Basic Concepts on

Laboratory Biosafety
and Biosecurity
 Lesson Intended Learning
Outcomes (LILO):
‐ Discuss the history and the related policies and guidelines
governing laboratory biosafety and biosecurity;
‐ Differentiate the fundamental concepts between laboratory
biosafety and biosecurity;
‐ Classify microorganisms according to risk group;
‐ Categorize laboratories according to biosafety level
Biosafety in Microbiological and Biomedical
Laboratories (BMBL)

Become the code of practice

for biosafety-the discipline
addressing the safe handling
and containment of infectious
microorganisms and
hazardous biological
materials.
CWA-15793:2008
‐ Laboratory Biorisk Management Standard

‐ the first internationally recognized management standard to

specifically address hazards associated with microbiological
laboratories at all containment levels
Laboratory Biosafety
‐ Containment principles,
technologies, and
practices implemented to
prevent unintentional
exposure to pathogens
and toxins, or their
unintentional release.

Laboratory Biosafety Manual, Third edition (World Health

Organization, 2004)
Laboratory Biosecurity
‐ Protection, control and accountability for
valuable biological materials within
laboratories, in order to prevent their
unauthorized access, loss, theft, misuse,
diversion or intentional release.

Biorisk management - Laboratory biosecurity guidance (World Health Organization, 2006)

BIOSAFETY is protecting people
from dangerous pathogens

BIOSECURITY is protecting
pathogens from bad people
BIORISK
Risk associated with biological materials

BIOSAFETY + BIOSECURITY = BIORISK

 Biorisk
Management
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
Key Components of Biorisk Management

‐ Biorisk Assessment
‐ 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
Key Components of Biorisk Management
‐ Biorisk Mitigation
‐ Actions and control measures that are put
into place to reduce or eliminate the risks
associated with biological agents and toxins
Key Components of Biorisk
Management
‐ Biorisk Performance
‐ Improving biorisk management by recording, measuring,
and evaluating organizational actions and outcomes to
reduce biorisk.
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
RISK ASSESSMENT
‐ A laboratory biorisk assessment is an analytical procedure
designed to characterize and evaluate safety and security
risks in a laboratory.

‐ A biorisk assessment allows a laboratory to determine the

relative level of risk its different activities pose, and helps
guide risk mitigation decisions so these are targeted to the
most important risk.
RISK ASSESSMENT
‐ Involves teamwork
‐ • identify all the risks : 5Ps
‐ Pathogen
‐ Procedures
‐ Personnel
‐ PE
‐ Place
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

What is Risk?
‐ the likelihood of an undesirable event happening, that
involves a specific hazard or threat and has consequences
Determining likelihood of an event
Assessing consequences
Factors that affect Likelihood and/or
Consequences
‐ Agent Properties
‐ Pathogenicity
‐ Virulence
‐ Host range
‐ Communicability
‐ Transmission
‐ Environmental Stability
‐ Procedures
‐ PPE
‐ Training
‐ SOPs
‐ Equipment used
Risk Characterization
‐ 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?
‐ Scenario:
‐ You are working with a suspect wild-type Ebola virus specimen
in a high containment BSL 3-type laboratory, conducting
nucleic acid extraction and RT-PCR. You are working in a
BSC and are using disposable PPE with respiratory protection.

‐ What is the likelihood of exposure?

‐ What are the consequences of exposure?
‐ What are some factors that should be considered?
Asset Characterization
‐ Asset Characterization is the process of gathering information
about the biological agents and toxins that could potentially be
targeted by notional adversaries.
‐ Determining the ease or difficulty of malicious use (likelihood)
should involve assessing the following:

‐ The difficulty of acquiring the agent

‐ The difficulty of processing the agent into a suitable quantity in
a suitable form
‐ The difficulty of disseminating the agent to cause harm
Adversary Characterization
‐ Adversary Characterization is the process of determining
specific attributes of potential adversaries that enable them to
pose a threat to a biological agent or toxin.

‐ In the security community, Adversary Characterization is also

known as Threat Assessment.
The question of opportunity raises the issue of insider versus
outsider threat.

‐ An insider is a person who has authorized access to a facility,

its units (such as laboratories), and its assets.

‐ An outsider is a person who does not have authorized

access.
Biorisk Characterization
‐ Comparability is the ability trust the accuracy of differences
between assessments, due to similarities in their bases,
assumptions, procedures and protocols.

‐ Repeatability is the ability to conduct the same process in the

same way for the same hazard or threat and situation over a
period of time, or for different hazards, threats, and situations
at the same time.
Risk Evaluation
‐ Risk Evaluation is the process of
determining, subjectively, whether a
risk is high or low, and whether it’s
acceptable or not.
RISK MITIGATION CONTROL
MEASURES
RISK MITIGATION
‐ PERSONAL PROTECTIVE EQUIPMENT (PPE)
‐ Last control in the hierarchy of controls
‐ Should be used with other controls.
‐ However, in many laboratories it is the first control implemented,
and sometimes the only control
• Eye protection
• Gloves
• Face shields
• Hair nets
• Ear plugs (when sonicating)
• Protective clothing (gowns)
• Footwear
• Respiratory Protection
Points to consider
‐ Breaking the chain to manage the risk
‐ Pathogen
‐ Reservoir of pathogen
‐ Portal of escape
‐ Transmission
‐ Route of entry/infectious dose
‐ Susceptible host
THANK YOU! ☺