Biotechnology facility is located in a rented space inside the well-established and specialized Marmara Teknokent industrial zone in Gebze, which is in an urban modified habitat. No indigenous peoples or cultural heritage is present in the project area. As such, the project does not result in E&S risks and impacts that must be managed in accordance with PS5 Land Acquisition and Involuntary Resettlement, PS6: Biodiversity Conservation and Sustainable Management of Living Natural Resources, PS7: Indigenous Peoples, and PS8: Cultural Heritage.

If IFC’s investment proceeds, IFC will periodically review the project’s ongoing compliance with the Performance Standards.

Environmental and Social Assessment and Management Systems and Policy:

Nobel Duzce plant has a documented E&S policy and an environmental and social management system certified compliant with ISO 9001, ISO 14001 and OHSAS 18001 standards. As part of the previous investment, Nobel updated its Environmental Policy and Business Code of Ethic that reiterates its commitment to protect people and environment and use natural resources, energy and materials by following Good International Industrial Practices. Nobel also updated the E&S management system manual and related EHS standard operating procedures to effectively manage new fill and finish line production and automatic warehouse operations. During IFC’s review, evidence of a robust implementation of the ESMS on the ground was noted.

Furthermore, the company meets the requirement of the Good Manufacturing Practices (GMP) in its facilities. GMP is a system that ensures that products are consistently produced and controlled according to quality, safety and hygiene standards as pre the requirements stipulated by various countries. Duzce plant holds GMP certifications from 27 countries including the European Union. Recently, Biotechnology facility also obtained GMP certification from the Turkish authorities for pilot manufacturing.

Prior to construction of the Biotechnology facility, in line with Turkish Environmental Impact Assessment (EIA) regulations, a “project description file” was prepared by a third-party consultancy company and submitted to the national regulatory agency. Because of the scope and characteristics of the development, the company was not required to conduct an EIA.

Biotechnology facility has documented OHS, waste management procedures and emergency preparedness and response plan (EPRP) and standard operating procedures in accordance with the GMP and national regulatory requirements. Biotechnology facility is currently in process of revising those procedures/plans and developing additional procedures including chemical spill management, monitoring procedures for ambient and workplace air quality to be in line with Nobel Duzce plant’s ESMS in commensurate with the risks of managing Biotechnology facility. It also actively monitors the E&S performance of the Biotechnology facility and frequently submits monthly reports to senior management.

Organizational Capacity and Competency:

At Biotechnology facility, facility director and two quality assurance specialists are responsible for E&S and OHS management. Biotechnology facility has hired an environmental and OHS consultancy firm to manage day-to-day operations. These firms have environmental and OHS specialists to assist the company to implement its environment and OHS procedures and perform monitoring activities. The consultants report directly to Biotechnology facility’s facility director.

Emergency Preparedness and Response:

In accordance with Turkish regulations, Nobel and Biotechnology facility maintain fire safety equipment based on the nature of the risk involved. The fire system includes portable fire extinguishers, fire hydrant system with dedicated fire water storage, and sprinklers. Smoke detectors and alarm systems were installed at its facilities. Potential hazardous areas have been clearly identified and evacuation routes and assembly points are determined and clearly marked. The emergency drills are periodically organized at both facilities. Observations and lessons learned from mock drills are reported to the senior management with time-bound action items.

For managing risks due to COVID-19 pandemic, Nobel Duzce facility and the Biotechnology facility have established an emergency committee to assess, identify and manage risks and to take appropriate actions. Employers have been provided with the Ministry of Health and The World Health Organization recommended personal protection equipment to reduce the risk of infection, e.g., disposable masks, globes, sanitizing gel and soap. The company developed an Emergency Action plan particularly for Covid-19 and strictly follows at all its facilities and employees have been communicated and trained about the procedures. 

Monitoring and Review:

As part of its certified management systems, Nobel Duzce plant has documented procedures to monitor and review key environmental, health and safety performance indicators including occupational health and safety, noise, fire safety, air emissions, effluent waste, generation and management of solid and hazardous waste. Monitoring results are in line with local legislation requirements, GMP standards and relevant WBG’s EHS guidelines values.

The Biotechnology facility also follows a similar approach and monitors key EHS matters including occupational health and safety, fire safety, effluent waste, management of wastes. Nevertheless, there is no documented monitoring procedures. As described earlier, the company is in the process of finalizing its E&S and OHS monitoring procedure for the Biotechnology facility as part of its documented ESMS.

Working Conditions and Management of Worker Relationship:

At the time of the appraisal, Nobel Duzce plant employed 446 employees, almost 25%of employees are female. As of end-2020, the Biotechnology facility had 62 staff (almost 50% are female) comprising of mainly scientists and doctors. Cleaning, security, environmental consultancy and minor construction works are outsourced to licensed contractors.

Human Resources Policies and Procedures:

As per the agreed ESAP under the existing investment, Nobel updated its HR policy and HR procedures, as required by the local labor laws and consistent with provisions of IFC PS2 which are applicable to all its employees in Duzce facility and the Biotechnology facility.

No retrenchment in either of its facilities took place during the pandemic. The company continues recruiting new employees as per business need.

Grievance Mechanism:

The company has developed a formal and documented grievance handling procedure which complies with IFC PS2. A specific email address is shared with workers who want to lodge any complaint and the process is duly explained to employees during the induction. All employees can also raise any grievances (also anonymously) by filling a designated form and submitting in the grievance boxes or directly to their supervisors. Workers with concerns about unfair treatment are encouraged to report to the plant management or HR business partners in respective facilities. All the employees as well as third-party workers at Biotechnology facility have access to this grievance mechanism procedure and mediums. Currently, the grievance collection boxes are not available in its facility. The Biotechnology facility will place the grievance/complaints boxes in the area of common accessibility.

Occupational Health and Safety:

Duzce plant is OHSAS 18001 certified and an established EHS manual is used on site, which also overlaps GMP requirements and occupational health for the employees. Nobel updated its OHS procedures to cover all activities including new fill and finish line and automatic warehouse.

The Biotechnology facility has reported to have an OHS risk register and documented procedures commensurate with the risk in a R&D lab. As described earlier under PS1 section, OHS procedures for the Biotechnology facility are being revised in line with IFC PS2 and WBG/IFC EHS Guidelines requirements. 

At both facilities, the company keeps detailed records of incidents and near-misses in their accident log system including the relevant corrective actions. A monthly OHS investigation report is prepared and submitted to management of the company. There are key performance indicators target for OHS performance at company level.

Biotechnology facility currently outsources OHS services to a local consultancy firm. The external specialist from this firm oversees the daily OHS management, organizes trainings and monitors incidents, near misses and prepare monthly report for the management. As in Nobel Duzce plant, the Biotechnology facility also has an OHS committee that has been chaired by the facility director and includes employee representative, medical doctor, OHS and environmental consultants that meets bi-monthly to review and discuss the OHS performance. 

At Nobel Duzce plant, workplace air quality and noise levels, dust, temperature and humidity for all important operational locations are monitored. The monitoring data shows that the company is compliant with local regulatory requirements and good international industry practices. At the Biotechnology facility, the workplace air quality and noise level measurements will commence in February 2021. Emissions generated during lab tests are provided with appropriate air pollution control equipment. The lab tests are conducted in biosafety cabinet (Class II). There are adequate HVAC systems in laboratories and filters are changed periodically by a licensed company and disposed properly.

Workers Engaged by Third Parties:

The company incorporates EHS clauses such as those related to OHS and living and working conditions to the contractual agreements with all its contractors including construction and transportation. Furthermore, it frequently monitors the activities of the contractors to ensure compliance with the contractual requirements and applicable local labor laws.

Resource Efficiency:

The company has defined corporate KPI for energy use and monitors its consumption. The company is working towards reduction in total energy consumption by using LED lighting and increasing awareness among workforce. In future, Nobel Duzce plant is planning to install solar power units (solar rooftop or field) in its existing footprint.

Primary energy requirement for the Duzce plant and Biotechnology facility is that of electricity and natural gas which are supplied from the national grid. Diesel fueled generators are installed on site as backup generators. The proposed investment is not expected to generate GHG emissions exceeding 25,000 tons per annum of CO2e.

Water and Wastewater Treatment:

In Duzce plant water used for production and other daily usage is sourced from a groundwater well and is further treated with activated carbon and reverse osmosis process. The treated water is checked daily in the company’s laboratories for chemical and microbiological analyses. Drinking water is supplied in bottles by third party vendors. At the Biotechnology facility, water is mainly used for sanitary purposes.

At Duzce plant, wastewater generated during the process are treated via a biological wastewater treatment plant. The capacity of the treatment plant is adequate. After treatment, Duzce facility discharges the effluent to a central municipality sewage system as per the environmental permit condition. Effluents are tested yearly according to local regulations externally. At the Biotechnology facility, water is sourced from municipal utilities. Wastewater generated at lab are subjected to primary treatment onsite before discharging it to the industrial zone treatment facility if it is above the permit levels. Currently, it is directly discharged to the industrial zone sewage network in accordance with the permit requirements.

Air Emissions and Ambient Air Quality:

Nobel monitors key air emission parameters from its facilities such as particulate matter (PM), CO, NO2, SO2 in line with local regulations and WBG/IFC General EHS Guideline Table 1.1.2. The results submitted for 2020 are in compliance with the local regulatory limits and WGB EHS Guidelines limits. As described earlier under PS2 section, emissions generated during lab tests are provided with appropriate air pollution control equipment.

Hazardous Material and Waste Management:

The Duzce plant and the Biotechnology facility have a formalized waste management procedure a waste management plan for both hazardous and non-hazardous waste. Hazardous and solid wastes are handled by certified authorized third-party contractors. Medical waste generated in the R&D lab (e.g. blood samples, syringes etc.) is handled by another contractor and disposed according to local medical wastes control legislation. Rejected and/or expired products are collected and disposed by authorized third party contractor under the supervision of local authorities. 

Nobel Duzce plant keeps a list of hazardous materials used in production, which are handled and stored according to respective material safety data sheets and GMP requirements. Standard operating procedures are in place to collect and temporarily store the small quantities of hazardous waste (e.g. spent solvents and organics) before they are collected and disposed by a licensed and authorized contractor.

The generated wastes are currently stored in a separate area inside the Biotechnology facility until a proper storage area will be designed and implemented. As per ESAP item #1, Biotechnology facility will design a temporary storage area and properly store hazardous and non-hazardous wastes in this designated area prior to disposal by a licensed company. The waste management procedure will be updated accordingly.

The Biotechnology facility does not conduct human trials as wells as animal testing. The lab works with an authorized clinic to conduct relevant trials.

There are a handful number of households in the vicinity of the Duzce plant. Given the nature of company, noise is not significant. As per GMP requirements, Nobel has established a customer complaints mechanism to regularly monitor the number and root cause of complaints under the scope of its quality assurance system. Traceability and product recall procedures are available in case of any need. This system is also implemented in the Biotechnology facility.

As transportation to work site is provided to employees, specific EHS measures for commuters are included in the contracts with transportation contractors. The Biotechnology facility is located in an established industrial zone, so no adverse impact to communities is expected.

Security Personnel:

As per the agreed ESAP under the existing investment, Nobel carried out a security risk assessment and developed security management plan. The Duzce facility is securely fenced and employs in total 7 security personnel, 2 of them is armed for 3 shifts and their main function is to regulate entrance and access to facilities. The Biotechnology facility also has a security management plan, and it does not employ armed security personnel. Main function of security personnel is to regulate entrance and access to facilities. Security forces are well trained and outsourced from a licensed security company.