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What is Biorisk?
× Risk associated with biological
materials
× Biorisk = Biosafety +
Biosecurity Risks

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Laboratory Biorisk
Management
× System or process to control safety and
security risks associated with the
handling or storage and disposal of
biological agents and toxins in
laboratories and facilities

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Biorisk Assessment 1
× Process of identifying the hazards and
evaluating the risks associated with
biological agents and toxins, taking into
account the adequacy of any existing
controls, and deciding whether or not
the risks are acceptable

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Biorisk Mitigation 2
× Actions and control measures that are
put into place to reduce or eliminate the
risks associated with biological agents
and toxins

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Biorisk Performance 3
× Improving biorisk management by
recording, measuring, and evaluating
organizational actions and outcomes to
reduce biorisk.

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Laboratory Biorisk
Management Standard
(CWA-15793:2008)

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Laboratory Biorisk
Management Standard
(CWA-15793:2008)
× the first internationally
recognized management
standard to specifically address
hazards associated with
microbiological laboratories at
all containment levels.”
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Laboratory Biorisk
Management Standard
(CWA-15793:2008)
× “The standard “also provides a
structured approach to
managing risk associated with
people, facilities and working
procedures in laboratory
environments.”
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Assessment Process to identify
the hazards and
 Risk evaluate the risks AMP
identification
 Hazard/threat
associated with
biological agents
model of
identification
 Likelihood and toxins BRM
evaluation
 Consequences
evaluation

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Mitigation Control measures
put into place to
 Elimination or
substitution reduce or eliminate AMP
 Engineering
controls
the risks model of
 Administrative
controls BRM
 Practices and
procedures
 Personal
protective
equipment 15
Performance monitoring and
continuous
 Control
 Assurance evaluation to ensure AMP
that the system is
 Improvement
working the way it model of
was designed and
identifying BRM
opportunities for
system improvement

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Risk Assessment
5 P’s
Pathogen
× Involves team work Personnel

Procedures

PE

Place

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Risk Assessment
× identify the specific hazard or threat
× determine the consequences of an
identified risk
× identify all the existing controls and any
additional ones that need to be applied

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Hazard, Threat, and Risk
× A hazard is an object that can cause harm
× A threat is a person who has intent and/or
ability to cause harm to other people,
animals, or the institution
× A risk can be based on either a hazard
and/or a threat

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What is Risk?
× Risk is the likelihood of an
undesirable event happening,
that involves a specific
hazard or threat and has
consequences

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Determining likelihood of an event 24
Assessing consequences 25
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Risk Assessment
× a procedure that analyzes a particular
process or situation in order to
determine the likelihood and
consequences of a certain adverse event.

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Risk Characterization
× a procedure that analyzes a particular
process or situation in order to
determine the likelihood and
consequences of a certain adverse event.

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× Suppose you are working with a seasonal
influenza virus, conducting testing on a human
respiratory specimen, on the bench-top, with
no respiratory protection.

× What is the likelihood of exposure?

× What are the consequences of exposure?
× What are some factors that should be
considered?

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Risk Characterization
× Characterizing biosecurity risk includes
an in-depth analysis of laboratory
assets, potential adversaries, and
laboratory vulnerabilities..

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Asset Characterization
× process of gathering information about
the biological agents and toxins that
could potentially be targeted by
notional adversaries

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 Asset
Characterization
ease or difficulty of malicious use (likelihood)

1. The 2. The difficulty 3. The difficulty of

difficulty of of processing disseminating
acquiring the agent into the agent to
the agent a suitable cause harm
quantity in a
suitable form
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Asset
Characterization
potential consequences of the malicious use
(consequences)
1. The physical impact of 3. The impact of changes in
an attack on a public perception
population 4. The impact on facility
2. The impact of an operations
attack on the economy
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Adversary Characterization
× the process of determining specific
attributes of potential adversaries that
enable them to pose a threat to a
biological agent or toxin.
× Threat Assessment

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Adversary Characterization
Some characteristics of potential adversaries that
could help determine the risk they pose, include:
× Motive

× Means

× Opportunity

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Risk Evaluation
× the process of determining, subjectively,
whether a risk is high or low, and
whether it’s acceptable or not.

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 two institutions with the
same computed risk “values”
for the risk characterization
process may have different risk
evaluations (meanings of risk).

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× An institution that considers a certain risk high
might be motivated to spend a large amount of
resources mitigating that risk.

× Another institution that considers the same risk

to be moderate might decide to spend a small
amount of resources in mitigation instead

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RISK MITIGATION CONTROL
MEASURES
Elimination
• Removing the risk

Substitution
• Substitution of a serious pathogen with one that is less
pathogenic
Engineering controls
• Physical changes to work stations, equipment, materials,
production facilities or any other relevant aspect of the work
environment that reduce or prevent exposure to hazards 42
RISK MITIGATION CONTROL
MEASURES
Administrative
• Policies, standards and guidelines

Practices and procedures

• Processes and activities

PPE
• Devices worn by the worker to protect against
hazard 43
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