KENYA MEDICAL RESEARCH INSTITUTE
HEALTH, SAFETY AND ENVIRONMENT POLICY

1.0. KEMRI€™s Health, Safety and Environmental (HSE) Policy Statement

The Kenya Medical Research Institute (KEMRI) is committed to providing a safe and healthy work environment for all employees, visitors, students, contract employees, human study participants and to protecting the environment, animals and the community.

It is the policy of the Institute to take every reasonable precaution to prevent personal injury or illness by the following:

€¢ identifying and controlling workplace hazards;
€¢ considering health, safety and environment (HSE) in all organizational activities; and
€¢ complying with all applicable HSE legislation including Occupational Safety and Health Act (OSHA, 2007), Biosafety Act 2009, The Environmental Management and Coordination Act (EMCA, 1999), Public Health Act (Cap 242), Radiation Control Act (Cap 243) and other applicable regulations in Kenya

KEMRI is committed to the principles of risk reduction, pollution prevention and undertaking its operations as a responsible corporate member of society. Therefore, all persons involved in activities with potentially hazardous materials which include but not limited to chemicals, equipment, radioactive substances, biological and recombinant DNA (rDNA) agents, plants, vertebrate and invertebrate animals, conducted at, or sponsored by, KEMRI must abide by the regulatory and policy requirements pertaining to the acquisition, use, handling, storage, transportation, and disposal of these materials.

Every employee has a legal duty to inform themselves of any health, safety and environmental rule (s), regulation and statute which applies to the performance of their job and to conduct themselves in accordance with such rules, regulations and statutes. Furthermore, every employee who supervises one or more employees and/or students shall ensure that these workers are informed of all HSE rules which apply to the performance of their functions and, comply with such rules, regulations and statutes. All employees have a duty to report unsafe or unhealthy conditions to their supervisors.

Failure to be informed, to comply and/or to supervise may result in disciplinary action by the Institute up to and including dismissal. Employees should also be aware that a person who violates the provisions of Regulations given in all applicable  HSE laws in Kenya commits an offence, and is liable on  conviction to imprisonment for such a term and fine as provided for in the applicable Acts.
All external contractors, sub-contractors and their workers are responsible to meet or exceed the requirements established in municipal, provincial and/or OSHA,2007.

2.0. Purpose

Research laboratories working with hazardous materials which include microorganisms and/or recombinant DNA technologies, chemicals (radioactive or non radioactive), animal or plant materials are special, often unique, work environments. The materials being used may pose special risks to persons working in or near the laboratory or to the environment should the material escape the containment procedures established for the laboratory or facility. The Institute has therefore established this policy in order to ensure the safe handling of hazardous agents, ensure the appropriate assessment of potential risks, and reduce the opportunity of personnel exposure or accidental environmental release.

3.0. Scope

This policy governs the use of hazardous materials in research and/or teaching.
The HSE Policy shall apply to research projects and teaching programs which use:

€¢ infectious biological materials in laboratories including off-KEMRI field sites;

€¢ recombinant DNA which may be hazardous to humans, animals, or other life forms;

€¢ potentially oncogenic biological and chemical materials;

€¢ human and non-human cell cultures and bodily fluids (e.g. blood, urine);

€¢ biological toxins and venoms (including off-KEMRI field sites);

€¢ transgenic material which may be hazardous to humans, animals, and plants;

€¢ animals, arthropods and other invertebrates for research;

€¢ radioactive and non radioactive compounds;

€¢ use of plant materials for research;

The policy shall also apply to all research activities and research conducted by other organizations involving the use of facilities under an agreement with KEMRI.

4.0. Applicable Legislation and Guidelines

The Occupational Safety and Health Act, 2007 (OSHA, 2007), and Regulations require everyone in the workplace to work together to identify and control health and safety hazards. The Ministry of Labour through the Directorate of Occupational Health and Safety (DOHS) implements the provisions of this act.

The Institute will implement the OSHA, 2007 through the establishment of Occupational Health and Safety program. Therefore, this policy is part of the Institute€™s overall programme on Occupational Health and Safety coordination.

Other applicable regulations in Kenya include:

€¢ The Environmental Management and Coordination Act (EMCA, 1999), Environmental Management and Coordination (Waste or Water Quality) Regulations, 2006
€¢ Biosafety Act, 2009
€¢ Public Health Act (Cap 242)
€¢ Food Drug and Chemical Substance Act (Cap 254)
€¢ The Pest Control Products Act (Cap 346)
€¢ The Animal Diseases Act (Cap 364)
€¢ The Public Procurement and Disposal Act N0. 3 of 2005

KEMRI reserves the right and obligation to impose additional terms and conditions on investigators who conduct research or testing or engage in teaching activities that involve microorganisms harmful to humans, animals, or the environment.

5.0. Responsibility

5.1. The role of the Director KEMRI

The Director KEMRI is ultimately responsible for all Institute HSE issues. This responsibility is exercised through the Health, Safety and Environment Advisory Committee (HSEAC) which is charged with ensuring that safe work practices and adherence to established policies and guidelines are followed.

5.2. Role of the Institute HSE Coordinator

The Institute will appoint an Institute HSE Coordinator/Director who will be responsible for: advising the HSEAC and staff concerning hazardous materials and their control, performance of surveys, reviews and inspections of hazardous activities; those specific duties required of the HSE in Directorate of Occupational Health and Safety (DOHS) implements the provisions of the implement the OSHA, 2007, Work Injury Act, 2007; coordination of HSE  efforts with National Committees within the National Council of Technology (NCST) requirements, National Environmental Management Authority (NEMA), Health Services and other applicable KEMRI collaborating Institutions and  agencies; and the day-to-day administration of activities for the HSEAC. The HSE Coordinator resides within the HSE Office, which organizationally reports to the Deputy Director Research and Training (DDR&T).

5.3. Role of Centre Directors/ Administrative Heads

Directors of Centres, Departments and Section/Units have the primary responsibility for the health and safety of people, animals and the environment within their jurisdiction. Appropriate planning, equipment, and trained personnel are essential in all potentially hazardous activities. No activity of a potentially hazardous nature is to be permitted unless there is a commitment of effort and expense to ensure that it can be safely accomplished.

Their health and safety responsibilities include:

a) Complying with the OSHA, 2007 and other appropriate regulations in Kenya;

b) Complying with this and other Safety Policies issued by  HSEAC or on behalf of the Director KEMRI;

c) Preparing and disseminating widely a written HSE Policy document which sets out Centre/Department specific safety arrangements and procedures, and identifies individuals with particular roles and responsibilities for the implementation of Institute and Centre/Department Policies;

d) Devoting adequate resources to enable subordinate staff to discharge their HSE responsibilities;

e) Ensuring that any safety responsibilities delegated to subordinate staff are clearly understood;

f) Periodically checking the performance of subordinate staff in discharging their safety duties;

g) Performing annual Centre/Departmental Safety Inspection(s) in accordance with this policy, reporting the findings and actions to be taken to the Institute HSE Office, and confirming annually that they are complying fully with this and other HSE policies, so far as is reasonably practicable;
 
h) Ensuring, so far as is reasonably practicable, that the health and safety of staff, students and visitors to their Centre/Department(s) are not adversely affected by the  acts and/or omissions of members of their Centre/Department(s);

i) Ensuring that risks to health and safety are assessed, appropriate control measures and safe systems of work are prepared, implemented and monitored;

j) Inspecting the facilities and equipment of their Centre/Department(s) at appropriate intervals to ensure that they are safe;

k) Reviewing the arrangements for fire safety in the Centre/Department in consultation with the  HSE Coordinator ;

l) Ensuring that where staff, students and others are involved in work in premises etc not under the Institute's direct control, the health and safety policies in operation at that place of work are consistent with KEMRI and Centre/Departmental Policies, and that staff and students are properly informed of the Policies in operation;

m) Notifying the Head Engineering and Maintenance of defects in the facilities and common services of buildings. After having notified the Head Engineering & Maintenance , the Centre Director/Head of Department must take every reasonable step to minimize risk and inform staff, students and visitors of the risks to health and safety until remedial work has been carried out, even if this means taking a particular facility out of use;

n) Ensuring no installation, construction, modification or alteration of buildings, rooms or engineering service takes place without permission of the Head Eng. & Maintenance;

o) Ensuring staff and students are given adequate instruction, information and training to perform their work safely;

p) Liaising with the Physicians based at the KEMRI staff clinic on the necessity for health surveillance and immunization of staff and students;
 
q) The Centre Directors/Administrative heads will be responsible for receiving and reviewing periodic and/or urgent reports from the HSE Coordinator/Director regarding but not limited to: 

i. Appointment of HSE coordinators from among staff in their respective laboratories;

ii. Requirements for staff training on HSE issues;

iii. Performing risk assessments when required and developing recommendations for procedural or physical laboratory modifications;

iv. Exposures of individuals to hazards and to provide status of certification and immunizations of individuals working in the laboratory;

v. Loss or theft of hazardous agents;

vi. Status of certifications of safety equipment (Biosafety cabinets, autoclaves etc;

vii. Records of hazardous waste disposal;

viii. Records of purchase/transfer of hazardous agents;

5.4. Role of Head Engineering and Maintenance Department

The CIE is responsible for the maintenance of buildings and their surrounds and for the provision of electrical, plumbing and similar services in Institute controlled premises. He/she shall take all reasonable steps to ensure that these facilities do not put at risk the health and safety of building users. In consequence, it is not permissible for any Centre Director/Department Head or persons in the Institute to carry out any installation, construction, modification or alteration to any building, rooms or any engineering service installation that is the responsibility of the CIE without permission of the Director KEMRI.

5.5. Role of Principal investigators, Instructors, Clinical supervisors in laboratories

The principal investigators, instructors, clinical supervisors and other in charges (e.g. Section Heads, Lab Directors etc) in charge of potentially hazardous activities are key persons in this HSE effort. They must:

a) Comply with health and safety legislation, codes of practice and Institute policies;

b) Ensure risk assessment of projects is carried out by competent persons and the results acted upon so that no one is put at undue risk. Record the findings of the process;

c) Monitor members of the research team to ensure they are following necessary safety working procedures;

d) Ensure that members of the research project team have received adequate training, information and instruction to perform their work competently;

e) Liaise with safety (and other) personnel in other groups in shared premises to ensure harmonized safety procedures are in force;

f) Report accidents and assist in any resulting decontamination, risk assessments, investigations and/or reporting which may be required;
g) In line with KEMRI procedures and investigate their causes to prevent a recurrence;

5.6. Role of supervisors in non-research or academic areas

The principal Heads of Departments, Administrators and supervisors in charge of non-research units in the Institute are also key persons in this HSE effort. They must:

a) Discharge adequately the HSE duties delegated to them by their head of their Centre Director/Department or Unit;

b) Make subordinate staff (and students where applicable) aware of the Institute policies and departmental rules and how they must comply;

c) Where instructed (and have been appropriately trained) should carry out risk assessments within their workplace and ensure that appropriate corrective  measures  are implemented;

d)  Prepare safe working procedures, implement the procedures and check that they are being followed;

e) Prepare, as necessary, safety and waste management rules within their workplace;

f) Check subordinates understand and ensure that they follow laid down procedures;

g) Report accidents in line with Institute procedures and investigate their causes with a view to preventing a recurrence;

5.7. Role of all persons

Much of the work in the Institute is highly specialized, and often only those who are engaged in it should have knowledge of the hazards inherent in the work. Although it is the duty of the Institute to provide suitable and safe equipment and systems of work, safety depends on individuals doing everything in their power to prevent injury to themselves and others. They must also keep the supervisor informed of any personal condition such as an illness, use of medication, pregnancy, or reduced immunity which could make the work more hazardous to themselves or others. The Institute therefore requires all staff and students to:

a) Use safe working practices and procedures at all times and in particular to use any machinery, equipment, material, chemical or biological agent, or safety device in accordance with the training and instructions given to them;

b) Report every accident at work which results in personal injury (however minor) and every dangerous occurrence (including fire) involving staff, students or visitors to their Head of Department /Section/Lab or his/her nominee. They must also report the incident to the member of HSEAC in the Centres;

c) Notify the Centre Director/Section Head when suffering from a disease or medical condition which may be caused by, or made worse by, work activities;

d) Not to proceed with any activity if they feel it poses a threat to their health and safety or to that of others and to report unsafe or unhealthy working conditions, or suspected faults in buildings and equipment, to the Centre Director/Head of  Department or their nominee without delay;

5. 7.1. Training
Health and Safety training is required by law. All Centre Directors and Heads of Department/Sections must ensure that all staff and students are provided with adequate training so that they are capable of carrying out their work without risk to themselves and others. They must also keep a record of this training. In certain circumstances temporary staff and visitors may require training also.

Training would be necessary:

a) On joining a Department to learn of its local arrangements and to acquire knowledge about specific hazards of the work proposed;

b) As a result of risk assessments prior to the introduction of new materials, equipment, substances or procedures;

c) When transferred to new work within the Department;

d) Periodically for refresher training

e) The HSE Office at KEMRI Hqs and the Training Department may be consulted when training is planned. Wherever possible, training should take place during normal working time.

5.7.2. Health Surveillance/Monitoring
Centre Directors/Heads of Department/Sections are responsible for ensuring the health, safety and welfare of their staff and students at work. They must ensure that risk assessments of work/work activities are carried out to identify, inter alia, where health surveillance/monitoring is needed to protect them. This will require close liaison with the HSE Coordinator and his/her staff. Surveillance/monitoring may be required:

a) Prior to employment ;
b) When there is a significant change to their work;
c) Following an accident/incident;
d) At regular intervals in-service;
e) When leaving the Institute;

6.0. Health, Safety an Environment Advisory Committee (HSEAC)

6.1. Constitution of the HSE Advisory Committee

The Committee is appointed by and is responsible to the Director KEMRI and will recommend actions necessary to maintain and/or improve HSE activities in the Institute. The Director KEMRI also appoints a Chair. The HSEAC shall be constituted of a minimum of ten (10) members. The Director KEMRI shall appoint a representative from each Research Centre at KEMRI. Additionally, administrative units and collaborators may also appoint representatives. Collectively the membership shall have experience and expertise in research involving hazardous materials and the capability to assess the safety of hazardous materials in research and to identify any potential risk to public health and the environment. The HSEAC shall include at least one individual with expertise in areas that include environmental impact assessment and audits (EIA/EA) chemical safety, biosafety, plant, plant pathogen or plant pest containment principles and animal containment principles. The HSE Coordinator and at least one technical laboratory staff person are mandatory members of the HSEAC. All appointments to the Committee shall be for a three-year term. Members shall be appointed, or reappointed, by the Director KEMRI and qualified successors shall be nominated as required. The Committee may invite resource people with necessary expertise to attend meetings as required. It must also have available and is encouraged to use consultants who are knowledgeable on institutional policies; applicable laws; occupational health and safety standards; environmental protection regulations; standards of professional conduct and practices. Additionally, when relevant the Director KEMRI, Deputy Director, Assistant Directors, Directors for collaborating partners may be invited for specific issues.

6.1.1. HSEAC Meetings and Quorum
The HSEAC shall meet quarterly and frequently if required. A quorum will consist of 10 members. BAC members will be permitted to have an alternate member form their respective Centres/Departments. Members who absent themselves during three consecutive meetings without a valid reason will be replaced. A passing vote or resolution will be a simple majority of members present; minority views will be recorded in the minutes.

6.1.2. Appeals Procedures
In case of dispute with respect to procedures or decisions of HSEAC, appeals may be made to the committee for reconsideration. Further appeals may be made to the Deputy Director Research & Training (DDR&T). The decision of the DDR&T with respect to the research protocol and attendant processes will be final in cases requiring intervention to resolve problems. In disputes involving contractual Institutions and Collaborators, the Director KEMRI shall make the final decisions.

6.2. Role of Health, Safety and Environment Advisory Committee (HSEAC)

a) The HSEAC reviews and grants approval for research, testing and teaching proposals involving recombinant DNA, artificial gene transfer, microorganisms that are harmful to humans, animals, or plants, and biologically derived toxins;

b) The HSEAC ensures that investigators comply with all the external and KEMRI regulations, procedures, policies, and standards for working with biological agents, to include, but not limited to: handling, storing, securing, and disposing;

c) The HSEAC, in concert with the HSE Coordinator, inspects research facilities and grants approval for these facilities to be used to conduct research, teaching, or testing;

d) The HSEAC has the authority to halt research in the event of non-compliance, or an unresolved safety hazard;

e) The HSEAC works closely with Government and International Organizations on Environment, Health Services, KEMRI Medical Services, Radiation Safety, and KEMRI Committees e.g. Scientific Steering Committee (SSC), Ethical Review Committee (ERC), Animal Care and Use Committee (ACUC), and other relevant National Committees in Kenya;

f) The HSEAC in addition to its advisory function shall register, review, and if appropriate approve biotechnology (bioengineering), recombinant DNA, and biohazardous proposals. The review shall include:

i. compliance with the KEMRI policy guidelines or other appropriate directives ;

ii. An independent assessment of the containment levels required for the proposed project ; and

iii. An assessment of the facilities, procedures, practices, and training and expertise of personnel involved in biologically hazardous and recombinant DNA research

6.2.1. Specific Roles of Members of the HSE Advisory Committee (HSEAC)
The members of the HSE Advisory Committee shall analyze operations and facilities within their Centres/Departments involving, or proposed to be involved in activities of a potentially biologically hazardous nature. Tasks of the HSEAC members will include but not limited to:

1. Ensuring maintenance of a current inventory in their respective Centres/Departments: of all potentially hazardous activities including their nature, location and Principal Investigators involved;

2. Reviewing policies, programs, and directives in their respective Centres: regarding hazards in academic, research, and clinical activities. It shall also develop such policies and directives as are required to conform to needs and this policy;

3. Reviewing of facility operation and maintenance procedures: changes to those procedures shall, when necessary, be submitted to the HSEAC. Changes shall not be made without approval by both the Committee and the Director KEMRI;

4. To perform surveillance of activities: for conformance with laws, directives, and guidelines of regulatory and funding agencies, through building and laboratory audits;

5. Ensuring Maintenance of reference libraries: and dissemination of information to all who may need such knowledge regarding potential biologically hazardous materials and their control;

6. Reviewing and approval of proposed activities: facilities and containment features when required by KEMRI, National, or International directives;

7. Developing Emergency planning: and the oversight of any decontamination, investigations, and reporting of incidents which may be required;

8. Advising the Administration and the staff members: regarding commendation for exemplary handling hazardous project; problems of a hazardous nature and of actions recommended. Such recommendations may include denial of proposed activities where suitable facilities, equipment or personnel are not available; modifications to facilities or equipment beyond the capability of those involved to attain safety; and/or sanctions against individuals who are non-cooperative in safety matters concerning their work. Under defined circumstances the HSEAC member may temporarily suspend any hazardous activity judged to pose a significant danger to health or safety.

6.3. Subcommittees of HSEAC

The HSEAC will appoint subcommittees as desired. The following subcommittees are recommended:

6.3.1. Biosafety and Biosecurity Sub-committee

This sub-committee will be appointed to develop policies; to consult on all matters concerning biological safety (including work with recombinant DNA /Genetically Modified Organisms), and to report their recommendations to the HSEAC. It is responsible for developing approval procedures (e.g. Biosafety permits) on all applications or proposals relating to working with rDNA/Genetically Modified Organisms (GMOs) in the Institute, for notifying the HSE Coordinator of all work with rDNA/GMOs in the Institute, for ensuring that policies on biosafety and inventories are adhered to in the Institute.

6.3.2. The Radiation and Chemical Protection Sub-Committee
This sub-committee will be appointed to develop policies and chemical hygiene plans (CHP); encourage best practices in Centres/ Departments responsible for handling and disposing of radioactive and other non radioactive materials; to encourage the adoption of the highest health and safety standards of practice by Centres/Departments in order to protect all Institute staff, students and visitors likely to come into contact with radioactive materials and/or equipment which emits ionizing radiations, and to report to the HSE Advisory Committee.

6.3.3. Environment Sub-Committee
This sub-committee will be responsible for developing policies and Guidelines on Environmental Management Systems (EMS); Waste Management and Disposal; Environmental Impact and Audit Assessments (EIA/EA); and to seek ways to minimize needless consumption of material and energy, coordinating information, education, and research related to environment.

6.3.4. Quality Management Systems and Accreditations Sub-Committee
The role of this sub-committee will be to ensure clinical, support and administrative service quality throughout the Institute and to ensure the formulation and attainment of a quality vision, oversee development of a quality plan, and implement and monitor quality improvement and accreditation activities.

6.4. Occupational Health Services

The KEMRI staff Clinics will be available to all staff and students, and aim to deal pro-actively with all aspects of health at work. Treatments will be limited to first aid and immediate care, and are aimed at keeping staff and students at work. It is expected that all staff and students will be registered with a general practitioner near to where they reside for primary care services. These Health Services will also provide health surveillance for specific groups of staff and students, health promotion and education, vaccination and health advice for business travel, basic counseling and specialist comprehensive medical advice on all Occupational Health issues.

6.5. Review of policy

This policy and procedure statement will be reviewed annually by the Coordinator HSE and HSEAC with recommendations for revision presented to the Director KEMRI.

Administrative Offices