FORMenvironmentclearance.nic.in/writereaddata/... · form – 1 & pre-feasibility report amendment...

FORM – 1 & PRE-FEASIBILITY REPORT

AMENDMENT IN EC

FOR

CHANGE IN PRODUCT MIX WITH

CHANGE IN CATEGORY

PESTICIDES & ALLIED AGRO-

CHEMICALS INGREDIENTS –

CATEGORY – 5(b)

TO

ACTIVE PHARMA INGREDIENTS

AND INTERMEDIATES –

CATEGORY – 5(f)

BY

M/s SHIVALIK RASAYAN LIMITED

PLOT NO D-2/CH/41/A , PCPIR

DAHEJ-II INDUSTRIAL ESTATE,

VILLAGE VADDALA, TEHSIL VAGRA,

DISTRICT – BHARUCH,

GUJARAT

Amendment in EC for change in Product mix with change in category for

Manufacturing Unit of Active Pharma Ingredients (API) and Intermediates. PFR

M/s SHIVALIK RASAYAN LIMITED C - 1

TABLE OF CONTENTS

FORM – 1 F-1 – F-22

PRE-FEASIBILITY REPORT 1 – 538

1.0 EXECUTIVE SUMMARY 1 – 21

1.1 Preamble 1

1.2 Salient Features of the Project as per present EC (F. No. J-

11011/556/2011-IA II (I), 27th August, 2014)

2

1.3 Salient features of the Project as per proposed Manufacture of

Active Pharma Ingredients (API’s) and Intermediates with in-house

Pilot R & D activity

3

1.4 Water requirement and wastewater treatment and discharge details

i). Quantity of Water required and Wastewater generated

ii). Waste water treatment and disposal details

8

8

11

1.5 Raw Material Storage & Handling 14

1.6 Solvent Recovery and Recycling 14

1.7 Air Pollution Details 14

1.8 Noise Pollution Details 15

1.9 Solid Waste Details 15

1.10 Hazardous raw materials used in the manufacturing process 16

1.11 Hazardous waste generation and its management during the

manufacturing process

17

1.12 Green Belt 18

1.13 Power & Fuel Requirements 18

1.14 Environmental Impacts and Management Plan

1.14.1 Environmental management Plan during construction phase

1.14.2 Environmental Management Plan during Operation Phase

19

19

20

2.0 INTRODUCTION OF THE PROJECT / BACKGROUND

INFORMATION

22 - 29




2.1 Planning Concept 22

2.2 Identification of Project & Project Proponent 22

2.3 Brief Description of Nature of the Project 23

2.4 Need for the Project and Its Importance to the Country and or

Region

23

2.5 Demands-Supply Gap 26

2.6 Imports vs. Indigenous Production 27

2.7 Export Possibility 27

2.8 Domestic/Exports Markets 28

2.9 Employment Generation due to the Project 29

3.0 PROJECT DESCRIPTION 30 - 526

3.1 Type of Project

3.1.1 Infrastructure

3.1.2 Technical Know-How

3.1.3 Construction Activities

30

30

31

31

3.2 Location of the Project 32

3.3 Site Description

3.3.1 Site Selection

36

36

3.4 Size or Magnitude of Operation 36

3.5 Project Description with Process Details (A Schematic

Diagram/Flow Chart Showing the Project Layout, Components of

the Project etc.)

1.0 Busulfan

2.0 Azacitidine

3.0 Bortezomib

4.0 Melphalan HCL

5.0 Pomalidomide

6.0 Bendamustine HCL

7.0 Pemetrexed di Na (PMD)

37

41

45

55

61

73

77

79




8.0 Anastrozole

9.0 Paclitaxel

10.0 Letrozole

11.0 Cabazitaxel

12.0 Oxaliplatin

13.0 Cisplatin

14.0 Carboplatin

15.0 Docetaxel

16.0 Imatinib mesylate

17.0 Enzalutamide

18.0 Erlotinib HCL

19.0 Palbociclib

20.0 Ibrutinib

21.0 Lenalidomide

22.0 Dimethyl fumarate

23.0 Pirfenidone

24.0 Fingolimod HCL

25.0 Trifloronamide

26.0 Sitagliptin

27.0 Vildagliptin

28.0 Teneligliptin

29.0 Sexagliptin

30.0 Dofetilide

31.0 Azilsartan Kamedoxamil

32.0 Eletriptan HCL

33.0 Methylphenidate HCL

34.0 Dexmethylphenidate HCL

35.0 Dasatinib

36.0 Gefitinib

37.0 Abiraterone Acetate

84

91

98

103

111

117

121

127

133

136

140

149

160

165

170

174

181

188

192

200

205

212

227

235

241

245

251

260

262

265




38.0 Clopidogrel Bisulfate

39.0 Montelukast Sodium

40.0 Darunavir Ethanolate

41.0 Sofosbuvir

42.0 Atazanavir Sulphate

43.0 Prasugrel Hydrochloride

44.0 Linezolid

45.0 Canagliflozin Hemihydrate

46.0 Tenofovir Disoproxil Fumarate

47.0 Sunitinib Malate

48.0 Decitabine

49.0 Gemcitabine HCL

50.0 Temozolomide

51.0 Bicalutamide

52.0 Capecitabine

53.0 Cytarabine

54.0 Acebrophylline

55.0 Cloferabine

56.0 Cyclophosphamide

57.0 Emtricitabine

58.0 Elvitegravir

59.0 Cobicistat

60.0 Ambroxol Hydrochloride

61.0 Sorafenib Tosylate

62.0 Irinotecan HCL Trihydrate

63.0 Praziquantel

269

273

277

279

281

284

289

292

295

300

307

318

323

328

331

338

342

346

356

363

370

387

404

407

413

423

3.6 Raw Materials

3.6.1 Quantity Requirement

3.6.2 Source of supply of raw materials

3.6.3 Storage facility for raw materials and Products

428

428

455

457




3.6.4 Machinery & Equipment Details 458

3.7 Resource Optimization/Recycling and Re-use envisaged in the

Project

3.7.1 Solvent Recovery & Re-use

3.7.2 By- Products generation during the process of manufacture of

APIs & Intermediates

3.7.3 Domestic Solid Waste Re-Use

468

468

478

485

3.8 Water, Energy/Power Requirement & Source

3.8.1 Water

3.8.2 Power

485

485

485

3.9 Wastes Generated & Scheme for their Management/Disposal

3.9.1 Water demand and wastewater/effluent discharge

3.9.2 Product-Wise Water Consumption and Discharge

3.9.3 Process Effluent Characteristics

3.9.4 Treatment Scheme for Wastewater

3.9.5 Rainwater Harvesting & Groundwater Recharging

3.9.6 Air pollution Sources

3.9.6.1 Scrubber Details

3.9.7 Noise Pollution Details

3.9.8 Solid Waste Details

3.9.9 Hazardous raw materials used in the manufacturing process

3.9.10 Hazardous waste generation and its management during the

manufacturing process

3.9.10.1 Process Residue

3.9.10.2 Spent Carbon

3.9.10.3 Inorganic Salt Generation from the Process

3.9.10.4 Spent Catalyst

3.9.11 Environmental Impacts and Management Plan

3.9.11.1 Environmental management plan during construction

phase

485

485

489

495

496

499

504

504

506

507

507

508

508

512

515

517

518

518




3.9.11.2 Environmental Management Plan during Operation Phase

3.9.11.3 Environment Management Cell

3.9.11.4 Environment Monitoring Program

3.9.11.5 Risk Reduction Measurement & Recommendation in view

of Safety Consideration

520

522

522

523

4.0 SITE ANALYSIS 526 – 532

4.1 Connectivity 526

4.2 Land Use

4.2.1 Site Selection

526

526

4.3 Topography 527

4.4 Existing Land Use Pattern 528

4.5 Existing Infrastructures 529

4.6 Soil Classification 530

4.7 Climatic Data 530

4.8 Social Infrastructure 531

5.0 PLANNING BRIEF 533 - 537

5.1 Planning Concept (Type of Industries, Facilities and Transportation

etc.) Town and Country Planning/ Development Authority

Classification

533

5.2 Population Projection 533

5.3 Green Belt Development 533

5.4 Assessment of Infrastructure Demand (Physical & Social)

5.4.1 System Design for High Productivity

5.4.2 Sizing of Critical Equipment- Margins &

Redundancy/Standby

5.4.3 Design for Efficient Operation

5.4.4 Operation Performance Management System (OPMS)

5.4.5 Operation & Maintenance Philosophy

534

534

534

534

535

535




5.5 Amenities/Facilities

5.5.1 In-Plant Facilities

5.5.2 Employment Generation

5.5.3 Peripheral Developmental Activities

535

535

536

536

6.0 REHABILITATION & RESETTLEMENT (R & R) PLAN 536

7.0 PROJECT COST ESTIMATES 536

8.0 ANALYSIS OF PROPOSAL 537

LIST OF TABLES

Table No. Name of Table Page No.

01.01 Salient Features of the Project as per present EC (F. No. J-

11011/556/2011-IA II (I), 27th August, 2014)

2

01.02 Salient features of the Project as per proposed Manufacture of

Active Pharma Ingredients (API’s) and Intermediates with in-

house Pilot R & D activity

3

01.03 Proposed API’s, Intermediates & Chemicals 4

01.04 Summary of water, wastewater, air & solid waste details 6

01.05 Water consumption and discharge (KLD) 9

01.06 Sewage/wastewater treatment and discharge 11

01.07 Air pollution sources, fuel consumption and chimney height

details

15

01.08 Solid waste generation during the operation phase 15

01.09 Hazardous Raw Materials 16

01.10 Summary of the total quantity of hazardous wastes: 17

02.01 Employment Generation due to the Project 29

03.01 Construction Details 31




03.02 Proposed API’s, Intermediates & Chemicals 37

03.03 Raw materials requirement 428

03.04 Raw Materials Suppliers 455

03.05 Details of Storage Facilities 457

03.06 List of the machinery & equipment’s 458

03.07 Solvent Recovery 469

03.08 Quantity of by-products generated 478

03.09 Water consumption and discharge 486

03.10 Sewage/wastewater treatment and discharge 487

03.11 Product-wise water consumption and effluent discharge 489

03.12 Effluent characteristics (expected) 495

03.13 Air pollution sources, fuel consumption and chimney height

details

504

03.14 Solid waste generation during the operation phase 506

03.15 Hazardous raw materials 507

03.16 Quantity of organic process residue generation from

manufacturing process.

508

03.17 Details of Spent Carbon 512

03.18 Details of Inorganic Salt Generation From The Process 514

03.19 Summary of the total quantity of hazardous wastes 517

03.20 Environmental management plan during construction phase 518

03.21 Environmental management plan during construction phase 518

03.22 Environmental Monitoring at Work Zone 522

04.01

05.01

05.02

Land break-up details

Employees Details

Cost of Project

528

533

536




LIST OF FIGURES

Figure No. Name of Figure Page No.

03.01 Location of the Project 33

03.02 Satellite Image of the Project Site 34

03.03 Map showing Distance between Severally Polluted Area & the

Project Site (Google Map)

35

03.04 Generalized Flow Chart for Bulk Drug Manufacturing 39

03.05 Schematic of Spent Solvent Management System 478

03.06 Design of Typical Recharge Pit 499

03.07 Cross section of Recharge Trench 500

03.08 Schematic for Rain Water Harvesting 503

04.01 Seismicity Map of Gujarat State 528

04.02 Pie chart of Land use 529

LIST OF ANNEXURES

Annexure – I Location of the Project

Annexure – II Layout Plan

Annexure – III Land Possession Documents

Annexure – IV Water Balance

Annexure – V Copy of Consent to Establish

Annexure – VI Copy of EC

Annexure – VII Information on Change in Product Mix

Annexure – VIII MSDS of Products

Annexure – IX Undertaking

FORM – 1


Manufacturing Unit of Active Pharma Ingredients (API) and Intermediates. Form-1

M/s SHIVALIK RASAYAN LIMITED F - 1

APPENDIX – I

(See paragraph – 6)

FORM 1

(I) Basic Information:

Sr.

No.

Item Details

1. Name of the Project/s: Amendment in EC for change in Product mix with

change in category from Pesticides & Allied Agro-

Chemicals Ingredients to manufacturing Unit of

Active Pharma Ingredients and Intermediates by

M/s Shivalik Rasayan Limited.

2. S. No. in the Schedule Activity 5 (f) from 5 (b)

3. Proposed capacity/ area/ length/

tonnage to be handled / command

area/lease area/number of Wells to

be drilled.

Production Capacity (MT)

Proposed Annual Production 1500

Production Details

Products as per

present EC

Activity – 5(b)

Proposed Products as

per amended EC

Activity – 5(f)

Product Qty.

(MTPA)

Product Qty.

(MTPA)

Pesticides

& Allied

Agro-

Chemicals

Ingredients

8250 Active

Pharma

Ingredients

(API’s) and

Intermediates

1500

The industry will manufacture any Ten Products

at a given point of time on campaign basis so that

the Maximum production capacity will not exceed

1500.00 MT/Annum.

Fresh Water will be supplied by GIDC, therefore

no requirement of drilling the bore wells.

4. New/Expansion/Modernization Amendment

Amendment in EC as granted earlier vide F. No. J-

11-11/556/2011-IA II (I), Dated 27.08.2014 for

setting up to manufacture Pesticides & Allied Agro-

Chemicals Ingredients (8250 MTPA). Now project

proponent proposes to diversify from Pesticides &




Chemicals to Bulk Drugs i.e. manufacturing of Active

Pharma Ingredients (API’s) and Intermediates after

assessing the potential viability aspects on the same

location.

5. Existing Capacity Area etc. Land area 50,000 Sq. mt.

6. Category of Project i.e. 'A' or 'B' Amendment in Category from “A” to “B”

7. Does it attract the general condition?

If yes, Please specify.

No

8. Does it attract the specific condition?

If yes, Please specify.

Yes, the existing industrial plot falls under

Petroleum, Chemical and Petro-chemical

Investment Region (PCPIR) at Dahej II Industrial

Estate, Tehsil Vagra, District Bharuch (Gujarat).

Environment clearance to develop PCPIR by

GIDC has been granted by MoEF & CC vide

Letter No. F. No. 21-49/2010-IA-III Dated 14th

September 2017.

(Although No EC is required w.r.t the Specific

condition of MoEF Notification No. S.O. 1533,

Dated 14th Sep’ 2006, however since Company

has obtain EC under activity 5(b) & now propose

to diversify under activity 5(f) with amended EC

for Product mix change).

With regards to Specific Condition (SC) “If any

Industrial Estate/Complex / Export processing Zones

/Special Economic Zones/Biotech Parks / Leather

Complex with homogeneous type of industries such as

Items 4(d), 4(f), 5(e), 5(f), or those Industrial estates

with pre –defined set of activities (not necessarily

homogeneous, obtains prior environmental clearance,

individual industries including proposed industrial

housing within such estates /complexes will not be

required to take prior environmental clearance, so

long as the Terms and Conditions for the industrial

estate/complex are complied with (Such

estates/complexes must have a clearly identified

management with the legal responsibility of ensuring

adherence to the Terms and Conditions of prior

environmental clearance, who may be held responsible

for violation of the same throughout the life of the




complex/estate).

9. Location PCPIR, Dahej – II, Industrial Estate (Annexure –

1)

Plot/Survey/Khasra No. Plot No. - D-2/CH/41/A

Village Vadadala

Tehsil Vagra

District Bharuch

State Gujarat

10. Nearest railway station/airport along

with Distance in kms.

Bharuch Railway Station – 36.88 Km SE

Vadodara Airport – 83.50 Km NE

11. Nearest Town, City, District

Headquarters along with distance in

kms.

Vadadala – 1.20 Km SW

Bharuch – 37.0 Km SE

12. Village Panchayats, Zilla Parishad,

Municipal Corporation, Local body

(complete postal address with

telephone nos. to be given)

V.P.O. Vadadala

Distt. Bharuch, Gujarat – 388435

13. Name of the Applicant Mr. S. K. Singh

14. Registered Address M/s Shivalik Rasayan Limited

Village – Kolhupani, P.O. Chandanwari

Via-Prem Nagar, Dehradun – 248006

Uttarakhand

15. Address for Correspondence:

Name Mr. S. K. Singh

Designation (Owner/Partner/CEO) Managing Director

Address M/s Shivalik Rasayan Limited

1506, Chiranjiv Tower,

43, Nehru Place, New Delhi

Pin Code 110019

E-mail [email protected], [email protected]

[email protected]

Telephone No. 0135-2773429/2772032 (Registered Office)

011-26221822/26418182 (Head Office)

Fax No. 0135-2773429/2772032 (Registered Office)

16. Details of Alternative Sites examined,

if any. Location of these sites should

be shown on a topo sheet.

No Alternative Sites examined.

mailto:[email protected]






17. Interlinked Projects No

18. Whether separate application of

interlinked Project has been

submitted?

NA

19. If yes, date of submission NA

20. If no, reason No Interlinked Projects

21. Whether the proposal involves

approval / clearance under: if yes,

Details of the same and their status to

be given.

(a) The Forest (Conservation) Act,

1980?

(b) The Wildlife (Protection) Act,

1972

(c) The C.R.Z. Notification, 1991?

NA

No, The Forest (Conservation) Act, 1980 is not

applicable

No, The wild life (Protection) Act, 1972 is not

applicable

No, The C.R.Z. Notification, 1991 is not

applicable

22. Whether there is any Government

Order/ Policy relevant/ relating to

the site?

Existing industrial plot falls under Petroleum,

Chemical and Petro-chemical Investment Region

(PCPIR) at Dahej II Industrial Estate, Tehsil

Vagra, District Bharuch (Gujarat). Environment

clearance to develop PCPIR by GIDC has been

granted by MoEF & CC vide Letter No. F. No. 21-

49/2010-IA-III Dated 14th September 2017.

23. Forest land involved (hectares) There is no involvement of forest land.

24. Whether there is any litigation

pending against the project and /or

land in which

the project is propose to be set up?

(a) Name of the Court

(b) Case No.

(c) Orders/directions of the Court,

if any and its relevance with the

proposed project.

No litigation is pending against the project and /

or land in which the project is proposed to be set

up.

Capacity corresponding to sectoral activity (such as production capacity for manufacturing, mining lease

area and production capacity for mineral production, area for mineral exploration, length for linear

transport infrastructure, generation capacity for power generation etc.,)

(II) Activity




1. Construction, operation or decommissioning of the Project involving actions, which will

cause physical changes in the locality (topography, land use, changes in water bodies, etc.)

Sr.

No.

Information/Checklist confirmation Yes/

No

Details thereof (with approximate

quantities /rates, wherever possible) with

source of information data

1.1 Permanent or temporary change in

land use, land cover or topography

including increase in intensity of

land use (with respect to local land use

plan)

No The proposed industrial land is in “PCPIR”

Dahej-II, Vagra, District Bharuch (Gujarat)

developed by GIDC.

1.2 Clearance of existing land, vegetation

and buildings?

No The plot is vacant with no vegetation or

building on it as no construction work is

initiated till now as per EC/CTE.

1.3 Creation of new land uses?

No There would be no change in the land use

pattern of the area. Site Layout for proposed

amended facility is enclosed as per

Annexure – II.

1.4 Pre-construction investigations e.g.

bore houses, soil testing?

Yes CBR testing to determine the load bearing

capacity of soil has been done and

construction of buildings shall be done

accordingly.

1.5

Construction works?

Yes

No any construction work is initiated till

now as per EC/CTE. Construction work

after amendment in EC for change in

Product mix to manufacture Active Pharma

Ingredients (API) and Intermediates would

be done as given below:-

S.

No.

Construction Area

(Sq.mt)

1. Plant Buildings 8766.00

2. Godown/warehouse 1936.38

3. Administrative Building 940.00

4. Open Tank Farm 459.00

5. Explosive / UG Tank

Farm

1006.68

6. Work Shop

Boiler House

Cooling Tower

1682.80




Electricity Utilities

Generator Room

Switch Gear Room

Switch Yard

7. QC Lab/Canteen 480.00

8. PCC Room 268.25

9. Time/Security Office

Guard Room

100.00

10. Water Storage 330.00

11. Effluent Treatment Plant 909.50

12. Parking Area 5067.48

13. Common Plot Area 3863.46

14. Roads 11296.75

15. Green Belt 12893.70

Total Land 50000.00

1.6 Demolition works?

No The plot is a vacant land; hence no

demolition work would be done.

1.7 Temporary sites used for construction

works or housing of construction

workers?

Yes Most of the laborers would be hired from

nearby areas during construction phase and

some of them may be from outside

depending on the availability of manpower.

Temporary shelters with adequate

sanitation facilities shall be provided for

outsiders. Approx number of construction

workers would be 100 during initial period

and 200 during peak period.

1.8 Above ground buildings, structures or

earthworks including linear structures,

cut and fill or excavations

Yes As per construction details in point 1.5

1.9 Underground works including mining

or tunneling?

No No underground mining or tunneling would

be required except construction of plinth.

1.10 Reclamation works? No No reclamation works will be done.

1.11 Dredging? No No dredging activity will be followed.

1.12 Offshore structures? No No offshore structures will be constructed

1.13 Production and manufacturing

processes?

Yes Details of proposed production of Bulk

Drugs (APIs & Intermediates) and

manufacturing process details is given in

Pre-Feasibility Report.

1.14 Facilities for storage of goods or Yes Construction Phase: Temporary storage




materials?

yard will be provided for the storage of

construction material. Storage yard will be

covered from all the sides.

Operation Phase: During operation phase,

the storage of raw materials as well as

Finished products will be done in storage

room.

Due to proposed facilities, changes in

physical environment will not be observed

as the proposed project is coming up in

PCPIR developed by GIDC.

1.15 Facilities for treatment or disposal of

solid waste or liquid effluents?

Yes Construction Phase:-

Solid Waste:-

Construction Waste will be generated, out

of which:-

Recyclable waste (Metal, Plastic Bags

etc) will be sold to the local vendors.

The inert waste (Brick, Masonry,

Aggregates Concrete etc.) will be used

for making of roads, loading &

unloading area.

Liquid Effluents:-

Domestic waste water will be generated

to the tune of 9.0 KLD.

The same will be treated in septic talk

followed by soak pit.

Operation Phase:- During operation phase

Hazardous waste, will be transported to

TSDF as per Hazardous and Other Wastes

(Management and Transboundary

Movement) Rules, 2016. Alternatively,

Organic and recyclable waste will use or

sold to authorized recyclers.

Liquid Effluents:-

Industrial effluent generation will be 47.0

KL per day. Effluent will be segregated into

High COD/TDS and low COD/TDS

effluent streams. Domestic Effluent shall be

treated in proposed STP. Treated water




(12.0 KLD) shall be reused in Green belt.

Effluent generated from Stream I of high

strength waste water i.e. Process and

Equipment Washing (23.0 KLD) shall be

subjected to MEE. Effluent stream RO

Reject (24.0 KLD) shall also be treated

through MEE. MEE condensate shall be

sent to CETP.

Effluent generated from Stream II of low

strength waste water Cooling, Boiler

Scrubber and polishing plant (50.0 KLD)

shall be treated in ETP followed by RO.

RO permeate shall be reused in Utility

purpose.

Online PH meter and flow meter will be

installed.

1.16 Facilities for long term housing of

operational workers?

No There will be no provision of housing for

workers within the site as the labor

employed will be from local area.

1.17 New road, rail or sea traffic during

construction or operation?

No There will be no new road, rail or sea traffic

proposed as the area is in GIDC and is well

connected with transportation facility.

1.18 New road, rail, air waterborne or

other transport infrastructure

including new or altered routes and

stations, ports, airports etc?

No There is no new rail, air borne transport

infrastructures required for the project. The

proposed project area is in GIDC and is

well connected to transport infrastructures.

1.19 Closure or diversion of existing

transport routes or infrastructure

leading to changes in traffic

movements?

No There will be no closure of existing

transport routes or infrastructures leading to

changes in traffic movements.

1.20 New or diverted transmission lines or

pipelines?

No Project will not involve any diversion of

transmission lines for power supply.

1.21 Impoundment, damming, culverting,

realignment or other changes to the

hydrology of watercourses or

aquifers?

No No impoundment, damming, culverting,

realignment activity is proposed.

1.22 Stream crossings? No No stream crossings will be involved.

1.23 Abstraction or transfers of water form No Initial Water Requirement will be 339.0




ground or surface waters? KLD, however fresh water demand will be

150.0 KLD. Recycled/Reuse Water: 189.0

KLD. Fresh water will be supplied by

GIDC.

1.24 Changes in water bodies or the land

surface affecting drainage or run-off?

Yes Quantity of Run-off will increase due to

reduced infiltration. The run-off of the site

will slightly change due to the paved roads,

etc. but the run-off of the locality will

remain intact.

The above land use break with respect to

run-off coefficient will change the existing

run-off coefficient. Thus, altering rate of

infiltration, this impact however, will be

confined within site itself with implantation

of effective storm water management. This

will have positive impact.

1.25 Transport of personnel or materials for

construction, operation or

decommissioning?

Yes Due to the proposed project, there will be

movement of material and man power.

Involving movement of vehicles in and out

of the plant. About 6-8 trucks/tankers will

ply in out of the unit weekly, thus,

contributing to fugitive emissions and noise

in the area. This will be effectively managed

by proper plantation and maintenance of

vehicle.

1.26 Long-term dismantling or

decommissioning or restoration

works?

No No such activity is proposed

1.27 Ongoing activity during

decommissioning which could have

an impact on the environment?


1.28 Influx of people to an area in either

temporarily or permanently?

Yes During construction phase, there will be

influx of semi-skilled and unskilled labor

from the nearby villages. Local people

based on their skill will be employed.

1.29 Introduction of alien species? No Not Applicable

1.30 Loss of native species or genetic

diversity?

No No loss to natives or genetic diversity.

1.31 Any other actions? No Not Applicable




Use of Natural resources for construction or operation of the Project (such as land,

water, materials or energy, especially any resources which are non-renewable or in short

supply):

Sr.

No.

Information/checklist confirmation Yes/

No


quantities /rates, wherever possible) with

source of information data

2.1 Land especially undeveloped or

agricultural land (ha)

No The proposed project site (Land area –

50000.0 Sq. m) is already in PCPIR

developed by GIDC.

Land Possession Certificate issued by

GIDC is attached as Annexure – III.

2.2 Water (expected source & competing

users) unit: KLD

No The total quantity of fresh water

requirement for the industry is about 150.0

KLD, which will be supplied by GIDC.

Competing users are other similar

industries proposed to be installed in the

PCPIR. Water Balance is attached as

Annexure – IV.

2.3 Minerals (MT) No There is no usage of minerals in the

proposed project.

2.4 Construction material – stone,

aggregates, sand / soil (expected

source – MT)

Yes Materials like Brick, Steel, Cement, Sand

aggregates, Tiles etc shall be procured

locally in the desired quantity as and when

required.

2.5 Forests and timber (source – MT) No Not Applicable

2.6 Energy including electricity and fuels

(source, competing users) Unit: fuel

(MT), energy (MW)

Yes The unit at full capacity will demand 1500

KVA of power, which shall be supplied by

GSPC. Apart from this the company

proposes 02 D.G. sets of 500 KVA each

(one as standby) in order to have

continuous supply of power during power

failure.

Fuel consumption: HSD – 82.0 lit / per

hour.

2.7 Any other natural resources (use

appropriate standard units)

Not Applicable




3. Use, Storage, Transport, Handling or Production of Substance or Material, Which

Could Be Harmful To Human Health or The Environment or Raise Concern About

Actual or Perceived Risks to Human Health.

Sr.

No.

Information/ Checklist

confirmation

Yes/

No


quantities / rates wherever possible)

with sources of information data.

3.1

Use of substances or material, which

are hazardous (as per MSIHC rules)

to human health or the environment

(flora, fauna and water supplies)

Yes The storage, transport, handling, etc. of

hazardous substances is within the

threshold limit as per MSIHC.

Details of Hazardous Substances /

Chemicals to human health or the

environment is given in PFR.

3.2 Changes in occurrences of disease or

affect diseases vectors (e.g. insect or

water born disease)

No There will not be any water stagnation and

the waste water generated from industrial

process will be treated in ETP followed by

MEE.

Domestic waste will be treated in proposed

STP. Proper sanitation facilities will be

provided to avoid insect and water borne

disease.

3.3 Affect the welfare of people e.g. by

changing living conditions?

Yes The proposed project would have positive

impact on the socioeconomic status, thus

contributing to the marginal growth of the

nearby area.

Increased employment opportunities,

Indirect employment for truck drivers,

Periodic medical check-up & use of

appropriate pollution control equipment’s

will be followed.

The proposed project is a Long- tending

Project thus, would serve as a stable source

of employment.

3.4 Vulnerable group of people who

could be affected by the project e.g.

hospital patients, children, the

elderly etc.,

No Not Applicable

3.5 Any other causes No Not Applicable




4. Production of Solid Wastes During Construction or Operation or Decommissioning

(MT/month)

Sr.

No.


confirmation

Yes/

No




4.1 Spoil, overburden or mines wastes No N.A.

4.2 Municipal waste (domestic and or

commercial wastes)

Yes The domestic wastes (70 kg/day approx.)

will be segregated at source and collected

in bins. The organic portion of the solid

wastes will be treated in compost pits and

recyclable portion will be disposed to the

recycler for scientific recycling.

4.3 Hazardous wastes (as per Hazardous

waste Management Rules)

Yes The hazardous wastes viz. Process residue

Inorganic salt, Spent Carbon, Waste oil

from DG set, Spent Solvent, Salt from

Multiple effect Evaporation System, ETP

Sludge, Discarded Containers shall be

dealt as per Hazardous and Other Wastes

(Management and Transboundary

Movement) Rules, 2016.

4.4 Other industrial process wastes Yes The following waste will be generated

during construction phase:

Recyclable waste: Metals, Plastic Bags

etc will be sold to the vendors.

The Inert Waste (Brick, Masonry,

Aggregates Concrete etc.): It will be used

for making of driveway and pathway

within the site.

4.5 Surplus product No There will be no surplus product.

4.6 Sewage sludge or other sludge from

effluent treatment

Yes The sewage sludge will be used as manure

in the green belt and sludge from effluent

treatment shall be dealt as per Hazardous

and Other Wastes (Management and

Transboundary Movement) Rules, 2016.

4.7 Construction or demolition wastes No Demolition Wastes: There is no structure

at the site; hence no demolition waste will

be generated.




Yes Construction Waste: Construction waste

will be generated out of which recyclable

waste (Metals, Plastic Bags etc) will be

sold to the vendors.

The inert waste (Brick, Concrete,

Masonry, Aggregates etc.) will be used for

making of driveway and pathway within

the site.

4.8 Redundant machinery or equipment No Not Applicable

4.9 Contaminated soils or other

materials

No Not Applicable

4.10 Agricultural wastes No Not Applicable

4.11 Other solid wastes No Not Applicable

5. Release of Pollutants or any Hazardous, Toxic or Obnoxious Substance to Air (kg/hr)

Sr.

No.


confirmation

Yes/

No




5.1 Emissions from combustion of fossil

fuels from stationary or mobile

sources

Yes The source of emissions will be boilers (02

Nos. 4.0 TPH, Coal fired). Multi-cyclone

separator followed by a stack (30 m height)

will be installed for controlling particulate

matter from Boiler.

Green insulated DG set (500 KVA x 02

Nos. (stand-by basis) is proposed. HSD

will be used as a fuel for the operation of

DG sets. However the consumption of

HSD would be only 82.0 Liters, per hour,

if required, during power failure.

The D.G. set will be provided with

adequate safe stack height of 5.0 M above

the roof of the D.G. house to regulate the

emission within the permissible norms.

In the proposed unit, emissions from

combustion of fossil fuels will be from

D.G. set and transportation. To control

the emission of exhaust gas following




measures will be adopted.

5.2 Emissions from production processes No Process emission will be controlled by

installing the Packed column scrubbers.

The solvents proposed to be recovered and

recycled to the process.

5.3 Emissions from material handling

including storage or transport

Yes The material handling including storage

and transportation may contribute to

fugitive emissions. The materials will be

stored in a closed room to contain the

emission. To control the fugitive emissions

in proposed unit, following measures will

be adopted:-

Storage and material handling will be

carried out in trucks (6-8 trucks per

week).

In plant training will be provided to the

plant personnel on operation and

maintenance of dust collectors,

techniques of dust emission

measurements, particle size analysis, etc.

Water spraying will be adopted in dust

prone area.

Green area will be developed.

Ambient air quality and stack emissions

will be regularly monitored to ensure that

ambient air quality standards and

suggested limits of the stack emission loads

are met honestly all the time.

5.4 Emissions from construction

activities including plant and

equipment

Yes Fugitive dusts from various activities of

construction are expected, which will be

temporary in nature.

The fugitive dust emission sources are:

1.Construction operation

Construction operations are significant

source of dust emissions that may have a

substantial temporary impact on local air

quality. Particulate dust emissions from

construction are a function of total land

disturbed and the volume of soil




excavated.

2.Road Construction

Particulate dust emissions from road

construction activities are function of the

total land disturbed during construction.

The road constructed is used to estimate

the total area disturbed using conversion

factors for area disturbed/road

constructed, as a function of road type.

Construction site shall be properly covered

& dust suppression system shall be

followed.

5.5 Dust or odors from handling of

materials including construction

material, sewage and waste

No Construction phase:-

During the construction of plant

area/office area, Adequate precautions

shall be taken to reduce those impacts on

construction workers and the surrounding

environment.

Operation phase:-

During manufacturing process, no dust

will be produced in the proposed unit.

There will be no odor problem to the best

of knowledge.

5.6 Emissions from incineration of waste No N.A.

5.7 Emissions from burning of waste in

open air (e.g. slash material,

construction debris)


5.8 Emissions from any other sources No -

6. Generation of Noise and Vibration, and Emissions of Light and Heat

Sr.

No.


confirmation

Yes/

No




6.1 From operation of equipment e.g.

engines, ventilation plant, crushers

Yes Noise would be generated during

construction activity. During Operational

phase Green insulated DG sets will be

installed along with acoustic enclosure,

which shall conform to noise standards set

by CPCB.




6.2 From industrial or similar processes No Not Applicable. Ambient noise levels will

be ensured within the ambient standards

by design of mechanical equipment and

building apart from vegetation (tree

plantations) along the periphery and at

various locations within the industry

premises.

6.3 From construction or demolition Yes Noise would be generated during

construction activity but adequate

precautions shall be taken to reduce the

noise generation.

6.4 From blasting or piling No No blasting will be involved and during

piling noise will be controlled.

6.5 From construction or operational

traffic

Yes During the construction phase, noise will

be generated from movement of vehicles,

earth work, etc. The construction site will

be shielded to avoid the noise propagation

and transportation of the material &

machineries at the peak time of the day.

During operation phase, raw material and

products will be transported at the peak

time of the day.

PUC checked vehicle will be used for

transportation purposes.

33% of plant area will be under green

cover with local plant and trees species,

which in turn would help reducing the

noise levels.

6.6 From lighting or cooling system No Cooling Towers will be functioning during

manufacturing process.

Cooling towers of latest technology will be

installed in order to suppress noise and

vibrations. Thus, the generation of noise

and vibrations will be minimal and would

be within prescribed limits.

6.7 From any other sources No N.A.

7. Risks of Contamination of Land or Water From Releases of Pollutants in to the

Ground or in to Sewers, Surface Waters, Ground Water, Coastal Waters or The Sea




Sr.

No.


confirmation

Yes/

No




7.1 From handling storage, use or

spillage of hazardous materials

Yes Transportation of raw material will be by

Air, railways & roadways. The raw

material to the project site will be

transported through trucks.

The solid waste generated from the

manufacturing process will be transported

to TSDF as per hazardous waste handling

norms.

7.2 From discharge of sewage or other

effluents to water or the land

(expected mode and place of

discharge)

Yes The industrial waste water will be

generated to the tune of 48.0 KLD.

Effluent generated from Stream I of high

strength waste water i.e. Process and

Equipment Washing (23.0 KLD) shall be

subjected to MEE. Effluent stream RO

Reject (25.0 KLD) shall also be treated

through MEE. MEE condensate shall be

sent to CETP.

The domestic waste water generated to the

tune of 12.8 KLD will be treated in STP.

Treated sewage will be reused in the green

belt.

7.3 By deposition of pollutant emitted to

air into the land or into water

Yes The unit will have both point source as

well as area source emission.

1. Air

Fugitive emission will be controlled by

adaptation of Water spraying in dust prone

area. PPEs will be used while working.

2. Water

Industrial process water will be recovered

through RO Plant. Effluent treatment

plant with MEE will be installed.

Domestic sewage will be treated in STP &

reused in the green belt.

3. Land

The plant will be equipped with air

pollution control equipments as mentioned




in the above sub-head (Air).

All the pumps shall be mechanical seal

type to avoid any leakage of solvent.

Thus, no contamination will be caused due

to deposition of pollutants emitted to air

into the land or into water.

7.4 From any other sources No Not Applicable

7.5 Is there a risk of long term build up of

pollutant in the environment from

these sources?

No Adequate pollution control equipments i.e.

Multi cyclone separator will be installed in

Boilers which will keep the emission

within the level as per the norms.

8. Risks of Accidents During Construction or Operation of the Project, Which Could

Affect Human Health or The Environment

Sr.

No.


confirmation

Yes/

No




8.1 From explosions , spillages, fires etc

from storage, handling, use or

production of hazardous substances

Yes For protection of the plant, following

measures will be adopted:-

On-site and off-site emergency

preparedness plan will be prepared.

Fire extinguisher will be installed at

strategic points all over the premises,

checked at regular intervals and a record

will be made and maintained.

First aid facilities will be provided for the

staff personals.

One vehicle will always be on standby

for instant mobilization during

emergency.

The workers will be provided with the

training for the first aid measures in case

of accident.

However, to meet out the minor

incidences and accidents first aid

measures will be provided at site.

Medical check-up of the workers will be

done periodically.

Safety items such as hand gloves, mask,




and apron will be providing while

dealing with the raw materials.

Training / Awareness program on safety

will be conducted on regular basis.

8.2 From any other causes No Not Applicable

8.3 Could the project be affected by

natural disasters causing

environmental damage (e.g. floods,

earthquake, landslides, cloudburst

etc)?

Yes Project Site falls in Bharuch district in

Gujarat which occupies in Seismic Zone

III.

Secondary data reveals that no major

natural calamity has been recorded so far

in the proposed project area.

9. Factors Which Should be Considered (Such As Consequential Development) Which

Could Lead to Environmental Effects or the Potential for Cumulative Impacts With

Other Existing or Planned Activities in the Locality

Sr.

No.


confirmation

Yes/

No




9.1 Lead to development of supporting.

Utilities, ancillary development or

development stimulated by the

project which could have impact on

the environment. e.g.

Supporting infrastructure (road,

power supply, waste water

treatment etc.)

Housing development

Extractive industries

Supply industries

Other

No Not Applicable.

9.2 Lead to after- use of the site, which

could have an impact on the

environment

No No Environment impacts envisaged

9.3 Set a precedent for later

developments

No --

9.4 Have cumulative effects due to

proximity to other existing or

planned project with similar effects

No There would not be any negative impact.




III Environmental Sensitivity

Sr.

No.

Areas Name/

Identity

Aerial distance (with in 15 km.)

Proposed project location boundary

1. Areas protected under international

conventions, national or local

legislation for their ecological,

landscape, cultural or other related

value

None --

2. Areas which are important or

sensitive for ecological reasons-

Wetland, water courses or other

water bodies, coastal zone, biosphere,

mountains, forests

None --

3. Areas used by protected , important

or sensitive species of flora or fauna

for breeding, nesting , foraging ,

resting , over wintering , migration

None --

4. Inland, coastal, marine or

underground waters

None --

5. State , National boundaries No NA

6. Routes or facilities used by the public

for access to recreation or other

tourist, pilgrim areas

Yes Bharuch Railway Station – 36.88 Km

SE

Vadodara Airport – 83.50 Km NE

SH – 64 – 31.55 Km E

SH – 161 – 26.46 Km NE

NH – 08 – 39.50 Km N

7. Defense installations None --

8. Densely populated or built up area No GIDC

9. Areas occupied by sensitive man –

made land uses (hospitals, schools,

places of worship, community

facilities)

No Hospitals, Recreational Places,

Temples, Shops, and Educational &

Institution Facilities are well developed

in Bharuch City.

10. Areas containing important, high

quality or scarce resources (ground

water resources, surface resources,

forestry, agriculture, fisheries,

tourism, minerals)

None --




11. Areas already subjected to pollution

or environmental damage. (those

where existing legal environmental

standards are exceeded)

None --

12. Areas susceptible to natural

hazardous which could cause the

project to present environmental

problems. (earthquake, subsidence,

landslides, erosion, flooding

or extreme or adverse climatic

conditions)

None Project Site falls in Bharuch district of

Gujarat which occupies Zone III.

Secondary data reveals that no major

natural calamity has been recorded so

far in the proposed project area.

“I hereby given undertaking that the data and information given in the application and

enclosures are true to the best of my knowledge and belief and I am aware that if any part of

the data and information submitted is found to be false or misleading at stage, the project will

be rejected and clearance and given, if any to the project will be revoked at our risk and cost.

Date: 24.10.2017

Place: New Delhi

Signature of the applicant

Mr. S. K. Singh

Managing Director

M/s Shivalik Rasayan Limited

1506 Chiranjiv Tower, 43 Nehru Place

New Delhi - 110019




NOTE:

The projects involving clearance under Coastal Regulation Notification, 1991 shall

submit with the application a C.R.Z. map duly demarcated by one of the authorized

agencies, showing the project activities, w.r.t. C.R.Z ( at the stage of EC).

Simultaneous action shall also be taken to obtain the requisite clearance under the

provisions of the C.R.Z Notification, 1991 for the activities to be located in the CRZ.

The projects to be located within 10 km the National Parks, Sanctuaries, Biosphere

Reserves, Migratory Corridors of Wild Animals, the project proponent shall submit

the map duly authenticated by Chief Wildlife Warden showing these features vis – a –

vis the project location and the recommendations or comments of the Chief Warden

“thereon (at the stage of EC)”.

All correspondence with the Ministry of Environment & Forest including submission

of application for TOR / Environment Clearance, subsequent clarification, as may be

required from time to time, participation in the EAC Meeting on behalf of the project

proponent shall be made by the authorized signatory only. The authorized signatory

should also submit a document in support of his claim of being an authorized

signatory for specific project”.

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