The proposed project consists of a loan to NPO Petrovax Pharm, a Russian niche pharmaceutical company based in Moscow. The loan will be used to finance construction of a green field facility near Moscow to manufacture a new generation vaccines, e.g. influenza vaccine, for the Russian and CIS market. The Project is a result of collaboration efforts of Petrovax and a major international pharmaceutical player, Solvay, which is a leading European chemicals and pharmaceuticals group. Solvay will provide project implementation and management support.
The Project has been categorised B/0. Environmental, health and safety risks associated with construction and operation of this pharmaceutical plant are not significant. The Bank’s environmental analysis has been based on the Environmental Impact Assessment (August 2004) prepared by an independent environmental consultant on behalf of the client. EBRD’s Initial Environmental Examination, carried out by ED staff member in May 2004, indicated that there are no environmental sensitivities associated with the project. The site was chosen among several alternatives on the basis of its good transport links and low ecological value. The proposed project site is adjacent to the existing motorway Moscow- Serpukhov and although the land plot it is formally classified as “agricultural”, there are no crops that have ever been grown on it. There are about twenty country houses located in the vicinity of the site (ca. 100 m away). However, this fact does not represent potential issue of concern as the residents have been informed about the future plans and have not expressed any objections to the project due to the fact that the required sanitary protection zone of 50 m will be observed. The nearest local river (Pakhra) is 1 km away from the project site. The Bank's environmental due diligence confirmed that the new plant will be built in accordance with applicable national environmental, health and safety requirements, with Good Manufacturing Practice (GMP) standards and generally in line with the World Bank Pollution Prevention Guidelines for Pharmaceuticals Manufacturing. No stand alone environmental action plan is required as the project design provides for minimisation of the environmental, health and safety impacts associated with construction and operation of the plant.
Key air emissions will include ethyl alcohol (from the antiseptic maintance of equipment surfaces); peroxide (from cleaning); nitrogen and carbon oxides, benzopyrene (from gas-fired hobs and boiler); volatile organic components, benzene hydrocarbons, sulphur oxides, ash (from the car park and garage). All the emissions will be within the maximum permissible emissions levels calculated on the basis of the applicable national standards for the maximum permissible concentrations (MPC) of the corresponding pollutants in the atmospheric air.
There will be no polluted process wastewaters as the project design envisaged closed loop water system (95% of water will be recirculated). The waste waters from the maintenance operation can be classified as sanitary and will be discharged into the municipal sewer system. The stormwater will be sent via the drainage system to on-site waste water treatment facilities and than discharged onto the relief/used in watering the site.
Key types of solid and hazardous waste from the production process and general operating practices will include mercury lamps, packaging waste, filters, rubber cuttings, polymeric waste (plastic containers), metal scrap, cloth, waste paper and solid municipal waste. All these will be stored temporarily on-site in designated areas and than either handed over to subcontractors for further recycling and re-use, as appropriate, or transported to a municipal landfill in accordance with the local waste managements regulations.
The noise levels resulting from the production facilities in the distance of 50-100 m from the boundary of the plant's sanitary protection zone (in the area of the country houses cluster) will be 20dBa, which is well below the applicable World Bank Guidelines (55 and 45 dBA during the day and at night respectively for the residential areas).
In the event of an accident or emergency the machinery in the plant shuts down automatically. The plant will co-ordinate with the municipal fire service to ensure a timely and adequate response to any emergency situation. Emergency response plan will be developed in a due course and will be reviewed by the Bank upon its submission.
Health and safety issues are, likewise, well recognised and managed by the client. Training will be provided when new employees start and repeated at regular intervals during the year. Health and safety controllers will be in charge of monitoring compliance with health and safety requirements and there will be a variety of sanctions which can be applied for non-compliance with health and safety rules.
There is likely to be a range of positive environmental opportunities associated with this project particularly those in relation to the proposed development of Good Manufacturing Practice (GMP) as well as the ISO 14001 and OHSAS18001 standards adhered to by Solvay, which will provide the implementation and management support for the project.
This will take form of annual environmental reports and periodic monitoring visits of the Bank’s ED staff as required.
Arkadiy Nekrasov, General director
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