| Form-1 | | APPLICATION FOR PRIOR ENVIRONMENTAL CLEARANCE | | | | 1. Basic Informations | | Project Name | M/s. Shilpa Albumin Pvt Ltd., Establishment of manufacturing facility for APIs, Intermediates and Recombinant Human Albumin | Company/Organisation Name | M/S. SHILPA ALBUMIN PRIVATE LIMITED | | Registered Address | Plot No. 286, 287, 288, Kadechur Industrial Area, Kadechur Village, Yadgir Taluk & District, Karnataka Karnataka 585221 | Legal Status of the Company | Private |
| | 2. | | Address for the correspondence: | | (a)Name of the Applicant | Vishnukanth B | | (b)Designation (Owner/ Partner/ CEO) | Director | | (c)Address | No. 12-6-214/A-1, Hyderabad Road,,Raichur, Karnataka,Raichur,Raichur,Karnataka-584135 | | (d)Pin code | 584135 | | (e)E-mail | madhav@vbshilpa.com | | (f)Telephone No. | 0 | | (g)Fax No. | | | (h)Copy of documents in support of the competence/authority of the person making this application to make application on behalf of the User Agency . | Annexure-Uploaded Copy of documents in support of the competence/authority | |
| | 3. | | Category of the Project/Activity as per Schedule of EIA Notification,2006: | | (a)Major Project/Activity | 5(f)-API
| | (b)Minor Project/Activity | NIL | | (c)Category | A | | (d)Proposal Number | IA/KA/IND2/176047/2020 | | (e)Master Proposal Number(Single Window) | SW/176045/2020 | | (f)EAC concerned (for category A Projects only) | Industrial Projects - 3 | | (g)Project Type(New/Expansion/Modernization) | Fresh EC |
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| | 4. | | (a)Number of States in which Project will be Executed | 1 | | (b)Main State of the project | Karnataka | |
| | Details of State of the project |
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| S. No. | State Name | District Name | Tehsil Name | Village Name |
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| NIL |
| | 5. | | Details of Public Consultation: | | (a)Whether the Project Exempted from Public Hearing? | Yes | | (c)Reason | -1 | | (d)Supporting Document | Copy of Supporting Document | |
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| 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 there of (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 | Project site is in a designated industrial area developed by KIADB. The earlier land use is now converted from agriculture to industrial and developed by KIADB.
The terrain is flat hence there is no change in topography. | | 1.2 | Clearance of existing land, vegetation and buildings? | No | Vacant land with rank vegetation | | 1.3 | Creation of new land uses? | No | No | | 1.4 | Pre-construction investigations e.g. bore houses, soil testing? | Yes | All necessary investigation related to construction will be carried out before taking up the construction work. | | 1.5 | Construction works? | Yes | Construction of buildings is yet to be taken up for proposed project | | 1.6 | Demolition works? | No | New Project. No structures are existing. | | 1.7 | Temporary sites used for construction works or housing of construction workers? | No | Local workers will be made use of | | 1.8 | Above ground buildings, structures or earthworks including linear structures,cut and fill or excavations and fill or excavations | Yes | All the buildings will be above ground level | | 1.9 | Underground works including mining or tunneling? | No | No underground work is involved except for foundation. | | 1.10 | Reclamation works? | No | No reclamation of land is needed. | | 1.11 | Dredging? | No | Not Applicable | | 1.12 | Offshore structures? | No | Not Applicable | | 1.13 | Production and manufacturing processes? | Yes | Facility is for manufacturing of Active Pharmaceutical Ingredients (APIs), Intermediates and Recombinant Human Albumin. Details of the same are covered in EMP report. | | 1.14 | Facilities for storage of goods or materials? | Yes | Construction Phase:
Temporary storage area will be provided at project site for storage of construction materials.
Operation Phase:
Dedicated storage facilities for Raw materials (warehousing), process building& finished products storage are present. Additional storage facilities are proposed and will be provided. Solvents are stored in above ground level tanks; details are covered in EMP report | | 1.15 | Facilities for treatment or disposal of solid waste or liquid effluents? | Yes | Domestic solid waste:
Organic wastes will be composted and inorganic waste will be segregated and given to authorized agents.
Liquid Waste:
Domestic Sewage and Industrial effluents:
Total wastewater generated in the facility will be 608.512 KLD. Details of watsewater generation, treatment & disposal is provided in the EMP report. ZLD concept will be followed and no treated water will be discharged outside. | | 1.16 | Facilities for long term housing of operational workers? | No | There will be no housing facility proposed in the project site for the workers.There will be no housing facility proposed in the project site for the workers. | | 1.17 | New road, rail or sea traffic during construction or operation? | No | Existing road and transport facilities will be used during construction and operation phase. | | 1.18 | New road, rail, air water borne or other transport infrastructure including new or altered routes and stations, ports, airports etc? | No | Only the existing infrastructure facilities will be utilized. | | 1.19 | Closure or diversion of existing transport routes or infrastructure leading to changes in traffic movements? | No | - | | 1.20 | New or diverted transmission lines or pipelines? | No | Transmission lines provided by GESCOM will be used. | | 1.21 | Impoundment, damming, culverting, realignment or other changes to the hydrology of watercourses or aquifers? | No | Hydrology of the area will not be disturbed due to the project. There are no primary or secondary drains passing through the site. | | 1.22 | Stream crossings? | No | - | | 1.23 | Abstraction or transfers of water from ground or surface waters? | Yes | Fresh water requirement will be met from KIADB supply (Bhima River water). | | 1.24 | Changes in water bodies or the land surface affecting drainage or run-off? | No | - | | 1.25 | Transport of personnel or materials for construction, operation or decommissioning? | Yes | The existing road will be utilized for access to the site for transportation of material and personnel during construction and operation phase. | | 1.26 | Long-term dismantling or decommissioning or restoration works? | No | This is a greenfield project therefore there is no dismantling or decommissioning related works | | 1.27 | Ongoing activity during decommissioning which could have an impact on the environment? | No | - | | 1.28 | Influx of people to an area in either temporarily or permanently? | Yes | Construction Stage: Approximately 250 People
Operation Stage: 350 people (Permanent: 250 and Contract: 100) | | 1.29 | Introduction of alien species? | No | - | | 1.30 | Loss of native species or genetic diversity? | No | - | | 1.31 | Any other actions? | No | Nil | |
| 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 confirmation | Yes/No | Details thereof (with approximate quantities/rates, wherever possible) with source of information data | | 2.1 | Land especially undeveloped or agricultural land (ha) | No | The proposed project is located in designated KIADB industrial area. Industrial area is developed. | | 2.2 | Water (expected source & competing users) unit: KLD | Yes | Source- KIADB supply (Bhima River)
Total fresh water requirement – 451.653 KLD
Competing users: Industries located within the industrial area, agriculture and villages on either side of the River Bhima. | | 2.3 | Minerals (MT) | No | Not Applicable. | | 2.4 | Construction material – stone, aggregates, sand / soil (expected source – MT) | Yes | Sand, coarse and fine aggregates etc. are sourced locally. Approximate estimated quantities are Sand: 10000 MT,Aggregates – 10000 MT, Metal – 4300 MT, Cement – 4200 MT. | | 2.5 | Forests and timber (source – MT) | No | Not applicable. Wooden furniture for the office will be procured from the market. | | 2.6 | Energy including electricity and fuels (source, competing users) Unit: fuel (MT),energy (MW) | Yes | Electric power will be sourced from Power supply from Gulbarga Electricity Supply Company (GESCOM).
Competing users: Industries located within the industrial area.
Power requirement during operation stageis 2500kVA.It is proposed to install 3x1500kVA DG sets asa source of alternative power supply during power failure. HSD will be used as fuel. | | 2.7 | Any other natural resources (use appropriate standard units) | No | Not Applicable. | |
| 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 are hazardous (as per MSIHC rules) to human health or the environment (flora, fauna, and water supplies | Yes | Hazardous chemicals will be used in the manufacturing process.
Dedicated storage area is proposed. MSDS for all chemicals and spill kit will be provided for storage of hazardous chemicals/solvents. PESO guidelines will be followed wherever it is applicable. Necessary safeguards will be taken as per the standard procedures for the storage and handling of such raw materials. | | 3.2 | Changes in occurrence of disease or affect disease vectors (e.g. insect or water borne diseases) | No | - | | 3.3 | Affect the welfare of people e.g. by changing living conditions? | Yes | There will be improvement in Socio economic condition around the project site by providing direct or indirect employment opportunities. | | 3.4 | Vulnerable groups 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 | There are no causes which would affect the people around. | |
| 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 commercial wastes) | Yes | The total quantity of domestic wastes will be about 25.2 TPA out of this about 23.94 TPA will be organic and 1.26 TPA will be inorganic waste. Organic waste will be composted and inorganic waste will be segregated and disposed through Local Municipality. | | 4.3 | Hazardous wastes (as per Hazardous Waste Management Rules) | Yes | Quantities of hazardous wastes and disposal methods are listed below:
Used oil of 3 KL, Spent solvents of 764 TPA, & 8,000 Nos. of empty barrels/containers will be disposed through Authorized recycler. 2920 TPA of Process residue, 63.58 TPA of Spent carbon & 1 TPA of Date Expired Products will be sent to Incineration / co-processing. ETP sludge/MEE Salts of 3900 TPA and Inorganic salts of 79.05 TPA will be sent to TSDF. | | 4.4 | Other industrial process wastes | No | - | | 4.6 | Sewage sludge or other sludge from effluent treatment | No | - | | 4.7 | Construction or demolition wastes | Yes | The debris generated during construction will be disposed to low lying areas in the approved disposal site identified by the local body or used for internal road construction | | 4.8 | Redundant machinery or equipment | No | - | | 4.9 | Contaminated soils or other materials | No | - | | 4.10 | Agricultural wastes | No | - | | 4.11 | Other solid wastes | No | - | |
| 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 fuels from stationary or mobile sources | Yes | Boilers: 2x10 TPH (Fuel: Rice Husk / Coal / Briquettes)
Thermic Fluid Heater: 1x12 Lakh kcal (Fuel: Furnace Oil)
DG Sets: 3x1500 kVA (Fuel: HSD)
Chimneys of adequate height and stipulated APC measures will be provided as per KSPCB norms for the proposed activity. | | 5.2 | Emissions from production processes | Yes | Scrubbers with stack of 3m ARL will be provided for process emissions.
Emissions Acid mist and VOC | | 5.3 | Emissions from materials handling including storage or transport | Yes | Materials handling is through pneumatic/pumps with minimum Fugitive emission/VOC | | 5.4 | Emissions from construction activities including plant and equipment | Yes | Construction Phase:
Fugitive dust generated during the construction phase due to handling of construction materials and activities.
Fugitive dust emission will be restricted as Ready Mix Concrete (RMC) will be used. Dust Emission will be controlled by sprinkling of water and barricading the project surrounding with GI sheets. | | 5.5 | Dust or odours from handling of materials including construction materials, sewage and waste | Yes | There will be dust emission due to handling of materials during the construction phase.
During Operation Phase:
Manufacturing process is carried out in closed system/ clean room operation. PPE will be provided to workers. | | 5.6 | Emissions from incineration of waste | No | Incinerator will not be installed. | | 5.7 | Emissions from burning of waste in open air (e.g. slash materials, construction debris) | No | Not Applicable. | | 5.8 | Emissions from any other sources | No | - | |
| 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 | | 6.1 | From operation of equipment e.g. engines, ventilation plant, crushers | Yes | Construction Phase:
The machineries and equipment used during construction will be regularly maintained. Hence, noise generation is minimised significantly.
Operation Phase:
Manufacturing process will be in closed system. DG set, compressors, centrifuge and pumps are provided with noise and vibration control and acoustic measures as per guidelines.
DG set is used only during the power failure. Development of greenbelt area will suppress the noise level and restrict to industry premises. | | 6.2 | From industrial or similar processes | No | - | | 6.3 | From construction or demolition | Yes | There will be marginal increase in ambient noise level due to construction activities which will be reduced by undertaking periodic preventive maintenance of construction equipments and restricting and reducing the speed of vehicles operated for the movement of construction materials apart from barricading the project site. | | 6.4 | From blasting or piling | No | - | | 6.5 | From construction or operational traffic | Yes | Movement of construction vehicles contribute to noise. It is temporary in nature.
As project site is located in industrial area existing road will be used for regular operation. There will be marginal increase in traffic due to movement of vehicles from the project. | | 6.6 | From lighting or cooling systems | Yes | Cooling tower will be used in operation | | 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 spillage of hazardous materials | Yes | The raw materials will be stored in the warehouse with proper secured flooring. The transfer of solvents will be done through pipelines and spillages will be avoided by monitoring.
Risk assessment for proposed products manufactured is prepared through HAZOP studies. Extra care will be taken while handling the hazardous materials.
Training will be given for workers for handling of solvents and hazardous chemicals. | | 7.2 | From discharge of sewage or other effluents to water or the land (expected mode and place of discharge) | Yes | ZLD concept will be followed and no treated water will be discharged outside. | | 7.3 | By deposition of pollutants emitted to air into the land or into water | Yes | Necessary air pollution control measures are installed to the air pollution sources. | | 7.4 | From any other sources | No | - | | 7.5 | Is there a risk of long term build up of pollutants in the environment from these sources? | No | - | |
| 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 storage, handling, use or production of hazardous substances | Yes | Hazardous chemicals will be stored & used in the manufacturing process.
MSDS for all products and raw materials will be in place. Risk analysis and HAZOP studies will be carried out before commencement of the manufacturing activity.
Onsite emergency plan has been prepared and approval has been taken from the competent Authority. Necessary information and input will be given to District Authority to prepare off-site Emergency plan | | 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, earthquakes, landslides, cloudburst etc)? | No | There are no possibilities of floods, earthquakes, landslides. However, other natural calamities cannot be ruled out. All precautions will be in place to meet the eventualities to reduce the damage/impact. | |
| 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 utilities, ancillary development or development stimulated by the project which could have impact on the environment e.g.:
- Supporting infrastructure (roads, power supply,waste or waste water treatment, etc.)
- housing development
- extractive industries
- supply industries
- Other
| Yes | There will not be any additional development of supporting infrastructure/housing development /supply industries as this project site is within an established Industrial Area. | | 9.2 | Lead to after-use of the site, which could have an impact on the environment | No | - | | 9.3 | Set a precedent for later developments | No | It is an independent activity with no collateral developments. | | 9.4 | Have cumulative effects due to proximity to other existing or planned projects with similar effects | No | - | |
| (III) | Environmental Sensitivity | | S.No | Areas | Name/Identity | Aerial distance (within 15km.) Proposed project location boundary | | 1 | Areas protected under international conventions, national or local legislation for their ecological, landscape, cultural or other related value
| No | Not Applicable. | | 2 | Areas which are important or sensitive for ecological reasons - Wetlands, watercourses or other water bodies, coastal zone, biospheres, mountains, forests | No | There are no ecologically sensitive areas within 10 km radius around the project site. | | 3 | Areas used by protected, important or sensitive species of flora or fauna for breeding, nesting, foraging, resting, over wintering, migration | No | - | | 4 | Inland, coastal, marine or underground waters | Yes | • River Bhima: About 8.2 km south west of the site.
• River Krishna is about 12.3 km south of the site.
• Bada talab (village irrigation tank) is about 1.45 km east of the site. | | 5 | State, National boundaries | No | The project site is at about 2.8 km away from the state boundary of Telangana | | 6 | Routes or facilities used by the public for access to recreation or other tourist, pilgrim areas | No | - | | 7 | Defence installations | No | - | | 8 | Densely populated or built-up area | Yes | Yadgir city 31 km in North West Direction | | 9 | Areas occupied by sensitive man-made land uses (hospitals, schools, places of worship, community facilities) | Yes | Details of hospitals, schools and place of worship near to the project site are provided in Section 2.9.1.14, Chapter 2 of EMP report | | 10 | Areas containing important, high quality or scarce resources.(ground water resources,surface resources,forestry,agriculture,fisheries,tourism,minerals) | Yes | • River Bhima: About 8.2 km south west of the site.
• River Krishna is about 12.3 km south of the site. | | 11 | Areas already subjected to pollution or environmental damage.(those where existing legal environmental standards are exceeded) | No | - | | 12 | Areas susceptible to natural hazard which could cause the project to present environmental problems (earthquakes, subsidence, landslides, erosion, flooding or extreme or adverse climatic conditions) similar effects | No | - | | | Essential Details Sought |
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| S. No. | EDS Sought Date | EDS Sought | Letter |
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| (1.) | 23/11/2020 | The correction have been made as per the instruction received | | | (2.) | 29/10/2020 | (i) Based on the information submitted by PP it is Category B2 project, PP submitted this application at Central Level due to general condition. In application it is mentioned that the proposal is for bulk drugs and intermediates, However, the Notification dated 27.03.2020 is only for API not for intermediates. If the proposal is for API & Intermediate, please apply for TOR. Please check your proposal once again.
(ii) PP has submitted the covering letter which marked to SEIAA not MoEFCC.
(iii) It is mentioned that the processing of EC proposal, in the Ministry, is through Parivesh Portal only, therefore providing the requisite information/documents shall be submitted. It is also mentioned that after acceptance the Proposal, proposal can not be revise. Therefore, PP/Consultant is requested to kindly do needful accordingly. | |
| | | Undertaking | | I hereby give undertaking that the data and information given in the application and enclosures are true to be best of my knowledge and belief. And I am aware that if any part of the data and information 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. In addition to above, I hereby give undertaking that no activity/ construction/ expansion has since been taken up. | | | | Name of Applicant | Vishnukanth B | | Designation | Director | | Name of Company (Applicant Name should not be given here) | M/S. SHILPA ALBUMIN PRIVATE LIMITED | | Address | Plot No. 286, 287, 288, Kadechur Industrial Area, |
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