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CEIA for Ranbaxy-PS, Fermentation Plant Expansion EXECUTIVE SUMMARY

1. PROJECT
HIGHLIGHTS
ƒ Ranbaxy Laboratories Ltd. has a fermentation plant at Paonta Sahib (Ranbaxy-PS), district Sirmaur, Himachal Pradesh, and is proposing to increase its production capacity from 8 tpa to 120 tpa of fermentation products by building additional fermentation facilities. ƒ Ranbaxy-PS is currently manufacturing 8 tpa of Lovastatin and Pravastatin and is planning to expand its products manufacturing capacity in two phases to 120 tpa. ƒ The project cost for existing plant is Rs. 342.5 million and the total additional cost of fermentation plant expansion will be nearly Rs. 929.5 million. Out of this amount, Rs. 122.5 million will be spent on incinerator, and effluent treatment R/O, MEE, SD and safety systems. ƒ Manufacturing process for fermentation products, Lovastatin and Pravastatin, involves three stage fermentation process consisting of inoculator stage, seed tank stage and fermentation/production stage. The harvested product is recovered through solvent extraction and purified by solvent washings, recrystallization and is finally vacuum dried. ƒ Major raw materials and chemicals used are: Yeast Extract Powder, Sodium 2 Ethyl Hexanoate, Sodium Chloride, Soya Peptone, Sugar, Sodium Acetate, Calcium Carbonate, Orthophosphoric Acid, Magnesium Sulphate Heptahydrate. ƒ Spent solvents are recovered in solvent recovery unit and are reused ƒ Mycellium and waste water from process and utilities are sent to ETP ƒ Solvent recovery residues and other hazardous wastes are incinerated. ƒ Existing and proposed utilities requirements and instal ed capacities CEIA for Ranbaxy-PS, Fermentation Plant Expansion Utilities
Existing First
Total After
Requirements
Phase of Phase of Expansion
Expansion Expansion

ƒ Effluent treatment capacities installed/proposed to be installed are: Utilities
Existing First
Total After
Requirements
Phase of Phase of Expansion
Expansion Expansion

Plant (m3/d) Tertiary Treatment Unit MGF and ACF ƒ Ranbaxy-PS plant is located in Kiar-da-dun val ey adjoining river Yamuna at a distance of nearly 0.9 km towards NNE direction of the confluence of river Bata with river Yamuna. ƒ 10 km radius study area with Ranbaxy-PS plant at its centre has 69 villages (56 in Sirmaur district of Himachal Pradesh, 5 in Dehradun district of Uttaranchal, 4 in Saharanpur district of Uttar Pradesh and 4 in Yamuna Nagar district of Haryana) and 1 town (Paonta Sahib). ƒ 32 forest ranges (29 reserve forests and 3 protected forests) are found in the study area and portions of Dhaula and Mahadevkhola reserve forests are within 3 km distance from Ranbaxy-PS plant. CEIA for Ranbaxy-PS, Fermentation Plant Expansion ƒ On the basis of Rapid EIA study report (January 2004), NOC from Himachal Pradesh Environment & Pollution Control Board (HPEPCB) and the Minutes of Public Hearing, MoEF granted the environmental clearance vide letter No. J-11011/177/2004-IA II(I) dated 19.01.2005 for the proposed expansion in fermentation products capacity. ƒ In July 2004 a public interest litigation (PIL) was initiated against the proposed capacity expansion at Paonta Sahib plant of Ranbaxy in the Hon’ble High Court of Himachal Pradesh at Shimla Vide CWP no. 490/2004. ƒ In July 2006 the Hon’ble High Court of Himachal Pradesh passed the judgement stating that the expansion of the fermentation plant at Ganguwala can not be permitted to go on until a Comprehensive EIA and EMP is prepared and the same is taken into consideration by the concerned authorities before granting requisite site permission for setting up of the plant. The court also mandated that the Comprehensive EIA and EMP should also take into consideration the Development Plan for Paonta Sahib, Zoning Atlas for Siting of Industry (Sirmaur District), Guidelines for Environmental Clearance (HPSPCB) and results of sampling and analysis carried out by three approved environmental laboratories. ƒ Most of the construction work including installation of equipments for the proposed fermentation plant expansion was completed during the period January 2005 when MoEF granted environmental clearance and July 2006 when Hon’ble High Court of Himachal Pradesh stopped the expansion of fermentation plant till a Comprehensive EIA/EMP is prepared and the same is considered by the concerned authorities before granting requisite site permission for setting up of fermentation plant expansion facility. ƒ While the proceedings in the Hon’ble High Court of Himachal Pradesh were going on, baseline data collection was started on 12/11/2005 for the Comprehensive EIA study of one year duration following the procedures of EIA notification of 1994. POLLUTANTS GENERATION, TREATMENT AND DISPOSAL

A. Pollution

Description
Existing
Expansion
Liquid Effluents (m3/d)
Mycelium
CEIA for Ranbaxy-PS, Fermentation Plant Expansion Emission
Incinerator
Emission Load (kg/h)
Incinerator
Solid Wastes (kg/d)
CEIA for Ranbaxy-PS, Fermentation Plant Expansion Note: indicates emission load only when Incinerator/DG Sets are
operating.
B. Pollution
ƒ Liquid effluents are presently treated in a well designed two stage effluent treatment plant (ETP) of appropriate capacity involving primary treatment and two phases of secondary biological treatment, namely, anaerobic/aerobic and secondary aerobic phases. Treated effluents from ETP are further treated in a tertiary treatment system consisting of multigrade sand filter (MGF) and activated carbon filter (ACF) of requisite capacities. ƒ Treated effluents meeting the limits for discharge on land for irrigation are currently used for green belt development at Ranbaxy-PS plant complex. ƒ Liquid effluents after expansion from existing facility and that proposed after expansion will be treated in a two stage ETP consisting of primary treatment and secondary aerobic biological treatment, tertiary treatment in MGF and ACF and post-tertiary treatment consisting of ultrafilteration (UF), two stage reverse osmosis (RO), multiple effect evaporator (MEE) and spray drier (SD). ƒ After proposed expansion treatment of 700 m3/d of effluent will result in the recovery of 667 m3/d of good quality water as RO permeate and
MEE distillates for recycle and reuse in process and utilities, which will
reduce fresh water requirement from borewell to only 403 m3/d and will
also make Ranbaxy-PS as a truly Zero Discharge facility.
ƒ All solid/liquid hazardous wastes, primary and secondary sludge from ETP, mycelium, contaminated filter pads, etc. will be incinerated. ƒ Concentrates from MEE will be spray dried using hot flue gases from incinerator as source of heat for evaporation. ƒ For effective dispersion of gaseous emissions, very tall stacks are/will be provided for all gaseous emission sources, 50 m high for each boiler and 30 m high for incinerator and each DG set. CEIA for Ranbaxy-PS, Fermentation Plant Expansion BASELINE ENVIRONMENTAL CONDITIONS

A. Physical
Environment
ƒ Soils of the area are loamy/sandy loam and have good fertility. Water Resources and Water Quality
ƒ Yamuna, Bata and Giri are the important perennial rivers of the area and largely meet irrigation requirement. Government canals are the dominant source of irrigation (56.62%) followed by electrified tubewells (25.83%) ƒ Monthly monitored values of surface and ground water quality in the area over one year period indicates that the water quality is extremely
good and values of all parameters are well within the desirable limits
for drinking water except for total alkalinity.

Climatology and Meteorology

ƒ Month of May in summer season (March to May) is fairly hot. Rainy season begins from third week of June and lasts till middle of September. Months of July and August have heavy rains and account for 52.8% of annual rainfall of 1781 mm at Paonta Sahib. October and November months correspond to post-monsoon season while January is the coldest month in winter season (December to February). ƒ Meteorological data col ected at the site for eight months indicates that the predominant winds are from N (3.99%) followed by S (3.29%), NNE (3.04%), SSW(2.93%) and SW (2.67%). Average calm period is 51.73% with December 2005 showing highest calm period (69.64%) and May 2006 showing the lowest calm period (33.28%). Average wind speed is 2.4 kmph with May 2006 showing highest wind speed (4.2 kmph) and November 2006 showing the lowest wind speed (1.5 kmph). Ambient Air Quality
ƒ Annual average values of SO2 and NOx monitored at four locations during 12/11/2005 to 15/11/2006 are well below the 24-hourly standards of 60 µg/m3 for residential, rural and other area. Annual average limit for residential, rural and other area of 140 µg/m3 for SPM is exceeded at two locations, Pataliyon (187 µg/m3) and Paonta Sahib Town (Ranbaxy Guest House) (152 µg/m3), and that 60 µg/m3 for RPM is exceeded at all four locations though only marginally (61 µg/m3) at Main Gate (Fermentation Plant) and Batamandi (New Formulation Plant Main Gate). CEIA for Ranbaxy-PS, Fermentation Plant Expansion ƒ Noise levels monitored at 5 locations every month during one year do not meet the ambient air standards for noise in residential area both during day and night-time, but these standards are exceed only once during day-time at Main Gate (Fermentation Plant) and twice during night-time at Kedarpur out of 12 monthly observations. ƒ Large percentage of total geographical area (31415.93 ha) is under forests. Culturable area is only 8756.17 ha and 46.52% of total culturable area is irrigated as per Census 2001. ƒ Paddy and wheat are the main crops respectively of kharif and rabi B. Biological
Environment
ƒ Study area has a large variety of vegetation, such as, timber, fruit, avenue and ornamental trees, shrubs and climbers. ƒ Reserve and protected forests have luxurious growth of large varieties ƒ Areas under forests support large variety of fauna (mammals, birds and Demographic and Socio-Economic
ƒ 68 villages and 1 town in the study area support a total population of 91719 with a sex ratio of 849 and literacy rate of 65.23% as per 1991 Census. Population of village Kulhal in tehsil Vikas Nagar, district Dehradun is not available. ƒ Rural population in 68 villages is 72629 and urban population in one ƒ Total main workers in the study area account for 28.23% and nearly ƒ Most of the villages have primary education facility, tap water supply for drinking and power supply for all purposes. CEIA for Ranbaxy-PS, Fermentation Plant Expansion
4. ENVIRONMENTAL
ASSESSMENT
Topography, Physiography, Soils, Climatology and Meteorology,
Noise, Land Use, Biological, Demographic and Socio-Economic

ƒ Proposed expansion of fermentation plant will have essentially no impact on these components of environment. Water Resources and Quality
ƒ 403 m3/h of additional ground water needed for fermentation plant expansion is unlikely to have any adverse impact on ground water resources of the area or other users of ground water in the area. Zero Discharge, there will be no impact whatsoever
on the quality of ground/surface water.

Ambient Air Quality

ƒ Operation of oil fired boilers to meet the additional steam requirement of 105 tpd and that of incinerator to incinerate 414 kg/d of solid/liquid wastes may have only marginal impact on SPM, RPM and SO2 concentrations in ambient air of the study area. ƒ The impact on the 24-hourly ambient air quality in the study area due to proposed net increase in steam requirement as a result of expansion in fermentation capacity estimated from dispersion modeling is as follows: Parameter Monitored
24- Likely Increase
24-Hourly
Concentration
Concentration Increase In Net
Range Expected
Emission Load
After Proposed
(µg/m3)
(µg/m3)
Expansion (µg/m3)
ASSESSMENT
ƒ A distance upto 15 m from tank farm boundary can be considered as a vulnerable zone from radiation heat intensity consideration as a result of pool fire of flammable solvent. CEIA for Ranbaxy-PS, Fermentation Plant Expansion ƒ A distance upto 51 m from tank farm boundary can be considered as a vulnerable zone from hazardous chemical release concentration consideration under worst environmental conditions.
6. DISASTER
MANAGEMENT
ƒ An on-site disaster management plan is prepared to handle worst
7. ENVIRONMENTAL

MANAGEMENT
ƒ Use of very high stacks for discharge of gaseous emissions, use of a comprehensive effluent treatment and management strategy resulting
into recovery of 667 m3/d of good quality water for recycle and reuse
thereby reducing fresh borewell water requirement to 403 m3/d in place
of 1070 m3/d and also achieving a truly Zero Discharge condition,
properly treated incineration of all solid/liquid hazardous wastes
including primary and secondary sludges from ETP in a properly
designed and operated incinerator meeting CPCB guidelines (not yet
notified), storage of all solid wastes (spray dried solids and incinerator
ash) in impervious solid wastes pit with a provision of sufficient area
within Ranbaxy-PS plant complex for 35 years storage, provision of
effective acoustic enclosures for DG sets, installation of requisite fire
fighting facility and use of personal protective equipments are the major
environmental management and safety aspects already implemented
for fermentation plant expansion by Ranbaxy-PS plant management.
ƒ The only additional environmental management steps recommended for expansion of fermentation plant capacity at Ranbaxy-PS are as follows: − Strengthening of existing green belt and extending it to fermentation plant expansion area so as to cover 30% of total plant area with at least 5 m thick of curtain plantation at the entire plant boundary especially in N-NE and S-SW sectors to ameliorate air and noise pol ution by acting as a sink for particulates/gaseous pol utants and as a barrier for noise propagation. − Use of low sulfur furnace oil/LSHS (maxm. 1% S) and HSD (maxm. 0.25% S) as fules for boiler and DG sets, respectively, for further reducing incremental glc values of SO2 due to flue gas emissions. − Implementing the environmental monitoring plan for assessing long term changes in environmental quality in and around Ranbaxy-PS fermentation plant. CEIA for Ranbaxy-PS, Fermentation Plant Expansion
8. PROJECT
BENEFITS
• Both Lovastatin and Pravastatin are life saving drugs and are of great importance to mankind. Expansion in production facility will ensure their easy availability within the country as well as for increasing their export to developed countries, such as, USA, United Kingdom, Germany, Australia, etc., thereby earning valuable foreign exchange. • The operation after proposed expansion will have definite beneficial impacts in nearby vil ages, eventhough marginal, on development of infrastructure facilities, gross economic product, employment opportunities to about 50 persons directly and for many more indirectly, and socio-economic development of the study area. • To specifically meet the social obligation, Ranbaxy-PS will provide assistance in nearby villages for the following:
- Mobile medical facility to provide free medical examination and treatment with focus on mother and child health, vaccination, family planning, AIDS/STD awareness, etc. Upgradation of infrastructure in schools. Creation of drinking water facilities, if required. Schemes for motivating bright students in schools. Technical support for rain water harvesting at Panchayat level. - Technical support to local administration for environment, health Improvement of overall civil infrastructure.
9. CONCLUSIONS

In view of excellent track record of existing fermentation facility of Ranbaxy-PS for environmental management and additional measures implemented/proposed to be implemented during expansion of fermentation facility as well as for agreeing to strengthen green belt in and around the plant with effective curtain plantation at plant periphery and after giving due consideration to the recommendations / guidelines given in Development Plan of Paonta Sahib, Zoning Atlas for Siting of Industry, Sirmaur District, HPSPCB Document for Environmental Clearance and analysis results of air, water and solids of three recognized environmental laboratories (SGS/AES/Nuchem) and also the findings during CEIA study, there appears to be no basis whatsoever for not approving the proposed fermentation plant expansion at Ranbaxy-PS.

Source: http://hppcb.nic.in/Publications/Ranbaxy/ES.pdf

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