Purpose
The Biosafety Plan template is intended as a tool to assist permit applicants/holders in the
development of a biosafety plan. Refer to the Biosafety Plan Guide for further information and
instructions on how to complete each element of the biosafety plan.
NOTE: All procedures, documents, templates, and forms referenced in this procedure are
bolded and italics, and can be found on the Safety Resources website:
http://safetyresources.usask.ca .
NOTE: Ensure to delete the above instructions and all other
instructions when complete.
Biosafety Plan
Year
College/Unit/Department
Permit Holder Name
Biosafety Permit Number:
Contents
1
Biosafety Permit Holder Information .................................................................................... 1
2
Emergency Contact Information .......................................................................................... 1
3
Nature of Research ............................................................................................................. 2
4
Biological Assessment and Inventory .................................................................................. 3
5
Health and Safety Hazard Assessment ............................................................................... 5
6
Biosecurity Assessment ...................................................................................................... 8
7
Work Locations ..................................................................................................................10
8
Standard Operating Procedures (SOPs) and Element Requirements ................................12
9
References ........................................................................................................................19
Revision History
Revisions to the biosafety plan are documented in Table 1, Revision History (e.g. New Biosafety
Plan, Addition of new biohazardous materials, etc.).
Table 1: Revision History
Document
Section
Details of Amendments
Date
Author
(Initials)
1
Biosafety Permit Holder Information
Biosafety Permit Number:
Biosafety Permit Issue Date:
Permit Holder Name:
Permit Holder Telephone Number:
Lab Telephone Number:
Email:
Secondary Contact Name:
Secondary Contact Telephone Number:
Email:
2
Emergency Contact Information
Refer to Section 1 of the Biosafety Plan Guide.
Primary Contact:
Name:
Office Phone Number:
Cell Phone Number:
Secondary Contact:
Name:
Office Phone Number:
Cell Phone Number:
Tertiary Contact:
Name:
Office Phone Number:
Cell Phone Number:
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3
Nature of Research
In the space provided below, provide a brief description in lay-man terms of the research
initiatives that will be conducted under the biosafety permit, which includes a summary of the
procedures involved, an outline of objectives, experimental approach, and/or significance of the
expected results.
For an example, refer to Table 1 found in Section 2 of the Biosafety Plan Guide.
Ensure to add all relevant reference and any other relevant documents.
ENTER INFORMATION HERE
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4
Biological Assessment and Inventory
Develop an up to date inventory of all biological/biohazardous materials in your possession, which will be handled, used, produced,
and/or stored under the biosafety permit.
Table 2 may be used to maintain the inventory of the biological/biohazardous material and document the risk group, containment
level, and dual-use potential for each biological agent. Refer to Section 3 of the Biosafety Plan Guide.
If the biological/biohazardous material has been identified as genetically modified or rDNA, the Risk Assessment for
rDNA/Genetically Modified Organisms Form, found on the Safety Resources website: www.safetyresources.usask.ca.
For Security Sensitive Biological Agents (SSBA), further details will be required, contact the Biosafety Officer for assistance. For the
comprehensive SSBA, refer to: http://www.phac-aspc.gc.ca/lab-bio/regul/ssba-abcse-eng.php .
For procurement or transferring materials from a campus, domestic, and/or international source(s), refer to the Procurement and/or
Transfer of Biological Agents process at the Safety Resources website: www.safetyresources.usask.ca , or contact the Biosafety
Officer.
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Table 2: Inventory of Biological/ Biohazardous Material.
Name of Biological
Material 1
Supplier/Source of
the Biological
Material 2
Purpose or Use 3
Concentration 4
Max.
quantity
to be
cultured
at one
time?
(in
Litres)
Risk
Group 5
(1, 2, 3)
Containment
Level 5
(1, 2, 3)
rDNA/
GMMO 6
(Yes or
No)
Dual-use
Potential 7
(Yes or
No)
List of Reference(s) 8
1 When
identifying the biological material, ensure to state the most descriptive name (e.g. genus species) and include the strain if it is a bacteria or virus.
State how the biological material(s) is acquired, or procured, such as naming the supplier and their location (e.g. Dr. Smith, University of Brisbane, Tawoomba,
Australia).
3 State the type of work which will be conducted with the biological material (e.g. in vitro, in vivo, both, storage only, etc.).
4 State the concentration of the biological material (e.g. cells: 10 6 cells per plate; bacteria: colony forming units; virus: plaque forming units/tissue culture infectious
does; toxins: unit of mass/unit of volume);
5 The identified risk group and containment level as specified by external sources, or as determined from a biological risk and containment level assessment.
6 If the biological material is identified as rDNA/GMMO, complete the Risk Assessment for rDNA/Genetically Modified Organisms (GMO) Form.
2
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7
Use the Dual-use assessment flow chart in Figure 2 in Section 3 of the Biosafety Plan Guide.
the reference(s) for the categorization of the risk group and containment level (e.g. risk assessment performed by researcher, PHAC, CFIA).
8 Indicate
5
Health and Safety Hazard Assessment
Use Table 4 to identify the health and safety hazards and state how the hazards will be mitigated, such as listing the procedures to be
used for each identified biological material, identifying the proper PPE, etc.
Use Table 5 and 6 to identify the potential risks of exposure to Biological materials that are known to cause disease (e.g. toxins, Risk
group 2 or 3 microorganisms) and provides information regarding available vaccinations and medical surveillance.
Refer to section 4 of the Biosafety Plan Guide.
Table 4: Hazards Assessment
Procedures Hazard Assessment
Biological Materials
1
List of Procedure
1
Potential Route(s) of Exposure
from Procedure
Safety Mitigation Strategies
Identify and list all Biological materials (Refer to biological material inventory listed in Table 3).
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Table 5: Biological Material Pathogenicity Assessment.
Name of
Biological
Material
Routes of
Exposure 1
List of Disease(s) 2
Symptoms 3
Time Onset for
Symptoms After
Exposure
1
State the route of exposure which may occur when working or storing of the biological material: ingestion, inoculation (e.g. needle stick injury, bites and scratches),
inhalation, and absorption through the skin and/or mucosal membranes.
2 List all potential diseases and/or allergies/sensitization that can or may be caused by the biological material (e.g. Human cell line HEK293T cells – cells contain
adenoviral components, and risk of Blood borne pathogens, such as Hepatitis, HIV, other blood borne diseases)
3 List the symptoms that can be obtained from each route of exposure from the biological material. If a TOXIN is used, state the rate of action for the toxin (how long
after exposure before effects of the toxin are observed) and state the LD50 for humans (if no available provide information for the animal).
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Table 6: Medical Surveillance and Immunization Assessment.
Vaccinations
Name of
Biological
Material
Available
1
(yes or
no)
Effective
(yes or
no)
Vaccination
Waiver
Needed
(yes or no) 2
Prophylaxis 3
Required
(yes or
no)
State Type of
Prophylaxis
Medical Surveillance 4
Serum Collection
Recommended for
Baseline
Reference Needed
(yes or no)
Annual Medical
Monitoring
Required
(yes or no)
Allergies
Can
individuals
develop an
allergy
(sensitized) to
the biological
material?
(yes or no)
1
If working with viral, bacterial, or disease causing agent, vaccinations may be available and used to prevent the disease if exposure occurs. If a vaccination is
available, it is recommended that individuals get vaccinated.
2 If a vaccination is declined, have the individual fill out the Vaccination Waiver form, which can found at the Safety Resources website:
http://safetyresources.usask.ca.
3 State the prophylaxis, or action taken to prevent disease, such as antibiotics, antiviral agents, antifungal, etc.
4 Medical surveillance, which is the identification of individuals exhibiting signs or symptoms of illnesses or diseases, are proactive exposure-specific initiatives that
monitor the effectiveness of workplace safety precautions over time. Medical surveillance may be used to monitor the health of those who are working with potential
exposure to blood borne pathogens, hepatitis C, tuberculosis, etc.
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6
Biosecurity Assessment
The development, implementation, evaluation, and maintenance of a biosecurity plan, based on a biosecurity risk assessment, is
required for facilities where biohazardous material or toxins are handled and/or stored.
Answer the following questions in the development of your biosecurity plan.
Who is allowed, or authorized in the facility (e.g. graduate students, technicians, other faculty, custodial staff, building service
technicians, FMD trades, etc.)?
ENTER TEXT HERE
Have you identified the roles and responsibilities for each authorized individual? Where is this documented?
ENTER TEXT HERE
Describe how is access to the facility controlled?
ENTER TEXT HERE
Are doors to the containment zone are kept closed at all times (no exceptions)?
ENTER TEXT HERE
How is access monitored in the facility?
ENTER TEXT HERE
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Are visitors supervised and sign a log book, which includes name, date and time-in and time-out, purpose of visit?
ENTER TEXT HERE
Is the intellectual property, including lab books, electronic files, etc. secured and how is this done?
ENTER TEXT HERE
Who is responsible to verify and check the biological and biohazardous material inventory? How often is the inventory updated?
ENTER TEXT HERE
List the individuals who has access to the biological and biohazardous material inventory and documentation.
ENTER TEXT HERE
If the biological and biohazardous material stored outside of the facility, is the storage device lockable?
ENTER TEXT HERE
How are suspicious or illicit activities reported?
ENTER TEXT HERE
If a biological/biohazardous material has been reported as missing or stolen, what are the steps taken to deal with this situation?
(Use building emergency response plan as resources).
ENTER TEXT HERE
Other biosecurity measures (describe below) (if applicable):
ENTER TEXT HERE
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7
Work Locations
Table 9 can be used to document the locations where the organism(s), biological materials and biohazardous materials will be used
and stored. Table 10 can be used to provide a description of the facility and safety equipment (e.g. biosafety cabinets, autoclaves) that
will be utilized.
Refer to Section 6 of the Biosafety Plan Guide.
Table 7: Biosafety permit work and storage locations.
Location
Building
Room #
Type of Research1
(in vitro, in vivo, &/or both)
Purpose of Work Area2
Containment Level3
1 State
the type of research which will be conducted at each location: in vitro or, in vivo, or both.
State what activity will be conducted at each location: research, diagnostic, storage, autoclave, class room, surgical room, animal holding room, animal surgery
room, post-mortem, biowaste storage area, etc.
3 Depending on the required containment level, there will be specific facility location, access, design and construction, air handling, containment perimeter, laboratory
services, and safety equipment. Refer to the PHAC and CFIA’s Canadian Biosafety Standards (2nd Ed., 2015) and other Containment Standards.
2
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Table 10: Safety Equipment Inventory and Location.
Equipment 1
Type of equipment
1
Model (if
applicable)
Location of Equipment
Serial number
Building
Room
Safety equipment includes but is not limited to, biosafety cabinets, fume hoods, autoclave, emergency eyewash, and shower equipment.
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8
Standard Operating Procedures (SOPs) and Element Requirements
Part 1 – List of SOPs:
In the space below, list all standard operating procedures (SOPs) and other procedures utilized
in the laboratory. State the location of the SOPs.
ENTER INFORMATION HERE
Part 2 – Required SOP Elements:
There are mandatory SOP elements which need to be identified and documented. This
component can be satisfied by answering the questions outlined in Table 11 below:
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Table 11: Summary of required standard operating procedures elements
SOP Type
Training






SOP Elements
What are the authorized workers'
and the permit holders’ roles and
responsibilities? (refer to the
Biosafety Code of Practice,
found on Safety Resources
website:
www.safetyresources.usask.ca)
What type of training is required?
(site specific and Safety
Resources required training)
How is site-specific training
delivered, verified, and
documented? (e.g. probationary
period of supervision, quizzes,
spot checks, direct supervision)
What are re-training
requirements and the frequency?
How are training records
maintained and for how long?
List of Authorized Workers,
include name and their NSID.
Comments
Training should include but is not limited to the
following topics:
General (institutional):
 Employee safety orientation
 Supervisor safety orientation (if
supervising individuals)
 Laboratory safety
 WHMIS
 Biosafety
 Biowaste (required if using BioMed
Disposals – contact the Biosafety
Officer)
NOTE: All above courses expires every 3 years.
Site specific:
 Site-specific safety orientation and
training
 Operating procedures, requirements
and rules including health and safety
control measures
 Emergency preparedness and response
 Other site specific procedure (e.g. tissue
culture, equipment, assays, etc.)
 Refresher training is required annually
for Site specific training on Standard
Operating Procedures and Building or
Site Specific Emergency Response
Plan; Incident Reporting; and Permit
Holder Biosafety Plan.
Records of all training are maintained by the
permit holder for a minimum of 5 years.
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SOP Type
Facility access and
control




Hazardous material
inventory and
management









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SOP Elements
Are there signage requirements
for the facility, including PPE
entry requirements, emergency
contact information, and
containment level?
What are minimum PPE
requirements for facility entry?
How is the PPE donned and
doffed when entering/exiting the
laboratory?
Define the traffic flow of
biological/biohazardous materials
from “clean” to “dirty” areas.
How are inventories of
hazardous materials managed
and updated?
How often is the inventory
updated?
Who is responsible for
maintaining inventories?
Where is the inventory of the
hazardous material kept?
Are hazardous substances
properly labelled?
Where and how are materials to
be stored?
Are there any physical or
operational requirements for
material storage
rooms/equipment (e.g.
containment, security, handling,
PPE)?
How often in the inventory
verified?
What happens if a material goes
missing or is stolen?
Comments
Security clearances are required if working with
security sensitive biological agents (SSBA). This
will need to be addressed in Section 6 of the
Biosafety Plan template.
Refer the Training SOP comment section found
in this table.
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SOP Type
Biohazardous material
procurement and
transport





Specific procedures
and techniques related
to the nature of the
research







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SOP Elements
What is the procedure for
procuring materials?
What PPE is required to
transport the material?
How are materials moved within
the facility, between facilities, or
off campus?
Who do you notify if any
materials are moved within the
facility, between facilities, or off
campus?
What happens if a material is
missing, stolen or does not
arrive?
What are the specific laboratory
tasks, procedures and
techniques being performed
under the permit?
Who is performing the tasks?
Who is responsible for
developing and approving
procedures?
What is the format(s) for
operating procedures (e.g. local
written procedures, books,
papers, worker experience,
verbal)?
Do procedures include
appropriate health and safety
requirements (e.g. controls
measures, PPE)?
How are staff/students made
aware of and trained on
procedures?
How often are the specific
laboratory procedures reviewed
and updated?
Comments
Refer to Section 5 of this template for further
information on health and safety hazard
assessment and approaches to controlling
hazards.
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SOP Type
Immunization and
Medical surveillance (if
applicable)






Working alone or after
hours



Facility and equipment
care and maintenance






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SOP Elements
Has a pre-placement medical
assessment been conducted
(e.g. known allergies, prior
immunizations, immune system
status, etc.)?
Has the individual been informed
of all preventative measures
available against working with
the pathogen or toxin?
What ongoing medical
surveillance is required (if
applicable)?
Are there vaccinations required?
How is medical surveillance to be
monitored and tracked?
What procedures are to be
followed by
faculty/staff/students?
What work may be carried out
alone or after hours?
How are working alone activities
reviewed and approved?
What control measures are
required to protect individuals
working alone (e.g. limitations,
procedures, communications,
emergency preparedness and
response)?
How are facility maintenance
concerns, needs, and
requirements managed?
What are the housekeeping
requirements for the facility?
What are staff/student
responsibilities for housekeeping
and for facility/equipment
maintenance and care?
How is laboratory equipment to
be operated, for which, and
under what conditions (e.g.
procedures, PPE, cleaning,
decontamination)?
What are the maintenance and
certification requirements for the
equipment?
What records are required
operationally for the equipment?
Comments
Refer to Section 5 of this Template for further
information on health and safety hazard
assessment and approaches to controlling
hazards. (If applicable)
Refer to U of S Working Alone Policy,
http://policies.usask.ca/ and Safety Resources
Working Alone Procedure,
http://safetyresources.usask.ca .
Includes: eye-wash station, emergency showers,
autoclaves, biosafety cabinets (BSC), fume
hoods, incubators, fridges, freezers, centrifuges,
sonicators, water baths, homogenizers, gas
cylinders, pipette aids, vacuum pump and
systems, liquid nitrogen storage units, cell
sorters, etc.
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SOP Type
Disinfection, and
decontamination



Hazardous waste
disposal



Workplace monitoring






Animal work
considerations (if
applicable)


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SOP Elements
What disinfectants are to be
used, in what format, contact
time, and concentration?
How are disinfectants to be used
for which biological/biohazardous
material?
Are there specific disinfection
processes to be followed (e.g. for
specific hazardous materials,
laboratory surfaces, equipment,
spills)?
What hazardous waste is being
generated?
How is the biohazardous waste
sterilized or inactivated?
What are the procedures for
collecting, packaging, storing
and/or disposal of hazardous
waste?
How are facilities and work
activities monitored?
Who is responsible for monitoring
the facility and faculty, staff and
students working in the facility?
How frequent are workplace
monitoring activities conducted?
How are workplace monitoring
activities documented? (e.g. selfinspections, meetings)?
How are safety issues and
incidents managed?
How are safety matters
communicated with
faculty/staff/students?
What are the specific procedures
that will be done when working
with the animals?
What health and safety
requirements are implemented
when working with animals (e.g.
engineering controls, procedures,
PPE)?
Comments
Refer to the Safety Resources Hazardous
Waste Disposal Standard for assistance found
on the Safety Resources website.
Include: entry/exit procedures for the animal
rooms, training requirements, restraints and
handling of the animals, decontamination,
animal transport, etc.
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SOP Type
Human work
considerations (if
applicable) (includes
clinical samples,
phlebotomy)
Emergency
preparedness and
response






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SOP Elements
What are the specific procedures
that will be conducted with
human blood, cells, tissues, or
bodily fluids?
What health and safety
requirements are implemented
when collecting human blood,
tissue, and/or bodily fluids (e.g.
engineering controls, procedures,
PPE)?
Does the college/building/local
emergency response plan (ERP)
meet your requirements?
What other types of emergencies
are possible within your facility
that may need to be captured in
the ERP?
Where is the location of the
ERP?
ERP training must be conducted
annually. How is the training
provided and documented?
Comments
Include: PPE requirements, training
requirements, decontamination, etc.
Refer to the Phlebotomy Guidelines on the
Safety Resources website.
The University of Saskatchewan has developed
and standardized building specific emergency
response plans (ERPs) for each college and
administrative unit on campus. The ERPs
provide procedures and guidelines for common
types of emergencies including for incidents,
medical emergencies, fires, hazardous spills,
inclement weather, and violence.
Additional emergency preparedness and
response requirements or procedures may need
to be considered as deemed appropriate based
on the research and work activities.
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9
References
In the space below, list all the references, including scientific literature, technical product sheets,
etc., that you used to compile you Biosafety Plan and SOPs.
Refer to Section 8 of the Biosafety Plan Guide.
ENTER INFORMATION HERE
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