Basics of Biosafety
Working Safely with Biological Materials
What is Biosafety?
Principles and practices employed to protect
laboratory personnel and the environment from
exposure or infection while working with living
organisms, biological materials = Agents.
Included are any materials that may be potentially
infectious.
Includes recombinant DNA research Products
Agents and Risks
The “agent” is the what creates risk
Risks to the worker or environment
are often unknown
Determining “acceptable risk”?
Assessing Risk
There is always risk!
The risk must be identified
The risk is evaluated
The risk must be measured
Plan to minimize the risk and
render it acceptable
Who Determines Acceptable Risk?
Assessment is conducted by a Biosafety Professional in
partnership with and based on information provided by
the Principal Investigator
The assessment is presented to the Institutional
Biosafety Committee (IBC) for approval
Identifying Risk
Understand the biology of the agent
Susceptibility and transmission within the
host
Hazards associated with equipment and
procedures
Goal:
Provide the highest practical protection and
the lowest practical exposure
Evaluating Risk Acceptability
Worst case scenario -What might happen?
Likelihood of an event
Seriousness of the incident
Actions needed to resolve the problems
What is Acceptable Risk?
Since there is no such thing as “no risk”
“Safe” means risk has been judged acceptable
Judging risk is a subjective - humans make decisions
Measuring risk is objective- use available guidelines,
data, and documentation
Keep records of how determinations were made due to
subjective nature of the process
WHO-World Health Organization
Agents Assigned Risk Groups
RG-1 Unlikely to cause disease in humans or animals
low individual or community risk
RG-2 May cause disease but typically not serious
individual risk, low community risk, treatable
RG-3 May cause serious disease, usually treatable
High individual but low community risk, serious respiratory agents
RG-4 Serious or fatal, often not treatable,
Easy transmission, high individual and community risk
We need to work with the
“Risk” to understand them
and use them, therefore:
We need to manage the
Risk
HOW???
Biosafety Levels (BSL)
Different than the Risk Groups!!
Risk groups used in risk assessment
BSL are used in risk management
BSL are ways to control the agent (Risk)
facilities, safety equipment, practices, etc.
Once risk is assessed then the appropriate BSL is
determined
The BSA Levels
BioSafety Level 1
Well characterized, non-pathogenic organisms or agents
Open bench - no containment
Use good laboratory practices, waste disposal, and aseptic techniques
Example: E. coli K-12 strains
Example: College Labs
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BioSafety Level 2
Agents of moderate hazard to personnel or
environment
Basic lab, but restricted access, containment during
certain processes (i.e. aerosols, large volumes, etc.)
Autoclave and Biological Safety Cabinet desired
Use good laboratory practices, waste disposal, and
aseptic techniques
Example: most non-respiratory, non lethal, agents
BioSafety Level 3
Agents of high hazard to personnel or environment
Respiratory exotic or indigenous agents which are
easily transmissible causing serious or lethal disease
All work is contained, engineering controls and
controlled environments we currently do not have the
facilities to handle.
Example: Mycobacterium tuberculosis, SARS, etc.
BioSafety Level 4
FORGET ABOUT IT ??!!!
Hemorrhagic fever, deadly viruses, etc.
Total containment, airtight labs, “submarine” doors, air
pumps, water treatment, HEPA filtration, etc.
Positive pressure “moonsuits”
THE BIOCONTAINMENT
LEVELS 1, 2, 3 & 4
What are they?
Different levels of Lab Infrastructure which enable
operations of the respective Biosafety levels
Currently, 4 levels
of containments
• Containment Level 1 (CL1)
• Containment Level 2 (CL2)
• Containment Level 3 (CL3)
• Containment Level 4 (CL4)
BIOCONTAINMENT:
The concept of biocontainment is related to laboratory
biosafety and refers to microbiology laboratories in
which the physical containment of highly pathogenic
organisms or agents (bacteria, viruses, and toxins) is
required, usually by isolation in environmentally and
biologically secure cabinets or rooms, to prevent
accidental infection of workers or release into the
surrounding community during scientific research
Containment Level 1 (CL1)
This applies to the basic laboratory that handles agents requiring
BioSafety Level 1 management. Requires no special design features
beyond those suitable for a well-designed and functional laboratory.
Biological safety cabinets (BSCs) are not required. Work may be
done on an open bench top, and containment is achieved through
the use of practices normally employed in a basic microbiology
laboratory…..further reading
Containment Level 2 (CL2)
This applies to the laboratory that handles agents requiring
BioSafety level 2 management. The primary exposure
hazards associated with organisms requiring CL2 are through
the ingestion, inoculation and mucous membrane route.
Agents requiring CL2 facilities are not generally transmitted by
airborne routes, but care must be taken to avoid the generation
of aerosols (aerosols can settle on bench tops and become an
ingestion hazard through contamination of the hands or
splashes. Primary containment devices such as BSCs and
centrifuges with sealed rotors or safety cups are to be used as
well as appropriate personal protective equipment …read
further
Containment Level 3 (CL3)
This applies to the laboratory that handles agents requiring
BioSafety level 3 management. These agents may be transmitted
by the airborne route, often have a low infectious dose to produce
effects and can cause serious or life-threatening disease. CL3
emphasizes additional primary and secondary barriers to minimize
the release of infectious organisms into the immediate laboratory
and the environment. Additional features to prevent transmission of
CL3 organisms are appropriate respiratory protection, HEPA
filtration of exhausted laboratory air and strictly controlled laboratory
access ……..further reading
Containment Level 4 (CL4)
This is the maximum containment available and is suitable for facilities
manipulating agents requiring BioSafety level 4 management. These
agents have the potential for aerosol transmission, often have a low
infectious dose and produce very serious and often fatal disease; there
is generally no treatment or vaccine available. This level of containment
represents an isolated unit, functionally and, when necessary,
structurally independent of other areas. CL4 emphasizes maximum
containment of the infectious agent by complete sealing of the facility
perimeter with confirmation by pressure decay testing; isolation of the
researcher from the pathogen by his or her containment in a positive
pressure suit or containment of the pathogen in a Class III BSC line; and
decontamination of air and other effluents produced in the facility………
further reading
