This is a Category B project according to IFC’s Procedure for Environmental and Social Review of Projects because a limited number of specific environmental impacts may result which can be avoided or mitigated by adhering to generally recognized performance standards, guidelines or design criteria. The review of this project consisted of appraising technical and environmental information submitted by the project sponsor. The following potential environment, health and safety impacts of the projects were analyzed:
- Site selection (including land ownership and land use), and environmental conditions;
- Air emissions and ambient air quality;
- Liquid effluent treatment and discharge;
- Solid waste handling and disposal;
- Hazardous materials handling;
- Hazardous waste handling and disposal;
- Fire prevention and emergency response plans;
- Environment, health and safety programs;
- Community involvement and relationship.
Bharat Biotech International Limited (BBIL) is located at Turkapally Village, Genome Valley, Shameerpet Mandal, Ranga Reddy District, Andhra Pradesh State, India, which is only 35 km from city of Hyderabad. BBIL purchased its land through local government. The present land of BBIL is approximately 7.5 hectares with 1.38 hectares of buildings and 2.0 hectares of greenbelt for lawns.
The plant is located in a rocky hill area, and the land is not arable. The surrounding areas are barren rocky lands and there is no residential house within one mile. But all the area is reserved by local government as future genome valley industrial park. BBIL has no plan to purchase new land now. But the management agrees to inform IFC if they decide to purchase more land.
There are three boilers at BBIL, two are in use and one is for backup. The boilers are the steam sources used in the production processes. There is also an incinerator on-site for disposal of killed animals used in the experiments. The emissions from boilers/incinerator and ambient air quality met both local and World Bank Group (WBG)/IFC Guideline limits, with the exceptions of particulate matter (PM). PM monitoring data exceeded WBG/IFC Guideline limits for both emission and ambient air. Diesel oil is the only energy source for these boilers and incinerator. However, there is no filter or other type of scrubber systems for the flue gases of the boilers and the incinerator, which causes the PM exceeds the WBG/IFC guidelines. The plant management agrees to install scrubber systems in the boilers and incinerator.
The water source of BBIL is from internal wells. The total process water consumption is approximately 40 m3/day, which is used for fermentation and equipment cleaning. The wastewater contains cell debris and sodium hydroxide (NaOH). The wastewater goes through Kill Tank for sterilization before sent to wastewater treatment plant (WWTP). The liquid effluent from wastewater treatment meets both local and IFC limits with the exception of total suspended solids (TSS), which exceeded WBG/IFC Guideline limit. There is no sedimentation process in the WWTP, which is the major reason for higher TSS level. The liquid effluent is used for watering green belt; therefore, the higher level of TSS has limited impact to the environment. The plant management agrees to add a sedimentation tank in the planned new WWTP.
Arsenic, cadmium, chromium (VI), and absorbable organic halogens (AOX) are not used in BBIL; therefore, the requirement of these compounds in WBG/IFC Guideline for pharmaceutical manufacturing does not apply to BBIL. Since the phenol usage is relative large in BBIL, it is suggested to monitor phenol from effluent of wastewater treatment plant. The sanitary wastewater goes through septic tank treatment before discharged. The effluents from both WWTP and septic tank is used for irrigation of the greenbelt, and the sludge is used as manure.
Solid wastes contractors come to BBIL periodically to pick up the solid wastes. The solid wastes are sent to the dump site that is approved by local government.
The fuel for boilers and incinerator is diesel oil. There are two oil storage tanks on site with secondary containment of enough volumes. There are minor leaks in the hoses for oil tanks and the boilers. There are also spills at the sieve changing area of boilers. Cotton adsorption mats are suggested for minimizing the oil leaks and spills.
There is no organic chlorides used on site. However, BBIL uses thiomersal (containing Hg) and phenol, probably for disinfection. Only 400 grams of thiomersal are used in the products; therefore, there is no Hg pollution problem. Phenol is also used in products. Since the phenol usage is relative large, it is suggested to monitor phenol from effluent of wastewater treatment plant.
Mice, rabbits and guinea pigs are raised in the animal house on-site for R&D purpose. The conditions of animal house are satisfactory. According to the experiment schedule, 2 or 3 small animals (mice or rabbits) are killed each day. The killed animals are wrapped in plastic bags and put into refrigerator at -21 oC. After accumulating enough dead animals, they are sent to the incineration.
The hazardous wastes generated from BBIL include killed animals/animal incineration ash, waste engine oil, and oil slag. The killed animals are treated at an on-site incinerator with the capacity of 17 kg/hr. The temperature in the incinerator is only 800 (C, which is far lower than the 1,000 (C suggested by WBG/IFC Guideline. However, there is no organic chloride used on site. It is strongly suggested that BBIL conduct one test to verify non-existing of dioxins and furans in the emission of incinerator.
The incineration ash is now treated as solid waste, which is either buried in the green belt as manure or disposed at municipal dump site. It is suggested that the incineration ash shall be packed in drum and sent to qualified hazardous waste landfill, which have impermeable liner systems and leachate collection systems.
The waste engine oil from oil sieve cleaning process is stored in plastic containers of different sizes at various locations. The waste oil is sold to unidentified receivers. It is suggested that the waste engine oil shall be transferred to drums, and the drums shall be stored at a location with secondary containment. The waste engine oil might be disposed at incinerator and recover the heat. But careful tests must be conducted to insure that the emission meets both WBG/IFC guideline and local regulation, and that the emission must not contain POPs if the waste engine oil is burned at the incinerator. If the emission could not satisfy these requirements, the waste engine oil should be sold to qualified hazardous waste treatment/recycle facilities, which have the government certificate for hazardous waste treatment/recycle.
The oil slag is generated from oil sieves. The slag is piled on site without any containment. The slag is also disposed at the municipal dump site. It is suggested that the oil slag shall be put in containers. The oil slag might also be disposed at incinerator and recover the heat. But careful tests must be conducted to insure that the emission meets both WBG/IFC guideline and local regulation, and that the emission must not contain POPs if the oil slag is burned at the incinerator. If the emission could not satisfy these requirements, the oil slag should be sold to qualified hazardous waste treatment/recycle facilities, which have the government certificate for hazardous waste treatment/recycle.
There are well-prepared fire prevention and emergency response plans on site. The employees have annual trainings for these issues. All the manufacturing buildings are large and have limited entrance and exits for various process lines due to the disinfection requirements. In case of fire or power failure, It is easy to lost and could not get out. It is suggested that there shall be signs for emergency evacuation which luminesce during fire or other emergency. There are not enough fire extinguishers on site, and there are no routine checks for most of the existing fire extinguishers.
The vice president of BBIL lead the environment, health and safety (EHS) issues. The general health and safety issues are satisfactory on site. There is established health and safety management plan on site. Safety Plan, Bio-Safety Manual, and Onsite Emergency Plan are prepared and available to each department. There are a full time environmental analyst and a safety/security officer assigned for environment and health/safety areas, respectively. The health and safety programs at BBIL follow the guidelines of US Department of Agriculture (USDA) and WHO regulations for bio-researches and biopharmaceutical manufacturing. The employees have annual health checks. Both fulltime employees and contractor enjoy the health insurance benefits. There is a doctor on site, who works part-time as the clinic staff for first aid. If required, the ambulance from nearby hospital can arrive at site in ten minutes
BBIL’s operations significantly increase the land value in the nearby area, which benefits the local residents. Besides, BBIL also purchase water from local residents during the dry seasons. BBIL hires 6 female villagers as contractors working at the packing process through an agent. Based on the conversation with these ladies, they are happy to work here. Otherwise, they could not find a decent job in this area. The high tech nature of BBIL limits it to hire more uneducated villagers. BBIL realizes the importance to keep a good relationship with local villagers. There is no complaints from local residents. Recently, BBIL just donated furniture for local school. BBIL also purchase water from local villagers during dry seasons.
