Svr Laboratories Pvt.Ltd. Updated Form I

SVR LABORATORIES PVT.LTD. SY.NO. 238 (Part), 239/A and 239/E, DHOTIGUDEM VILLAGE, POCHAMPALLY MANDAL, NALGONDA DISTRICT, TELANGANA

UPDATED FORM I

M/s. SVR Laboratories Pvt. Ltd. STUDIES AND DOCUMENTATION BY H.No. 7‐1‐307/14/F/52, TEAM Labs and Consultants Jayaprakash Nagar, Sanathnagar B‐115‐117 & 509, Annapurna Block, Hyderabad, Telangana State Aditya Enclave, Ameerpet, Phone: +91 9010204953 Hyderabad‐500 038. E‐mail: [email protected] Phone: 040‐23748 555/23748616, [email protected] Telefax: 040‐23748666

SUBMITTED TO MINISTRY OF ENVIRONMENT, FORESTS AND CLIMATE CHANGE GOVERNMENT OF INDIA INDIRA PARYAVARAN BHAWAN, JOR BAGH ROAD, NEW DELHI M/s.SVR Laboratories Pvt. Ltd.,

APPENDIX – I (See Paragraph – 6) FORM I I) Basic Information S.No. Item Details 1 Name of the Project/s M/s. SVR Laboratories Pvt. Ltd., 2 S. No in the Schedule 5 (f) –A category (Synthetic Organic Chemicals) 3 Proposed capacity/area/length/tonnage to Area Existing: 2 Acres be handled/command area/lease Area after Expansion: 6 Acres area/number of wells to be drilled Permitted Production Capacity: 1 TPM Capacity after Expansion: 65 TPM It is proposed to manufacture 10 products at a time on campaign basis out of 30 Products 4 New/Expansion/Modernization Expansion 5 Existing Capacity/Area etc. Existing Capacity: 15 TPM Area Existing: 2 Acres 6 Category of Project i.e 'A' or 'B' “A” 7 Does it attract the general condition? If yes, No please specify 8 Does it attract the Specific condition? If yes, No please specify. 9 Location Plot/Survey/Khasra No. Survey No. : 238 (Part), 239/A and 239/E Village Dhotigudem Village Tehsil Pochampalle Mandal District Nalgonda District State Telangana 10 Nearest railway station/airport along with Railway Station: Nagireddypalli Railway Station– 18 Km distance in km.

11 Nearest Town, City, District Headquarters Choutuppal –7.8Km along with distance in kms. 12 Village Panchayats, Zilla Parishad, Municipal Dothigudem –Village Panchayat Corporation, Local body (complete postal address with telephone nos. to be given) 13 Name of the Applicant Mr. V. Venkata Ravi Kumar 14 Registered Address SVR Laboratories Pvt. Ltd., Sy No. 238 (Part), 239/A and 239/E Dhotigudem Village, Pochampally Mandal Nalgonda District, Telangana 15 Address for Correspondence: Name V. Venkata Ravi Kumar Designation(Owner/Partner/CEO) Director Address H.No. 7‐1‐307/14/F/52, Jayaprakash Nagar, Sanathnagar, Hyderabad Pin Code 500018 E‐mail [email protected];

Form I Page 1

M/s.SVR Laboratories Pvt. Ltd.,

Telephone Number 040‐23712445/ +91 9010204953 Fax No. 040‐23712445 16 Details of alternative Sites examined, if any. Not Applicable Location of these sites should be shown on a topo sheet. 17 Interlinked Projects Not applicable 18 Whether separate application of interlinked ‐NA‐ project has been submitted? 19 If yes, date of submission ‐NA‐ 20 If no, reason 21 Whether the proposal involves ‐NA‐ 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? 22 Whether there is any Government No Order/Policy relevant/relating to the site? 23 Forest land involved (hectares) No 24 Whether there is any location pending No 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.

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M/s.SVR Laboratories Pvt. Ltd.,

(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.) S.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 NO The proposal is for expansion of existing bulk drug and land use, land cover or topography intermediate manufacturing unit. The additional land including increase in intensity of acquired for proposed expansion is 4 Acres. The Total land use (with respect to local land Land Area after expansion is 6 Acres. use plan) 1.2 Clearance of existing land, NO The proposal is for expansion of existing bulk drug and vegetation and buildings? intermediate manufacturing unit. The additional land acquired for proposed expansion is 4 acres. 1.3 Creation of new land uses? NO Existing – industrial

1.4 Pre‐construction investigations e.g. YES Soil test done and soil load bearing capacity bore houses, soil testing? established 1.5 Construction works? YES Construction activity involves creation of Production Block, Utilities, enhancement of ZLD system. 1.6 Demolition works? NO The proposal is for expansion of existing bulk drug and intermediate manufacturing unit. The proposed expansion activity involves creation of Production Block, Utilities, enhancement of ZLD system 1.7 Temporary sites used for NO Construction labor from local villages shall be construction works or housing of employed. construction workers? 1.8 Above ground buildings, structures YES Storage facilities shall be constructed. No major cut or earthworks including linear and fill or excavation is anticipated. structures, cut and fill or excavations 1.9 Underground works including mining NO No underground works like mining and tunneling. or tunneling? 1.10 Reclamation works? NO 1.11 Dredging? NO 1.12 Offshore structures? NO 1.13 Production and manufacturing YES Enclosed in Annexure – I processes? 1.14 Facilities for storage of goods or NO Raw materials and solvents shall be stored with in materials? factory premises. Materials in bags and drums will be stored in flame proof ware houses. 1.15 Facilities for treatment or disposal of YES High TDS and low TDS effluents are treated in ZLD solid waste or liquid effluents? system. Organic waste is sent to cement plants for co‐ processing or to TSDF. Details of waste treatment facilities presented in Annexure II 1.16 Facilities for long term housing of NO Operational workers stay in surrounding villages. operational workers? 1.17 New road, rail or sea traffic during YES Construction materials shall be transported to the site.

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M/s.SVR Laboratories Pvt. Ltd.,

construction or operation? The traffic density of the existing connecting road is negligible. 1.18 New road, rail, air waterborne or NO other transport infrastructure including new or altered routes and stations, ports, airports etc? 1.19 Closure or diversion of existing NO transport routes or infrastructure leading to changes in traffic movements? 1.20 New or diverted transmission lines o NO pipelines? 1.21 Impoundment, damming, culverting, NO realignment or other changes to the hydrology of watercourses or aquifers? 1.22 Stream crossings? NO All raw materials, solvents and waste streams are pumped through pipe lines above ground level. 1.23 Abstraction or transfers of water YES Total water required shall be met from ground water form ground or surface waters? using bore‐wells within the plant premises. Permitted water consumption is 7.5 KLD. Total water required after expansion shall be 130.1 KLD out of which 75.1 KLD is fresh water requirement and balance 55 KLD is recycled water. 1.24 Changes in water bodies or the land NO surface affecting drainage or run‐off? 1.25 Transport of personnel or materials YES The construction material shall be drawn from local for construction, operation or sources within 10 km. There is no transport of decommissioning? personnel, as the construction workers shall be drawn from local villages. 1.26 Long‐term dismantling or NO decommissioning or restoration works? 1.27 Ongoing activity during NO decommissioning which could have an impact on the environment? 1.28 Influx of people to an area in either YES The proposed project shall increase the employment temporarily or permanently? potential. 1.29 Introduction of alien species? NO 1.30 Loss of native species or genetic NO There are no major losses of tree/shrub species. diversity? 1.31 Any other actions? NO

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M/s.SVR Laboratories Pvt. Ltd.,

2. 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): S.No. Information/checklist Yes/No Details thereof (with approximate quantities /rates, confirmation wherever possible) with source of information data 2.1 Land especially undeveloped or YES Land area after expansion 6 acres agricultural land (ha) Located at Sy No. 238 (Part), 239/A and 239/E Dhotigudem Village, Pochampally Mandal Nalgonda District, Telangana 2.2 Water (expected source & YES Total water required shall be met from ground water using competing users) unit: KLD bore‐wells within the plant premises. Permitted water consumption is 7.5 KLD. Total water required after expansion shall be 130.1 KLD out of which 75.1 KLD is fresh water requirement and balance 55 KLD is recycled water (Water Balance Enclosed in Annexure III) 2.3 Minerals (MT) NA 2.4 Construction material – stone, YES Shall be sourced from the local villages. aggregates, sand / soil (expected source – MT) 2.5 Forests and timber (source – NO MT) 2.6 Energy including electricity and YES The required energy shall be drawn from TSPDCL. Standby fuels (source, competing users) DG sets of 2 X 1000 KVA is proposed in addition to existing Unit: fuel (T), energy (MW) 250 KVA DG set.

It is proposed to establish 1 X 5 TPH to meet the steam requirement both for process and ZLD system and proposed 1 x 4 TPH coal fired boiler and existing 1 x 1 TPH coal fired shall be kept as standby after expansion. It is proposed to establish coal based Thermic fluid heater of capacity 4 lakh K.cal for process requirement. 2.7 Any other natural resources NA (use appropriate standard units)

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M/s.SVR Laboratories Pvt. Ltd.,

3. Use, storage, transport, handling or production of substances or materials, which could be harmful to human health or the environment or raise concerns about actual or perceived risks to human health. S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates, wherever possible) with source of information data 3.1 Use of substances or materials, which YES Hazardous chemicals shall be used for manufacturing are hazardous (as per MSIHC rules) to of Synthetic Organic Chemicals and intermediates. human health or the environment MSIHC rules shall be followed during storage, (flora, fauna, and water supplies) transportation and handling of raw materials. Hazardous chemicals and solvent shall be stored and handled in closed systems. 3.2 Changes in occurrence of disease or NO affect disease vectors (e.g. insect or water borne diseases). 3.3 Affect the welfare of people e.g. by YES Shall increase the employment potential for locals changing living conditions? and affect the living conditions for betterment. 3.4 Vulnerable groups of people who could NO No sensitive receptors are present in the immediate be affected by the project e.g. hospital vicinity of the site. The project shall not have any patients, children, the elderly etc., significant impact on vulnerable groups of people. 3.5 Any other causes NO

4. Production of solid wastes during construction or operation or decommissioning (MT/month) S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates, wherever possible) with source of information data 4.1 Spoil, overburden or mine wastes NO 4.2 Municipal waste (domestic and or NO Wastes from canteen, other commercial wastes like commercial wastes) paper, empty containers etc. The canteen wastes and commercial wastes shall be in the range of 30 kg/day 4.3 Hazardous wastes (as per Hazardous YES Hazardous waste generation during construction shall Waste Management Rules) be limited to waste oils, batteries and containers of paints etc. The quantity of hazardous wastes generated during operation contain salts from evaporators, process residue, and solvent residues, ETP sludge and filtration media etc. 4.4 Other industrial process wastes YES Enclosed at Annexure IV 4.5 Surplus product NO 4.6 Sewage sludge or other sludge from YES Sludge from Effluent treatment plant and evaporation effluent treatment salts shall be sent to TSDF. 4.7 Construction or demolition wastes NO Construction activities involve creation of Production Blocks, Utilities and enhancement of ZLD system. 4.8 Redundant machinery or equipment NO 4.9 Contaminated soils or other materials NO All pipe lines including pipe lines of waste streams are above ground level to eliminate the possibility of any contamination due to seepage and for ease of maintenance. 4.10 Agricultural wastes NO 4.11 Other solid wastes YES

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M/s.SVR Laboratories Pvt. Ltd.,

5. Release of pollutants or any hazardous, toxic or noxious substances to air (Kg/hr) S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates, wherever possible) with source of information data 5.1 Emissions from combustion of fossil YES Coal Shall be used as fuel. Emissions details are fuels from stationary or mobile sources enclosed in Annexure V 5.2 Emissions from production processes YES Gaseous emissions from process are ammonia, HCl, SO2, are scrubbed in two stage scrubbers while carbondioxide, oxygen and nitrogen gases are let out into atmosphere using standard operating procedure. Hydrogen gas send to atmosphere through water column. 5.3 Emissions from materials handling NO Material transfer takes place in closed pipeline including storage or transport systems using pumps with mechanical seals. 5.4 Emissions from construction activities YES Dust may rise during transport of material and including plant and equipment construction activity. The dust emissions shall be mitigated by water spraying on the roads within the premises. 5.5 Dust or odors from handling of NO Domestic wastewater sent to zero liquid discharge materials including construction system. materials, sewage and waste 5.6 Emissions from incineration of waste NO Organic waste streams are sent to cement plants for co‐incineration. 5.7 Emissions from burning of waste in NO open air (e.g. slash materials, construction debris) 5.8 Emissions from any other sources NO

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M/s.SVR Laboratories Pvt. Ltd.,

6. Generation of Noise and Vibration, and Emissions of Light and Heat: S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates, wherever possible) with source of information data with source of information data 6.1 From operation of equipment e.g. YES Material transport and construction equipment shall be engines, ventilation plant, crushers source of noise, while transfer pumps, vacuum systems, DG sets are the sources of noise during operation. 6.2 From industrial or similar processes YES DG sets controlled by providing Acoustic Enclosures. 6.3 From construction or demolition YES Noise during construction shall be due to construction equipment and emergency DG sets. 6.4 From blasting or piling NO 6.5 From construction or operational NO The increased traffic shall not have any significant traffic impact. 6.6 From lighting or cooling systems NO 6.7 From any other sources NO

7.Risks of contamination of land or water from releases of pollutants into the ground or into sewers, surface waters, groundwater, coastal waters or the sea: S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates, wherever possible) with source of information data 7.1 From handling, storage, use or NO All the hazardous materials will be stored in MS drums, spillage of hazardous materials in a covered shed and no contamination of soil is expected. Same philosophy will be followed for the after expansion 7.2 From discharge of sewage or other NO All the waste from domestic operations sent to ZLD effluents to water or the land system. (expected mode and place of discharge) 7.3 By deposition of pollutants emitted NO All the emissions from process are controlled by to air into the land or into water providing control equipment like scrubbers, Bag filters. 7.4 From any other sources NO 7.5 Is there a risk of long term build up NO of pollutants in environment from these sources?

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M/s.SVR Laboratories Pvt. Ltd.,

8.Risk of accidents during construction or operation of the Project, which could affect human health or the environment S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates, wherever possible) with source of information data 8.1 From explosions, spillages, fires etc from YES All Inbuilt Safety precautions will be storage, handling, use or production of adopted and there will not be any hazardous substances damage to environment or human health 8.2 From any other causes NA 8.3 Could the project be affected by natural disasters NO causing environmental damage (e.g. Floods, earthquakes, landslides, cloudburst etc)?

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 S. No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates, wherever possible) with source of information data 9.1 Lead to development of supporting. YES The project shall enhance the socio facilities, ancillary development or development economic status of the area by stimulated by the project which could have impact increasing the demand for housing, on the environment e.g.: improving the employment. • Supporting infrastructure (roads, power supply, waste or waste water treatment, etc.) • housing development • extractive industries • supply industries • other 9.2 Lead to after‐use of the site, which could haven NO impact on the environment 9.3 Set a precedent for later developments NO 9.4 Have cumulative effects due to proximity to other NO The baseline environmental status of existing or planned projects with similar effects the surrounding areas is within the prescribed limits as observed from the Secondary data.

(III) Environmental Sensitivity

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M/s.SVR Laboratories Pvt. Ltd.,

S.No. Areas Name/ Aerial distance (within 15 km.) Identity Proposed project location boundary 1 Areas protected under international conventions, NA national or local legislation for their ecological, landscape, cultural or other related value 2 Areas which are important or sensitive for YES Lakkaram RF ‐ SE ‐ 0.9 km ecological reasons ‐ Wetlands, watercourses or Chauttuppal RF – SE ‐ 4.4 km other water bodies, coastal zone, biospheres, Malkapuram RF – SW ‐ 2.6 km mountains, forests Hafizpura RF – SW – 7.2 km Ailaupur RF – SW ‐ 6.9 km Meharnagar RF – NW ‐ 5.6 km Jalalpur RF – NW ‐ 7.1 km

Chinna Musi River is passing from SW to NW at a Distance of 5.9 Km in NW direction to the site 3 Areas used by protected, important or sensitive NA species of flora or fauna for breeding, nesting, foraging, resting, over wintering, migration 4 Inland, coastal, marine or underground waters NO 5 State, National boundaries NO 6 Routes or facilities used by the public for access to NO recreation or other tourist, pilgrim areas 7 Defense installations NO 8 Densely populated or built‐up area YES Nearest habitation from the site is Antammagudem village with a population of 1500 at a distance of 1 km in west direction 9 Areas occupied by sensitive man‐made land uses NA (hospitals, schools, places of worship, community facilities) 10 Areas containing important, high quality or scarce NO resources (ground water resources, surface resources, forestry, agriculture, fisheries, tourism, minerals) 11 Areas already subjected to pollution or NO environmental damage. (those where existing legal environmental standards are exceeded) 12 Areas susceptible to natural hazard which could NO cause the project to present environmental problems (earthquakes, subsidence, landslides, erosion, flooding or extreme or adverse climatic conditions)

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M/s.SVR Laboratories Pvt. Ltd.,

(IV) Proposed Terms of Reference for EIA studies Scope of Work of EIA

The standard terms of reference (page 181‐187) issued by the Ministry of Environment Forest and Climate change shall be followed for preparation of EIA report. Any additional study proposed by the SEAC shall also be completed.

Ref: Standard Terms of Reference (TOR) for EIA/EMPO report for projects/activities requiring environmental clearance under EIA notification, 2006, MoEFCC, GOI, and April 2015.

I hereby give the undertaking that 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 any stage, the project will be rejected and clearance given, if any to the project will be revoked at our risk and cost.

Date: Place:

Signature of the applicant With Name and Full Address (Project Proponent/Authorized Signatory)

V. Venkata Ravi Kumar Director SVR Laboratories Pvt. Ltd. H.No. 7‐1‐307/14/F/52, Jayaprakash Nagar, Sanathnagar Hyderabad, Telangana State. Pin code‐500018

Form I Page 11

SVR LABORATORIES PVT.LTD. SY.NO. 238 (Part), 239/A and 239/E, DHOTIGUDEM VILLAGE, POCHAMPALLY MANDAL, NALGONDA DISTRICT, TELANGANA

ANNEXURES

SUBMITTED TO MINISTRY OF ENVIRONMENT, FORESTS AND CLIMATE CHANGE GOVERNMENT OF INDIA INDIRA PARYAVARAN BHAWAN, JOR BAGH ROAD, NEW DELHI M/s. SVR Laboratories Pvt. Ltd., Form I Annexures

, s. SVR Laboratories Pvt. Ltd. Laboratories Pvt. SVR s. / of M p A.1 Location Ma g Fi

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M/s. SVR Laboratories Pvt. Ltd., Form I Annexures

SVR Laboratories Pvt. ltd.

Sy. 238, 239/A & 239/E, EM UD A G MM Dothigudem (V), Pochampally (M) HA NT

A UT

500.KVA T.

Nalgonda (Dist.) Telangana R O

A ‐ D TRA YARD 51.9 ‐ EM 006 UD I G TH DO BORE GATE

WELL FIRST SECURITY 4.76X2.43 CANTEEN 4.76X2.43 ROOM 4.75X12.44 ROOM

AID

7.64M CHIMNY HOUSE BOILER HOUSE BOILER

2 1 WATER 3.04X3.04

TANK GENERATOR 117 4.00X6.45 ROOM

2 O COMPRESSOR

107 P

ROOM 5.51X6.45 E

TOI N SUMP

MOTOR A CHILLING

5.51X6.45

6 N PLANT OLD

TANK

3.04X6.09 D

SUMP

115 116 O BINE

SITE PLAN F

E N

SCALE 1:400 2.3M dia 2.0M dia

NEW U

TANK G

U BRINE

2.0M dia 2.0M dia

M M

. A 3.1M dia 2.0M dia

L 0

L 1

2.0M dia 2.0M dia

E D 3.1M dia

2.0M dia

D Y ENGINEERING 5.44X6.89 STORES

8.05m 1.64m 18.80X13.80 MATERIAL STORE PRODUCTION BLOCK 18.69X19.32 181.40M

NO.1 PRODUCTION 4.65X11.28 BLOCK

2.0M dia 2.0M dia 2.0M dia ‐ 3 STORAGE 4.15X7.08 HOT 4.15X3.54 SYSTEM

SALT 5.23M PRODUCTION BLOCK 12.04X10.09 MATERIAL 12.16X19.32 STORE 2.0M

OIL

dia D D 2.0M 2.0M

2.0M NO.1 MEE 4.65X11.28

dia dia

dia

2.0M 1.0M dia 1. 0M dia 1.0M dia

2.0M PLANT

dia

dia 2.0M

dia WATER BIOLOGICAL TREATMENT

TANK PLANT 8.96m PLANT

2 RO PRODUCTION 6 BLOCK .1 14.00X19.76 6 M Hydrogen

NO.2

Cylinders 3.04M PRODUCTION PRODUCTION PROPOSED PROPOSED BLOCK BLOCK 14.00X19.76 14.00X19.76 Ammonia

Cylinders PRODUCTION PRODUCTION PROPOSED PROPOSED 14.00X19.76 14.00X19.76 BLOCK BLOCK

2.0M 2.0M 2.0M 2.0M

dia dia

dia dia 2.0M 2.0M

dia

dia 2.0M 2.0M

dia

Fig A.2 Plant Layout after Expanion of M/s. SVR Laboratories Pvt. Ltd.,

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M/s. SVR Laboratories Pvt. Ltd., Form I Annexures

ANNEXURE - I

M/s. SVR Laboratories Pvt. Ltd., located at Sy. No 238 (Part), 239/A, 239/E, Dhotigudem (V), Pochampally Mandal, Nalgonda District, Telangana obtained consent and authorization (CFO) for manufacturing of 1 TPM of vide Letter No. APPCB/RCP/NLG/HO/CFO/2013-2568 dated 15.07.2013 in an area of 2 acres. SVR Laboratories Pvt. Ltd., obtained TOR vide letter no. F.No. J-11011/7/2013-IA II (I) dated 29.04.2013 for its expansion from 1 TPM to 65 TPM in an area of 6 acres. Expansion includes addition of production blocks, facility for utility proposed and enhancement of ZLD system. Capacity before and after expansion is presented in Table A-1 and A-2.

Table A-1 Manufacturing Capacity - Permitted S.No Name of the Product Capacity Kg/day TPM 1 4 hydroxy corbonole (stage -1 intermediate of carvidilol) 16.67 0.5 2 2(2,4 Difluorophenyl)-1-(1H-1,2,4)-Trrizole-1-YL)-2,3 16.67 0.5 epoxy-propane methane) sulfonate(state 2 intermediate of Fluconazole) Total 33.34 1.0

Table A-2 Manufacturing Capacity –After Expansion S.No Name of the Product CAS No. Capacity Kg/Day TPM I.Bulk drugs 1 Acyclovir 59277-89-3 130 3.9 2 Atorvastatin Calcium 134523-03-8 150 4.5 3 Capecitabine 154361-50-9 50 1.5 4 CBZ-L-Valine 158257-41-1 100 3 5 Cevimeline Hydrochloride 107220-28-0 70 2.1 6 Clofarabine 123318-82-1 40 1.2 7 Eprsartan Mesylate 144143-96-4 50 1.5 8 Felbamate 106817-52-1 160 4.8 9 Gemcitabine Hydrochloride 122111-03-9 100 3 10 Levofloxacin 100986-85-4 60 1.8 11 Lopinavir 192725-17-0 125 3.75 12 Losartan Potassium 124750-99-8 300 9 13 Methyl 1,2,4-tri-O-catyl-3-O-benzyl-L- 40 1.2 idopyranuronate (SDP) 14 Methyl 2,3-di-O-benzyl-4-O-chloro acetyl- b-D- 50 1.5

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M/s. SVR Laboratories Pvt. Ltd., Form I Annexures

glucopyranuronate (MKM) 15 Methyl 6- O-acetyl-3-O-benzyl-2-(benzyl 180 5.4 oxyarbonyl )amino - 2- deoxy-a - D- glucopyranoside (MVR) 16 Moxifloxacin Hydrochloride 186826-86-8 70 2.1 17 Pantoprazole Sodium 164579-32-2 333.33 10 18 Pregabalin 148553-50-8 300 9 19 Ritonavir 155213-67-5 100 3 20 Rizatriptan Benzoate 145202-66-0 70 2.1 21 Rosuvastatin Clacium 147098-20-2 100 3 22 Saxagliptin monohydrate 709031-78-7 70 2.1 23 Tenofovir Disoproxil 201341-05-1 100 3 24 Valacyclovir Hydrochloride 124832-27-5 180 5.4 25 Valsartan 137862-53-4 130 3.9 26 Zileuton 111406-87-2 100 3 27 1,6-anhydro-2-azido-2-deoxy-b-D- 50 1.5 gloucopyranuronate (DHA) 28 3-O-acetyl-1,6-anhydro-2-azido-2-deoxy-D- 60 1.8 gloucopyranuronate (DRV) Total- I – Maximum 8 Products on Campaign basis. 1733.33 52 II.Intermediates 1 ( )-3-(Carbamoylmethyl)-5-methyl hexanoic 100 3 acid 2 2- chloromethyl-3,4-dimethoxy pyridine 72830-09-2 333.33 10 Hydrochloride(Pantoprazole Chloro compound) Total - II 433.33 13 Grand Total (I + II) 2166.66 65

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M/s. SVR Laboratories Pvt. Ltd., Form I Annexures

List of By-Products – After Expansion S.No Name of Product Stage Name of By-Product Capacity Kg/day TPM 1 Acyclovir II Potassium Chloride 128.2 3.8 IV Sodium Acetate 75.8 2.3 2 Atorvastatin Calcium I Sodium Acetate 38.7 1.2 3 Capecitabine III Triethylamine HCl 21.7 0.7 4 Clofarabine I Triethylamine HCl 47.4 1.4 5 Gemcitabine Hydrochloride II Triethylamine HBr 107.5 3.2 III Pyridine HCl 115.2 3.5 V Triethylamine HCl 53.6 1.6 6 Losartan Potassium III Triethylamine 69.7 2.1 7 Methyl 1,2,4-tri-O-catyl-3-O- IV Trityl Alcohol 28.9 0.9 benzyl-L-idopyranuronate (SDP) 8 Methyl 2,3-di-O-benzyl-4-O- V Trityl Alcohol 34.5 1.0 chloro acetyl- b-D- glucopyranuronate (MKM) 9 Methyl 6- O-acetyl-3-O-benzyl-2- III Triethylamine HCl 107.8 3.2 (benzyl oxyarbonyl)amino - 2- deoxy-a - D-glucopyranoside (MVR) 10 Pregabalin I R-(+)- 120.2 3.6 phenylethylamine 11 Tenofovir Disoproxil VI Triethylamine HCl 53 1.6 Valsartan II Triethylamine HCl 58.5 1.8 12 III Triethylamine HCl 47.8 1.4 13 1,6-anhydro-2-azido-2-deoxy-b- I Triethylamine HCl 264.4 7.9 D- gloucopyranuronate (DHA) 14 3-O-acetyl-1,6-anhydro-2-azido- I Triethylamine HCl 77.6 2.3 2-deoxy-D-gloucopyranuronate (DRV) 15 2- chloromethyl-3,4-dimethoxy I Potssium Sulphate 150.1 4.5 pyridine Hydrochloride (Pantoprazole Chloro compound)

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M/s. SVR Laboratories Pvt. Ltd., Form I Annexures

Process Description of CBZ-L-Valine Reaction Schemes

2 NaOH (40) Toluene Water HCl (36.5) 2 H20 2 NaCl Water (18) Sodium chloride (58.5)

L-Valine (117) Benzyl chloroformate (170.5) CBZ-L-Valine (251)

Process Description: Stage I: Condensation of L-Valine with Benzyl chloro formate in presence of Sodium hydroxide and Toluene followed by crystallization from Hexane gives N- Benzyloxycarbonyl-L-Valine (CBZ-L-Valine). Schematic diagram of CBZ-L-Valine is shown in Fig A.3 and material balance for CBZ-L-Valine is presented in Table A.3

L-Valine Toluene Benzyl chloroformate

Water

Sodium hydroxide Toluene recovery Hexane Hexane recovery Hydrochloric acid Sodium chloride Activated carbon Reactor Water to ETP Hiflo spent carbon Hiflo

N-Benyloxycarbonyl-L-Valine (CBZ-L-Valine)

Fig A.3 Process Flow Diagram of CBZ-L-Valine

Table 2.7 Material Balance for CBZ-L-Valine Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) L-Valine 50 CBZ-L-Valine 100 Final Product Benzyl chloro formate 72.9 Sodium Chloride 51.7 To wastewater Sodium hydroxide 34.2 Toluene Recovered 285 Recovery & reuse Hydrochloric acid 15.6 Toluene Loss 3 Fugitive Loss Toluene 300 Toluene to Wastewater 1.5 To wastewater Hexane 250 Toluene to Residue 10.5 Solvent in Residue Activated Carbon 5 Hexane Recovered 236.3 Recovery & reuse Hyflow 1.5 Hexane Loss 1.3 Fugitive Loss Water 500 Hexane to Residue 12.5 Solvent in Residue Sodium Hydroxide 1.2 L-Valine 3.4 To wastewater Hydrochloric Acid 2.1 Benzyl chloro formate 4.9 Organic Residue Activated Carbon 5 Organic Residue Hyflow 1.5 Inorganic Residue Water 515.9 To wastewater Total Input 1232.4 Total Output 1232.4

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M/s. SVR Laboratories Pvt. Ltd., Form I Annexures

ANNEXURE – II: Wastewater Treatment Facilities The main sources of effluent generation from the plant are from process, floor washings, blowing downs from boiler and cooling tower, and domestic effluents. The effluents generated in the process, separation techniques and during purification contain organic residues of raw materials, solvents, and products. Some of the raw materials used in the process are also inorganic in nature. Hence the effluents contain both organics and in- organics in various quantities leading to high COD and TDS levels respectively. The quantity of effluents generated and mode of treatment is presented in Table A-4.

Table A-4 Quantity of Effluent Generated and Mode of Treatment Source of Effluents Quantity (KLD) Mode of Treatment Permitted After Expansion HTDS Effluents (TDS & COD> 15000 mg/l) Process 3.5 34 Sent to Stripper followed by MEE and Washings 3 ATFD. Stripper Condensate sent to Cement Plants for Co-Incineration. MEE and ATFD Condensate sent to Biological treatment plant followed by RO. RO rejects sent to MEE and permeate is reused in cooling towers/Boilers make-up. Scrubber Effluent 2 Sent to MEE followed by ATFD, Biological DM rejects 5 treatment plant and RO. Total - I 3.5 44 LTDS Effluents (TDS & COD< 15000 mg/l) Boiler Blow downs 0.6 2 Sent to Biological Treatment System Cooling Tower Blow 10 followed by RO. downs RO permeate reused for cooling tower makeup. RO rejects sent to MEE. Domestic 0.5 4.5 Septic tank followed by soak pit. Total - II 1.1 16.5 Grand Total (I+II) 4.6 60.5

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M/s. SVR Laboratories Pvt. Ltd., Form I Annexures

ANNEXURE – III: Water Balance

Water is required for process, scrubbers, washing, cooling tower makeup, steam generation and domestic purposes. The total water requirement shall increase from 7.5 KLD to 130.1 KLD after expansion, out of which 75.13 KLD shall be fresh water and balance 55 KLD shall be recycled water. The required water shall be drawn from ground water sources in addition to reuse of treated wastewaterTotal water balance after expansion is presented in Table A-5. Table A-5 Total Water Balance – After Expansion Purpose INPUT (KLD) OUTPUT (KLD) Fresh Water Recycled Water Loss Effluent Process 31.1 34* Washings 3 3 Scrubber 2 2 Boiler Feed 20 5 23 2 Cooling Tower 5 50 45 10 Reject from RO/DM Plant 5 5 Domestic 5 0.5 4.5 Gardening 4 4 Total 75.1 55 72.5 60.5 Grand Total 130.1 133 * Process effluents contain soluble raw materials, byproducts, solvents etc.

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M/s. SVR Laboratories Pvt. Ltd., Form I Annexures

ANNEXURE – IV: Solid Waste

Solid wastes are generated from the process, solvent distillation, wastewater treatment and utilities. The effluent treatment system generates, stripper distillate, ATFD salts and ETP sludge. The process operations generate process residue, filter media, used catalysts, activated carbon and inorganic residue. The recycling operation of distillation generates solvent residue and spent mixed solvents. The utilities i.e., coal fired boiler generates ash while DG sets generate waste oil and used batteries. All the wastes except coal ash are considered hazardous. The other non hazardous wastes are container, packing material, empty drums etc. The containers and drums are detoxified before disposing to authorized buyers. The hazardous wastes of process residue, stripper distillate, solvent residue, and activated carbon are sent cement plants for co-incineration, thereby reducing the load on TSDF facility and consumption of non renewable resource of coal in cement plant kilns. Mixed solvents shall be sent to authorized recyclers/cement plant for co-incineration while spent solvents are recovered within plant premises. The inorganic wastes, filter media, used catalysts, salts from ATFD, and ETP sludge are sent to TSDF facility located at Dundigal, Ranga Reddy district. The waste oil and used batteries are sold to authorized recyclers. Coal ash is sold to brick manufacturers in the local area. Total solid waste generated and mode of disposal is presented in Table A-6.

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M/s. SVR Laboratories Pvt. Ltd., Form I Annexures

Table A-6 Total Solid Waste Generated and Mode of Disposal S.No Description Units Permitted After Mode of Disposal Expansion 1 Ash from Boiler TPD 1 6.7 Sold to Brick manufactures 2 Process Organic TPD 0.01 1.5 Sent to TSDF/Cement residue Industries 3 Solvent Residue TPD 1.25 Sent to TSDF/Cement Industries 4 Spent Carbon Kg/day 0.002 148 Sent to TSDF/Cement Industries 5 Process Inorganic TPD 0.008 0.37 Sent to TSDF Residue 6 Spent Solvents KLD 51.7 Recovered within the plant premises. 7 Mixed Solvents KLD 5.75 Sent to authorized recovery units/Cement plants for co-incineration 8 Evaporation Salts TPD 0.04 2.25 Sent to TSDF 9 Stripper Distillate KLD 0.54 Sent to Cement Industries for Co- incineration. 10 Hyflow Kg/day 74 Sent to TSDF 11 ETP Sludge Kg/day 80 Sent to TSDF 12 Detoxified No.s/year 300 After detoxification sent containers to Authorized agencies 13 Waste oil Kl/Month 5.4 Sent to Authorized Recyclers 14 Used batteries No.s/year 20 Sent to Authorized Recyclers

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M/s. SVR Laboratories Pvt. Ltd., Form I Annexures

ANNEXURE – V: Stack Emissions Details

The sources of air pollution are from proposed 5TP, 4TPH Coal fired boilers, 4.0 Lac K. Cal Thermic Fluid Heater and existing 1 TPH boiler. It is proposed keep existing 1TPH and proposed 4TPH boilers as standby. Backup DG sets of 2 x 1000 KVA proposed and 250KVA existing. The proposed air pollution control equipment for Coal fired boilers is Bag filters. DG sets shall be provided with stack heights based on the CPCB formula for effective stack height.

Stack Emission Details S. Stack Connected to Stack Dia of Temp. of Exit Pollutant Emission No Ht stack exhaust Velocity Rate (g/sec) (m) at gases (m/sec) PM SO2 NOx top(m) (OC) Existing 1 1TPH Coal fired Boiler* 15 1 180 4.5 0.56 0.24 0.25 2 250KVA DG Set 4 0.2 320 5 0.004 0.002 0.01 Proposed 1 5TPH Coal fired Boiler 30 0.5 180 8.5 0.12 0.04 0.03 2 4TPH Coal fired Boiler* 25 0.5 180 7.2 0.096 0.032 0.024 3 4.0 Lakh K. Cal Thermic 10 0.25 165 8.23 0.05 0.14 0.18 Fluid Heater 4 2x1000 KVA DG Set** 10 0.15 151 13.86 0.01 0.02 0.03 * Boilers Shall be kept as standby ** DG sets stack heights are above the roof level.

Process Emissions: The process emissions contain Ammonia, Hydrogen Chloride, Sulfur dioxide, Hydrogen Bromide, Carbon dioxide, Nitrogen, Oxygen and Hydrogen. The ammonia, Hydrogen Chloride, Sulfur dioxide, Hydrogen Bromide emissions are sent to a scrubber and the resultant scrubbing effluent sent to ETP. The other gases are Carbon dioxide, Nitrogen, Oxygen, which are let out into atmosphere following a standard operating procedure while Hydrogen gas let out into atmosphere through water column.

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M/s. SVR Laboratories Pvt. Ltd., Form I Annexures

Quantity and Mode of Treatment of Process Emissions Product Name Stage Type of Emission Quantity Mode of treatment (Kg/Day) Acyclovir II Carbon Dioxide 42.1 Safely released into atmosphere Atorvastatin I Hydrogen 0.9 Let out into atmosphere Calcium through water column III Hydrogen Chloride 84.6 To Scrubber Sulphur Dioxide 30.9 To Scrubber IV Hydrogen Bromide 34.6 To Scrubber V Carbon Dioxide 7.4 Safely released into atmosphere VI Ammonia 1.5 To Scrubber Cevimeline II Carbon Dioxide 18.5 Safely released into Hydrochloride atmosphere Hydrogen 0.4 Let out into atmosphere III Hydrogen 0.7 through water column IV Carbon Dioxide 7.2 Safely released into atmosphere Clofarabine IX Hydrogen 0.3 Let out into atmosphere through water column XI Ammonia 0.3 To Scrubber Eprosartan I Carbon Dioxide 2.9 Safely released into Mesylate atmosphere V Carbon Dioxide 4.9 Safely released into atmosphere Levofloxacin II Carbon Dioxide 8.5 Safely released into atmosphere III Hydrogen Fluoride 3.3 To Scrubber Lopinavir II Carbon Dioxide 4.8 Safely released into atmosphere SDP V Carbon Dioxide 2.3 Safely released into atmosphere MKM VI Carbon Dioxide 2.8 Safely released into atmosphere Moxifloxacin II Hydrogen 0.4 Let out into atmosphere Hydrochloride through water column V Hydrogen 0.3 Let out into atmosphere through water column Rizatriptan I Carbon Dioxide 5.4 Safely released into Benzoate atmosphere V Carbon Dioxide 16.8 Safely released into atmosphere Saxaglipting II Sulphur Dioxide 15.4 To Scrubber Monohydrate Hydrogen Chloride 17.6 To Scrubber Tenofovir IV Carbon Dioxide 9.9 Safely released into

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M/s. SVR Laboratories Pvt. Ltd., Form I Annexures

Disoproxil atmosphere Valsartan I Sulphur Dioxide 28.3 To Scrubber Hydrogen Chloride 16.2 To Scrubber Zileuton IV Hydrogen Chloride 15.5 To Scrubber (±)-3-(Carbamoyl I Carbon Dioxide 25.6 Safely released into methyl) -5-methyl atmosphere hexanoic acid 2- chloromethyl- I Carbon Dioxide 38 Safely released into 3,4-dimethoxy atmosphere pyridine Ammonia 2.6 To Scrubber Hydrochloride V Sulphur Dioxide 95.2 To Scrubber (Pantoprazole Chloro compound)

Page 13

F. No. J-11011/7/2013- IA II (I) Government of India Ministry of Environment and Forests (I.A. Division) Paryavaran Bhawan CGO Complex, Lodhi Road New Delhi – 110 003

E-mail : [email protected] Telefax : 011: 2436 2875 Dated 29th April, 2013

To, Shri P. Nageswara Rao (Managing Director) M/s SVR Laboratories Pvt. Ltd. H.No. 7-1-307/14/F/52, Jayaprakash Nagar, Sanathnagar, Hyderabad 500 018

E-mail: [email protected] ; [email protected] ; Fax No.: 040- 23712445

Subject: Expansion of Synthetic Organic Chemicals Manufacturing Unit at Village Dothigudem, Mandal Pochampally, District Nalgonda, Andhra Pradesh by M/s SVR Laboratories Pvt. Ltd. -regarding TORs Ref. : Your letter no. nil dated 5th December, 2012. Sir, Kindly refer your letter no. nil dated 5th December, 2012 alongwith project documents including Form-I, Pre-feasibility Report and draft ‘Terms of Reference’ as per the EIA Notification, 2006. It is noted that proposal is for expansion of Synthetic Organic Chemicals Manufacturing Unit at Village Dothigudem, Mandal Pochampally, District Nalgonda, Andhra Pradesh by M/s SVR Laboratories Pvt. Ltd. Following is the details of existing and proposed products:

Name of the Product (Existing ) Capacity (Kg/day)

4 hydroxy corbonole (Intermediate for stage -1 intermediate of carvidilol) 16.67

2(2,4 Difluorophenyl)-1-(1H-1,2,4)-Trrizole-1-YL)-2,3 epoxy-propane 16.67 methane) sulfonate(state 2 intermediate of Fluconazole)

Total 33.34

S.N. Name of the Product (Proposed Capacity

Kg/Day Kg/Month

I.Bulk drugs

1 Acyclovir 130 3900

2 Atorvatatin Calcium 150 4500

3 Capecitabine 50 1500

4 CBZ-L-Valine 100 3000

5 Cevimeline Hydrochloride 70 2100 6 Clofarabine 40 1200

7 Eprsartan mesylate 50 1500

8 Felbamate 160 4800

9 Gemcitabine Hydrochloride 100 3000

10 Levofloxacin 60 1800

11 Lopinavir 125 3750

12 Losartan Potassium 300 9000

13 Methyl 1,2,4-tri-O-catyl-3-O-benzyl-L-idopyranuronate 40 1200

14 Methyl 2,3-di-O-benzyl-4-O-chloro acetyl- b-D- 50 1500 glucopyranuronate

15 Methyl 6- O-acetyl-3-O-benzyl-2-(benzyl 180 5400 oxyarbonyl)amino - 2- deoxy-a - D-glucopyranoside

16 Moxifloxacin Hydrochloride 70 2100

17 Pantoprazole Sodium 333.33 10000

18 Pregabalin 300 9000

19 Ritonavir 100 3000

20 Rizatriptan 70 2100

21 Rosuvastatin Clacium 100 3000

22 Saxagliptin monohydrate 70 2100

23 Tenofovir Disoproxil 100 3000

24 Valacyclovir Hydrochloride 180 5400

25 Valsartan 130 3900

26 Zileuton 100 3000

27 1,6-anhydro-2-azido-2-deoxy-b-D-gloucopyranuronate 50 1500

28 3-O-acetyl-1,6-anhydro-2-azido-2-deoxy-D- 60 1800 gloucopyranuronate

Total- I - Worst Case (Any 8 products on campaign basis.) 1733.33 52000

II.Intermediates

1 ( )-3-(Carbamoylmethyl)-5-methyl hexanoic acid 100 3000

2 2- chloromethyl-3,4-dimethoxy pyridine 333.33 10000 Hydrochloride(Pantoprazole Chloro compound)

Total - II 433.33 13000

Grand Total (I + II) 2167.66 65000

2.0 Draft Terms of Reference (TOR) have been discussed and finalized during the 6th Reconstituted Expert Appraisal Committee (Industry) held during 5th March, 2013-7th March, 2013 for preparation of EIA/EMP report. Following are the ‘TORs’: 1. A separate chapter on status of compliance of Environmental Conditions granted by State/Centre to be provided. As per circular dated 30th May, 2012 issued by MoEF, a certified report by RO, MoEF on status of compliance of conditions on existing unit to be provided in EIA/EMP report. 2. Executive summary of the project 3. Justification of the project. 4. Promoters and their back ground. 5. Regulatory framework. 6. Environment clearance for the existing unit issued by the Ministry (reasons, if not obtained), Consent to Operate and Authorization accorded by the APPCB. 7. Data for the stack emissions, fugitive emissions; water requirement and water balance chart; wastewater generation, treated effluent quality, re-utilization and disposal of solid/hazardous waste for the existing unit. 8. Project location and plant layout. 9. Infrastructure facilities including power sources. 10. Total cost of the project alongwith total capital cost and recurring cost/annum for environmental pollution control measures. 11. Project site location alongwith site map of 10 km area and site details providing various industries, surface water bodies, forests etc. 12. Present land use based on satellite imagery for the study area of 10 km radius. Details of land availability for the project alongwith supporting document. 13. Location of National Park/Wild life sanctuary/Reserve forest within 10 km radius of the project. 14. Permission from the State Forest Department regarding the impact of the proposed plant on the surrounding reserve forests. 15. Details of the total land and break-up of the land use for green belt and other uses. 16. List of products alongwith the production capacities. 17. Detailed list of raw material required and source, mode of storage. 18. Manufacturing process details alongwith the chemical reactions and process flow chart. 19. Action plan for the transportation of raw material and products. 20. Site-specific micro-meteorological data using temperature, relative humidity, hourly wind speed and direction and rainfall is necessary. 21. Ambient air quality monitoring at 6 locations within the study area of 5 km., aerial coverage from project site as per NAAQES notified on 16th September, 2009. Location of one AAQMS in downwind direction. 22. One season site-specific micro-meteorological data using temperature, relative humidity, hourly wind speed and direction and rainfall and AAQ data (except monsoon) for PM10, SO2, NOx, CO including VOCs shall be collected. The monitoring stations shall take into account the pre-dominant wind direction, population zone and sensitive receptors including reserved forests. Data for water and noise monitoring shall also be included. 23. Air pollution control measures proposed for the effective control of gaseous/process emissions within permissible limits. 24. Name of all the solvents to be used in the process and details of solvent recovery system. 25. Design details of ETP, incinerator, if any alongwith boiler, scrubbers/bag filters etc. 26. Details of water and air pollution and its mitigation plan. 27. Action plan to control ambient air quality as per NAAQS Standards notified by the Ministry on 16th September, 2009. 28. An action plan prepared by SPCB to control and monitor secondary fugitive emissions from all the sources. 29. Determination of atmospheric inversion level at the project site and assessment of ground level concentration of pollutants from the stack emission based on site- specific meteorological features. Air quality modelling for proposed plant. 30. Permission from competent Authority for the drawl of water. Water balance chart for existing and expansion project including quantity of effluent generated recycled and reused and effluent discharge. 31. Attempt to be made for reduction for usage of water. 32. Complete scheme of effluent treatment. Characteristics of untreated and treated effluent to meet the standard. 33. Zero discharge effluent concepts to be adopted. 34. Ground water quality monitoring minimum at 6 locations shall be carried out. Geological features and Geo-hydrological status of the study area and ecological status (Terrestrial and Aquatic). 35. The details of solid and hazardous wastes generation, storage, utilization and disposal particularly related to the hazardous waste calorific value of hazardous waste and detailed characteristic of the hazardous waste. Action plan for the disposal of fly ash generated from boiler shall be included. 36. Precautions to be taken during storage and transportation of hazardous chemicals shall be clearly mentioned and incorporated. 37. Material Safety Data Sheet for all the Chemicals are being used/will be used. CAS No./RTECS No./DOT/UN etc to be mentioned against each chemicals. 38. Authorization/Membership for the disposal of solid/hazardous waste in TSDF. 39. Risk assessment for storage for chemicals/solvents. Action plan for handling & safety system. 40. An action plan to develop green belt in 33 % area. Layout plan for green belt shall be provided. 41. Action plan for rainwater harvesting measures at plant site shall be included to harvest rainwater from the roof tops and storm water drains to recharge the ground water. 42. Details of occupational health programme. i) To which chemicals, workers are exposed directly or indirectly. ii) Whether these chemicals are within Threshold Limit Values (TLV)/ Permissible Exposure Levels as per ACGIH recommendation. iii) What measures company have taken to keep these chemicals within PEL/TLV. iv) How the workers are evaluated concerning their exposure to chemicals during pre-placement and periodical medical monitoring. v) What are onsite and offsite emergency plan during chemical disaster. vi) Liver function tests (LFT) during pre-placement and periodical examination. 43. Details of occupational health surveillance programme. 44. Socio-economic development activities shall be in place. 45. Note on compliance to the recommendations mentioned in the CREP guidelines. 46. 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 shall be provided. 47. EMP shall include the concept of waste-minimization, recycle / reuse / recover techniques, Energy conservation, and natural resource conservation. 48. Total capital cost and recurring cost/annum for environmental pollution control measures. 49. Corporate Environmental Responsibility (a) Does the company have a well laid down Environment Policy approved by its Board of Directors? If so, it may be detailed in the EIA report.

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

(c ) What is the hierarchical system or Administrative order of the company to deal with the environmental issues and for ensuring compliance with the EC conditions. Details of this system may be given.

(d) Does the company have a system of reporting of non compliance / violations of environmental norms to the Board of Directors of the company and / or shareholders or stakeholders at large? This reporting mechanism should be detailed in the EIA report.

50. Any litigation pending against the project and/or any direction/order passed by any Court of Law against the project, if so, details thereof. 51. Public hearing issues raised and commitments made by the project proponent on the same should be included separately in EIA/EMP Report in the form of tabular chart. 52. A tabular chart with index for point wise compliance of above TORs.

The following general points shall be noted: i. All documents shall be properly indexed, page numbered. ii. Period/date of data collection shall be clearly indicated. iii. Authenticated English translation of all material provided in Regional languages. iv. The letter/application for EC shall quote the MOEF file No. and also attach a copy of the letter. v. The copy of the letter received from the Ministry shall be also attached as an annexure to the final EIA-EMP Report. vi. The final EIA-EMP report submitted to the Ministry must incorporate the issues in this letter. The index of the final EIA-EMP report must indicate the specific chapter and page no. of the EIA-EMP Report. vii. Certificate of Accreditation issued by the QCI to the environmental consultant shall be included.

3.0 These ‘TORs’ should be considered for the preparation of EIA / EMP report for expansion of Synthetic Organic Chemicals Manufacturing Unit at Village Dothigudem, Mandal Pochampally, District Nalgonda, Andhra Pradesh in addition to all the relevant information as per the ‘General Structure of EIA’ given in Appendix III and IIIA in the EIA Notification, 2006. The EIA/EMP as per TORs should be submitted to the Chairman, Andhra Pradesh Pollution Control Board, (APPCB) for public consultation. The APPCB shall conduct the public hearing/public consultation as per the provisions of EIA notification, 2006. 4.0 You are requested to kindly submit the final EIA/EMP prepared as per TORs and incorporating all the issues raised during Public Hearing / Public Consultation to the Ministry for considering the proposal for environmental clearance within 2 years as per the MoEF O.M. No. J-11013/41/2006-IA.II (I) dated 22nd March, 2010. 5.0 The consultants involved in the preparation of EIA/EMP report after accreditation with Quality Council of India / National Accreditation Board of Education and Training (QCI/NABET) would need to include a certificate in this regard in the EIA/EMP reports prepared by them and data provided by other Organization(s)/Laboratories including their status of approvals etc.

(V.P.Upadhyay) Director Copy to : The Chairman, Andhra Pradesh Pollution Control Board, Paryavaran Bhavan, A- 3, Industrial Estate, Sanathnagar, Hyderabad 500 018, Andhra Pradesh (E-mail : [email protected] ; Fax No. : 040-23733261)

(V.P.Upadhyay) SVR LABORATORIES PVT.LTD. SY.NO. 238 (Part), 239/A and 239/E, DHOTIGUDEM VILLAGE, POCHAMPALLY MANDAL, NALGONDA DISTRICT, TELANGANA

STUDIES AND DOCUMENTATION BY TEAM Labs and Consultants QCI: MoE&F OM, List A‐1, S.No.25. (An ISO 9001:2008, ISO 14001:2004 & OHSAS 18001:2007 Certified Organization) B‐115, Annapurna Block, Aditya Enclave Ameerpet, Hyderabad‐500 038. Phone: 040‐23748 555/616, Telefax: 040‐23748666 Email: [email protected]