Basic Concepts On Laboratory Biosafety and Biosecurity

Basic Concepts on
Laboratory Biosafety
and Biosecurity
Rochelle D. Darlucio, RMT
College of Medical Laboratory Science
Our Lady of Fatima University
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
Biorisk Mitigation
Actions and control measures that are put
into place to reduce or eliminate the risks
associated with biological agents and toxins
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 team work
• 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 RTPCR. 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! 
Acknowledgement:
JOY POTENCIANO-CALAYO, RMT, MSC, CBO
ANNA G. GIBSON, PhD

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Basic Concepts on

the first internationally recognized management

Laboratory Biosafety Manual, Third edition (World Health

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

BIOSAFETY + BIOSECURITY = BIORISK

A biorisk assessment allows a laboratory to determine

A threat is a person who has intent and/or

A risk can be based on either a hazard

What is the likelihood of exposure?

What is the likelihood of exposure?

The difficulty of acquiring the agent

In the security community, Adversary

An insider is a person who has authorized access to a

An outsider is a person who does not have authorized

Repeatability is the ability to conduct the same

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