PS5: Land Acquisition and Involuntary Resettlement does not apply as the project will be located on the land within the current footprint of the company;

PS6: Biodiversity Conservation and Sustainable Management of Living Natural Resources is not applicable given that the project is located in urban setting and does not have an impact on biodiversity and ecosystem services.  

PS7: Indigenous Peoples does not apply as none are present in the project vicinity; and

PS8: Cultural Heritage does not apply given the use of the site currently operated by the Company and there are no impacts on cultural heritage.

This is category B project according to IFC’s Policy on Environmental and Social Sustainability because the project will result in limited potential adverse E&S risks and/or impacts that are few in number, generally site-specific, largely reversible and readily addressed thorough mitigation measures. Based on the review of available project information, key project related EHS and social aspects were identified as: assessment and management of EHS risks and impacts due to the new facility; labor and working conditions including occupational health and safety (OHS), resource efficiency and waste management practices during operational phases and the impacts of the project activities on the community safety and security.

Environmental and Social Assessment and Management Systems

The new greenfield facility is located within the existing perimeter of the final dosage form plant in Duzce. The company has necessary environmental permit for the current manufacturing facility since 2000 when the facility was owned and operated by Plantafarma. For the proposed project, the company submitted its “Project Description File” application to the General Director of Impact Assessment and Monitoring, Ministry of Environment and Urban Planning (MoEUP) in 2016 and is still waiting for the approval. In line with the scope and characteristics of the proposed development within an existing facility, the document provided a high level overview of the potential risks during construction and operation of the facilities.

Moreover, aspect-impact analysis and job risk assessment are carried out for EHS and OHS aspects in Duzce plant in accordance with the requirements of ISO 9001, and14001 and OHSAS 18001 standards. The hazard assessment has been updated as per changes in manufacturing practices in Duzce.

Nobel facility in Duzce is certified for Good Manufacturing Practice (GMP) certified and hence undergo several external audits. 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. The new facility is being developed to comply with these GMP requirements and shall be certified in due course.

Duzce facility operates as per an EHS manual covering provisions on safety (e.g. risk classification, personal protective equipment (PPE), training, fire prevention, injuries reporting, etc.) and environment (e.g., waste disposal, treatment of wastewater, cross contamination prevention). This manual is developed in accordance with the requirements of ISO 9001, ISO 14001 and OHSAS 18001, and the company’s Duzce facility is certified compliant with those. As part of the IFC investment, Nobel will update and implement the EHS management system manual and related EHS standard operating procedures (SOPs) to the new proposed facility once it is operational [ESAP #1]

Policy

The Group’s corporate approach to EHS management is underpinned by the EHS section articulated in the company’s Business Code of Ethics and the Environmental Policy that is published on the company website (http://www.nobel.com.tr/en/production-rd). As noted, the group’s strategy is to continuously develop an environmental management system to be applied to all activities and services of the company, in line with national and international regulations.

Going forward, the company will update its Environmental Policy and Business Code of Ethic to include its commitment to comply with the requirements of IFC Performance Standards (PSs) and applicable World Bank Group (WBG) EHS Guidelines (General, Pharmaceuticals and Biotechnology Manufacturing) for the existing and any new development in the future [ESAP #2].

Management Programs

The company has management programs to address EHS/OHS risks and oversee contractors and primary suppliers’ performance as per the ISO 9001, ISO 14001 and OHSAS 18001 certified management systems. Procedures and instructions are communicated to relevant personnel and appropriate training is provided to all employees. The company commits to replicate the same procedure in the new Duzce greenfield development [ESAP #1].

Organizational Capacity and Competency

Ulkar Group, has established adequate EHS organization across its facilities. At plant level Quality Assurance Manager is responsible for overseeing the implementation of the group EHS policy. In addition, a robust EHS committee is in place at facility level and is in-charge of managing day-to-day operational EHS issues. The EHS committee is chaired by the plant director and comprises of an outsourced EHS consultant and the heads of quality control and quality assurance departments. While the plant director has the ultimate responsibility and oversight on the EHS issues at the facility level, the outsourced EHS specialist is responsible for the day to day operational matters. The EHS specialists visit the plants three times per week and they are reporting to the in-house quality assurance manager.  As per the [ESAP#1], Nobel will extend the scope of the EHS committee to the new facility.

At the Group level, Ulkar Group has a corporate HR team consisting of one HR director and HR Business partners, Organizational Development, Compensation & Benefits, Training & Development, Corporate Communication as well as Facility Management teams. There is a dedicated HR Business Partner who is responsible for Industrial relations & all HR activities on sites (Duzce Plant, R&D and Ulkar Kimya). Corporate social responsibility falls under Corporate Communication which is led by Human Resources Department.

Emergency Preparedness and Response

In accordance with Turkish regulations, Nobel maintains fire safety equipment at its facilities 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 observed and been installed at the visited facilities. Potential hazardous areas have been clearly identified and evacuation routes and assembly points are determined and clearly marked. The emergency response plan, drills and trainings are supervised by OHS specialist with the support of an outsourced consultant. Name and contact information of the OHS specialist are displayed all across the facilities. Some minor improvements are needed at the Duzce plant, regarding the provision of noise protecting kits for the employees and review of the signage for security exits. The company will develop and implement a similar emergency preparedness and response programs for the new plant, as part of the management procedures to be developed under [ESAP #1].

Monitoring and Review

Nobel has a robust monitoring and reporting program in place in accordance with local regulatory requirements and GMP standards. The program covers regulated emission, production areas parameters (e.g., temperature, humidity, differential pressure, noise at workstations, etc.), and waste parameters and falls under the responsibility of the plant quality control manager. Internal weekly audits are conducted by an assigned team including plant director, quality control manager and an OHS specialist and OSH consultant. Standard Operational Procedures (SOPs) are in place at plant level for monitoring OHS performance. Noise and illumination measurements are done annually in compliance to local regulation. Nobel also benefits from periodical external EHS and GMP audits by third party certification bodies and regulatory authorities as part of required certification/compliance protocols. A similar approach will be applied to the new facility and Nobel will be required to report to IFC annually on environmental performance of the operations via the Annual Monitoring Report.

Working Conditions and Management of Worker Relationship

Nobel currently employs a total of about 1316 employees. Of this workforce, 306 are employed at corporate level while 500 employees make up the field sales force. Duzce plant employs 339 while Tekirdag plant has 70 employees. The company also has 32 expat employees around the world on the company’s payroll. Women make up one third of the total workforce. The numbers of workers during peak period of construction of the greenfield facility is expected to be around 70. The workforce for construction and operation phases is recruited locally, including local subcontractors. Once the new facility becomes operational, 40 new employees are expected to be recruited. Security at both corporate and plant level is directly controlled by the company while roles such as housekeeping, transportation, catering, and gardening services are outsourced to licensed contractors.

Human Resources Policies and Procedures

At corporate level, Nobel has established a Business Code of Ethics and documented staff regulations at plant level.  All the employees receive a copy of the staff handbook at the time of joining, together with their appointment letter and contract. Site specific HR procedures are in place in both visited facilities. The company is in process of finalizing a corporate HR policy that outlines the general framework covering all Nobel staff and includes elements such as equal employment opportunities, non-discrimination, anti-bribery and corruption and ethics and integrity, in compliance with Turkish Labor Code and PS 2[ESAP #3].

Working Conditions and Terms of Employment

All workers have a signed contract that spells out terms of employment (e.g., salary, benefits vacation, etc.) and includes reference to relevant labor laws (overtime, various benefits).  In addition, Nobel’s HR team provides additional details on the workers’ rights, benefits, and requirements while under contract with the group.  The majority of workers holds open-ended contracts.  Nobel provides statutory benefits to its employees.  Additional benefits like bonuses, payment of one extra monthly salary, free on-site canteen, are available to employees depending on location. Transportation services are offered to employees from plant to central locations in the city of Duzce while female workers are accompanied up to their residence.

Retrenchment

As mentioned earlier, the project will result in the recruitment of about 40 new employees, and no retrenchment is expected in the foreseeable future. Workers’ termination is regulated by the Turkish labor law and internal HR procedures.

Grievance Mechanism

Currently an Ethics Committee is in place at corporate level to handle cases and complaints in case of violation of the company’s business ethics code.  A specific email is shared with workers who want to lodge any complaint and the process is duly explained to employees during the induction period. Moreover, in both Duzce and Ulkar plants, employees can raise any grievances by filling a designated form and submitting in the grievance boxes or directly to their supervisors. Workers with concerns or feeling an unfair treatment are encouraged to report to the plant management or HR officer in the facility.

While there are adequate channels to receive grievances from the workers, going forward the company will formalize the grievance handling mechanism. For this, the company will develop a formal and documented grievance handling procedure and share it with all employees. The procedure will be compliant with PS2 requirements and based on confidentiality and fairness.  The procedure will cover the way grievances can be submitted to HR, how they are logged, processed and resolved, and outlines steps available to appeal any decision all the way up to the plant’s manager. Nobel will ensure that the procedure includes clear deadline for each step of the procedure, ensure that the process is fully documented, including responses and feedback to the interested party, and consider setting up a committee to deal with appeals before they reach the plant manager. Once implemented, an explanation of the grievance process will be included in the induction plan for each employee [ESAP # 4].

Freedom of Association

There is no evidence of the company restricting the freedom of association for its employees, or efforts to discourage workers’ organization. However, employees have not formed any union at Nobel.

Protecting the Work Force

Nobel has corporate policies against hiring of workers below the age of 18 years and forced labor. These requirements also apply to all the temporary workers hired by third party contractors.

Occupational Health and Safety

Duzce plant is OHSAS 18001 certified and an EHS manual is used on site, which also overlaps GMP requirements and occupational health for the employees. In this facility, a job hazards and risk assessment (JHRA) is conducted and updated for each position. Based on the JHRA, operation procedures are developed and proper personal protection equipment (PPE) is provided.

The OHS management is also implemented through a set of safety tools and methods, including systematic inspections, walk through/observation. 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. Nobel sets up key performance indicators target for OHS performance. An OHS risk assessment is conducted by a third party OHS specialist with support of an outsourced consultant (DONUSUM) which is also responsible of daily visual inspections. Nobel will update and implement similar OHS systems at the new facility and aligned with the requirements of this Performance Standard including the development and implementation of appropriate procedures for contractor OHS performance management and monitoring [ ESAP #5]

A Permit to Work system is in place for working at high temperatures, working at height, electrical works and confined spaces working. Nobel records lost time incidents, performs root cause analysis and develops corrective actions, in line with Turkish Legislation.  

PPE such as gloves, safety shoes, masks and glasses are provided to all the workers in the production areas, as per the GMP requirements, commensurate with the nature of operations and potential safety hazards. All chemicals are labeled and stored appropriately with relevant MSDSs. Periodical maintenance programs for equipment, such as forklifts, pressurized vessels, boilers, etc. are implemented. A workplace doctor is available 3 days / a week on site. 

Nobel measures workplace air quality and noise levels, dust, temperature and humidity for all important operational locations. The monitoring data shows that the company is generally compliant with local regulatory requirements and good international industry practices. Nobel will also measure volatile organic compounds (VOC) at the workplace. As noise levels seems to be problematic in some of the manufacturing areas, the company will ensure that hearing protection equipment are used by all employees at these locations where noise levels cannot be engineered below required limits.

Workers Engaged by Third Parties

No specific EHS clauses are included as contractual requirements with main contractors such as construction and transportation company. For the greenfield site in Duzce, the company commits to include a specific a contractual requirement for the construction contractor to comply with the local legal requirements as well as the requirements of IFC PS 2, such as those related to OHS and living and working conditions [ESAP #5]. In addition, Nobel will include in its monitoring plan referenced above a procedure for monitoring contractor compliance with the contractual requirements.

Supply Chain

Raw materials or active pharmaceutical ingredients used in the manufacturing process are specialty materials, sourced from five highly specialized and reputed manufacturers in China and India – many of whom comply with GMP requirements. As such, the OHS related risks in the Company’s supply chain are limited.

Resource Efficiency

Recently the Company has developed an energy efficiency project mainly with the intent to reduce operational costs and contribute to sustainable development. The company has also defined corporate KPI for energy use.

Water

In Duzce plant water used for production and other daily usage is sourced from a ground-water 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. The total water consumed in 2016 was recorded at 110,000 m³in Duzce facility. Drinking water is supplied in bottles by third party vendors. 

In Turkey, a specific permit or license associated to water use right on one’s own land are required from General Directorate of State Hydraulic Works (DSI). A hydrogeological study is required before the construction of the plant by international reputable experts to assess that communities in the proximity of the project area will not be negatively affected from water use of the new facility. Nobel has accordingly conducted studies and procured the necessary permits.

GHG Emissions

Primary energy requirement for the Duzce plant is that of electricity and natural gas, which are supplied from the national grid. Diesel fueled generators are installed on site as backup generators, and are in use in case of power failure. Therefore, GHG emissions for the group are dominated by electricity consumption with a very small contribution from diesel consumption. In 2016, the electricity consumption per product is given as 1.05 kWh/ kg per annum. The proposed investment is not expected to produce GHG emissions in exceedance of IFC’s threshold of 25,000 tons per annum of CO2e.

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 main air emissions sources in Duzce facility are four boilers at the facility, stand-by diesel generators and three process emission stacks. Particulate emissions from sensitive production areas (e.g. production of cephalosporins) are controlled through high efficiency particulate air filters, and the collected materials is disposed of by licensed contractors according to local requirements. The R&D laboratory will be equipped with fume hoods.  Dichloroethane and benzene have been collected as per Turkish legislation (each two years) and appear to be above the limits in WBG/IFC EHS Guidelines for Pharmaceutical and Biotechnology Manufacturing. As per ESAP # 6 Nobel will monitor air emissions on an annual basis and assess corrective and preventive measures to comply with the limits included in the WBG EHS Guidelines for Pharmaceutical and Biotechnology Manufacturing, and accordingly implement the same.

Wastewater Treatment

Wastewater generated during the process are treated via a biological wastewater treatment plant (WWTP) that has been integrated into the design of the processing plant.  The plant was designed and constructed by ARITIM MUHENDISLIK and comprises a settlement pond, an aeration pond and a chemical and biological treatment unit. The WWTP has been designed to operate in max. 80 m3/day and currently 40 m3/day process water treated in WWTP from the Duzce plant operations and the capacity of WWTP is adequate to treat process water will be sourced from new plant’s operations. After treatment, Duzce facility (including the new plant) discharges the effluent to a central municipality sewage system as per the environmental permit condition. Effluents are tested bi-yearly according to local regulations externally.

Solid Waste Management

The Duzce plant has a waste management plan for both hazardous and non-hazardous waste. Hazardous wastes are handled by certified third party contractors IZAYDAS, GEP and CEVKO. Small quantities from of medical waste from the in-house clinic is handled by another contractor and is taken to the hospital by company doctor and disposed according to Medical Wastes Control Legislation. Nobel has a formalized waste management procedure that is implemented in Duzce. Cardboard and papers, as well as plastic wrapping, grass, leaves, tree branches and others are segregated on site and then handled by Municipality of Duzce. Rejected and/or expired products are collected and disposed by authorized third party contractor under the supervision of local authorities. 

Nobel 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.

Community Health and Safety

There are a handful number of households in the vicinity of the Duzce plant. Given the nature of company activities, 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. As transportation to work site is provided to employees, specific EHS measures for commuters are included in the contracts with transportation contractors. 

Security Personnel

The Duzce facility is securely fenced and employs 8 armed security personnel for 3 shifts and their main function is to regulate entrance and access to facilities.  Security forces are well trained and outsourced from a national security company. As part of the IFC investment, Nobel will carry out a security risk assessment and, if necessary, develop a detailed security management plan in line with recognized international principles: Voluntary Principles on Security and Human Rights [ESAP #7].

Nobel recognizes corporate social responsibility (CSR) as an essential part of the company identity and therefore supports, through various activities, targeted initiatives for identified internal and external stakeholders. Activities include donation of unused company assets (e.g. information technology material, laptop, etc.) and sponsorship. Currently, the company’s communication with neighboring communities is mainly limited to informal engagement on project development between plant director and local authorities.

 As agreed in the ESAP for this project, a site-specific Stakeholder Engagement Plan will be developed, focused on local residents adjacent to the construction site. They will be pro-actively informed and consulted on the project to avoid potential complaints during development. All stakeholder engagement activities undertaken for this project will be documented. Currently, the public has the opportunity to lodge complaints on the Nobel’s Duzce web-site, but there is no formal recording of verbal claims if received at the project site by security. As part of the stakeholder engagement plan, a grievance mechanism will be implemented, which will detail the process and procedure to receive and facilitate resolution of adjacent residents and other identified stakeholders promptly and effectively [ESAP #3].

Contact Person: Erdinc KARLI

Company Name:  NOBEL

Address: Saray Mah. Dr. Adnan Büyükdeniz Cad. No:14 Ümraniye, 34768 Istanbul Türkiye

Email: erdinc.karli@nobel.com.tr

Phone: +90 (216) 633 6000