not available.

Section 13: Disposal Considerations

Waste Disposal:Waste must be disposed of in accordance with federal, state and local environmental control regulations.

Section 14: Transport Information

DOT Classification: Class 8: Corrosive material

Identification: : Ammonia Solution UNNA: 2672 PG: III

Special Provisions for Transport: Not available.

Section 15: Other Regulatory Information

Federal and State Regulations:Connecticut hazardous material survey.: Ammonium hydroxide Illinois toxic substances disclosure to employee act:Ammonium hydroxide Illinois chemical safety act: Ammonium hydroxide New York release reporting list: Ammoniumhydroxide Pennsylvania RTK: Ammonium hydroxide Massachusetts RTK: Ammonium hydroxide Massachusetts spill list:Ammonium hydroxide New Jersey: Ammonium hydroxide New Jersey spill list: Ammonium hydroxide New Jersey toxiccatastrophe prevention act: Ammonium hydroxide Louisiana spill reporting: Ammonium hydroxide California Director's List ofHazardous Substances (8 CCR 339): Ammonium hydroxide TSCA 8(b) inventory: Ammonium hydroxide CERCLA: Hazardoussubstances.: Ammonium hydroxide: 1000 lbs. (453.6 kg)

Other Regulations:

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OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200). EINECS: This product is on theEuropean Inventory of Existing Commercial Chemical Substances.

Other Classifications:

WHMIS (Canada):CLASS D-1B: Material causing immediate and serious toxic effects (TOXIC). CLASS E: Corrosive liquid.

DSCL (EEC):

HMIS (U.S.A.):

Health Hazard: 3

Fire Hazard: 0

Reactivity: 0

Personal Protection:

National Fire Protection Association (U.S.A.):

Health: 2

Flammability: 0

Reactivity: 0

Specific hazard:

Protective Equipment:Gloves. Full suit. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Wear appropriate respiratorwhen ventilation is inadequate. Face shield.

Section 16: Other Information

References: Not available.

Other Special Considerations: Not available.

Created: 10/09/2005 03:55 PM

Last Updated: 05/21/2013 12:00 PM

The information above is believed to be accurate and represents the best information currently available to us. However, wemake no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assumeno liability resulting from its use. Users should make their own investigations to determine the suitability of the information fortheir particular purposes. In no event shall ScienceLab.com be liable for any claims, losses, or damages of any third party or forlost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if ScienceLab.comhas been advised of the possibility of such damages.

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Material Safety Data SheetCyclohexane MSDS

Section 1: Chemical Product and Company Identification

Product Name: Cyclohexane

Catalog Codes: SLC3520, SLC2305

CAS#: 110-82-7

RTECS: GU6300000

TSCA: TSCA 8(b) inventory: Cyclohexane

CI#: Not applicable.

Synonym: Benzene, hexahydro-; Hexahydrobenzene;Hexamethylene; Hexanaphthene

Chemical Name: Cyclohexane

Chemical Formula: C6-H12

Contact Information:

Sciencelab.com, Inc.14025 Smith Rd.Houston, Texas 77396

US Sales: 1-800-901-7247International Sales: 1-281-441-4400

Order Online: ScienceLab.com

CHEMTREC (24HR Emergency Telephone), call:1-800-424-9300

International CHEMTREC, call: 1-703-527-3887

For non-emergency assistance, call: 1-281-441-4400

Section 2: Composition and Information on Ingredients

Composition:

Name CAS # % by Weight

Cyclohexane 110-82-7 100

Toxicological Data on Ingredients: Cyclohexane: ORAL (LD50): Acute: 12705 mg/kg [Rat]. 813 mg/kg [Mouse]. DERMAL(LD): Acute: &gt;18000 mg/kg [Rabbit].

Section 3: Hazards Identification

Potential Acute Health Effects: Slightly hazardous in case of skin contact (irritant, permeator), of eye contact (irritant), ofingestion, of inhalation.

Potential Chronic Health Effects:CARCINOGENIC EFFECTS: Not available. MUTAGENIC EFFECTS: Not available. TERATOGENIC EFFECTS: Not available.DEVELOPMENTAL TOXICITY: Not available. The substance may be toxic to kidneys, liver, cardiovascular system, centralnervous system (CNS). Repeated or prolonged exposure to the substance can produce target organs damage.

Section 4: First Aid Measures

Eye Contact:

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Check for and remove any contact lenses. Immediately flush eyes with running water for at least 15 minutes, keeping eyelidsopen. Get medical attention.

Skin Contact:In case of contact, immediately flush skin with plenty of water. Cover the irritated skin with an emollient. Remove contaminatedclothing and shoes. Wash clothing before reuse. Thoroughly clean shoes before reuse. Get medical attention.

Serious Skin Contact:Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek medical attention.

Inhalation:If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medicalattention.

Serious Inhalation:Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. Ifbreathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. Seek medicalattention.

Ingestion:If swallowed, do NOT induce vomiting. Do NOT induce vomiting unless directed to do so by medical personnel. Never giveanything by mouth to an unconscious person. Aspiration hazard if swallowed- can enter lungs and cause damage. Loosentight clothing such as a collar, tie, belt or waistband. Get medical attention. Get medical attention if symptoms appear.

Serious Ingestion: Not available.

Section 5: Fire and Explosion Data

Flammability of the Product: Flammable.

Auto-Ignition Temperature: 245°C (473°F)

Flash Points: CLOSED CUP: -18°C (-0.4°F). (Setaflash)

Flammable Limits: LOWER: 1.3% UPPER: 8.4%

Products of Combustion: These products are carbon oxides (CO, CO2).

Fire Hazards in Presence of Various Substances: Highly flammable in presence of open flames and sparks, of heat.

Explosion Hazards in Presence of Various Substances:Risks of explosion of the product in presence of mechanical impact: Not available. Slightly explosive in presence of openflames and sparks.

Fire Fighting Media and Instructions:Flammable liquid, insoluble in water. SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use water spray or fog.

Special Remarks on Fire Hazards: Vapor may travel considerable distance to source of ignition and flash back.

Special Remarks on Explosion Hazards: When mixed hot with liquid dinitrogen tetraoxide an explosion can result.

Section 6: Accidental Release Measures

Small Spill: Absorb with an inert material and put the spilled material in an appropriate waste disposal.

Large Spill:Flammable liquid, insoluble in water. Keep away from heat. Keep away from sources of ignition. Stop leak if without risk.Absorb with DRY earth, sand or other non-combustible material. Do not get water inside container. Do not touch spilledmaterial. Prevent entry into sewers, basements or confined areas; dike if needed. Call for assistance on disposal. Be carefulthat the product is not present at a concentration level above TLV. Check TLV on the MSDS and with local authorities.

Section 7: Handling and Storage

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Precautions:Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do notbreathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratoryequipment. If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin andeyes. Keep away from incompatibles such as oxidizing agents.

Storage:Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed andsealed until ready for use. Avoid all possible sources of ignition (spark or flame).

Section 8: Exposure Controls/Personal Protection

Engineering Controls:Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their respectivethreshold limit value. Ensure that eyewash stations and safety showers are proximal to the work-station location.

Personal Protection:Splash goggles. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.

Personal Protection in Case of a Large Spill:Splash goggles. Full suit. Vapor respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoidinhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling thisproduct.

Exposure Limits:TWA: 300 (ppm) from ACGIH (TLV) [United States] TWA: 300 (ppm) from OSHA (PEL) [United States] TWA: 1050 (mg/m3)from OSHA (PEL) [United States] TWA: 100 STEL: 300 (ppm) [United Kingdom (UK)] TWA: 350 STEL: 1050 (mg/m3) [UnitedKingdom (UK)]Consult local authorities for acceptable exposure limits.

Section 9: Physical and Chemical Properties

Physical state and appearance: Liquid.

Odor:Chloroform-like odor; solvent odor; mild sweet odor

Taste: Not available.

Molecular Weight: 84.16 g/mole

Color: Clear Colorless.

pH (1% soln/water): Not applicable.

Boiling Point: 80.7°C (177.3°F)

Melting Point: 6.47°C (43.6°F)

Critical Temperature: 280.4°C (536.7°F)

Specific Gravity: 0.7781 (Water = 1)

Vapor Pressure: 12.9 kPa (@ 20°C)

Vapor Density: 2.98 (Air = 1)

Volatility: Not available.

Odor Threshold: 25 ppm

Water/Oil Dist. Coeff.: The product is more soluble in oil; log(oil/water) = 3.4

Ionicity (in Water): Not available.

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Dispersion Properties: See solubility in water, methanol.

Solubility:Soluble in methanol. Insoluble in cold water.

Section 10: Stability and Reactivity Data

Stability: The product is stable.

Instability Temperature: Not available.

Conditions of Instability: Heat, ignition sources, incompatible materials

Incompatibility with various substances: Reactive with oxidizing agents.

Corrosivity: Not considered to be corrosive for metals and glass.

Special Remarks on Reactivity: Not available.

Special Remarks on Corrosivity: Not available.

Polymerization: Will not occur.

Section 11: Toxicological Information

Routes of Entry: Absorbed through skin. Eye contact. Inhalation. Ingestion.

Toxicity to Animals: Acute oral toxicity (LD50): 813 mg/kg [Mouse].

Chronic Effects on Humans: May cause damage to the following organs: kidneys, liver, cardiovascular system, centralnervous system (CNS).

Other Toxic Effects on Humans: Slightly hazardous in case of skin contact (irritant, permeator), of ingestion, of inhalation.

Special Remarks on Toxicity to Animals:Lowest Published Lethal Dose: LCL[Mouse] - Route: Inhalation; Dose: 70000 mg/m3/2H LCL[Rabbit] - 89600 mg/m3/1H

Special Remarks on Chronic Effects on Humans:Human: passes the placental barrier, detected in maternal milk. May affect genetic material (mutagenic)

Special Remarks on other Toxic Effects on Humans:Acute Potential Health Effects: Skin: It may cause skin irritation. It may be absorbed through the skin. Eyes: It may causeeye irritation. Inhalation: It may cause respiratory tract (nose, throat) irritation. Exposure to high concentrations of vapormay cause nausea, increased respiration rate. It may also affect behavior/central nervous system(dizziness, lethargy,somnolence, lightheadedness, seizures/convulsions, weakness, loss of coordination and judgement, trembling, drowsiness).Unconsciousness and death may occur at high exposures. In experimental animals there is a narrow margin between dosescausing narcosis, loss of reflexes and death. Generalized vascular damage/collapse and degenerative changes were seenin the heart, lung, liver kidneys and brain of experimental animals exposed to lethal concentrations by inhalation or ingestion.Ingestion: May cause gastrointestinal irritation and diarrhea. May affect behavior/central nervous system with symptomssimilar that that of inhalation. May cause liver and kidney damage. Aspiration of cyclohexane into the lungs may causechemical pneumonitis. Chronic Potential Health Effects: Skin: Prolonged or repeated skin contact may cause drying, crackingand chapping of exposed areas. Ingestion and Ingestion: Prolonged or repeated inhalation or ingestion may causeliver andkidney damage. It may also affect behavior/central nevous system with symtoms similar to that of acute ingestion or inhalation.

Section 12: Ecological Information

Ecotoxicity: Not available.

BOD5 and COD: Not available.

Products of Biodegradation:

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Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise.

Toxicity of the Products of Biodegradation: The product itself and its products of degradation are not toxic.

Special Remarks on the Products of Biodegradation: Not available.

Section 13: Disposal Considerations

Waste Disposal:Waste must be disposed of in accordance with federal, state and local environmental control regulations.

Section 14: Transport Information

DOT Classification: CLASS 3: Flammable liquid.

Identification: : Cyclohexane UNNA: 1145 PG: II

Special Provisions for Transport: Not available.

Section 15: Other Regulatory Information

Federal and State Regulations:Connecticut hazardous material survey.: Cyclohexane Illinois toxic substances disclosure to employee act: CyclohexaneIllinois chemical safety act: Cyclohexane New York release reporting list: Cyclohexane Rhode Island RTK hazardoussubstances: Cyclohexane Pennsylvania RTK: Cyclohexane Minnesota: Cyclohexane Massachusetts RTK: CyclohexaneMassachusetts spill list: Cyclohexane New Jersey: Cyclohexane New Jersey spill list: Cyclohexane Louisiana spill reporting:Cyclohexane TSCA 8(b) inventory: Cyclohexane SARA 313 toxic chemical notification and release reporting: CyclohexaneCERCLA: Hazardous substances.: Cyclohexane: 1000 lbs. (453.6 kg)

Other Regulations:OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200). EINECS: This product is on theEuropean Inventory of Existing Commercial Chemical Substances.

Other Classifications:

WHMIS (Canada): CLASS B-2: Flammable liquid with a flash point lower than 37.8°C (100°F).

DSCL (EEC):

HMIS (U.S.A.):

Health Hazard: 1

Fire Hazard: 3

Reactivity: 0

Personal Protection: h

National Fire Protection Association (U.S.A.):

Health: 1

Flammability: 3

Reactivity: 0

Specific hazard:

Protective Equipment:Gloves. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Wear appropriate respiratorwhen ventilation is inadequate. Splash goggles.

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Section 16: Other Information

References: Not available.

Other Special Considerations: Not available.

Created: 10/10/2005 08:17 PM

Last Updated: 11/06/2008 12:00 PM

The information above is believed to be accurate and represents the best information currently available to us. However, wemake no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assumeno liability resulting from its use. Users should make their own investigations to determine the suitability of the information fortheir particular purposes. In no event shall ScienceLab.com be liable for any claims, losses, or damages of any third party or forlost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if ScienceLab.comhas been advised of the possibility of such damages.

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Material Safety Data SheetN,N-Dimethylformamide MSDS

Section 1: Chemical Product and Company Identification

Product Name: N,N-Dimethylformamide

Catalog Codes: SLD4261, SLD3331

CAS#: 68-12-2

RTECS: LQ2100000

TSCA: TSCA 8(b) inventory: N,N-Dimethylformamide

CI#: Not applicable.

Synonym: DMF; Dimethyl Formamide

Chemical Name: N,N-Dimethylformamide

Chemical Formula: HCON(CH3)2

Contact Information:

Sciencelab.com, Inc.14025 Smith Rd.Houston, Texas 77396

US Sales: 1-800-901-7247International Sales: 1-281-441-4400

Order Online: ScienceLab.com

CHEMTREC (24HR Emergency Telephone), call:1-800-424-9300

International CHEMTREC, call: 1-703-527-3887

For non-emergency assistance, call: 1-281-441-4400

Section 2: Composition and Information on Ingredients

Composition:

Name CAS # % by Weight

{N,N-}Dimethylformamide 68-12-2 100

Toxicological Data on Ingredients: N,N-Dimethylformamide: ORAL (LD50): Acute: 2800 mg/kg [Rat]. 2900 mg/kg [Mouse].5000 mg/kg [Rabbit]. DERMAL (LD50): Acute: 4720 mg/kg [Rabbit].

Section 3: Hazards Identification

Potential Acute Health Effects: Hazardous in case of skin contact (irritant, permeator), of eye contact (irritant), of ingestion,of inhalation.

Potential Chronic Health Effects:CARCINOGENIC EFFECTS: 3 (Not classifiable for human.) by IARC. MUTAGENIC EFFECTS: Mutagenic for mammaliansomatic cells. Mutagenic for bacteria and/or yeast. TERATOGENIC EFFECTS: Classified POSSIBLE for human.DEVELOPMENTAL TOXICITY: Classified Reproductive system/toxin/female, Reproductive system/toxin/male [POSSIBLE].The substance is toxic to kidneys, liver, central nervous system (CNS). The substance may be toxic to blood, the nervoussystem. Repeated or prolonged exposure to the substance can produce target organs damage.

Section 4: First Aid Measures

Eye Contact:

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Check for and remove any contact lenses. Immediately flush eyes with running water for at least 15 minutes, keeping eyelidsopen. Cold water may be used. Get medical attention.

Skin Contact:In case of contact, immediately flush skin with plenty of water. Cover the irritated skin with an emollient. Remove contaminatedclothing and shoes. Cold water may be used.Wash clothing before reuse. Thoroughly clean shoes before reuse. Get medicalattention.

Serious Skin Contact:Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek immediate medicalattention.

Inhalation:If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medicalattention.

Serious Inhalation:Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. Ifbreathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. WARNING: It maybe hazardous to the person providing aid to give mouth-to-mouth resuscitation when the inhaled material is toxic, infectious orcorrosive. Seek medical attention.

Ingestion:Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconsciousperson. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention if symptoms appear.

Serious Ingestion: Not available.

Section 5: Fire and Explosion Data

Flammability of the Product: Flammable.

Auto-Ignition Temperature: 445°C (833°F)

Flash Points: CLOSED CUP: 57.778°C (136°F). (Tagliabue.) OPEN CUP: 67°C (152.6°F).

Flammable Limits: LOWER: 2.2% UPPER: 15.2%

Products of Combustion: These products are carbon oxides (CO, CO2), nitrogen oxides (NO, NO2...).

Fire Hazards in Presence of Various Substances:Flammable in presence of open flames and sparks, of heat. Non-flammable in presence of shocks.

Explosion Hazards in Presence of Various Substances:Risks of explosion of the product in presence of mechanical impact: Not available. Risks of explosion of the product inpresence of static discharge: Not available.

Fire Fighting Media and Instructions:Flammable liquid, soluble or dispersed in water. SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use alcohol foam,water spray or fog. Cool containing vessels with water jet in order to prevent pressure build-up, autoignition or explosion.

Special Remarks on Fire Hazards: Not available.

Special Remarks on Explosion Hazards:A mixture of triethylaluminum and DMF explodes when heated. DMF + potassium permanganate may explode.

Section 6: Accidental Release Measures

Small Spill:Dilute with water and mop up, or absorb with an inert dry material and place in an appropriate waste disposal container.

Large Spill:

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Flammable liquid. Keep away from heat. Keep away from sources of ignition. Stop leak if without risk. Absorb with DRY earth,sand or other non-combustible material. Do not touch spilled material. Prevent entry into sewers, basements or confinedareas; dike if needed. Be careful that the product is not present at a concentration level above TLV. Check TLV on the MSDSand with local authorities.

Section 7: Handling and Storage

Precautions:Keep locked up.. Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Donot ingest. Do not breathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of insufficient ventilation, wearsuitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Avoidcontact with skin and eyes. Keep away from incompatibles such as oxidizing agents, acids.

Storage:Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed andsealed until ready for use. Avoid all possible sources of ignition (spark or flame).

Section 8: Exposure Controls/Personal Protection

Engineering Controls:Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their respectivethreshold limit value. Ensure that eyewash stations and safety showers are proximal to the work-station location.

Personal Protection:Splash goggles. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.

Personal Protection in Case of a Large Spill:Splash goggles. Full suit. Vapor respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoidinhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling thisproduct.

Exposure Limits:TWA: 10 (ppm) from ACGIH (TLV) [United States] TWA: 30 (mg/m3) from ACGIH (TLV) [United States] Consult localauthorities for acceptable exposure limits.

Section 9: Physical and Chemical Properties

Physical state and appearance: Liquid.

Odor: Amine like. (Slight.)

Taste: Not available.

Molecular Weight: 73.09 g/mole

Color: Colorless to light yellow.

pH (1% soln/water): Not available.

Boiling Point: 153°C (307.4°F)

Melting Point: -61°C (-77.8°F)

Critical Temperature: 374°C (705.2°F)

Specific Gravity: 0.949 (Water = 1)

Vapor Pressure: 0.3 kPa (@ 20°C)

Vapor Density: 2.51 (Air = 1)

Volatility: Not available.

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Odor Threshold: 100 ppm

Water/Oil Dist. Coeff.: The product is more soluble in water; log(oil/water) = -1

Ionicity (in Water): Not available.

Dispersion Properties: See solubility in water, diethyl ether, acetone.

Solubility:Easily soluble in cold water, hot water. Soluble in diethyl ether, acetone. Miscible organic solvents. Soluble in benzene, andchloroform.

Section 10: Stability and Reactivity Data

Stability: The product is stable.

Instability Temperature: Not available.

Conditions of Instability: Heat, ignition sources (sparks, flames), incompatible materials

Incompatibility with various substances: Reactive with oxidizing agents, acids.

Corrosivity: Non-corrosive in presence of glass.

Special Remarks on Reactivity:Can react vigorously with oxidizing agents, halogenated hydrocarbons, and inorganic nitrates. Incompatible with carbontetrachloride, alkyl aluminums, sodium tetrahydroborate, nitrates, chromic acid, diisocyanatomethane, triethylaluminum,sodium hydride, lithium azide, metallic sodium, bromine, magnesium nitrate, potassium permanganate, nitric acid, chromiumtrioxide, borohydrides, phosphorus trioxide, diborane, octafluoroisobutyrate, sodium nitrite, perchloryl fluoride, postassiummethyl 4,4'-dinitrobutyrate. Reaction with inorganic acid chlorides, such as phosphorous oxychloride and thionyl chloride, mayform dimethylcarbamoyl, a suspect carcinogen. May release dimethylamine and carbon monoixde if heated above 350 C (662F).

Special Remarks on Corrosivity:Pure dimethylformamide is essentially non-corrosive to metals. However copper, tin and their alloys should be avoided.

Polymerization: Will not occur.

Section 11: Toxicological Information

Routes of Entry: Absorbed through skin. Dermal contact. Eye contact. Inhalation. Ingestion.

Toxicity to Animals:WARNING: THE LC50 VALUES HEREUNDER ARE ESTIMATED ON THE BASIS OF A 4-HOUR EXPOSURE. Acute oraltoxicity (LD50): 2800 mg/kg [Rat]. Acute dermal toxicity (LD50): 4720 mg/kg [Rabbit]. Acute toxicity of the vapor (LC50): 94001 hours [Mouse].

Chronic Effects on Humans:CARCINOGENIC EFFECTS: 3 (Not classifiable for human.) by IARC. MUTAGENIC EFFECTS: Mutagenic for mammaliansomatic cells. Mutagenic for bacteria and/or yeast. TERATOGENIC EFFECTS: Classified POSSIBLE for human.DEVELOPMENTAL TOXICITY: Classified Reproductive system/toxin/female, Reproductive system/toxin/male [POSSIBLE].Causes damage to the following organs: kidneys, liver, central nervous system (CNS). May cause damage to the followingorgans: blood, the nervous system.

Other Toxic Effects on Humans: Hazardous in case of skin contact (irritant, permeator), of ingestion, of inhalation.

Special Remarks on Toxicity to Animals:Lowest Published Lethal Dose: LCL[Rat] - Route: Inhalation; Dose: 5000 ppm/6H

Special Remarks on Chronic Effects on Humans:May affect genetic material. May cause adverse reproductive effects(paternal and maternal) and birth defects. Embryotoxicand/or foetotoxic in animal. Passes through the placental barrier in animal. May cause cancer although IARC evidence forcancer in humans shows inadequate data.

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Special Remarks on other Toxic Effects on Humans:Acute Potential Health Effects: Skin: Causes skin irritation with itching, burning, redness, swelling, or rash. It may be absorbedthrough the skin in toxic amounts and cause systemic effects similar to that of ingestion. It may facilitate the absorptionof other chemical substances through the skin. If there is significant potential for skin contact, monitoring should be doneto measure the level of DMF metabolites in urine specimans at the end of the shift. It is common practice to limit end-of-shift metabolites at or below 40 ppm expressed as n-monomethylformamide or a single individual or at or below 20 ppmMMF for several workers doing the same job. Eyes: Causes eye irritation (possibly severe) with tearing pain or blurredvision. Inhalation: May cause respiratory tract irritation. Short-term overexposure by inhalation may affect behavior/centralnervous system (convulsions, muscle weakness and other symptoms similar to that of acute ingestion), respiration (dyspnea).Ingestion: It can cause gastrointestinal tract irritation with heartburn, abdominal pain, nausea, vomiting or diarrhea. It may alsoaffect the cardiovascular system (hypertension, tachycardia, ECG abnormalities), blood (elevated white blood cell counts), andliver damage (hepatomegaly, jaundice, altered liver enzymes, fatty liver

Section 12: Ecological Information

Ecotoxicity: Not available.

BOD5 and COD: Not available.

Products of Biodegradation:Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise.

Toxicity of the Products of Biodegradation: The products of degradation are less toxic than the product itself.

Special Remarks on the Products of Biodegradation: Not available.

Section 13: Disposal Considerations

Waste Disposal:Waste must be disposed of in accordance with federal, state and local environmental control regulations.

Section 14: Transport Information

DOT Classification: CLASS 3: Flammable liquid.

Identification: : N,N-Dimethylformamide UNNA: 2265 PG: III

Special Provisions for Transport: Not available.

Section 15: Other Regulatory Information

Federal and State Regulations:Illinois toxic substances disclosure to employee act: N,N-Dimethylformamide Illinois chemical safety act: N,N-Dimethylformamide New York release reporting list: N,N-Dimethylformamide Rhode Island RTK hazardous substances: N,N-Dimethylformamide Pennsylvania RTK: N,N-Dimethylformamide Minnesota: N,N-Dimethylformamide Massachusetts RTK:N,N-Dimethylformamide Massachusetts spill list: N,N-Dimethylformamide New Jersey: N,N-Dimethylformamide New Jerseyspill list: N,N-Dimethylformamide Louisiana spill reporting: N,N-Dimethylformamide California Director's List of HazardousSubstances: N,N-Dimethylformamide TSCA 8(b) inventory: N,N-Dimethylformamide TSCA 8(d) H and S data reporting: N,N-Dimethylformamide: 12/19/95 SARA 313 toxic chemical notification and release reporting: N,N-Dimethylformamide CERCLA:Hazardous substances.: N,N-Dimethylformamide: 100 lbs. (45.36 kg)

Other Regulations:OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200). EINECS: This product is on theEuropean Inventory of Existing Commercial Chemical Substances.

Other Classifications:

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WHMIS (Canada):CLASS B-3: Combustible liquid with a flash point between 37.8°C (100°F) and 93.3°C (200°F). CLASS D-2A: Material causingother toxic effects (VERY TOXIC).

DSCL (EEC):R20/21- Harmful by inhalation and in contact with skin. R36- Irritating to eyes. R61- May cause harm to the unborn child.S45- In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible). S53- Avoidexposure - obtain special instructions before use.

HMIS (U.S.A.):

Health Hazard: 2

Fire Hazard: 2

Reactivity: 0

Personal Protection: h

National Fire Protection Association (U.S.A.):

Health: 1

Flammability: 2

Reactivity: 0

Specific hazard:

Protective Equipment:Gloves. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Wear appropriate respiratorwhen ventilation is inadequate. Splash goggles.

Section 16: Other Information

References: Not available.

Other Special Considerations: Not available.

Created: 10/09/2005 05:12 PM

Last Updated: 05/21/2013 12:00 PM

The information above is believed to be accurate and represents the best information currently available to us. However, wemake no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assumeno liability resulting from its use. Users should make their own investigations to determine the suitability of the information fortheir particular purposes. In no event shall ScienceLab.com be liable for any claims, losses, or damages of any third party or forlost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if ScienceLab.comhas been advised of the possibility of such damages.

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Material Safety Data SheetEthyl Alcohol 190 Proof MSDS

Section 1: Chemical Product and Company Identification

Product Name: Ethyl Alcohol 190 Proof

Catalog Codes: SLE1036, SLE1609, SLE1288

CAS#: Mixture.

RTECS: Not applicable.

TSCA: TSCA 8(b) inventory: Water; Ethyl alcohol 200Proof

CI#: Not applicable.

Synonym: Ethyl Alcohol 190 Proof

Chemical Formula: Not applicable.

Contact Information:

Sciencelab.com, Inc.14025 Smith Rd.Houston, Texas 77396

US Sales: 1-800-901-7247International Sales: 1-281-441-4400

Order Online: ScienceLab.com

CHEMTREC (24HR Emergency Telephone), call:1-800-424-9300

International CHEMTREC, call: 1-703-527-3887

For non-emergency assistance, call: 1-281-441-4400

Section 2: Composition and Information on Ingredients

Composition:

Name CAS # % by Weight

Water 7732-18-5 5

Ethyl alcohol 200 Proof 64-17-5 95

Toxicological Data on Ingredients: Ethyl alcohol 200 Proof: ORAL (LD50): Acute: 7060 mg/kg [Rat]. 3450 mg/kg [Mouse].VAPOR (LC50): Acute: 20000 ppm 8 hours [Rat]. 39000 mg/m 4 hours [Mouse].

Section 3: Hazards Identification

Potential Acute Health Effects:Hazardous in case of skin contact (irritant), of eye contact (irritant), . Slightly hazardous in case of skin contact (permeator), ofingestion. Non-corrosive for skin. Non-corrosive to the eyes. Non-corrosive for lungs.

Potential Chronic Health Effects:Slightly hazardous in case of skin contact (sensitizer) CARCINOGENIC EFFECTS: Classified PROVEN by State of CaliforniaProposition 65 [Ethyl alcohol 200 Proof]. Classified A4 (Not classifiable for human or animal.) by ACGIH [Ethyl alcohol 200Proof]. MUTAGENIC EFFECTS: Mutagenic for mammalian somatic cells. [Ethyl alcohol 200 Proof]. Mutagenic for bacteriaand/or yeast. [Ethyl alcohol 200 Proof]. TERATOGENIC EFFECTS: Classified PROVEN for human [Ethyl alcohol 200 Proof].DEVELOPMENTAL TOXICITY: Classified Development toxin [PROVEN] [Ethyl alcohol 200 Proof]. Classified Reproductivesystem/toxin/female, Reproductive system/toxin/male [POSSIBLE] [Ethyl alcohol 200 Proof]. The substance is toxic to blood,the reproductive system, liver, upper respiratory tract, skin, central nervous

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Section 4: First Aid Measures

Eye Contact:Check for and remove any contact lenses. Immediately flush eyes with running water for at least 15 minutes, keeping eyelidsopen. Cold water may be used. Get medical attention.

Skin Contact:In case of contact, immediately flush skin with plenty of water. Cover the irritated skin with an emollient. Remove contaminatedclothing and shoes. Cold water may be used.Wash clothing before reuse. Thoroughly clean shoes before reuse. Get medicalattention.

Serious Skin Contact:Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek medical attention.

Inhalation:If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medicalattention if symptoms appear.

Serious Inhalation:Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. Ifbreathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. Seek medicalattention.

Ingestion:Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconsciousperson. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention if symptoms appear.

Serious Ingestion: Not available.

Section 5: Fire and Explosion Data

Flammability of the Product: Flammable.

Auto-Ignition Temperature: The lowest known value is 363°C (685.4°F) (Ethyl alcohol 200 Proof).

Flash Points: CLOSED CUP: 18.5°C (65.3°F).(estimated)

Flammable Limits: The greatest known range is LOWER: 3.3% UPPER: 19% (Ethyl alcohol 200 Proof)

Products of Combustion: These products are carbon oxides (CO, CO2).

Fire Hazards in Presence of Various Substances:Highly flammable in presence of open flames and sparks, of heat. Slightly flammable to flammable in presence of oxidizingmaterials. Non-flammable in presence of shocks, of reducing materials, of combustible materials, of organic materials, ofmetals, of acids, of alkalis.

Explosion Hazards in Presence of Various Substances:Slightly explosive in presence of open flames and sparks, of heat, of oxidizing materials, of acids. Non-explosive in presenceof shocks.

Fire Fighting Media and Instructions:Flammable liquid, soluble or dispersed in water. SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use alcohol foam,water spray or fog.

Special Remarks on Fire Hazards:Containers should be grounded. CAUTION: MAY BURN WITH NEAR INVISIBLE FLAME Vapor may travel considerabledistance to source of ignition and flash back. May form explosive mixtures with air. Contact with Bromine pentafluoride is likelyto cause fire or explosion. Ethanol ignites on contact with chromyl chloride. Ethanol ignites on contact with iodine heptafluoridegas. It ignites than explodes upon contact with nitrosyl perchlorate. Additon of platinum black catalyst caused ignition. (Ethylalcohol 200 Proof)

Special Remarks on Explosion Hazards:Ethanol has an explosive reaction with the oxidized coating around potassium metal. Ethanol ignites and then explodes oncontact with acetic anhydride + sodium hydrosulfate (ignites and may explode), disulfuric acid + nitric acid, phosphorous(III)

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oxide platinum, potassium-tert-butoxide+ acids. Ethanol forms explosive products in reaction with the following compound :ammonia + silver nitrate (forms silver nitride and silver fulminate), iodine + phosphorus (forms ethane iodide), magnesiumperchlorate (forms ethyl perchlorate), mercuric nitrate, nitric acid + silver (forms silver fulminate) silver nitrate (forms ethylnitrate) silver(I) oxide + ammonia or hydrazine (forms silver nitride and silver fulminate), sodium (evolves hydrogen gas).Sodium Hydrazide + alcohol can produce an explosion. Alcohols should not be mixed with mercuric nitrate, as explosivemercuric fulminate may be formed. May form explosive mixture with manganese perchlorate + 2,2-dimethoxypropane. Additionof alcohols to highly concentrate hydrogen peroxide forms powerful explosives. Explodes on contact with calcium hypochloriteVapor may explode if ignited in an enclosed area. Containers may explode when heated or involved in a fire. (Ethyl alcohol200 Proof)

Section 6: Accidental Release Measures

Small Spill:Dilute with water and mop up, or absorb with an inert dry material and place in an appropriate waste disposal container.

Large Spill:Flammable liquid. Keep away from heat. Keep away from sources of ignition. Stop leak if without risk. Absorb with DRY earth,sand or other non-combustible material. Do not touch spilled material. Prevent entry into sewers, basements or confinedareas; dike if needed. Be careful that the product is not present at a concentration level above TLV. Check TLV on the MSDSand with local authorities.

Section 7: Handling and Storage

Precautions:Keep locked up.. Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Donot ingest. Do not breathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of insufficient ventilation, wearsuitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Avoidcontact with skin and eyes. Keep away from incompatibles such as oxidizing agents, acids, alkalis, moisture.

Storage:Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed andsealed until ready for use. Avoid all possible sources of ignition (spark or flame). Do not store above 23°C (73.4°F).

Section 8: Exposure Controls/Personal Protection

Engineering Controls:Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their respectivethreshold limit value. Ensure that eyewash stations and safety showers are proximal to the work-station location.

Personal Protection:Splash goggles. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.

Personal Protection in Case of a Large Spill:Splash goggles. Full suit. Vapor respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoidinhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling thisproduct.

Exposure Limits:Ethyl alcohol 200 Proof TWA: 1900 (mg/m3) from OSHA (PEL) [United States] TWA: 1000 (ppm) from OSHA (PEL) [UnitedStates] TWA: 1900 (mg/m3) from NIOSH [United States] TWA: 1000 (ppm) from NIOSH [United States] TWA: 1000 (ppm)[United Kingdom (UK)] TWA: 1920 (mg/m3) [United Kingdom (UK)] TWA: 1000 STEL: 1250 (ppm) [Canada] Consult localauthorities for acceptable exposure limits.

Section 9: Physical and Chemical Properties

Physical state and appearance: Liquid.

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Odor:Alcohol like. Mild to strong. Like wine or whiskey; Ethereal, vinous. Pleasant.

Taste: Burning. Pungent.

Molecular Weight: Not applicable.

Color: Clear Colorless.

pH (1% soln/water): Neutral.

Boiling Point: The lowest known value is 78.5°C (173.3°F) (Ethyl alcohol 200 Proof). Weighted average: 79.58°C (175.2°F)

Melting Point: May start to solidify at -114.1°C (-173.4°F) based on data for: Ethyl alcohol 200 Proof.

Critical Temperature: The lowest known value is 243°C (469.4°F) (Ethyl alcohol 200 Proof).

Specific Gravity: Weighted average: 0.8 (Water = 1)

Vapor Pressure: The highest known value is 5.7 kPa (@ 20°C) (Ethyl alcohol 200 Proof). Weighted average: 5.53 kPa (@20°C)

Vapor Density: The highest known value is 1.59 (Air = 1) (Ethyl alcohol 200 Proof). Weighted average: 1.54 (Air = 1)

Volatility: Not available.

Odor Threshold: 100 ppm

Water/Oil Dist. Coeff.: Not available.

Ionicity (in Water): Not available.

Dispersion Properties: See solubility in water, methanol, diethyl ether, acetone.

Solubility:Easily soluble in cold water, hot water, methanol, diethyl ether. Soluble in acetone.

Section 10: Stability and Reactivity Data

Stability: The product is stable.

Instability Temperature: Not available.

Conditions of Instability: Incompatible materials, heat, sources of ignition.

Incompatibility with various substances: Reactive with oxidizing agents, acids, alkalis.

Corrosivity: Non-corrosive in presence of glass.

Special Remarks on Reactivity:Ethanol rapidly absorbs moisture from the air. Can react vigorously with oxiders. The following oxidants have beendemonstrated to undergo vigorous/explosive reaction with ethanol: barium perchlorate, bromine pentafluoride, calciumhypochlorite, chloryl perchlorate, chromium trioxide, chromyl chloride, dioxygen difluoride, disulfuryl difluoride, fluorine nitrate,hydrogen peroxide, iodine heptafluoride, nitric acid nitrosyl perchlorate, perchloric acid permanganic acid, peroxodisulfuricacid, potassium dioxide, potassium perchlorate, potassium permanganate, ruthenium(VIII) oxide, silver perchlorate, silverperoxide, uranium hexafluoride, uranyl perchlorate. Ethanol reacts violently/expodes with the following compounds: acetylbromide (evolves hydrogen bromide) acetyl chloride, aluminum, sesquibromide ethylate, ammonium hydroxide & silveroxide, chlorate, chromic anhydride, cyanuric acid + water, dichloromethane + sulfuric acid + nitrate (or) nitrite, hydrogenperoxide + sulfuric acid, iodine + methanol + mercuric oxide, manganese perchlorate + 2,2-dimethoxy propane, perchlorates,permanganates + sulfuric acid, potassium superoxide, potassium tert-butoxide, silver & nitric acid, silver perchlorate, sodiumhydrazide, sulfuric acid + sodium dichromate, tetrachlorisilane + water. Ethanol is also incompatible with platinium, andsodium. No really safe conditions exist under which ethyl alcohol and chlorine oxides can be handled. Reacts vigorously withacetyl chloride (Ethyl alcohol 200 Proof)

Special Remarks on Corrosivity: Not available.

Polymerization: Will not occur.

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Section 11: Toxicological Information

Routes of Entry: Absorbed through skin. Eye contact. Inhalation. Ingestion.

Toxicity to Animals: Acute oral toxicity (LD50): 3632 mg/kg (Mouse) (Calculated value for the mixture).

Chronic Effects on Humans:CARCINOGENIC EFFECTS: Classified PROVEN by State of California Proposition 65 [Ethyl alcohol 200 Proof]. ClassifiedA4 (Not classifiable for human or animal.) by ACGIH [Ethyl alcohol 200 Proof]. MUTAGENIC EFFECTS: Mutagenicfor mammalian somatic cells. [Ethyl alcohol 200 Proof]. Mutagenic for bacteria and/or yeast. [Ethyl alcohol 200 Proof].TERATOGENIC EFFECTS: Classified PROVEN for human [Ethyl alcohol 200 Proof]. DEVELOPMENTAL TOXICITY:Classified Development toxin [PROVEN] [Ethyl alcohol 200 Proof]. Classified Reproductive system/toxin/female, Reproductivesystem/toxin/male [POSSIBLE] [Ethyl alcohol 200 Proof].

Other Toxic Effects on Humans:Hazardous in case of skin contact (irritant), of inhalation. Slightly hazardous in case of skin contact (permeator), of ingestion.

Special Remarks on Toxicity to Animals:Lowest Published Dose/Conc: LDL[Human] - Route: Oral; Dose: 1400 mg/kg LDL[Human child] - Route: Oral; Dose: 2000 mg/kg LDL[Rabbit] - Route: Skin; Dose: 20000 mg/kg (Ethyl alcohol 200 Proof)

Special Remarks on Chronic Effects on Humans:May affect genetic material (mutagenic) Causes adverse reproductive effects and birth defects (teratogenic) , based onmoderate to heavy consumption. May cause cancer based on animal data. Human: passes through the placenta, excreted inmaternal milk. (Ethyl alcohol 200 Proof)

Special Remarks on other Toxic Effects on Humans:Acute potential health effects: Skin: causes skin irritation Eyes: causes eye irritation Ingestion: May cause gastrointestinal tractirritation with nausea, vomiting, diarrhea, and alterations in gastric secretions. May affect behavior/central nervous system(central nervous system depression - amnesia, headache, muscular incoordination, excitation, mild euphoria, slurred speech,drowsiness, staggaring gait, fatigue, changes in mood/personality, excessive talking, dizziness, ataxia, somnolence, coma/narcosis, hallucinations, distorted perceptions, general anesthetic), peripherial nervous system (spastic paralysis)vision(diplopia). Moderately toxic and narcotic in high concentrations. May also affect metabolism, blood, liver, respiration (dyspnea),and endocrine system. May affect respiratory tract, cardiovascular(cardiac arrhythmias, hypotension), and urinary systems.Inhalation: May cause irritation of the respiratory tract and affect behavior/central nervous system with symptoms similarto ingestion. Chronic Potential Health Effects: Skin: Prolonged or repeated skin contact may casue dermatitis, an allergicreaction. Ingestion: Prolonged or repeated ingestion will have similiar effects as acute ingestion. It may also affect the brain.(Ethyl alcohol 200 Proof)

Section 12: Ecological Information

Ecotoxicity: Not available.

BOD5 and COD: Not available.

Products of Biodegradation:Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise.

Toxicity of the Products of Biodegradation: The product itself and its products of degradation are not toxic.

Special Remarks on the Products of Biodegradation: Not available.

Section 13: Disposal Considerations

Waste Disposal:Waste must be disposed of in accordance with federal, state and local environmental control regulations.

Section 14: Transport Information

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DOT Classification: CLASS 3: Flammable liquid.

Identification: : Ethanol (Ethyl alcohol 200 Proof) UNNA: 1170 PG: II

Special Provisions for Transport: Not available.

Section 15: Other Regulatory Information

Federal and State Regulations:California prop. 65: This product contains the following ingredients for which the State of California has found to causecancer, birth defects or other reproductive harm, which would require a warning under the statute: Ethyl alcohol 200 Proof (inalcoholic beverage) California prop. 65: This product contains the following ingredients for which the State of California hasfound to cause birth defects which would require a warning under the statute: Ethyl alcohol 200 Proof (in alcoholic beverage)Connecticut hazardous material survey.: Ethyl alcohol 200 Proof Illinois toxic substances disclosure to employee act: Ethylalcohol 200 Proof Rhode Island RTK hazardous substances: Ethyl alcohol 200 Proof Pennsylvania RTK: Ethyl alcohol 200Proof Florida: Ethyl alcohol 200 Proof Minnesota: Ethyl alcohol 200 Proof Massachusetts RTK: Ethyl alcohol 200 ProofMassachusetts spill list: Ethyl alcohol 200 Proof New Jersey: Ethyl alcohol 200 Proof TSCA 8(b) inventory: Water; Ethylalcohol 200 Proof

Other Regulations: OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200).

Other Classifications:

WHMIS (Canada):CLASS B-2: Flammable liquid with a flash point lower than 37.8°C (100°F). CLASS D-2B: Material causing other toxic effects(TOXIC).

DSCL (EEC):R11- Highly flammable. S7- Keep container tightly closed. S16- Keep away from sources of ignition - No smoking.

HMIS (U.S.A.):

Health Hazard: 2

Fire Hazard: 3

Reactivity: 0

Personal Protection: h

National Fire Protection Association (U.S.A.):

Health: 2

Flammability: 3

Reactivity: 0

Specific hazard:

Protective Equipment:Gloves. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Wear appropriate respiratorwhen ventilation is inadequate. Splash goggles.

Section 16: Other Information

References: Not available.

Other Special Considerations: Not available.

Created: 10/09/2005 05:28 PM

Last Updated: 05/21/2013 12:00 PM

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The information above is believed to be accurate and represents the best information currently available to us. However, wemake no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assumeno liability resulting from its use. Users should make their own investigations to determine the suitability of the information fortheir particular purposes. In no event shall ScienceLab.com be liable for any claims, losses, or damages of any third party or forlost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if ScienceLab.comhas been advised of the possibility of such damages.

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Material Safety Data SheetEthyl acetate MSDS

Section 1: Chemical Product and Company Identification

Product Name: Ethyl acetate

Catalog Codes: SLE2452, SLE2317

CAS#: 141-78-6

RTECS: AH5425000

TSCA: TSCA 8(b) inventory: Ethyl acetate

CI#: Not available.

Synonym: Acetic Acid, Ethyl Ester Acetic Ether

Chemical Name: Ethyl Acetate

Chemical Formula: C4-H8-O2

Contact Information:

Sciencelab.com, Inc.14025 Smith Rd.Houston, Texas 77396

US Sales: 1-800-901-7247International Sales: 1-281-441-4400

Order Online: ScienceLab.com

CHEMTREC (24HR Emergency Telephone), call:1-800-424-9300

International CHEMTREC, call: 1-703-527-3887

For non-emergency assistance, call: 1-281-441-4400

Section 2: Composition and Information on Ingredients

Composition:

Name CAS # % by Weight

Ethyl acetate 141-78-6 100

Toxicological Data on Ingredients: Ethyl acetate: ORAL (LD50): Acute: 5620 mg/kg [Rat]. 4100 mg/kg [Mouse]. 4935 mg/kg[Rabbit]. VAPOR (LC50): Acute: 45000 mg/m 3 hours [Mouse]. 16000 ppm 6 hours [Rat].

Section 3: Hazards Identification

Potential Acute Health Effects:Hazardous in case of ingestion, of inhalation. Slightly hazardous in case of skin contact (irritant, permeator), of eye contact(irritant).

Potential Chronic Health Effects:CARCINOGENIC EFFECTS: A4 (Not classifiable for human or animal.) by ACGIH. MUTAGENIC EFFECTS: Not available.TERATOGENIC EFFECTS: Not available. DEVELOPMENTAL TOXICITY: Not available. The substance is toxic to mucousmembranes, upper respiratory tract. The substance may be toxic to blood, kidneys, liver, central nervous system (CNS).Repeated or prolonged exposure to the substance can produce target organs damage.

Section 4: First Aid Measures

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Eye Contact:Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15minutes. Cold water may be used. Get medical attention.

Skin Contact:Wash with soap and water. Cover the irritated skin with an emollient. Get medical attention if irritation develops. Cold watermay be used.

Serious Skin Contact: Not available.

Inhalation:If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medicalattention if symptoms appear.

Serious Inhalation:Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. Ifbreathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. Seek medicalattention.

Ingestion:Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconsciousperson. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention if symptoms appear.

Serious Ingestion: Not available.

Section 5: Fire and Explosion Data

Flammability of the Product: Flammable.

Auto-Ignition Temperature: 426.67°C (800°F)

Flash Points: CLOSED CUP: -4.4°C (24.1°F). (TAG) OPEN CUP: 7.2°C (45°F) (Cleveland).

Flammable Limits: LOWER: 2.2% UPPER: 9%

Products of Combustion: These products are carbon oxides (CO, CO2).

Fire Hazards in Presence of Various Substances:Highly flammable in presence of open flames and sparks, of heat. Slightly flammable to flammable in presence of oxidizingmaterials, of acids, of alkalis. Non-flammable in presence of shocks.

Explosion Hazards in Presence of Various Substances:Risks of explosion of the product in presence of static discharge: Not available. Slightly explosive in presence of heat. Non-explosive in presence of shocks.

Fire Fighting Media and Instructions:Flammable liquid, soluble or dispersed in water. SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use alcohol foam,water spray or fog.

Special Remarks on Fire Hazards:Vapor may travel considerable distance to source of ignition and flash back. When heated to decomposition it emits acridsmoke and irritating fumes.

Special Remarks on Explosion Hazards:The liquid produces a vapor that forms explosive mixtures with air at normal temperatures. Explosive reaction with lithiumtetrahydroaluminate.

Section 6: Accidental Release Measures

Small Spill:Dilute with water and mop up, or absorb with an inert dry material and place in an appropriate waste disposal container.

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Large Spill:Flammable liquid. Keep away from heat. Keep away from sources of ignition. Stop leak if without risk. Absorb with DRY earth,sand or other non-combustible material. Do not touch spilled material. Prevent entry into sewers, basements or confinedareas; dike if needed. Be careful that the product is not present at a concentration level above TLV. Check TLV on the MSDSand with local authorities.

Section 7: Handling and Storage

Precautions:Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do notbreathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratoryequipment. If ingested, seek medical advice immediately and show the container or the label. Keep away from incompatiblessuch as oxidizing agents, acids, alkalis.

Storage:Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed andsealed until ready for use. Avoid all possible sources of ignition (spark or flame). Moisture sensitive.

Section 8: Exposure Controls/Personal Protection

Engineering Controls:Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their respectivethreshold limit value. Ensure that eyewash stations and safety showers are proximal to the work-station location.

Personal Protection:Safety glasses. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.

Personal Protection in Case of a Large Spill:Splash goggles. Full suit. Vapor respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoidinhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling thisproduct.

Exposure Limits:TWA: 400 (ppm) from OSHA (PEL) [United States] TWA: 400 from ACGIH (TLV) [United States] TWA: 1400 (mg/m3) fromNIOSH [United States] TWA: 400 (ppm) from NIOSH [United States] TWA: 400 (ppm) [Canada] TWA: 1440 (mg/m3) [Canada]TWA: 1400 (mg/m3) from OSHA (PEL) [United States]3 Consult local authorities for acceptable exposure limits.

Section 9: Physical and Chemical Properties

Physical state and appearance: Liquid.

Odor: Ethereal. Fruity. (Slight.)

Taste: Bittersweet, wine-like burning taste

Molecular Weight: 88.11 g/mole

Color: Colorless.

pH (1% soln/water): Not available.

Boiling Point: 77°C (170.6°F)

Melting Point: -83°C (-117.4°F)

Critical Temperature: 250°C (482°F)

Specific Gravity: 0.902 (Water = 1)

Vapor Pressure: 12.4 kPa (@ 20°C)

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Vapor Density: 3.04 (Air = 1)

Volatility: Not available.

Odor Threshold: 3.9 ppm

Water/Oil Dist. Coeff.: The product is more soluble in oil; log(oil/water) = 0.7

Ionicity (in Water): Not available.

Dispersion Properties: See solubility in water, diethyl ether, acetone.

Solubility: Soluble in cold water, hot water, diethyl ether, acetone, alcohol, benzene.

Section 10: Stability and Reactivity Data

Stability: The product is stable.

Instability Temperature: Not available.

Conditions of Instability: Heat, ignition sources (flames, sparks, static), incompatible materials

Incompatibility with various substances: Reactive with oxidizing agents, acids, alkalis.

Corrosivity: Non-corrosive in presence of glass.

Special Remarks on Reactivity:Also incompatible with nitrates, chlorosulfonic acid, oleum, potassium-tert-butoxide, and lithium tetrahydroaluminate. Moisturesensitive. On storage, it is slowly decomposed by water.

Special Remarks on Corrosivity: Not available.

Polymerization: Will not occur.

Section 11: Toxicological Information

Routes of Entry: Absorbed through skin. Eye contact. Inhalation. Ingestion.

Toxicity to Animals:WARNING: THE LC50 VALUES HEREUNDER ARE ESTIMATED ON THE BASIS OF A 4-HOUR EXPOSURE. Acute oraltoxicity (LD50): 4100 mg/kg [Mouse]. Acute toxicity of the vapor (LC50): 45000 mg/m3 3 hours [Mouse].

Chronic Effects on Humans:CARCINOGENIC EFFECTS: A4 (Not classifiable for human or animal.) by ACGIH. Causes damage to the following organs:mucous membranes, upper respiratory tract. May cause damage to the following organs: blood, kidneys, liver, central nervoussystem (CNS).

Other Toxic Effects on Humans:Hazardous in case of ingestion, of inhalation. Slightly hazardous in case of skin contact (irritant, permeator).

Special Remarks on Toxicity to Animals: LD50 [Rabbit] - Route: skin; Dose >20,000 ml/kg

Special Remarks on Chronic Effects on Humans:May affect genetic material (mutagenic). May cause adverse reproductive effects. based on animal test data. No human datafound at this time.

Special Remarks on other Toxic Effects on Humans:Acute Potential Health Effects: Skin: May cause skin irritation. Eyes: Causes eye irritation. May cause irritation of theconjunctivia. Inhalation: May cause respiratory tract and mucous membrane irritation. May affect respiration and may causeacute pulmonary edema. May affect gastrointestinal tract (nausea, vomiting). May affect behavior/central nervous system(mild central nervous system depression - exhilaration, talkativeness, boastfulness, belligerancy, vertigo, diplopia, drowsiness,slurred speech, slowed reaction time, dizziness, lightheadedness, somnolence, ataxia, unconciousness, irritability, fatigue,sleep disturbances, reduced memory and concentration, stupor, coma), cardiovascular system (peripheral vascular collapse(shock) - rapid pulse, hypotension, cold pale skin, hypothermia). Other symptoms may include: flushing of face and sweating.

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Ingestion: May cause gastrointestinal tract irritation with nausea and vomiting. May affect blood, behavior/central nervoussystem (CNS depression - effects may be similar to that of inhalation). Chronic Potential Health Effects: Skin: Repeated orprolonged skin contact may cause drying and cracking of the skin. IngestIon: Prolonged or repeated ingestion may affectthe liver. Inhalation: Prolonged inhalation may affect behavior/central nervous system (symptoms similar to those of acuteinhalation), and cause liver, kidney, lung, and heart damage. It may also affect metabolism, and blood (anemia, leukocytosis).

Section 12: Ecological Information

Ecotoxicity:Ecotoxicity in water (LC50): 220 mg/l 96 hours [Fish (Fathead minnow)]. 212.5 ppm 96 hours [Fish (Indian catfish)].

BOD5 and COD: Not available.

Products of Biodegradation:Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise.

Toxicity of the Products of Biodegradation: The product itself and its products of degradation are not toxic.

Special Remarks on the Products of Biodegradation: Not available.

Section 13: Disposal Considerations

Waste Disposal:Waste must be disposed of in accordance with federal, state and local environmental control regulations.

Section 14: Transport Information

DOT Classification: CLASS 3: Flammable liquid.

Identification: : Ethyl Acetate UNNA: 1173 PG: II

Special Provisions for Transport: Not available.

Section 15: Other Regulatory Information

Federal and State Regulations:Connecticut hazardous material survey.: Ethyl acetate Illinois toxic substances disclosure to employee act: Ethyl acetateIllinois chemical safety act: Ethyl acetate New York release reporting list: Ethyl acetate Rhode Island RTK hazardoussubstances: Ethyl acetate Pennsylvania RTK: Ethyl acetate Florida: Ethyl acetate Minnesota: Ethyl acetate MassachusettsRTK: Ethyl acetate Massachusetts spill list: Ethyl acetate New Jersey: Ethyl acetate New Jersey spill list: Ethyl acetateLouisiana spill reporting: Ethyl acetate California Director's list of Hazardous Substances: Ethyl acetate TSCA 8(b) inventory:Ethyl acetate TSCA 4(a) final test rules: Ethyl acetate TSCA 8(a) IUR: Ethyl acetate TSCA 12(b) annual export notification:Ethyl acetate CERCLA: Hazardous substances.: Ethyl acetate: 5000 lbs. (2268 kg)

Other Regulations:OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200). EINECS: This product is on theEuropean Inventory of Existing Commercial Chemical Substances.

Other Classifications:

WHMIS (Canada): CLASS B-2: Flammable liquid with a flash point lower than 37.8°C (100°F).

DSCL (EEC):R11- Highly flammable. R36- Irritating to eyes. S2- Keep out of the reach of children. S16- Keep away from sources of ignition- No smoking. S26- In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S33-Take precautionary measures against static discharges. S46- If swallowed, seek medical advice immediately and show thiscontainer or label.

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HMIS (U.S.A.):

Health Hazard: 2

Fire Hazard: 3

Reactivity: 0

Personal Protection: g

National Fire Protection Association (U.S.A.):

Health: 1

Flammability: 3

Reactivity: 0

Specific hazard:

Protective Equipment:Gloves. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Wear appropriate respiratorwhen ventilation is inadequate. Safety glasses.

Section 16: Other Information

References: Not available.

Other Special Considerations: Not available.

Created: 10/10/2005 08:18 PM

Last Updated: 05/21/2013 12:00 PM

The information above is believed to be accurate and represents the best information currently available to us. However, wemake no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assumeno liability resulting from its use. Users should make their own investigations to determine the suitability of the information fortheir particular purposes. In no event shall ScienceLab.com be liable for any claims, losses, or damages of any third party or forlost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if ScienceLab.comhas been advised of the possibility of such damages.

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Material Safety Data SheetIsobutyl acetate MSDS

Section 1: Chemical Product and Company Identification

Product Name: Isobutyl acetate

Catalog Codes: SLB3337

CAS#: 110-19-0

RTECS: AI4025000

TSCA: TSCA 8(b) inventory: Isobutyl acetate

CI#: Not available.

Synonym: 2-Methyl-1-propyl acetate

Chemical Name: Isobutyl acetate

Chemical Formula: C6-H12-O2

Contact Information:

Sciencelab.com, Inc.14025 Smith Rd.Houston, Texas 77396

US Sales: 1-800-901-7247International Sales: 1-281-441-4400

Order Online: ScienceLab.com

CHEMTREC (24HR Emergency Telephone), call:1-800-424-9300

International CHEMTREC, call: 1-703-527-3887

For non-emergency assistance, call: 1-281-441-4400

Section 2: Composition and Information on Ingredients

Composition:

Name CAS # % by Weight

Isobutyl acetate 110-19-0 100

Toxicological Data on Ingredients: Isobutyl acetate: ORAL (LD50): Acute: 13400 mg/kg [Rat]. 4763 mg/kg [Rabbit].DERMAL (LD50): Acute: 17400 mg/kg [Rabbit].

Section 3: Hazards Identification

Potential Acute Health Effects:Very hazardous in case of skin contact (irritant, permeator), of eye contact (irritant), of inhalation (lung irritant). Inflammation ofthe eye is characterized by redness, watering, and itching. Skin inflammation is characterized by itching, scaling, reddening,or, occasionally, blistering.

Potential Chronic Health Effects:CARCINOGENIC EFFECTS: Classified None. by NTP, None. by OSHA. A4 (Not classifiable for human or animal.) byACGIH. MUTAGENIC EFFECTS: Classified None. for human. TERATOGENIC EFFECTS: Classified None. for human.DEVELOPMENTAL TOXICITY: Not available. The substance is toxic to lungs, upper respiratory tract, eyes, eye, lens orcornea. Repeated or prolonged exposure to the substance can produce target organs damage.

Section 4: First Aid Measures

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Eye Contact:Check for and remove any contact lenses. Immediately flush eyes with running water for at least 15 minutes, keeping eyelidsopen. Cold water may be used. Do not use an eye ointment. Seek medical attention.

Skin Contact:After contact with skin, wash immediately with plenty of water. Gently and thoroughly wash the contaminated skin with runningwater and non-abrasive soap. Be particularly careful to clean folds, crevices, creases and groin. Cold water may be used.Cover the irritated skin with an emollient. If irritation persists, seek medical attention. Wash contaminated clothing beforereusing.

Serious Skin Contact:Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek medical attention.

Inhalation: Allow the victim to rest in a well ventilated area. Seek immediate medical attention.

Serious Inhalation:Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. Ifbreathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. Seek medicalattention.

Ingestion:Do not induce vomiting. Loosen tight clothing such as a collar, tie, belt or waistband. If the victim is not breathing, performmouth-to-mouth resuscitation. Seek immediate medical attention.

Serious Ingestion: Not available.

Section 5: Fire and Explosion Data

Flammability of the Product: Flammable.

Auto-Ignition Temperature: 421°C (789.8°F)

Flash Points: CLOSED CUP: 17.8°C (64°F). OPEN CUP: 85°C (185°F).

Flammable Limits: Not available.

Products of Combustion: These products are carbon oxides (CO, CO2).

Fire Hazards in Presence of Various Substances: Highly flammable in presence of open flames and sparks, of heat.

Explosion Hazards in Presence of Various Substances:Risks of explosion of the product in presence of mechanical impact: Not available. Risks of explosion of the product inpresence of static discharge: Not available. Highly explosive in presence of oxidizing materials, of metals, of acids.

Fire Fighting Media and Instructions:Flammable liquid, soluble or dispersed in water. SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use alcohol foam,water spray or fog.

Special Remarks on Fire Hazards: Not available.

Special Remarks on Explosion Hazards: May explode if ignited in an enclosed area.

Section 6: Accidental Release Measures

Small Spill:Dilute with water and mop up, or absorb with an inert dry material and place in an appropriate waste disposal container.

Large Spill:Flammable liquid. Keep away from heat. Keep away from sources of ignition. Stop leak if without risk. Absorb with DRY earth,sand or other non-combustible material. Do not touch spilled material. Prevent entry into sewers, basements or confinedareas; dike if needed. Eliminate all ignition sources. Be careful that the product is not present at a concentration level aboveTLV. Check TLV on the MSDS and with local authorities.

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Section 7: Handling and Storage

Precautions:Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Donot breathe gas/fumes/ vapour/spray. In case of insufficient ventilation, wear suitable respiratory equipment If ingested,seek medical advice immediately and show the container or the label. Avoid contact with skin and eyes Keep away fromincompatibles such as oxidizing agents, metals, acids.

Storage:Flammable materials should be stored in a separate safety storage cabinet or room. Keep away from heat. Keep away fromsources of ignition. Keep container tightly closed. Keep in a cool, well-ventilated place. Ground all equipment containingmaterial. A refrigerated room would be preferable for materials with a flash point lower than 37.8°C (100°F).

Section 8: Exposure Controls/Personal Protection

Engineering Controls:Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their respectivethreshold limit value. Ensure that eyewash stations and safety showers are proximal to the work-station location.

Personal Protection:Splash goggles. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.

Personal Protection in Case of a Large Spill:Splash goggles. Full suit. Vapor respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoidinhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling thisproduct.

Exposure Limits:United States: TWA: 150 STEL: 200 (ppm) from ACGIH (TLV) [1998] Mexico: TWA: 150 STEL: 187 (ppm) Israel: TWA: 150(ppm) Australia: TWA: 150 (ppm) Consult local authorities for acceptable exposure limits.

Section 9: Physical and Chemical Properties

Physical state and appearance: Liquid.

Odor: Fruity. (Slight.)

Taste: Not available.

Molecular Weight: 116.16 g/mole

Color: Colorless.

pH (1% soln/water): Not available.

Boiling Point: 117.2°C (243°F)

Melting Point: -98.6°C (-145.5°F)

Critical Temperature: 296°C (564.8°F)

Specific Gravity: Not available.

Vapor Pressure: 13 mm of Hg (@ 20°C)

Vapor Density: 4 (Air = 1)

Volatility: Not available.

Odor Threshold: 0.64 ppm

Water/Oil Dist. Coeff.: Not available.

Ionicity (in Water): Not available.

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Dispersion Properties:Dispersed in methanol, diethyl ether. See solubility in water, diethyl ether, acetone.

Solubility:Soluble in hot water, diethyl ether, acetone. Partially soluble in cold water.

Section 10: Stability and Reactivity Data

Stability: The product is stable.

Instability Temperature: Not available.

Conditions of Instability: Not available.

Incompatibility with various substances: Highly reactive with oxidizing agents, metals, acids.

Corrosivity: Non-corrosive in presence of glass.

Special Remarks on Reactivity: Not available.

Special Remarks on Corrosivity: Not available.

Polymerization: Not available.

Section 11: Toxicological Information

Routes of Entry: Absorbed through skin. Dermal contact. Eye contact. Inhalation. Ingestion.

Toxicity to Animals:Acute oral toxicity (LD50): 4763 mg/kg [Rabbit]. Acute dermal toxicity (LD50): 17400 mg/kg [Rabbit].

Chronic Effects on Humans:CARCINOGENIC EFFECTS: Classified None. by NTP, None. by OSHA. A4 (Not classifiable for human or animal.) by ACGIH.MUTAGENIC EFFECTS: Classified None. for human. TERATOGENIC EFFECTS: Classified None. for human. The substanceis toxic to lungs, upper respiratory tract, eyes, eye, lens or cornea.

Other Toxic Effects on Humans: Very hazardous in case of skin contact (irritant, permeator), of inhalation (lung irritant).

Special Remarks on Toxicity to Animals: Not available.

Special Remarks on Chronic Effects on Humans: Not available.

Special Remarks on other Toxic Effects on Humans: Not available.

Section 12: Ecological Information

Ecotoxicity: Not available.

BOD5 and COD: Not available.

Products of Biodegradation:Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise.

Toxicity of the Products of Biodegradation: The product itself and its products of degradation are not toxic.

Special Remarks on the Products of Biodegradation: Not available.

Section 13: Disposal Considerations

Waste Disposal:

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Section 14: Transport Information

DOT Classification: Class 3: Flammable liquid.

Identification: : Isobutyl Acetate : UN1213 PG: II

Special Provisions for Transport: Not available.

Section 15: Other Regulatory Information

Federal and State Regulations:Rhode Island RTK hazardous substances: Isobutyl acetate Pennsylvania RTK: Isobutyl acetate Florida: Isobutyl acetateMassachusetts RTK: Isobutyl acetate New Jersey: Isobutyl acetate TSCA 8(b) inventory: Isobutyl acetate SARA 311/312MSDS distribution - chemical inventory - hazard identification: Isobutyl acetate: immediate health hazard CERCLA: Hazardoussubstances.: Isobutyl acetate

Other Regulations: OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200).

Other Classifications:

WHMIS (Canada): CLASS B-2: Flammable liquid with a flash point lower than 37.8°C (100°F).

DSCL (EEC): R11- Highly flammable.

HMIS (U.S.A.):

Health Hazard: 2

Fire Hazard: 3

Reactivity: 0

Personal Protection: h

National Fire Protection Association (U.S.A.):

Health: 2

Flammability: 3

Reactivity: 0

Specific hazard:

Protective Equipment:Gloves. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Wear appropriate respiratorwhen ventilation is inadequate. Splash goggles.

Section 16: Other Information

References: Not available.

Other Special Considerations: Not available.

Created: 10/09/2005 04:27 PM

Last Updated: 11/06/2008 12:00 PM

The information above is believed to be accurate and represents the best information currently available to us. However, wemake no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assumeno liability resulting from its use. Users should make their own investigations to determine the suitability of the information fortheir particular purposes. In no event shall ScienceLab.com be liable for any claims, losses, or damages of any third party or forlost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if ScienceLab.comhas been advised of the possibility of such damages.

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Material Safety Data SheetIsopropyl alcohol MSDS

Section 1: Chemical Product and Company Identification

Product Name: Isopropyl alcohol

Catalog Codes: SLI1153, SLI1579, SLI1906, SLI1246,SLI1432

CAS#: 67-63-0

RTECS: NT8050000

TSCA: TSCA 8(b) inventory: Isopropyl alcohol

CI#: Not available.

Synonym: 2-Propanol

Chemical Name: isopropanol

Chemical Formula: C3-H8-O

Contact Information:

Sciencelab.com, Inc.14025 Smith Rd.Houston, Texas 77396

US Sales: 1-800-901-7247International Sales: 1-281-441-4400

Order Online: ScienceLab.com

CHEMTREC (24HR Emergency Telephone), call:1-800-424-9300

International CHEMTREC, call: 1-703-527-3887

For non-emergency assistance, call: 1-281-441-4400

Section 2: Composition and Information on Ingredients

Composition:

Name CAS # % by Weight

Isopropyl alcohol 67-63-0 100

Toxicological Data on Ingredients: Isopropyl alcohol: ORAL (LD50): Acute: 5045 mg/kg [Rat]. 3600 mg/kg [Mouse]. 6410mg/kg [Rabbit]. DERMAL (LD50): Acute: 12800 mg/kg [Rabbit].

Section 3: Hazards Identification

Potential Acute Health Effects:Hazardous in case of eye contact (irritant), of ingestion, of inhalation. Slightly hazardous in case of skin contact (irritant,sensitizer, permeator).

Potential Chronic Health Effects:Slightly hazardous in case of skin contact (sensitizer). CARCINOGENIC EFFECTS: A4 (Not classifiable for human or animal.)by ACGIH, 3 (Not classifiable for human.) by IARC. MUTAGENIC EFFECTS: Not available. TERATOGENIC EFFECTS: Notavailable. DEVELOPMENTAL TOXICITY: Classified Reproductive system/toxin/female, Development toxin [POSSIBLE].The substance may be toxic to kidneys, liver, skin, central nervous system (CNS). Repeated or prolonged exposure to thesubstance can produce target organs damage.

Section 4: First Aid Measures

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Eye Contact:Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15minutes. Cold water may be used. Get medical attention.

Skin Contact:Wash with soap and water. Cover the irritated skin with an emollient. Get medical attention if irritation develops. Cold watermay be used.

Serious Skin Contact: Not available.

Inhalation:If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medicalattention if symptoms appear.

Serious Inhalation:Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. Ifbreathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. Seek medicalattention.

Ingestion:Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconsciousperson. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention if symptoms appear.

Serious Ingestion: Not available.

Section 5: Fire and Explosion Data

Flammability of the Product: Flammable.

Auto-Ignition Temperature: 399°C (750.2°F)

Flash Points: CLOSED CUP: 11.667°C (53°F) - 12.778 deg. C (55 deg. F) (TAG)

Flammable Limits: LOWER: 2% UPPER: 12.7%

Products of Combustion: These products are carbon oxides (CO, CO2).

Fire Hazards in Presence of Various Substances:Highly flammable in presence of open flames and sparks, of heat. Flammable in presence of oxidizing materials. Non-flammable in presence of shocks.

Explosion Hazards in Presence of Various Substances:Risks of explosion of the product in presence of mechanical impact: Not available. Explosive in presence of open flames andsparks, of heat.

Fire Fighting Media and Instructions:Flammable liquid, soluble or dispersed in water. SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use alcohol foam,water spray or fog.

Special Remarks on Fire Hazards:Vapor may travel considerable distance to source of ignition and flash back. CAUTION: MAY BURN WITH NEAR INVISIBLEFLAME. Hydrogen peroxide sharply reduces the autoignition temperature of Isopropyl alcohol. After a delay, Isopropylalcohol ignites on contact with dioxgenyl tetrafluorborate, chromium trioxide, and potassium tert-butoxide. When heated todecomposition it emits acrid smoke and fumes.

Special Remarks on Explosion Hazards:Secondary alcohols are readily autooxidized in contact with oxygen or air, forming ketones and hydrogen peroxide. It canbecome potentially explosive. It reacts with oxygen to form dangerously unstable peroxides which can concentrate andexplode during distillation or evaporation. The presence of 2-butanone increases the reaction rate for peroxide formation.Explosive in the form of vapor when exposed to heat or flame. May form explosive mixtures with air. Isopropyl alcohol +phosgene forms isopropyl chloroformate and hydrogen chloride. In the presence of iron salts, thermal decompositon canoccur, whicn in some cases can become explosive. A homogeneous mixture of concentrated peroxides + isopropyl alcohol arecapable of detonation by shock or heat. Barium perchlorate + isopropyl alcohol gives the highly explosive alkyl perchlorates.

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It forms explosive mixtures with trinitormethane and hydrogen peroxide. It produces a violent explosive reaction when heatedwith aluminum isopropoxide + crotonaldehyde. Mixtures of isopropyl alcohol + nitroform are explosive.

Section 6: Accidental Release Measures

Small Spill:Dilute with water and mop up, or absorb with an inert dry material and place in an appropriate waste disposal container.

Large Spill:Flammable liquid. Keep away from heat. Keep away from sources of ignition. Stop leak if without risk. Absorb with DRY earth,sand or other non-combustible material. Do not touch spilled material. Prevent entry into sewers, basements or confinedareas; dike if needed. Be careful that the product is not present at a concentration level above TLV. Check TLV on the MSDSand with local authorities.

Section 7: Handling and Storage

Precautions:Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do notbreathe gas/fumes/ vapor/spray. Avoid contact with eyes. Wear suitable protective clothing. In case of insufficient ventilation,wear suitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Keepaway from incompatibles such as oxidizing agents, acids.

Storage:Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed andsealed until ready for use. Avoid all possible sources of ignition (spark or flame).

Section 8: Exposure Controls/Personal Protection

Engineering Controls:Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their respectivethreshold limit value. Ensure that eyewash stations and safety showers are proximal to the work-station location.

Personal Protection:Splash goggles. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.

Personal Protection in Case of a Large Spill:Splash goggles. Full suit. Vapor respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoidinhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling thisproduct.

Exposure Limits:TWA: 983 STEL: 1230 (mg/m3) [Australia] TWA: 200 STEL: 400 (ppm) from ACGIH (TLV) [United States] [1999] TWA: 980STEL: 1225 (mg/m3) from NIOSH TWA: 400 STEL: 500 (ppm) from NIOSH TWA: 400 STEL: 500 (ppm) [United Kingdom(UK)] TWA: 999 STEL: 1259 (mg/m3) [United Kingdom (UK)] TWA: 400 STEL: 500 (ppm) from OSHA (PEL) [United States]TWA: 980 STEL: 1225 (mg/m3) from OSHA (PEL) [United States]Consult local authorities for acceptable exposure limits.

Section 9: Physical and Chemical Properties

Physical state and appearance: Liquid.

Odor:Pleasant. Odor resembling that of a mixture of ethanol and acetone.

Taste: Bitter. (Slight.)

Molecular Weight: 60.1 g/mole

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Color: Colorless.

pH (1% soln/water): Not available.

Boiling Point: 82.5°C (180.5°F)

Melting Point: -88.5°C (-127.3°F)

Critical Temperature: 235°C (455°F)

Specific Gravity: 0.78505 (Water = 1)

Vapor Pressure: 4.4 kPa (@ 20°C)

Vapor Density: 2.07 (Air = 1)

Volatility: Not available.

Odor Threshold:22 ppm (Sittig, 1991) 700 ppm for unadapted panelists (Verschuren, 1983).

Water/Oil Dist. Coeff.: The product is equally soluble in oil and water; log(oil/water) = 0.1

Ionicity (in Water): Not available.

Dispersion Properties: See solubility in water, methanol, diethyl ether, n-octanol, acetone.

Solubility:Easily soluble in cold water, hot water, methanol, diethyl ether, n-octanol, acetone. Insoluble in salt solution. Soluble inbenzene. Miscible with most organic solvents including alcohol, ethyl alcohol, chloroform.

Section 10: Stability and Reactivity Data

Stability: The product is stable.

Instability Temperature: Not available.

Conditions of Instability: Heat, Ignition sources, incompatible materials

Incompatibility with various substances: Reactive with oxidizing agents, acids, alkalis.

Corrosivity: Non-corrosive in presence of glass.

Special Remarks on Reactivity:Reacts violently with hydrogen + palladium combination, nitroform, oleum, COCl2, aluminum triisopropoxide, oxidantsIncompatible with acetaldehyde, chlorine, ethylene oxide, isocyanates, acids, alkaline earth, alkali metals, caustics, amines,crotonaldehyde, phosgene, ammonia. Isopropyl alcohol reacts with metallic aluminum at high temperatures. Isopropyl alcoholattacks some plastics, rubber, and coatings. Vigorous reaction with sodium dichromate + sulfuric acid.

Special Remarks on Corrosivity: May attack some forms of plastic, rubber and coating

Polymerization: Will not occur.

Section 11: Toxicological Information

Routes of Entry: Absorbed through skin. Dermal contact. Eye contact. Inhalation.

Toxicity to Animals:WARNING: THE LC50 VALUES HEREUNDER ARE ESTIMATED ON THE BASIS OF A 4-HOUR EXPOSURE. Acute oraltoxicity (LD50): 3600 mg/kg [Mouse]. Acute dermal toxicity (LD50): 12800 mg/kg [Rabbit]. Acute toxicity of the vapor (LC50):16000 8 hours [Rat].

Chronic Effects on Humans:CARCINOGENIC EFFECTS: A4 (Not classifiable for human or animal.) by ACGIH, 3 (Not classifiable for human.) by IARC.DEVELOPMENTAL TOXICITY: Classified Reproductive system/toxin/female, Development toxin [POSSIBLE]. May causedamage to the following organs: kidneys, liver, skin, central nervous system (CNS).

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Other Toxic Effects on Humans:Hazardous in case of ingestion, of inhalation. Slightly hazardous in case of skin contact (irritant, sensitizer, permeator).

Special Remarks on Toxicity to Animals: Not available.

Special Remarks on Chronic Effects on Humans:M a y c a u s e a d v e r s e r e p r o d u c t i v e / t e r a t o g e n i c e f f e c t s ( f e r t i l i t y , f e t o x i c i t y , d e v e l o p m en t a l abnormalities(developmental toxin)) based on animal studies. Detected in maternal milk in human.

Special Remarks on other Toxic Effects on Humans:Acute Potential Health Effects: Skin: May cause mild skin irritation, and sensitization. Eyes: Can cause eye irritation.Inhalation: Breathing in small amounts of this material during normal handling is not likely to cause harmful effects. However,breathing large amounts may be harmful and may affect the respiratory system and mucous membranes (irritation), behaviorand brain (Central nervous system depression - headache, dizziness, drowsiness, stupor, incoordination, unconciousness,coma and possible death), peripheral nerve and senstation, blood, urinary system, and liver. Ingestion: Swallowing smallamouts during normal handling is not likely to cause harmful effects. Swallowing large amounts may be harmful. Swallowinglarge amounts may cause gastrointestinal tract irritation with nausea, vomiting and diarrhea, abdominal pain. It also mayaffect the urinary system, cardiovascular system, sense organs, behavior or central nervous system (somnolence, generallydepressed activity, irritability, headache, dizziness, drowsiness), liver, and respiratory system (breathing difficulty). ChronicPotential Health Effects: May cause defatting of the skin and dermatitis and allergic reaction. May cause adverse reproductiveeffects based on animal data (studies).

Section 12: Ecological Information

Ecotoxicity: Ecotoxicity in water (LC50): 100000 mg/l 96 hours [Fathead Minnow]. 64000 mg/l 96 hours [Fathead Minnow].

BOD5 and COD: Not available.

Products of Biodegradation:Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise.

Toxicity of the Products of Biodegradation: The product itself and its products of degradation are not toxic.

Special Remarks on the Products of Biodegradation: Not available.

Section 13: Disposal Considerations

Waste Disposal:Waste must be disposed of in accordance with federal, state and local environmental control regulations.

Section 14: Transport Information

DOT Classification: CLASS 3: Flammable liquid.

Identification: : Isopropyl Alcohol UNNA: 1219 PG: II

Special Provisions for Transport: Not available.

Section 15: Other Regulatory Information

Federal and State Regulations:Connecticut hazardous material survey.: Isopropyl alcohol Illinois toxic substances disclosure to employee act: Isopropylalcohol Rhode Island RTK hazardous substances: Isopropyl alcohol Pennsylvania RTK: Isopropyl alcohol Florida: Isopropylalcohol Minnesota: Isopropyl alcohol Massachusetts RTK: Isopropyl alcohol New Jersey: Isopropyl alcohol New Jersey spilllist: Isopropyl alcohol Director's list of Hazardous Substances: Isopropyl alcohol Tennesee: Isopropyl alcohol TSCA 8(b)inventory: Isopropyl alcohol TSCA 4(a) final testing order: Isopropyl alcohol TSCA 8(a) IUR: Isopropyl alcohol TSCA 8(d) H

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and S data reporting: Isopropyl alcohol: Effective date: 12/15/86 Sunset Date: 12/15/96 TSCA 12(b) one time export: Isopropylalcohol SARA 313 toxic chemical notification and release reporting: Isopropyl alcohol

Other Regulations:OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200). EINECS: This product is on theEuropean Inventory of Existing Commercial Chemical Substances.

Other Classifications:

WHMIS (Canada):CLASS B-2: Flammable liquid with a flash point lower than 37.8°C (100°F). CLASS D-2B: Material causing other toxic effects(TOXIC).

DSCL (EEC):R11- Highly flammable. R36- Irritating to eyes. S7- Keep container tightly closed. S16- Keep away from sources of ignition- No smoking. S24/25- Avoid contact with skin and eyes. S26- In case of contact with eyes, rinse immediately with plenty ofwater and seek medical advice.

HMIS (U.S.A.):

Health Hazard: 2

Fire Hazard: 3

Reactivity: 0

Personal Protection: h

National Fire Protection Association (U.S.A.):

Health: 1

Flammability: 3

Reactivity: 0

Specific hazard:

Protective Equipment:Gloves. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Wear appropriate respiratorwhen ventilation is inadequate. Splash goggles.

Section 16: Other Information

References: Not available.

Other Special Considerations: Not available.

Created: 10/09/2005 05:53 PM

Last Updated: 05/22/2009 09:11 AM

The information above is believed to be accurate and represents the best information currently available to us. However, wemake no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assumeno liability resulting from its use. Users should make their own investigations to determine the suitability of the information fortheir particular purposes. In no event shall ScienceLab.com be liable for any claims, losses, or damages of any third party or forlost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if ScienceLab.comhas been advised of the possibility of such damages.

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Material Safety Data SheetMethyl alcohol MSDS

Section 1: Chemical Product and Company Identification

Product Name: Methyl alcohol

Catalog Codes: SLM3064, SLM3952

CAS#: 67-56-1

RTECS: PC1400000

TSCA: TSCA 8(b) inventory: Methyl alcohol

CI#: Not applicable.

Synonym: Wood alcohol, Methanol; Methylol; WoodSpirit; Carbinol

Chemical Name: Methanol

Chemical Formula: CH3OH

Contact Information:

Sciencelab.com, Inc.14025 Smith Rd.Houston, Texas 77396

US Sales: 1-800-901-7247International Sales: 1-281-441-4400

Order Online: ScienceLab.com

CHEMTREC (24HR Emergency Telephone), call:1-800-424-9300

International CHEMTREC, call: 1-703-527-3887

For non-emergency assistance, call: 1-281-441-4400

Section 2: Composition and Information on Ingredients

Composition:

Name CAS # % by Weight

Methyl alcohol 67-56-1 100

Toxicological Data on Ingredients: Methyl alcohol: ORAL (LD50): Acute: 5628 mg/kg [Rat]. DERMAL (LD50): Acute: 15800mg/kg [Rabbit]. VAPOR (LC50): Acute: 64000 ppm 4 hours [Rat].

Section 3: Hazards Identification

Potential Acute Health Effects:Hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation. Slightly hazardous in case ofskin contact (permeator). Severe over-exposure can result in death.

Potential Chronic Health Effects:Slightly hazardous in case of skin contact (sensitizer). CARCINOGENIC EFFECTS: Not available. MUTAGENIC EFFECTS:Mutagenic for mammalian somatic cells. Mutagenic for bacteria and/or yeast. TERATOGENIC EFFECTS: ClassifiedPOSSIBLE for human. DEVELOPMENTAL TOXICITY: Not available. The substance is toxic to eyes. The substance may betoxic to blood, kidneys, liver, brain, peripheral nervous system, upper respiratory tract, skin, central nervous system (CNS),optic nerve. Repeated or prolonged exposure to the substance can produce target organs damage. Repeated exposure to ahighly toxic material may produce general deterioration of health by an accumulation in one or many human organs.

Section 4: First Aid Measures

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Eye Contact:Check for and remove any contact lenses. Immediately flush eyes with running water for at least 15 minutes, keeping eyelidsopen. Cold water may be used. Get medical attention.

Skin Contact:In case of contact, immediately flush skin with plenty of water for at least 15 minutes while removing contaminated clothingand shoes. Cover the irritated skin with an emollient. Cold water may be used.Wash clothing before reuse. Thoroughly cleanshoes before reuse. Get medical attention immediately.

Serious Skin Contact:Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek immediate medicalattention.

Inhalation:If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medicalattention immediately.

Serious Inhalation:Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. Ifbreathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. WARNING: It maybe hazardous to the person providing aid to give mouth-to-mouth resuscitation when the inhaled material is toxic, infectious orcorrosive. Seek immediate medical attention.

Ingestion:If swallowed, do not induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to anunconscious person. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention immediately.

Serious Ingestion: Not available.

Section 5: Fire and Explosion Data

Flammability of the Product: Flammable.

Auto-Ignition Temperature: 464°C (867.2°F)

Flash Points: CLOSED CUP: 12°C (53.6°F). OPEN CUP: 16°C (60.8°F).

Flammable Limits: LOWER: 6% UPPER: 36.5%

Products of Combustion: These products are carbon oxides (CO, CO2).

Fire Hazards in Presence of Various Substances:Highly flammable in presence of open flames and sparks, of heat. Non-flammable in presence of shocks.

Explosion Hazards in Presence of Various Substances:Risks of explosion of the product in presence of mechanical impact: Not available. Explosive in presence of open flames andsparks, of heat.

Fire Fighting Media and Instructions:Flammable liquid, soluble or dispersed in water. SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use alcohol foam,water spray or fog.

Special Remarks on Fire Hazards:Explosive in the form of vapor when exposed to heat or flame. Vapor may travel considerable distance to source of ignitionand flash back. When heated to decomposition, it emits acrid smoke and irritating fumes. CAUTION: MAY BURN WITH NEARINVISIBLE FLAME

Special Remarks on Explosion Hazards:Forms an explosive mixture with air due to its low flash point. Explosive when mixed with Choroform + sodium methoxide anddiethyl zinc. It boils violently and explodes.

Section 6: Accidental Release Measures

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Small Spill:Dilute with water and mop up, or absorb with an inert dry material and place in an appropriate waste disposal container.

Large Spill:Flammable liquid. Poisonous liquid. Keep away from heat. Keep away from sources of ignition. Stop leak if without risk.Absorb with DRY earth, sand or other non-combustible material. Do not get water inside container. Do not touch spilledmaterial. Use water spray to reduce vapors. Prevent entry into sewers, basements or confined areas; dike if needed. Callfor assistance on disposal. Be careful that the product is not present at a concentration level above TLV. Check TLV on theMSDS and with local authorities.

Section 7: Handling and Storage

Precautions:Keep locked up.. Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Donot ingest. Do not breathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of insufficient ventilation, wearsuitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Avoidcontact with skin and eyes. Keep away from incompatibles such as oxidizing agents, metals, acids.

Storage:Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed andsealed until ready for use. Avoid all possible sources of ignition (spark or flame).

Section 8: Exposure Controls/Personal Protection

Engineering Controls:Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their respectivethreshold limit value. Ensure that eyewash stations and safety showers are proximal to the work-station location.

Personal Protection:Splash goggles. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.

Personal Protection in Case of a Large Spill:Splash goggles. Full suit. Vapor respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoidinhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling thisproduct.

Exposure Limits:TWA: 200 from OSHA (PEL) [United States] TWA: 200 STEL: 250 (ppm) from ACGIH (TLV) [United States] [1999] STEL: 250from NIOSH [United States] TWA: 200 STEL: 250 (ppm) from NIOSH SKIN TWA: 200 STEL: 250 (ppm) [Canada] Consultlocal authorities for acceptable exposure limits.

Section 9: Physical and Chemical Properties

Physical state and appearance: Liquid.

Odor: Alcohol like. Pungent when crude.

Taste: Not available.

Molecular Weight: 32.04 g/mole

Color: Colorless.

pH (1% soln/water): Not available.

Boiling Point: 64.5°C (148.1°F)

Melting Point: -97.8°C (-144°F)

Critical Temperature: 240°C (464°F)

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Specific Gravity: 0.7915 (Water = 1)

Vapor Pressure: 12.3 kPa (@ 20°C)

Vapor Density: 1.11 (Air = 1)

Volatility: Not available.

Odor Threshold: 100 ppm

Water/Oil Dist. Coeff.: The product is more soluble in water; log(oil/water) = -0.8

Ionicity (in Water): Non-ionic.

Dispersion Properties: See solubility in water.

Solubility: Easily soluble in cold water, hot water.

Section 10: Stability and Reactivity Data

Stability: The product is stable.

Instability Temperature: Not available.

Conditions of Instability: Heat, ingnition sources, incompatible materials

Incompatibility with various substances: Reactive with oxidizing agents, metals, acids.

Corrosivity: Non-corrosive in presence of glass.

Special Remarks on Reactivity:Can react vigorously with oxidizers. Violent reaction with alkyl aluminum salts, acetyl bromide, chloroform + sodium methoxide,chromic anhydride, cyanuirc chlorite, lead perchlorate, phosphorous trioxide, nitric acid. Exothermic reaction with sodiumhydroxide + chloroform. Incompatible with beryllium dihydride, metals (potassium and magnesium), oxidants (bariumperchlorate, bromine, sodium hypochlorite, chlorine, hydrogen peroxide), potassium tert-butoxide, carbon tetrachloride, alkalimetals, metals (aluminum, potassium magnesium, zinc), and dichlormethane. Rapid autocatalytic dissolution of aluminum,magnesium or zinc in 9:1 methanol + carbon tetrachloride - sufficiently vigorous to be rated as potentially hazardous. Mayattack some plastics, rubber, and coatings.

Special Remarks on Corrosivity: Not available.

Polymerization: Will not occur.

Section 11: Toxicological Information

Routes of Entry: Absorbed through skin. Eye contact. Inhalation. Ingestion.

Toxicity to Animals:WARNING: THE LC50 VALUES HEREUNDER ARE ESTIMATED ON THE BASIS OF A 4-HOUR EXPOSURE. Acute oraltoxicity (LD50): 5628 mg/kg [Rat]. Acute dermal toxicity (LD50): 15800 mg/kg [Rabbit]. Acute toxicity of the vapor (LC50):64000 4 hours [Rat].

Chronic Effects on Humans:MUTAGENIC EFFECTS: Mutagenic for mammalian somatic cells. Mutagenic for bacteria and/or yeast. TERATOGENICEFFECTS: Classified POSSIBLE for human. Causes damage to the following organs: eyes. May cause damage to thefollowing organs: blood, kidneys, liver, brain, peripheral nervous system, upper respiratory tract, skin, central nervous system(CNS), optic nerve.

Other Toxic Effects on Humans:Hazardous in case of skin contact (irritant), of ingestion, of inhalation. Slightly hazardous in case of skin contact (permeator).

Special Remarks on Toxicity to Animals: Not available.

Special Remarks on Chronic Effects on Humans:

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Passes through the placental barrier. May affect genetic material. May cause birth defects and adverse reproductiveeffects(paternal and maternal effects and fetotoxicity ) based on animal studies.

Special Remarks on other Toxic Effects on Humans:

Section 12: Ecological Information

Ecotoxicity: Ecotoxicity in water (LC50): 29400 mg/l 96 hours [Fathead Minnow].

BOD5 and COD: Not available.

Products of Biodegradation:Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise.

Toxicity of the Products of Biodegradation: The products of degradation are less toxic than the product itself.

Special Remarks on the Products of Biodegradation:Methanol in water is rapidly biodegraded and volatilized. Aquatic hydrolysis, oxidation, photolysis, adsorption to sediment, andbioconcentration are not significant fate processes. The half-life of methanol in surfact water ranges from 24 hrs. to 168 hrs.Based on its vapor pressure, methanol exists almost entirely in the vapor phase in the ambient atmosphere. It is degraded byreaction with photochemically produced hydroxyl radicals and has an estimated half-life of 17.8 days. Methanol is physicallyremoved from air by rain due to its solubility. Methanol can react with NO2 in pollulted to form methyl nitrate. The half-life ofmethanol in air ranges from 71 hrs. (3 days) to 713 hrs. (29.7 days) based on photooxidation half-life in air.

Section 13: Disposal Considerations

Waste Disposal:Waste must be disposed of in accordance with federal, state and local environmental control regulations.

Section 14: Transport Information

DOT Classification: CLASS 3: Flammable liquid.

Identification: : Methyl alcohol UNNA: 1230 PG: II

Special Provisions for Transport: Not available.

Section 15: Other Regulatory Information

Federal and State Regulations:Connecticut hazardous material survey.: Methyl alcohol Illinois toxic substances disclosure to employee act: Methyl alcoholIllinois chemical safety act: Methyl alcohol New York release reporting list: Methyl alcohol Rhode Island RTK hazardoussubstances: Methyl alcohol Pennsylvania RTK: Methyl alcohol Minnesota: Methyl alcohol Massachusetts RTK: Methylalcohol Massachusetts spill list: Methyl alcohol New Jersey: Methyl alcohol New Jersey spill list: Methyl alcohol Louisianaspill reporting: Methyl alcohol California Directors List of Hazardous Substances (8CCR 339): Methyl alcohol TennesseHazardous Right to Know : Methyl alcohol TSCA 8(b) inventory: Methyl alcohol SARA 313 toxic chemical notification andrelease reporting: Methyl alcohol CERCLA: Hazardous substances.: Methyl alcohol: 5000 lbs. (2268 kg)

Other Regulations:OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200). EINECS: This product is on theEuropean Inventory of Existing Commercial Chemical Substances.

Other Classifications:

WHMIS (Canada):CLASS B-2: Flammable liquid with a flash point lower than 37.8°C (100°F). CLASS D-1B: Material causing immediate andserious toxic effects (TOXIC). CLASS D-2A: Material causing other toxic effects (VERY TOXIC). Class D-2B: Material causingother toxic effects (TOXIC).

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DSCL (EEC):R11- Highly flammable. R23/24/25- Toxic by inhalation, in contact with skin and if swallowed. R39- Danger of very seriousirreversible effects. R39/23/24/25- Toxic: danger of very serious irreversible effects through inhalation, in contact with skin andif swallowed. S7- Keep container tightly closed. S16- Keep away from sources of ignition - No smoking. S36/37- Wear suitableprotective clothing and gloves. S45- In case of accident or if you feel unwell, seek medical advice immediately (show the labelwhere possible).

HMIS (U.S.A.):

Health Hazard: 2

Fire Hazard: 3

Reactivity: 0

Personal Protection: h

National Fire Protection Association (U.S.A.):

Health: 1

Flammability: 3

Reactivity: 0

Specific hazard:

Protective Equipment:Gloves. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Wear appropriate respiratorwhen ventilation is inadequate. Splash goggles.

Section 16: Other Information

References:-SAX, N.I. Dangerous Properties of Indutrial Materials. Toronto, Van Nostrand Reinold, 6e ed. 1984. -Material safetydata sheet emitted by: la Commission de la Santé et de la Sécurité du Travail du Québec. -Hawley, G.G.. TheCondensed Chemical Dictionary, 11e ed., New York N.Y., Van Nostrand Reinold, 1987. LOLI, HSDB, RTECS, HAZARDTEXT,REPROTOX databases

Other Special Considerations: Not available.

Created: 10/10/2005 08:23 PM

Last Updated: 05/21/2013 12:00 PM

The information above is believed to be accurate and represents the best information currently available to us. However, wemake no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assumeno liability resulting from its use. Users should make their own investigations to determine the suitability of the information fortheir particular purposes. In no event shall ScienceLab.com be liable for any claims, losses, or damages of any third party or forlost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if ScienceLab.comhas been advised of the possibility of such damages.

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Material Safety Data Sheetn-heptane MSDS

Section 1: Chemical Product and Company Identification

Product Name: n-heptane

Catalog Codes: SLH2152, SLH2998, SLH1675, SLH1948

CAS#: 142-82-5

RTECS: MI7700000

TSCA: TSCA 8(b) inventory: n-heptane

CI#: Not available.

Synonym: Dipropyl methane; Heptyl hydride

Chemical Name: Heptane

Chemical Formula: C7H16

Contact Information:

Sciencelab.com, Inc.14025 Smith Rd.Houston, Texas 77396

US Sales: 1-800-901-7247International Sales: 1-281-441-4400

Order Online: ScienceLab.com

CHEMTREC (24HR Emergency Telephone), call:1-800-424-9300

International CHEMTREC, call: 1-703-527-3887

For non-emergency assistance, call: 1-281-441-4400

Section 2: Composition and Information on Ingredients

Composition:

Name CAS # % by Weight

{n-}heptane 142-82-5 100

Toxicological Data on Ingredients: n-heptane: VAPOR (LC50): Acute: 103000 mg/m 4 hours [Rat].

Section 3: Hazards Identification

Potential Acute Health Effects: Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, ofinhalation.

Potential Chronic Health Effects:CARCINOGENIC EFFECTS: Not available. MUTAGENIC EFFECTS: Not available. TERATOGENIC EFFECTS: Not available.DEVELOPMENTAL TOXICITY: Not available. The substance may be toxic to lungs, peripheral nervous system, upperrespiratory tract, skin, central nervous system (CNS). Repeated or prolonged exposure to the substance can produce targetorgans damage.

Section 4: First Aid Measures

Eye Contact:Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15minutes. Get medical attention if irritation occurs.

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Skin Contact:In case of contact, immediately flush skin with plenty of water. Cover the irritated skin with an emollient. Remove contaminatedclothing and shoes. Wash clothing before reuse. Thoroughly clean shoes before reuse. Get medical attention.

Serious Skin Contact: Not available.

Inhalation:If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medicalattention if symptoms appear.

Serious Inhalation:Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. Ifbreathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. Seek medicalattention.

Ingestion:If swallowed, do NOT induce vomiting. Never give anything by mouth to an unconscious person. Aspiration hazard ifswallowed- can enter lungs and cause damage. Loosen tight clothing such as a collar, tie, belt or waistband. Get medicalattention.

Serious Ingestion: Not available.

Section 5: Fire and Explosion Data

Flammability of the Product: Flammable.

Auto-Ignition Temperature: 203.89°C (399°F) - 223 C (433 F)

Flash Points: CLOSED CUP: -4°C (24.8°F). (TAG) OPEN CUP: -1.1111°C (30°F).

Flammable Limits: LOWER: 1.05% UPPER: 6.7%

Products of Combustion: These products are carbon oxides (CO, CO2).

Fire Hazards in Presence of Various Substances: Highly flammable in presence of open flames and sparks, of heat.

Explosion Hazards in Presence of Various Substances:Risks of explosion of the product in presence of mechanical impact: Not available. Risks of explosion of the product inpresence of static discharge: Not available. Slightly explosive in presence of heat.

Fire Fighting Media and Instructions:Flammable liquid, insoluble in water. SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use water spray or fog.

Special Remarks on Fire Hazards:Flaming occurs when liquid chlorine in n-Heptane is added to added to red phosphorous. Vapors may form explosive mixtureswith air. Vapor may travel considerable distance to source of ignition and flash back.

Special Remarks on Explosion Hazards: Vapors may form explosive mixtures in air.

Section 6: Accidental Release Measures

Small Spill: Absorb with an inert material and put the spilled material in an appropriate waste disposal.

Large Spill:Flammable liquid, insoluble in water. Keep away from heat. Keep away from sources of ignition. Stop leak if without risk.Absorb with DRY earth, sand or other non-combustible material. Do not get water inside container. Do not touch spilledmaterial. Prevent entry into sewers, basements or confined areas; dike if needed. Call for assistance on disposal. Be carefulthat the product is not present at a concentration level above TLV. Check TLV on the MSDS and with local authorities.

Section 7: Handling and Storage

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Precautions:Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do notbreathe gas/fumes/ vapor/spray. If ingested, seek medical advice immediately and show the container or the label. Keep awayfrom incompatibles such as oxidizing agents.

Storage:Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed andsealed until ready for use. Avoid all possible sources of ignition (spark or flame).

Section 8: Exposure Controls/Personal Protection

Engineering Controls:Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their respectivethreshold limit value. Ensure that eyewash stations and safety showers are proximal to the work-station location.

Personal Protection:Safety glasses. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.

Personal Protection in Case of a Large Spill:Splash goggles. Full suit. Vapor respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoidinhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling thisproduct.

Exposure Limits:TWA: 500 (ppm) from OSHA (PEL) [United States] TWA: 2000 (mg/m3) from OSHA (PEL) [United States] TWA: 350 CEIL:1800 (mg/m3) from NIOSH [United States] TWA: 85 CEIL: 440 (ppm) from NIOSH [United States] TWA: 400 STEL: 500 (ppm)from ACGIH (TLV) [United States] TWA: 500 (ppm) [United Kingdom (UK)] TWA: 400 STEL: 500 (ppm) [Canada] TWA: 1640STEL: 2049 (mg/m3) [Canada] TWA: 400 STEL: 500 (ppm) [Belgium] TWA: 200 (ppm) [Norway] TWA: 300 STEL: 500 (ppm)[Finland] TWA: 500 (ppm) [Austria]Consult local authorities for acceptable exposure limits.

Section 9: Physical and Chemical Properties

Physical state and appearance: Liquid.

Odor: Hydrocarbon. Gasoline-like

Taste: Not available.

Molecular Weight: 100.21 g/mole

Color: Clear Colorless.

pH (1% soln/water): Not applicable.

Boiling Point: 98.4 (209.1°F)

Melting Point: -90.7°C (-131.3°F)

Critical Temperature: Not available.

Specific Gravity: 0.6838 (Water = 1)

Vapor Pressure: 5.3 kPa (@ 20°C)

Vapor Density: 3.5 (Air = 1)

Volatility: Not available.

Odor Threshold: 150 ppm

Water/Oil Dist. Coeff.: The product is more soluble in oil; log(oil/water) = 4.7

Ionicity (in Water): Not available.

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Dispersion Properties: See solubility in water, diethyl ether, acetone.

Solubility:Soluble in diethyl ether, acetone. Insoluble in cold water. Soluble in alcohol. Solubility in Chloroform, Petroleum Ether, Ether,Acetone: >10% Floats on water.

Section 10: Stability and Reactivity Data

Stability: The product is stable.

Instability Temperature: Not available.

Conditions of Instability: Heat, ignition sources (flames, sparks), incompatible materials

Incompatibility with various substances: Reactive with oxidizing agents.

Corrosivity: Not considered to be corrosive for metals and glass.

Special Remarks on Reactivity: Not available.

Special Remarks on Corrosivity: Not available.

Polymerization: Will not occur.

Section 11: Toxicological Information

Routes of Entry: Absorbed through skin. Inhalation.

Toxicity to Animals:WARNING: THE LC50 VALUES HEREUNDER ARE ESTIMATED ON THE BASIS OF A 4-HOUR EXPOSURE. Acute toxicityof the vapor (LC50): 103000 mg/m3 4 hours [Rat].

Chronic Effects on Humans:May cause damage to the following organs: lungs, peripheral nervous system, upper respiratory tract, skin, central nervoussystem (CNS).

Other Toxic Effects on Humans: Slightly hazardous in case of skin contact (irritant), of ingestion, of inhalation.

Special Remarks on Toxicity to Animals: Not available.

Special Remarks on Chronic Effects on Humans: Not available.

Special Remarks on other Toxic Effects on Humans:Acute Potential Health Effects: Skin: Causes skin irritation. It can be absorbed through the skin. Eyes: Contact with liquid maycause eye irritation. Contact with vapors is not expected to cause eye irritation. Inhalation: Inhalation of vapor or mist causesrespiratory tract and mucous membrane irritation. It can affect behavior/central nervous system and cause central nervoussystem effects (mild excitement followed CNS depression which is characterized by headache, nausea, dizziness, hilarity,hallucinations, lightheadness, distorted perceptions, convulsions, weakness, loss of judgement and coordination, narcosis,semi-conciousness, coma and death at higher doses). It may cause cardiac effects (irregular heartbeat/cardiac arrhythmias, orheart to stop beating), and pulmonary edema. It is readily absorbed by the inhalation route. Ingestion: Causes gastrointestinaltract irritation with nausea, vomiting, swelling of the abdomen. Aspiration into the lungs can produce chemical pneumonitis.It can also affect behavior/central nervous system with symptoms paralleling those of inhalation. Chronic Potential HealthEffects: Skin: Prolonged or repeated skin contact can defat the skin and product irritation and dermatitis. Inhalation: Repeatedor prolonged inhalation may affect behavior/central nervous system (symptoms similar to acute inhalation) and may produceminimal peripheral nerve damage (polyneuropathy) with numbness and tingling of the extremities in a stocking-and -glovepattern. Reversible of polyneuropathy as been reversible by a year following removal from exposure. It may also affect thebrain, blood (anemia), and hearing (mild change in auditory threshold), and may also cause weight loss, Ingestion: Prolongedor repeated ingestion may affect the liver, urinary system, blood (changes in blood serum compostion).

Section 12: Ecological Information

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Ecotoxicity: Not available.

BOD5 and COD: Not available.

Products of Biodegradation:Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise.

Toxicity of the Products of Biodegradation: The product itself and its products of degradation are not toxic.

Special Remarks on the Products of Biodegradation: Not available.

Section 13: Disposal Considerations

Waste Disposal:Waste must be disposed of in accordance with federal, state and local environmental control regulations.

Section 14: Transport Information

DOT Classification: CLASS 3: Flammable liquid.

Identification: : Heptane UNNA: 1206 PG: II

Special Provisions for Transport: Not available.

Section 15: Other Regulatory Information

Federal and State Regulations:Connecticut hazardous material survey.: n-heptane Illinois toxic substances disclosure to employee act: n-heptane RhodeIsland RTK hazardous substances: n-heptane Pennsylvania RTK: n-heptane Minnesota: n-heptane Massachusetts RTK: n-heptane Massachusetts spill list: n-heptane New Jersey: n-heptane California Director's List of Hazardous Substances: n-heptane TSCA 8(b) inventory: n-heptane TSCA 4(a) proposed test rules: n-heptane TSCA 8(d) H and S data reporting: n-heptane: Effective date: 1/26/94; Sunset date: 6/30/98

Other Regulations:OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200). EINECS: This product is on theEuropean Inventory of Existing Commercial Chemical Substances.

Other Classifications:

WHMIS (Canada):CLASS B-2: Flammable liquid with a flash point lower than 37.8°C (100°F). CLASS D-2B: Material causing other toxic effects(TOXIC).

DSCL (EEC):

HMIS (U.S.A.):

Health Hazard: 1

Fire Hazard: 3

Reactivity: 0

Personal Protection: g

National Fire Protection Association (U.S.A.):

Health: 1

Flammability: 3

Reactivity: 0

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Specific hazard:

Protective Equipment:Gloves. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Wear appropriate respiratorwhen ventilation is inadequate. Safety glasses.

Section 16: Other Information

References: Not available.

Other Special Considerations: Not available.

Created: 10/09/2005 05:42 PM

Last Updated: 05/21/2013 12:00 PM

The information above is believed to be accurate and represents the best information currently available to us. However, wemake no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assumeno liability resulting from its use. Users should make their own investigations to determine the suitability of the information fortheir particular purposes. In no event shall ScienceLab.com be liable for any claims, losses, or damages of any third party or forlost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if ScienceLab.comhas been advised of the possibility of such damages.

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Material Safety Data SheetSulfuric acid MSDS

Section 1: Chemical Product and Company Identification

Product Name: Sulfuric acid

Catalog Codes: SLS2539, SLS1741, SLS3166, SLS2371,SLS3793

CAS#: 7664-93-9

RTECS: WS5600000

TSCA: TSCA 8(b) inventory: Sulfuric acid

CI#: Not applicable.

Synonym: Oil of Vitriol; Sulfuric Acid

Chemical Name: Hydrogen sulfate

Chemical Formula: H2-SO4

Contact Information:

Sciencelab.com, Inc.14025 Smith Rd.Houston, Texas 77396

US Sales: 1-800-901-7247International Sales: 1-281-441-4400

Order Online: ScienceLab.com

CHEMTREC (24HR Emergency Telephone), call:1-800-424-9300

International CHEMTREC, call: 1-703-527-3887

For non-emergency assistance, call: 1-281-441-4400

Section 2: Composition and Information on Ingredients

Composition:

Name CAS # % by Weight

Sulfuric acid 7664-93-9 95 - 98

Toxicological Data on Ingredients: Sulfuric acid: ORAL (LD50): Acute: 2140 mg/kg [Rat.]. VAPOR (LC50): Acute: 510 mg/m2 hours [Rat]. 320 mg/m 2 hours [Mouse].

Section 3: Hazards Identification

Potential Acute Health Effects:Very hazardous in case of skin contact (corrosive, irritant, permeator), of eye contact (irritant, corrosive), of ingestion,of inhalation. Liquid or spray mist may produce tissue damage particularly on mucous membranes of eyes, mouth andrespiratory tract. Skin contact may produce burns. Inhalation of the spray mist may produce severe irritation of respiratorytract, characterized by coughing, choking, or shortness of breath. Severe over-exposure can result in death. Inflammation ofthe eye is characterized by redness, watering, and itching. Skin inflammation is characterized by itching, scaling, reddening,or, occasionally, blistering.

Potential Chronic Health Effects:CARCINOGENIC EFFECTS: Classified 1 (Proven for human.) by IARC, + (Proven.) by OSHA. Classified A2 (Suspected forhuman.) by ACGIH. MUTAGENIC EFFECTS: Not available. TERATOGENIC EFFECTS: Not available. DEVELOPMENTALTOXICITY: Not available. The substance may be toxic to kidneys, lungs, heart, cardiovascular system, upper respiratory tract,eyes, teeth. Repeated or prolonged exposure to the substance can produce target organs damage. Repeated or prolonged

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contact with spray mist may produce chronic eye irritation and severe skin irritation. Repeated or prolonged exposure to spraymist may produce respiratory tract irritation leading to frequent attacks of bronchial infection. Repeated exposure to a highlytoxic material may produce general deterioration of health by an accumulation in one or many human organs.

Section 4: First Aid Measures

Eye Contact:Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15minutes. Cold water may be used. Get medical attention immediately.

Skin Contact:In case of contact, immediately flush skin with plenty of water for at least 15 minutes while removing contaminated clothingand shoes. Cover the irritated skin with an emollient. Cold water may be used.Wash clothing before reuse. Thoroughly cleanshoes before reuse. Get medical attention immediately.

Serious Skin Contact:Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek immediate medicalattention.

Inhalation:If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medicalattention immediately.

Serious Inhalation:Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. Ifbreathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. WARNING: It maybe hazardous to the person providing aid to give mouth-to-mouth resuscitation when the inhaled material is toxic, infectious orcorrosive. Seek immediate medical attention.

Ingestion:Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconsciousperson. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention if symptoms appear.

Serious Ingestion: Not available.

Section 5: Fire and Explosion Data

Flammability of the Product: Non-flammable.

Auto-Ignition Temperature: Not applicable.

Flash Points: Not applicable.

Flammable Limits: Not applicable.

Products of Combustion:Products of combustion are not available since material is non-flammable. However, products of decompostion include fumesof oxides of sulfur. Will react with water or steam to produce toxic and corrosive fumes. Reacts with carbonates to generatecarbon dioxide gas. Reacts with cyanides and sulfides to form poisonous hydrogen cyanide and hydrogen sulfide respectively.

Fire Hazards in Presence of Various Substances: Combustible materials

Explosion Hazards in Presence of Various Substances:Risks of explosion of the product in presence of mechanical impact: Not available. Risks of explosion of the product inpresence of static discharge: Not available. Slightly explosive in presence of oxidizing materials.

Fire Fighting Media and Instructions: Not applicable.

Special Remarks on Fire Hazards:Metal acetylides (Monocesium and Monorubidium), and carbides ignite with concentrated sulfuric acid. White Phosphorous +boiling Sulfuric acid or its vapor ignites on contact. May ignite other combustible materials. May cause fire when sulfuric acidis mixed with Cyclopentadiene, cyclopentanone oxime, nitroaryl amines, hexalithium disilicide, phorphorous (III) oxide, andoxidizing agents such as chlorates, halogens, permanganates.

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Special Remarks on Explosion Hazards:M i x t u r e s o f s u l f u r i c a c i d a n d a n y o f t h e f o l l o w i n g c a n e x p l o d e : p - n i t r o t o l u e n e , p e n t a s il v e r trihydroxydiaminophosphate, perchlorates, alcohols with strong hydrogen peroxide, ammonium tetraperoxychromate,mercuric nitrite, potassium chlorate, potassium permanganate with potassium chloride, carbides, nitro compounds, nitrates,carbides, phosphorous, iodides, picratres, fulminats, dienes, alcohols (when heated) Nitramide decomposes explosivelyon contact with concentrated sulfuric acid. 1,3,5-Trinitrosohexahydro-1,3,5-triazine + sulfuric acid causes explosivedecompositon.

Section 6: Accidental Release Measures

Small Spill:Dilute with water and mop up, or absorb with an inert dry material and place in an appropriate waste disposal container. Ifnecessary: Neutralize the residue with a dilute solution of sodium carbonate.

Large Spill:Corrosive liquid. Poisonous liquid. Stop leak if without risk. Absorb with DRY earth, sand or other non-combustible material.Do not get water inside container. Do not touch spilled material. Use water spray curtain to divert vapor drift. Use water sprayto reduce vapors. Prevent entry into sewers, basements or confined areas; dike if needed. Call for assistance on disposal.Neutralize the residue with a dilute solution of sodium carbonate. Be careful that the product is not present at a concentrationlevel above TLV. Check TLV on the MSDS and with local authorities.

Section 7: Handling and Storage

Precautions:Keep locked up.. Keep container dry. Do not ingest. Do not breathe gas/fumes/ vapor/spray. Never add water to this product.In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and showthe container or the label. Avoid contact with skin and eyes. Keep away from incompatibles such as oxidizing agents, reducingagents, combustible materials, organic materials, metals, acids, alkalis, moisture. May corrode metallic surfaces. Store in ametallic or coated fiberboard drum using a strong polyethylene inner package.

Storage:Hygroscopic. Reacts. violently with water. Keep container tightly closed. Keep container in a cool, well-ventilated area. Do notstore above 23°C (73.4°F).

Section 8: Exposure Controls/Personal Protection

Engineering Controls:Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their respectivethreshold limit value. Ensure that eyewash stations and safety showers are proximal to the work-station location.

Personal Protection:Face shield. Full suit. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Gloves. Boots.

Personal Protection in Case of a Large Spill:Splash goggles. Full suit. Vapor respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoidinhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling thisproduct.

Exposure Limits:TWA: 1 STEL: 3 (mg/m3) [Australia] Inhalation TWA: 1 (mg/m3) from OSHA (PEL) [United States] Inhalation TWA: 1 STEL: 3(mg/m3) from ACGIH (TLV) [United States] [1999] Inhalation TWA: 1 (mg/m3) from NIOSH [United States] Inhalation TWA: 1(mg/m3) [United Kingdom (UK)]Consult local authorities for acceptable exposure limits.

Section 9: Physical and Chemical Properties

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Physical state and appearance: Liquid. (Thick oily liquid.)

Odor: Odorless, but has a choking odor when hot.

Taste: Marked acid taste. (Strong.)

Molecular Weight: 98.08 g/mole

Color: Colorless.

pH (1% soln/water): Acidic.

Boiling Point:270°C (518°F) - 340 deg. C Decomposes at 340 deg. C

Melting Point: -35°C (-31°F) to 10.36 deg. C (93% to 100% purity)

Critical Temperature: Not available.

Specific Gravity: 1.84 (Water = 1)

Vapor Pressure: Not available.

Vapor Density: 3.4 (Air = 1)

Volatility: Not available.

Odor Threshold: Not available.

Water/Oil Dist. Coeff.: Not available.

Ionicity (in Water): Not available.

Dispersion Properties: See solubility in water.

Solubility:Easily soluble in cold water. Sulfuric is soluble in water with liberation of much heat. Soluble in ethyl alcohol.

Section 10: Stability and Reactivity Data

Stability: The product is stable.

Instability Temperature: Not available.

Conditions of Instability:Conditions to Avoid: Incompatible materials, excess heat, combustible material materials, organic materials, exposure to moistair or water, oxidizers, amines, bases. Always add the acid to water, never the reverse.

Incompatibility with various substances:Reactive with oxidizing agents, reducing agents, combustible materials, organic materials, metals, acids, alkalis, moisture.

Corrosivity:Extremely corrosive in presence of aluminum, of copper, of stainless steel(316). Highly corrosive in presence of stainlesssteel(304). Non-corrosive in presence of glass.

Special Remarks on Reactivity:Hygroscopic. Strong oxidizer. Reacts violently with water and alcohol especially when water is added to the product.Incompatible (can react explosively or dangerously) with the following: ACETIC ACID, ACRYLIC ACID, AMMONIUMHYDROXIDE, CRESOL, CUMENE, DICHLOROETHYL ETHER, ETHYLENE CYANOHYDRIN, ETHYLENEIMINE, NITRICACID, 2-NITROPROPANE, PROPYLENE OXIDE, SULFOLANE, VINYLIDENE CHLORIDE, DIETHYLENE GLYCOLMONOMETHYL ETHER, ETHYL ACETATE, ETHYLENE CYANOHYDRIN, ETHYLENE GLYCOL MONOETHYL ETHERACETATE, GLYOXAL, METHYL ETHYL KETONE, dehydrating agents, organic materials, moisture (water), Acetic anhydride,Acetone, cyanohydrin, Acetone+nitric acid, Acetone + potassium dichromate, Acetonitrile, Acrolein, Acrylonitrile, Acrylonitrile+water, Alcohols + hydrogen peroxide, ally compounds such as Allyl alcohol, and Allyl Chloride, 2-Aminoethanol, Ammoniumhydroxide, Ammonium triperchromate, Aniline, Bromate + metals, Bromine pentafluoride, n-Butyraldehyde, Carbides, Cesiumacetylene carbide, Chlorates, Cyclopentanone oxime, chlorinates, Chlorates + metals, Chlorine trifluoride, Chlorosulfonicacid, 2-cyano-4-nitrobenzenediazonium hydrogen sulfate, Cuprous nitride, p-chloronitrobenzene, 1,5-Dinitronaphthlene +

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sulfur, Diisobutylene, p-dimethylaminobenzaldehyde, 1,3-Diazidobenzene, Dimethylbenzylcarbinol + hydrogen peroxide,Epichlorohydrin, Ethyl alcohol + hydrogen peroxide, Ethylene diamine, Ethylene glycol and other glycols, , Ethylenimine,Fulminates, hydrogen peroxide, Hydrochloric acid, Hydrofluoric acid, Iodine heptafluoride, Indane + nitric acid, Iron, Isoprene,Lithium silicide, Mercuric nitride, Mesityl oxide, Mercury nitride, Metals (powdered), Nitromethane, Nitric acid + glycerides,p-Nitrotoluene, Pentasilver trihydroxydiaminophosphate, Perchlorates, Perchloric acid, Permanganates + benzene, 1-Phenyl-2-methylpropyl alcohol + hydrogen peroxide, Phosphorus, Phosphorus isocyanate, Picrates, Potassium tert-butoxide,Potassium chlorate, Potassium Permanganate and other permanganates, halogens, amines, Potassium Permanganate +Potassium chloride, Potassium Permanganate + water, Propiolactone (beta)-, Pyridine, Rubidium aceteylene carbide, Silverpermanganate, Sodium, Sodium carbonate, sodium hydroxide, Steel, styrene monomer, toluene + nitric acid, Vinyl acetate,Thalium (I) azidodithiocarbonate, Zinc chlorate, Zinc Iodide, azides, carbonates, cyanides, sulfides, sulfites, alkali hydrides,carboxylic acid anhydrides, nitriles, olefinic organics, aqueous acids, cyclopentadiene, cyano-alcohols, metal acetylides,Hydrogen gas is generated by the action of the acid on most metals (i.e. lead, copper, tin, zinc, aluminum, etc.). Concentratedsulfuric acid oxidizes, dehydrates, or sulfonates most organic compounds.

Special Remarks on Corrosivity:Non-corrosive to lead and mild steel, but dillute acid attacks most metals. Attacks many metals releasing hydrogen. Minorcorrosive effect on bronze. No corrosion data on brass or zinc.

Polymerization: Will not occur.

Section 11: Toxicological Information

Routes of Entry: Absorbed through skin. Dermal contact. Eye contact. Inhalation. Ingestion.

Toxicity to Animals:WARNING: THE LC50 VALUES HEREUNDER ARE ESTIMATED ON THE BASIS OF A 4-HOUR EXPOSURE. Acute oraltoxicity (LD50): 2140 mg/kg [Rat.]. Acute toxicity of the vapor (LC50): 320 mg/m3 2 hours [Mouse].

Chronic Effects on Humans:CARCINOGENIC EFFECTS: Classified 1 (Proven for human.) by IARC, + (Proven.) by OSHA. Classified A2 (Suspectedfor human.) by ACGIH. May cause damage to the following organs: kidneys, lungs, heart, cardiovascular system, upperrespiratory tract, eyes, teeth.

Other Toxic Effects on Humans:Extremely hazardous in case of inhalation (lung corrosive). Very hazardous in case of skin contact (corrosive, irritant,permeator), of eye contact (corrosive), of ingestion, .

Special Remarks on Toxicity to Animals: Not available.

Special Remarks on Chronic Effects on Humans:Mutagenicity: Cytogenetic Analysis: Hamster, ovary = 4mmol/L Reproductive effects: May cause adverse reproductive effectsbased on animal data. Developmental abnormalities (musculoskeletal) in rabbits at a dose of 20 mg/m3 for 7 hrs.(RTECS)Teratogenecity: neither embryotoxic, fetoxic, nor teratogenetic in mice or rabbits at inhaled doses producing some maternaltoxicity

Special Remarks on other Toxic Effects on Humans:Acute Potential Health Effects: Skin: Causes severe skin irritation and burns. Continued contact can cause tissue necrosis.Eye: Causes severe eye irritation and burns. May cause irreversible eye injury. Ingestion: Harmful if swallowed. May causepermanent damage to the digestive tract. Causes gastrointestial tract burns. May cause perforation of the stomach, GIbleeding, edema of the glottis, necrosis and scarring, and sudden circulatory collapse(similar to acute inhalation). It mayalso cause systemic toxicity with acidosis. Inhalation: May cause severe irritation of the respiratory tract and mucousmembranes with sore throat, coughing, shortness of breath, and delayed lung edema. Causes chemical burns to the repiratorytract. Inhalation may be fatal as a result of spasm, inflammation, edema of the larynx and bronchi, chemical pneumonitis,and pulmonary edema. Cause corrosive action on mucous membranes. May affect cardiovascular system (hypotension,depressed cardiac output, bradycardia). Circulatory collapse with clammy skin, weak and rapid pulse, shallow respiration, andscanty urine may follow. Circulatory shock is often the immediate cause of death. May also affect teeth(changes in teeth andsupporting structures - erosion, discoloration). Chronic Potential Health Effects: Inhalation: Prolonged or repeated inhalationmay affect behavior (muscle contraction or spasticity), urinary system (kidney damage), and cardiovascular system, heart(ischemic heart leisons), and respiratory system/lungs(pulmonary edema, lung damage), teeth (dental discoloration, erosion).Skin: Prolonged or repeated skin contact may cause dermatitis, an allergic skin reaction.

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Section 12: Ecological Information

Ecotoxicity: Ecotoxicity in water (LC50): 49 mg/l 48 hours [bluegill/sunfish].

BOD5 and COD: Not available.

Products of Biodegradation:Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise.

Toxicity of the Products of Biodegradation: The products of degradation are less toxic than the product itself.

Special Remarks on the Products of Biodegradation: Not available.

Section 13: Disposal Considerations

Waste Disposal:Sulfuric acid may be placed in sealed container or absorbed in vermiculite, dry sand, earth, or a similar material. It may alsobe diluted and neutralized. Be sure to consult with local or regional authorities (waste regulators) prior to any disposal. Wastemust be disposed of in accordance with federal, state and local environmental control regulations.

Section 14: Transport Information

DOT Classification: Class 8: Corrosive material

Identification: : Sulfuric acid UNNA: 1830 PG: II

Special Provisions for Transport: Not available.

Section 15: Other Regulatory Information

Federal and State Regulations:Illinois toxic substances disclosure to employee act: Sulfuric acid New York release reporting list: Sulfuric acid RhodeIsland RTK hazardous substances: Sulfuric acid Pennsylvania RTK: Sulfuric acid Minnesota: Sulfuric acid MassachusettsRTK: Sulfuric acid New Jersey: Sulfuric acid California Director's List of Hazardous Substances (8 CCR 339): Sulfuric acidTennessee RTK: Sulfuric acid TSCA 8(b) inventory: Sulfuric acid SARA 302/304/311/312 extremely hazardous substances:Sulfuric acid SARA 313 toxic chemical notification and release reporting: Sulfuric acid CERCLA: Hazardous substances.:Sulfuric acid: 1000 lbs. (453.6 kg)

Other Regulations:OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200). EINECS: This product is on theEuropean Inventory of Existing Commercial Chemical Substances.

Other Classifications:

WHMIS (Canada):CLASS D-1A: Material causing immediate and serious toxic effects (VERY TOXIC). CLASS E: Corrosive liquid.

DSCL (EEC):R35- Causes severe burns. S2- Keep out of the reach of children. S26- In case of contact with eyes, rinse immediately withplenty of water and seek medical advice. S30- Never add water to this product. S45- In case of accident or if you feel unwell,seek medical advice immediately (show the label where possible).

HMIS (U.S.A.):

Health Hazard: 3

Fire Hazard: 0

Reactivity: 2

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Personal Protection:

National Fire Protection Association (U.S.A.):

Health: 3

Flammability: 0

Reactivity: 2

Specific hazard:

Protective Equipment:Gloves. Full suit. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Wear appropriate respiratorwhen ventilation is inadequate. Face shield.

Section 16: Other Information

References:-Material safety data sheet emitted by: la Commission de la Santé et de la Sécurité du Travail du Québec. -The Sigma-AldrichLibrary of Chemical Safety Data, Edition II. -Hawley, G.G.. The Condensed Chemical Dictionary, 11e ed., New York N.Y., VanNostrand Reinold, 1987.

Other Special Considerations: Not available.

Created: 10/09/2005 11:58 PM

Last Updated: 05/21/2013 12:00 PM

The information above is believed to be accurate and represents the best information currently available to us. However, wemake no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assumeno liability resulting from its use. Users should make their own investigations to determine the suitability of the information fortheir particular purposes. In no event shall ScienceLab.com be liable for any claims, losses, or damages of any third party or forlost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if ScienceLab.comhas been advised of the possibility of such damages.

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Material Safety Data SheetToluene MSDS

Section 1: Chemical Product and Company Identification

Product Name: Toluene

Catalog Codes: SLT2857, SLT3277

CAS#: 108-88-3

RTECS: XS5250000

TSCA: TSCA 8(b) inventory: Toluene

CI#: Not available.

Synonym: Toluol, Tolu-Sol; Methylbenzene; Methacide;Phenylmethane; Methylbenzol

Chemical Name: Toluene

Chemical Formula: C6-H5-CH3 or C7-H8

Contact Information:

Sciencelab.com, Inc.14025 Smith Rd.Houston, Texas 77396

US Sales: 1-800-901-7247International Sales: 1-281-441-4400

Order Online: ScienceLab.com

CHEMTREC (24HR Emergency Telephone), call:1-800-424-9300

International CHEMTREC, call: 1-703-527-3887

For non-emergency assistance, call: 1-281-441-4400

Section 2: Composition and Information on Ingredients

Composition:

Name CAS # % by Weight

Toluene 108-88-3 100

Toxicological Data on Ingredients: Toluene: ORAL (LD50): Acute: 636 mg/kg [Rat]. DERMAL (LD50): Acute: 14100 mg/kg[Rabbit]. VAPOR (LC50): Acute: 49000 mg/m 4 hours [Rat]. 440 ppm 24 hours [Mouse].

Section 3: Hazards Identification

Potential Acute Health Effects:Hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation. Slightly hazardous in case ofskin contact (permeator).

Potential Chronic Health Effects:CARCINOGENIC EFFECTS: A4 (Not classifiable for human or animal.) by ACGIH, 3 (Not classifiable for human.) by IARC.MUTAGENIC EFFECTS: Not available. TERATOGENIC EFFECTS: Not available. DEVELOPMENTAL TOXICITY: Notavailable. The substance may be toxic to blood, kidneys, the nervous system, liver, brain, central nervous system (CNS).Repeated or prolonged exposure to the substance can produce target organs damage.

Section 4: First Aid Measures

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Eye Contact:Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15minutes. Get medical attention.

Skin Contact:In case of contact, immediately flush skin with plenty of water. Cover the irritated skin with an emollient. Remove contaminatedclothing and shoes. Wash clothing before reuse. Thoroughly clean shoes before reuse. Get medical attention.

Serious Skin Contact:Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek immediate medicalattention.

Inhalation:If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medicalattention.

Serious Inhalation:Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. Ifbreathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. WARNING: It maybe hazardous to the person providing aid to give mouth-to-mouth resuscitation when the inhaled material is toxic, infectious orcorrosive. Seek medical attention.

Ingestion:Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconsciousperson. If large quantities of this material are swallowed, call a physician immediately. Loosen tight clothing such as a collar,tie, belt or waistband.

Serious Ingestion: Not available.

Section 5: Fire and Explosion Data

Flammability of the Product: Flammable.

Auto-Ignition Temperature: 480°C (896°F)

Flash Points: CLOSED CUP: 4.4444°C (40°F). (Setaflash) OPEN CUP: 16°C (60.8°F).

Flammable Limits: LOWER: 1.1% UPPER: 7.1%

Products of Combustion: These products are carbon oxides (CO, CO2).

Fire Hazards in Presence of Various Substances:Flammable in presence of open flames and sparks, of heat. Non-flammable in presence of shocks.

Explosion Hazards in Presence of Various Substances:Risks of explosion of the product in presence of mechanical impact: Not available. Risks of explosion of the product inpresence of static discharge: Not available.

Fire Fighting Media and Instructions:Flammable liquid, insoluble in water. SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use water spray or fog.

Special Remarks on Fire Hazards: Not available.

Special Remarks on Explosion Hazards:Toluene forms explosive reaction with 1,3-dichloro-5,5-dimethyl-2,4-imidazolididione; dinitrogen tetraoxide; concentrated nitricacid, sulfuric acid + nitric acid; N2O4; AgClO4; BrF3; Uranium hexafluoride; sulfur dichloride. Also forms an explosive mixturewith tetranitromethane.

Section 6: Accidental Release Measures

Small Spill: Absorb with an inert material and put the spilled material in an appropriate waste disposal.

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Large Spill:Toxic flammable liquid, insoluble or very slightly soluble in water. Keep away from heat. Keep away from sources of ignition.Stop leak if without risk. Absorb with DRY earth, sand or other non-combustible material. Do not get water inside container.Do not touch spilled material. Prevent entry into sewers, basements or confined areas; dike if needed. Call for assistance ondisposal. Be careful that the product is not present at a concentration level above TLV. Check TLV on the MSDS and with localauthorities.

Section 7: Handling and Storage

Precautions:Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do notbreathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratoryequipment. If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin andeyes. Keep away from incompatibles such as oxidizing agents.

Storage:Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed andsealed until ready for use. Avoid all possible sources of ignition (spark or flame).

Section 8: Exposure Controls/Personal Protection

Engineering Controls:Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their respectivethreshold limit value. Ensure that eyewash stations and safety showers are proximal to the work-station location.

Personal Protection:Splash goggles. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.

Personal Protection in Case of a Large Spill:Splash goggles. Full suit. Vapor respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoidinhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling thisproduct.

Exposure Limits:TWA: 200 STEL: 500 CEIL: 300 (ppm) from OSHA (PEL) [United States] TWA: 50 (ppm) from ACGIH (TLV) [United States]SKIN TWA: 100 STEL: 150 from NIOSH [United States] TWA: 375 STEL: 560 (mg/m3) from NIOSH [United States] Consultlocal authorities for acceptable exposure limits.

Section 9: Physical and Chemical Properties

Physical state and appearance: Liquid.

Odor: Sweet, pungent, Benzene-like.

Taste: Not available.

Molecular Weight: 92.14 g/mole

Color: Colorless.

pH (1% soln/water): Not applicable.

Boiling Point: 110.6°C (231.1°F)

Melting Point: -95°C (-139°F)

Critical Temperature: 318.6°C (605.5°F)

Specific Gravity: 0.8636 (Water = 1)

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Vapor Pressure: 3.8 kPa (@ 25°C)

Vapor Density: 3.1 (Air = 1)

Volatility: Not available.

Odor Threshold: 1.6 ppm

Water/Oil Dist. Coeff.: The product is more soluble in oil; log(oil/water) = 2.7

Ionicity (in Water): Not available.

Dispersion Properties: See solubility in water, diethyl ether, acetone.

Solubility:Soluble in diethyl ether, acetone. Practically insoluble in cold water. Soluble in ethanol, benzene, chloroform, glacial aceticacid, carbon disulfide. Solubility in water: 0.561 g/l @ 25 deg. C.

Section 10: Stability and Reactivity Data

Stability: The product is stable.

Instability Temperature: Not available.

Conditions of Instability: Heat, ignition sources (flames, sparks, static), incompatible materials

Incompatibility with various substances: Reactive with oxidizing agents.

Corrosivity: Non-corrosive in presence of glass.

Special Remarks on Reactivity:Incompatible with strong oxidizers, silver perchlorate, sodium difluoride, Tetranitromethane, Uranium Hexafluoride. FrozenBromine Trifluoride reacts violently with Toluene at -80 deg. C. Reacts chemically with nitrogen oxides, or halogens to formnitrotoluene, nitrobenzene, and nitrophenol and halogenated products, respectively.

Special Remarks on Corrosivity: Not available.

Polymerization: Will not occur.

Section 11: Toxicological Information

Routes of Entry: Absorbed through skin. Dermal contact. Eye contact. Inhalation. Ingestion.

Toxicity to Animals:WARNING: THE LC50 VALUES HEREUNDER ARE ESTIMATED ON THE BASIS OF A 4-HOUR EXPOSURE. Acute oraltoxicity (LD50): 636 mg/kg [Rat]. Acute dermal toxicity (LD50): 14100 mg/kg [Rabbit]. Acute toxicity of the vapor (LC50): 44024 hours [Mouse].

Chronic Effects on Humans:CARCINOGENIC EFFECTS: A4 (Not classifiable for human or animal.) by ACGIH, 3 (Not classifiable for human.) by IARC.May cause damage to the following organs: blood, kidneys, the nervous system, liver, brain, central nervous system (CNS).

Other Toxic Effects on Humans:Hazardous in case of skin contact (irritant), of ingestion, of inhalation. Slightly hazardous in case of skin contact (permeator).

Special Remarks on Toxicity to Animals:Lowest Published Lethal Dose: LDL [Human] - Route: Oral; Dose: 50 mg/kg LCL [Rabbit] - Route: Inhalation; Dose: 55000ppm/40min

Special Remarks on Chronic Effects on Humans:Detected in maternal milk in human. Passes through the placental barrier in human. Embryotoxic and/or foetotoxic in animal.May cause adverse reproductive effects and birth defects (teratogenic). May affect genetic material (mutagenic)

Special Remarks on other Toxic Effects on Humans:

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Acute Potential Health Effects: Skin: Causes mild to moderate skin irritation. It can be absorbed to some extent throughthe skin. Eyes: Cauess mild to moderate eye irritation with a burning sensation. Splash contact with eyes also causesconjunctivitis, blepharospasm, corneal edema, corneal abraisons. This usually resolves in 2 days. Inhalation: Inhalationof vapor may cause respiratory tract irritation causing coughing and wheezing, and nasal discharge. Inhalation of highconcentrations may affect behavior and cause central nervous system effects characterized by nausea, headache, dizziness,tremors, restlessness, lightheadedness, exhilaration, memory loss, insomnia, impaired reaction time, drowsiness, ataxia,hallucinations, somnolence, muscle contraction or spasticity, unconsciousness and coma. Inhalation of high concentration ofvapor may also affect the cardiovascular system (rapid heart beat, heart palpitations, increased or decreased blood pressure,dysrhythmia, ), respiration (acute pulmonary edema, respiratory depression, apnea, asphyxia), cause vision disturbancesand dilated pupils, and cause loss of appetite. Ingestion: Aspiration hazard. Aspiration of Toluene into the lungs may causechemical pneumonitis. May cause irritation of the digestive tract with nausea, vomiting, pain. May have effects similar to thatof acute inhalation. Chronic Potential Health Effects: Inhalation and Ingestion: Prolonged or repeated exposure via inhalationmay cause central nervous system and cardiovascular symptoms similar to that of acute inhalation and ingestion as well liverdamage/failure, kidney damage/failure (with hematuria, proteinuria, oliguria, renal tubular acidosis), brain damage, weightloss, blood (pigmented or nucleated red blood cells, changes in white blood cell count), bone marrow changes, electrolyteimbalances (Hypokalemia, Hypophostatemia), severe, muscle weakness and Rhabdomyolysis. Skin: Repeated or prolongedskin contact may cause defatting dermatitis.

Section 12: Ecological Information

Ecotoxicity:Ecotoxicity in water (LC50): 313 mg/l 48 hours [Daphnia (daphnia)]. 17 mg/l 24 hours [Fish (Blue Gill)]. 13 mg/l 96 hours [Fish(Blue Gill)]. 56 mg/l 24 hours [Fish (Fathead minnow)]. 34 mg/l 96 hours [Fish (Fathead minnow)]. 56.8 ppm any hours [Fish(Goldfish)].

BOD5 and COD: Not available.

Products of Biodegradation:Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise.

Toxicity of the Products of Biodegradation: The products of degradation are less toxic than the product itself.

Special Remarks on the Products of Biodegradation: Not available.

Section 13: Disposal Considerations

Waste Disposal:Waste must be disposed of in accordance with federal, state and local environmental control regulations.

Section 14: Transport Information

DOT Classification: CLASS 3: Flammable liquid.

Identification: : Toluene UNNA: 1294 PG: II

Special Provisions for Transport: Not available.

Section 15: Other Regulatory Information

Federal and State Regulations:California prop. 65: This product contains the following ingredients for which the State of California has found to cause cancer,birth defects or other reproductive harm, which would require a warning under the statute: Toluene California prop. 65 (nosignificant risk level): Toluene: 7 mg/day (value) California prop. 65 (acceptable daily intake level): Toluene: 7 mg/day (value)California prop. 65: This product contains the following ingredients for which the State of California has found to cause birthdefects which would require a warning under the statute: Toluene Connecticut hazardous material survey.: Toluene Illinois

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toxic substances disclosure to employee act: Toluene Illinois chemical safety act: Toluene New York release reporting list:Toluene Rhode Island RTK hazardous substances: Toluene Pennsylvania RTK: Toluene Florida: Toluene Minnesota: TolueneMichigan critical material: Toluene Massachusetts RTK: Toluene Massachusetts spill list: Toluene New Jersey: Toluene NewJersey spill list: Toluene Louisiana spill reporting: Toluene California Director's List of Hazardous Substances.: Toluene TSCA8(b) inventory: Toluene TSCA 8(d) H and S data reporting: Toluene: Effective date: 10/04/82; Sunset Date: 10/0/92 SARA 313toxic chemical notification and release reporting: Toluene CERCLA: Hazardous substances.: Toluene: 1000 lbs. (453.6 kg)

Other Regulations:OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200). EINECS: This product is on theEuropean Inventory of Existing Commercial Chemical Substances.

Other Classifications:

WHMIS (Canada):CLASS B-2: Flammable liquid with a flash point lower than 37.8°C (100°F). CLASS D-2A: Material causing other toxic effects(VERY TOXIC).

DSCL (EEC):R11- Highly flammable. R20- Harmful by inhalation. S16- Keep away from sources of ignition - No smoking. S25- Avoidcontact with eyes. S29- Do not empty into drains. S33- Take precautionary measures against static discharges.

HMIS (U.S.A.):

Health Hazard: 2

Fire Hazard: 3

Reactivity: 0

Personal Protection: h

National Fire Protection Association (U.S.A.):

Health: 2

Flammability: 3

Reactivity: 0

Specific hazard:

Protective Equipment:Gloves. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Wear appropriate respiratorwhen ventilation is inadequate. Splash goggles.

Section 16: Other Information

References: Not available.

Other Special Considerations: Not available.

Created: 10/10/2005 08:30 PM

Last Updated: 11/06/2008 12:00 PM

The information above is believed to be accurate and represents the best information currently available to us. However, wemake no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assumeno liability resulting from its use. Users should make their own investigations to determine the suitability of the information fortheir particular purposes. In no event shall ScienceLab.com be liable for any claims, losses, or damages of any third party or forlost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if ScienceLab.comhas been advised of the possibility of such damages.

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Material Safety Data SheetXylenes MSDS

Section 1: Chemical Product and Company Identification

Product Name: Xylenes

Catalog Codes: SLX1075, SLX1129, SLX1042, SLX1096

CAS#: 1330-20-7

RTECS: ZE2100000

TSCA: TSCA 8(b) inventory: Xylenes

CI#: Not available.

Synonym: Xylenes; Dimethylbenzene; xylol;methyltoluene

Chemical Name: Xylenes (o-, m-, p- isomers)

Chemical Formula: C6H4(CH3)2

Contact Information:

Sciencelab.com, Inc.14025 Smith Rd.Houston, Texas 77396

US Sales: 1-800-901-7247International Sales: 1-281-441-4400

Order Online: ScienceLab.com

CHEMTREC (24HR Emergency Telephone), call:1-800-424-9300

International CHEMTREC, call: 1-703-527-3887

For non-emergency assistance, call: 1-281-441-4400

Section 2: Composition and Information on Ingredients

Composition:

Name CAS # % by Weight

Xylenes 1330-20-7 100

Toxicological Data on Ingredients: Xylenes: ORAL (LD50): Acute: 4300 mg/kg [Rat]. 2119 mg/kg [Mouse]. DERMAL(LD50): Acute: &gt;1700 mg/kg [Rabbit].

Section 3: Hazards Identification

Potential Acute Health Effects: Hazardous in case of skin contact (irritant, permeator), of eye contact (irritant), of ingestion,of inhalation.

Potential Chronic Health Effects:CARCINOGENIC EFFECTS: 3 (Not classifiable for human.) by IARC. MUTAGENIC EFFECTS: Not available. TERATOGENICEFFECTS: Not available. DEVELOPMENTAL TOXICITY: Not available. The substance may be toxic to blood, kidneys, liver,mucous membranes, bone marrow, central nervous system (CNS). Repeated or prolonged exposure to the substance canproduce target organs damage.

Section 4: First Aid Measures

Eye Contact:

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Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15minutes. Get medical attention.

Skin Contact:In case of contact, immediately flush skin with plenty of water. Cover the irritated skin with an emollient. Remove contaminatedclothing and shoes. Wash clothing before reuse. Thoroughly clean shoes before reuse. Get medical attention.

Serious Skin Contact:Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek immediate medicalattention.

Inhalation:If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medicalattention if symptoms appear.

Serious Inhalation:Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. Ifbreathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. Seek medicalattention.

Ingestion:Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconsciousperson. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention if symptoms appear.

Serious Ingestion: Not available.

Section 5: Fire and Explosion Data

Flammability of the Product: Flammable.

Auto-Ignition Temperature: 464°C (867.2°F)

Flash Points: CLOSED CUP: 24°C (75.2°F). (Tagliabue.) OPEN CUP: 37.8°C (100°F).

Flammable Limits: LOWER: 1% UPPER: 7%

Products of Combustion: These products are carbon oxides (CO, CO2).

Fire Hazards in Presence of Various Substances:Highly flammable in presence of open flames and sparks, of heat. Non-flammable in presence of shocks.

Explosion Hazards in Presence of Various Substances:Risks of explosion of the product in presence of mechanical impact: Not available. Slightly explosive in presence of openflames and sparks, of heat.

Fire Fighting Media and Instructions:Flammable liquid, soluble or dispersed in water. SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use alcohol foam,water spray or fog. Cool containing vessels with water jet in order to prevent pressure build-up, autoignition or explosion.

Special Remarks on Fire Hazards: Vapors may travel to source of ignition and flash back.

Special Remarks on Explosion Hazards:Vapors may form explosive mixtures with air. Containers may explode when heated. May polymerize explosively when heated.An attempt to chlorinate xylene with 1,3-Dichloro-5,5-dimethyl-2,4-imidazolidindione (dichlorohydrantoin) caused a violentexplosion

Section 6: Accidental Release Measures

Small Spill: Absorb with an inert material and put the spilled material in an appropriate waste disposal.

Large Spill:Flammable liquid. Keep away from heat. Keep away from sources of ignition. Stop leak if without risk. Absorb with DRY earth,sand or other non-combustible material. Do not touch spilled material. Prevent entry into sewers, basements or confined

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areas; dike if needed. Be careful that the product is not present at a concentration level above TLV. Check TLV on the MSDSand with local authorities.

Section 7: Handling and Storage

Precautions:Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do notbreathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratoryequipment. If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin andeyes. Keep away from incompatibles such as oxidizing agents, acids.

Storage:Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed andsealed until ready for use. Avoid all possible sources of ignition (spark or flame).

Section 8: Exposure Controls/Personal Protection

Engineering Controls:Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their respectivethreshold limit value. Ensure that eyewash stations and safety showers are proximal to the work-station location.

Personal Protection:Splash goggles. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.

Personal Protection in Case of a Large Spill:Splash goggles. Full suit. Vapor respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoidinhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling thisproduct.

Exposure Limits:TWA: 100 (ppm) [Canada] TWA: 435 (mg/m3) [Canada] TWA: 434 STEL: 651 (mg/m3) from ACGIH (TLV) [United States]TWA: 100 STEL: 150 (ppm) from ACGIH (TLV) [United States] Consult local authorities for acceptable exposure limits.

Section 9: Physical and Chemical Properties

Physical state and appearance: Liquid.

Odor: Sweetish.

Taste: Not available.

Molecular Weight: 106.17 g/mole

Color: Colorless. Clear

pH (1% soln/water): Not available.

Boiling Point: 138.5°C (281.3°F)

Melting Point: -47.4°C (-53.3°F)

Critical Temperature: Not available.

Specific Gravity: 0.864 (Water = 1)

Vapor Pressure: 0.9 kPa (@ 20°C)

Vapor Density: 3.7 (Air = 1)

Volatility: Not available.

Odor Threshold: 1 ppm

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Water/Oil Dist. Coeff.: The product is more soluble in oil; log(oil/water) = 3.1

Ionicity (in Water): Not available.

Dispersion Properties: Not available.

Solubility:Insoluble in cold water, hot water. Miscible with absolute alcohol, ether, and many other organic liquids.

Section 10: Stability and Reactivity Data

Stability: The product is stable.

Instability Temperature: Not available.

Conditions of Instability: Heat, ignition sources, incompatibles

Incompatibility with various substances: Reactive with oxidizing agents, acids.

Corrosivity: Non-corrosive in presence of glass.

Special Remarks on Reactivity: Store away from acetic acid, nitric acid, chlorine, bromine, and fluorine.

Special Remarks on Corrosivity: Not available.

Polymerization: Will not occur.

Section 11: Toxicological Information

Routes of Entry: Absorbed through skin. Dermal contact. Eye contact. Inhalation.

Toxicity to Animals:WARNING: THE LC50 VALUES HEREUNDER ARE ESTIMATED ON THE BASIS OF A 4-HOUR EXPOSURE. Acute oraltoxicity (LD50): 2119 mg/kg [Mouse]. Acute dermal toxicity (LD50): >1700 mg/kg [Rabbit]. Acute toxicity of the vapor (LC50):5000 4 hours [Rat].

Chronic Effects on Humans:CARCINOGENIC EFFECTS: 3 (Not classifiable for human.) by IARC. May cause damage to the following organs: blood,kidneys, liver, mucous membranes, bone marrow, central nervous system (CNS).

Other Toxic Effects on Humans: Hazardous in case of skin contact (irritant, permeator), of ingestion, of inhalation.

Special Remarks on Toxicity to Animals:Lowest Lethal Dose: LDL [Human] - Route: Oral; Dose: 50 mg/kg LCL [Man] - Route: Oral; Dose: 10000 ppm/6H

Special Remarks on Chronic Effects on Humans:Detected in maternal milk in human. Passes through the placental barrier in animal. Embryotoxic and/or foetotoxic in animal.May cause adverse reproductive effects (male and femael fertility (spontaneous abortion and fetotoxicity)) and birth defectsbased animal data.

Special Remarks on other Toxic Effects on Humans:Acute Potential Health Effects: Skin: Causes skin irritation. Can be absorbed through skin. Eyes: Causes eye irritation.Inhalation: Vapor causes respiratory tract and mucous membrane irritation. May affect central nervous system and behavior(General anesthetic/CNS depressant with effects including headache, weakness, memory loss, irritability, dizziness, giddiness,loss of coordination and judgement, respiratory depression/arrest or difficulty breathing, loss of appetite, nausea, vomiting,shivering, and possible coma and death). May also affects blood, sense organs, liver, and peripheral nerves. Ingestion: Maycause gastrointestinal irritation including abdominal pain, vomiting, and nausea. May also affect liver and urinary system/kidneys. May cause effects similar to those of acute inhalation. Chronic Potential Health Effects: Chronic inhalation may affectthe urinary system (kidneys) blood (anemia), bone marrow (hyperplasia of bone marrow) brain/behavior/Central Nervoussystem. Chronic inhalation may alsocause mucosal bleeding. Chronic ingestion may affect the liver and metabolism (loss ofappetite) and may affect urinary system (kidney damage)

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Section 12: Ecological Information

Ecotoxicity: Not available.

BOD5 and COD: Not available.

Products of Biodegradation:Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise.

Toxicity of the Products of Biodegradation: The products of degradation are less toxic than the product itself.

Special Remarks on the Products of Biodegradation: Not available.

Section 13: Disposal Considerations

Waste Disposal:Waste must be disposed of in accordance with federal, state and local environmental control regulations.

Section 14: Transport Information

DOT Classification: CLASS 3: Flammable liquid.

Identification: : Xylenes UNNA: 1307 PG: III

Special Provisions for Transport: Not available.

Section 15: Other Regulatory Information

Federal and State Regulations:Connecticut hazardous material survey.: Xylenes Illinois chemical safety act: Xylenes New York acutely hazardoussubstances: Xylenes Rhode Island RTK hazardous substances: Xylenes Pennsylvania RTK: Xylenes Minnesota: XylenesMichigan critical material: Xylenes Massachusetts RTK: Xylenes Massachusetts spill list: Xylenes New Jersey: Xylenes NewJersey spill list: Xylenes Louisiana spill reporting: Xylenes California Director's List of Hazardous Substances: Xylenes TSCA8(b) inventory: Xylenes SARA 302/304/311/312 hazardous chemicals: Xylenes SARA 313 toxic chemical notification andrelease reporting: Xylenes CERCLA: Hazardous substances.: Xylenes: 100 lbs. (45.36 kg)

Other Regulations:OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200). EINECS: This product is on theEuropean Inventory of Existing Commercial Chemical Substances.

Other Classifications:

WHMIS (Canada):CLASS B-2: Flammable liquid with a flash point lower than 37.8°C (100°F). CLASS D-2A: Material causing other toxic effects(VERY TOXIC).

DSCL (EEC):R10- Flammable. R21- Harmful in contact with skin. R36/38- Irritating to eyes and skin. S2- Keep out of the reach of children.S36/37- Wear suitable protective clothing and gloves. S46- If swallowed, seek medical advice immediately and show thiscontainer or label.

HMIS (U.S.A.):

Health Hazard: 2

Fire Hazard: 3

Reactivity: 0

Personal Protection: h

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National Fire Protection Association (U.S.A.):

Health: 2

Flammability: 3

Reactivity: 0

Specific hazard:

Protective Equipment:Gloves. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Wear appropriate respiratorwhen ventilation is inadequate. Splash goggles.

Section 16: Other Information

References: Not available.

Other Special Considerations: Not available.

Created: 10/11/2005 12:54 PM

Last Updated: 05/21/2013 12:00 PM

The information above is believed to be accurate and represents the best information currently available to us. However, wemake no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assumeno liability resulting from its use. Users should make their own investigations to determine the suitability of the information fortheir particular purposes. In no event shall ScienceLab.com be liable for any claims, losses, or damages of any third party or forlost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if ScienceLab.comhas been advised of the possibility of such damages.

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Annexure-V

Certified Compliance report of existing EC by

RO, MoEF&CC

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A-169

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Annexure-VI

NABET/QCI Certificate

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Annexure-VII

Copy of Environmental Clearance

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Annexure-VIII

Photographs of existing site, proposed expansion area &

Plantation/Greenbelt

Photographs of Existing plant

Main gate of the company

Overview of the plant

Overview of the plant

A-192

Tank farm Existing ETP

Solvent recovery system Utility area with stack of D G Set

RO Plant

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Greenbelt in existing plant

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Land for proposed expansion

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Annexure-IX Land Documents

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Annexure-X Health record of workers

. . Concord Biotech Limited

I

1482- 1486. Trasad road;Dholka, Dist- Ahmedabad- 382 225

-- STANDARD OPEIWTING PROCEDURE SOP No. 1 HR/SOP/002 I Effective Date / 15.04.201 6 I Page I of 1

Identi,fication Marlts: ~ o i s e : QW& hi%.

Revision No. Title

I I I

05 I ReviewDate 14.04.2019 I Copy No. I EMPLOYEE MEDICAL CEIECICUP

- -

PERSONAL HABIT: ,(Tick d whichever is applicable)

Education: (Tick d whichever is applicable) I

MEDICAL EXAMINATION FORM Format No : HR / F / 007 Date:-01, 10% /do 1 t

Under Graduate

GENEIRAE EXAMINATION:

Diet :

Tobacco:

( Particulars 1 Remarks 1 Particulars I Remarks I Particulars

Name of Employee

Designation

Marital Status

FBMI[LY MEDICAL HISTORY :- (write N.A. if not applicable)

! have e m n ~ i ~ ~ e d blr.lb~rs.1 Miss % 3 ' ' .

and foynd l l i~~ lhe r (tick the box) FITfor duty U FIT . r duty . <: Pencling

r??

J -.:"?. Sign of Employee examined Sign of Medical iffis&

', .. , - I Seal with Reg. NO-. .:. (.f-w I a.

Dr. H. J. Patel M.B.B.S. Nr. S. T. Starld. ~ a l a v ~ o a d , Oholka. T)ist.Ahrnedabad..

em^- Code

DOJ

DOBIAS

Graduate

v

2

f rgo 4 a-1 16

-ibl%I34

I\\CUW~ kUw~9, e. F)M te 1 T4h- c h e ~ \ . S k

Post Graduate Technical

Married 1 m d ( Sex

AdministratiCe

Sm&W/ EkSmGKer /Non Smolter

Wl No 5

Veg. I llb&%'g. I Mixed-

W / No

mule

Smoking

Alcohol:

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Dr. Palak Shah Diagnostic centre Computerised Pathology Laboratory

Dr. Palak Shah .." ---.-------------- ------- ----- -- M.D. (Pathology), D.C.P.

S' Complex, First Floor, Near H.D.F.C Bank, Opp S.T. Workshop, . University First - Lunawada - 389 230. Ph.: (02674) 250958, M.: 98256 38041,98256 70841 Reg. NO. : G-14783 . - -- - . -

Patient Name : Nikunj Patel Reffered by : Concord Biotech Ltd.

Ref. No : 6734 Address : Lunawada

Date . : 30/06/2016

Parameter

Haemogram Report

Result - Unit Normal Ranae

Haemoglobin G% : 13.4 gm"/o New Born : 15.0 - 24.0 I ABOVE 10 YRS : 1 -2 YRS : 10.5 - 14.0 1 (M) : 13.0 - 18.0

2-9YRS :10.5-14.0 )(F):ll.5-16.5

Total R.B.C. : 4.27 Millionlcmm M: 4.5 - 5.5 milllcmm F: 3.5 - 4.5 milllcmm

Blood Indices P.C.V. M. C. V. M. C. H. M. C. H. C.

TOTAL W. B. C. : 8000 per cu.mm INFANTS : 6,000-ia,ooo 1 ABOVE 10 YRS :

1 -2 YRS :6,000-14,000 1 4,000 - 10,000

2 -9 Y ~ S :6,000-14,000 ( Differential Leucocyte Count:

Neutrophils : 63 % [40 - 70 %] Lymphocytes : 32 % [20 - 50 %] Eosinophils : 02 % [OI - 06 %] Monocytes : 03 % [02 - 10 %] Basophils : 00 % [00 - 0.5 %]

Erythrocyte Sedimentation Rate (E.S.R.) (Westergren method) After one hour : 08 mm M[Q2-09 ]mmF[04-11 ]mm

Blood Group & Rh Type Blood Group : "0 Rh (D) Factor : Positive

Peripheral Smear R. B. C. : Macrocytic , Normochromic W. 8. C : No Premature or abnormal WBC seen. Platelate : Adequet & Normal Parasites : M.P. Not Detected #

Total Platelet count : 2,06,000 1c.rnm 1,50,000 - 4,50,000 3 .mm For, m. PaGz&9iah Dugmstic Centre 72Lwl&b gyZ4%.%..... .............................................................................................................

The Above Results Are Subject To Variations Due To Technical Limitations Hence Co-relations With Clinical Findings And Other Investigations Should Be Done.

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Dr. Palak Shah Diagnostic centre ~ o m ~ u t e r i s 2 Pathology Laboratory .--------------------- -----------..----.

S' Complex, First Floor, Near M.D.F.C Bank, Opp S.T. Workshop, Lunawada . . - - 389 - . 230. -- Ph.: (02674) 250958, M.: 98256 38041,98256 70841 -

DV. Palak Shah M.D. (Pathology), D.C.P.

University First Reg. No. : G-14783

Patient Name : Nikunj Patel Reffered by : Concord Biotech Ltd.

Ref. No : 6734 Address : Lunawada

Date : 30/06/2016

Test - Random Blood Sugar

Random Urine Sugar

Random Urine Acetone

Blood Glucose Estimation

GOD - PAP METHOD

Result

:85mg%

: Nil

: Absent

Normal Ranne

60 - 140 mg %

Remarks : Values -$ R checked

(N.A = Not Available)

Test - Blood Urea Method : Fix Time Kinetic

Result - : 29

Renal Function Tests

Units - ~orrilal Value

nlgldl 15 to 40 mgldl

F q Fa,ah. &G&~fuzh Diagftostic centre 72Lww4&fi ? $ j L 4 e . . .............................................................................................................. The Above Results Are Subject To Variations Due To Technical Limitations Hence Co-,relations With Clinical Findings And Other Investigations Should Be Done.

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Dr. Palak Shah Diagnostic centre Computerised Pathology Laboratory

Dr. Pulak huh M.D. (Pathology), D.C.P.

S' ~oi~ i~?;~ i~Floor ,Nei~N.D.F.C~Ba~~O~~S.T. works hop, University First - Lunawada - 389 230. P h.: (02674) 250958, M.: 98256 38041,98256 70841 Reg. No. : G-14783 - - . - -- - -

Patient Name : Nikunj Patel ~effered by : Concord Biotech Ltd.

Ref. No : 6734 Address :Lunawada

AgeISex : 22 YearslMale

Date : 30/0612016

U RI NANALYSIS

Specimen: Random Phvsical Examination

Volume : 25ml Color : Yellow Transparency : Clear Deposits : Absent Reaction : Acidic Specific Gravity --

Chemical Examination

Protein Sugar Bile Pigment Bile Salt Ketone PH.

R.B.C.'s Pus Cells Epithelial Cells Yeast Cells Amorphous Monilia Trichomona Spermatozoa Crystals Casts Mucus threads

: Present [Trace] : Nil : Absent : Absent : Absent : 6.5

Microscopic Examination (Per H.P.F After centrifugation at 2500 R.P.M for 10 minutes.)

: 1-2 : 2-3 : 4-5 -: Absent : Absent : Absent : Absent : AbsentIHPF : Absent : AbsentIHPF : Absent

/

DiqnoStic Centre R-.k.b ciya%.w. .. ..................................... _. ...................................................................... The Above Results Are Subject To Variations Due To Technical Limitations Hence Co-relations With Clinical Findings And Other Investigations Should Be Done.

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Concord Biotech Limited 1482- 1486. Trasad road, Dhollca, Dist- Allmedabad- 382 225

STANDARD OPERATING PROCEDURE SOP No. ( HRlSOP/002 ( Effective Date 1 15.04.2016 I Page 1 of 1

' MEDICAL EiAMlNATION FO& I

Format No : HR / F / 007 Date:- ih / 07 / 2 s l g

L

Revision No. Title

- I I I

05 I Review Date 1 14.04.201 9 I Copy No. 1 EMPLOYEE MEDICAL CEIECKUP

Identification Marks: A

.Name of Employee

Designation

Marital Status

FAMILY MEDICAL HTSTORY :- (write N.A. if not applicable)

Emp. Code

DOJ

D O B / A ~ ~

Education: (Tick 4 whichever is applicable) 8

l ~ q q l"lb+! r C 0!116/19gjl

fib U 7-03 .Y 0 P 6 0 fly fl \/ L ?

6 F F [el?.

I have examined Mr./Mrs./ Miss FITfor duty WCY 'UNFI

Sign of X'mpioyee examined

M e d l Unmarried

Under Graduate

I I I I

Child

PERSONAL HABIT: (Tick 4 whichever is applicable)

Sex I ~ I P L E

Technical

r

Diet :

Tobacco:

Graduate /

Adrninistratite Post Graduate

GENERAL EXAMINATION:

w/ Non Veg. I Mixed

Yes /M

2

Smoking Alcohol:

Smoker / Ex-Smoker I N o n ~ o k e r ,

Yes / P C 3

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. MBHOTRl MEDlCll liB@RIT@IlE$ PVT, SCO - 2425-26, First Floor, Sector 224, Chandigarh I Above Sony Showroom, Near Aroma Hotel

DIAGNOSTIC AND CANCER SCREENING CUM RESEARCH CENTRE Phone : 2700860,2721860,4644860 Fax : 0172-2703905

ernail : malhotra labs22~ahoo.com A Fully Automated Medical Diagnostic Laboratory

Dr. Vijay Malhotra M. D. (Pathology)

Patient's Name MR. ASHUTOSH UPADHYAY Reg. Date 07/07/2016 16:49:35 Patient ID 101616906 Sample Received 0710712016 1651 :34 F/H Name Reported On 07/07/2016 18:01:18 AgeISex 29 Yrs Male Printed On 07/07/2016 18:01:26 Address Panel Comp. --------------------

Ref by Doctor ------------------- Specimen :- BLOOD EDTA Ref.CentrelLab CITY HEALTH CARE DERABA,

lnvestigatioq - Value - Unit

M?J&%TOLOGY

TOTAL LEUKOCYTE COUNT 6800 " /cmm Tech - IMPEDANCE

DIFFERENTIAL LEUCOCYTE COUNT NEUTROPHIL 60 %

LYMPHOCYTE 3 6 Yo

MONOCYTE 03 Yo

EOSINOPHIL 0 1 %

BASOPHIL 00 %

ERYTHROCYTES SEDIMENTATION RATE Tech - WlNTROBE'S WZIWOD

10 rnmllst hr

RED BLOOD CELL (RBC) COUNT Tech - IMPEDANCE

4.68 milliodcrp

Biolorrical Ref Interval

4000 - 1 1000

BLOOD GROUP ABO Tech - MONOCi.ONAL AGGLIlNATING ANllCERA

"B" POSITIVE

** End of Report **

WISHING YOU GOOD HEALTH

Page No: I of I

1

Reviewed By: DR V U ~ Y M A L H O T ~ (MD Path) Director, Pathology S e r v i c e s .

Timings: 7.30A.M. to 8:OO P.M., Sunday 7.30 to 2.30 P.M. ! e $conditions of Reporting

%his report represents only an opinion. As such it is not valid for medico-lagal purposes. If clinical findings of the patient do not correlate with the opinion1 %indings givenlinferred in the report then the patientl referring doctor may please contact the lab immediately for re-confirmation by repeating the investigation.

The blood and other samples received from outside will be presumed to be of patients named on the samples. The blood samples and fluids for cytology are discarded after conducting the required tests unless otherwise informed earlier by the patients, referring doctor or hospital. The histopathological samples will be preserved for one month only whereas wax blocks and glass slides will be discarded after six months. A-207

MLLHOTRL MEDIGIIL LLBORITORIES PVT. LTU. SCO - 2425-26, First Floor, Sector 224, Chandigarh Above Sony Showroom, Near Aroma Hotel

DIAGNOSTIC AND CANCER SCREENING CUM RESEARCH CENTRE

Phone : 2700860,2721 860,4644860 Fax : 01 72-2703905 ernail : rnalhotra_labs~ahoo.com

A Fully Automated Medical Diagnostic Laboratory Dr. Vijay Malhotra M.D. (Pathdogy)

Patient's Name MR. ASHUTOSH UPADHYAY Patient ID 101616906 FIH Name Age/Sex 29 Yrs Male Address

Reg. Date 07/07/20 16 16:49:35 Sample Received 07/07/2016 1651 :34

Reported On 07/07/20 16 17: 19: 17 Printed On 07/07/2016 17:19:22 Panel Comp. ------------------ Refby Doctor ---------- ----------

Specimen :- URJNE Ref.Centre/Lab CITY HEALTH CARE DERABA:

Investigation

URINE R/E

PHYSICALICHEMICAL Appearance Colour Reaction Specific Gravity Albumin Glucose Bile Salts Bile Pigments Urobilinogen

CLEAR PALE YELLOW ACIDIC -- NIL NIL

Value - Unit Biolo~ical Ref Interval

Page No: 1 of 1

s

Pus cells RBC's Crystals Epithelial cells Casts Bacteria Any Other Remarks

00 - OlmF NIL NIL NIL NIL NIL

* * End of Report **

WISHING YOU GOOD HEALTH

Review . &: DR W A Y MALHO* (MD Path) DirectorfPathology Services.

Timinas: 7.30 A.M. t o 8:00 P.M.. Sundav 7.30 t o 2.30 P.M.

2 Fondltlons of Reporting

$his report represents only an opinion. As such it is not valid for medico-lagal purposes. If clinical findings of the patient do not correlate with the opinion1 findings givenlinferred in the report then the patient/ referring doctor may please contact the lab immediately for re-confirmation by repeating the Investigation. The blood and other samples received from outside will be pres'umed to be of patients named on the samples. The blood samples and fluids for cytology are discarded after conducting the required tests unless otherwise informed earlier by the patients, referring doctor or hospital. The histopathological samples will be preserved for one month only whereas wax blocks and glass slides will be discarded after six months.

A-208

MILHOTRI MEDICIL lABORlTORlE$ PVT. LTR SCO - 2425-26, First Floor, Sector 224, Chandigarh Above Sonv Showroom. Near Aroma Hotel

DIAGNOSTIC AND CANCER SCREENING CUM RESEARCH CENTRE ,

Phone : 2700860,2721860,4644860 Fax : 0172-2703905 email : malhotra [email protected]

A Fully Automated Medical Diagnostic Laboratory Dr. Vijay Malhotra

M.D. (Pathology)

Patients Name MR. ASHUTOSH UPADHYAY Patient ID 101616906

F/H Name AgeJSex 29 Yrs Male Address

Specimen :- F1,UORIDE-F, SERUM

Reg. Date 07/07/2016 16:49:35 Sample Received 07/07/2016 16:5 1 :34

Reported On 07/07/20 16 19: 19: 16

Printed On 07/07/20 16 19: 19:32

Panel Comp. ------------------ Ref by Doctor ------------------- RefCentrdLab CITY HEALTH CARE DERABP

PLASMA SUGAR FASTING Tech - GOD-MD MlTHOD.END POIM

SERUM UREA Tech - GLDH - UREASE METIIOD

Value . Unit BIOCrnMSTRY

r '

79.32 rng %

24.73 rng %

Biolopical Ref Interval

** End of Report **

WISHING YOU GOOD HEALTH

Page No: 1 of I * k d By:

DR VIJAY MALHOTL (MD Path) Director, Pathology Services.

2 Timings: 7.30A.M. to 8:00 P.M., Sunday 7.30 t o 2.30 P.M. L

gnditions of Reporting

%is report represents only an opinion. As such it is not valid for medico-lagal purposes. If clinical findings of the patient do not correlate with the opinion1 %dings givenlinferred in the report then the patient1 referring dbctor may please contact the lab immediately for re-confirmation by repeating the investigation. The blood and other samples received from outside will be presumed to be of patients named on the samples. The blood samples and fluids for cytology are discarded after conducting the required tests unless otherwise informed earlier by the patients, referridg doctor >r hospital. The histopathological samples will be preserved for one month only whereas wax blocks and alass slides wlll be discarded after cir mnn+h-

A-209

Annexure-XI EHS policy

A-210

Annexure-XII Copy of Terms of Reference (TOR)

A-211

A-212

A-213

A-214

Annexure-I

GENERIC TERMS OF REFERENCE (TOR) IN RESPECT OF INDUSTRY SECTOR 1. Executive Summary 2. Introduction

i. Details of the EIA Consultant including NABET accreditation ii. Information about the project proponent iii. Importance and benefits of the project

3. Project Description i. Cost of project and time of completion. ii. Products with capacities for the proposed project. iii. If expansion project, details of existing products with capacities and whether

adequate land is available for expansion, reference of earlier EC if any. iv. List of raw materials required and their source along with mode of

transportation. v. Other chemicals and materials required with quantities and storage capacities vi. Details of Emission, effluents, hazardous waste generation and their

management. vii. Requirement of water, power, with source of supply, status of approval, water

balance diagram, man-power requirement (regular and contract) viii. Process description along with major equipments and machineries, process

flow sheet (quantities) from raw material to products to be provided ix. Hazard identification and details of proposed safety systems. x. Expansion/modernization proposals:

a. Copy of all the Environmental Clearance(s) including Amendments thereto obtained for the project from MOEF/SEIAA shall be attached as an Annexure. A certified copy of the latest Monitoring Report of the Regional Office of the Ministry of Environment and Forests as per circular dated 30th May, 2012 on the status of 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 Iexisting 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

i. Location of the project site covering village, Taluka/Tehsil, District and State, Justification for selecting the site, whether other sites were considered.

A-215

ii. A toposheet of the study area of radius of 10km and site location on 1:50,000/1:25,000 scale on an A3/A2 sheet. (including all eco-sensitive areas and environmentally sensitive places)

iii. Details w.r.t. option analysis for selection of site iv. Co-ordinates (lat-long) of all four corners of the site. v. Google map-Earth downloaded of the project site.

vi. Layout maps indicating existing unit as well as proposed unit indicating storage area, plant area, greenbelt area, utilities etc. If located within an Industrial area/Estate/Complex, layout of Industrial Area indicating location of unit within the Industrial area/Estate.

vii. Photographs of the proposed and existing (if applicable) plant site. If existing, show photographs of plantation/greenbelt, in particular.

viii. Landuse break-up of total land of the project site (identified and acquired), government/private - agricultural, forest, wasteland, water bodies, settlements, etc shall be included. (not required for industrial area)

ix. A list of major industries with name and type within study area (10km radius) shall be incorporated. Land use details of the study area

x. Geological features and Geo-hydrological status of the study area shall be included.

xi. Details of Drainage of the project upto 5km radius of study area. If the site is within 1 km radius of any 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)

xii. Status of acquisition of land. If acquisition is not complete, stage of the acquisition process and expected time of complete possession of the land.

xiii. R&R details in respect of land in line with state Government policy

5. Forest and wildlife related issues (if applicable):

i. Permission and approval for the use of forest land (forestry clearance), if any, and recommendations of the State Forest Department. (if applicable)

ii. Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineating the forestland (in case of projects involving forest land more than 40 ha)

iii. Status of Application submitted for obtaining the stage I forestry clearance along with latest status shall be submitted.

iv. 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 by Chief Wildlife Warden showing these features vis-à-vis the project location and the recommendations or comments of the Chief Wildlife Warden-thereon

v. Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the State Government for conservation of Schedule I fauna, if any exists in the study area

vi. Copy of application submitted for clearance under the Wildlife (Protection) Act, 1972, to the Standing Committee of the National Board for Wildlife

6. Environmental Status

i. Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature, relative humidity, hourly wind speed and direction and rainfall.

A-216

ii. AAQ data (except monsoon) at 8 locations for PM10, PM2.5, SO2, NOX, CO and other parameters relevant to the project shall be collected. The monitoring stations shall be based CPCB guidelines and take into account the pre-dominant wind direction, population zone and sensitive receptors including reserved forests.

iii. Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in the NAQQM Notification of Nov. 2009 along with – min., max., average and 98% values for each of the AAQ parameters from data of all AAQ stations should be provided as an annexure to the EIA Report.

iv. Surface water quality of nearby River (100m upstream and downstream of discharge point) and other surface drains at eight locations as per CPCB/MoEF&CC guidelines.

v. Whether the site falls near to polluted stretch of river identified by the CPCB/MoEF&CC, if yes give details.

vi. Ground water monitoring at minimum at 8 locations shall be included. vii. Noise levels monitoring at 8 locations within the study area. viii. Soil Characteristic as per CPCB guidelines. ix. Traffic study of the area, type of vehicles, frequency of vehicles for

transportation of materials, additional traffic due to proposed project, parking arrangement etc.

x. Detailed description of flora and fauna (terrestrial and aquatic) existing in the study area shall be given with special reference to rare, endemic and endangered species. If Schedule-I fauna are found within the study area, a Wildlife Conservation Plan shall be prepared and furnished.

xi. Socio-economic status of the study area.

7. Impact and Environment Management Plan

i. 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 sources of emissions (including transportation) on 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.

ii. Water Quality modelling – in case of discharge in water body iii. 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 transport of raw materials and finished products and 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 plant operations, extent recycled and reused for 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.

v. Details of stack emission and action plan for control of emissions to meet standards.

vi. Measures for fugitive emission control vii. Details of hazardous waste generation and their storage, utilization and

management. Copies of MOU regarding utilization of solid and hazardous waste in cement plant shall also be included. EMP shall include the concept of waste-minimization, recycle/reuse/recover techniques, Energy conservation, and natural resource conservation.

A-217

viii. Proper utilization of fly ash shall be ensured as per Fly Ash Notification, 2009. A detailed plan of action shall be provided.

ix. 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, planning schedule etc. shall be included. The green belt shall be around the project boundary and a scheme for greening of the roads used for the project shall also be incorporated.

x. Action plan for rainwater harvesting measures at plant site shall be submitted to harvest rainwater from the roof tops and storm water drains to recharge the ground water and also to use for the various activities at the project site to conserve fresh water and reduce the water requirement from other sources.

xi. Total capital cost and recurring cost/annum for environmental pollution control measures shall be included.

xii. Action plan for post-project environmental monitoring shall be submitted.

xiii. Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency Management Plan including Risk Assessment and damage control. Disaster management plan should be linked with District Disaster Management Plan.

8. Occupational health

i. Plan and fund allocation to ensure the occupational health & safety of all contract and casual workers

ii. Details of exposure specific health status evaluation of worker. If the workers’ health is being evaluated by pre designed format, chest x rays, Audiometry, Spirometry, Vision testing (Far & Near vision, 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.

iii. Details of existing Occupational & Safety Hazards. What are the exposure levels of hazards and whether they are within Permissible Exposure level (PEL). If these are not within PEL, what measures the company has adopted to keep them within PEL so that health of the workers can be preserved,

iv. Annual report of heath status of workers with special reference to Occupational Health and Safety.

9. Corporate Environment Policy

i. Does the company have a well laid down Environment Policy approved by its Board of Directors? If so, it may be detailed in the EIA report.

ii. Does the Environment Policy prescribe for standard operating process / procedures to bring into focus any infringement / deviation / violation of the environmental or forest norms / conditions? If so, it may be detailed in the EIA.

iii. What is the hierarchical system or Administrative order of the company to deal with the environmental issues and for ensuring compliance with

A-218

the environmental clearance conditions? Details of this system may be given.

iv. Does the company have system of reporting of non compliances / violations of environmental norms to the Board of Directors of the company and / or shareholders or stakeholders at large? This reporting mechanism shall be detailed in the EIA report

10. Details regarding infrastructure facilities such as sanitation, fuel, restroom etc. to be

provided to the labour force during construction as well as to the casual workers including truck drivers during operation phase.

11. Enterprise Social Commitment (ESC)

i. Adequate funds (at least 2.5 % of the project cost) shall be earmarked towards the Enterprise Social Commitment based on Public Hearing issues and item-wise details along with time bound action plan shall be included. Socio-economic development activities need to be elaborated upon.

12. 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 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.

13. ‘A tabular chart with index for point wise compliance of above TORs.

14. The TORs prescribed shall be valid for a period of three years for submission of the EIA-EMP reports.

The following general points shall be noted:

i. All documents shall be properly indexed, page numbered. ii. Period/date of data collection shall be clearly indicated. iii. Authenticated English translation of all material in Regional languages shall be

provided. iv. The letter/application for environmental clearance shall quote the MOEF file

No. and also attach a copy of the letter. v. The copy of the letter received from the Ministry shall be also attached as an

annexure to the final EIA-EMP Report. vi. The index of the final EIA-EMP report must indicate the specific chapter and

page no. of the EIA-EMP Report vii. While preparing the EIA report, the instructions for the proponents and

instructions for the consultants issued by MOEF vide O.M. No. J-11013/41/2006-IA.II (I) dated 4th August, 2009, which are available on the website of this Ministry shall also be followed.

viii. The consultants involved in the preparation of EIA-EMP report after accreditation with Quality Council of India (QCl) /National Accreditation Board of Education and Training (NABET) would need to include a certificate in this regard in the EIA-EMP reports prepared by them and data provided by other organization/Laboratories including their status of approvals etc. Name of the Consultant and the Accreditation details shall be posted on the EIA-EMP Report as well as on the cover of the Hard Copy of the Presentation material for EC presentation.

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TORs’ prescribed by the Expert Appraisal Committee (Industry) shall be considered for preparation of EIA-EMP report for the project in addition to all the relevant information as per the ‘Generic Structure of EIA’ given in Appendix III and IIIA in the EIA Notification, 2006. Where the documents provided are in a language other than English, an English translation shall be provided. The draft EIA-EMP report shall be submitted to the State Pollution Control Board of the concerned State for conduct of Public Hearing. The SPCB shall conduct the Public Hearing/public consultation, district-wise, as per the provisions of EIA notification, 2006. The Public Hearing shall be chaired by an Officer not below the rank of Additional District Magistrate. The issues raised in the Public Hearing and during the consultation process and the commitments made by the project proponent on the same shall be included separately in EIA-EMP Report in a separate chapter and summarised in a tabular chart with financial budget (capital and revenue) along with time-schedule of implementation for complying with the commitments made. The final EIA report shall be submitted to the Ministry for obtaining environmental clearance.

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Annexure-XIII Undertaking from Consultant & PP

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UNDERTAKING 8

I, Dr. Mahendra Sadaria, EIA Coordinator of San Envirotech P%. Ltd. 3

located at 424, Medicine Market, Paldi Cross Road, Paldi, Ah f a undertake that; cn . . .

N m t t t

0 0 2 I undertake that, prescribed TORS have been complied with and @I# d B 2

0 TI a * 0 ,, submitted is factually correct. - c 3 5

I 0 .< Y * 0

I hereby declare that, what is stated herein above is true to the b g t ofrfl"y s 'l: eGR

knowledge and same I believed to be true. ? c L, ? J " & . g N 9 3 !2 x m 2 P ;3 -i - 5) 9 * <

Date: 21/01/2017 Name: Dr. Mahendra ~ a d = ~ j & 8118q36 Place: Ahmedabad Designation: EIA Coordinator

Signature:

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