EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to...

104
EnvironmentaI Impact Assessment Report: Greenfield Facility of Manufacturing Plant for Methylcobalamin (b12) at HSIIDC , Barhi part 2, Tehsil - Ganaur, District - Sonipat July -2015 Project Proponent: M/s Royal Enterprises;H.NO. 1185,Sector-12,HUDA Panipat,Haryana

Transcript of EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to...

Page 1: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

EnvironmentaI Impact Assessment Report: Greenfield Facility of

Manufacturing Plant for Methylcobalamin (b12) at

HSIIDC , Barhi part 2, Tehsil - Ganaur, District -

Sonipat

July -2015

Project Proponent: M/s Royal

Enterprises;H.NO. 1185,Sector-12,HUDA

Panipat,Haryana

Page 2: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

1 Consultant name

Table of Contents

Executive Summary Chapter 1. Introduction and Background....................................................................................... 7

1.1. Introduction ......................................................................................................................... 7 1.2. Proposed Products and Project Location ............................................................................ 7 1.3. Salient Features of the Project ............................................................................................ 9 1.4. Need of the Proposed Project ........................................................................................... 10 1.5. Environmental Regulatory Applicability ............................................................................. 10 1.6. Scope and Methodology of the Study ............................................................................... 11 1.7. Structure of the Report ...................................................................................................... 12 1.8. Compliance to approved TOR ........................................................................................... 14

Chapter 2. Project Description .................................................................................................... 17 2.1. The Site ............................................................................................................................ 17 2.2. Justification of Project Location ......................................................................................... 17 2.3. Land allocation within plant ............................................................................................... 19 2.4. Process Description .......................................................................................................... 21 2.5. Solvents Used in the Manufacturing Process .................................................................... 23

2.5.2. Solvent Recovery System ............................................................................................. 23 2.6. Raw Material ..................................................................................................................... 24

2.6.2. Water Requirement ....................................................................................................... 25 2.6.3. Fuel ............................................................................................................................... 26 2.6.4. Power ........................................................................................................................... 26 2.6.5. Employement ................................................................................................................ 26

2.7. Generation of Pollutants ................................................................................................... 26 2.7.1. Sewage Treatment ........................................................................................................ 27 2.7.2. Effluent Treatment Plant ............................................................................................... 27 2.7.3. Hazardous Wastes and Management ........................................................................... 27 2.7.4. Air Emissions ................................................................................................................ 28

2.8. OHS System ..................................................................................................................... 28 2.9. Project Cost and Cost towards Environmental Protection ................................................. 29 2.10. CSR Plan .......................................................................................................................... 30

Chapter 3. Anticipated Environmental Impacts and Mitigation Measures .................................... 64 3.1. Prelude ............................................................................................................................. 64 3.2. Potential Impacts and Mitigation Measures during construction phase ............................. 64

3.2.1. Air Environment ............................................................................................................ 64 3.2.2. Noise Environment ........................................................................................................ 66 3.2.3. Water Environment ....................................................................................................... 67 3.2.4. Land Environment ......................................................................................................... 68 3.2.5. Materials (Chemicals, Input material) and Waste ( Solid and Hazardous)

Management: ................................................................................................................ 69 3.2.6. Socio-Economic Environment ....................................................................................... 70 3.2.7. Occupational Health and SafetyManagement ............................................................... 70

3.3. Potential Impacts and Mitigation Measures during Project Operation ................................ 71 3.3.1. Air Environment (Changed after modeling) ................................................................... 71 3.3.2. Foul Odour Problem ...................................................................................................... 75 3.3.3. Noise Environment ........................................................................................................ 75 3.3.4. Water Environment ....................................................................................................... 76 3.3.5. Storm Water Management ............................................................................................ 77 3.3.6. Land Environment ......................................................................................................... 77

Page 3: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

2 Consultant name

3.3.7. Soil Environment ........................................................................................................... 77 3.3.8. Solid and Hazardous Waste Management during operation phase ............................... 77 3.3.9. Socio-Economic Environment ....................................................................................... 78 3.3.10. Ecology and Biodiversity ............................................................................................... 79 3.3.11. Energy Conservation..................................................................................................... 79 3.3.12. Safety Provisions .......................................................................................................... 79

Chapter 4. Environmental Management Plan ............................................................................. 80 4.1. Prelude ............................................................................................................................. 80 4.2. The EMP ........................................................................................................................... 80 4.3. Environmental, Health and Safety Management System .................................................. 81 4.4. Construction Phase........................................................................................................... 82 4.5. Operation Phase ............................................................................................................... 82

4.5.1. Air Environment ............................................................................................................ 82 4.5.2. Water Environment ....................................................................................................... 85 4.5.3. Solid and Hazardous Waste Management .................................................................... 85 4.5.4. Noise Environment ........................................................................................................ 86 4.5.5. Occupational Health Programme .................................................................................. 86 4.5.6. Hazard Communication and Chemical Safety ............................................................... 87 4.5.7. Environmental Audit ...................................................................................................... 87 4.5.8. Manpower for Environmental Health and Safety Management ...................................... 87

4.6. ENVIRONMENT MANAGEMENT CELL ........................................................................... 88 4.7. EMP BUDGET .................................................................................................................. 88 4.8. Environmental Monitoring Programme .............................................................................. 89

Chapter 5. Hazards Analysis & Risk Assessment ....................................................................... 92 5.1. Introduction ....................................................................................................................... 92 5.2. Risk Assessment .............................................................................................................. 92

Chapter 6. Summary and Conclusion ......................................................................................... 92 6.1. Prelude ............................................................................................................................. 92

Chapter 7. Disclosure of Consultants ........................................................................................ 103 7.1. Declaration by Experts Contributing to this Report .......................................................... 103

List of Tables

Table 1.1 : Salient features of the project and site ........................................................... 9 Table 1.2 : Compliance with the Terms of Reference .................................................... 15 Table 2.1 : Connectivity and Surrounding Area Profile .................................................. 17 Table 2.2 : Land Distribution at Site ............................................................................... 19 Table 2.3 List of Solvents used in Manufacturing Process ............................................. 23 Table 2.4 Details of distillation system. .......................................................................... 24 Table 2.5 Raw Material Requirement ............................................................................ 24 Table 2.6 Raw Material and Finished Good Storage Area and its Specifications. .......... 24 Table 2.7 :Water Consumption for Various Activities during Operation Phase ............... 26 Table 2.8 : Fuel quantity and source ............................................................................. 26 Table 2.9 : Quantity of Hazardous Waste to be Generated............................................ 27 Table 2.10 : Type and Quantity of Solid Waste to be Generated in the Construction and

Operation Phases .................................................................................................. 27 Table 2.11 Details of Air Emissions ............................................................................... 28 Table 2.12 Stacks in the API Plant (Example) ............................................................... 28 Table 2.13 Pollutant Concentration ............................................................................... 28 Table 2.14 Proposed CSR Activities & Annual Allocation of Fund ................................. 31

Page 4: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

3 Consultant name

Table 3.1 : Typical Noise Sources during Construction Phase ...................................... 66 Table 3.2 : Stack Details (Example )give detail .............................................................. 73 Table 4.1 List of Plant species to be planted under greenbelt development pogramme . 84 Table 4.2 : Design Features for Minimization of Fugitive Emissions .............................. 85 Table 4.3 : Environmental Management Cell ................................................................. 88 Table 4.4 : Environmental budget .................................................................................. 89 Table 4.5 : Matrix of Environmental Monitoring Plan...................................................... 89

List of Figures

Figure 1.1 : Location of the Project ......................................................................................... 8 Figure 1.2 Map Showing Road Connectivity ............................................................................. 9 Figure 1.3 : Methodology of EIA Study .......................................................................... 12 Figure 2.1 : Location Map .............................................................................................. 18 Figure 2.2 : Site Layout Map (Source : Royal enterprises)............................................. 20 Figure 3.1 : Isopleth of Ground level Concentration of SOx ........................................... 74 Figure 3.2 : Isopleth of Ground level Concentration of NOx ........................................... 75 Figure 3.3 : Isopleth of Ground level Concentration of PM10 .......................................... 75 Figure 3.4 : Isopleth of Ground level Concentration of PM2.5 ......................................... 75 Figure 3.5 : Isopleth of Ground level Concentration of NH3 ........................................... 75 Figure 3.7 ...................................................................................................................... 77

Page 5: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

4 Consultant name

List of Annexures

Annexure I: Approved TOR letter

Annexure II: Land Allotment by HSIIDC

Annexure III: MET data

Annexure IV: Site Photograph

Annexure V: Monitoring Results

Page 6: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

5 Consultant name

Abbreviation

PNBBr Para nitro benzyl bromide

A Acid Acetic acid H2O2 Hydrogen peroxide

KBr Potassium bromide CF Centrifuge ML Mother liquor MeOH Methanol SRP Solvent recovery plant H2SO4 Sulphuric acid DMF Dimethylformamide MEE Multiple effect evaporators Rxn Reaction ETP Effluent treatment plant HTDS High Total dissolve solid LTDS Low Total dissolved solid TMP Trimethylphosphite EA Ethyl acetate TMPO Trimethoxy phosphine oxide MDC Methylene chloride PtSCl Para toluene Sulphonyl Chloride

PTC Phase transfer catalyst 4M Morhaline NH4OH Ammonium hydroxide TPP Triphenylphosphite MEG Ethylene glycol DMA Dimethyl aniline PCl5 Phosphorus pentachloride TPPO Triphenoxy phosphine oxide Hydro Sodium dithionite HCl Hydrochloric acid 7ACCA 7Amino3chlorocephalosporanic acid HMDS Hexamethyldisilazane

TMCS Trimethylchlorosilane

EDTA Ethylene diamine tetra acetic acid D. salt Dane salt HMDSO Hexamethyldisiloxane NMM NMethylmorphaline

ECF Ethylchlroformate C Acid Methane sulphonic acid CFC Cefaclor NaBr Sodium bromide HCHO Formaldehyde

TFA Tri-fluroacetic acid

NBA N-butyl acetate NaCl Sodium chloride

Na2CO3 Sodium carbonate

SBC Sodium bicarbonate 7AVCA 7-Amino-3-vinyl-3-cephem-4-carboxylic acid

Page 7: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

6 Consultant name

NaOH Sodium hydroxide THF Tetra-hydrofuran TEA Tri-ethyl amine DMAc Di-methylacetamide CSI Chlorosulphonyl-isocynate CFU Acid Cefuroxime acid AEB 1-Acetoxyethylbromide NaI sodium iodide SMBS Sodium metabisulphite IPA Propanol HWTDF Hazardous waste treatment & disposal facility Thio Sodium thio - sulphate DBU 1,8- Diazabicyclo[5.4.0]-undec7ene So.succinate Sodium succinate CIIPC 1-Chlorethyl isopropyl carbonate Cat Crown ether

Na2SO4 Sodium sulphate

Org.Layer Organic layer Aq.Layer Aqueous layer

CHCl3 Chloroform K2S2O5 Potassium metabisulphite

PA or NPA N-Propanol BA Butyl acetate

NaEHA Sodium hexanoate TBAB tetrabutylammonium bromide Iodo Iodomethylpivalate

CMP Chloromethylpivalate

MSC methane sulphonyl chloride

ACN Acetonitrile

DIPA Diisopropylamine STS Sodium thio sulphate

MIBK methylisobutyl ketone

BF3 Boron trofluoride

POCl3 Phosphorus oxy chloride

ECNA Ethyl cynoacetate DNPA Di – n - propylamine

DEM Di- ethyl malonate EtOH ethanol

A carbon Activated carbon Abs -alcohal Ethyl alcohal K2HPO4 Dipotassium hydrogen phosphate

RCVD RotaconeVaccum Drier

Page 8: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

7 Consultant name

CHAPTER 1. INTRODUCTION AND BACKGROUND

1.1. Introduction

Royal Enterprises established as a manufacturers. Their business model is based on the

manufacturing of Methylcobalamin (b12). In order to reduce the usage of hazardous and

polluting solvents, methods are developed using enzymatic process and wherever

possible, strict control over emissions at all levels is maintained. The present proposal is

to set up a unit for manufacturing for Methylcobalamin (b12) at HSIIDC Barhi part 2,

Tehsil Ganaur, District Sonipat

1.2. Proposed Products and Project Location

Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing

unit of 30 kg/monthcapacity. The chemical name for methylcobalamin is Coα-[α-(5,6-

dimethylbenz-1H-imidazolyl)]-Coβ- methylcobamide. Synonyms and trade names are

mecobalamin, methylcobalamin, cobaltmethylcobalamin, Algobaz and Cobamet. The

proposed product is Methylcobalamin (b12) and by product is Sodium iodide

The proposed project is to be established at HSIIDC Barhi part 2, Tehsil Ganaur, District

Sonipat(Refer figure 1.1 and 1.2 for location map and toposheet map respectively).

This chapter provides background information of the project i.e. project proponent, project

justification, regulatory framework location of the proposed project, the scope of EIA study,

methodology adopted for EIA study and structure of the report, and compliance to the TOR

issued by MoEF.

Page 9: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

8 Consultant name

(Source: Google earth imagery)

Figure 1.1 : Location of the Project

Page 10: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

9 Consultant name

(Source: Google earth imagery)

Figure 1.2 Map Showing Road Connectivity

1.3. Salient Features of the Project

The salient features of the project and site aresummarised below at Table 1.2.

Table 1.1 : Salient features of the project and site

Items Details

Project Greenfield Facility of Manufacturing Plant for Methylcobalamin (b12)

Category of Project As per EIA Notification 2006 and amendment thereof Proposed project fall in Category ―A‖ (because Haryana committee is dissolve so we apply in MoEFCC)

Location HSIIDC Barhi part 2, Tehsil Ganaur, District Sonipat

Coordinates Refer attached googe map

Page 11: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

10 Consultant name

Project area Approx. 1800 square metre

Production Capacity 30kg/month

Location features The project is proposed in the approved HSIIDC industrial

area. Project shall be having the advantages of facilities of

industrial area like water supply,electricity supply etc.

Power requirement & source

Power shall be obtained from State Electricity Board

Water requirement & source

No ground water extraction is required. The water to be used shall be supplied by HSIIDC

ETP Facility Zero liquid discharge facility shall be provided

STP Facility A compact unit for sewage treatment shall be proposed.

Project Cost The total Project cost shall be approx.155 lakh

1.4. Need of the Proposed Project

India ranks third with respect to the production capacity of pharmaceuticals in the world,

whereas in terms of value, India is in 14th place. The total turnover of pharmaceutical

industry in 2010 was US $ 20 billion, which is 20 times when compared with the turnover

in 1990 (Indian Pharmaceutical Industry, 2010). All major therapeutic groups of drugs

are manufactured in India. In terms of generics production India ranks 4th, but in terms

of export value India ranks 17th. The need of APIs is increasing every year due to

continual growth of pharmecutical industry. This project is expected to partially fulfil the

demand of APIs of pharmecutical industries.

1.5. Environmental Regulatory Applicability

The proposed project falls under underSl.No. 5(f) of the schedule I of Environmental

Impact Assessment Notification S.O. 1533 dated 14thSeptember, 2006 and as amended

thereof. Project classified as Category 'B' but consider in Category ‘A’ because

Haryana SEAC committee is dissolve so we apply our case in MOEF.

It does not attract any specific or general condition as per EIA notification dated 14th

September 2006 and its amendment on 1st December 2009.MoEF has granted

preliminary clearance for setting up this project and approved TOR for carrying out EIA

study vide its letter ( enclosed as Annexure I)

The project also requires consents and authorisation under Air ( Prevention and

Controlof Pollution) act 1981, Water (Prevention and Control of Pollution) Act,1974 and

The Hazardous Waste (Management, Handling and Transboundary Movement) Rules

2008 amended to date.

Page 12: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

11 Consultant name

1.6. Scope and Methodology of the Study

The scope of the EIA study is based on the generic structure of environmental

impact assessment document as stated in the Appendix III of the EIA Notification

2006 (S.O. 1533), Ministry of Environment and Forests, Government of India.

The scope of the study includes a detailed Environmental impact assessment of the

proposed project on valued environmental components. The proposed project is

currently in the design preparation stage. For the purpose of environmental

assessment, areas within 10 km radius of the project have been studied and the

following steps shall be followed:

o Generation of baseline data for valued environmental components as per the

EIA guidelines& approved TOR

o Identification and quantification of significant environmental impacts due to

the project and its associated activities.

o identification of mitigation measures eliminate or minimize the impacts

o Preparation of appropriate Environmental Management Plan (EMP)

encompassing plan for minimizing identified adverse impacts along with

budgetary provisions to be made by the project authorities for implementation

of mitigation measures.

o Delineation of post Environmental Quality Monitoring Programme (EQMP)

along with organizational setup required for monitoring the effectiveness of

mitigation measures.

Page 13: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

12 Consultant name

Figure 1.3 : Methodology of EIA Study

1.7. Structure of the Report

Page 14: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

13 Consultant name

The EIA report contains project detail, baseline environmental setup, assessment of

environmental impacts, and formulation of mitigation measures, environmental

management and monitoring plan with risk & disaster management plan.

The report includes 9Chapters in addition to the Executive Summary as follows:

Executive Summary

Chapter 1: Introduction

This chapter provides background information on need of project, need of EIA study and

brief of the project. The scope and EIA methodology adopted in preparation of EIA report

have also been described in this Chapter. It also covers the identification of project &

project proponent, brief description of nature, size, location of the project and its

importance to the country and the region. Scope of the study details about the regulatory

scoping carried out as per the generic structure given in the EIA Notification, 2006.

Chapter 2: Project Description

This chapter deals with the project details of the proposed Drugs Manufacturing Plant,

with type of project, need for the project, location, size & magnitude of operation

including associated activities required by and for the project, manufacturing process,

proposed schedule for approval and implementation, including technical details of raw

material, quality and quantity etc.

Chapter 3: Description of the Environment

This chapter presents the existing environmental status of the study area around the

proposed project including topography, drainage pattern, water environment, geological,

climate, transport system, land use, flora & fauna, socio-economic aspects, basic

amenities etc. Environmental assessment of the proposed project site in regard to its

capability to receive the proposed new development is also discussed in this Chapter.

Chapter 4: Anticipated Environmental Impacts and Mitigation Measures

This chapter describes the overall impacts of the proposed project activities and

underscores the areas of concern, which need mitigation measures. It predicts the

overall impact of the proposed project on different components of the environment viz.

air, water, land, noise, biological, and socio-economic during construction & operation

stages.

Chapter 5: Environmental Management Plan

Page 15: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

14 Consultant name

This chapter details the inferences drawn from the environmental impact assessment

exercise. It also provides mitigation and control measures for environmental

management plan (EMP) for minimizing the negative environmental impacts and to

strengthening the positive environmental impacts of the proposed project.Technical

aspects of monitoring the effectiveness of mitigation measures

Chapter 6: Risk Assessment & Disaster Management Plan

This chapter deals in brief with hazards and risks associated with proposed project

activities and recommends various safety measures. The risk assessment shall be

carried out for the proposed API manufacturing plant and a model disaster management

plan is presented.

Chapter 7: Disaster Management Plan

This chapter deals in brief of disaster management plan.

Chapter 8 :Summary & Conclusion

This chapter provides the summary and conclusions of the EIA study of the proposed

project with overall justification for implementation of the project and also explanation of

how, adverse effects will be mitigated. This chapter also includes the conclusions of the

Public Hearing.

Chapter 9: Disclosure of Consultants Engaged

This chapter provides the disclosure of consultants engaged to carryout the EIA study

along with other additional studies.

1.8. Compliance to approved TOR

The EIA study has been conducted in-line with the approved ToR by MoEF and taking

into consideration the structure of the report given in the EIA Notification 2006. The

compliance to the approved ToR .

Page 16: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

15 Consultant name

Table 1.2 : Compliance with the Terms of Reference

S. No.

Proposed Terms of Reference Compliance

1 Justification of the project

4 A map indicating location of the project

5 Project location and plant layout

6 Infrastructure facilities including power sources

7 Total cost of the project along with total capital cost and recurring cost/annum for environmental pollution control measures.

8 Project site location along with site map of 10 km area and site details providing various industries, surface water bodies etc, along with landuse around 10 kms of the study area

9 Details of the total land and break-up of the land use for green belt and other uses.

10 List of products along with the production capacities

11 Detailed list of raw materials required and source, mode of storage and transportation

12 Manufacturing process details along with the chemical reactions and process flow chart.

13 Action plan for the transportation of raw material and products.

15 Ambient air quality monitoring at 4 locations within the study area of 10 km., aerial coverage from project site as per NAAQES notified on 16th September, 2009. Location of one AAQMS in downwind direction.

16 Site-specific micro-meteorological data of one season of the year 2014 using temperature, relative humidity, hourly wind speed and direction and rainfall and AAQ data (except monsoon) for PM2.5, PM10, SO2, NOx will be collected. The monitoring stations will be take into account the pre-dominant wind direction, population zone and sensitive receptors including reserved forests. Data for surface water, groundwater and noise monitoring will also be included.

17 Air pollution control measures proposed for the effective control of gaseous emissions within permissible limits.

20 Ground water monitoring at 4 locations

22 The details of solid and hazardous wastes generation, storage, utilization and disposal

Page 17: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

16 Consultant name

S. No.

Proposed Terms of Reference Compliance

particularly related to the hazardous waste calorific value of hazardous waste and detailed characteristic of the hazardous waste.

23 Precautions to be taken during storage and transportation of hazardous chemicals will be clearly mentioned and incorporated

24 Risk assessment for storage, handling, transportation hazardous chemicals with action plan for handling & safety system

27 Socio-economic development activities

29 Detailed Environment management Plan (EMP) with specific reference to details of air pollution control system, water & wastewater management, monitoring frequency, responsibility and time bound implementation plan for mitigation measure will be provided.

Page 18: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

17 Consultant name

CHAPTER 2. PROJECT DESCRIPTION

2.1. The Site

Royal enterprisesproposed unit for manufacturing for Methylcobalamin (b12) at

HSIIDCBarhi part 2, Tehsil Ganaur, District Sonipat

The project will not change the land use, land cover pattern, being located within HSIIDC

industrial area. Table 2.1 provide brief location aspects of the proposed project. The

layout map of the proposed unit is given at Figure 2.1.

Table 2.1 : Connectivity and Surrounding Area Profile

Description Name

Tehsil / Taluka / Mandal Ganaur

District Sonipat

State Haryana

Nearest railway station / airport / along with distance in km.

Narela railway station 30 KM in South

Nearest town, city, district headquarters along with distances in km

IGI airport 62 KM in South

2.2. Justification of Project Location

Need of drugs is increasing every year due to continual growth of pharmaceutical

industry. This project is expected to contribute in partially fulfilling the demand of

Methylcobalamin (b12) forpharmaceutical industries withinHaryana&rest of India.

The proposed project will be located inside the HSIIDC Industrial Area. The

HSIIDC Industrial Area has well developed roads, and is located near the NH 1

(within 0.25 km – East direction), which is advantageous in terms of

transportation of raw materials as well as finished goods. This justifies the

proposed site location.The location map shown in Figure 2.1.

This chapter deals with the brief details of the establishment of new proposed bulk drug

project; Location Consideration, Technology Description, Raw material Requirement and

its source, Process flow diagram, Environmental aspects etc.

Page 19: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

18 Consultant name

Figure 2.1 : Location Map

(Source: Google Earth)

Page 20: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

19 Consultant name

2.3. Land allocation within plant

The land allocation at the site is presented in Table 2.2, corresponding to plant layout

shown in figure 2.2

Table 2.2 : Land Distribution at Site

S. No. Description Area (sq m)

1. Total Plot Area 1800

2. Manufacturing 800

3. Green Belt 600

4. Utilities

Security & Time Office

Miscelleneous-Parking /Open Areaetc

400

Total 1800 (Source:Royal enterprises)

Page 21: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

20 Consultant name

Figure 2.2 : Site Layout Map (Source : Royal enterprises)

Page 22: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 21

2.4. Process Description

The chemical name for methylcobalamin is Coα-[α-(5,6-dimethylbenz-1H-imidazolyl)]-Coβ-

methylcobamide. Synonyms and trade names are mecobalamin, methylcobalamin,

cobaltmethylcobalamin, Algobaz and Cobamet. The molecular formula is

C63H91CoN13O14P and its molecular weight is 1344.4 g/mol. The manufacturing process

are as follows:

Step-I: Check the Glass flask is cleaned and dry. Charge Process water, heating and

addition of cynocobalamin. Cooling and addition of sodium borohydride, stirring and addition

of methyl iodide.Addition of chloroform and phenol mixure, stirring, settling for layer

separation.

Step-II: Check the Glass flask clean and dry. Charge process water, organic layer,

chloroform and acetone. Stirring settling, layer separation, distillation of process water.

Addition of acetone, cooling, filtration, drying, sieving.

Page 23: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 22

Chemical reaction and mass balance

Page 24: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 23

2.5. Solvents Used in the Manufacturing Process

The solvents used in the manufacturing process of APIs are tabulated below (Table

2.3) All fresh solvents listed below will be stored in tank farm area in 10-20 KL

tanks. Flame arrester & dyke wall with sufficient height, width, free board (equal to

the volume of maximum capacity tank) and impervious floor. All storage tanks will be

under negative pressure to avoid any leakage. Condenser with brine chilling shall be

provided to minimise loses.

Table 2.3 List of Solvents used in Manufacturing Process

Sl. No. Name of the Raw Material Storage Area and

Capacity

Storage

Specifications

1. Methanol 20 KL SS-304

2. Toluene 10 KL SS-304

3. Acetone 20 KL SS-304

4. IPA 10 KL SS-304

5. Ethanol 5 KL SS-304

6. Cyclohexane 10 KL SS-304 ( jacketed)

7. n-Butyl acetate 20 KL SS-304

8. Ethyl acetate 20 Kl SS-304

9. Methylene Chloride 20 KL SS-304 ( jacketed)

2.5.2. Solvent Recovery System

The recovery and recycling of solvents in the process is a key issue in achieving

productivity and an edge in competitive world. Hence, all the solvent mixtures

generated from different stages of the products will be fractionated in a state of the

Page 25: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 24

art solvent recovery system to give 95-98% recovery depending upon composition of

solvent mixtures and their boiling point. Therefore, Royal enterprises has planned

distillation columns with varying specification to take care of the all the spent solvents

recovered from various stages of the production.

To minimise solvent losses during distillation following measurers will be adopted:

Chilled brine of -10°C will be circulated in condensers to condense the solvent

vapours.

Transfer of solvents to be done through pumps instead of manual handling.

Vent condensers to be provided on all storage tanks.

2.6. Raw Material

The raw materials used in manufacturing process, their quantity aregiveninTable

2.5.D.M water purchase from market for processing—400 ltr / 5kg batch.

Table 2.4 Raw Material Requirement

Sr. No. Raw Material Unit Quantity Standard

Per Month

5.0 KG BATCH

SIZE

30 kg/month

1 Cyanocobalamin Kg 5.00 30

2 Methyl Iodide Kg 4.50 27

3 Sodium Borohydride

Kg 5.50 33

4 Chloroform Kg 98.00 588

5 Acetone Kg 60.00 360

6 Phenol Kg 25.00 150

7 Methanol Kg 13.00 78

The chemicals shall be stored based on compatibility analysis. The warehouse for

storage of chemicals will be constructed in RCC structure in solid walls and sufficient

hard floor, which is impermeable to liquids. An impervious sill or low bund will be

installed to prevent spillage in outer storage area.

The warehouse will be well ventilated taking into account the products stored. It will

be provided with flameproof electrical fittings and equipments. It will have two

emergency doors on each floor for smooth escape in case of emergency.

Certain chemicals which are sensitive to heat shall be stored separately in cold

rooms at a temperature < +8°C and < +25 °C.

Storage area for hazardous chemicals will be isolated from the rest of the warehouse

with impervious walls, floors and provision of safe disposal of spillages. The area will

be provided with emergency showers and eye wash facility as well. Hazardous gases

(Chlorine, ammonia and bromine) will be stored in a separate cage type shed.

Utilities

Page 26: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 25

A. Laboratory

S. No. Equipment Make

1. HPLC (Manual) Younglin

2. G.C. Nucon

3. pH Meter Analab Scientific

4. Karl Fischer Analab Scientific

5. Analytical Balance Shimadzu

6. Ultrasonic Bath Analab Scientific

7. Stability Chamber (Long Term) Thermolab

8. Stability Chamber (Accelerated) Thermolab

9. Melting Point Apparatus Jay Lab Instruments

10. Vacuum Drying Oven Durga Traders

11. Freeze LG

12. Hot Plate

13. Thermometer (-10º to 110º C)

14. Thermometer (-10º to 360º C)

B. Plant Equipment

S No Equipment Qty. Capacity

1. Glass Flask 1 200 L

2. Glass Flask 1 100 L

3. Nutch Filter 1 125 L

4. Vaccum tray T.Ddryer 1 6 Tray

C. Others

S. No. Equipment Qty. Capacity

1 Cooling Tower 2 200 TR

2 Chilling plant 3 26 TR

3 Hot Water System 2 2 KL

4 D.G. Set 1 60 K.V.A

5 Electric Heater 1 200 Kg

6 Vacuum Pump 1 20 HP

7 Air handling handing 1 3000 C.F.M

2.6.2. Water Requirement

Page 27: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 26

During construction phase 300LD and during operation phase 300 LD of fresh water

will be required sourced from HSIIDC through tankers.

Table 2.5 :Water Consumption for Various Activities during Operation Phase

Sl. No. Component Fresh Water Required

(LD)

1 Manufacturing Process 155

3 Drinking & Sanitation 100

4 Green Belt 45

TOTAL 300LD Fresh Water

(Source: Royal enterprises)

The water balance diagram during operation phase has been shown in Figure 2.33.

2.6.3. Fuel

High-speed diesel (HSD) will be used in the DG sets. Table 2.8 gives the fuel quantity and the source.

Table 2.6 : Fuel quantity and source

Sl. No.

Fuel Quantity Source Transportation Mode

Storage

2 HSD 50L/day Locally By road 20 Kl MS tank

2.6.4. Power

The Power requirement for the proposed project during operation phase is 49 KWA The

power supply shall be from sourced from Haryana Vidhyut Nigam Limited, In addition there

is provision of DG sets capacity of 60 KVA for backup..

2.6.5. Employement

During construction phaseroyal enterprises will employe 10 person and the manpower

requirement during the operation phase will be approx 15. Royal enterprises will make sure

to employ local labour to the extent possible.

2.7. Generation of Pollutants

The generation of pollutants associated with the Royal enterprises during operation of

Methylcobalamin (b12)Unit can be in the form of liquid effluent,no solid waste shall be

Page 28: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 27

generated. The all byprodcuts shall be sold out separately. The advance and ecofriendly

production procedure shall be used. As such there is no source of air pollution envisaged by

the naufacturinguni, however only emissions shall be from DG set.To mitigate noise pollution

from DG acoustic hood shall be provided in compliance with the GOI protocol..

2.7.1. Sewage Treatment

The sewage will be generated form the employes/workers during the operation phase of the

proposed project shall be treated in soak pit

2.7.2. Effluent Treatment Plant

Company policy and prime aim is to ensure that Environmental Norms are strictly adhered

to.

Some of the key features with respect to effluents and waste disposal in this unit are:

The trade effluents generated from proposed project are treated in ETP send to Common

Effluent Treatment Plant (maintained by HSIIDC govt organization).

The Domestic and sewage waste water stream send to Septic tank.

Our laboratories and production sites are engineered to be safe working environments in

accordance with local regulations and the company‘s high-level operating standards.

Stringent safety procedures, applicable to both internal company and external sub-

contracted employees, are practiced during the sites‘ erection stages.

The project is not likely to cause any significant impact to the ecology of the area since

adequate preventive measures will be adopted to control various pollutants within

permissible limits. Green belt development around the area would also be taking up an

effective pollution mitigative technique.

2.7.3. Hazardous Wastes and Management

The hazardous wastes anticipated to be generated from the proposed unit is send to

authorised dealer

The type and quantity of solid wastes, which are anticipated to be generated from the

proposed project during construction and operation phase are tabulated in Table.

Table 2.7 : Type and Quantity of Solid Waste to be Generated in the Construction and Operation Phases

Sl. No. Type of Solid Waste Quantity Treatment/ Disposal Method

Construction Phase

1 Construction waste It will be Debris will be used for internal road

Page 29: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 28

(debris) minimal laying purpose & landscaping

Operation Phase

2 Empty barrels (used for non-hazardous materials)

5-7 barrels / day

Collected and sold to authorize recyclers after cleaning.

3 Scrap metals 200 kg/day Collected and sold to authorize recyclers.

4 Used / Spent oil 10 L/Day To be incinerated & ash will be sent to TSDF

2.7.4. Air Emissions

Emission control will be through Air handling unit .The details of air emissions are provided

in Table 2.23.

Table 2.8 Details of Air Emissions

S. No. Source of air emissions

Type of Pollutant Considered

1. DG Sets (60 KVA) NO2,SO2, PM2.5, PM10,

2. AHU NO2, SO2, PM2.5, PM10,

2.8. OHS System

The existing plant of Royal enterprises haswell-organized Safety Management system with

well defined ―Safety Health & Environment Policy‖, ―Quality Policy‖, ―Environment Policy‖ and

―Occupational Health & Safety Policy‖ which are certified by external agency of international

repute. Royal enterprises are committed to the principles of sustainable development. As a

part of this commitment, roral enterprises protect the environment in which they operate and

ensure the health and safety of our employees, contractors, visitors and communities. All

employees are responsible for being aware about safety, health and environment needs in

their area of work. The proposed plant will also have these policies in place. The significance

of safety & health in chemical industries has been a vital issue in achieving productivity and

an edge in competitive world. Hence, all the pollution control measures envisaged at

feasibility stage will be implemented with due care.

The proposed plant will be designed as per international guidelines viz. WHO GMP, USFDA

etc comprising of separate entry &exit for workers and material. The layout of plants will be

under purview of various statutory regulations and these regulations will be reviewed

regularly. All reaction vessels will be connected with scrubber so that any toxic fumes/

vapour generated during reaction gets neutralized.

Page 30: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 29

The proposed plant will have Air Handling Units to keep temperature <25 deg in powder

processing area and filtered air will be supplied in other areas. Dust collector will be provided

in powder processing area to remove dust generated during sifting/ milling of product.

Workers engaged in powder processing work will be provided personal protective

equipments like dust masks, respirators etc

The proposed plant will be provided with sophisticated instrumentation for continuously

monitoring of operating parameters.

The plant premises will be strictly maintained as a ―NO SMOKING ―area. Fire fighting facility

will be provided at site consisting of underground fire hydrant system and various fire

extinguishers.

For electrical instrumentation and installations, the entire plant will be sub divided into

hazardous and non hazardous zone. In the hazardous zone, flameproof fittings &fixtures will

be provided. Arrangements will be made in each equipment to avoid static spark.

All reaction vessels will be provided safety valve, rupture disc, pressure gauges etc to avoid

any explosion. Provision for inert gas purging will be there in each reactor to avoid possibility

of developing any hazardous mixture.

The company will have On Site Emergency Plan to handle any emergencies e.g. fire,

chemical spillage and medical arising from any unforeseen reason.

Workers will be trained & make them aware regarding safety and proper hygiene in plant. All

workers will undergo periodic medical examination and will be provided personal protective

equipments for their safety.

Major hazards can be avoided by proper implementation of Maintenance and Inspection

Schedule, Periodic maintenance will be in place to check the various types of compressors,

pumps, fan, and blowers and monitor the vibration level. Compliance of Statuary Regulations

related to Factory act. All hot/cold surfaces will be insulated. Waste generated during

process will be removed regularly. Proper housekeeping in maintenance block, utility block

will be done so as to ensure that spillage of oil, litters of maintenance material are cleared

off.

2.9. Project Cost and Cost towards Environmental Protection

The total estimated cost of the proposed project is approximately Rs155 lacs, which include

the cost of the land, internal development and construction cost,administrative cost and

associated contingencies.

Page 31: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 30

Serial No. Particulars Amount In Lacs

1. Land And Site Development 35

2. Building & Civil Construction 50

3. Plant & Machinery with laboratory 45

4. Controlling equipments (AHU, ETP other utilities) 25

Total 155

2.10. CSR Plan

Royal enterprises will contribute 2% of the project cost of Rs.1.5 crores, that is Rs 3 lakhs

towards CSR plan. The above amount will be spent in next 5 years for infrastructure

development of surrounding area. Need based study have been conducted in surrounding

villages in the adjoining areas.

Page 32: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 31

CHAPTER 3. DESCRIPTION OF THE ENVIRONMENT

Introduction

1. EIA Notification 2006 typically specifies that an EIA report should contain a description of the existing

environment that would be or might be affected directly or indirectly by the proposed project.

Environmental baseline monitoring (EBM) is a very important stage of EIA. On one hand it plays a very

vital role in EIA and on the other hand it provides feedback about the actual environmental impacts of a

project. EBM during the operational phase helps in judging the success of mitigation measures in

protecting the environment. Mitigation measures, in turn are used to ensure compliance with

environmental standards, and to facilitate any needed project design or operational changes.

2. It includes the natural, cultural, socio-economic Systems and their inter-relationships. The intention is

not to describe all baseline conditions, but to focus the collection and description of baseline data on

those VECs (Valuable Environmental Components) that are important and are likely to be affected by

the proposed fertilizer project activity.

Study Period:

3. Baseline environmental conditions are based on the field studies carried out during 25th May, 2015 to

25th June, 2015 at and around the proposed site.

Site Description and Its environs:

4. Baseline Study has been carried out in a 10 km radial zone from the project site. Figure 3.1& figure 3.2

show the study area.

Connectivity Details

5. There is no railway station within 10 Km radial Distance from project site However Transport Facility

like Roadways Buses, Local Buses are available. The nearest Railway station is Narela Railway

Station: 30 Km from site, in S Direction and the nearest airport is New Delhi Airport: 62 Km from site in

S direction. The road network of 10km radius is provided in figure 3.3.

This Chapter describes the baseline environmental conditions around the project site for various

environmental attributes, viz., physical, biological and socio-economic, within the 10 km radial

zone, which is termed as the study area. Topography, soil, water, meteorology, air, noise, and land

constitute the physical environment, whereas flora and fauna constitute the biological

environment. Demographic details and occupational pattern in the study area constitute socio-

economic environment. Baseline environmental conditions are based on the field studies carried

out during 20th May, 2015 to 20th June, 2015 at and around the proposed site, Base Maps of all

environmental components through secondary data collected from published sources

Page 33: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 32

Source: Topo Sheet

:Study area map(10km Radius)

Page 34: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 33

Methodology adopted for Base Line Studies

6. Base line Studies in Project site was carried out for valuable environmental attributes by our team

(constitutes of Laboratory Person, Socio Economic Experts, and Ecology Experts etc. The Purpose of

field survey/investigation is to decide the Location of monitoring stations, Sampling Locations and

collection, Collection of Other Primary Data and to cross check the Secondary information extracted

from authentic Data sources/Web sites.

7. The Studies of Some Attributes of Baseline condition are carried out by Kamal lab, Manesar following

Standard Methods recommended by the BIS, CPCB, MoEF ,(MoEF/NABET certificate attached as

Annexure-III) were followed for all sample analysis and other base line data collection / study.

8. The complete baseline chapter is further divided into three main sections viz : Physical environment,

Ecological Environment and Socio-economic Environment

Physical Environment

9. Physical environment constitutes Land details, Surface water details, ground water details,

atmosphericdetails (meteorology), Noise and vibration

Land Environment

10. Land Environment comprises of lithology, geomorphology, slope stability, contour & DEM, subsidence,

seismicity, landuse, soil composition and characteristics, etc.

Geology:

11. Hard rock geology of the district is concealed under alluvial and Aeolian deposits. The alluvial deposits

of quaternary age are divisible as newer and older. The former usually occurs in the active flood-plain

of the Ghagghar River, in the northern part of the district and comprises sand, silt clay and occasional

gravel. Calcareous concretions in various proportions are found mixed with other constituents. The

sediments are heterogeneous in character, and are deposited on a basement of metamorphic and

igneous rocks of pre-Cambrian age. The bed rock topography over which the alluvial deposits rest,

slopes towards north-east. The maximum thickness of alluvium as encountered in a borehole at

Jhalnian (Fatehabad tehsils) is 345.51 metres below ground level. TheAeolian deposits comprising

accumulation of sand blown from Thar Desert of Rajasthan are mostly confined to south-western part

of the district. These sand accumulations occupy vast stretches of land and occur in the shape of

sandy flats, mounds and ridges at places attaining dunal shapes over the sandy flats.

Lithology, geomorphology,

12. The district area forms a part of Indo-Gangetic plain. The area as a whole is almost flat alluvial plain

dotted with sand hummocks and sand dunes. The general altitude of the area varies from 203 to 225 m

amsl and having a gentle slope towards south-westerly direction.Physiographically, the district is

characterized by two distinct features i.e. upland plain and Sand dune clusters.

Contour & DEM,

13. A digital elevation model (DEM) is a digital representation of ground surface topography or terrain. It is

also widely known as a digital terrain model (DTM). A DEM can be represented as a raster (a grid of

squares, also known as a height map when representing elevation) or as a triangular irregular network.

The proposed plant location is shown in that Relief map.

Page 35: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 34

14. For the relief study of the area very higher quality ASTER (Advanced Space borne Thermal Emission

and Reflection Radiometer) DEM is downloaded. These DEMs of the Terra satellite is freely available

for 99% of the globe, and represents elevation at a 30 meter resolution. After downloading the DEMs

the farther processing is done using the ARC GIS 9.3 version.30 m interval contours are generated

using the 3 D Analyst -Surface analysis – Contour option.

Source: Interpitation of Satelite Image

: DEM of the study area

Discussion:

15. Topographically, the study area is almost plain. The general ground slope is from North West to South

East. The digital elevation model and Contour of the project site is shown in the Figure 3.4 and Figure

3.5 with the elevation range 204 – 238 m.

Seismicity

16. According to tectonic map, the district lies on Delhi-Lahore Ridge which is bounded by thrusts. No

earthquake of any significance has originated in the zone in the past. It has, however, experienced

earthquakes originating in the great Himalayan boundary fault and the, Hindu Kush region. The notable

Kangra earthquake of April 4, 1905 and Chamba earthquake of June 22, 1945 affected the district. The

maximum intensity experienced was VI M-M.l and the district has been assigned to zone II in seismic

zoning map of· India where .the maximum seismic intensity may reach VI MM. For important structures

founded on consolidated soil, a provision of horizontal acceleration of 4 per cent gravity and its 50 per

Page 36: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 35

cent regarding vertical acceleration would ensure a reasonable amount of safety.

Source:http://revenueharyana.gov.in/html/gazeteers/gazetteer_india_hisar.pdf

Source: Interpitation of Satelite Image

: Contour of the study area

Baseline Environment

Page 37: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 36

: Sampling map of the study area

Parameter Sampling sites Distance(Km) Direction

Air Project site 00 00

Pipli khera 2.42 SE

Lalehri 1.47 SW

Rajalu garhi 4.40 W

Gannour 4.38 NW

Dhauri 4.48 SE

Ground Water Project site 00 00

Pipli khera 2.42 SE

Lalehri 1.47 SW

Rajalu garhi 4.40 W

Gannour 4.38 NW

Dhauri 4.48 SE

Surface water Yamuna river 9.52 E

Soil Project site 00 00

Pipli khera 2.42 SE

Lalehri 1.47 SW

Rajalu garhi 4.40 W

Gannour 4.38 NW

Noise Project site 00 00

Pipli khera 2.42 SE

Lalehri 1.47 SW

Rajalu garhi 4.40 W

Gannour 4.38 NW

Page 38: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 37

Land use

17. The basic purpose of land use pattern and classification in an EIA study is to identify the manner in

which different parts of land in an area are being utilized or not utilized. Remote sensing data provides

reliable accurate baseline information for land use mapping as it is a rapid method of acquiring up-to-

date information of over a large geological area.

18. A systematic digital image interpretation approach was used to delineate the land use classes. The

present study was focused on demarcating boundaries of different land use/land cover units from an

analysis of different types of colour registrations of land use/land cover units from satellite imagery.

Soil composition and characteristics

19. 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 favourable tilts

Representative soil samples from depth (0-15cm) were collected from these villages around

the project site for estimation of the physio-chemical characteristics and microbiological

analysis of soil. Standard methods were followed for the analysis of soil samples.

The International Pipette Method (Black, 1964) was adopted for the

determination of particle size analysis. The textural diagram was generated using "SEE Soil

Class 2.0 version" based on United States Department of Agriculture (USDA) classification of

soils. Physical parameters such bulk density, porosity and water holding capacity were

determined by following KR Box Method (Keen and Raczkowski, 1921).

The samples were examined for various parameters, thus the sampling locations are decided

based on one or more criteria these are:

To determine the existing soil characteristics of the study area;

To determine the impact on soil characteristics due to the activities of the existing industries

located in the study area;

To determine the impact on agricultural productivity of soil due to the proposed activity;

Soil samples were collected from the project site as well as from nearby areas to assess its

physio-chemical characteristics in the study area.

Analysis Results of Soil Sampling

S. No. Parameters

Project site

Pipli Khera lalehri Rajalu garhi

Gannaur Dhauri

1. Texture Sandy Loam

Sandy Loam Sandy Loam Sandy Loam

Sandy Loam

Sandy Loam

i Sand (%) 84 88 89 84 88 89

ii Silt (%) 10 08 06 10 08 06

iii Clay (%) 06 04 05 06 04 05

2. pH 7.94 8.12 7.86 7.94 8.12 7.86

3. EC (mho/cm) 427 398 501 427 398 501

4. Bulk Density (gm/cm3) 1.67 1.68 1.7 1.67 1.68 1.7

5. Sodium Adsorption Ratio (%)

0.621 0.712 0.681 0.621 0.712 0.681

Page 39: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 38

6. Potassium mg/Kg 49 41 46 49 41 46

7. Nitrogen as N, mg/Kg 19 24 28 19 24 28

8. Phosphrus ,mg/Kg 10 14 16 10 14 16

9. NPK index 24 26 21 24 26 21

10. Exchangeable Ca (meq/100gr)

1.2 0.6 1.1 1.2 0.6 1.1

11. Exchangeable Mg (meq/100gr)

0.3 0.4 0.4 0.3 0.4 0.4

12. Exchangeable Na (meq/100gr)

<0.1 0.1 <0.1 <0.1 0.1 <0.1

13. Organic Carbon (%) 0.6 0.8 0.9 0.6 0.8 0.9

14. Manganese (meq/100gr) <0.1 0.1 <0.1 <0.1 0.1 <0.1

15. Zinc (meq/100gr) <0.1 <0.1 0.1 <0.1 <0.1 0.1

16. Boron (meq/100gr) <0.1 0.1 0.1 <0.1 0.1 0.1

17 Fluoride (meq/mg) <0.1 <0.1 <0.1 <0.1 <0.1 <0.1

20. : The soil samples collected from the project site reveal sandy characteristics. The soil is slightly

alkaline. Organic content of the soil in the study area is average with available nitrogen content varying

in the range of 19 mg/kg to 28 mg/kg and available phosphorous content in the range of 10 to 16

mg/kg. Soil of the area is fertile.

Surface Water Environment

Drainage system: There is only a natural stream i.e. Yamuna river the analysis result of the

surface water are as follows

Surface Water Quality in the Study Area S. No.

Parameters Yamuna river

Test protocol

1 Conductivity (μmhos/cm)

629 IS:3025 Part-14

2 pH 7.43 IS:3025 Part-11

3 Total Suspended Solid, mg/l

14 IS:3025 Part-16

4 Total Disolves Solids, mg/l

445 IS:3025 Part-16

5 Oil & Grease, mg/l Nil IS:3025 Part-39

6 Chemical Oxygen demand, mg/l

14 IS:3025 Part-58

7 Bio-chemical Oxygen Demand (for 3 days at 27

0C),

mg/l

4.1 IS:3025 Part-44

8 Dissolved Oxygen mg/l

4.1 IS:3025 Part-38

9 Total coliform, MPN/100m

67 IS:3025 Part-43

Source: Water Analysis during study period

Page 40: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 39

Observation on Surface Water Quality: Surface water quality of the Yamuna river was found to

meet the Best Designated Use – ‘C’ Criteria of CPCB (fit for drinking after conventional treatment).

No metallic contamination was found in surface water of study area. The pond water quality of the

study area is satisfactory. .

Ground Water Environment

Hydrology of the study area is broadly classified into following two categories:

Surface water hydrology consisting of river, stream, canal, ponds, dams, etc.

Ground water hydrology consisting of accumulation of water in deeper strata of ground.

Selected water quality parameters for water resources within 10 km of the study area have

been used for describing the water environment, and assessing the impacts on it. To assess

the water quality impacts, water resources in the impact area have been grouped into two

classes.

Surface water resources including streams, tanks, rivers, etc.

Ground water resources in the deeper strata of the ground

The ground and surface water sampling locations are shown in Figure 3.8 And Table- 3.3

Flow regime

21. The elevation of the water table in the district varies from 188.82 to 224.42 m amsl. The average

gradient of the water table worked out for the district in the order of 0.09 m/km. The overall flow of the

ground water is towards south-west direction. However, in northern, western and south western and

southern parts the ground water flow is towards south western direction whereas in south eastern part

is towards western and north western direction.

Seasonal Fluctuation

22. The seasonal fluctuation in water level ranges from – 2.50 to 2.33 m. In general there is rise in water

table in almost whole of the district. About 67 % of the hydrograph stations has shown seasonal rise in

water levels whereas 33 % has shown seasonal decline.

Aquifer characteristics

23. The principle aquifer material comprises of fine-grained sand mixed with gravel and kanker forms the

potential ground water reservoir. Ground water in the district occurs in the alluvium under water table

and semi confined to confined conditions. In general, the water table (unconfined) aquifers occurs from

10 m to 60 m depth below ground level in the district.

24. The ground water in unconfined condition is abstracted through hand pumps, dug wells and shallow

irrigation tube wells.

Water Quality

25. The study of water environment aspect in the ecosystem is to identify sensitive issues, and to take

preventive measures by maintaining ecological homeostasis. Ground water samples were collected

from different sources within the study area for impact assessment study. Important physical and

chemical parameters were analysed for establishing the water quality status of the study area. Most of

the domestic water requirement is met from ground water sources that are from the bore wells inside

the study area.

26. Preliminary Survey

Page 41: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 40

27. A reconnaissance survey was conducted and water samples collected and assessed for the water

quality based on the following considerations.

Location of ground water resources

Representative conditions

Potential users

Water resources within 10 km of the study area were selected and water parameter measured

describing the water environment.

Page 42: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 41

Source: CGWB/192/ch/2007Water table

Page 43: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 42

Source: CGWB/192/ch/2007

Page 44: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 43

Source: CGWB/192/ch/2007

Methodology

Page 45: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 44

28. Ground water from Bore wells and hand pumps cater to the drinking water needs of the villages in the

region. The quality of ground water was assessed by taking samples and analysed as per CPCB

guidelines. The methodology followed for sampling and analysis is as follows:

29. Reconnaissance survey was undertaken and monitoring locations were selected based usage and

source. Water samples were collected in pre-washed bottles in ice boxes and analysed later in

laboratory. Physical parameters like Temperature, EC, and pH were monitored onsite

30. Water Quality Assessment

31. The results of water analysis were compared with IS: 10500-1993 drinking water standard to study

their suitability for drinking purpose and surface water were classified on basis of CPCB standard.

Sampling locations for water samples are shown in Figure 3.8

:Ground Water Quality analysis Result

S.No. Parameters Unit Project site

Pipli Khera

lalehri Rajalu garhi

Gannaur Dhauri Permissible Limit

1. pH - 6.94 7.31 7.24 6.94 7.31 7.24 6.5-8.5

2. Turbidity NTU <5 <5 <5 <5 <5 <5 5

3. EC µMho/cm 824 904 982 824 904 982 -

4. TDS mg/L 648 691 713 648 691 713 2000

5. Total Alkalinity as CaCo3

mg/L 248 274 266 248 274 266 600

6. Chloride as Cl-

mg/L 58 104 92 58 104 92 250

7. Sulphate as SO42-

mg/L 64 121 106 64 121 106 400

8. Nitrate as NO3

mg/L 05 06 04 05 06 04 100

9. Phosphate as PO4

mg/L 04 05 06 04 05 06

10. Total Hardness as CaCo3

mg/L 158 175 186 158 175 186 300

11. Calcium as Ca

mg/L 86 115 119 86 115 119 75

12. Magnesium as Mg

mg/L 72 60 67 72 60 67 100

13. Sodium as Na

mg/L 25 29 34 25 29 34

14. Potassium as K

mg/L 08 12 18 08 12 18

15. Flouride as F- mg/L 2.1 1.8 2.4 2.1 1.8 2.4 1.5

16. Iron as Fe mg/L 0.2 0.3 0.2 0.2 0.3 0.2 0.30

17. Phenolic Compounds

mg/L N.D. N.D. N.D. N.D. N.D. N.D. 0.002

18. Cyanide as CN-

mg/L N.D. N.D. N.D. N.D. N.D. N.D. NR

19. Residual Chlorine as Cl-

mg/L 1.2 1.4 1.3 1.2 1.4 1.3 1000

20. Cadmium as Cd

mg/L N.D. N.D. N.D. N.D. N.D. N.D. NR

21. Total Chromium as Cr

mg/L N.D. N.D. N.D. N.D. N.D. N.D. NR

Page 46: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 45

22. Lead as Pb mg/L N.D. N.D. N.D. N.D. N.D. N.D. NR

23. Zinc as Zn mg/L 1.1 0.8 0.5 1.1 0.8 0.5 15

24. Manganese as Mn

mg/L N.D. N.D. N.D. N.D. N.D. N.D. 0.3

25. Copper as Cu

mg/L N.D. N.D. N.D. N.D. N.D. N.D. 1.5

26. Nickel as Ni mg/L N.D. N.D. N.D. N.D. N.D. N.D.

27. Total coliforms

MPN/ 100 ml

Absent Absent Absent Absent Absent Absent

28. E-coli Absent/ml Absent Absent Absent Absent Absent Absent 29. Boron mg/L N.D. N.D. N.D. N.D. N.D. N.D. 5

30. Anionic Detergents

mg/L N.D. N.D. N.D. N.D. N.D. N.D. 1.0

31. Mineral Oil mg/L N.D. N.D. N.D. N.D. N.D. N.D. 0.003

32. Arsenic as As

mg/L N.D. N.D. N.D. <0.03 <0.03 <0.03 NR

33. Aluminum as Al

mg/L <0.03 <0.03 <0.03 N.D. N.D. N.D. 0.2

34. Mercury as Hg

mg/L N.D. N.D. N.D. <0.002 <0.002 <0.002 NR

35. Pesticides mg/L <0.002 <0.002 <0.002 N.D. N.D. N.D. 0.001

Source: Soil Analysis during study period by Kamal enviro

Discussion:

Observation on Ground water Quality:

32. The pH value of drinking water is an important index of acidity or alkalinity. pH value of the sample vary

from 6.94 to 7.24 in all locations. Electric Conductivity levels vary from 824 to 982 µmho/cm.Total

dissolved solids ranges from 306 to 447 mg/l which is within permissible limit. The total hardness is an

important parameter of water quality. The hardness values in ground water of the study area ranges

between 648 to 713 mg/l which is well within the limit. Flouride contents in water samples is exceeding

the prescribed limit. No biological and metallic contamination has been found in any of the ground

water sample of the study area. All the parameters in ground water sample were well within the

permissible limit of Indian Standard IS: 10500-2012.

Air Quality

33. The ambient air quality in the 10 Km radius study area will form baseline information over which the

predicted impacts can be superimposed to find out the net impact on the air quality in the project

impact area. The design of the network of ambient air quality monitoring stations in the study area was

carried out based on the following criteria:

Meteorological conditions on a synoptic scale;

Topography of the study area;

Representation of the regional background levels;

Influence of the existing sources;

Major human settlements in the study area.

34. Preliminary air sampling and monitoring was carried out in the months 25th May, 2015 to 25th June,

2015 to establish the air quality of the study area. The main sources of air pollution in the study area

are vehicular emission, resuspended dust from the paved and unpaved tracks, fuel burning for

domestic requirements and windblown dust from the open agricultural and waste land. Sampling

locations were selected based upon:

Page 47: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 46

35. Sensitivity of site, where the construction activity and traffic due to the proposed project will take place.

36. Presence of sensitive receptors such as settlements.

37. Monitoring of particulate matter of aerodynamic diameter less than 10 micron (PM10), particulate

matter of aerodynamic diameter less than 2.5 micron (PM2.5), Sulphur Dioxide (SO2), Oxides of

Nitrogen (NOx), were conducted twice a week at four locations during the study period

Meteorology

38. Meteorological study exerts a critical influence on air quality as it is an important factor in governing the

ambient air quality. The meteorological data recorded during the study period is used for interpretation

of the baseline information as well as input for air quality simulation models.

39. A meteorological station was installed in the project site at about 10 m above the ground level. All care

was taken to see that the station is free from obstructions to free flow of winds. Wind speed, wind

direction, temperature and relative humidity data was collected daily on hourly basis during the study

period

Climate

40. The climate of Hissar owes to its continental location on the outer margins of the south-west (SW)

monsoon region. It has tropical monsoonal climate and is characterized as arid type of climate. The

district has characteristically four seasons during the year viz., summer (March to May), SW Monsoon

(June to September), Post-Monsoon (October to November) and winter (December to February)

season. SW monsoon also known as summer monsoon brings rain during last week of June to mid-

September. The period from October onward until next June remains almost dry except, few light

showers received due to westerly depressions/western disturbances (WDs). The summers are

generally quite hot and winters are fairly cool. The main characteristics of climate of in the district are

its dryness, extremes of temperature and scanty rainfall. (http://www.hisar.nic.in/climate.aspx)

41. This is one of the important factors deciding the dispersion of air pollutants due to factors like lapse

rate; inversion etc. In the study area during three months study period, it is observed that the

temperature varies between the lowest of 13°C & the maximum of 47°C

42. Relative Humidity:

43. Humidity is measured in terms of Relative Humidity which is the percentage of moisture present in the

air, complete saturation being taken as 100. The greater the “RH” more the air is saturated. The RH

below 30% is also unpleasant which can cause, drying of mucous, sore throat and cough. Moisture

indicates the potentiality for fog formation in relation to the degree of air pollution.

:Micro meteorology during study period

Month Temperature Relative Humidity (%)

23 May to 22 Jun

Min 21 7

Max 47 100

Mean 33.26 41

Source: Field Survey by during study Period

Precipitation

Page 48: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 47

44. Precipitation serves as a two-fold cleansing action on the pollutants discharged into the atmosphere. It

accelerates the deposition of particulate matter on the ground and hence its removal from the

atmosphere. Precipitation is almost negligible during study period

Temperature in the study area

Wind Speed and Wind Direction

45. Meteorological study exerts a critical influence on air quality as it is an important factor in governing the

ambient air quality. The meteorological data recorded during the study period is used for interpretation

of the baseline information as well as input for air quality simulation models.

-

5,000.00

10,000.00

15,000.00

63

,35

0.0

0

20,000.00 12,000.00 9,000.00 10,000.00 2,000.00 5,000.00

Page 49: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 48

:Wind Rose Diagram

:Frequency Distribution

Page 50: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 49

Discussion:

46. The wind rose diagram for the study area is shown in Figure 3.12 the wind class frequency distribution

is shown in Figure 3.13 and the analysis of the average wind pattern shows predominant winds from E

having 16% wind frequency, and other directions that include EENand NE with wind frequencies of

13%, 7% respectively. The calm wind conditions were prevailed for 13.9% of the total time.

: Ambient air quality (during study period)

Location Parameters

PM2.5 (g/m3) PM10 (g/m3) SO2 (g/m3)) NO2 (g/m3)

NAAQ Norms 60 100 80 80

Project Site Max 120 149 10.9 14.8

Min 58 90 6.7 8.7

Mean 88.9 117.5 8.9 11.0

98 Percentile 118.9 148.6 10.8 14.8

Gavad Village Max 115 165 11.6 15.9

Min 61 94 7.3 8.9

Mean 90.6 129.0 9.3 11.3

98 Percentile 113.9 163.6 11.5 15.4

Chaudharywas Max 143 170 12 17.9

Min 78 99 7.9 10.1

Mean 103.2 134.9 10.1 13.7

98 Percentile 139.8 170.0 11.9 17.5

Barwa Max 149 183 12.3 18.4

Min 81 104 8 11.2

Mean 110.1 141.5 10.4 14.8

98 Percentile 147.6 180.8 12.2 18.3

Source: Analysis during Study Period by kamal

47. From the tabulated results it is observed that monitored ambient air quality for SO2 and NOx is within

the limit prescribed in National Ambient Air Quality Standards except concentration of PM2.5 and

PM10 at all four locations, which are more than the prescribed limits due to windblown dust from the

unpaved area..

Noise Environment

48. Noise after a certain level can have a very disturbing effect on the people and animals exposed to it.

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 proposed project.

49. Noise monitoring was carried out at four locations as shown in Table 3.8.

50. Noise measurements were done using Cygnet Sound Level Meter Model 2031A. Monitoring was

carried out both in the day and night time and accordingly Leq day and night were derived from the

monitored data including the peak values.

51. The results of the monitoring are provided in Table 3.8.Monitored levels were compared against

Ambient Noise Standards prescribed under Gazette Notification 643 of Ministry of Environment and

Forests, Government of India.

Page 51: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 50

Noise Sampling Location& Result

Station Code Station Name

NQ1 Project site

NQ2 Pipli khera

NQ3 Lalehri

NQ4 Rajalu garhi

NQ5 Gannour

NQ6 Dhauri

Location Code

Project site Project site

Pipli Khera lalehri Rajalu garhi Gannaur Dhauri

Monitoring Date

28/05/2013 28/05/2013 28/05/2013 28/05/2013 28/05/2013 28/05/2013 28/05/2013

Noise Level (dBA)

Noise Level (dBA)

Noise Level (dBA)

Noise Level (dBA)

Noise Level (dBA)

Noise Level (dBA)

Noise Level (dBA)

Time Hrly. Leq Hrly. Leq Hrly. Leq Hrly. Leq Hrly. Leq Hrly. Leq Hrly. Leq

Maximum 46.5 64.1 60.2 53.4 60.2 53.4 53.4

Minimum 39.2 40.2 39.4 39.7 39.4 39.7 39.7

Ld 43.5 58.3 54.2 48.6 54.2 48.6 48.6

Ln 41.2 41.6 41.1 41.2 41.1 41.2 41.2

L dn 47.8 57.1 53.4 49.7 53.4 49.7 49.7

Source: Analysis during Study Period

52. Noise levels at all the locations were observed within norms.

Ecological Environment

Project Site

53. The project site is predominantly agricultural land. The waste land is without any vegetation and only

sparsely scattered plants of Leonotis sp., Lantana sp., Calotropis spp, Croton sp., Zyziphus sp.,

Xanthium Straumarium, etc are growing. There is no forest land involved within the project site. The

project area is predominantly double crop agriculture land. In between the agricultural fields, at the

bund of the plots trees have been planted in scattered manner. There are about few Eucalyptus spp

trees growing in the project site, out of which the plant area located in the central part of the project

area contains small trees.

Study Area

54. The study area is almost plain in topography. The plain areas are best utilized for cultivation during

kharif and Rabi seasons. Tree species found in cultivated fields, waste lands and habitations are Jand,

Rohera, Khairi, Beri, Reru, Jal Or Van, Barh, Peepal, Mesquite or Pahari Kikar, Kachnar, Amaltas,

Page 52: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 51

Lasura, Imli, Banna, etc. Shisham, Kikar, Siris, Neem, Bakain Gultmohar. Parkinsonia Eucalyptus, etc.

have been planted along rail, road and canal strips and in other private areas. Eucalyptus is also

planted in agricultural and under farm forestry scheme. The Jand, Farash, Khairi, Castor, kana and

Ruhera have been planted to check soil erosion by high velocity winds.

55. Shrubs found are Hins, Bansa, Panwar, Babool, Karir, Phoa, Khip and Ak. Medicinal herbs found in the

district are Bansa, Indirain, Asgandha, Glo, Kharuthi, Bhakhra, Dhatura, etc. Their collection becomes

uneconomical because these are available in scattered form.

56. The important grasses found in the district are Anjan, Dhamang, Dub, Kana and Dabh. Anjan, Dhaman

and Dub which are palatable fodder grasses are dwindling on account of uncontrolled grazing. The

grasses in waste, lands are poor in quality and quantity. The plant species found in the study area is

given in Table 4.7b. The authenticated list of flora and fauna found in the study area is given in

Annexure V.

Flora in Study Area

Trees Botanical Names Shrubs Botanical Names

Jand Prosopis cineraria (L) Druce. Hins Capparis sepiaria L. Carissa

Rohera Tecomella undulata (Sm.)Seem. spinarum L.

Khairi Acacia senegal (L.)Wild Castor Ricinus Communis L.

Beri Zizyphusw mauritiana (Lam.)

Syn. Z. Panwar Cassia tora L., Cassia occidentallis L.

Jujuba (Lam.) (non Mill.)

Reru Acacia Leucophloea (Roxb.) Wild Babool Acacia jacquemontii Benth.

Jal or van Salvadora oleoides Decne. Mallah Zizyphus nummularia (Burm. f.) Wight

Barh Ficus bengalensis L. and Arn.

Peepal Ficus religiosa L. Karir Capparis decidua (Forsk.) Edgew.

Mesquite or

pahari kikar Prosopis juliflora (Sw.) Dc. Phoa Calligonum polygonoides L.

Kachnar Bauhinia racemosa Lamk Khip Leptadenia pyrotechnica (Forsk.) Decne.

Amaltas Cassia fistula L. Syn. L. spartium Wight.

Lasura Cordia dichotema Forst. f. Syn.

C. myxa Ak Calotropis procera (Ait.) R. Br.

auctt. plur. (non Linn.) C. Medical Herbs

Imli Tamarindus indica L. Bansa Adhatoda vasida Nees.

Banna Cratava adansoni DC. Subsp.

odora Indirain Citrullus colocynthis (L.) Schard.

(Buch.Ham.) Jacobs Syn. C.

religiosa forst. f. nurvala Asgandha Withania somnifera (L.) Dunal

(Buch.Ham) Hook.f. and Thorn. Glo Tinospera Cordifolia Miers ex. Hock.

Shisham Dalbergia sissoo Roxb. F. & T. Thoms.

Kikar Acacia nilotica (L) Delila ex Del. Kharuthi Sida acuta Burm. f.

Subsp. indica (Benth) Brenan

syn. A. Dhatura Datura stramonium L.

arabica auct non Wild. Bhakhra Tribulus terrestrial L.

Siris Albizia lebbeck (L.) Benth. D. Grasses

Page 53: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 52

Source: Field Survey

The ecological features of the study area can be described under following heads:

ii) Plantations around Human Settlements

57. Near the villages, the vegetation pattern abruptly changes from that in the agricultural fields. The

species found are given in Table 4.7d. The trees grown are mostly of economic importance. Among the

fruit trees mostly Mango, Guava, Ber, Neebu, Banana, Papaya, etc are grown. Among the non-fruit

trees Neem, Karanj, etc are grown.

: List of Trees/Shrubs Growing in and Around Human Settlement

Scientific Name Common Name Scientific Name Common Name

Albezzia lebbeck Siris Mangifera indica Mango

Annona squamosa Sita Phal Moringa oleifera Saijan

Azadirchta indica Musa sapientum Kela

Bougainvellea spectabilis Bougainvellea Pongamia pinnata Karanj

Carica papaya Papita Tamarindus indica Imli

Citrus lemon Nimbu Zyziphus sp. Ber

Delonix regia Gulmohar Embelica officinalis Aonla / Amloki

Eucalyptus hybrid Eucalyptus Psidium guajava Amrud

Ficus bengalensis Bargad Polyalthia longifolia Ashok

Ficus religiosa Peepal Ricinus communis Rendi Source: Field Survey

Waste land

58. Wasteland has developed in the area where the soil conditions are poor and under high biotic

pressure. Places where soil conditions are not appropriate to support plant growth are also seen in the

area. All such areas are either without any vegetation or are covered with species like Lantana sp.,

Calotropis spp, Croton sp., Zyziphus sp., Leonotis sp., Xanthium straumarium, etc.

Endangered Plants

59. The study area did not record the presence of any critically threatened species.

Fauna and avifauna

60. There are no forest stretches in the study area. The animals and avi-fauna found in the study area is

given Tables 3.11 and 3.12, respectively.

: List of Faunal Species and their Conservation Status in Study Area

Neem Azadirachta indica Juss. Syn.

Melia Anjan Cenchrus ciliaris L.

azadirachta L. Dhamanq Cenchrus setigerus Vahl.

Bakain Melia azedarach L. Dub Cynodon dactylon (L.) Pers.

Gulmohar Delonix regia (Boj.) Raf. Kana Saccharum bengalense Retz. (Syn. Erian

thus munja (Roxb.) Jesw.

Parkinsonia Parkinsonia aculeata L. Dabh Desmostachya bipinnatta (L.) Stapf.

Page 54: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 53

Name Scientific Name WLPAS Name Scientific Name WLPAS

Mammals

Blackbuck Antilope

cervicapra I Indian hare

Lepus nigricollis

ruficaudatus IV

Nilgai / Blue Bull Boselaphus

tragocamelus III

Rhesus

Macaque /

Bandar

Macaca mulatta II

Indian Jackal Canis aureus II Indian Field

Mouse Mus booduga V

Jungle Cat Felis chaus II Mice Mus musculus V

Palm Squirrels Funambulus

pennanti IV

Common

Langur

Presbytis

entellus II

Chinkara or ravine deer Gazella gazella I Common house

Rat Rattus rattus V

Common Mongoose Herpestres

edwardsii II Bandar

Rhesus

macaque II

Indian Porcupine Hystrix indica IV Common yellow

bat

Scotophilus

heathi V

Reptiles

Garden

Lizard /

Kiria or

girgit Calotes versicolor - Mendhak Rana tigrana IV

Common

Skink

Mabuya

macularia - Blind snake

Typhlops

parrectus IV

Nag

Naja naja II Sanda Uromastrix

hardwickii II

Yellow Rat Snake Plyas mucosus II Russel’s Viper Vipera russelii II

Amphibians

Toad Bufo bufo - Indian

burrowing frog Rana breviceps IV

Common toad Bufo

melanostictus -

Indian cricket

frog

Rana

limnocharis IV

Tortoise Geoclemys

hamitloni I Indian bull frog Rana tigrina IV

Source: Field Survey

List of Birds and their Conservation Status in the Study Area

Common Name Scientific Name WLPAS Common Name Scientific Name WLPAS

Jungle Myna Acridotheres

fuscus fuscus IV

Northern green

barbet

Megalaima

zeylanica IV

Common Mynah Acridotheres

tristris IV Crested bunting Melophus lathami IV

Small blue

kingfisher Alcedo atthis IV

Indian small

green bee-eater Merops orientalis IV

Cattle Egret Bubulcus ibis - Pariah Kite Milvus migrans -

Common crow Centropus IV Pied Wagtail Motacilla IV

Page 55: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 54

pheasant sinensis maderaspatensis

Indian pied

kingfisher Ceryle rudis IV Painted Stork

Mycteria

leucocephala IV

Blue Rock Pegion Columba livia IV Indian purple

sunbird Nectarinia asiatica IV

Indian magpie robin Copsychus

saularis IV

Indian golden

oriole Oriolus oriolus IV

Blue jay Coracias

benghalensis IV Tailor Bird

Orthotomus

sutorius IV

Jungle Crow Corvus

macrorhynchos IV House Sparrow Passer domesticus -

Common Crow Corvus splendens V Peafowl Pavo cristatus I

Common quail Coturnix coturnix IV Baya Weaver

Bird Ploceus philiphinus IV

Black Drongo Dicrurus adsimilis IV Large Indian

parakeet Psittacula eupatria IV

Northern golden

backed woodpecker

Dinopium

benghalense IV

Rose-ringed

Parakeet Psittacula krameri IV

Lal munia Estrilda amandava - Red Vent Bulbul Pycnonotus cafer IV

Koel Eudynamis

scolopacea -

White eared

bulbul Pycnonotus leucotis IV

Black Partridge Francolinus

francolinus IV Little Brown Dove

Streptopelia

senganis IV

Red Jungle Fowl Gallus gallus IV Common Green

Pigeon

Treron

phoenicoptera IV

Saras Grus antigone IV Jungle Babbler Turdoides caudatus IV

White breasted

kingfisher

Halcyon

smyrnensis IV Hoopoe Upupa epops IV

Stilts Himantopus

himantopus Lapwing Vanellus spp -

Indian spotted

munia

Lonchura

punctulata IV Coppersmith

Megalaima

haemacephala IV

Source: Field Survey

Socio-Economic Environment

61. The Study Area of 10 km radial Zone mainly falls in the Hisar Tehsil of HisarDistrct, Siwani Tehsil of

Bhiwani District in Haryana and Bhadra Tehsil of Hanumangarh District in Rajsthan. There are total 17

Villages in Study Area, out of which 9 villages belong to Hisar Tehsil, 5 villages belongs to Siwani

Tehsil and 3 Villages belongs to Bhadra Tehsil.

Page 56: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 55

: Administrative setup of study area (radius 10 km)

Demographic Profile

Population

62. Total Population of the Study area as per Census of India, 2001 is 56464, the total number of

Household being 9922. Total Male Population of the Study area is 29967 and total Female Population

of the Study Area is 26497. Village-wise details of population are given in Table 3.13

: Village-wise Population Details of Study Area

State District Tehsil Village No. of

Household

Total

Population

Male

Population

Female

Population

Haryana Hisar Hisar

Gawar(19) 443 2584 1362 1222

Chaudhriwas(18) 1005 5847 3081 2766

Gorchhi(20) 662 3686 1947 1739

PaniharChak(17) 560 3136 1677 1459

Chiraud(14) 457 2589 1401 1188

RawalwasKalan(51) 516 2931 1565 1366

Bherian(16) 432 2365 1291 1074

Sarsana(21) 877 5009 2734 2275

BhiwaniRuhelan(50) 508 3006 1544 1462

Total 5460 31153 16602 14551

Study area(17 villages)

Hanuman garh district(3 villages)

Hissar district (9 villages)Bhiwani

district(5 villages)

Page 57: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 56

Bhiwani Siwani

Siwani (Rural) (128) 74 382 231 151

Barwa (133) 1715 9829 5213 4616

Naloi (132) 458 2698 1389 1309

Gurera (131) 752 4140 2199 1941

Kikral(129) 267 1629 866 763

Total 3266 18678 9898 8780

Rajsthan Hanuman

garh Bhadra

BIBIPURA 165 936 495 441

SHERARA 841 4663 2429 2234

MEHRIYAN 190 1034 543 491

Total 1196 6633 3467 3166

Grand Total 9922 56464 29967 26497

Source: Cencus Data 2001

Source:Analysys of Cencus Data 2001

: Tehsil wise population of the Study Area

Sex Ratio

63. The Sex Ratio of the Study area is 884 Female / 1000 Male.

SC / ST Population

0

10000

20000

30000

40000

50000

60000

Hisar Siwani Bhadra Total

Hisar (HR) Bhiwani (HR) Hanumangarh (RJ)

Total Population Male Population Female Population

Page 58: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 57

64. Only 21.31% of the Total population of the study area belongd to SC/ST Populations as depicted in

following Figure 3.18.

Source:Analysys of Cencus Data 2001

: Percentage of SC/ST Population in Study Area

Literacy Rate

65. Literacy Rate of the study area is 50.7 %. Distribution of male and female literacy rate in the study zone

is 62.2% and 37.6% respectively. Gender-wise distribution of literacy in each Patwari Circle of Study

Area is given in Figure 3.17.

0

2000

4000

6000

8000

10000

12000

14000

Male Female Male Female Male Female

Hisar Siwani Bhadra

Hisar (HR) Bhiwani (HR) Hanumangarh (RJ)

General SC ST

Page 59: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 58

Source:Analysys of Cencus Data 2001

: Gender-wise Distribution of Literacy in Study Area

Workers Scenario

66. As revealed from Census of India 2001, 50% population of the Study Area are Non-workers. Main and

marginal Workers constitutes approximately 38 % and 12% respectively as depicted in Figure 3.18.

The Genderwise distribution of Workers in the study area is also given in Figure 3.21.

Source: Analysys of Cencus Data 2001

0

2000

4000

6000

8000

10000

12000

Male Female Male Female Male Female

Hisar Siwani Bhadra

Hisar (HR) Bhiwani (HR) Hanumangarh (RJ)

Literates Illiterates

Main Workers38%

Marginal Workers12%

Non Workers50%

Workers Scenario

Page 60: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 59

Workers Scenario of Study Area

Source: Analysys of Cencus Data 2001

Genderwise Distribution of Workers

Main Workers: A considerable percentage of Main workers in the Study area belong to casual labours 69%,

agricultural labours 7%,household workers constitutes 2% andother workers 4% respectively.

0

5000

10000

15000

20000

25000

30000

Total Male Female

Main Workers Marginal Workers Non Workers

Page 61: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 60

Source: Analysys of Cencus Data 2001

: Types of Main Workers in Study Area

67. Marginal Workers: A considerable percentage of Marginal workers in the Study area belong to casual

labours 47%, agricultural labours 20%,household workers constitutes 5% andother workers 28%

respectively.

Source: Analysys of Cencus Data 2001

: Types of Marginal Workers in Study Area

Casual Labour69%

Agricultural Labour7%

Household Workers

2%

Other Workers22%

Main Workers

Casual Labour47%

Agricultural Labour20%

Household Workers5%

Other Workers28%

Marginal Workers

Page 62: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 61

Infrastructure

Education facilities

68. There are 32 Primary Schools, 24 Middle schools, 19 Secondary Schools, 7 Higher Secondary Schools

and there is no College in Study Area. 16 villages have primary School, 14 villages have Middle and

Secondry School and 7 villages have atleast one higher secondry school.

Health facilities

69. There are nohospitals in the study area. 4 Ayurvedic Dispensaries have in Study Area. There are 4

Primary Health Centre and 10 Primary Health Sub-centres found in the study Area. However, several

private medical practitioner and community health workers are also found.

Communication Facilities

70. There are 10 post office found in the study area. 196 Telephone connections were observed.

Banking Facilities

71. 4 Banks and 22 Credit Societies are found within the Villages of Study Area. A comprehensive List of

Infrastructures present in the Study Area is given in Table 3.14.

Page 63: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 62

Village-wise details of Basic facilities in Study Area

PS =Primary School, UPS = UpperPrimary School, SS = Secondary School, HS = HigherSecondary school, PrHS = PrivateHigherSecondary School,

PHSC = Primary Health Sub-Centre, PHC = Primary Health Centre, AyD = Ayurvedic Dispensary, VF = Veternary Facility, HD = Homeopathic Dispensary,

AlD = Alopathic Dispensary, HH = Homeopathic Hospital, AlH = AlopathicHospital, AlD = Alopathic Dispensary,

WW = Well Water, TW= Tap Water, HP = Handpump

St

ate

Distr

ict

T

e

h

sil

Villag

e

Pr

im

ar

y

Sc

ho

ol

Mi

d

dl

e

S

c

h

o

ol

Se

co

nd

ary

Sc

ho

ol

Hig

her

Se

co

nd

ary

Sc

ho

ol

C

oll

eg

e

Ho

sp

ita

l

Dis

pen

sar

y

P

H

C

P

H

S

C

P

o

st

O

ffi

c

e

Tel

eph

one

Co

nne

ctio

n

B

a

n

k

Cr

ed

it

S

oc

iet

y

Sou

rce

of

Wat

er

P

o

w

er

S

u

p

pl

y

A

p

pr

.

P

a

v

e

d

R

o

a

d

Com

muni

catio

n

facili

ties

(Bus

servi

ces)

Ha

ry

an

a

Hisa

r

Hi

sa

r

Gawar

(19) 2 1 1 1 0 0 0 1 1 1 9 0 1

TW,

WW

, HP A A Y

Chaud

hriwas

(18) 2 2 2 1 0 0 0 1 1 1 28 1 1

TW,

WW

, HP A A Y

Gorch

hi(20) 2 2 2 0 0 0 0 0 1 1 0 0 1

TW,

WW

, HP A A Y

Panih

arCha

k(17) 1 1 1 0 0 0 0 0 0 1 0 0 1

TW,

WW A A Y

Chirau

d(14) 2 1 1 0 0 0

1

AY 0 0 1 0 0 1

TW,

HP A A Y

Rawal

wasKa

lan(51

) 3 3 1 1 0 0 0 0 1 0 1 0 1

TW,

WW A A Y

Bheria

n(16) 1 1 1 0 0 0

1

AY 0 1 0 0 0 1

TW,

WW A A Y

Sarsa

na(21) 5 3 3 0 0 0 0 0 0 1 16 0 1

TW,

WW

, HP A A Y

Bhiwa

niRuh

elan(5

0) 1 1 1 0 0 0

1

AY 0 1 0 2 0 1

TW,

WW A A Y

Total 19 15 13 3 0 0 3

2 6 6 56 1 9 - - - -

Page 64: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 63

AY

Bhi

wani

Si

w

an

i

Siwani

(Rural)

(128) 0 0 0 0 0 0 0 0 0 0 6 0 9

TW,

WW A N N

Barwa

(133) 2 1 1 1 0 0 0 1 1 1 105 1 1

TW,

WW

, HP A A Y

Naloi

(132) 1 1 1 1 0 0 0 0 1 1 10 0 1

TW,

WW

, HP A A Y

Gurer

a

(131) 3 2 1 1 0 0 0 1 1 1 18 1 1

TW,

WW A A Y

Kikral(

129) 1 1 1 1 0 0 0 0 1 0 1 0 0

TW,

HP A A Y

Total 7 5 4 4 0 0 0 2 4 3 140 2 12 - - - -

Ra

jst

ha

n

Han

uma

ngar

h

B

ha

dr

a

BIBIP

URA 1 0 0 0 0 0 0 0 0 0 0 0 0 -

A A Y

SHER

ARA 4 4 2 0 0 0

1

AY 0 0 1 0 1 1

TW,

HP A A Y

MEHR

IYAN 1 0 0 0 0 0 0 0 0 0 0 0 0 -

A A Y

Total 6 4 2 0 0 0 0 0 0 1 0 1 1 - - - -

Grand Total 32 24 19 7 0 0 4

AY 4

1

0

1

0 196 4 22 - - - -

Page 65: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

| Name of the consultant 64

CHAPTER 4. ANTICIPATED ENVIRONMENTAL IMPACTS AND MITIGATION MEASURES

4.1. Prelude

Prediction of environmental impacts is the most important component in the impact

assessment study, as it provides quantitative information on anticipated environmental

impacts from a project well in advance. Several mathematical/statistical techniques and

methodologies are available for predicting impacts from developmental projects on the

surrounding physico-chemical, ecological and socio-economic components of

environment. The results obtained from the predictions are superimposed over the

baseline data (pre-project) of study area to derive the ultimate (post-project) scenario of

environmental quality status in the study area around the proposed project site. The

quantitative impacts derived from predictions are also essential to delineate effective

environmental management plan for minimizing the adverse impacts on the surrounding

environment during construction and operation phases of the project.

The following sections identify the potential impacts on the environment from the

proposed project based on the nature and extent of the various activities associated with

the project implementation and operation, as well as the current status of the

environmental quality at the project site. Both beneficial (positive) and adverse

(negative) impacts are considered.

4.2. Potential Impacts and Mitigation Measures during construction phase

Construction activities are normally spread over pre-construction, preparatory

construction, machinery installation and commissioning stages and end with the

induction of manpower and start-up.

Preparatory construction phase mainly consists of transportation of machinery,

equipment and materials to the site for construction, clearing and leveling of land,

construction of foundations, buildings and approach roads.

4.2.1. Air Environment

Impact:

The sources of air emission during construction phase will include site clearing, vehicles

movement, materials storages and handling and operation of construction equipment.

Emissions from them are expected to result in temporary degradation of air quality,

primarily in the working environment affecting construction employees. However, dust

This chapter details the inferences drawn from the environmental impact assessment

ofthe proposed project. It describes the overall impacts of the project activities

andunderscores the areas of concern, which need mitigation measures. Predictions

havebeen done based on the various quantitative and qualitative methods suggested

byMinistry of Environment & Forests, New Delhi.

Page 66: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

| Name of the consultant 65

generation and particulate matter rise in the ambient air will be coarse and will settle

within a short distance close to the construction sites. Hence, dust and other emissions

are unlikely to spread sufficiently to affect the surroundings of the construction site.

During construction phase, traffic at theroad which connects with the projectsiteis

expected to be slightly more intensive than the traffic at present. However due to well

connectivity of the site with NH-1, which is located at distance of 0.25 km from the

project site, significant stress on the traffic is not anticipated. The present road

conditions are good for the proposed additional movement of vehicular traffic. Hence the

impacts on the ambient air quality during construction phase will be temporarily for short

duration, reversible in nature and restricted to small area.

Fugitive dust sources associated with construction phase include vehicular traffic

generating fugitive dust on paved and unpaved roads, aggregate material handling, and

other aggregate processing operations.

Mitigation Measures:

4.2.1.1 Dust Control

Paving is an appropriate solution for access road to the project. Another appropriate use

of paving is for parking lots and for material storage areas, where gravel cover is not

adequate for dust control or erosion.

Locally found gravels can also be applied to access roads and to add a protective layer

over the exposed soil and helps to control dust generation. However, gravels shall

contain a minimal percentage of fines and clean gravel shall be added periodically, as

the fines migrate to the surface and create dust.

Water spray, through water trucks is an effective way to keep dust under control.

Sprinklers can also be employed to deliver continuous moisture in dust prone areas.

Vehicles running at high speed may increase the amount of fugitive dust created from

unpaved areas. Hence reduction in the speed of vehicle to 20 km/hr. is suggested so as

to reduce emissionsfrom vehicular traffic by a large extent.

Care shall be taken to keep all material storages adequately covered and contained so

that they are not exposed to winds on site,whichcould lead generation of dust/

particulate emissions. Usage of fabrics and plastics for covering piles of soils and debris

can serve as an effective means to reduce fugitive dust from the material stores/

warehouses.

Spills of dirt or dusty materials shall be cleaned up promptly so that the spilled materials

do not become a source of fugitive emission.

Spilled concrete slurries or liquid wastes shall be contained/ cleaned up immediately

before itsinfiltration into soil/ ground or runoff in nearby areas.

Page 67: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

| Name of the consultant 66

4.2.1.2 Gaseous Emissions Control

Regular maintenance of machinery and equipment will be carried out.

All the vehicles used for construction activity shall be checked for ‗Pollution under

Control‘. Ambient air quality monitoring should be carried out during construction phase.

If monitored parameters are above the prescribed limits, suitable control measures must

be taken.

4.2.2. Noise Environment

Impact:

The general noise levels during construction phase viz., due to working of heavy earth

moving equipment and machinery installation may sometimes go up to 90 dB(A) at the

work sites during day time. The workers in general are likely to be exposed to an

equivalent noise level of 80-90 dB (A) in 8 hours shift for which all statutory measures

will be implemented. Use of proper personal protective equipment will further mitigate

any adverse impact of noise to the workers.

The noise generation will be considerable during such type of large scale construction

activities. Typical noise sources during construction phases are mentioned in Table 4.1.

Different phases of construction activities at project site are scheduled to take place for

about 4 - 6 months. The impacts during construction phase are temporary and will be

marginal. Necessary mitigative measures are required to be implemented during

construction period. The noise impact will be relatively more on construction workers

during their duty hours, which will be mitigated to comply occupational exposure

standards alongwith usage of personal protective devices like ear muffs/plugs etc.

whichwould further minimize the noise impacts.

It is anticipated that the increase in the ambient noise levels will be temporary and are

likely to occur for short duration.

Table 4.1 : Typical Noise Sources during Construction Phase

Description Noise Level dB(A)

Earth Movers

Dozers 95-100

Front Loaders 72-84

Backhoes 72-93

Tractors 76-96

Tippers/Trucks 82-94

Material Handlers

Concrete mixers 75-83

Concrete pumps 81-83

Cranes (movable) 75-86

Vehicular Traffic 85-98

Page 68: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

| Name of the consultant 67

(Construction material & plant machinery)

Stationary Equipment

DG Sets 90-95

Pumps 69-71

Compressors 74-86

Impact Based Equipment

Pneumatic Wrenches 83-88

Jack hammer 81-98

Pile drivers (peak) 95-105

Mitigation Measures:

There will be increase in ambient noise levels during the construction phase due to all

the project activities during construction phase, which will be temporary in nature and for

a shorter duration (i.e. construction phase). The measures described below will be able

to mitigate the noise levels generated at site:

Provision of rubber padding/ noise isolators

Provision of silencers to modulate the noise generated by machines.

Provision of protective devices like ear muff/plugs to the workers.

As far as possible no construction activities will be carried out during night time.

Maintenance of construction equipments shall be carried out in appropriate

manner. This shall be ensured through the provision laid under the various

contracts with the contractors.

Vehicular movement towards the construction sites shall be properly regulated to

minimize air and noise pollution.

Movement of trucks shall be controlled during night time.

4.2.3. Water Environment

Impact:

On the basis of construction activities,during the construction phase of the project, total

water requirement is estimated to be…. LD. This requirement of water will be fulfilled

from the HSIIDC. Sewage will be sent to septic tank during the construction phase.

Adequate drainage system will be required for channelization of the run off water to

avoid water logging which would be further utilized during the construction phase for the

proposed plant. Therefore, no long term adverse impact on water quality (surface as well

as ground) is anticipated during construction phase.

Mitigation Measures:

4.2.3.1 Construction Wastewater Management

Wastewater generated during the construction phase of the project. Water will be used

only for curing of concrete, which will be absorbed by land or will get evaporated. A

Page 69: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

| Name of the consultant 68

separate drainage shall be provided for the construction wastewater and collected in a

separate basin. If required, water shall be discharged into the drain only after its

pretreatment including filtration and removal of contaminants in accordance with the

standards prescribed for disposal.

4.2.3.2 Sanitation

The construction work force will use water for drinking and other the sanitation purposes.

The sewage so generated should be disposed off in sceptic tank.

4.2.4. Land Environment

Impact:

Soil around construction site, haulage road, and workshop areas, will get compacted due

to transportation of man, machine and materials. Soil may also get contaminated around

construction site, machine maintenance area, fuelling station, and internal road

construction material storage (not much involved) & preparation site and haulage road.

No soil erosion is anticipated due to the construction activities during the rainy season,

as the project site located in the flat land of industrial area.

Mitigation Measures:

Measures for top soil preservation, soil erosion & sedimentation control are given below:

To keep the damage to topsoil minimum, excavators shall be used for

construction. The excavated material such as topsoil shall be stacked at safe

places for reuse at a later stage of construction.

Preserving existing vegetation or re-vegetation of disturbed soils is one of the

most effective ways to control soil erosion, which shall be ensured by the project

proponent.

During dry weather, control of the dust nuisance created by excavation, levelling,

and transportation activities shall be carried out by water sprinkling.

Spill prevention and control plans shall be made, clearly stating measures to stop

the source of the spill, to contain the spill, to dispose the contaminated material

and hazardous wastes including chemicals, paints, cleaners, and petroleum

products.

Movement of construction vehicles, machinery and equipment shall be restricted

to the pre-defined haulage roads. The non-usable, non-saleable, non-hazardous

construction waste shall be disposed off in the properly delineated places.

Usable or saleable waste shall not be disposed off to landfill.

All efforts shall be made to prevent soil contaminations. Following measures shall be

taken to ensure the same:

No fuelling/ repairing of vehicles at the project site shall be permitted, as the

volume of construction activities is very limited.

Page 70: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

| Name of the consultant 69

To avoid the soil contamination at the wash down areas, ―oil interceptors‖ shall

be provided.

Oil and grease spill and oil soaked materials shall be sold off only to Haryana

SPCB/ CPCB authorized vendors respectively.

4.2.5. Materials (Chemicals, Input material) and Waste ( Solidand Hazardous) Management:

During construction phase, solid waste such as excavated soil, debris, metal waste and

oil & grease from construction machines will be generated. This waste may contaminate

soil at plant site temporarilywhich would be restricted to a small area. Excavated topsoil

will be used for backfilling/ plantation and as soon as construction is over, all wastes

from the site will be cleared in appropriate manner. This shall be strictly carried out in

compliance withtheregulatory requirements.

During the construction phase, hydraulic oil, fuels and lubricating oils will be used. There

is potential for accidental spills while re-fuelling or servicing vehicles and through the

breakage due to wear and tear. Procedures for maintenance of equipment will ensure

that this risk is minimized and cleanup response is rapid, if any spill occurs.

During construction phase, waste oil will be generated as and when lubricating oil is

changed. Waste oil will be collected through the drain ports and stored in leak proof steel

drums. The waste oil drums will be properly identified and its contents shall be labeled

both in local language (Hindi) and English. It will be mainly disposed off by selling to

appropriate vendors as per Hazardous Waste (Management, Handling and Trans

boundary Movement) Rules, 2008.

Municipal waste will be minimal as most of workforce will be from nearby areas. The

waste so generated will be collected and segregated and will be sent to municipal waste

disposal site allocated by the local administrative authorities. Hence impacts will be

insignificant and confined to the construction site only.

Mitigation Measures:

The best option of solid and hazardous waste management is to reduce its generation at

source with the help of following good practices in construction management:

Hazardous materials shall not be stored near surface waters and shall be stored

near plastic sheeting to prevent leaks and spills.

The recyclable items like metal, plastic shall be sent torecyclable industry, and

rest of this scrap shall be stored in a covered area.

Wherever materials (aggregates, sand, etc.) are morelikely to generate fine

airborne particles during operations, nominal wetting by water shall bepracticed.

Workers / labour shall be given proper air masks and helmets.

Skilled labour and good workmanship is mustforjudicious utilization of materials

and minimization the waste.

Page 71: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

| Name of the consultant 70

Contaminated runoff from storage shall be capturedin ditches or ponds with an oil

trap at the outlet.

Utmost care shall be taken to store these materials at a suitable place and then

disposed off at a place in consultation with and as per the guidelines of Haryana

SPCB/CPCB

4.2.6. Socio-Economic Environment

Impact:

All the activities to be carried out during the planning, and construction phases will

require skilled, semi-skilled and un-skilled labours, hence creating temporary as well as

permanent employment for the local people. The workforce required during the

construction phase will be about 10 persons. Most of the unskilled and semi-skilled

labour will be by and large available from the nearby villages. Details of man power

requirement during construction and operation phase given in section 2.12. Thus, impact

on the physical and aesthetic resources will be minimal. Further, local skilled, semiskilled

and unskilled labourers will get direct and indirect employment during the construction

phase. This might also result in a steep rise in wages of theagriculturallabourers living in

surrounding villages, especially at the time of harvesting. Hence, the short-term positive

impacts on socio-economic conditions of the area are anticipated during the construction

phase.

Mitigation Measures:

Short term positive impacts will result in better quality of life. The project proponent/

contractors shall ensure that most of the workforce shall be engaged from the nearby

villages/ town.

4.2.7. Occupational Health and SafetyManagement

Impact:

A construction site forms a potentially hazardous environment due to the various

construction activities, involvement of heavy construction machinery, vehicular

movement etc. To ensure health and safety of the workers during construction, with

effective provisions for the basic facilities of sanitation, drinking water, safety of

equipment or machinery etcAny accident happens in the project site can affect the

construction workers..

Mitigation Measures:

Comply with the safety procedures, norms and guidelines (as applicable) as

outlines in the Constructional Practices and Safety, 2005, National Building Code

of India, Bureau of Indian Standards.

Training module on construction safety shall be prepared and impart training to

the construction workers.

Page 72: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

| Name of the consultant 71

To ensure that the surrounding population is not exposed to these hazards, the

site shall be properly secured by fencing or by construction of a boundary wall

and also guards shall be posted at entry points.

First aid facilities shall be created at different locations for immediate assistance

in case of emergencies and accidents.

Important information about nearby hospitals, fire stations, police station etc.

should be kept available in the first aid centres for speedy action at the time of

emergency.

In case inflammable materials are to be kept at the site, they shall be stored and

handled in accordance with guidelines of Inspectorate of Safety and Health of the

State and Central Governments.

Fire extinguishers shall be located at all vulnerable sites.

4.3. Potential Impacts and Mitigation Measures during Project Operation

The operation stage impacts will largely be associated with operation of the

Manufacturing Unit. The impacts associated with this phase are described below:

4.3.1. Air Environment

4.3.2. Impact:

The main sources of air pollution due to the operation of the plant will be the emissions

(from crubbing system vents of reactor streams), and DG sets. The continuous source

of air emission will be stacks attached with scrubber, boiler and incinerator only. DG sets

will be used for power backup only. HCl, AmmoniaandVOCare the main concern of

process emission from the reactors. PM, SO2 and NOx are the main air pollutant

generated from the utility units.

4.3.2.1 Air Quality Dispersion Model

Air dispersion modelling can be used to predict atmospheric concentrations of pollutants

at specific locations (receptors) over specific averaging times (i.e. annual, daily, and

hourly).

In the proposed project, prediction of impacts on air environment has been carried out by

employing mathematical model based on a Steady State Gaussian Plume Dispersion

Model designed for multiple point sources for short term. In the present case, Industrial

Source Complex Short-term [ISCST3] dispersion model based on steady state Gaussian

Plume Dispersion, designed for multiple point sources for short term and developed by

United States Environmental Protection Agency (USEPA) has been used for simulations

from point sources.

The predictions for air quality during operation phase were carried out for particulate

matter less than 10 microns (PM10), particulate matter less than 2.5 microns (PM2.5),

oxides of sulphur (SOx), oxides of Nitrogen (NOx), from the process stacks

concentration using ISCST3.

Page 73: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

| Name of the consultant 72

The options used for short-term computations are:

The plume rise is estimated by Briggs formulae, but the final rise is always

limited to that of the mixing layer

Stack tip down-wash is not considered

Buoyancy induced dispersion is used to describe the increase in plume

dispersion during the ascension phase

Calms processing routine is used by default

Wind profile exponents is used by default

Flat terrain is used for computation

Pollutants do not undergo any physico-chemical transformation

No pollutant removal by dry deposition

Universal Transverse Meter (UTM) coordinates have been used for

computation

A uniform polar grid was used with an extent of 10 km from the centre of the

proposed project. In addition to that, receptors were placed at the sampling

locations to assess the incremental load on the baseline environmental

scenario.

Meteorological Parameters:

The meteorological data consisting of wind speed, direction, temperature, humidity, solar

radiation, cloud cover and rainfall was recorded from the mid of March through June,

2014, on an hourly basis. Wind speed, wind direction and temperature have been

processed to extract the 24 hourly mean meteorological data for application in ISCST3.

Stack and Emission Characteristics:

The major source of emissions is from the stacks attached to boiler, incinerator and six

process stacks (through scrubber) during the manufacturing of APIs at the proposed

project. The stack and emission characteristics pertaining to the stacks present in the

proposed plant are reported in Table 4.5. The modelling has been carried out as per the

guidelines of the CPCB.

Due to the lack of NAAQS limit prescribed by CPCB and United States Environmental

Protection Agency (USEPA), 200g/m3for bromine and 700 g/m3for acid misthas been

taken from North Carolina‘s Division of Air Quality (NCDAQ) Ambient Air Levels (AALs)

respectively.

Receptor Locations:

A total of about 108 polar grid receptors were considered over a 10 km zone around the

project site. Apart from these polar grid receptors, the sampling locations were also

Page 74: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

| Name of the consultant 73

taken into account to assess the incremental load on the baseline environmental

scenario.

Table 4.2 : Stack Details

S. No.

Stacks Stack

Height

(m)

Stack

Diameter (m)

Stack

Exit Flow Rate (m

3/h

r)

Stack Temper

ature (°C)

Emissions (g/sec)

SO2 NOx

PM

10 PM2.

5 HCl Bro

mine

NH3 VOC

1 Process Scrubber

22 0.15 270 25 0.0043

- - - 0.0018

0.0014

- 0.0069

Page 75: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

| Name of the consultant 74

Figure 4.1 : Isopleth of Ground level Concentration of SOx

Page 76: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 75

4.3.3. Foul Odour Problem

Impact

Some of the processes and wastes generated from the plant may release high odour.

Undesirable odour contributes to air quality concerns and affect human lifestyles. On the

economic front, loss of property value near odour-causing operations/industries and

odorous environment is partly a consequence of offensive odour.

Mitigation Measures:

4.3.3.1 Control of VOC and fugitive Emissions

To control VOC emissions chilled brine system of 35°C and 15°C in vent

condensers will be installed.

Sampling points will be provided with double valve followed by suction hoods

which will be connected to ducting system leading to charcoal bed.

Odour causing raw materials will be charged in closed chambers with exhaust of

chambers connected to ducting system leading to waste gas incineration/

scrubbing system/ Charcoal Bed.

All waste storage tanks and waste preparation and raw material storage tanks

will be connected to vacuum system. These off gases will be incinerated in the

incinerator. Well designed two/three stage scrubbing system will be provided as

a standby to gas incineration. The change over from incinerator to Scrubbing or

vice-versa will take place through a fully automated system with no human

interface.

All tanks being used for storage of odorous chemicals/ products/ by-products will

be connected to vacuum system. Manometers will be provided on these tanks.

The vacuum will be monitored on daily basis and actions will be taken

accordingly.

4.3.3.2 Additional Measures

Odour rounds by non-plant personnel will hold regular meetings and ―odour

rounds‖ in the factory premises for ensuring effective implementation of odour

control measures.

As a long term measure to improve the environment, plantation of trees within

factory premises as well as along the nearby roads is proposed.

All critical vessels, pumps and reactors which have potential to generate odour

will be fitted with mechanical seals to prevent leakage and therefore odour.

De-odorizer solution will be sprayed through special network, which will be laid

around the plant. It will help in neutralizing the fugitive emissions.

Beneath all sample points/ drain points, spill control powder containing trays will

be kept so as to adsorb even slightest of leakage, if at all arises from these

points. The spill control powder will then be sent for incinerator as a solid waste.

4.3.4. Noise Environment

Page 77: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 76

Impact:

The sources of noise during the operational phase of the plant are mainly DG

setcompressors, blowers, pumps and Boiler. The other sources of noise are the

movement of vehicles along the road. The proposed project will be similar but will have

advanced technology and improved equipment both in terms of energy efficiency and

less noisy.

Noise level contributed from light medium and heavy vehicles on the roads can be

considerabledepending upon the traffic density. The area around the employees and

material gates is the traffic- affected areas due to transportation activities. The light

vehicles and two wheelers pass at the shift hours only except vehicles of the visitors,

which are limited only. The heavy commercial vehicles traffic is limited depending upon

the material receipt and dispatch of fertiliser through road transport.

The noise level norms in villages of study area are being met with respect to the

norms of ‗Ambient Air quality Standards in Respect of Noise‘.

The operation of royal enterprises proposed project will have some noise level and as

such will not have any adverse impact on the human settlement around it. The noise will

not be audible outside the plant.

4.3.5. Water Environment

Impact:

About 300LD of fresh water (source through tanker, HSIIDC) will be utilized during

operation phase for the proposed project.. In addition to process effluents,sewage will be

generated in the operation phase. Disposal of sewage from the project site onto the

nearby water body and/or onto the land will lead to water pollution. Improper disposal of

the same without prior treatment into a water body or land will affect the water quality.

Discharge of contaminated storm water onto the water body or in rainwater harvesting

system without any pretreatment, will also lead to water pollution.

Mitigation:

The trade effluents generated from proposed project are treated in ETP send to

Common Effluent Treatment Plant (maintained by HSIIDC govt organization).

The effluent arising out of the manufacturing process will be treated and recycled and

reused and green belt development. Hence, no effluent will be discharged. Proper

sanitation facilities will be provided in the proposed plant unit and the sewage will be

collected in septic tanks and it will be treated along with the process effluent in the

anaerobic digester of ETP.Proposed project has no adverse impact is expected on water

resources or land.

Page 78: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 77

A proper storm water drainage system with pre treatment for removal of sediment will be

installed, prior to its discharge into rainwater harvesting system.

4.3.6. Storm Water Management

Rainwater harvesting

Rain water harvesting is not possible in plant premises due to proposedMethylcobalamin

(b12) productions inside the plant premises. If we will install rain water facility inside the

plant boundary, the polluted water directly will go to groundwater and it will contaminate

it. It may be taken up at alternative place in consultation and approval of HPPCB.

4.3.7. Land Environment

Impact:

Out of the total land area of 1800 m2,large part of area at present is vacant land,

whichwill be utilized for setting up the proposed plant. Approx33% has been earmarked

for the green area development.

Mitigation Measures:

Green belt development should be ensured and should be undertaken in consultation

with forest department.Topsoil conserved during the construction phase shall be utilized

for landscaping and greenbelt development.

4.3.8. Soil Environment

Impact:

There are no major sources of land contamination from waste spillage. The used oil shall

be collected in barrels and shall be sold to the authorized recyclers identified by the

HSPCB/ CPCB. All other hazardous wastes shall also be stored safely within the site

before its final disposal to the landfill site or will be incinerated at the plant premises.

Mitigation Measures:

No further mitigation measures will be required.

4.3.9. Solid and Hazardous Waste Management during operation phase

Solid wastes like process waste and organic waste are to be separately collected & sent

for incineration. The final hazardous wastes from the plant as classified under

Hazardous Waste (Management, Handling and Transboundary Movement) Rules, 2008

are to be disposed off in the common hazardous waste secured landfill site and through

authorized dealer.The authorization certificate is provided attached as Annexure. The

details of hazardous wastes, which will be generated from the proposed plant along with

the quantity, are provided in Error! Reference source not found..

Page 79: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 78

Mitigation Measures:

Hazardous waste generated from the facility shall be disposed off in suitable manner as

per the Hazardous Waste (Management, Handling and Transboundary Movement)

Rules, 2008. The storage, handling and disposal practices proposed to be followed in

the plant have been presented in Error! Reference source not found.. The used oil

generated from the proposed project shall also be collected in barrels and shall be sold

to the authorized recyclers identified by the HSPCB/ CPCB. The Detail of solvent

recovery system is given in section 2.5.2. Hazardous Waste generated from incinerator

and other sources will be disposed off to TSDF site in Haryana.

Mitigation Measures:

Solidwaste management includes following:

Measures to minimize waste generation

Operation of waste handling, treatment and disposal facilities The hazardous solid wastes generated from the proposed plant shall be sent for landfill

as well as for incineration as per HSPCB guidelines. The waste management plan

includes:

Waste inventory

Classification of waste

Packaging, storing and transporting wastes to disposal site

Data management and reporting

Contingency plan

Personnel training

Waste minimization

The requirements which will be specified in the Authorization from HSPCB shall be

followed. The manifest system shall also be implemented for control and record keeping.

4.3.9.1 Discarded Container/ Barrels/ Liners Management

Discarded containers/ barrels/ liners will be kept at a designated place with paved

surface. These will be decontaminated (washed/ cleaned) and after that will be stored in

the designated area in scrap yard. Later on these will be sold to the actual users/

recyclers as per the Hazardous Waste (Management, Handling and Transboundary

Movement) Rules, 2008. The record of discarded containers/ barrels/ liners stored in

scrap yard shall be maintained and also, inventory of their selling to the registered

recyclers shall be maintained. The same shall be reviewed by the HSE Department of

the project.

4.3.10. Socio-Economic Environment

Impact:

Page 80: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 79

The proposed Methylcobalamin (b12) project will have some positive impact on the

industrial growth in the region. It is anticipated that during the operation phase, the

proposed project will generate some direct/indirect employment in various plant related

activities / transportation/ services etc. In addition to that, the project will generate

significant opportunities for indirect benefits through important drugs availability/ CSR

activities etc.

4.3.11. Ecology and Biodiversity

Impact:

The project activity does not require tree cutting during land clearing as it is state

sponsored industrial area. Also, the study zone does not have any ecologically sensitive

location and hence, the plant activities are not expected to have any impact on the

ecology and biodiversity.

Mitigation Measures:

A total 33% of the total plot area has been earmarked for greenbelt development, which

will help in development of biodiversity. The indigenous plants shall be planted along

with ornamental trees/ shrubs to provide an aesthetic environment within and around the

plant. The maintenance of the greenbelt developed shall be ensured and survival rate

ofthe plants shall also be studied every half yearly. Treated domestic water will be used

for greenbelt development and irrigation purposes.

4.3.12. Energy Conservation

During the operation phase of the project, energy resources will be required for

operating various pumping machineries for water & wastewater, internal road

lighting, common utilities etc. The following options can be used for energy

conservation:

Energy efficient machineries shall be used during operation phase as per ECBC

2007.

Wherever possible in the plant, utilization of renewable sources of energy for

conservation of non-renewable sources of energy shall be ensured.

Sufficient care shall be taken to prevent/ minimize energy losses at each stage of

development.

Every year energy audit shall be conducted through competent authority

nominated by Govt. of India.

4.3.13. Safety Provisions

All the provisions as per the Factories Act, 1948, Manufacture, Storage and

Import of Hazardous Chemicals (MSIHC) Rules, 1989 and amendments

thereafter and also, the Hazardous Waste (Management, Handling &Trans

boundary Movement) Rules, 2008 to be followed.

In the proposed plant of Royal enterprises, Adoctor has also been contracted for

regular health check-ups of the employees.

Page 81: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 80

CHAPTER 5. ENVIRONMENTAL MANAGEMENT PLAN

5.1. Prelude

The Environmental Management Plan (EMP) is the synthesis of all proposed mitigation

and monitoring actions, set to a time frame with specific responsibility assigned and

follow-up actions defined. An equally essential element of this process is to develop

measures to eliminate, offset, or reduce impacts to acceptable levels during project

implementation and operation of the project. 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 aim of the EMP is

to ensure that the various adverse impacts associated with the project are properly

mitigated; either by preventing the impacts or by mitigating those to reduce the effect to

an acceptable level by adopting the most suitable techno-economic option. The EMP

also ensures that the positive impacts are conserved and enhanced.

5.2. The EMP

The Environmental Management Plan (EMP) consists of a set of mitigation, monitoring

and institutional measures to be taken during the design, construction and operation

phases of the project. The plan also includes the actions needed for implementation of

these measures. Overall objective of EMP:

Prevention: Measures aimed at impeding the occurrence of negative environmental

impacts and/or preventing such an occurrence having harmful environmental impacts.

Preservation: Preventing any future actions that might adversely affect an

environmental resource or attribute.

Minimization: Limiting or reducing the degree, extent, magnitude, or duration of adverse

impacts.

The major components of the Environmental Management Plan are:

Mitigation of potentially adverse impacts

Monitoring during project implementation and operation

Implementation schedule and environmental cost estimates

Integration of EMP with project planning, design, construction and operation

This Chapter provides mitigation and control measures to attenuate and/or eliminate

environmental impacts, which are likely to be caused by the proposed project. An

Environmental Management Plan (EMP) has been developed to mitigate the potential

adverse impacts and to strengthen the beneficial impacts during the construction and

operation phase.

Page 82: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 81

The EMP has been designed keeping in view the regulatory and other requirements to

ensure the following:

Minimum disturbance to the native flora and fauna.

Compliance with the air, water, soil and noise quality norms.

Conservation of water to the extent possible.

Encourage the socio-economic development.

Royal enterprises will incorporate all necessary steps to mitigate environmental pollution

in the design stage itself. In addition to that during the operation phase of the project, the

company will take all the mitigation measures suggested in the environmental

management plan and also comply with the statutory requirements as per the guidelines

of Central and/or State Government. It also provides detailed post-project monitoring

which is required to be undertaken by the authorities to maintain the environmental

quality within the stipulated standards specified by the Haryana State Pollution Control

Board (HSPCB), Central Pollution Control Board (CPCB) and the Ministry of

Environment & Forests (MoEF).

The environmental impacts due to different project activities and proposed mitigation

measures have been detailed in Chapter 4. The mitigation measures for reducing the

adverse environmental impacts together constitute a part of EMP.

5.3. Environmental, Health and Safety Management System

Chemical industries prefer an integrated approach and make environmental

management a part of overall Environmental, Health and Safety (EHS) Management

system.

This model EHS system suggests and addresses EMS issues such as:

Management system expectation

Management leadership, responsibilities and accountability

Risk assessment and management

Compliance and other requirements

Personnel, training and contractor services

Documentation and communications

Facilities design and construction

Operation, maintenance and management

Community awareness and emergency response

EHS performance monitoring and measurement

Incident investigation reporting and analysis

EHS management system audit

Management review and audit

With this type of EHS management approach, proposed project of Royal enterprises

would be able to meet all statutory norms.

Page 83: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 82

5.4. Construction Phase

Adequate and effective environment protection measures will be planned and designed

to minimize the impacts due to activities related to pre-construction (preparatory phase)

of the project, machinery installation and commissioning stages and end with the

induction of manpower and start up. The impacts identified during the construction

phase are mainly due to site preparation, foundation work, material handling,

construction of buildings and installation of the machinery. The impacts identified on air

environment, water environment, land environment and biological environment are

localized in nature and can be mitigated by adopting the mitigation measures suggested

in the Chapter 4 with associated impacts.

In view of the above, the following measures are recommended to reduce the impact

during this period:

Due provision of necessary infrastructural services like water and power supply

etc., for the construction area.

All possible care will be taken to reduce the noise level due to construction

activity. Also, noise prone activities shall be restricted to the extent possible

during night particularly during the period 10 PM to 6 AM in order to have

minimum environmental impact.

5.5. Operation Phase

5.5.1. Air Environment

5.5.1.1 Measures for Reducing Stack Emissions

In the proposed project, DG set will be used only during the power failure and will be

connected with a separate stack. Multi cyclone separator with stack height of 30 mtr

shall be installed for dispersion of particulate matter from Boiler. All process vents/

incinerator vents will be routed through dedicated two stage venturyscrubbing system.

The recovery and recycling of solvents in the process is a key issue in achieving

productivity and an edge in competitive world. Hence, all the solvent mixtures generated

from different stages of the products will be fractionated in a state of the art solvent

recovery system to give 95-98% recovery depending upon composition of solvent

mixtures and their boiling point. Chilled brine will be used in condensers to recover the

solvents.

Royal enterprises to ensure no leakage occurs from various process equipments

(equipment flanges, pumps, drains, sample points etc.) to pollute the working area.

5.5.1.2 Greenbelt Development

It is proposed to develop a green area 33% of the total area within the plant premises of

proposed project site. The green area development and tree plantation will be done by

using indigenous species as well as ornamental plants. Separate budget will be

Page 84: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 83

allocated for green belt development within the premises. Royal enterprises is committed

to develop healthy green belt, which will help in absorbing the pollutants as well as

providing aesthetic environment within and around the plant. Treated effluents will be

used for greenbelt development and irrigation within the plant premises.

Few guidelines for green belt development are as below:

Strict surveillance shall be made to increase the survival rate of the trees.

Plants with higher height, medium and low height should be planted to ensure

thick belt for attenuation of fugitive emission.

Open spaces, where tree plantation may not be possible, will be covered with

shrubs and grass to prevent erosion of topsoil.

Adequate attention will be paid to plantation of trees, their maintenance and

protection.

Project management has proposed to develop a greenbelt all along the boundary

wall of plant, along the roads, and surroundings of the production blocks, boiler,

ETP and other open areas etc.

Plant Species for Greenbelt

While selecting the plant species for the proposed green belt, the following guidelines

will be considered.

Fast growing type

Should have a thick canopy cover

Should be perennial green

Native origin

Should have a large leaf area index.

Design of Green Belt

As far possible the following guidelines will be considered in green belt development.

The spacing between the trees will be maintained slightly less than the normal

spaces, so that the trees may grow vertically and slightly increase the effective

height of the green belt.

Planting of trees in each row will be in staggered orientation.

In the front row shrubs consisting of Callistemon, Prosopis etc. will be grown.

Since the trunks of the tall trees are generally devoid of foliage, it will be useful to

have shrubs and trees in front of the trees so as to give coverage to this portion.

Shrubs and trees will be planted in encircling rows around the project site

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).

Tall trees one line and short trees one line will be planted around the boiler house, DG

set room and around the production blocks to control the fugitive emissions and to

reduce the noise. The species planted for greenbelt development is given in Table 5.1.

Page 85: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 84

Table 5.1 List of Plant species to be planted under greenbelt development pogramme

Sl. No. Name Scientific Name Importance

1 Aam Mangiferaindica NB, HI

2 Amaltas Cassia fistula AP

3 Ashoka Polyalthialongifolia AP, OP, IP, DR

4 Casuarina Casuarina sp HI

5 Bel Aegle marmelos MP

6 Bougainvillea Bougainvillea sp AP, DR

7 Dhak Butea monosperma NB

8 Dodonea Dodoneasp LH

9 Gudhal Hibiscus rosasinenis AP, OP

10 Gulmohar Delonixregia AP

11 Kachnar Bahuniavariagata HI

12 Neem Azadirachtaindica NB

13 Nerium Neriumodorum AP, OP

14 Ficus Ficussp HI

15 Poisenttia Euphorbia pulcherrima LH

16 Reetha Sapindusmukorossi MP

17 Sahtoot Morus alba HI

18 Shisham Dalbergiasissoo NB

19 Siris Albezialebbek HI

20 Eucalyptus Eucalyptus sp HI

21 Subabool Leucenaleucocephala NB, AP

22 Teak Tectonagrandis NB

NB- Noise Barrier, AP- Avenue Plant, OP- Ornamental Plant, LH-Live Hedge, MP- Medicinal Plant,

HI- Habitat Improvement, IP-Indicator Plants (to monitor pollution level), DR- Dust Receptor

5.5.1.3 Measures for Fugitive Emissions

The fugitive emissions of organic chemicals and VOCs may come from leakage through

valves, fittings, pumps, etc. Though this is not expected to be significant, it may be

reduced further by adopting the following measures:

LDAR system should be strictly followed.

All process drains/ equipment washing should be collected in closed pit (to avoid fouling of work area through odour etc.) and taken to ETP.

Regular maintenance of valves, pumps and other equipment to prevent leakage

and thus minimizing the fugitive emissions of VOCs.

Regular monitoring of VOCs shall be conducted in the areas prone to fugitive

emissions.

The monitoring at working environment shall be carried out and shall be recorded

in the prescribed form of the Factories Act.

Page 86: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 85

The design features as suggested in Table 5.2for new equipment may be considered.

Table 5.2 : Design Features for Minimization of Fugitive Emissions

S. No. Equipment Design Features Control Efficiency, %

1 Pumps Seal less design 100

Dual Mechanical Seal 100

2 Valves Seal less Design 100

3 Compressor Dual Mechanical Seal 100

4 Connectors Weld together 100

5 Pressure Relief Devices Rupture Disc 100

6 Sampling Connection Closed loop sampling 100

5.5.2. Water Environment

Water conservation measures shall be taken to optimize the fresh water requirement.

The fresh water shall be taken from the ground water.

The mitigation measures for minimizing the impacts on water environment in general

includes following:

Minimization of water use

Wastewater from different sources to be discharged after proper metering.

Segregation and collection philosophy for effluent to minimize waste generation

and facilitate treatment as well as recycle and reuse

Treatment philosophy to achieve regulatory standards

Reuse/recycle and disposal

Some of the measures, which have to be implemented, include:

Use equipment wash down waters as makeup solutions for subsequent batches, if feasible.

Use high-pressure jet hoses for equipment cleaning to reduce the amount of

water consumption and wastewater generation.

Reducing the actual process water consumption by way of improvement in

operation of processing units

Ensuring proper operation and maintenance schedule for the ETP.

5.5.3. Solid and Hazardous Waste Management

The solid and hazardous waste management have been provided in the mitigation

measures of Section 4.3.8. Also, the list of hazardous wastes and their proposed

disposal options as per the Hazardous Waste (Management, Handling and

Transboundary Movement) Rules, 2008 has been provided in Error! Reference source not

found..

Page 87: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 86

Hazardous wastes shall be incinerated in the incinerator to the extent possible and all

balance hazardous wastes including incinerator ash should be safely collected in seal

proof containers and stored in safe dedicated place. It should be regularly sent to TSDF

site in safe aurhorised vehicle.

5.5.4. Noise Environment

The statutory national standards for noise levels at the plant boundary will be met. The

selection of all new plant equipment will be made with specification of low noise levels.

Noise suppression measures such as enclosures, buffers and/or protective measures

may be provided (wherever noise level is more than 90 dB(A) and exposure limits to

workers is more than 8 hours a day) to limit noise levels within occupational exposure

limits. Areas with high noise levels will be identified and segregated where possible and

will include prominently displayed caution boards.

However, in areas where noise levels are high and exposure time is less, employees are

to be provided with ear protection measures like earplugs or earmuffs. Earplugs are to

be provided to all workers where exposure will be 85 dB(A) or more. The exposures of

employees working in the noisy area shall be regularly monitored to ensure compliance

with the regulatory requirements.

Monitoring of noise levels is essential to assess the efficacy of maintenance schedules

undertaken to reduce noise levels and noise protection measures.

5.5.5. Occupational Health Programme

Some of the measures under the occupational health programin the proposed project

have been provided below:

Annual health check for employees shall be carried out and record shall be

maintained.

Fire protection system, fire detection system, continuous monitoring system and

qualified fire staff shall maintain round the clock for handling any emergency.

Regular training to plant personnel in safety, fire fighting and first aid shall be

provided.

The proposed plant shall maintain a healthy work environment. This shall be

accomplished through the identification, evaluation and control of workplace

environmental factors, which may cause sickness, impaired health or significant

discomfort and inefficiency among workers. Environmental factors such as noise,

physical hazards toxicity/chemical hazard and ergonomic hazards shall be

regularly monitored to assist in maintaining a healthy work environment.

Worker‘s exposure to noise and toxic materials shall be evaluated against

applicable recognised exposure levels in the Factories Act.

Hearing protection aids shall be provided to workers who work in the high noise

areas, during construction of the proposed facilities and also to those who will

continue through the life of the facility.

Page 88: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 87

5.5.6. Hazard Communication and Chemical Safety

A hazardous chemical directory shall be developed to maintain information on the

hazards associated with each chemical used. Copies of Material Safety Data Sheets for

all hazardous materials at the proposed facility shall be provided at the unit and shall

available for employee review. The hazard communication programshall be arranged

regularly to serve as the basis for selection of personal protective equipment such as

gloves, goggles, face shields, etc. A select group of employees at the proposed facilities

shall be trained on first aid to provide an immediate response and medical care for

injuries. Safety department shall arrange the in-house safety training programs for

workers, supervisors, senior staff and management personnel at regular intervals. The

Safety Training Calendars shall be made on the basis of identifying training needs at

different level of employees (Management staff, company supervisory staff and

contractor employees). Three tiers of training programsshall be conducted regularly as:

Induction Safety Training

Basic Safety Training and

Specialized Training Programs

5.5.7. Environmental Audit

Environmental audits shall be carried out as per regulatory requirements. Records of

quality and quantity of air emissions and liquid effluent shall be monitored and

maintained records. An inventory of waste storage area in the complex shall also be

maintained, which shall include details of the type of waste and the quantity stored.

Manifest system shall also be followed for disposal of hazardous waste.

Data on influent to the effluent treatment plant and treated effluent quality; stack

emissions shall be used to ascertain compliance with stipulated standards.

The quantity of waste generated from various units will be compared with previous

year‘s data and efforts will be made to minimise wastes for more efficient utilisation of

resources.

5.5.7.1 External Safety Audits and Inspections

External safety Audits & Inspection shall be carried out as per the statutory requirement

i.e. once in two year.

5.5.7.2 Internal Safety Audits & inspection

Safety Officer as per Standard Operating Procedure and checklists to be prepared for

respective area shall conduct internal safety audit & inspection. Observations &

discrepancy report shall be sent to all concerns department for corrective action and

preventive action.

5.5.8. Manpower for Environmental Health and Safety Management

Page 89: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 88

A dedicated Environmental Management Cell with trained staff will look after the proper

environmental management of the proposed plant including operation & maintenance of

all facilities outlined earlier. Royal enterprises will assign responsibilities to officers from

various disciplines to co-ordinate the activities concerned with management and

implementation of environment control measures. Basically, the EHS department will

undertake the monitoring of environmental pollution level by measuring stack emissions,

ambient air quality, water and effluent quality, noise level, etc. either departmentally or

appointing external agency whenever necessary. Royal enterprises will also set up its

own laboratory equipped with different equipment for environmental monitoring and

analysis.In addition to that Royal enterpriseswill have a quality control laboratory, which

will be equipped with sophisticated equipment. Equipment of quality control laboratory

will also be available for monitoring of environment pollution. In case the monitored

results of environment pollution are found to exceed the prescribed limits, remedial

actions shall be taken through the concerned plant authorities. The actual operation and

maintenance of pollution control equipments of each department will be under respective

department heads.

The Environmental, Health and Safety department will ensure preparation of

environment statement, carrying out environment audit, preparation of Water Cess

Return and various consent applications and renewal under water (Prevention and

Control of Pollution) Act, 1974 and Air (Prevention and Control of Pollution) Act, 1981 as

well as application for authorization and its renewal under Hazardous Waste

(Management, Handling and Trans boundary Movement) Rules, 2008 under

Environment Protection Act, 1986.

5.6. ENVIRONMENT MANAGEMENT CELL

An Environment Management Cell (EMC) will be formed which will be responsible for

implementation of the aforesaid post project monitoring/management plan. The

composition of the Environment Management Cell and responsibilities of its various

members are given in Table: 5.3

Table 5.3 : Environmental Management Cell

S.No. Designation Proposed Responsibility

1. Vice President Policy decisions and overall responsibility of the Royal Laboratories Ltd.

2. General Manager (Production)

Responsible for management and implementation of EMP.

3 Manager (EHS) & supporting Staff

Carry out all EHS related tasks to implement Royal enterprises EHS policy.

5.7. EMP BUDGET

A total capital cost and recurring cost provision of about INR155 lac and 25 Lakh has

been kept in the project cost towards the environmental protection, control and mitigation

measures and implementation of the EMP.

Page 90: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 89

5.8. Environmental Monitoring Programme

Based on the findings of the Environmental Impact Assessment study, various mitigation

measures have been proposed, which have been detailed out in Environmental

Management Plan (EMP). In order to monitor the impacts and efficiency of these plans,

monitoring of various environmental attributes have been proposed during and after the

completion of the management plans. A well defined environmental monitoring program

would be employed with trained and qualified staff of Environmental Management Cell of

the proposed agro-chemicals, fine chemicals & intermediate chemicals manufacturing

plant to monitor the environmental attributes of the area with respect to EMP as well as

the guidelines of the HSPCB/ CPCB. Environmental monitoring schedule proposed to be

adopted by the project authorities is as presented in Table 5.4.

Table 5.4 : Matrix of Environmental Monitoring Plan

S. No. Aspect Source of

Impact

Monitoring

Methods and

Parameters

Frequency Executing

Agency

Monitoring

Agency

1.0 Construction Phase

1.1 Local Manpower Absorption

Construction Works

Contractor‘s report No. of people working in the project

Monthly Contractor Royal Enterprises

1.2 Soil Erosion Excavation, disposal, cut & fill for site leveling and internal roads, disposal

Survey &observation; Extent and degree of erosion;

Monthly Contractor Royal Enterprises

1.3 Biodiversity Land clearing activities; Fauna in the project area

Composition of flora & fauna

Twice in a year

Contractor Royal Enterprises

1.4 Re-vegetation & Greenbelt Development

Land clearing & disposal works

Survey & observation; Survival rate of species planted; Density of vegetation

Half Yearly Royal Enterprises

Environmental Management Cell of Royal Enterprises

1.5 Water Quality Excavation, disposal, sewage disposal, land clearing activities

Surveys & sample collection and field measurements for turbidity, pH, TDS, DO, and other chemical

Monthly Contractor Royal Enterprises

Page 91: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 90

S. No. Aspect Source of

Impact

Monitoring

Methods and

Parameters

Frequency Executing

Agency

Monitoring

Agency

parameters

1.6 Air Quality Operation of DG sets, transportation of construction materials, road construction, construction of utilities

Survey & observations; Levels of PM10, SO2 and NOx

Monthly Royal Enterprises

Royal Enterprises

1.7 Public Health Dust, Noise, Influx of labours

Regular medical checkups

Quarterly Contractors Royal

Enterprises

1.8 Waste Management

Restoration of disposal sites and construction areas

Status of protection measures

Half Yearly Contractor Royal

Enterprises

2.0 Operation Phase

2.1 Water Quality & Quantity

Surface & Ground water quality within the Project Area

Surveys, sample collection & field measurement

Quarterly Royal Enterprises

HSPCB (half yearly reporting) [Three nosPeizeometric Wells at strategic locations ]

2.2 Effluent Quality

Quality of effluent discharged and reused

ETP sample collection & quality analysis

Daily (Internal); Monthly (Third Party)

Royal

Enterprises

HSPCB (half yearly reporting)

2.3 Air Quality Emission from utility and process

Air quality monitoring at 2-3 locations at plant boundary (SO2, NOx, PM10, HF, VOC) Stack emission monitoring (Boiler, Process& DG) Work area ambient air quality

Ambient -Monthly (24 hourly); Stack – Monthly (third party) Monthly

Royal

Enterprises

HSPCB (half yearly reporting)

Page 92: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 91

S. No. Aspect Source of

Impact

Monitoring

Methods and

Parameters

Frequency Executing

Agency

Monitoring

Agency

monitoring as per Factories Rules

2.4 Noise Levels Noise levels compliance with respect to industrial standards

Ambient Equivalent Sound Pressure Levels (Leq) at day and Night time at 4 to 6locations

Monthly Royal

Enterprises

HSPCB (half yearly reporting)

Monitoring of Occupational Noise Levels

Near the noise generating sources

Fortnightly Royal

Enterprises

HSPCB (half yearly reporting)

2.5 Biological Environment

Horticulture/ Greenbelt Development

Survival rate of plants and shrubs

Half Yearly Royal

Enterprises

HSPCB (half yearly reporting)

2.6 Solid Waste Management

Disposal of waste

Tracking of waste collection, segregation and disposal

Fortnightly Royal

Enterprises

HSPCB (half yearly reporting)

2.7 Hazardous Waste Management

Disposal of Hazardous Waste

Tracking of hazardous waste collection,segregation, storage and disposal

Fortnightly Royal Enterprises

HSPCB (half yearly reporting)

Page 93: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 92

CHAPTER 6. HAZARDS ANALYSIS & RISK ASSESSMENT

6.1. Introduction

The Proposed manufacturing products shall be prepared on Batch basis like 5 kg batch

whenever required or per day.

Royal enterprises proposed API project is hazardous in nature. The RA for this plant is

based on Level 1 and Level 2.

The list of raw material and products (and their monthly production capacity) to be

manufactured for the proposed project are given in chapter2.

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 anyone. 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 QuantitativeRisk 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

This Chapter provides details risk associated with the project activities and storage of

harzardous chemical.

Page 94: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 93

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.

6.2. Risk Assessment

.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 are 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;

Page 95: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 94

Risk reduction measures.

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:

i. Hazards identification utilising formal approach (Level 2, HAZOP

etc.);

ii. Frequency Analysis. Based on past safety data (incidents /

accidents); Identifying likely pathway of failures and quantifying the

toxic / inflammable material release;

iii. 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.

iv. 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

analysed 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.

The risk analysis of hazardous chemical on Level 1 and Level 2 basis is given below:

6.2.1. Physical &Chemicl Properties

S/N

Chemical Name CAS No. Imp Properties

1 Cyanocobalamin 68-19-9 Physical state and appearance: Solid.

Molecular Weight: 1355.39 g/mole

Boiling Point: Decomposes.

Melting Point: 102.5°C (216.5°F)

Dispersion Properties: See solubility in water.

Solubility: Partially soluble in cold water.

Page 96: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 95

2 Methyl iodide 74-88-4 Physical state and appearance: Liquid.

Odor: Pungent. Sweet. Ethereal.

Molecular Weight: 141.95 g/mole

Color: Colorless. Clear

Boiling Point: 42.5°C (108.5°F)

Melting Point: -66.5°C (-87.7°F)

Critical Temperature: 254.8°C (490.6°F)

Specific Gravity: 2.28 (Water = 1)

Vapor Pressure: 53.3 kPa (@ 20°C)

Vapor Density: 4.89 (Air = 1)

Water/Oil Dist. Coeff.: The product is more soluble in

oil; log(oil/water) = 1.5

Dispersion Properties: See solubility in water,

acetone.

Solubility: Soluble in acetone, benzene, carbon

tetrachloride, and chloroform. Miscible in alcohol and

ether. Partially soluble

in cold water.

3 Chloroform 67-66-3 Physical state and appearance: Liquid.

Odor: Pleasant. Sweetish. Etheric. Non-irritating

Taste: Burning. Sweet.

Molecular Weight: 119.38 g/mole

Color: Colorless. Clear

pH (1% soln/water): Not available.

Boiling Point: 61°C (141.8°F)

Melting Point: -63.5°C (-82.3°F)

Critical Temperature: 263.33°C (506°F)

Specific Gravity: 1.484 (Water = 1)

Vapor Pressure: 21.1 kPa (@ 20°C)

Vapor Density: 4.36 (Air = 1)

Odor Threshold: 85 ppm

Water/Oil Dist. Coeff.: The product is more soluble in

oil; log(oil/water) = 2

Solubility: Very slightly soluble in cold water.

4 Sodium borohydride

16940-66-2 Physical state and appearance: Solid.

Molecular Weight: 37.84 g/mole

Color: White. Grayish white.

Melting Point: Decomposes.

Specific Gravity: 1.074 (Water = 1)

Vapor Pressure: Not applicable.

Vapor Density: 1.3 (Air = 1)

Volatility: Not available.

Dispersion Properties: See solubility in water.

Solubility: Easily soluble in cold water.

Page 97: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 96

6.2.2. Hazard Identification

S/N

Chemical Name CAS No. Possible Hazards

1 Cyanocobalamin 68-19-9 Potential Acute Health Effects: Hazardous in case of ingestion. Hazardous in case of skin contact (irritant), of eye contact (irritant), of inhalation. Slightly hazardous in case of skin contact (permeator). Potential Chronic Health Effects: CARCINOGENIC EFFECTS: Not available. MUTAGENIC EFFECTS: Not available. TERATOGENIC EFFECTS: Not available. DEVELOPMENTAL TOXICITY: Not available. The substance is toxic to lungs, mucous membranes. Repeated or prolonged exposure to the substance can produce target organs damage.

2 Methyl iodide 74-88-4 Potential Acute Health Effects: Hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation (lung irritant). Slightly hazardous in case of skin contact (permeator). Severe over-exposure can result in death. Potential Chronic Health Effects: CARCINOGENIC EFFECTS: Classified A2 (Suspected for human.) by ACGIH. 3 (Not classifiable for human.) by IARC. MUTAGENIC EFFECTS: Mutagenic for mammalian somatic cells. Mutagenic for bacteria and/or yeast. TERATOGENIC EFFECTS: Not available. DEVELOPMENTAL TOXICITY: Not available. Repeated exposure to a highly toxic material may produce general deterioration of health by an accumulation in one or many human organs

3 Chloroform 67-66-3 Potential Acute Health Effects: Hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation.Slightly hazardous in case of skin contact (permeator). Potential Chronic Health Effects: CARCINOGENIC EFFECTS: 2B (Possible for human.) by IARC. Classified 2 (Some evidence.) by NTP. MUTAGENIC EFFECTS: Mutagenic for mammalian somatic cells. Mutagenic for bacteria and/or yeast. TERATOGENIC EFFECTS: Not available. DEVELOPMENTAL TOXICITY: Not available. The substance may be toxic to kidneys, liver, heart. Repeated or prolonged exposure to the substance can produce target organs damage.

4 Sodium borohydride

16940-66-2 Potential Acute Health Effects: Extremely hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation. Very hazardous in case of skin contact (corrosive). The amount of tissue damage depends on length of contact. Eye contact can result in corneal damage or blindness. Skin contact can produce inflammation and blistering.

Page 98: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 97

Inhalation of dust will produce irritation to gastrointestinal or respiratory tract, characterized by burning, sneezing and coughing. Severe over-exposure can produce lung damage, choking, unconsciousness or 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: Extremely hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation. Very hazardous in case of skin contact (corrosive). CARCINOGENIC EFFECTS: Not available. MUTAGENIC EFFECTS: Not available. TERATOGENIC EFFECTS: Not available. DEVELOPMENTAL TOXICITY: Not available. Repeated exposure of the eyes to a low level of dust can produce eye irritation. Repeated skin exposure can produce local skin destruction, or dermatitis. Repeated inhalation of dust can produce varying degree of respiratory irritation or lung damage. Repeated exposure to an highly toxic material may produce general deterioration of health by an accumulation in one or many human organs. Repeated or prolonged inhalation of dust may lead to chronic respiratory irritation.

6.2.3. Handling and Storage

S/N

Chemical Name CAS No. Suggested Handling and storage precautions

1 Cyanocobalamin 68-19-9 Precautions: Keep away from heat. Keep away from sources of ignition. Empty containers pose a fire risk, evaporate the residue under a fume hood. Ground all equipment containing material. Do not breathe dust. Wear suitable protective clothing In case of insufficient ventilation, wear suitable respiratory equipment If you feel unwell, seek medical attention and show the label when possible. Avoid contact with skin and eyes Storage: Keep container dry. Keep in a cool place. Ground all equipment containing material. Keep container tightly closed. Keep in a cool, well-ventilated place. Combustible materials should be stored away from extreme heat and away from strong oxidizing agents.

2 Methyl iodide 74-88-4 Precautions: Keep locked up.. Keep away from heat. Keep away from sources of ignition. Empty containers pose a fire risk, evaporate the residue under a fume hood. Ground all equipment containing material. Do not ingest. Do not breathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and show

Page 99: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 98

the container or the label. Avoid contact with skin and eyes. Keep away from incompatibles such as oxidizing agents. Storage: Light Sensitive. Store in light-resistant container. Keep container tightly closed. Keep container in a cool, well ventilated area. Do not store above 24°C (73.4°F).

3 Chloroform 67-66-3 Precautions: Do not ingest. Do not breathe gas/fumes/ vapor/spray. 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. Avoid contact with skin and eyes. Keep away from incompatibles such as metals, alkalis. Storage: Keep container tightly closed. Keep container in a cool, well-ventilated area. Sensitive to light. Store in light-resistant containers.

4 Sodium borohydride

16940-66-2 Precautions: Keep locked up Keep container dry. Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not breathe dust. Never add water to this product 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 from incompatibles such as oxidizing agents, acids, alkalis, moisture. Storage: Flammable materials should be stored in a separate safety storage cabinet or room. Keep away from heat. Keep away from sources of ignition. Keep container tightly closed. Keep in a cool, well-ventilated place. Ground all equipment containing material. Keep container dry. Keep in a cool place.

6.2.4. Accidental Release Measures

S/N

Chemical Name CAS No. Suggested accidental release measures

1 Cyanocobalamin 68-19-9 Small Spill: Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by spreading water onthe contaminated surface and dispose of according to local and regional authority requirements. Large Spill: Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on thecontaminated surface and allow to evacuate through the sanitary system.

2 Methyl iodide 74-88-4 Small Spill: Dilute with water and mop up, or absorb with an inert dry material and place in an appropriate

Page 100: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 99

waste disposalcontainer. Large Spill: Poisonous liquid. Stop leak if without risk. Do not get water inside container. Do not touch spilled material. Usewater spray to reduce vapors. Prevent entry into sewers, basements or confined areas; dike if needed. Eliminate all ignitionsources. Call for assistance on disposal. Be careful that the product is not present at a concentration level above TLV. Check TLV on the MSDS and with local authorities.

3 Chloroform 67-66-3 Small Spill: Absorb with an inert material and put the spilled material in an appropriate waste disposal. Large Spill: Absorb with an inert material and put the spilled material in an appropriate waste disposal. Be careful that theproduct is not present at a concentration level above TLV. Check TLV on the MSDS and with local authorities.

4 Sodium borohydride

16940-66-2 Small Spill: Use appropriate tools to put the spilled solid in a convenient waste disposal container. Large Spill: Corrosive solid. Flammable solid that, in contact with water, emits flammable gases. Stop leak if without risk. Do not get waterinside container. Do not touch spilled material. Cover with dry earth, sand or other non-combustible material. Use water sprayto reduce vapors. Prevent entry into sewers, basements or confined areas; dike if needed. Eliminate all ignition sources. Call for assistance on disposal.

6.2.5. First Aid Measures

S/N

Chemical Name CAS No. Suggested First Aid Measures

1 Cyanocobalamin 68-19-9 Eye Contact: Check for and remove any contact lenses. Immediately flush eyes with running water for at least 15 minutes, keeping eyelids open. 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 running water 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 before reusing. 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. Ingestion: Do not induce vomiting. Loosen tight clothing such as a

Page 101: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 100

collar, tie, belt or waistband. If the victim is not breathing, perform mouth-to-mouth resuscitation. Seek immediate medical attention.

2 Methyl iodide 74-88-4 Eye Contact: Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. 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 contaminated clothing and shoes. Cold water may be used.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 medical attention. Inhalation: If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention 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. If breathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. WARNING: It may be hazardous to the person providing aid to give mouth-to-mouth resuscitation when the inhaled material is toxic, infectious or corrosive. 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 an unconscious person. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention immediately.

3 Chloroform 67-66-3 Eye Contact: Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. Cold water may be used. WARM water MUST 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 contaminated clothing 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 medical attention. Inhalation: If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention. Serious Inhalation: Evacuate the victim to a safe area

Page 102: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 101

as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. If breathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. WARNING: It may be hazardous to the person providing aid to give mouth-to-mouth resuscitation when the inhaled material is toxic, infectious or corrosive. Seek medical attention. Ingestion: Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. If large quantities of this material are swallowed, call a physician immediately. Loosen tight clothing such as a collar, tie, belt or waistband.

4 Sodium borohydride

16940-66-2 Eye Contact: Check for and remove any contact lenses. Immediately flush eyes with running water for at least 15 minutes, keeping eyelids open. Cold water may be used. Do not use an eye ointment. Seek medical attention. Skin Contact: If the chemical got onto the clothed portion of the body, remove the contaminated clothes as quickly as possible, protecting your own hands and body. Place the victim under a deluge shower. If the chemical got on the victim's exposed skin, such as the hands ; Gently and thoroughly wash the contaminated skin with running water and non-abrasive soap. Be particularly careful to clean folds, crevices, creases and groin. Cold water may be used. If irritation persists, seek medical attention. Wash contaminated clothing before reusing. Serious Skin Contact: Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek immediate 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. If breathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. WARNING: It may be hazardous to the person providing aid to give mouth-to-mouth resuscitation when the inhaled material is toxic, infectious or corrosive. Seek immediate medical attention. Ingestion: Do not induce vomiting. Examine the lips and mouth to ascertain whether the tissues are damaged, a possible indication that the toxic material was ingested; the

Page 103: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 102

absence of such signs, however, is not conclusive. Loosen tight clothing such as a collar, tie, belt or waistband. If the victim is not breathing, perform mouth-to-mouth resuscitation. Seek immediate medical attention.

6.2.6. Exposure Controls/Personal Protection

S/N

Chemical Name CAS No. Suggested personal protection

1 Cyanocobalamin 68-19-9 Engineering Controls: Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommended exposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure to airborne contaminants below the exposure limit. Personal Protection: Splash goggles. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent. Gloves. Personal Protection in Case of a Large Spill: Splash goggles. Full suit. Dust respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling this product.

2 Methyl iodide 74-88-4 Engineering Controls: Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their respective threshold limit value. Ensure that eyewash stations and safety showers are proximal to the workstation 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 avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling this product.

3 Chloroform 67-66-3 Engineering Controls: Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their respective threshold limit value. Ensure that eyewash stations and safety showers are proximal to the workstation 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 avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist

Page 104: EnvironmentaI Impact Assessment Report: Greenfield ...€¦ · Royal enterprises proposes to establish a bulk drug intermediates (APIs) manufacturing unit of 30 kg/monthcapacity.

Royal enterprises

EIA Report for Manufacturing Plant for MethylcobalaminAPI Plant at HSIIDC

Page | 103

BEFORE handling this product. 4 Sodium

borohydride 16940-66-2 Engineering Controls:

Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommended exposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure to airborne contaminants below the exposure limit. Personal Protection: Splash goggles. Lab coat. Vapor and dust 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 and dust respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling this product.