IFC’s appraisal considered the environmental and social management planning process and documentation for the Project and gaps, if any, between these and IFC’s requirements. Where necessary, corrective measures, intended to close these gaps within a reasonable period of time, are summarized in the paragraphs that follow and (if applicable) in an agreed Environmental and Social Action Plan (ESAP). Through implementation of these measures, the Project is expected to be designed and operated in accordance with Performance Standards objectives.
PS 1 - Assessment and Management of Environmental and Social Risks and Impacts
Policy, E&S Management System, and Programs
IPD has corporate environmental, security and hygiene, and quality policies. These policies articulate the Company’s commitment to comply with the applicable laws and regulations and their objective is to identify, prevent and manage risks to people and the environment, and define specific targets to drive implementation of the associated policies.
The Company has established and implemented an integrated management system (IMS) which is certified against ISO 9001 (quality), ISO 13485 (medical devices), ISO 15189 (medical laboratories) and ISO 17025 (medical testing). The IMS includes a risk assessment framework and evaluation forms for identifying and assessing occupational health and safety risks. Management of environmental impacts such as waste management, hazardous materials management, air emissions, wastewater management, amongst other, is addressed through the implementation of quality management systems and compliance with national legislation requirements.
In accordance with ESAP#1, IPD will apply existing similar management systems as detailed above to the Project. Further, to ensure these systems align with the PS’s, applicable WBG EHS Guidelines and GIIP, the Company will develop and implement plans related to the following: i) security policy/code of conduct; ii) supplier code of conduct; and iii) stakeholder engagement plan and grievance mechanism.
Identification and Assessment of Risks and Impacts
IPD identifies E&S risks and impacts associated with their activities via risk assessments relative to compliance with applicable national standards, E&S regulatory permitting requirements and the corporate level EHS and quality policies and systems.
IPD commissioned an Initial Environmental Analysis (IEA) and Environmental and Social Management Plan (ESMP) in accordance with the applicable national requirements for the Project. Key risks identified in the IEA include contractor management, labor and working conditions and occupational health and safety, waste management, traffic and dust management, community relations as well as organizational capacity and systems to manage these risks. The ESMP defines measures to avoid, minimize and mitigate Project specific E&S risks and impacts during both construction and operations. In addition to the ESMP, contractors have also developed Project specific health and safety plans. These plans include a description of roles and responsibilities, emergency contacts in case of accidents, a risk assessment framework including identification of the most common risks linked with the associated site activities and measures to prevent and manage these risks, use of personal protective equipment (PPE), prevention and response in case of accidents, and work permit requirements, amongst others.
As per ESAP#1, IPD will apply an existing similar process for identifying the environmental and social risks and impacts of the Project’s operations as they have in the existing operations.
Organizational Capacity
IPD has a quality and EHS team at the corporate level that includes three officers. In line with the applicable national legislation, IPD have appointed a Hygiene and Work Safety Committee (CHS) and a Quality Hygiene Safety and Environment (QHSE) team responsible for quality and EHS management. The objective of the CHS Committee is to contribute to the protection of employee health and safety by setting prevention measures as well as undertaking training, employee engagement, inspections, accident investigation and monitoring of corrective measures in line with applicable regulatory requirements. The QHSE team is part of the Supportive Services Department. The team is responsible for planning and implementation of risk management across all operations, including training. Trainings are conducted every year and topics include occupational health and safety risks, quality, document administration and biosecurity amongst others.
For Project construction, IPD appointed an EHS officer and requested each contractor to also appoint similar. Furthermore, an external consultant appointed by IPD undertakes EHS monitoring and worker training on site.
As agreed with IPD, the Project will have a minimum of two dedicated Environmental Health and Safety (EHS) officers during operations (ESAP#1).
Emergency Response Plan
IPD has a corporate standard on emergency response planning and Project contractors have developed project specific emergency response plans. Workers have been trained on emergency response in the event of fire during toolbox sessions.
In accordance with Senegalese and French regulatory requirements, the Project has been designed to manage risks associated with the production of pharmaceuticals. Specific issues considered in relation to this during design and construction include structural fire resistance, fire compartmentalization, provision of fire detection and alarm systems, means of egress, fire control and suppression measures, smoke control and protection from fire hazards. The fire safety and emergency response equipment at the Project will include an alarm system, armed fire valves, calibrated fire detectors, automatic fire suppression systems, fire extinguishers and sandpits, fire hydrants, as well as the emergency numbers of the fire department available at the guard post.
As per ESAP#1, the Project will develop an emergency preparedness and response plan (EPRP) aligned with the WBG EHS Guideline requirements.
Monitoring and Review
IPD has corporate standards on HSE audits. Monitoring and auditing activities are defined in annual plans and findings are regularly reported to management.
The IEA includes an E&S monitoring plan for construction and operations. Aspects to be monitored under the plan include air emissions, noise, solid waste, medical and hazardous waste, wastewater, occupational health and safety, control of electrical installations and pressurized equipment, among others. During construction, reports are regularly sent to environmental authorities who may undertake site visits to verify implementation.
As noted, an external consultant undertakes EHS construction monitoring for the Project and also compiles weekly HSE supervision reports summarizing the works at site, EHS findings and provides recommendations for improvements where applicable.
As per ESAP#1, the Project will develop monitoring and reporting procedures specifying the type and frequency of monitoring to be conducted during operations as per applicable local requirements, the ESMP requirements and the applicable WBG EHS Guidelines and GIIP. These procedures will form part of the Project’s ESMS.
PS 2 – Labor and Working Conditions
The number of contracted, construction workers on site varies and currently, the Project has between 200 and 250 workers on site. During operations, there will be approximately 300 workers.
Working Conditions and Management of Worker Relationship
IPD has documented HR policies and procedures compiled in a staff-rules document which is aligned with applicable legal requirements in Senegal. The staff-rules document is available on the Company’s intranet and accessible to all workers and applies to all personnel at IPD including direct workers, intermediaries, seconded agents, interns, apprentices, permanent and temporary workers. The areas covered by the staff rules are working conditions and terms of employment, hygiene and security, and discipline and sanctions. Any forms of workplace harassment (moral or sexual) are strictly forbidden and there are no known instances of such having been reported in the past. IPD provides medical coverage for all employees and their families and the conditions for access are clearly specified. Working hours including overtime adhere to national labor regulations. The Company will apply existing approach to HR management to the Project.
Non-discrimination and Equal Opportunity
The principles of equality and non-discrimination are underpinned in the Constitution of Senegal and IPD’s HR policies and procedures are aligned with the Senegalese legal requirements. While IPD implicitly adheres to the principles of non-discrimination and equal opportunity, these are not clearly articulated in the HR policies.
Thus, as per ESAP#2, the Project will clearly define the principles of equal opportunity and non-discrimination in their HR policies and communicate these to workers.
Freedom of Association
The Company supports freedom of association and recognizes the right to collective bargaining. Out of 300 permanent employees, 88 employees are members of the National Confederation of Senegalese Workers (CNTS) and there is a signed collective bargaining agreement with the union.
Worker Grievance Mechanism:
The staff regulations clearly states that all workers have the right to lodge a grievance either directly with their managers or with worker delegates. There are five worker delegates that often serve as intermediaries between the workers and the Company management on worker grievances. These delegates can escalate grievances to management during monthly meetings. Worker grievances can also be addressed directly with management; however, this process has not been formalized in a written procedure.
As per the ESAP#2, the Project will develop and implement a worker grievance mechanism aligned with PS and which will be accessible to employees and contract workers alike and allow for anonymous and confidential filing of complaints.
Occupational Health Safety
IPD has corporate standards/tools on risk analysis, incident-accident investigation, HSE management for contractors, safety and hygiene, and EHS auditing.
For Project activities during construction the external consultant and EHS officers conduct toolbox talks and regular EHS monitoring. Weekly reports are prepared by the consultant and corrective measures implemented. No serious accidents/fatalities have occurred at the Project since the commencement of construction.
IPD has processes and procedures to identify and mitigate the OHS risks during operations. A risk evaluation form is completed for each activity, and this includes: i) identification of risks, including physical, biological, chemical, electrical and fire, ergonomic, social, road related amongst others ii) an evaluation of risks, and (iii) prevention measures. Risks are classified and prioritized based of frequency and severity. Regular inspections and audits are undertaken by the EHS personnel and the CHS committee. Use of personal protective equipment and incident reporting are two key areas being monitored. Findings and corrective actions are reported to management and monitored until completion. IPD will apply the existing OHS approach to the new facility.
IPD has implemented COVID-19 response measures as per national requirements including undertaking all necessary health and safety precautions in the workplace to minimize potential COVID-19 infections. There have been no cases of staff being made redundant and no instances of no-pay-leave arrangements due to COVID-19.
Third-party Workers
As noted, contractors associated with construction have developed appropriate EHS management plan and there is active oversight of associated performance by the Company and the external consultant. Contractors have established informal worker grievance mechanisms whereby workers report their concerns to their supervisor and then this is addressed with the appropriate department (e.g. HR).
Going forward as and per ESAP#1 the Company will develop and implement a Contractor Management Procedure aligned with IFC’s requirements for contractors associated with operational activities and any future Project related construction activities. This procedure will clearly define the approach to the management of grievances for contractors in alignment with the requirements of the Performance Standards.
Supply Chain
IPD has developed a procurement procedure for goods and services in line with the quality management system and other corporate standards. This procedure does not address E&S related aspects in the supply chain.
As per ESAP #2, to address E&S related aspects in the supply chain the Project will develop and implement a supplier code of conduct aligned with the Performance Standards. This will specifically focus on ensuring suppliers have appropriate EHS practices and, while not considered a key risk given the nature of activities, include reference to ensuring there is no child or forced labor associated with suppliers.
PS 3 – Resource Efficiency and Pollution Prevention
Greenhouse Gas Emissions (GHG)
Power for purposes of construction and operations is provided via the national grid. Two to four back-up diesel generator (DG) sets of 1000 kVA minimum each are available in case of power failure. Based on available data on electricity and diesel consumption, the current GHG emissions (Scope 1 and Scope 2) are estimated as being below 25,000 tons per year of CO2 equivalent.
Air Emissions and Ambient Air Quality
The main potential air emission sources during construction are primarily associated with dust emissions from construction activities and vehicular traffic. IPD has been monitoring air emissions during the construction period and the results indicate that while gaseous emissions (SO2, NOx) are within the applicable limits, dust emissions are above the limits in areas with ongoing construction activities and adjacent to the unpaved site access road. To suppress dust, contractors have thus been regularly applying water within the site and on the road.
During operations, the main potential sources of air emissions are dust from laterite access road, and SO2 and NOx from backup DG sets and the incinerator which will be fitted with a wet scrubber. Other than the potential for a refrigerant leak from the cooling systems and incinerator, there are no point source emissions associated with the manufacturing process.
As part of ESMP implementation and monitoring and review procedures (covered under PS1), the Project will undertake incinerator air quality and stack emissions monitoring to ensure its compliance with applicable national and local standards and WBG EHS guidelines.
Water Supply and Wastewater Treatment
Water during construction is mainly used for dust suppression and drinking purposes. Water for dust suppression is sourced from an on-site borehole, while potable water is from an on-site storage tank; water is procured from the municipal system. There are also toilets for workers at the site.
Water during operations will be used in the Project’s manufacturing processes including for steam generation, cleaning of equipment and facilities and employee hygiene. The source of water will be either municipal supply or water purchased and stored in tanks at the Project site.
The Project will have a wastewater treatment plant for domestic wastewater and process wastewater; process water will undergo thermal pre-treatment before being discharged to the treatment plant. Wastewater will be monitored in-house prior to discharge to the municipal stormwater system to ensure legal compliance with local permit conditions (once this becomes available, the system may be connected to the municipal wastewater treatment system). Treated wastewater may also be re-used for landscaping and dust suppression. Sludge from the treatment plant will be collected and disposed of by a service provider approved by the relevant authorities.
The stormwater system was designed in line with national law requirements, whereby the water is routed from the site into the natural drainage canal at the north edge of the site through multiple exit points.
As part of ESMP implementation and monitoring and review procedures (covered under PS1), the Project will develop and implement a wastewater and stormwater monitoring program to ensure compliance with national legislation and the WBG EHS Guidelines as applicable.
Management of Solid Waste and Hazardous Waste
The primary general and hazardous waste generated during operations will include sludge from the effluent treatment plant, used oil, electronic waste, expired/discarded chemicals, empty containers and general office and packaging waste. The facility will also generate bio-medical waste. Off spec vaccines will be inactivated in an autoclave, after which they are sent to a mechanical jaw crusher and the remaining glass will be collected by a licensed service provider for final disposal. For the disposal of other biomedical waste such as animal waste from lab testing, IPD will use a licensed incinerator off the Project premises. If an incinerator will be installed on the Project premises, IPD will be required to choose technology aligned with GIIP and will monitor emissions as per the monitoring procedure as referenced above.
IPD has established and implements a corporate waste management standard to manage both hazardous and non-hazardous waste, including tracking to the point of disposal, in compliance with the waste management legislation. The Project will implement a waste management standard complaint with the corporate standard.
Management of Hazardous Materials
During operations, diesel will be stored in an above ground storage tank which will be bunded. There are no other large volume hazardous materials stored on site. Production materials are stored in appropriate storage areas. IPD has established and implements a corporate hazardous materials management standard in accordance with national legislation and this will be applied to the Project.
PS 4 – Community Health, Safety and Security
The Project is located in a non-residential setting, adjacent to IPD’s greenfield yellow fever vaccine facility, and is adjacent to the village of Dani Malick Gueye to the west of the site. Stakeholder feedback has been gathered during the IEA process and subsequently incorporate into EHS mitigation measures.
Community health and safety risks associated with Project activities are limited and include dust generation during construction and vehicle movement, water runoff, site security, emergency preparedness and hazardous waste management. These issues are managed via the management plans as applied for purposes of construction or will be addressed via the Project ESMS.
The site is connected to the highway through a main access road that does not traverse any communities. During operations vehicular traffic will be relatively limited and will not involve the use of heavy vehicles and thus impacts associated with traffic are considered insignificant.
Unarmed private security guards are employed at the Project facility during construction and this will similarly apply to operations.
As per the ESAP#1, the Project will develop and implement a specific security policy/code of conduct that will include requirements associated with community conduct, a code of ethics and implement clear guidelines on use of force as well as processes on background checks of the guards. The policy will be contractually binding for the private security provider and communicated to the security guards as part of the induction, as well as refresher training. In addition, the community grievance mechanism (discussed under stakeholder engagement) will also allow for complaints related to security forces.