BIOSAFETY MANAGEMENT

Biorisk- risk associated with biological

materials

BIORISK=BIOSAFETY+BIOSECURITY Risk

LABORATORY BIORISK MANAGEMENT

-system or process to control safety and
security risks associated with the handling or
storage and disposal of biological agents and
-identifies specific hazard or threat
toxins in laboratories and facilities.
-determine the consequence of an identified
KEY COMPONENTS:
risk
1. assessment
2. mitigation Hazard- is an object that can cause harm
3. performance
1. Biorisk Assessment Threat- is a person who has intent and/or
ability to cause harm to other people,
- process of identifying the hazards and animals, or institution
evaluating the risks associated with biological
agents and toxins and deciding whether or
not the risks are acceptable

2. Biorisk Mitigation

- actions and control measures that are put

into place to reduce or eliminate the risks
associated with biological agents and toxins

3.Biorisk Performance
RISK, LIKELIHOOD AND CONSEQUENCES
- improving biorisk management by recording, Risk- is the likelihood of an event/incident
measuring, and evaluating organizational with a hazard that has consequences
actions and outcomes to reduce biorisk Likelihood- is the probability of an event
occurring
RISK ASSESSMENTS Consequence- is severity of an event
- It is an analytical procedure designed
to characterized and evaluate safety FACTORS THAT AFFECT LIKELIHOOD AND
and security risks in lab. CONSEQUENCES
- It must consider every activity and [Agent Properties]
procedure conducted in a lab. That - Pathogenicity
involves infectious disease agents - Virulence
- Consider every asset, adversary, and - Host range communicability
vulnerability in an institution and its - Transmission
component lab. and units - Environmental stability
- -allows lab. to determine the relative [Procedures]
level of risk its activities pose, and - PPE
helps guide risk mitigation decisions - Training
- SOP’s
so these are targeted to the most
- Equipment used
important risk
5 Ps may identify the risk:
a. Pathogen
b. Procedures
c. Personnel
d. PPE
e. Place
BIOSECURITY RISK CHARACTERIZATION
-characterizing biosecurity risk includes an in-
depth analysis of laboratory assets, potential
adversaries and laboratory vulnerabilities MITIGATION PROCEDURES
Asset Characterization
BIORISK MITIGATION
Asset- process of gathering info. About the -actions and control measures that are put
biological agents and toxins into place to reduce or eliminate the risks
associated with biological agents and toxins
Adversary- biological agents and toxins are
5 Mitigation Measures
referred to as “assets”
1. Elimination
Determining the likelihood should involve 2. Substitution
assessing the ff.: 3. Engineering
-difficulty acquiring the agent 4. Administrative
-difficulty processing the agent 5. PP3
-difficulty of disseminating the agent to cause
harm
Determining the consequence should involve
assessing the ff.:
-physical impact on a population and
economy
-impact of changes in public perception
-impact on facility operations

(ADVERSARIES)
Determining specific attributes of potential
adversaries that enable them to pose a
threat to an asset
-Motive
-Means
-Opportunity
Risk Evaluation
-process of determining subjectively, whether
a risk is high or low, and whether it’s
acceptable or not
-evaluating a risk as acceptable or not may
depend on the perception of individuals,
institutions and the community
-if an institution finds a particular risk
unacceptable, it will either cease the work
resulting in that unacceptable risk, or It will
find ways to mitigate that risk to a more
acceptable level
ELIMINATION
-most difficult and the most effective method
-act of removing the risk by deciding not to
work with the agent or not doing the intended
work
SUBSTITUTON
-replacement of procedure or biologic agent
with similar entity to reduce the risk
-substitution of serious pathogen with less
pathogenic organism
-e.g use of non-pathogenic E.coli
ENGINEERING
-physical changes in the workstation,
equipment or facilities that aids in the
prevention of exposure to hazards
-e.g installation of Biosafety cabinets, use of
closed tube sampling, safety needles,
emergency showers
ADMINISTRATIVE CONTROLS PERFORMANCE EVALUATION

-these are policies or guidelines that is being
established for awareness
-strict implementations of policies/procedures
to prevent contacting/exposure to infectious
agents
-e.g controlling visitors/assess, SOP’s to
reduce risk like no mouth pipetting, no eating
in the lab.
PERSONAL PROTECTIVE EQUIPMENT (PPE)
-these are devices worn by workers for
protection against the hazard
-least effective control measure
-e.g glove, lab coats, mask
-Involves systematic process intended to
achieve organizational objectives and goals
BIORISK PERFORMANCE
-improving biorisk management by recording,
measuring, and evaluating organizational
actions and outcomes to reduce biorisk
Performance Assessment/Management
- assess the difference
-performance changes over time: a sustained
level of performance requires a continual
effort
-re-evaluation of mitigation strategy

Points to consider:
PERFORMANCE EVALUATION PROCEDURES
-ideally, elimination or substitution must be
considered first

- combination of control measures should be

used based on their effectiveness and your
ability to implement them

PERSONAL PROTECTIVE EQUIPMENT

-last control in the hierarchy of controls

-should be used with other control

-however, in many lab., it is the first control

implemented, and sometimes the only control

Acceptable Risk

-Justify decisions
-Evaluate impact of certain risk mitigation
decision
-Compare the cost effectiveness of various
risk mitigation decisions
Points to consider:
-proper recording, documentation and
communication to all stakeholders about the
risk assessment to establish a clear
manifestation of implementation of the
fundamental concept of biosafety and
biosecurity in the lab.