University of Nebraska Medical Center
Biosafety Policies and Procedures
TITLE:
Biosafety Risk Factor Assessment Process to Determine
Appropriate Containment
[UNMC-IBC34]
OVERVIEW:
Each planned experiment where biohazard agents are used must
undergo an initial risk assessment to decide on the appropriate
containment for an experiment. This policy gives guidance on the
steps necessary to conduct a biosafety risk assessment
APPLIES TO:
All research undergoing review by the Institutional Biosafety
Committee
DEFINITION(S):
Not applicable
PROCEDURES:
Refer to the IBC website at <<www.unmc.edu/ibc/>> and link to the
page entitled, “Exempt Experiments” for examples of experiments
that are exempt from the NIH Guidelines and thus do not require
registration with the IBC.
For experiments that are not exempt, Addendum 1 provides a
template to conduct a Biosafety Risk Assessment as part of the process
in preparing an IBC protocol. This assessment includes the following
risk factor categories as they pertain to the biohazardous agent under
review:
Pathogenicity/virulence
Infectious dose
Route of spread
Communicability
Environmental stability
Host range
Economic aspects
Availability of prophylactic and therapeutic treatments
Vectors
Concentration/volume
Recombinant properties
For the IBC Application, the Principal Investigator is required to
complete a biosafety risk assessment to complete Section II, Part 3
(Biosafety Level of Containment) of the IBC submission form,
Protocol for Research Involving Biohazardous Material.
The overall Risk Group Classification will be used by the IBC to
determine the appropriate containment for the proposed experiment.
The IBC will ultimately be responsible for setting the containment
level for the requested experiment.
IBC34_011907
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University of Nebraska Medical Center
Biosafety Policies and Procedures
RECORD
KEEPING:
A copy of the Biosafety Risk Assessment Summary will be included
with the protocol paperwork in the IBC office.
OTHER
INFORMATION:
The NIH Guidelines state that, “the IBC must approve the risk
assessment and the biosafety containment level of….experiments”
[Section II-A-3, Comprehensive Risk Assessment] and “the IBC is
responsible for….reviewing research….(which) should include….an
independent assessment of the containment levels required……for the
proposed research” [Section IV-B-2-b-(1)].
REFERENCES:
NIH Guidelines, Section II, Safety Considerations
STATUS:
Drafted:
Approved:
IBC34_011907
November 20, 2006
January 12, 2007
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University of Nebraska Medical Center
Biosafety Policies and Procedures
UNMC IBC
Biosafety Risk Assessment Summary
IBC# _______________________ (to be determined by the IBC Office)
Title of Project
____________________________________________________________________________
____________________________________________________________________________
Principal Investigator ______________________________
Date __________________
____________________________________________________________________________
Risk Factor
Risk Group
Pathogenicity/virulence
_________
Infectious Dose
_________
Route of Spread
_________
Communicability
_________
Environmental stability
_________
Host range
_________
Economic impact
_________
Availability of prophylactic/treatment
_________
Vectors
_________
Concentration/volume
_________
Recombinant properties
_________
Overall Risk Group
_________
Recommended Containment Level
_________
Notes:_______________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
IBC34_011907
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University of Nebraska Medical Center
Biosafety Policies and Procedures
Risk Factor Assessment Outline
Pathogenicity/virulence
RG1
Unlikely to cause disease, low individual and community risk.
RG2
Mild or moderate disease with moderate individual risk and low community risk; any pathogen that can
cause disease but under normal circumstances, is unlikely to be a serious hazard to a healthy worker, the
community, livestock, or the environment.
RG3
Serious livestock, poultry or wildlife disease with high individual risk and low community risk; any
pathogen that usually causes serious disease or can result in serious economic consequences or does not ordinarily
spread by causal contact from one individual to another.
RG4
Severe livestock, poultry or wildlife disease with high individual risk and high community risk; any
pathogen that usually produces very serious and often fatal disease, often untreatable and may be readily
transmitted from one individual to another or from animal to human or vice-versa, directly or indirectly, or by
casual contact.
Infectious dose
RG1
RG2
RG3
RG4
Not applicable
High
Medium
Low
(rare cause of human disease)
(>1,000 organisms)
(10-1,000 organisms)
(1-10 organisms)
Route of spread
RG1
RG2
RG3
RG4
Not applicable (rare cause of human disease)
Primary exposure hazards are through ingestion, inoculation, and mucous membrane route
May be transmitted through airborne route; direct contact or via vectors
Readily by aerosol transmission
Communicability
RG1
RG2
RG3
RG4
Not applicable (rare cause of human disease)
Geographical risk of spread if released from the laboratory is limited.
Geographical risk of spread if released from the laboratory is moderate
Geographical risk of spread if released from the laboratory is high.
Environmental stability
RG1
RG2
RG3
RG4
Not applicable
Short term survival (days), can survive under ideal conditions
Moderately resistant (days to months)
Highly resistant (months to years), e.g. spores.
Host range
RG1
RG2
RG3
RG4
Not applicable
Infects a limited number of species
Infects multiple species
Infects many species
Economic aspects
RG1
RG2
RG3
RG4
Not applicable
Limited economic impact
Severe economic impact
Extreme economic impact
Availability of prophylactic and therapeutic treatments
RG1
RG2
RG3
RG4
Not applicable
Effective treatment and preventative measures are available
Prophylactic and/or treatments may or may not be readily available
Prophylactic and/or treatments are not available
Vectors
RG1
RG2
IBC34_011907
Not applicable
Do not depend on vectors or intermediate hosts for transmission
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University of Nebraska Medical Center
Biosafety Policies and Procedures
RG-3
RG4
May depend on vectors or intermediate host for transmission
May depend on vectors or intermediate host for transmission.
Concentration/volume
RG1
RG2
RG3
RG4
Not applicable
Low quantity of high titer
High quantity (10 liters or more) of high titer as described by the BMBL
Not applicable
Recombinant properties
RG1
Recombinant is a RG1 organism and modifications have not changed the risk; low probability of RG2
replication-incompetent virus becoming competent
RG2
Recombinant is a RG2 organism and modifications have not changed the risk, DNA from RG2 or RG3
organism is transferred into RG1 organism but not the whole genome, DNA from RG4 organism is transferred
into RG1 organism, or the recombinant is a RG3 or RG4 organism and the modification has resulted in proven
attenuation; moderate probability of RG2 replication-incompetent virus becoming competent
RG3
Recombinant is a RG3 organism and modifications have not change the risk, the recombinant is based on
a RG2 organism; however, the modifications have increased to RG3 organism.
RG4
Recombinant is a RG4 organism and modifications have not changed the risk, DNA from RG4 organism
is transferred into RG1organism in absence of demonstration of lack of virulence or pathogenicity.
IBC34_011907
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