This document defines key terms related to biosafety and biosecurity risk assessment. It discusses the importance of risk assessment for effective resource allocation and regulatory compliance. Risk assessments should be performed initially and periodically, or when changes occur. They involve identifying hazards and risks, characterizing risks based on likelihood and consequences, determining if risks are acceptable, and implementing mitigation measures if needed. The processes for biosafety and biosecurity risk assessments are outlined, including defining the scenario or situation, risks, characterizing risks, acceptability determination, and risk mitigation implementation.

1. Preventing the next Pandemic through
Biosafety
and
Biosecurity Risk Assessment

2. IFBLSA Biosafety & Biosecurity
Committee
In collaboration with
African Union of Medical Laboratory
Students, AUMLS
Energizing sustainable diagnosis through Research and Innovations

3. DEFINITION OF TERMS
Hazard:A source, situation, or act with a potential for causing harm
(Source: CWA 15793).
Biohazard:The potential source of harm caused by biological agents or
toxins (Source: CWA 15793).
Risk:A combination of the probability of occurrence of harm and the
severity of that harm (Source: CWA 15793).
Biorisk:A combination of the probability of occurrence of harm and the
severity of that harm where the source of harm is a biological agent or toxin
(Source: CWA 15793).
Risk assessment:A process of evaluating the risk(s) arising from a hazard(s),
taking into account the adequacy of any existing controls and deciding
whether or not the risk(s) is acceptable (Source: CWA 15793).

4. Definition of terms…..
Biorisk mitigation:Actions and control measures that are put
into place to reduce or eliminate the risks associated with
biological agents and toxins and otherValuable Laboratory
Material (VLM).
Biorisk Assessment:A process of evaluating the biorisk(s) arising
from a biohazard(s), taking into account the adequacy of any
existing controls, and deciding whether or not the biorisk(s) is
acceptable (Source: CWA 15793).
Biorisk management:This is the analysis of ways and
development of strategies to minimize the likelihood of the
occurrence of biorisks.
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5. Definition of terms…………
Biosafety: This is a set of containment principles, technologies and practices
that are implemented to prevent the unintentional exposure to biological
agents and toxins, or their accidental release.
Biosafety risk assessment:An analytical procedure designed to characterize
safety risks in a laboratory.
Biosecurity:The set of measures aimed at the protection, control and
accountability for valuable biological materials (VBM) and protection of
other valuable items (e.g. equipment) within laboratories, in order to prevent
their loss, theft, misuse, diversion of, and/or unauthorized access or
intentional unauthorized release.
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6. Definition of terms…………
Biosecurity risk assessment:An analytical procedure designed to
characterize security risks in a laboratory.
Valuable Biological Material (VBM):These are biological materials that
require (according to their owners, users, custodians, caretakers or
regulators) administrative oversight, control, accountability, and specific
protective and monitoring measures in laboratories to protect their economic
and historical (archival) value, and/or the population from their potential to
cause harm.
Valuable Laboratory Material (VLM): It is a material of value to the
laboratory due to its replacement cost and its necessity for the laboratory
operational purposes.
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7. IMPORTANCE AND BENEFITS OF
RISK ASSESSMENT
Effective allocation of resources to mitigate risks
Identification of training needs and supervision
Advance planning for renovation
Evaluation of procedural changes
Compliance with governmental regulations
Justification for space and equipment needs
Evaluation of emergency plans
Planning for preventative maintenance
Evaluation of exchanges and workflow with other laboratories/units
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8. WHEN TO PERFORM AND REVIEW
LABORATORY RISK ASSESSMENT
A risk assessment should therefore be performed and
reviewed:
Periodically,
Annually or possibly,
An organization should consider conducting a risk
assessment more often as circumstances warrant, for
example, following the occurrence of problems or if
laboratory practices change.
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9. WHEN TO PERFORM AND REVIEW LABORATORY RISK
ASSESSMENT………….
A laboratory should perform an initial risk assessment before any work is started and in cases
of:
 new infectious agents, toxins, reagents or other dangerous substances
 new animal species, model, or route of administration of biological agents
 new procedures and practices
 new equipment
 personnel changes
 aging of equipment
 advances in scientific understanding and technology
 a relocation or renovation
 a recent or “near-miss” accident, laboratory-acquired infection (LAI), theft, or security
 violation
 national or regional changes in disease status (endemicity of disease or disease eradication)
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10. WHO SHOULD CONDUCT RISK
ASSESSMENT?
Biorisk management advisors (biosafety officers or professionals)
Principal investigators/scientists/researchers
External Safety and Security personnel
Laboratory contractors, waste handlers, maintenance staff, and janitorial
crews
Legal consultant or department/public relations/labour safety officer
Upper management
Administration
Community stakeholders
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11. 1. Define the scenario (what can go wrong?)
1a. Identify the hazards
1b. Consider hosts
1c. Define the work activities and laboratory environment
BIOSAFETY RISK ASSESSMENT PROCESS
2. Define the risks (what can go wrong?)
2a. Consider all risks and determine which risks should be defined
• Risk to individual(s) inside the laboratory
• Risk to an individual(s) outside the laboratory (the human
community)
• Risk to animals outside the laboratory (the animal community)
• Risks to humans and animals resulting from a secondary exposure.

12. BIOSAFETY RISK ASSESSMENT PROCESS…………
3. Characterize the risks (how likely is it to happen & what are the
consequences)
3a. HazardAssessment
3b. HostAssessment
3c.WorkActivities and Laboratory EnvironmentAssessment
3d. Overall Risk Characterization
4. Determine if the risks are acceptable
4a. Discuss with management and other stakeholders
5. Implement risk mitigation measures, as needed
5a. Discuss with management and other stakeholders
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13. BIOSECURITY RISK ASSESSMENT PROCESS
1. Define the situation
1a. Identify the assets
1b. Identify the threats
1c. define the facility and lab security environment
2. Define the risks
2a. construct a series of potential risks
• risk of a theft of an agent by a technician aiming to make others ill
• risk of an outsider stealing or destroying laboratory information
(specifically test results)
• risk of a criminal stealing laboratory equipment, and
• risk of an environmental or community exposure of an infectious agent
due to theft of laboratory equipment which was contaminated.
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14. 3. Characterise the risk
3a. asset assessment
3b. adversary assessment
3c. facility vulnerability assessment
BIOSECURITY RISK ASSESSMENT PROCESS………
4. Determine if the risks are acceptable
4a. Discuss with management and other stakeholders
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5. Implement mitigation measures, if needed
5a. Discuss with management and other stakeholders

15. THANKS
NOTE
This plate presents a guide of the steps involved in
biosafety (biological material) and biosecurity
(Personnel) risk assessment processes. As such, it is
permitted to be use for this purpose.
International Federation of Biomedical Laboratory StudentsAssociations
IFBLSA, Energizing sustainable diagnosis through Research and Innovations
https://ifblsa.simdif.com
www.facebook.com/AUMLStudents
ifblsa.net@gmail.com
IFBLSA Desk (mobile contact): (+237) 667 436 766