Microorganism Risk Assessment Worksheet
Date Completed: __________________
Completed By: __________________
1. Bioagent/Microorganism Category
 Bacteria/chlamydia/ Ricketssia
 Mycoplasm
 Virus
 Prion
 Parasite
 Other: Speciify_________________
2. Species Name:____________________________________________________
3. Strain Name: _____________________________________________________
4. Proposed Risk Group
 1
 2
 3
5. Is a PHAC or CFIA MSDS/PSDS available for your RG 2 or 3 biological agent(s)?
 Yes  No
IF No, Risk Group was determined according to:
 Human Pathogens and Toxins Act Schedules 2-4
 Risk Group definitions found in the PHAC Laboratory Biosafety Guidelines (3rd Edition)
 PI independent summary of Risk Factor Analysis as per Table below (based on PHAC
LBG3rd classification criteria)
 ATCC or other vendor information
 ABSA table
 Published article: specify
 Best Guess
6. Host Range
 Human
 Non-Human Primate
 Plant
 Animal Specify all:_____________________________________________
7. Bioagent is
 wild type OR select from one of the options below
 attenuated  replication incompetent – if yes to either provide supporting evidence
 antibiotic resistance If yes, describe
 Other: describe the variation ______________
8. Are toxins actively secreted?
October 2012
 Yes  No  Don’t Know
If Yes what is the LD50? _________________-
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9. Micro-organism obtained From
 Commercial source: e.g. ATCC
Company Name ________________________
 Catalogue Number _______________________
 Other Source: e.g. Dr. X at U of YZ, clinical isolate
________________________
If an MSDS is not available, you can document your risk assessment using the PHAC Risk
Factor Group definitions and PHAC Risk Summary table (as found in the PHAC e-learning
modules) in support of the final Risk Group determination. For Risk Group 2 and 3
biological agents, use this information to develop a PSDS if one is not available. A blank
PSDS is available on the following web-site:
http://www.umanitoba.ca/admin/human_resources/ehso/media/MSDS_blank_for_biol
ogical_agents.doc.
Risk Group Summary Table
Risk Factor
Risk Group Risk Factor
Risk Group Risk Factor
Pathogenicity/Virulence
Environmental
Stability
Mode of Transmission
/Route of Infection
Infectious Dose
Host range
Availability of
effective
treatment or
preventive
measures
Vectors
Endemicty
rDNA?
Communicability
Economic impact of
release into the
environment/public
Overall Risk
Group
Risk
Group
Individual Risk Factor Risk Group definitions
Risk Factor
Pathogenicity &
Virulence
Risk Group 1
Unlikely to cause
disease, low
individual and
community risk
Risk Group 2
Mild or moderate disease,
moderate individual risk, low
community risk, any pathogen
that can cause disease but
under normal circumstances, is
unlikely to be a serious hazard
to a healthy laboratory worker,
the community, livestock or the
environment
Mode of
Transmission /
Route of
Infection
Not applicable (not
known to cause
disease)
Primary exposure hazards are
through ingestion, inoculation
and mucous membrane route
(not generally through the
airborne route)
October 2012
Risk Group 3
Serious livestock, poultry or
wildlife disease; high
individual risk, 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 form one
individual to another
Risk Group 4
Severe livestock, poultry or
wildlife disease / high
individual risk, high
community risk, also causes
human disease, any
pathogen that usually
produces very serious and
often fatal disease, often
untreatable and may be
readily transmitted form one
individual to another, or from
animal to human or viceversa, directly or indirectly,
or by casual contact.
May be transmitted through Readily transmitted,
airborne route; direct
potential for aerosol
contact; vectors
transmission
2
Risk Group 1
Not applicable (not
known to cause
disease)
Not applicable (not
known to cause
disease)
Risk Group 2
Variable or high (1,000-5,000
organisms or greater)
Risk Group 3
Medium (10 –1,000
organisms)
Risk Group 4
High (1-10 organisms)
Geographical risk of spread if
released form the laboratory is
limited, very limited or no
transmission is relatively
limited
Geographical risk of spread
if released form the
laboratory is widespread
Environmental
Stability
Host Range
Not applicable
Short term survival (days); can
survive under ideal conditions
Infects a limited number of
species
Geographical risk of spread
if released form the
laboratory is moderate,
direct animal to animal or
human to human
transmission occurs
relatively easily –
transmission between
different animal species
may readily occur
Resistant (days to months)
Endemicity
Enzootic
Economic
aspects of
introduction
and/or release
into the
environment of
the Canadian
public
Availability of
prophylactic and
therapeutic
treatments
Risk Factor
Infectious Dose
Ability to Spread
/ Transmission /
Communicability
Not applicable (not
known to cause
disease)
Infects multiple species
Highly resistant (months to
years) e.g. spores
Infects many species of
animals
Exotic or enzootic but
subject to official control
Exotic
No economic and /or
clinical significance
Generally enzootic (some lowrisk exotics, or reportable
diseases)
Limited economic and/or
clinical significance
Severe economic and/or
clinical significance
Extremely severe
economic and/or clinical
significance
Not applicable (not
known to cause
disease)
Effective treatment and
preventive measures are
available
Prophylactic and /or
treatments may or may not
be readily available (or of
limited benefit)
Prophylactic and/or
treatments are not usually
available
Vectors
Not applicable (not
known to cause
disease)
Do not depend on vectors or
intermediate hosts for
transmission May depend on
vectors or intermediate host for
transmission
May depend on vectors or
intermediate host for
transmission
May depend on vectors or
intermediate host for
transmission
RecombinantsRefer also to
rDNA risk
assessment
worksheet
The recombinant is
a risk group 1
organism;
modifications have
not changed the risk
-The recombinant is a risk
group 2 organism;
modifications have not
changed the risk
- DNA from risk group 2 or 3
organism is transferred into risk
group 1 organism: but not the
whole genome.
- DNA from risk group 4
organism is transferred into risk
group 1 organism (only after
demonstration of a totally and
irreversible defective fraction of
the organism genome is
present in the recombinant.
- The recombinant is a risk
group 3 or 4 organism,
however, the modification has
resulted in proven attenuation.
The recombinant is a RG3
organism and the
modifications have not
changed the risk
- the recombinant is based
on a risk group 2 organism,
however, the modifications
have increased the risk
group to a RG 3 organism;.
The recombinant is a risk
group 4 organism;
modifications have not
changed the risk
- DNA from a risk group 4
organism is transferred into
a risk group 1 organism in
with an absence of
demonstrations of a lack of
virulence or pathogenicity.
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Personnel Factors
10. Vaccine available?
 Yes  No Name______________________
11. All personnel working with or near any of the above material in use have been:
 Offered any available vaccinations
 Offered any available vaccinations and the department has a record of vaccination being
received OR being declined with counselling.
 Medical surveillance plan in place and documented.
Describe:
Refer also to the U of M Governance Procedure: Immunizations Standard
12. Personnel health assessment required? i.e. risks communicated for discussion with personal
health care provider
 Immune status
 allergen issues
13. Worker’s experience with agent
 Beginner
 Intermediate
 Advanced
14. Personnel Biosafety training completed
 Generic WHMIS
 Generic Biosafety
 New Lab Personnel Safety Checklist for site-specific/project specific procedures
 MSDS, and pertinent SWP read
 U of M Biosafety Guide read
 Autoclave use
 Centrifuge use
 Specific equipment use: list Technical proficiency in Procedures
 Emergency Procedures, Spill clean-up, fire, electrical failure/loss of power,
 1st Aid, PEP, location of bandaids
 Other
15. PPE required when working with agent . Mark M-for mandatory
 CL1 – standard – lab coat, gloves, close-toed shoes – safety glasses as per procedure
 CL2 – standard – lab coat, gloves, close-toed shoes, covered legs – safety glasses as per
procedure
 Face shield
 safety glasses
 N-95
 face mask
 back closing gown at BSC
16. Frequency of Contact with agent:  Routine/daily  Weekly  Random/monthly /yearly
17. Potential Routes of contact with Bioagent
 Sharps /puncture wounds /inoculation
 Ingestion from indirect contact
 Mucous membranes –eyes, mouth, nose,
 Broken skin, including facial blemishes
 Respiratory from aerosols
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Assessment of Factors Associated with the Laboratory Operation
18. Will the agent be:
 cultured - Indicate typical concentrations and volumes in use:_____________________
 concentrated – Specify method:  centrifuging  precipitation  freeze-drying
 filtration
 other
19. Concentration/dose of potential exposure:
20. Largest single volume used:
___________________________
 < 1Litres
 1-10LItres
 >10Litres
21. OR Typical Volumes, containers, concentrations used: __________________________
22. Will sharps be used?
 Yes
If YES, are you using safety engineered sharps? If not, explain:
Potential for auto-inoculation?
 No
If YES, do you have approved sharps containers (autoclavable, puncture resistant, secure lid,
labelled) available for disposal? If not, explain sharps disposal procedure:
23. At what stage of the experiment is the infectious agent inactivated or lysed and how is this
achieved ( what is the method of terminal inactivation?)
Yes

No
25. Is the agent inactivated prior to manipulation on the open bench
 Yes
If NO, indicate the type of procedures that will be done on the open bench. OR
List Aerosol/ droplet-Generating Procedures in Use :

No
24. Is all work with the active agent done in a BSC?( not required for CL1 )

List Aerosol/ droplet-Generating Equipment in Use:
-OR26. If bench work is done, identify procedures that would increase the hazard:
 Aerosol producing procedures including cell sorting, sonication, centrifuging in open
containers, shaking or vigorous mixing, vortexing, pipetting, blending, flaming loops,
homogenizing, grinding, opening containers whose internal pressures may be different from
ambient pressure?
 Procedures that create a splash, spill hazard
27. If bench work is done, describe measures to be used for the protection of personnel and the
environment -OR -How will the hazards be mitigated? Or – How are the resulting aerosols
controlled?
28. Will your experiments involve centrifugation?
October 2012
 Yes  No
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29. If YES, are sealed rotors, or sealed centrifuge safety cups available for use?  Yes  No
If NO, do you only use screw –cap non-glass tubes?
30. Will you open the tubes in the BSC after centrifuging?
 Yes  No
 Yes  No
31. Disinfectants and decontaminants in use: ____________________________________
How is efficacy of the above determined?
OR
32. Specify disinfectants and decontaminants and decontamination procedures in use.
33.
Surface Disinfection
List all decontaminants used in the laboratory to surface disinfect hard surfaces and laboratory gloves:
Disinfectant
Working
Contact Time
Preparation
Used Against
Concentration
(min)
Frequency
Physical Waste
Check all practices that apply to the disposal of biohazardous waste generated by your research group:
Yes No N/A
Solid waste contaminated with biohazardous material and all microbial and
eukaryotic cell cultures, including broth cultures, will be treated by autoclaving at
___________oC for at minimum ____________of minutes.
Yes No N/A
Needle and syringe assemblies will be placed into a puncture-resistant, autoclavable
sharps container with a secure lid, without attempting to clip or recap the needle
until being treated by autoclaving at ___________oC for at minimum
____________of minutes.
Yes No N/A
Used glass and hard plastic pipettes and Pasteur pipettes will be immersed in a
solution of ___________for a minimum of _______hours. After treatment items will
be rinsed with water, placed into broken glass containers and picked up by Caretaking
Services.
Yes No N/A
A. Liquid waste contaminated with biohazardous material will be treated via
autoclaving at _____oC for a minimum of _______minutes OR
Yes No N/A
B. Liquid waste contaminated with biohazardous material will be treated chemically
with _________for a minimum of ____ hours prior to pouring the material down the
drain. Drain will be flushed with cold water for one minute to flush out sink trap.
Yes No N/A
Other, specify:
Facility Design :
Refer to the U of M Biosafety Guide (2012), Section 7.1.2-7.1.3 and PHAC LBG and CFIA CSVF for
pertinent facility design and operational requirements.
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Summary
Risk Group
1
2
3
Containment Level
1
2
 2+  2e
3
Refer to the U of M Biosafety Guide (2012) Section 7.1 & 7.2 for definitions of the Containment
Levels.
Lab or Project Specific Operational Practices Based upon the assessment of your pathogen risk factors, personnel and the specific laboratory
operation or project, summarize the specific operational practices that may be required in
addition to those outlined in the PHAC-LBG Section 3.1 Standard Operational Practices and the
pertinent Containment level operational practises. Refer also to the U of M Biosafety Guide
(2012) Section 8 U of M Biosafety- Operational Practices for additional resource information and
specific U of M requirements. Suggested topics include:
TrainingAccess Control- Entrance Signage or Biosecurity measures
Medical Surveillance-Immunizations, Medical Surveillance Statement or Post-Exposure Protocol
Personal Protective Equipment Disinfectants, DecontaminationSpill Clean-up ProtocolOperations or procedures that may only be done in the BSCSafety Procedure for work with sharps-
October 2012
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