BIOLOGICAL RISK GROUP AND CONTAINMENT LEVEL ASSESSMENT
SCOPE
This template is intended as a tool to assist in determining the appropriate risk group and
containment level requirements of organisms, biological material and biohazardous material
proposed to be used in research, or other activities at the University of Saskatchewan. This
template is based closely on the risk assessment tool employed by the Public Health Agency of
Canada (PHAC) and the Canadian Food Inspection Agency (CFIA).
INSTRUCTIONS
Known Risk Group and Containment Level
If the organism, biological material or biohazardous material risk group and containment level
have been determined from another source (e.g. PHAC, CFIA), complete only SECTION 1
BIOLOGICAL MATERIAL IDENTIFICATION section of the assessment template (page 1). The
remainder of the risk assessment does not have to be completed with the exception as
indicated for recombinant DNA.
Listed below are resources that provide risk group and containment level information for various
organisms and biohazardous materials. These resources are assessable on the Safety
Resources website, http://safetyresources.usask.ca/.
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Human Pathogens and Toxins Act,
(http://www.phac-aspc.gc.ca/lab-bio/regul/index-eng.php);
Pathogen Safety Data Sheets and Risk Assessment, Public Health Agency of Canada
(PHAC),
(http://www.phac-aspc.gc.ca/lab-bio/res/psds-ftss/index-eng.php);
Disease Agent Information, Canadian Food Inspection Agency,
(http://www.inspection.gc.ca/english/sci/bio/anima/disemala/disemalae.shtml);
Risk Group Classification for Infectious Agents, American Biological Safety Association
(ABSA), (http://www.absa.org/riskgroups/index.html); or
National Institutes of Health Guidelines for Research Involving Recombinant DNA
Molecules, National Institutes of Health (NIH),
(http://oba.od.nih.gov/oba/rac/Guidelines/APPENDIX_B.htm#_Toc7238342).
Safety Resources also maintains a database of organisms, biological materials and
biohazardous materials that are, or have been used at the university together with their
identified risk group and containment level.
Biological Risk Group and Containment Level Assessment
Safety Resources
February 7, 2012
Page 1 of 20
Unknown Risk Group and Containment Level
If the organism, biological material or biohazardous material risk group and containment level is
not already determined, a complete biological risk group and containment level assessment
must be performed. Complete all applicable sections of the risk assessment template.
Safety Resources biosafety staff is available to assist individuals with the completion of the
Biological Risk Group and Containment Level Assessment.
Biological Risk Group and Containment Level Assessment
Safety Resources
February 7, 2012
Page 2 of 20
SECTION 1
BIOLOGICAL RISK GROUP ASSESSMENT
BIOLOGICAL MATERIAL IDENTIFICATION
Complete the following table including a brief description of the organism, biological material, or
biohazardous material.
Name of Biological Material:
Family:
Genus:
Species:
Provide a brief description of organism, biological material or biohazardous material:
Is the risk group determined by another source (e.g. PHAC, CFIA, ABSA)?
If yes, indicate the source:
Yes
No
Yes
No
Risk Group listed (1,2,3,4):
Is the containment level determined by another source (e.g. PHAC, CFIA, ABSA)?
If yes, indicate the source:
Containment Level listed (1,2,3,4):
Is the organism a recombinant DNA?
Yes
If yes, also complete RECOMBINANT DNA section of the risk assessment.
References:
No
The information provided in this assessment is complete and accurate to the best of my knowledge. I understand and accept my
responsibilities pursuant to the University of Saskatchewan Biosafety Code of Practice.
Risk assessment completed by (Print Name):
Signature: ___________________________
Date completed: 11/22/2012
Biological Risk Group and Containment Level Assessment
Safety Resources
February 7, 2012
Page 3 of 20
SECTION 2
RISK FACTORS
PATHOGENICITY/VIRULENCE
Consider the risk group levels presented below. In the following table, indicate to which level the
organism, biological material or biohazardous material would belong. Provide a brief description
of the pathogenicity/virulence of the organism, biological material or biohazardous material
referencing relevant literature.
Level 1 - Unlikely to cause disease
- Low individual and community risk
Level 2 - Mild or moderate risk of disease/moderate risk to individual, low risk to community
- Any pathogen that can cause disease but, under normal circumstances, is unlikely to
be a serious hazard to healthy laboratory workers, the community, livestock, or the
environment
Level 3 - Serious human, livestock, poultry, or wildlife disease/high individual risk, high
community risk
- Any pathogen that usually causes serious disease or can result in serious economic
consequences but does not ordinarily spread by casual contact from one individual to
another
Level 4 - Very serious human, livestock, poultry, or wildlife disease
- 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
Pathogenicity/virulence Level (1-4):
Provide a brief summary of the pathogenicity/virulence of the organism/biological material/biohazardous
material:
References:
Biological Risk Group and Containment Level Assessment
Safety Resources
February 7, 2012
Page 4 of 20
INFECTIOUS DOSE
Based on the infectious dose information provided for each risk group level, complete the table
below.
Level 1 - Not applicable (not known to cause disease)
Level 2 - Variable or high (1000 – 5000 organisms or greater)
Level 3 - Medium (10 – 1000 organisms)
Level 4 - Low (1 – 10 organisms)
Infectious dose level (1-4):
Provide brief description about the infectious dose:
References:
Biological Risk Group and Containment Level Assessment
Safety Resources
February 7, 2012
Page 5 of 20
MODE OF TRANSMISSION/ROUTE OF INFECTION
Based on the transmission/route of infection information provided for each risk group level,
complete the table below.
Level 1 - Not applicable (not known to cause disease)
Level 2 - Primary exposure hazards are through ingestion, inoculation, and mucous membrane
route (not generally through airborne route)
Level 3 - May be transmitted through airborne; direct contact; vectors
Level 4 - Readily transmitted, potential for aerosol transmission
State the mode of transmission/route of infection level (1-4):
Provide a brief description of the mode of transmission:
References:
Biological Risk Group and Containment Level Assessment
Safety Resources
February 7, 2012
Page 6 of 20
ABILITY TO SPREAD/TRANSMISSION/COMMUNICABILITY
Based on the spread/transmission/communicability information provided for each risk group
level, complete the table below for the organism/biological material/biohazardous material.
Level 1 - Not applicable (not known to cause disease)
Level 2 - Geographical risk of spread if released from the laboratory is limited
- Direct animal to animal or human to human transmission is relatively limited
- Very limited or no transmission between different animal species
Level 3 - Geographical risk of spread if released from the laboratory is moderate
- Direct animal to animal or human to human transmission occurs relatively easily
- Transmission between different animal species may readily occur
Level 4 - Geographical risk of spread if released from the laboratory is widespread
- Direct animal to animal or human to human transmission occurs very easily
- Transmission between different animal species may occur very readily
- Transmission from animal to human or vice-versa may occur readily, directly or
indirectly, or by casual contact
Level of the Ability to Spread/Transmission/Communicability (1-4):
Provide a brief description about the Ability to Spread/Communicability:
References:
Biological Risk Group and Containment Level Assessment
Safety Resources
February 7, 2012
Page 7 of 20
SURVIVAL IN THE ENVIRONMENT
Based on the survival in the environment information provided for each risk group level,
complete the table below for the organism/biological material/biohazardous material. The longer
an organism/biological material/biohazardous material can survive outside of the host, the
higher the risk.
Level 1 - Not applicable
Level 2 - Short term survival (days); can survive under ideal conditions
Level 3 - Resistant (days to months)
Level 4 - Highly resistant (months to years) (e.g. spores)
Ability to survive in the environment (1-4):
Provide a brief summary about the ability of the organism/biological material/biohazardous material to
survive in the environment:
Is the biological agent stable outside of the host?
Can the biological agent survive for long periods of time outside of the host
(e.g. on lab equipment or surfaces)?
Can the biological agent survive harsh environmental conditions?
Can the biological agent survive in lab effluent (e.g. sewer)?
References:
Biological Risk Group and Containment Level Assessment
Safety Resources
Yes
No
Yes
No
Yes
Yes
No
No
February 7, 2012
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HOST RANGE
Based on the host range information provided for each risk group level, complete the table
below for the organism/biological material/biohazardous material.
Level 1 - Not applicable (not known to cause disease)
Level 2 - Infects limited number of species
Level 3 - Infects multiple species
Level 4 - Infects many species of animals and humans
Host Range level (1-4):
List the host species and geographical areas:
Provide a brief description about the host range:
Is the biological agent zoonotic, or does it infect only animals or
humans?
Are the host species found in Canada?
Can the biological agent survive harsh environmental
conditions?
Are the host species economically important in Canada?
References:
Biological Risk Group and Containment Level Assessment
Safety Resources
Human
Animals
Yes
No
Yes
No
Yes
No
Both
February 7, 2012
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ENDEMICITY
Endemicity is defined as a disease or pathogen that is found in or confined to a particular
location, region, or people. Malaria, for example, is endemic to tropical regions.
Enzootic is defined as a disease that is constantly present in an animal community but only
occurs in a small number of cases.
Based on the endemicity information provided for each risk group level, complete the table
below for the organism/biohazardous material.
Level 1 - Enzootic
Level 2 - Generally enzootic (some low risk exotics or reportable disease)
Level 3 - Exotic or enzootic but subject to official control
Level 4 - Exotic
For list of reportable diseases, refer to CFIA’s website:
http://www.inspection.gc.ca/english/anima/disemala/rep/repe.shtml
Endemicity level (1-4):
Provide brief description about the endemicity:
References:
Biological Risk Group and Containment Level Assessment
Safety Resources
February 7, 2012
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ECONOMIC ASPECTS OF INTRODUCTION AND/OR RELEASE INTO THE ENVIRONMENT
OR THE CANADIAN PUBLIC
Based on the economic aspects information provided for each risk group level, complete the
table below for the organism/biological material/biohazardous material.
Level 1 - No economic and/or clinical significance
Level 2 - Limited economic and/or clinical significance
Level 3 - Severe economic and/or clinical significance
Level 4 - Extremely severe economic and/or clinical significance
Economical Aspect level (1-4):
Provide brief description about the economic impact aspects of introduction and/or release into the
environment or the Canadian public:
References:
Biological Risk Group and Containment Level Assessment
Safety Resources
February 7, 2012
Page 11 of 20
AVAILABILITY OF PROPHYLACTIC AND THERAPEUTIC TREATMENTS
Prophylactic is a medication or a treatment designed and used to prevent a disease from
occurring.
Based on the treatment information provided for each risk group level, complete the table below
for the biological agent.
Level 1 - Not applicable (not known to cause disease)
Level 2 - Effective treatment and preventive measures are available
Level 3 - Prophylactic and/or therapeutic treatments may or may not be readily available (or
of limited benefit)
Level 4 - Prophylactic and/or therapeutic treatments are not usually available
Availability of prophylactics and Treatment level (1-4):
Provide a brief description about the types of prophylactics and/or treatments that are available:
Are antibiotics or antivirals available to treat the disease?
Are there effective vaccines available?
References:
Biological Risk Group and Containment Level Assessment
Safety Resources
Yes
Yes
No
No
February 7, 2012
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VECTORS
A vector is defined as an organism, often an invertebrate arthropod that transmits a pathogen
from reservoir to host.
Based on the vector information provided for each risk group level, complete the table below for
the biological agent.
Level 1 - Not applicable (not known to cause disease)
Level 2 - Do not depend on vectors or intermediate hosts for transmission
Level 3 - May depend on vectors or intermediate hosts for transmission
Level 4 - Depend on vectors or intermediate hosts for transmission
Vector level (1-4):
Provide a brief description about the vector and its lifecycle (pertaining to infectious stage) and its
geographical range:
Is the vector present in Canada?
Is the intermediate host present in Canada?
Does the climate or other environmental factors lower the
chance of the vector survival?
Can pathogen survive in surrogate or alternate vector?
If so, state the vector?
References:
Biological Risk Group and Containment Level Assessment
Safety Resources
Yes
Yes
No
No
Yes
No
Yes
No
February 7, 2012
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RECOMBINANT DNA
A recombinant is defined as any biological agent produced by the combining of genetic material
from more than one origin (e.g. chromosome, cell, organism, etc., the genetic makeup of which
results from recombination).
Risk group assessment for recombinant organisms will require the researcher to take into
consideration the effect of modification on all of the previous 10 risk factors in this assessment.
As per guidelines from PHAC, CFIA, and the National Institutes of Health (NIH), there are
standard risk group assessments based on the modification, however, for the most part, a
comprehensive examination on the effect of modification is required. The risk factor can be
more subjective.
Based on the recombinant information provided for each risk group level, complete the table
below for the biological agent.
Level 0 - Not applicable, biological agent not a recombinant
Level 1 - The recombinant is a risk group 1 organism; the modifications have not changed the
risk
Level 2 - The recombinant is a risk group 2 organism; the modifications have not changed the
risk; or
- DNA from risk group 2 or 3 organisms is transferred into risk group 1 organism, but
not the whole genome; or
- The recombinant is a risk 3 or 4 organism; however, the modification has resulted in
proven attenuation.
Level 3 - The recombinant is a risk group 3 organisms; the modifications have not changed the
risk; or
- The recombinant is based on a risk group 2 organism; however, the modifications
have increased the risk.
Level 4 - The recombinant is a risk group 4 organisms; the modifications have not changed the
risk; or
- DNA from the risk group 4 organism is transferred into a risk group 1 organism in
absence of demonstration of lack of virulence or pathogenicity
Biological Risk Group and Containment Level Assessment
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February 7, 2012
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Recombinant level (1-4):
Provide a brief description of the recombinant:
If the modification has resulted in a form of attenuation, how extensively has this strain been utilized
without incident and/or has the attenuation been proven in animal models?
rDNA research be conducted with (select type)
Human
Animal
Plant cell lines
Yes
No
Yes
No
Will the research involve the expression of cloned DNA?
Will research involve the purification of cloned DNA product?
Does the inserted material increase virulence or decrease the
Increase
Decrease
effectiveness of the anti-infective agents?
Does the inserted gene encode a known toxin or relatively
Yes
No
uncharacterized toxin?
Does the modification have the potential to alter the host range or cell
Yes
No
tropism of the virus or bacteria?
Does the modification have the potential to increase the replication
Yes
No
capacity of the virus or bacteria?
Does the inserted gene encode a known oncogene?
Yes
No
Does the inserted gene have the potential for altering the host cell
Yes
No
cycle?
Does the viral or bacterial DNA integrate into the host genome?
Yes
No
What is the probability of generating replication-competent virus or
Low/Intermediate/High
bacteria?
Does the modification have an effect of increasing or decreasing the
Increase
Decrease
efficacy of available treatment or prohylaxis?
Will the genetic material be released to the environment?
Yes
No
For each gene, describe the potential for adverse health effects on humans/animals/plans arising from
exposure to the gene/gene product as found in the source organism:
For each gene, describe the potential for adverse health effects on humans/animals/plans arising from
exposure to the gene/gene product as found in the host organism:
Describe the replication competency of the recombinant (if replication is deficient, explain the propagation
system):
If available, attach a copy of the genetic map of your vectors.
References:
Biological Risk Group and Containment Level Assessment
Safety Resources
February 7, 2012
Page 15 of 20
RECOMBINANT DNA SUMMARY SHEET
(Complete the following table for all recombinants)
Organism That is
Source of Gene
Risk Group
Level for
Source
Organism
2
Gene or DNA
Fragment
Function of Gene or DNA
Fragment and Identify of
its Product(s)
Chaperonin60 (cpn60),
partial
Molecular chaperone
involved in protein folding
Vector
List Propagation
Mechanism or
Recipient of Gene or
DNA Fragment ( e.g.
cells line, bacteria)
Risk Group
Level of
Recipient
pGEM T Easty
E. coli JM109
1
Example:
Cambylobacter
jejuni
Biological Risk Group and Containment Level Assessment
Safety Resources
January 19, 2012
Page 16 of 20
AVAILABILITY OF DATA
Data availability refers to the literature, journals, references, or documentation that is readily
available about the biological material of interest.
Based on the availability of data information provided for each Risk Group level, complete the
table below for the organism/biological material/biohazardous material.
Level 1 – Well documented as benign under all conditions
Level 2 – Well documented under many conditions
Level 3 – Information and trends identified, but not proven conclusive
Level 4 – Very sparse information available
Data Availability level (1-4):
References:
Biological Risk Group and Containment Level Assessment
Safety Resources
February 7, 2012
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SECTION 3
SUMMARY MATRIX FOR THE ASSESSMENT OF RISK GROUP DETERMINATION
Based on the information gathered, complete the table below by making an X in the level
associated with biological agent for each risk factor.
Risk Factor
Level 0
Level 1
Level 2
Level 3
Level 4
Pathogenicity/Virulence
Infectious Dose
Mode of Transmission/ Route of
Infection
Ability to Spread
Survival in the Environment
Host Range
Zoonotic? (Yes/No)
Endemicity
Economic Consequences
Availability of Prophylactic and
Therapeutic Treatments
Vectors
Recombinant /modifications
TOTAL (sum each column)
Biological Risk Group and Containment Level Assessment
Safety Resources
February 7, 2012
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The level with the highest total from the risk assessment will identify the primary risk group level
for the organism/biological material/biohazardous material. If the totals for different levels are
the same or similar, then the higher risk group shall be adopted.
Decision (risk group level):
(Circle the risk group)
1
2
3
4
Date completed:
Risk assessment completed by:
Comments:
Biological Risk Group and Containment Level Assessment
Safety Resources
February 7, 2012
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SECTION 4
CONTAINMENT LEVEL ASSESSMENT
Containment level is defined as the set of controls, including safe methods, equipment, and
facilities needed to protect workers and the environment from biohazardous materials. Controls
used for containment in laboratories are described in PHAC Laboratory Biosafety Guidelines (3rd
Edition, 2004) and CFIA Containment Standards for Veterinary Facilities (1st Edition, 1996). The
levels of containment range from the lowest containment level 1 to the highest at containment
level 4.
Generally, the containment level assessment falls in line with the risk group assessment. For
example, risk group 2 pathogens are used in a containment level (CL) 2 laboratory. However,
certain work practices or research objectives can affect the risk of working with the organism.
For example:
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Rabies is a Risk Group 3 pathogen, however, diagnostic work can be safely performed
in a CL2 laboratory with additional CL3 operational protocols.
Third generation lentiviral vector is fairly benign and can be utilized at CL2, however,
dependent on the inserted gene, work with the vector may have to take place at CL2
with CL3 operational protocols or CL3.
Research done with E. coli O157:H7 strains can be safely performed in a CL2 laboratory
with additional CL3 operational protocols.
in vivo work with an attenuated strain of an organism may have to take place at CL3
dependent on the mechanism of attenuation (Lymphocytic Choriomeningitis Virus
(LCMV) – potential neurotropic).
This is not to be considered a job hazard analysis for routine CL assessment for permit
application and request for advice, therefore, we will not consider the following although they
can be given consideration by the Principal Investigator:
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Health status of the individual performing the work (immune compromised, pregnant,
inherited genetic factors, etc.).
Skills and experience of the individual performing the work (i.e. is this a new
procedure?).
Will repetitive and tedious procedures be used?
A detailed review of the task from initiation to completion.
To determine the containment level standards, both physical and operational, the following
questions need to be answered:
Biological Risk Group and Containment Level Assessment
Safety Resources
February 7, 2012
Page 20 of 22
Risk group designation for biological material of interest (1-4):
Answer questions below, and enter the appropriate containment levels
What type of work will be done on the
biological material?
If in vivo, what types of animals will be
used?
If in vivo, what risk may be associated
with that specific animal (e.g. exposure
routes, aerosol generation, etc.)?
Does the project involve modifications of
wild type pathogen which may affect
host range, virulence, pathogenicity, or
any other factors?
If the work is not large scale, is there an
increased concentration of the
pathogen?
Will a large volume of aerosols be
produced?
Will needles or sharps be used?
What is the origin of the pathogens, i.e.,
indigenous, exotic?
References:
Containment Level
(Choose CL 1, 2, 3, or 4)
Physical
Operational
in vitro/in vivo/both/large scale
Yes
No
Yes
No
Yes
No
Yes
No
All of these factors must be considered for CL assessment and the answers to each question
will outline what physical and operational requirements are needed to ensure safety of the
worker and the environment. For each question, list whether CL 1, 2, 3 or 4 physical and/or
operational requirements apply and at the end you will have either a straight answer for CL or a
combination of one CL for physical and another for operational requirements; a CL assessment
is the result of these conclusions.
Containment Level Assessment Results
Containment level designation:
Physical
Operational
Date completed:
Risk assessment completed by:
Comments:
Biological Risk Group and Containment Level Assessment
Safety Resources
February 7, 2012
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REFERENCES
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Biosafety Code of Practice, University of Saskatchewan.
New Biosafety Permit Application Procedure, Safety Resources.
Biosafety Permit Amendment Procedure, Safety Resources.
Laboratory Biosafety Guidelines, Public Health Agency of Canada (PHAC), 3rd Edition,
2004.
Containment Standards for Veterinary Facilities, Canadian Food Inspection Agency, 1st
Edition. 1996.
Containment Standards for Facilities Handling Plant Pests, Canadian Food Inspection
Agency, 1st Edition, 2007.
Containment Standards for Facilities Handling Aquatic Animal Pathogens, Canadian Food
Inspection Agency, 1st Edition, 2010.
Laboratory Biosafety Manual, World Health Organization, 3rd Edition, 2004.
Biosafety in Microbiological and Biomedical Laboratories, Centers for Disease Control and
Prevention, National Institutes of Health, 5th Edition, 2009.
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February 7, 2012
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