The site for the new plant was previously occupied by a warehouse and a parking lot for a commercial office.  Performance Standard 5 (Land Acquisition and Involuntary Resettlement) is therefore not applicable for this project as the site was acquired through a willing-buyer willing-seller transaction and there was no physical or economic displacement. PS 6 (Biodiversity Conservation and Sustainable Management of Living Natural Resources) is not applicable as the project is located in an industrial area and there are no occurrences of significant biodiversity values. PS7 (Indigenous Peoples) does not apply because the project will not cause adverse impacts to Indigenous Peoples. PS8 (Cultural Heritage) does not apply as there is no planned expansion in known cultural heritage areas.

This is Category B project according to IFC’s Policy on Environmental and Social Sustainability because E&S risks and impacts for this project are expected to be limited, generally site-specific, and readily addressed through standard mitigation measures. Main environmental and social (E&S) risks include environmental, health and safety (EHS) risks and impacts during construction of the new plant; potential cleanup costs due to the decommissioning of the existing plants; worker exposure to chemicals; risks of fire and explosions due to flammable liquids and explosive dust; management of industrial effluents; and disposal of hazardous wastes.

 Environmental and Social Assessment and Management System

Labinco and Bussie have implemented quality management systems certified under ISO 9001:2015 standard and the national Good Manufacturing Practices for the pharmaceutical industry certified by INVIMA. The company has also implemented an environmental management system in line with the requirements of ISO 14001 environmental management system standard, and an OHS management program has been developed in line with regulatory requirements.

Policy

Sanfer has adopted a corporate Code of Ethics (CoE) and corporate E&S policies in line with the objectives of IFC Performance Standards (https://www.sanfer.com.mx/images/pdf/codigo-de-etica-sanfer.pdf). In addition, Sanfer Colombia has a documented environmental and OHS policies committing to comply with the local environmental and OHS regulations, prevent pollution from its manufacturing operations, reduce the generation of hazardous wastes, and provide a safe work environment.

Identification of Risks and Impacts

Sanfer Colombia keeps a (i) regularly updated registry of its applicable environmental legal requirements and authorizations (e.g., discharge of industrial effluents, handling and disposal of hazardous waste, air emissions, licenses for import of pesticides for veterinary drugs, etc.) and (ii) an environmental risk identification and assessment matrix. The OHS risk assessment (a.k.a. hazard identification and risk assessments - HIRA) is described under Performance Standard 2 – Occupational Health and Safety.

The new plant will be located close to the existing plants on a small site (0.25 ha) previously occupied by a parking lot and a warehouse. An environmental impact assessment (EIA) is not legally required for the construction and operation of this manufacturing facility but, as for the existing facilities, the company must obtain permits for the discharge of treated effluents and air emissions and register as generator of hazardous wastes. In addition, to obtaining the construction license, the structural and life and fire safety (LFS) designs must be approved by the Municipality of Bogota.

Management Programs 

Documented procedures including detailed staff responsibilities, have been developed for key environmental aspects such as: (i) management of industrial effluents and waste water treatment (WWT) plant; (ii) identification, segregation, handling, storage and disposal of hazardous wastes; (iii) storage of flammable/combustible liquids; and (iv) and operation, cleaning and maintenance of dust collection systems.

About six contractors are expected to be retained for the construction of the new manufacturing plant. Contract documentation include the requirement to comply with labor laws and ensure all workers are enrolled in the national social security system. Demolition works are ongoing; badges have been issued to workers to prevent the entry of unauthorized personnel and the company maintains a daily register of construction workers onsite. Sanfer Colombia will include in contract documentation with construction contractors the requirement to implement a client-approved EHS management plans, which will include at a minimum, plans for workers’ occupational health and safety including Covid-19 infection prevention measures, emergency response, management of hazardous materials and hazardous waste, and general pollution prevention. Sanfer Colombia will also retain an EHS Supervisor to monitor contractors’ EHS performance. Among his/her responsibilities will be (i) providing induction training to all workers including the relevant aspects of Sanfer’s corporate Code of Ethics and grievance mechanism (e.g. línea de ética);  (ii) controlling that all workers have completed the required OHS training and are wearing adequate personal protective equipment (PPE); (iii) ensuring that welfare facilities for workers are adequate (e.g. access to potable water, bathrooms, lunch area); (iv) implementing a permit to work system; (v) conducting regular EHS inspections; (vi) ensuring that Covid-19 infection prevention measures are implemented; and (vii) maintaining and reviewing records of accidents.  The EHS Supervisor will participate in the project management meetings with contractors (at least weekly). During these meetings, contractors will present the activities to be carried out, describe what are the OHS risks, and how they will be controlled (ESAP #1).

Organizational Capacity and Competency

The management of environmental and OHS aspects are assigned to an Environmental Analyst reporting to the Operations and Maintenance Department, and an OHS Officer reporting to the Human Resources Department. Training on environmental aspects (e.g. waste management) is delivered by the Environmental Analyst under the request of each head of division. OHS training covers aspects such as handling and storage of chemicals, content of safety data sheets and Globally Harmonized System of Classification and Labeling of Chemicals (GHS), and targeted training for the OHS joint committee (e.g. workplace inspections, root-cause analysis, PPE) and emergency brigades (e.g. first aid, vital signs, evacuation, emergency plan). OHS training is delivered by the workers compensation insurance company (ARL - Administradora de Riesgos Laborales).

Emergency Preparedness and Response

Emergency Preparedness and Response Plans (EPRP) have been developed for the existing operations of Bussie and Labinco. Separate plans have been developed for environmental and OHS emergencies. Sanfer Colombia will develop a consolidated Emergency Preparedness and Response Plan (EPRP) for the new manufacturing plant covering all emergencies. The EPRP will include: (i) potential emergencies based on hazard assessment; (ii) procedures to respond to the identified emergency situations; (iii) procedures to shut down equipment; (iv) procedures for rescue and evacuation; (v) list and location (i.e. map) of emergency response equipment; (vi) schedule for periodic inspection and maintenance of key components (e.g. fire detection, alarm and suppression system, emergency lighting); (vii) graphics indicating the safe evacuation routes and meeting areas for different risk scenarios (e.g. fire, earthquake); (viii) schedule of trainings and drills, including with local emergency response services (fire fighters); (ix) procedures for emergency drills; (x) emergency contacts and communication protocols, including with neighbors when necessary, and procedures for interaction with the government authorities; (xi) procedures for periodic review and update of emergency response plan. The EPRP will be incorporated in the company’s quality management system documentation and, will include: (i) identification number; (ii) issue and revision dates; (iii) approving authority; (iv) objective; (v) scope; and (vi) record of revisions and changes (ESAP #2).

Key emergency risks in the production of pharmaceutical finished dosage forms are fires due to the storage of flammable/combustible liquids and explosions due to the presence of combustible dust. A life and fire safety (LFS) master plan was developed by a qualified company for the new manufacturing plant. The LFS master plan describes the fire detection, alarm and control systems that will be installed (e.g. the entire facility will be covered by sprinklers) and the means of egress to allow for a safe evacuation in case of an emergency. To prevent the risk of fires and explosions in the new facilities, Sanfer Colombia will implement a maintenance and inspection program to (i) ensure the grounding of lines in flammable/combustible liquids storage rooms and any other operation where volatile chemicals are handled and transferred, and of (ii) grounding and bonding of the heating, ventilation and air conditioning (HVAC) and dust collection systems to prevent the buildup of static electricity and sparks that could trigger a fire or explosion. In addition, if the quantities of flammable/combustible liquids stored in the new manufacturing plant exceed the maximum allowable quantity (MAQ) per control area permitted by NFPA codes, the company will implement additional necessary additional protection requirements as per the applicable NFPA codes (ESAP #3).

Monitoring and Review

Sanfer Colombia keeps records of utility consumption (e.g. water, natural gas, electricity) and waste generation, and conducts tests of effluents and air emissions as per regulatory requirements. Likewise, Sanfer Colombia keeps records of accidents.  Nevertheless, this information isn’t systematically reviewed by senior management for benchmarking and to identify areas of improvement.

 Working Conditions and Management of Worker Relationship

At the time of the appraisal, Sanfer Colombia had a labor force of 580 direct employees (396 female and 184 male) and 69 indirect or third-party employees (50 female and 19 male). The proportion of women is higher in all job categories: operational (132 female and 91 male), administrative (165 female and 85 male), sales force (147 female and 42 male), and management (17 female and 14 male). The annual rate of staff turnover is about 7% showing that staff retention is high.

Human Resources Policies and Procedures

Sanfer Colombia has a Human Resources Department (Direccion de Talento Humano) in charge of the management of human capital (e.g. recruitment, training, development), payroll management, and the provision of services to workers.

Working Conditions and Terms of Employment

Working conditions and terms of employment are established in the Internal Work Regulations approved by the national labor authority. This document is currently being revised to include rules for home-based work in the context of the Covid-19 pandemic.  All employees at Sanfer Colombia have indefinite contracts and are affiliated to the national social security system. Statutory working hours are 48 hours per week and the company limits overtime to eight hours per week. Workers in the manufacturing plants are organized in three 8-hour shifts to provide 24-hour coverage six days per week. Allocation of overtime is agreed among workers based on their availability. Remuneration for overtime and nightwork is paid in accordance with labor law.

Workers’ Organization

Workers at Sanfer Colombia (aka, Labinco and Bussie) are not affiliated to any union. However, according to the Internal Works Regulation, the employer is not allowed to restrict workers’ right to form and join workers’ associations. 

Non-discrimination and Equal Opportunity

Sanfer’s corporate Code of Ethics (CoE) (https://www.sanfer.com.mx/images/pdf/codigo-de-etica-sanfer.pdf) includes the commitment to provide a work environment free of harassment and discrimination. The CoE also includes a zero-tolerance policy for perpetrators of sexual harassment. Anonymous and confidential complaints related to breaches to the CoE can be submitted to the corporate Ethics Committee through a dedicated email or hotline. In addition, Sanfer Colombia has a documented anti-harassment and complaint management procedure (e.g.  HUM-P06-I08 “Directrices para la prevención y el manejo del acoso laboral”) as per regulatory requirements (Ley 10/2016 Acoso Laboral). Confidential harassment complaints can be submitted for investigation to an elected joint worker-management committee called Committee of Labor Relations (Comité de Convivencia Laboral). As sexual harassment in the workplace is not typified in the Colombian legislation, this procedure does not address sexual harassment.

Sanfer Colombia will thus create a new procedure or revise the existing anti-harassment and complaint management procedure, to address sexual harassment complaints. The new or revised procedure will include: (i) what types of behaviors in the workplace constitute sexual harassment; (ii) disciplinary procedures as deemed appropriate given the severity of the harassing behavior (including for false accusations and reprisals); (iii) anonymous and confidential channels to present a sexual harassment complaints; (iv) and what type of support (e.g., legal, psychosocial) will be available for survivors of sexual harassment. The procedure will have a survivor-centered approach enabling survivors of sexual harassment to make informed decisions about future actions and confidentiality of their information. People in charge of receiving and investigating sexual harassment complaints will receive training on how to ensure confidentiality and prevent further harm to survivors. The relevant parts of this procedure will be communicated to all workers as part of their induction and reinduction training (ESAP #4).

Retrenchment

Despite the Covid-19 pandemic, Sanfer Colombia has continued operations as the manufacturing of pharmaceuticals is categorized as an essential business. The Ministry of Labor in Colombia has established the following alternatives to protect employment during the pandemic: home based and remote work, flexible and reduced workday, and mandatory use of annual leave (Circular 0021 de 2020). Unilateral mandatory unpaid leave is not allowed, and collective dismissals for force majeur must be previously approved by the government.

In case the construction of the new manufacturing plant results in staff optimization, Sanfer Colombia will assess alternatives to retrenchment prior to implementing any collective dismissals. If collective dismissals are unavoidable, the company will develop and implement a retrenchment plan consistent with PS: 2 to reduce adverse impacts of retrenchment on workers. The retrenchment plan will be based on the principles of non-discrimination and will reflect client’s consultation with workers and government if needed. All outstanding payments, social security benefits and pension contributions, and severance payments will be paid on or before termination of the working relationship to the workers. Prior to implementation, the retrenchment plan shall be submitted to IFC for review and agreement (ESAP #5).

Grievance Mechanism

As described above in the section Non-discrimination and Equal Opportunity, anonymous and confidential complaints related to breaches to the CoE can be submitted to the corporate Ethics Committee through a dedicated email or hotline, and harassment complaints can be submitted locally to the Committee of Labor Relations.  The Committee of Labor Relations is comprised of seven members (both male and female) selected by employees through a democratic process (e.g. secret vote). The committee meets regularly every quarter and on an extraordinary basis when it receives a complaint (in 2018 and 2019 it received 9 complaints). The committee keeps a registry of complaints and completed investigations. This information is handled in a confidential manner and can only be accessed if requested by local authorities. According to the anti-harassment and complaint management procedure (e.g.  HUM-P06-I08 “Directrices para la prevención y el manejo del acoso laboral”), the Committee of Labor Relations does not investigate anonymous complaints.

Protecting the Work Force

According to the Internal Work Regulations, children between the ages of 15 and 17 are allowed to work up to a maximum of six hours per day and in positions that are not harmful their development (e.g. exposed to dangerous chemicals) as per national laws provision for the employment of minors.  Likewise, as per the Internal Work Regulations, the company keeps a registry of all workers under 18 years old. Sanfer Colombia currently does not have hire workers under 18 year old, but occasionally hosts interns from the National Training Services (SENA) apprentice program, who fulfill an apprenticeship contract monitored by both SENA and the Ministry of Labor. Interns are high school graduates and may be younger than 18 years old. During the period of the contract, the company covers part of the program expenses in accordance with the legal minimum wage.

Occupational Health and Safety

Sanfer Colombia keeps records of accidents (the lost time injury frequency rate is about 20 which is above the industry benchmark for pharmaceuticals, ref. USDOL 2013) and has completed a hazard identification and risk assessment (HIRA) (Panorama de Riesgos as it is known in Colombia) as per regulatory requirements. However, the current analysis misses important hazards and thus cannot plan for effective preventative controls. In particular, the company has not identified the risk of workers’ exposure to chemicals being handled in operations and quality control laboratory, especially exposure to Active Pharmaceutical Ingredients (APIs). Therefore, 6. Sanfer Colombia will retain the professional services of a certified industrial hygienist and laboratory to (i) carry out an Industrial Hygiene (IH) Risk Assessment for workers’ exposure to hazardous chemicals; (ii) develop and implement an IH Exposure Monitoring Program; and (iii) develop and implement a Health Surveillance Program for workers exposed to hazardous chemicals at dangerous concentrations. The IH Risk Assessment will include the API used by third party contractors for the production of veterinary drugs. (ESAP #6).

Sanfer Colombia also lacks a machine safety assessment using a formal methodology and has not identified the hazardous energies (e.g. electrical, mechanical, hydraulic, pneumatic, or other energy that can harm personnel) in machinery and equipment so that exposed employees can be protected during machine service and maintenance activities. Therefore, Sanfer Colombia will (i) develop a lockout/tagout program including machine specific lockout/tagout procedures to prevent injuries during machine service and maintenance activities; (ii) include OHS criteria for the selection of new equipment; and (iii) conduct a machine risk assessment utilizing a formal approach (e.g. ISO 12100 – Safety of Machinery). (ESAP #7).

COVID 19

Covid19 biosafety protocols have been implemented by the company. Some elements include the distribution and mandatory use of masks by all workers, temperature checks at the entrance of the plants (Bussie and Labinco), home based work for all personnel that qualify for working remotely, social distancing rules for office/plant based staff, mandatory annual leave workers showing symptoms of Covid19, and increased disinfection of commonly based areas.

Workers Engaged by Third Parties

Occasionally, Sanfer relies on third-party resources to cover for staff on maternity or medical leave or during temporary increases in demand. These workers are hired only through legitimate and reputable labor companies. These workers can be hired up to a maximum of one year after which they would need to become employees, or the working relationship has to be discontinued.

Veterinary drugs are produced by three third-party contract manufacturers. As part of the GMP audit of these manufacturers, Sanfer Colombia verifies that the company has an OHS program in place, that workers are enrolled in social security, and that they are provided PPE.

The protection of contracted workers during the construction of the new plant is covered above in section PS1 – Management Programs.

  Resource Efficiency

GHG Emissions

Greenhouse Gas (GHG) emissions are primarily due to the consumption of electrical energy and natural gas in the manufacturing facility. Sanfer Colombia does not keep a GHG inventory but based on utility data consumption, GHG emissions are estimated to be around 1,000 tons CO2eq. As GHG emissions are well below 25,000 tons CO2eq, no GHG reporting is required for this client.

Pollution Prevention

Air Emissions

A 30 Peak Horsepower (PHP) boiler and a 20 PHP boiler are located at Labinco and Bussie’s respectively. Both boilers are fueled with natural gas. Emissions from these boilers are required to be tested every three years and results from the previous three measurements have met regulatory requirements (Resolucion 6982/2011) and emission guidelines for small combustion facilities in Table 1.1.2 of WBG EHS General Guidelines. Both boilers will be moved to the new manufacturing plant. Emergency generators are also installed at both facilities, but no monitoring of emissions is required as they are used well below 500 hours per year.

Forced ventilation systems are installed throughout both facilities and dust is collected in cyclones and dust collectors. A HVAC system with high efficiency particulate air (HEPA) filters will be installed in the new facility.

Wastewater and Water Quality

Labinco and Bussie generate about 0.4 l/s of industrial effluents each (less than 4 m3 per hour in total). Industrial wastewater in pharmaceutical manufacturing plants producing finished dosage forms mostly consists on rinsing water used to clean equipment between two different production batches. At Labinco, industrial wastewater is treated in an on-site WWT plant before being discharged into the municipal sewage. Bussie does not have an on-site WWT plant, therefore, the water from the first two rinses is collected in containers and transported daily to Labinco for treatment.  Wastewater is tested annually in both locations (8-hour composite samples) and results from the previous three years have met regulatory requirements (e.g. Resolucion 0631/2015). The main components of the existing WWT plant consists on a grease trap, activated sludge and filtration system with activated charcoal. Sludge from the WWT plant is handled as hazardous waste (e.g. encapsulation and immobilization). A new WWT plant with a larger capacity will be installed in the new manufacturing plant. Sanfer Colombia will conduct a complete characterization of Bussie’s and Labinco’s industrial wastewater and submit the information to the suppliers of WWT plants to ensure the technology selected is adequate to meet the guideline values for effluent levels listed in Table 2 of WBG EHS Guidelines for Pharmaceuticals and Biotechnology Manufacturing (ESAP #8).

Wastes

Detailed procedures are documented for the handling, segregation, temporary storage, and disposal of non-hazardous and hazardous wastes.  Paper, glass and plastics are recycled, and domestic non-recyclable waste is disposed through the municipal waste collection system. Liquid hazardous wastes from the quality control laboratory are stored in a separate room and biological waste from the microbiology laboratory is sterilized in the autoclave before disposal. Hazardous waste storage areas were observed cleaned and organized during IFC’s virtual visit.  Only licensed companies are used for the transportation, treatment and disposal of hazardous wastes and an auditable chain-of-custody is maintained until their final point of disposal.

Hazardous Materials

More than 600 chemicals are used by Bussie and Labinco for manufacturing and laboratory analysis. Hazardous materials storage areas were observed cleaned and organized during IFC’s virtual visit.  The OHS Officer, in coordination with the warehouse manager, has developed chemical compatibility charts for the correct storage of chemicals. These charts also include the main risks of each chemical and the required personal protective equipment (PPE) according to their safety data sheets (SDS). However, there is a discrepancy between the list of chemicals handled by the procurement department and the list managed by OHS (e.g. warehouse manager).

Historical Pollution

As the existing plants will be decommissioned and the manufacturing processes will be transferred into the new plant, some of the buildings will be either repurposed or sold. The company will retain an independent consultant to conduct a phase I environmental site assessment (ESA) for these sites. If the phase I ESA reveals potential contamination, the company will retain an independent consultant to conduct a phase II ESA. It the assessment determines that land or ground water contamination exists, and the client is legally responsible, these liabilities will be resolved by the company in accordance with national law, or where this is silent, with good international industry practice (GIIP) (ESAP #9).

 Community Health and Safety

The new manufacturing plant will be adjacent to a mechanical workshop and a warehouse, and no residences are located in the vicinity of the plant.

Security Personnel

Sanfer Colombia relies on the services of a licensed security company to provide protection to its assets and personnel. Security guards are equipped with firearms and communication devices and their main role is to prevent unauthorized entry to the company’s facilities. Sanfer Colombia has a Security Officer responsible for conducting security risk assessments, defining the necessary controls, overseeing security guards, and maintaining open channels of communication with neighbors in the area. A specific risk assessment was conducted for the construction of the new plant to prevent the theft of contractors’ equipment and the entry of unauthorized personnel to the working site. Sanfer Colombia does not vet the security personnel but evaluate their performance based on their customer service. In Colombia, private security services are licensed, inspected and controlled by an entity ascribed to the Ministry of Defense  (https://www.supervigilancia.gov.co).

The new plant will be located close to the existing plants in a small lot (0.25 ha) previously occupied by a parking lot and a warehouse. During demolition and construction works, neighbors can report complaints (e.g. noise, dust, traffic) to the entity in charge of issuing the construction license, of which number is posted at the exterior of the construction site. In addition, the company has a contact page in its website (see http://bussie.com.co/bussie/contacto). To ensure that the local public is always able to communicate the company in the eventuality of complaints (e.g. traffic, abuses from security personnel, etc.), Sanfer Colombia will post the company’s contact phone number at the entrance of the plant (ESAP #10).                              

 Contact Person: Suany Orrego Carvajal

Company Name: Laboratorios Bussié S.A.

Address: Diagonal 19 d No. 39 – 41, Bogota, Colombia

Email: suany.orrego@bussie.com.co

Phone: +571-3351135

Facsimile: n/a