Download University of Windsor Biological Safety Manual ()


2008
University
of
Windsor’s
Biological
Safety
Manual
University
of
Windsor
Biological
Safety
Committee
(UWinBSC)
3/6/2008
Emergency
Response
Procedure
for
Biological
Material
Spill
In
case
of
a
spill
involving
biological
material
it
is
important
to
reduce
the
possibility
of
further
contamination
outside
the
initial
spill
area.
By
preventing
the
spreading
of
contamination
you
effectively
reduce
the
potential
exposure
of
others.
All
spills
of
biological
materials
must
be
cleaned
up
immediately.
Quick
Reference
Steps:
1. Treat
Injured
People
First:
Providing
first
aid
to
injured
people
takes
priority
over
cleaning
a
radioactive
spill.
Inform
emergency
personnel
that
spill
involves
biological
material.
2. Alert
Everyone
in
the
Area:
Inform
everyone
within
the
vicinity
of
the
spill
that
an
accident
involving
biological
material
has
occurred.
Identify
an
individual
to
coordinate
spill
response.
Mark
the
spill
zone
and
post
appropriate
signage
(if
needed)
to
reduce
the
potential
for
further
contamination.
3. Control
Contamination:
Take
action
to
prevent
the
spread
of
contaminated
materials.
If
the
spill
is
dry
–
apply
a
small
amount
of
water
from
the
outside
of
the
spill
working
inwards.
If
the
spill
is
wet,
cover
with
absorbent
material.
4. Clear
Area:
Remove
all
unnecessary
individuals
from
the
area
of
the
spill.
Attempt
to
reduce
the
movement
of
people
within
the
spill
zone.
5. Decontamination:
Apply
decontamination
procedures
in
priority
order:
(1)
personnel;
(2)
laboratory;
and
(3)
equipment.
6. Summon
Aid:
If
you
are
unsure
of
how
to
effectively
clean
the
spill,
contact
the
Biological
Safety
Officer
(ext.
3524).
In
case
of
emergency,
contact
Campus
Community
Police
at:
Ext.
911
Provide
dispatcher
with
the
following:
your
name,
phone
number,
location
(room
#
&
building),
that
incident
involves
biohazardous
materials,
and
if
anyone
is
injured.
.
BIOLOGICAL
SAFETY
MANUAL
BIOLOGICAL
SAFETY
COMMITTEE
UNIVERSITY
OF
WINDSOR
FIRST
Edition
2008
Approved:
08/27/2008
(UWinBSC)
Table
of
Contents
1
MANAGEMENT
OF
BIOLOGICAL
SAFETY
AT
THE
UNIVERSITY
OF
WINDSOR ....................... 1
1.1
University
of
Windsor’s
Biological
Health
&
Safety
Policy...........................................................................1
1.2
Regulation
of
Biological
Agents
at
the
University
of
Windsor....................................................................1
1.3
Responsibilities...............................................................................................................................................................2
1.3.1
Biological
Safety
Committee
(UWinBSC) ..........................................................................................................2
1.3.2
Vice­President,
Research ..........................................................................................................................................2
1.3.3
Academic
Administrative
Unit
(AAU)
Head .....................................................................................................3
1.3.4
Responsible
Official
–
Biological
Safety
Officer ..............................................................................................3
1.3.5
Principle
Investigators ..............................................................................................................................................4
1.3.6
Individuals
working
with
biological
materials ..............................................................................................5
1.3.7
Hazardous
Materials
Leaders ................................................................................................................................5
1.4
Licencing
and
Biological
Safety
Certificates .......................................................................................................5
1.4.1
Requirement
for
University
of
Windsor
Biological
Safety
Certificates ................................................5
1.4.2
Types
of
Biological
Safety
Certificates ...............................................................................................................6
1.4.3
Application
for
a
Biological
Safety
Certificate ...............................................................................................7
1.4.4
Biological
Safety
Certificate
Renewal
and
Validation
Periods................................................................7
1.4.5
Laboratory
Decommissioning................................................................................................................................8
1.4.6
Enforcement
of
Biological
Safety
Policies.........................................................................................................8
1.4.7
Information
and
inquiries........................................................................................................................................9
1.5
Materials
Safety
Data
Sheets .....................................................................................................................................9
2
APPLICABLE
LEGISLATION,
GUIDELINES,
AND
STANDARDS.............................................. 10
2.1
Importation,
Use,
and
Distribution
of
Biological
Agents............................................................................ 10
2.1.1
Importaton
of
biological
agents
affecting
humans ................................................................................... 10
2.1.2
Importation
of
biological
agents
affecting
animals.................................................................................. 11
2.2
Export
Requirements
for
Biological
Agents .................................................................................................... 12
2.3
Transportation
of
Biological
Agents ................................................................................................................... 12
2.4
Laboratory
Animals ................................................................................................................................................... 14
2.5
Waste
Management.................................................................................................................................................... 14
2.5.1
Liquid
Waste............................................................................................................................................................... 15
2.5.2
Solid
Waste.................................................................................................................................................................. 15
2.6
Autoclaves
/
Steam
sterilizers............................................................................................................................... 19
2.7
Fume
hoods ................................................................................................................................................................... 21
2.8
Biological
Safety
Cabinets:
Assessment
and
Testing ................................................................................... 21
2.8.1
Testing
services ......................................................................................................................................................... 22
2.8.2
Required
procedures
and
tests ........................................................................................................................... 22
3
BIOLOGICAL
SAFETY
PRACTICES
AND
PROCEDURES ........................................................ 25
3.1
General
Laboratory
Safety
Practices .................................................................................................................. 25
3.2
Working
with
Laboratory
Animals...................................................................................................................... 27
3.3
Working
with
Human
Pathogens ......................................................................................................................... 29
i
|
P a g e 3.3.1
Human
Bloodborne
Pathogens........................................................................................................................... 30
3.3.2
Universal
Blood
and
Body
Fluid
Precautions ............................................................................................... 30
3.4
Physical
Containment
Levels ................................................................................................................................. 33
3.4.1
Laboratory
Requirements
–
Biological
Containment
Level
1 ............................................................... 34
3.4.2
Laboratory
Requirements
–
Biological
Containment
Level
2 ............................................................... 36
4
EMERGENCY
PROCEDURES ............................................................................................. 39
4.1
Biological
Spill
Response ......................................................................................................................................... 39
4.1.1
Classification
of
Spills ............................................................................................................................................. 40
4.1.2
Biohazardous
Spill
Procedure
–
Minor
Biological
Spill ........................................................................... 40
4.1.3
Biohazardous
Spill
Procedure
–
Major
Biological
Spill ........................................................................... 42
4.1.4
Biohazardous
Spill
Procedure
–
On
Body....................................................................................................... 42
4.1.5
Biohazardous
Spill
Procedure
–
Inside
a
Biological
Safety
Cabinet................................................... 43
4.1.6
Biohazardous
Spill
Procedure
–
within
a
Centrifuge................................................................................ 44
4.1.7
Biohazardous
Spill
Procedure
–
during
Transportation......................................................................... 45
4.1.8
Biohazardous
Spill
Procedure
–
Involving
Prions ...................................................................................... 46
4.1.9
Disposal
of
Spill
Materials .................................................................................................................................... 46
4.1.10
Biological
Spill
Reporting................................................................................................................................... 47
4.2
Emergency
Medical
Procedures ........................................................................................................................... 47
4.2.1
Medical
Surveillance
&
Immunioprophylaxis .............................................................................................. 48
4.2.2
Animal
Bites
and
Scratches.................................................................................................................................. 48
4.2.3
Exposure
to
Human
Blood
and
Body
Fluids.................................................................................................. 49
4.2.4
Exposure
to
Infectious
and
Communicable
Disease
Agents................................................................... 49
4.2.5
Important
Medical
Emergency
Numbers
&
Contacts ............................................................................... 49
4.3
Medical
Incident
Reporting
Requirements...................................................................................................... 50
4.3.1
Individual:.................................................................................................................................................................... 50
4.3.2
Supervisor/Principle
Investigators: ................................................................................................................. 50
4.3.3
Chemical
Control
Centre
–
Laboratory
Safety,
Compliance,
and
Assurance:................................. 51
4.3.4
Office
of
Occupational
Health
&
Safety ........................................................................................................... 51
5
CLASSIFICATION
OF
BIOLOGICAL
AGENTS ....................................................................... 52
5.1
General
Information .................................................................................................................................................. 52
5.2
Genetically
Engineered
Organisms
and
Cell
Lines ....................................................................................... 52
5.2.1
Recombinant
DNA
and
Genetic
Manipulation............................................................................................. 53
5.2.2
Transgenic
Plants..................................................................................................................................................... 55
5.3
Animal
Cells,
Blood
and
Body
Fluids,
and
Fixed
Tissues ........................................................................... 56
5.3.1
Primary
Cell
Cultures
and
Animal
Iissues...................................................................................................... 57
5.3.2
Established
Cell
Lines.............................................................................................................................................. 57
5.3.3
Blood
and
Body
Fluids............................................................................................................................................ 57
5.3.4
Fixed
Tissues
and
Tissue
Sections...................................................................................................................... 58
5.4
Cell
Line
Contamination
with
Infectious
Agents ........................................................................................... 58
5.5
Biological
Agent
Risk
Group
Criteria
and
Categories .................................................................................. 60
6
SECURITY ........................................................................................................................ 62
6.1
General............................................................................................................................................................................. 62
ii
|
P a g e 6.2
6.3
6.4
6.5
Physical
Protection..................................................................................................................................................... 62
Personnel
Reliability
&
Suitability....................................................................................................................... 62
Pathogen
Accountablity ........................................................................................................................................... 63
Storage ............................................................................................................................................................................. 63
Appendixes .......................................................................................................................... 64
Appendix
A
–
Agents
not
indigenous
to
Canada........................................................................................................ 64
Appendix
B
–
Risk
Group
Categorization
of
Agents................................................................................................. 66
Appendix
C
–
Safety
Equipment ....................................................................................................................................... 76
Appendix
D
–
Biological
Safety
Cabinets ...................................................................................................................... 77
Appendix
E
–
Laboratory
Design...................................................................................................................................... 80
Appendix
F
–
References ..................................................................................................................................................... 87
iii
|
P a g e 1 MANAGEMENT
OF
BIOLOGICAL
SAFETY
AT
THE
UNIVERSITY
OF
WINDSOR
1.1 University
of
Windsor’s
Biological
Health
&
Safety
Policy
“The
University
of
Windsor
is
committed
to
providing
a
safe
and
healthy
workplace
and
learning
environment
for
its
employees,
students
and
visitors.
The
University
is
committed
to
preventing
occupational
illness
and
injury
in
the
workplace,
continually
improving
health
and
safety
practices
and
performance
and
believes
that
all
tasks
can
be
accomplished
in
a
safe
manner
and
in
compliance
with
relevant
health
and
safety
legislation,
codes,
standards
and
practices”
(University
of
Windsor
Health
and
Policy
Statement,
July
9/2007).
The
University
is
responsible
for
establishing,
implementing
and
maintaining
program,
such
as
the
Biological
Safety
Program
that
are
designed
to
protect
the
health
and
safety
of
employees,
students
and
visitors.
General
safety
policies
and
workplace
specific
procedures
will
be
developed,
documented,
and
implemented.
This
Manual
describes
the
requirements
and
procedures
established
by
the
University
for
work
with
potentially
hazardous
biological
agents.
It
is
based
upon
the
Public
Health
Agency
of
Canada’s
Laboratory
Biosafety
Guidelines
(2004
/
3rd
edition)
and
reflects
current
best
practices.
All
work
conducted
by
University
members
with
potentially
hazardous
biological
agents
on
University
premises
or
under
the
control
of
the
University
is
to
be
performed
in
accordance
with
the
requirements
of
this
manual.
Questions
regarding
application
or
interpretation
of
the
Biological
Safety
Program
or
this
manual
should
be
directed
to
the
Biosafety
Officer,
Chemical
Control
Centre,
at
(519)
253‐3000
ext.
3523
or
by
email
at
[email protected].
1.2 Regulation
of
Biological
Agents
at
the
University
of
Windsor
The
Board
of
Governors
of
the
University
of
Windsor
has
delegated
to
the
President
or
his
designate
(the
Vice‐President,
Research)
responsibility
for
the
approval
of
University
regulations
and
other
actions
to
ensure
regulatory
compliance,
safe
working
conditions,
and
a
professional
laboratory
environment
which
is
conducive
to
research
&
teaching
activities,
as
it
relates
to
the
management
of
Biological
Agents
on
campus.
The
Vice‐President,
Research
(VP‐R),
has
delegated
the
management
of
the
program
to
the
University
of
1
|
P a g e Windsor
Biological
Safety
Committee
(UWinBSC),
and
its
Chair,
responsibility
for
the
development
and
promulgation
of
safety
standards
for
the
conduct
of
research
and
teaching
activities
involving
potentially
hazardous
biological
agents
by
members
of
the
University.
The
Chemical
Control
Centre,
under
the
direction
of
the
Responsible
Official
–
Biological
Safety,
is
responsible
for
administering
the
Biosafety
program
on
a
day‐to‐day
basis,
for
providing
technical
advice
on
safety
procedures
and
equipment,
conducting
laboratory
compliance
reviews,
providing
biological
safety
training,
and
providing
guidance
and
information
related
to
compliance
with
pertinent
regulations.
For
additional
information,
please
visit
the
Biosafety
website
at:
www.uwindsor.ca/biosafety
or
telephone
the
Responsible
Official
–
Biological
Safety,
Chemical
Control
Centre,
at
(519)
253‐3000
ext.
3523
or
by
email
at
[email protected].
1.3 Responsibilities
1.3.1 Biological
Safety
Committee
(UWinBSC)
The
University
of
Windsor
Biological
Safety
Committee
(UWinBSC)
is
responsible
for
setting
and
enforcing
appropriate
standards
of
safety
for
work
with
potentially
hazardous
biological
agents
within
University
workplaces.
The
Committee
has
formally
approved
the
contents
of
this
manual
and
enforces
the
standards
through
the
issuance
of
Biosafety
Certificates
for
all
work
with
potentially
hazardous
biological
agents.
1.3.2 Vice­President,
Research
The
Vice‐President,
Research
(VP‐R)
plays
a
key
role
in
ensuring
that
the
University
of
Windsor’s
Biological
Safety
Program
is
being
implemented
according
to
this
manual;
specifically,
he/she
is
responsible
for:
•
•
•
•
•
•
•
Notify
the
University
Biosafety
Officer
of
any
research
which
utilizes
biohazardous
materials;
Approve
terms
and
conditions
for
research
involving
biohazardous
materials
conducted
by
other
organizations
involving
the
use
of
University
facilities
under
a
service
agreement
with
the
University;
such
research
shall
also
be
approved
by
the
Biosafety
Committee;
Approve
projects
involving
dual
use
research;
Administer
Material
Transfer
Agreements
involving
biohazardous
materials.
Copies
of
such
agreements
shall
be
forwarded
to
the
Biosafety
Officer;
Establish
and
administer
the
appeal
procedure;
Receive
and
act
upon
recommendations
of
the
Biological
Safety
Committee
(UWinBSC)
and
its
Chair;
Order
corrective
actions
for
cases
of
non‐compliance;
2
|
P a g e •
•
•
•
Ensure
that
research
funds
are
not
released
until
the
appropriate
biosafety
project
permit
has
been
submitted
and
approved
by
the
Biological
Safety
Committee
(UWinBSC)
or
Chair
of
the
Biosafety
Committee
as
appropriate;
Suspend
funding
for
research
projects
that
contravene
the
Public
Health
Agency
of
Canada
Laboratory
Biosafety
Guidelines,
violate
applicable
federal,
provincial
or
municipal
laws
or
regulations,
or
are
not
in
compliance
with
the
permit
or
this
policy;
Rescind
the
suspension
of
funding
once
the
contravention
is
rectified
to
the
satisfaction
of
the
Biological
Safety
Committee
(UWinBSC);
and
Advise
the
relevant
granting
Agency
of
any
changes
in
eligible
status
of
Grant
Holders
and
Award
Holders
and/or
of
serious
problems
in
the
use
of
research
funds
as
required
by
the
Memorandum
of
Understanding
between
the
University
and
the
The
Tri‐Council
(NSERC,
SSHRC
and
CIHR).
The
Biosafety
Officer
shall
also
be
advised
of
such
changes
of
status.
1.3.3 Academic
Administrative
Unit
(AAU)
Head
For
departments
that
utilize
potentially
hazardous
biological
materials,
the
department
head
must
be
familiar
with
and
follow
all
directions
contained
within
this
manual,
or
within
any
training
program.
In
particular,
AAU
Heads
are
responsible
for:
•
•
•
•
•
•
•
Ensure
that
any
activities
involving
the
use
of
biohazardous
materials
in
his/her
department
has
received
approval
prior
to
the
acquisition
of
the
biohazardous
materials
and
the
commencement
of
the
activities;
Ensure
that
Principal
Investigators
in
his/her
department
are
fully
aware
of
the
University
policies
and
guidelines
regarding
biohazardous
materials;
Co‐sign
all
permit
application
forms
confirming
the
validity
of
the
information;
Advise
the
Biosafety
Officer
when
a
Principal
Investigator
is
no
longer
employed
by
the
University;
Ensure
that
current
inspection
certificates
for
steam
sterilizers
in
the
department
are
posted,
that
sterilization
cycles
are
verified
using
biological
indicators
on
a
regular
basis,
and
that
records
of
users,
cycles,
and
verification
are
maintained;
and
Ensure
the
activities
involving
biohazardous
materials
in
the
department
are
in
compliance
with
the
permits;
and
Report
issues
regarding
non‐compliance
to
the
Chair
of
the
University
of
Windsor’s
Biological
Safety
Committee
(UWInBSC)
and
the
University
Biological
Safety
Officer.
1.3.4 Responsible
Official
–
Biological
Safety
Officer
The
Vice‐President
–
Research
(VP‐R)
in
consultation
with
the
Chair
of
the
University
of
Windsor
Biological
Safety
Committee
(UWinBSC)
will
appoint
a
University
employee
who
is
knowledgeable
by
virtue
of
education,
training,
or
experience
in
the
handling
of
biological
agents
to
be
responsible
on
behalf
of
the
institution
for
all
aspects
related
to
biological
safety
within
the
institution’s
laboratories
or
workplace.
In
particular,
this
individual
is
responsible
for:
•
•
Serve
as
the
audit
and
control
manager
for
the
Biosafety
Committee;
Co‐sign
approved
biohazard
permits;
3
|
P a g e •
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Maintain
and
provide
information
on
all
elements
of
the
biosafety
program;
Provide
advice
on
biohazardous
materials
and
work
procedures;
Provide
general
biosafety
training;
Liaise
with
the
Public
Health
Agency
of
Canada,
the
Canadian
Food
Inspection
Agency,
Animal
Care
Services,
Occupational
Health
Services,
Student
Health
Services,
Security
Services,
and
Physical
Resources
personnel
on
biohazard
issues;
Audit
work
areas
for
compliance
with
certificate
requirements,
legislation,
codes,
and
guidelines
and
submit
compliance
reports
to
the
Chair;
Perform
inspections
and
sign
documentation
for
import
permit
applications;
Approve
purchase
orders
and
co‐sign
material
transfer
agreements
for
the
acquisition
and/or
transfer
of
biohazardous
materials;
Investigate
incidents
involving
biohazardous
materials
including
exposures
and
lab‐acquired
infections
and
report
the
findings
to
the
Chair;
Maintain
project
files
including
permits
and
associated
material;
Coordinate
and
maintain
records
of
the
annual
certification
of
biocontainment
cabinets;
Order,
on
advice
of
the
Vice‐President,
Finance
and
Administration
or
the
Vice‐President,
Research,
the
suspension
of
any
activity
involving
biohazardous
materials
when
there
is
reason
to
suspect
that
the
health
and
safety
of
University
personnel,
the
public,
and/or
the
environment
is
at
risk
or
that
regulatory
conditions
of
the
project
have
been
breached;
Register
the
Biological
Safety
Committee
(UWinBSC)
with
the
National
Institutes
of
Health
and
file
annual
membership
updates.
Prepare
and
submit
New
Substance
Notifications
as
required
by
the
New
Substances
Notification
Regulations
of
the
Canadian
Environmental
Protection
Act;
Liaise
with
local
health
and
safety
committees
as
applicable;
and
Serve
on
the
Animal
Care
Committee
and
the
Research
Ethics
Board
(at
their
request).
1.3.5 Principle
Investigators
The
primary
responsibility
for
the
safety
of
staff,
students
and
the
public
lies
with
the
Principal
Investigator
in
charge
of
the
research
or
teaching
activities.
Principal
Investigators
must
be
familiar
with,
follow,
and
ensure
that
all
individuals
working
within
their
laboratories
follow
the
procedures
outlined
in
this
manual.
In
particular,
Principal
Investigators
are
responsible
for:
•
•
•
•
•
Obtaining
biological
safety
certificates
where
required;
Ensuring
that
all
conditions
of
the
certificate
are
followed;
Ensuring
that
the
appropriate
containment
cabinets
are
functioning
properly
by
having
them
tested
at
the
stipulated
intervals;
Ensuring
that
all
persons
working
under
their
control
have
had
appropriate
training
in
working
safely
with
potentially
hazardous
biological
materials;
Providing
appropriate
personal
protective
equipment
and
standard
operating
procedures.
4
|
P a g e 1.3.6 Individuals
working
with
biological
materials
Individuals
who
work
with
potentially
hazardous
biological
materials
must
be
familiar
with
and
follow
all
directions
given
to
them
by
their
supervisor,
contained
within
this
manual,
or
within
any
training
program.
In
particular,
Persons
working
with
potentially
hazardous
biological
materials
are
responsible
for:
•
•
•
Follow
all
safety
procedures;
Wear
protective
equipment;
and
Participate
in
medical
surveillance
programs
when
appropriate.
1.3.7 Hazardous
Materials
Leaders
Completed
Biosafety
Certificate
application
forms
should
be
submitted
to
the
Local
Hazardous
Materials
Leaders
(HazMat
Leader)
for
the
building
and/or
department
where
the
work
is
to
be
performed.
HazMat
Leaders
are
individuals
who
are
familiar
with
the
operation
of
various
programs
and
on
campus
involving
hazardous
materials.
They
act
as
a
liaison
and
advocate
between
the
University
of
Windsor’s
Biological
Safety
Committee
and
principle
investigators.
The
HazMat
Leader
will
review
the
application
and
forward
it
for
additional
review
and
approval.
If
a
HazMat
Leader
is
not
appointed
within
your
building
and/or
department,
please
direct
all
applications
directly
to
the
Chemical
Control
Centre
for
review
and
approval.
1.4 Licencing
and
Biological
Safety
Certificates
1.4.1 Requirement
for
University
of
Windsor
Biological
Safety
Certificates
A
University
of
Windsor
Biological
safety
Certificate
is
required
for
all
(research
and
teaching)
laboratory
activities
which
involve
the
use
or
manipulation
of
potentially
hazardous
biological
agents,
and
materials
containing
such
agents
(including
viruses,
bacteria,
fungi,
parasites,
recombinant
DNA,
prions
and
other
micro‐organisms
/
genetic
systems,
and
human
and
animal
tissues,
cells,
blood
and
body
fluids),
and
which
are:
(i)
(ii)
(iii)
supervised
or
conducted
by
employees
or
members
of
the
University,
or
conducted
on
University
premises,
or
in
a
building
or
location
administered
by
or
under
the
control
of
the
University,
or
supported
by
funds
provided
by
or
through
the
University,
including
start‐up
and
operating
funds.
All
such
activities
are
to
be
conducted
and
performed
in
accordance
with
the
University
of
Windsor’s
Biological
Safety
Manual
and
any
relevant
guidelines
or
legislation.
All
activities
involving
potentially
hazardous
biological
agents
and
meeting
any
of
the
above
criteria,
and
all
sources
of
financial
support
for
such
activities
whether
or
not
directly
supported
by
grants
or
5
|
P a g e contracts
administered
by
the
University,
must
be
identified
on
the
application
for
a
University
of
Windsor
Biological
Safety
Certificate.
The
release
of
grants
and
supporting
funds
by
the
University
is
dependent
on
a
University
Biological
Safety
Certificate.
For
animal
based
activities,
a
copy
of
the
approved
Animal
Care
Utilization
Protocol
(AUPP)
Certificate
must
be
provided
and
attached
to
the
application
for
a
University
Biological
Safety
Certificate.
The
submission
of
an
application
for
a
University
of
Windsor
Biological
Safety
Certificate
implies
willingness
to
allow
the
University
of
Windsor’s
Biosafety
Officer
to
visit
the
laboratory
sites
used
by
the
Biological
Safety
Certificate
holder
in
order
to
determine
compliance
with
the
University
of
Windsor’s
Biological
Safety
Manual.
1.4.2 Types
of
Biological
Safety
Certificates
The
University
of
Windsor
issues
Biological
Safety
Certificates
based
on
the
classification
of
organisms
according
to
risk
group
has
traditionally
been
used
to
categorize
the
relative
hazards
of
infective
organisms.
The
factors
used
to
determine
which
risk
group
an
organism
falls
into
is
based
upon
the
particular
characteristics
of
the
organism,
such
as:
•
•
•
•
•
•
pathogenicity
infectious
dose
mode
of
transmission
host
range
availability
of
effective
preventive
measures
availability
of
effective
treatment.
These
classifications
presume
ordinary
circumstances
in
the
research
&
teaching
laboratories
or
growth
in
small
volumes
for
diagnostic
and
experimental
purposes.
Four
levels
of
risk
have
been
defined
as
follows:
Risk
Group
1
(low
individual
and
community
risk)
Any
biological
agent
that
is
unlikely
to
cause
disease
in
healthy
workers
or
animals.
Examples:
Risk
Group
2
(moderate
individual
risk,
low
community
risk)
Any
pathogen
that
can
cause
human
disease
but,
under
normal
circumstances,
is
unlikely
to
be
a
serious
hazard
to
laboratory
workers,
the
community,
livestock
or
the
environment.
Laboratory
exposures
rarely
cause
infection
leading
to
serious
disease;
effective
treatment
and
preventive
measures
are
available,
and
the
risk
of
spread
is
limited.
Examples:
hepatitis
A,
B,
and
C,
Influenza
A,
Lyme
disease,
Dengue
fever,
Salmonella,
Mumps,
Bacillus
subtilis,
and
Measles,
Risk
Group
3
(high
individual
risk,
low
community
risk)
6
|
P a g e Any
pathogen
that
usually
causes
serious
human
disease
or
can
result
in
serious
economic
consequences
but
does
not
ordinarily
spread
by
casual
contact
from
one
individual
to
another,
or
that
causes
diseases
treatable
by
antimicrobial
or
antiparasitic
agents.
Examples:
Anthrax,
West
Nile
virus,
Venezuelan
equine
encephalitis,
Eastern
equine
encephalitis,
SARS,
Tuberculosis,
Typhus,
Rift
Valley
fever,
Rocky
Mountain
spotted
fever,
and
Yellow
fever.
1.4.3 Application
for
a
Biological
Safety
Certificate
Application
forms
for
a
University
Biological
Safety
Certificate
are
provided
with
Explanatory
Notes
to
assist
the
applicant
and
can
be
obtained
by
contacting
the
Chemical
Control
Centre,
Laboratory
Safety
Technician,
at
(519)253‐3000
ext.
3523,
option
#4.
This
application
form
is
also
available
in
electronic
format
via
the
Biological
Safety
homepage
at:
www.uwindsor.ca/biosafety.
The
form
may
then
be
printed,
completed,
signed
by
the
applicant
and
submitted
to
the
Local
Hazardous
Materials
Leader
or
directly
to
the
Chemical
Control
Centre
for
review
and
approval.
The
required
information
must
be
legibly
printed
or
typed
on
the
application
form.
In
general,
the
Principal
Investigator
may
use
a
single
form
to
identify
more
than
one
project
if
these
require
similar
containment
conditions,
instead
of
completing
a
separate
application
for
a
Biological
Safety
Certificate
for
each
project.
The
project
titles
must
be
matched
with
the
corresponding
granting
agency.
Identify
and
specify
the
hazardous
biological
agents
to
be
used
(e.g.
human
whole
blood,
Hepatitis
B
virus,
chick
embryo
primary
cell
culture,
CHO
cells,
E.
coli
O157).
Following
the
review
and
approval
process,
a
photocopy
of
the
validated
Biological
Safety
Certificate
will
be
returned
to
the
applicant.
The
original
will
be
retained
on
file
at
the
Chemical
Control
Centre.
Information
will
also
be
entered
into
RIS
(Research
Information
System)
for
review
by
the
Office
of
Research
Services.
A
valid
Biological
Safety
Certificate
must
be
on
file
before
the
University
will
release
grant
funds.
1.4.4 Biological
Safety
Certificate
Renewal
and
Validation
Periods
Containment
Level
2
and
Containment
Level
3
(1
year
only):
A
Biological
Safety
Certificate
for
activities
requiring
Containment
Level
2
or
Containment
Level
3
conditions
is
valid
for
one
year
from
the
date
of
approval
by
the
University
of
Windsor’s
Biological
Safety
Committee
(UWinBSC)
Chair.
In
the
case
of
multi‐year
research
or
recurring
teaching
programs
involving
potentially
hazardous
biological
agents,
the
Biological
safety
Certificate
must
be
renewed
annually.
The
renewal
is
valid
for
one
year
from
the
expiration
date
of
the
previous
Certificate.
The
Principal
Investigator
/
Course
Instructor
must
submit
a
new
application
form,
even
if
the
activities
involving
biological
agents
have
not
been
altered
or
modified
since
the
previous
submission.
7
|
P a g e Containment
Level
1
(2
years):
A
Biological
Safety
Certificate
for
activities
requiring
only
Containment
Level
1
is
valid
for
2
years
from
the
date
of
approval
by
the
University
of
Windsor’s
Biological
Safety
Committee
(UWinBSC)
Chair
or,
in
the
case
of
a
renewal,
from
the
expiration
date
of
the
previous
Certificate,
after
which
it
must
be
renewed.
The
Principal
Investigator
/
Course
Instructor
must
submit
a
new
application
form
even
if
the
activities
involving
biological
agents
have
not
been
altered
or
modified
since
the
previous
submission.
1.4.5 Laboratory
Decommissioning
At
least
30
days
prior
to
the
expected
date
of
vacating
the
laboratory
or
laboratory
space,
the
Principal
Investigator
(PI)
must
notify,
in
writing,
the
Biosafety
officer.
The
Principal
Investigator
must
ensure
that
appropriate
decontamination
measures
have
been
taken
prior
to
the
relocation
or
disposal
of
laboratory
equipment
used
for
the
manipulation
of
biological
agents.
After
decontamination,
the
laboratory
equipment
may
be
recycled
through
the
Facilities
Services
–
Custodial
Services.
A
"Safe‐To‐Work"
tag
should
be
completed
and
attached
to
the
equipment,
prior
to
it
being
removed
from
the
laboratory.
The
tag
may
be
obtained
from
the
Chemical
Control
Centre
at
(519)
253‐3000
ext.
3523.
Inspection
and
retesting
is
mandatory
if
a
biological
safety
cabinet
is
relocated.
Moves
of
a
minor
nature
(i.e.
within
the
same
room)
may
be
exempt
from
this
requirement
if
the
move
is
observed
by
the
testing
technologist
and
the
cabinet
has
not
been
subjected
to
excessive
stress
or
rough
handling
which
could
result
in
damage.
1.4.6 Enforcement
of
Biological
Safety
Policies
In
the
event
that
a
Permit
Holder
fails
to
observe
the
rules
and
regulations
governing
the
safe
use
of
biological
agents,
the
BSO,
shall
advise
such
Permit
Holder
of
the
violation(s)
and
shall
report
same
to
the
Committee.
The
Committee
shall
review
reports
of
violations
and
when
appropriate
issue
a
written
warning
to
the
Permit
Holder
and/or
suspend
or
withdraw
approval
of
the
user(s)
permit.
If,
in
the
judgment
of
the
BSO,
there
is
an
emergency
situation
involving
a
biological
hazard(s),
he/she
shall
take
immediate
action
to
ensure
the
safety
of
personnel
and
the
environment.
A
meeting
of
the
Committee
shall
be
called
as
soon
as
possible
following
such
a
situation
to
review
the
circumstances
of
the
event.
Decisions
of
the
Committee
will
be
reported
to
the
Vice‐President,
Research,
through
the
BSO,
for
action.
Disagreement
with
any
Committee
decision
may
be
appealed
to
the
President
of
the
University.
Such
appeals
must
be
forwarded
in
writing
to
the
President
and
a
copy
must
be
sent
to
the
Committee.
8
|
P a g e 1.4.7 Information
and
inquiries
Explanatory
Notes
offering
more
detail
are
provided
with
the
University
of
Windsor’s
Biological
Safety
Certificate
application
form.
Should
you
encounter
difficulty
or
have
any
questions
regarding
the
completion
or
submission
of
your
application
form,
please
contact:
Chemical
Control
Centre
Manager
TEL:
(519)
253
‐
3000
ext.
3524
1.5 Materials
Safety
Data
Sheets
Material
Safety
Data
Sheets
for
infectious
micro‐organisms
(biological
agents)
have
been
prepared
by
the
Office
of
Laboratory
Security,
Public
Health
Agency
of
Canada
(http://www.phac‐aspc.gc.ca/msds‐
ftss/index.html).
In
addition,
all
MSDS,
including
for
infectious
micro‐organisms,
can
also
be
located
on
the
University
of
Windsor’s
online
MSDS
service
(www.uwindsor.ca/msds)
The
MSDS
are
organized
to
contain
health
hazard
information
such
as
infectious
dose,
viability
(including
decontamination),
medical
information,
laboratory
hazard,
recommended
precautions,
handling
information
and
spill
procedures.
The
intent
of
these
documents
is
to
provide
a
safety
resource
for
laboratory
personnel
working
with
these
infectious
substances.
Because
these
workers
are
usually
working
in
a
scientific
setting
and
are
potentially
exposed
to
much
higher
concentrations
of
these
human
pathogens
than
the
general
public,
the
terminology
in
these
MSDS
is
technical
and
detailed,
containing
information
that
is
relevant
specifically
to
the
laboratory
setting.
It
is
hoped
along
with
good
laboratory
practises,
these
MSDS
will
help
provide
a
safer,
healthier
environment
for
everyone
working
with
infectious
substances.
Please
note
that
although
the
information,
opinions
and
recommendations
contained
in
Material
Safety
Data
Sheets
are
compiled
from
sources
believed
to
be
reliable,
the
University
of
Windsor
along
with
the
MSDS
author
accepts
no
responsibility
for
the
accuracy,
sufficiency,
or
reliability
or
for
any
loss
or
injury
resulting
from
the
use
of
the
information.
Newly
discovered
hazards
are
frequent
and
this
information
may
not
be
completely
up
to
date.
Access
Material
Safety
Data
Sheets
(MSDS)
for
all
biological
agents
on
campus
at:
www.uwindsor.ca/msds
9
|
P a g e 2 APPLICABLE
LEGISLATION,
GUIDELINES,
AND
STANDARDS
Activities
involving
the
use
of
biological
agents
and
laboratory
animals,
the
production
and
disposal
of
waste,
and
the
use
of
certain
equipment
are
governed
by
various
legislation,
guidelines
and
standards.
Adherence
to
the
requirements
of
this
Manual
will
ensure
that
work
is
performed
safely
and
in
compliance
with
the
requirements
of
external
agencies
and
regulatory
bodies.
2.1 Importation,
Use,
and
Distribution
of
Biological
Agents
2.1.1 Importaton
of
biological
agents
affecting
humans
Anyone
wishing
to
import
human
pathogens
requiring
containment
levels
2,
3,
or
4
must
have
a
valid
Public
Health
Agency
of
Canada
permit
prior
to
importation.
The
importation
of
human
pathogens
is
regulated
by
the
Importation
of
Human
Pathogens
Regulations
(IHPR)(1994).
Pathogens
requiring
containment
level
1
facilities
are
not
regulated
by
the
IHPR,
and
therefore
a
permit
is
not
required
for
their
importation.
Permits
are
required
for
the
importation
of
all
infectious
substances
into
Canada
regardless
of
whether
they
infect
humans,
animals
or
plants.
The
importation
of
infectious
agents
which
are
predominantly
pathogenic
to
animals
is
regulated
by
means
of
the
Health
of
Animals
Act
and
Regulations
administered
by
Agriculture
and
Agri‐Food
Canada.
It
may
also
be
necessary
to
obtain
permission
to
transfer
listed
pathogens
within
Canada
from
one
scientist
or
laboratory
to
another.
Requests
for
single‐entry
and
long‐standing
permits
to
import
infectious
substances
affecting
humans
should
be
directed
to:
Director
Public
Health
Agency
of
Canada
130
Colonnade
Road
Ottawa,
Ontario
K1A
0K9
http://www.phac‐aspc.gc.ca
A
copy
of
the
application
for
a
permit
to
import
biological
agents
into
Canada,
or
to
transfer
biological
agents
within
Canada,
must
be
provided
to
the
University
of
Windsor’s
Chemical
Control
Centre
to
facilitate
the
acquisition
process.
Applications
can
be
located
on
the
University
of
Windsor’s
Biological
Safety
Committee
website
(www.uwindsor.ca/biosafety).
In
addition,
if
you
require
assistance
or
clarification
please
contact
the
Chemical
Control
Centre
at
(519)253‐3000
ext.
3523
or
by
email
at
[email protected].
If
the
agent
can
also
impact
animals,
you
may
require
an
importation
certificate
from
the
Canadian
Food
Inspection
Agency.
10
|
P a g e 2.1.2 Importation
of
biological
agents
affecting
animals
The
Health
of
Animals
Act
(1990)
and
its
Regulations
gives
Agriculture
and
Agri‐Food
Canada
(AAFC)
the
legislative
authority
to
control
the
distribution
and
use
of
any
pathogen
which
may
cause
infectious
or
contagious
disease
in
animals.
This
includes
materials
of
animal
origin
which
contain
potential
pathogens.
In
practical
terms,
this
means
that
AAFC
approval
must
be
obtained
for
the
importation
of
every
animal
pathogen.
In
the
case
of
pathogens
which
affect
both
humans
and
animals,
importation
permits
are
required
from
both
Health
Canada
and
AAFC.
If
an
agent
was
brought
into
Canada
under
an
import
permit
which
restricts
its
distribution,
further
approval
must
be
obtained
before
transferring
it
to
another
scientist
or
laboratory.
Recombinant
organisms
and
their
release
into
the
environment
may
also
be
restricted.
AAFC
will
also
establish
the
conditions
under
which
the
animal
pathogens
will
be
maintained
and
the
work
will
be
carried
out.
It
is
necessary
to
consider
not
only
the
risk
to
human
health,
but
also
the
level
of
containment
needed
to
prevent
escape
of
an
animal
pathogen
into
the
environment
where
it
may
constitute
a
risk
to
any
indigenous
animal
species.
Animal
pathogens,
including
pathogens
which
affect
both
humans
and
animals,
under
the
control
of
AAFC,
are
listed
in
a
data
base
maintained
by
the
Animal
and
Plant
Health
Directorate,
AAFC.
This
is
a
dynamic
listing
which
is
continuously
amended
to
include
emerging
pathogens
that
may
require
restriction.
Animal
disease
agents
considered
as
not
indigenous
to
Canada
form
a
portion
of
this
data
base
and
are
severely
restricted.
For
each
animal
pathogen,
AAFC
must
be
consulted
for
its
importation,
use
and
distribution.
Information
on
the
status
of
veterinary
pathogens
may
be
obtained
from:
Agriculture
and
Agri‐Food
Canada
Animal
Health
Division
59
Camelot
Drive
Nepean,
Ontario
K1A
0Y9
(613)
952‐8000
Information
regarding
veterinary
pathogens
and
import
permits
may
be
obtained
from:
Canadian
Food
Inspection
Agency
59
Camelot
Drive
Nepean,
Ontario
K1A
0Y9
(613)
225‐2342
A
copy
of
the
application
for
a
permit
to
import
biological
agents
into
Canada,
or
to
transfer
biological
agents
within
Canada,
must
be
provided
to
the
University
of
Windsor’s
Chemical
Control
Centre
to
facilitate
the
acquisition
process.
Applications
can
be
located
on
the
University
of
Windsor’s
Biological
Safety
Committee
website
(www.uwindsor.ca/biosafety).
In
addition,
if
you
require
assistance
or
clarification
please
contact
the
Chemical
Control
Centre
at
(519)253‐3000
ext.
3523
or
by
email
at
[email protected].
If
the
agent
can
also
impact
humans,
you
may
require
an
importation
certificate
from
the
Public
Health
Agency
of
Canada.
11
|
P a g e 2.2 Export
Requirements
for
Biological
Agents
Permits
are
required
for
the
export
from
Canada
of
certain
micro‐organisms
and
associated
equipment.
Canada
presently
imposes
controls
on
certain
toxicological
and
biological
agents,
as
well
as
their
related
equipment,
components,
materials
and
technology
under
item
2007
of
the
Export
Control
List.
For
assistance
or
advice,
contact:
Foreign
Affairs
and
International
Trade
Canada
Export
Control
Division
Lester
B.
Pearson
Building
125
Sussex
Drive
Ottawa,
Ontario
K1A
0G2
(613)
996‐2387
A
copy
of
the
application
for
a
permit
to
export
biological
agents
from
Canada
must
be
provided
to
the
University
of
Windsor’s
Chemical
Control
Centre.
In
addition,
if
you
require
assistance
or
clarification
please
contact
the
Chemical
Control
Centre
at
(519)253‐3000
ext.
3523
or
by
email
at
[email protected].
2.3 Transportation
of
Biological
Agents
The
careful
handling,
transport
and
shipment
of
diagnostic
specimens
and
infectious
agents
is
absolutely
essential
if
Canada
is
to
maintain
an
effective
health
care
system.
Transportation
methods
must
minimize
risks
to
employees
of
the
carrier,
the
public
and
the
staff
of
the
receiving
laboratory.
Hazards
are
compounded
by
improper
packaging;
a
broken
specimen
container
may
lead
to
contamination
of
both
laboratory
and
non‐laboratory
personnel,
and
an
improperly
labelled
package
may
be
opened
inadvertently
by
secretarial,
clerical
or
other
untrained
staff.
In
Canada,
effective
July
1,
1985,
Transport
Canada
has
become
responsible
for
regulations
concerning
the
transportation
of
dangerous
goods.
Any
person
handling,
offering
for
transport
or
transporting
dangerous
goods
must
comply
with
the
Transportation
of
Dangerous
Goods
Act
and
Regulations,
Registration
SOR
85‐77,
as
amended
in
1994.
Inquiries
regarding
these
Regulations
should
be
directed
to:
Director
General
Transport
of
Dangerous
Goods
Directorate
Transport
Canada
Canada
Building
344
Slater
Street
14th
Floor
Ottawa,
Ontario
12
|
P a g e K1A
0N5
(613)
998‐0517
The
efficient
and
safe
transfer
of
infectious
substances
requires
good
co‐ordination
between
the
sender,
carrier,
and
receiver
to
ensure
safe
and
prompt
transport
and
arrival
in
proper
condition.
It
is
important
that
the
sender
make
advance
arrangements
with
the
carrier
and
the
receiver
to
ensure
that
specimens
will
be
accepted
and
promptly
processed.
In
addition,
the
sender
must
prepare
the
appropriate
dispatch
documents
according
to
the
Transportation
of
Dangerous
Goods
Act
and
Regulations.
The
sender
should
also
forward
all
transportation
data
to
the
receiver.
No
infectious
substances
shall
be
dispatched
before
advance
arrangements
have
been
made
between
the
sender,
the
carrier
and
the
receiver,
or
before
the
receiver
has
confirmed
with
national
authorities
that
the
substance
can
be
imported
legally
and
that
no
delay
will
be
incurred
in
the
delivery
of
the
consignment
to
its
destination.
Information
can
be
obtained
from:
Canadian
Transport
Emergency
Centre
(CANUTEC)
(613)
992‐4624
(during
business
hours)
(613)
996‐6666
(Emergencies:
24
hours
per
day)
Under
the
Transportation
of
Dangerous
Goods
Act
and
Regulations,
biological
agents
and
micro‐
organisms
belonging
to
Risk
Groups
2,
3,
and
4
as
identified
and
listed
in
Laboratory
Biosafety
Guidelines
and
Section
5.4
of
this
document,
are
classed
as
"infectious
substances"
in
Division
6.2.
Very
specific
packaging
and
documentation
requirements
must
be
met
before
such
materials
may
be
shipped
from
the
University
of
Widnsor.
A
certified
packaging
system
(Saf‐T‐Pak,
or
equivalent)
suitable
for
the
legal
transport
of
an
"infectious
substance"
must
be
used.
Risk
Group
1
micro‐organisms
are
not
subject
to
these
regulations.
Only
individuals
who
are
certified
in
the
Transportation
of
Dangerous
Goods
are
legally
able
to
prepare
packages
and
documentation
for
all
dangerous
goods,
including
biological
agents.
The
University
of
Windsor’s
Office
of
Occupational
Health
and
Safety
offers
Transportation
of
Dangerous
Goods
Training
please
contact
them
by
phone
at
(519)
253‐3000
ext.
2055
or
visit
their
website
for
more
information
(www.uwindsor.ca/safety).
Contact
the
University
of
Windsor’s
Chemical
Control
Centre
for
assistance
in
the
transportation
of
biological
agents
within
Risk
Group
2
or
3
from
the
University
of
Windsor
by
phone
at
(519)
253‐3000
ext.
3523
or
by
email
at
[email protected].
13
|
P a g e 2.4 Laboratory
Animals
All
aspects
of
the
proposed
use
of
vertebrate
animals
in
research
&
teaching
and
their
associated
operational
procedures
for
the
care
and
maintenance
of
vertebrate
animals
must
satisfy
the
Guidelines
for
the
Care
and
Use
of
Experimental
Animals
of
the
Canadian
Council
on
Animal
Care
and
the
local
animal
care
authority
as
well
as
this
manual
if
the
animals
are
exposed
to
or
infected
with
biological
agents,
in
order
to
ensure
not
only
protection
for
laboratory
personnel
and
the
environment,
but
to
ensure
that
every
care
is
taken
to
avoid
causing
the
animals
unnecessary
pain
or
suffering
and
to
provide
the
animals
with
the
highest
quality
care.
Under
the
Ontario
Animals
for
Research
Act,
and
its
Regulations,
it
is
a
requirement
that
all
Principal
Investigators
who
intend
to
conduct
research,
testing
or
teaching
projects
at
the
University
of
Windsor
that
involve
the
use
of
vertebrate
animals,
must
obtain
the
approval
of
the
University
of
Windsor
Animal
Care
Committee
before
commencing
the
project.
To
obtain
such
approval,
the
Principal
Investigator
must
submit
the
University
of
Windsor
Animal
Use
Protocol
Form
which
is
available
electronically
at:
http://www.uwindsor.ca/acc
The
completed
protocol
form
must
be
signed
by
the
Principal
Investigator
and
should
then
be
submitted
to
the
Ethics
&
Grant
Coordinator
of
the
Animal
Care
Committee
for
review
and
approval.
Ethics
&
Grant
Coordinator
Office
of
Research
Services
519.253.3000
ext.
3948
[email protected]
2.5 Waste
Management
The
University
of
Windsor
is
a
large
diverse
workplace
which
generates
many
kinds
of
hazardous
and
non‐hazardous
waste.
The
handling,
packaging,
transport
and
disposal
of
waste
in
Ontario
are
governed
by
municipal,
provincial
and
federal
government
legislation.
To
enable
compliance
with
these
regulations,
the
University
has
developed
programs,
procedures
and
internal
services
focused
on
specific
waste
categories.
The
Chemical
Control
Centre’s
Environmental
Protection
Services
has
prepared
a
Laboratory
Hazardous
Waste
Management
Manual
which
consolidates
existing
information
and
identifies
procedures
for
the
packaging,
labelling
and
disposal
of
biological,
chemical,
radioactive,
sharp,
and
other
hazardous
waste
at
the
University
of
Windsor.
A
copy
of
this
document
may
be
obtained
from
Chemical
Control
Centre
at
(519)
253‐3000
ext.
3523,
option
#2.
An
electronic
version
is
available
on
their
website
under
Environmental
Protection
Services
at:
www.uwindsor.ca/ccc.
14
|
P a g e 2.5.1
Liquid
Waste
Vacuum
lines
are
commonly
used
to
aspirate
culture
media
and
other
cell
culture
reagents.
This
technique
serves
as
a
conduit
through
which
air
may
leave
the
laboratory.
These
must
be
protected
in
a
manner
commensurate
with
the
other
air
exhausts.
Reusable
filter
holders
with
replaceable
elements
and
sealed
disposable
filter
cartridges
are
available
for
this
application.
Laboratory
waste
contaminated
with
or
containing
biological
agents
should
be
autoclaved
or
disinfected
to
inactivate
the
biological
agents
prior
to
disposal.
Where
on‐site
functioning
autoclaves
(steam
sterilizers)
are
not
available
and
the
conventional
use
of
chemical
disinfectants
for
the
inactivation
of
hazardous
biological
agents
in
laboratory
waste
is
not
practicable
or
not
efficacious,
other
waste
handling
and
disposal
methods
must
be
considered.
2.5.2
Solid
Waste
Reusable
items
such
as
glassware
should
be
sterilized
by
autoclaving
whenever
this
is
possible.
Otherwise,
a
specific
chemical
disinfection
procedure,
proven
to
be
effective
against
the
particular
biological
agent,
must
be
used.
Disposable
items
that
are
contaminated
with
biological
agents
only,
should
be
incinerated
or
must
be
autoclaved
or
chemically
disinfected
before
disposal.
Disposable
sharp
waste
(sharp
or
pointed
items
capable
of
causing
punctures,
cuts,
or
tears
in
skin
or
mucous
membranes
and
including
hypodermic,
surgical,
suture,
or
IV
needles,
syringes
with
needles,
lancets,
scalpels
and
blades)
must
be
carefully
collected
in
a
puncture‐resistant
waste
container.
These
containers
are
available
from
either
the
Chemical
Control
Centre
or
the
Department
of
Biological
Sciences
Stockroom.
Needles
and
blades
for
disposal
must
be
collected
in
a
designated,
puncture‐resistant
container.
After
autoclaving,
if
required,
the
filled
container
of
needles
and
blades
must
be
placed
into
a
yellow
plastic
20
litre
broken
glass
and/or
sharps
pail
that
are
provided
for
the
collection
of
broken
and
intact
glassware
for
disposal.
Intact
and
broken
glassware
for
disposal
must
be
collected
in
puncture‐resistant
containers.
Yellow
plastic
20
litre
pails
are
provided
for
this
purpose.
If
the
material
collected
in
the
waste
container
is
contaminated
with
viable
hazardous
biological
agents,
the
waste
must
be
decontaminated,
preferably
by
autoclaving,
to
inactivate
the
biological
agents.
Chemical
disinfection
of
sharp
waste
is
generally
not
recommended
since
it
requires
additional
handling.
Disposable
non‐sharp
items
(gloves,
empty
plastic
culture
dishes,
flasks
and
tubes,
absorbent
tissue,
etc.)
that
are
contaminated
with
biological
agents
must
be
collected
in
autoclavable
bags.
After
autoclaving
and
cooling,
these
bags
of
waste
must
be
placed
into
black
plastic
garbage
bags
for
disposal.
15
|
P a g e Hazardous
chemical
and
radioactive
solid
wastes
may
require
an
additional
procedure
to
inactivate
viable
biological
agents
that
may
be
present,
before
removal
from
the
laboratory.
Autoclaving
is
generally
not
recommended
in
all
situations
involving
such
wastes,
since
the
high
temperature,
steam
and
pressure
may
contribute
to
potentially
hazardous
reactions.
It
is
dangerous
and
illegal
to
dispose
of
hazardous
chemicals
and
radioactive
materials
in
the
regular
garbage
going
to
landfill.
To
provide
another
alternative,
the
University
of
Windsor
has
negotiated
a
contract
with
a
commercial
firm
which
is
licensed
to
remove
and
transport
biologically
contaminated
("pathological")
laboratory
waste
to
a
designated
disposal
site.
Specific
packaging
of
waste
and
special
documentation
is
required.
For
more
information,
contact
the
Hazardous
Materials
Technician
Chemical
Control
Centre
–
Environmental
Protection
Services
(519)
253‐3000
ext.
3523,
option
#2.
16
|
P a g e Guide to Waste Management
– Solid Waste Disposal –
Phone: 519-253-3000 Ext. 3523 • E-mail: [email protected] • Web: www.uwindsor.ca/ccc
Location: Essex Hall / B-37 • Hours: 8:30 am to 4:30 pm (M-F)
Non-hazardous Waste and Recyclables - Housekeeping
N O N - HAZAR D OU S
W A S TE
RECYCLABLE S
REGULAR WASTE (Garbage)
PAPER
Secondary Container: Black garbage bag
Secondary Container: “Blue box”
Acceptable:
• All non-hazardous commercial solid waste
Acceptable:
• Paper,
• Newsprint,
• Corrugated cardboard
Prohibited:
Chemicals, biologically active material, broken glass, and
sharps waste
BROKEN GLASS WASTE
Secondary Container: Yellow - “Broken Glass”
Acceptable:
• Broken lab glass
• Disposable glass pipettes
• Glass bottles
Prohibited:
Plastics (e.g. overheads), food wrappers, paper towels
and cups, facial tissue, blue prints, spiral and large
metal clip bound books
BEVERAGE CONTAINERS
Secondary Container:
“Metal Cans and Plastic Pop Bottles Only”
Acceptable:
• All food and beverage cans
Prohibited:
Paper, hazardous material, and garbage
Prohibited:
Chemical containers, paint cans, metal lids from glass or
plastic containers
SHARPS WASTE
Secondary Containers:
Approved Plastic “Sharps Containers”
DO NOT OVERFILL
Caution:
Please ensure that all materials are properly segregated
to maintain the continued safety of our staff and the
environment.
Acceptable:
• Syringe needle, scalpel blades, razor blades which
have not been used with biological materials
If you believe that waste is improperly segregated, please
contact your supervisor, the Chemical Control Centre or
Occupational Health and Safety (ext. 2055).
Prohibited:
Paper, hazardous material, biological hazardous waste
and garbage
HAZARDOUS WASTE - Chemical Control Centre
For more information on biological, chemical or radioactive waste collection and disposal please call the
Chemical Control Centre (ext. 3523). NOT COLLECTED BY HOUSEKEEPING.
CHEMICAL WASTE
BIOLOGICAL WASTE
Secondary Containers: Approved chemical waste containers,
which are provided free-of-charge from the Chemical
Control Center.
Secondary Containers: “BIOHAZARDOUS” bags and/or
“BIOHAZARDOUS” sharps container.
Principle Investigators and/or Departments are responsible
for arranging disposal by the Chemical Control Centre. It is
illegal to dispose any chemical down either a drain or by
placing material within the garbage.
Acceptable:
• Medical waste (blood or body fluids)
• Contaminated plastics and gloves
• Animal tissues, etc.
• Sharps containers with needles, etc.
Must be sterilized or chemically decontaminated to render
the waste non-hazardous. The treated waste must be
appropriately labeled “non-hazardous” and then can be
disposed of as regular waste.
RADIOACTIVE WASTE
Secondary Containers: Approved “RADIOACTIVE” waste
containers, provided free-of-charge from the Chemical
Control Center.
Principle Investigators and/or Departments are responsible
for arranging disposal by the Chemical Control Centre.
Contaminated articles
Arrange for disposal by the Chemical Control Centre.
IN CASE OF Campus Emergency
Dial ext. 4444
( 5 1 9 - 2 5 3 - 3 0 0 0 e x t . 4 4 4 4 )
OF
www.uwindsor.ca/biosafety
Biohazardous Sharps Container
CCC Part #LAB0617 / LAB0618
Biohazardous Sharps
Biological Safety
Program
Double-Lined Corrugated Biohazard Box
CCC Part #LAB1245 / Liner LAB1246
Animal Blood and/or Biological Fluids
UNIVERSITY
Double-Lined Corrugated Biohazard Box
CCC Part #LAB1245 / Liner LAB1246
Human Blood and/or Biological Fluids
WINDSOR
Red Bio-Pail
CCC Part #LAB1251
Non-Infected Animal Anatomical Waste
September 2007
Red Bio-Pail
CCC Part #LAB1251
Infected Animal Anatomical Waste
Double-Lined Corrugated Biohazard Box
(Third-party disposal only)
CCC Part #LAB1245 / Liner LAB1246
Red Bio-Pail
CCC Part #LAB1251
Solid
Autoclave Bag
(Internal Treatment)
Third-Party
Disposal
( 5 1 9 - 2 5 3 - 3 0 0 0
e x t. 4 4 4 4 )
IN CASE OF Campus Emergency
Dial ext. 4444
Third-Party Disposal
* Approval from UWindsor Biological Safety Committee required
Steam Sterilization (*)
Internal Process
Material Bulking
(Small 14Gal
Fiber Drum)
Third-Party Disposal
* Approval from UWindsor Biological Safety Committee required
Steam Sterilization (*)
Internal Process
Liquid
Suitable/Autoclavable Container
Treatment
Containment
Human Anatomical Waste
General Biomedical Waste
Classification
Phone: 519-253-3000, Ext. 3523 • E-mail: [email protected] • Web: www.uwindsor.ca/ccc • Location: Essex Hall / B-37 • Hours: 8:30 am to 4:30 pm (M-F)
Biological Materials
Segregation
2.6 Autoclaves
/
Steam
sterilizers
Autoclaves
/
steam
sterilizers
which
have
steam
in
the
piping
at
a
pressure
of
15
psi
(pounds
per
square
inch)
or
higher
are
covered
by
Chapter
B9
of
the
Boilers
and
Pressure
Vessels
Act
of
Ontario.
This
equipment
should
have
a
valid
certificate
of
operation
issued
by
a
Boiler
Inspector
holding
a
valid
Certificate
of
Competency.
Generally,
in
Ontario
this
service
is
provided
by
the
Insurer
which
provides
Boiler
and
Machinery
Insurance
coverage.
The
University
of
Windsor
has
such
insurance
coverage
through
CURIE,
an
insurance
broker.
Every
autoclave
must
be
inspected
at
the
time
of
installation
and
should
have
a
valid
certificate
from
TSSA
(Technical
Safety
and
Standards
Authority)
of
Ontario.
After
the
initial
installation,
this
equipment
is
to
be
inspected
annually
by
a
Boiler
Inspector.
The
scope
of
inspection
will
include
a
visual
inspection,
a
review
of
the
conditions
of
operation
and
the
protective
devices
such
as
the
pressure
relief
valves,
temperature
controls
(if
any),
steam
quality
control,
and
the
measures
being
taken
by
the
user
for
its
safe
and
efficient
operation
as
required
by
the
Boilers
and
Pressure
Vessels
Act
of
Ontario.
Upon
satisfactory
completion
of
the
inspection,
a
certificate
of
inspection
will
be
issued
which
will
authorize
operation
of
the
equipment.
The
user
should
not
operate
any
sterilizer
which
has
steam
heating
coils
with
a
pressure
of
15
psi
or
higher
without
a
valid
certificate
of
operation.
The
persons
responsible
for
the
operation
should
be
fully
familiar
with
the
requirements
of
the
Boilers
and
Pressure
Vessels
Act
of
Ontario.
The
University’s
insurer
maintains
a
list
indicating
the
locations
of
autoclaves.
Annual
inspections
are
performed
automatically,
according
to
this
list.
If
you
have
received
a
new
autoclave
or
are
using
one
that
has
not
been
inspected
during
the
previous
12
months,
please
notify
the
University
of
Windsor’s
Department
of
Finance
(Attn:
Manager
‐
Risk
Management
&
Insurance)
and
provide
the
information
necessary
to
have
this
equipment
added
to
the
equipment
list
so
that
the
required
inspections
are
scheduled
and
performed
in
future.
For
autoclave
inspection
services
or
information
contact:
University
of
Windsor
Department
of
Finance
(519)
253
–
3000
ext.
2080
19
|
P a g e Autoclave
Standard Operating Procedures
Phone: 519-253-3000, Ext. 3523 • E-mail: [email protected] • Web: www.uwindsor.ca/ccc
Location: Essex Hall / B-37 • Hours: 8:30 am to 4:30 pm (M-F)
Anyone using the autoclave must first be trained by a
University Technician. Refresher training is required once a year.
Biohazardous Waste Treatment
Culture Media & Solutions Sterilization
Temperature: 121°C Pressure: 15psi Time: 30 minutes
Temperature: 121°C Pressure: 15psi Time: 20 minutes
• Waste should be placed with in a biohazard bag with
autoclave indicator tape attached
• Always place containers in chamber, with autoclave tape
attached (Container should never be more than 50% full)
• Place bag in the steel pan and then into the chamber
• A tray must be used to avoid spilling liquid into
the chamber.
• Close and seal the door, and “Start” the cycle
• Once the cycle is complete carefully open the door taking
care to avoid the steam
• Use autoclave gloves to remove autoclaved materials and
check sterilization tape (see Validation Verification)
• Place “Treated” sticker on bag and throw in the garbage
• Close and seal the door, and “Start” the cycle
• Once the cycle is complete carefully open the door taking
care to avoid the steam
• Use autoclave gloves to remove autoclaved materials and
check sterilization tape (see Validation Verification)
Liquids can become super
saturated causing them
to boil over.
Sample Treated Label
Remove all items carefully!
Validation Verification
• Autoclave tape indicators confirm that an item has been
exposed to the stem sterilization process but does not
indicate that the process was sufficient to achieve sterility
Pipet Tips & Labware Sterilization
• Weekly Biological Indicator tests need to be run by
technicians to verify that the autoclave is functioning
properly. Should this test fail, there will be an “Out of
Service” sign until a contractor has serviced the autoclave.
Temperature: 121°C Pressure: 15psi
Time: 20 minutes and 15 minutes for drying
• Document waste stream as per University of Windsor
Steam Sterilization Guidelines
• Attach autoclave tape to all labware that will be sterilized
• Autoclaves are subject to annual TSSA inspection
• Neatly stack labware leaving space between the stacks
to assure proper sterilization
• Close and seal the door, and “Start” the cycle
• Once the cycle is complete carefully open the door taking
care to avoid the steam
• Use autoclave gloves to remove autoclaved materials and
check sterilization tape (see Validation Verification)
Spill Control
• Using a 5% bleach solution, encircle the spill
• Use gloves and move the bleach in towards the spill with
paper towels
• Let sit for 2 minutes then wipe up
For more information visit www.uwindsor.ca/biosafety
UNIVERSITY
OF
WINDSOR
Biological Safety
Program
IN CASE OF Campus Emergency
Dial ext. 4444
( 5 1 9 - 2 5 3 - 3 0 0 0
e x t. 4 4 4 4 )
2.7 Fume
hoods
Fume
hoods
should
be
tested
by
qualified
personnel
in
accordance
with
CSA
Standard
Z316.5‐94,
or
equivalent.
The
University
of
Windsor’s
Fume
Hood
Standard
is
available
from
the
Chemical
Control
Centre’s
Laboratory
Safety,
Assurance,
and
Compliance
website
at
www.uwindsor.ca/ccc.
The
Chemical
Control
Centre’s
Laboratory
Safety,
Assurance,
and
Compliance
group
audits
fume
hood
performance
works
in
collaboration
with
Facilities
Services
to
recalibrate
the
airflow
to
meet
operational
requirements
on
an
annual
basis.
To
report
fume
hood
malfunctions
or
if
you
require
more
information,
contact:
Facilities
Services
Heating
&
Cooling
‐
Energy
Conversion
Centre
(ECC)
(519)
253
–
3000
ext.
7027
or
Chemical
Control
Centre
Laboratory
Safety,
Assurance,
and
Compliance
(519)
253
–
3000
ext.
3523,
option
#
4
2.8 Biological
Safety
Cabinets:
Assessment
and
Testing
The
purpose
of
an
air
exhaust
system
is
to
remove
contaminated
air
from
a
work
area,
to
convey
it
through
a
decontaminating
system
if
necessary,
and
to
discharge
it
to
the
outside.
Its
design
should
provide
adequate
air
exchanges,
a
negative
pressure
differential
between
the
room
and
the
air
source
to
ensure
that
contaminated
air
departs
only
through
the
exhaust
system,
and
air
flow
patterns
through
the
room
so
that
all
parts
of
the
room
are
swept
by
the
air
flow.
The
influence
of
opening
and
closing
doors
on
these
air
flow
patterns
is
of
particular
importance.
Decontamination
of
air
is
best
achieved
with
a
high
efficiency
particulate
air
(HEPA)
filter.
HEPA
filters
are
ineffective
unless
properly
installed.
Testing
of
these
filters
in
situ
with
an
aerosol
at
the
time
of
installation
and
at
regular
intervals
is
essential
to
ensure
the
integrity
of
the
barrier.
Normally,
HEPA
filters
will
require
replacement
only
when
they
offer
excessive
resistance
to
air
flow
due
to
loading
or
when
irreparable
leaks
are
detected.
Biological
safety
cabinets,
when
properly
used
in
research
and
teaching
activities
involving
the
manipulation
of
hazardous
biological
agents,
are
effective
in
containing
and
controlling
particulates
and
aerosols
and
complement
good
laboratory
practices
and
procedures.
21
|
P a g e Biological
safety
cabinets
used
in
laboratory
activities
requiring
Containment
Level
2
or
3
conditions
at
the
University
of
Windsor
must
be
inspected,
tested
and
approved
for
use
annually,
unless
otherwise
noted,
by
trained
service
personnel
to
ensure
that
the
cabinet
is
functioning
as
intended
by
the
manufacturer.
Inspection
and
testing
is
mandatory
if
a
biological
safety
cabinet
is
relocated.
Moves
of
a
minor
nature
(i.e.
within
the
same
room)
may
be
exempt
from
this
requirement
if
the
move
is
observed
by
the
testing
technologist
and
the
cabinet
has
not
been
subjected
to
excessive
stress
or
rough
handling
which
could
result
in
damage.
The
routine
decontamination
and
testing
of
used
Class
II
biological
safety
cabinets
shall
include
the
following
required
procedures
and
tests
which
shall
be
conducted
in
accordance
with,
and
in
the
manner
described
below.
2.8.1 Testing
services
The
testing
of
biological
safety
cabinets
at
the
University
is
conducted
by
an
external
contractor.
Fees
for
this
service
are
charged
to
the
Principal
Investigator
/
researcher
or,
in
the
case
of
teaching,
to
the
instructor's
department.
The
University
of
Windsor’s
Chemical
Control
Centre
coordinates
the
annual
testing,
servicing
or
repair
of
all
biological
safety
cabinets
on
campus.
2.8.2 Required
procedures
and
tests
Decontamination
Cabinet
decontamination
with
paraformaldehyde
vapour
shall
be
conducted
prior
to
the
testing
of
biological
safety
cabinets
which
have
been
used
for
activities
involving
biological
agents
assigned
to
the
Risk
Groups
identified
by
Health
Canada.
The
biological
safety
cabinet
shall
be
sealed
and
decontaminated
using
the
paraformaldehyde
vapour
technique
which
is
described
in
NSF
Standard
49,
and
cited
in
CSA
Z316.3‐95,
or
an
equivalent
procedure
acceptable
to
the
University
of
Windsor.
The
paraformaldehyde
holding
/
contact
time
shall
be
a
minimum
of
2
hours,
after
which
the
paraformaldehyde
vapour
shall
be
neutralized
or
vented
to
the
exterior
of
the
building.
Containment
System
Integrity
Containment
system
integrity
(pressure)
testing
shall
be
performed
on
all
biological
safety
cabinets
having
air
plenums
which
convey
potentially
contaminated
air
at
positive
pressure
and
where
any
portion
of
these
plenums
also
forms
part
of
the
containment
shell
of
the
cabinet.
The
cabinet
interior
shall
be
pressurized
with
air
to
a
differential
pressure
of
2"w.g.
A
liquid
leak
detector
shall
be
applied
along
all
welds,
gaskets,
penetrations,
and
seals
on
the
exterior
surfaces
of
the
cabinet
air
plenums.
Leakage
will
be
indicated
by
the
presence
of
bubbles
or
by
the
feel
or
sound
of
escaping
air.
Detected
leakage
shall
be
corrected
using
acceptable
methods
and
materials
and
the
repaired
area
shall
be
retested
to
confirm
the
success
of
the
corrective
action.
Note:
The
performance
of
this
test
is
required
22
|
P a g e at
the
time
of
initial
cabinet
installation,
following
cabinet
relocation,
and
at
least
once
in
every
three
year
period.
Air
Velocities
and
Volumes
Air
velocities
shall
be
measured
at
multiple
points
on
a
grid,
across
the
face
of
the
HEPA
filters.
The
location
and
spacing
of
the
co‐ordinates
shall
be
according
to
the
manufacturer's
recommendations
and
/
or
applicable
standards.
Additional
air
velocity
measurements
may
be
required
by
the
manufacturer
of
the
cabinet.
The
blower
speed
and
air
dampers
shall
be
adjusted
as
required
so
that
the
final
measured
and
calculated
values
are
within
the
acceptable
ranges
indicated
by
the
manufacturer
of
the
biological
safety
cabinet.
HEPA
Filter
Integrity
HEPA
filter
leak
testing
shall
be
performed
using
sufficient
dioctylphthalate
(DOP)
aerosol
(or
equivalent)
to
challenge
the
air
filtration
system.
The
aerosol
concentration
upstream
of
the
HEPA
filters
shall
be
sampled
and
used
as
the
100%
reference
for
photometer
adjustment
prior
to
testing.
All
air
diffusers
and
protective
grilles
downstream
of
HEPA
filters
shall
be
removed
to
allow
direct
access
to
the
entire
filter
surface
and
perimeter
(bond
area,
gasket,
filter
frame,
and
mounting
frame)
which
shall
be
scanned
in
overlapping
strokes
at
a
traverse
rate
of
not
more
than
2"
per
second.
Aerosol
penetration
exceeding
0.01%
of
the
upstream
concentration
shall
be
sealed
or
corrected
using
generally
accepted
methods
and
the
repaired
area
shall
be
retested
to
confirm
the
success
of
the
corrective
action.
Airflow
Smoke
Patterns
These
tests
shall
be
performed
using
a
source
of
visible
smoke
to
demonstrate
the
acceptability
of
airflows
associated
with
the
biological
safety
cabinet:
(a) Downflow
Supply
Air
Distribution
The
source
of
visible
smoke
shall
be
passed
along
the
('smoke
split')
centreline
of
the
work
surface,
from
one
side
of
the
workspace
to
the
other.
The
smoke
shall
show
smooth
flow
with
no
dead
spots
or
upward
flow.
No
smoke
shall
escape
from
the
cabinet.
(b) Supply
Air
Entrainment
/
View
Screen
Retention
The
source
of
visible
smoke
shall
be
passed
from
one
side
of
the
cabinet
to
the
other,
behind
the
view
screen,
and
6"
above
the
top
of
the
front
access
opening.
The
smoke
shall
show
smooth
downward
flow
with
no
dead
spots
or
upward
flow.
No
smoke
shall
escape
from
the
cabinet.
(c) Intake
Air
Entrainment
/
Work
Access
Opening
Retention
The
source
of
visible
smoke
shall
be
passed
along
the
entire
work
access
perimeter,
about
1.5"
outside
of
the
workspace
of
the
cabinet.
No
smoke
shall
escape
from
the
cabinet
once
it
is
23
|
P a g e drawn
in.
For
Class
II
cabinets,
no
smoke
shall
pass
over
the
work
surface
or
penetrate
the
work
zone.
(d) Window
Seal
The
source
of
visible
smoke
shall
be
passed
along
the
perimeter
of
the
view
screen,
inside
the
workspace
of
the
cabinet.
No
smoke
shall
escape
from
the
cabinet.
Other
Procedures
and
Tests
Other
procedures
and
tests
(electrical
safety,
fluorescent
and
UV
lighting
intensity,
vibration,
noise
level,
etc.)
may
be
recommended
or
performed,
depending
on
the
cabinet
design
and
the
circumstances
of
its
installation
and
usage,
but
their
performance
is
not
required
on
a
routine
basis.
24
|
P a g e 3 BIOLOGICAL
SAFETY
PRACTICES
AND
PROCEDURES
3.1 General
Laboratory
Safety
Practices
The
following
requirements
are
basic
for
any
laboratory
using
hazardous
biological
or
toxic
agents:
1. All
laboratory
personnel
and
others
whose
work
requires
them
to
enter
the
laboratory
must
understand
the
chemical
and
biological
hazards
with
which
they
will
come
in
contact
during
their
normal
work
in
the
laboratory,
and
be
trained
in
appropriate
safety
precautions
and
procedures.
A
standard
operating
procedure
(SOP)
must
be
prepared
or
adopted
for
use
with
biological
agents.
It
is
the
responsibility
of
the
principal
investigator
and/or
laboratory
supervisor
to
ensure
that
it
identifies
known
and
potential
biological
hazards
and
specifies
the
practices
and
procedures
to
eliminate
or
minimize
such
risks.
The
SOP
must
contain
an
emergency
response
plan.
Personnel
must
be
required
to
know,
understand,
and
follow
standard
practices
and
procedures.
Training
in
laboratory
safety
shall
be
provided
by
the
laboratory
director
/
principal
investigator
and
competence
in
safe
technique
must
be
demonstrated
before
work
is
allowed
with
hazardous
agents
or
toxic
material.
2. The
laboratory
must
be
kept
neat,
orderly
and
clean,
and
storage
of
materials
not
pertinent
to
the
work
must
be
minimized.
3. Protective
laboratory
clothing
(uniforms,
coats,
gowns)
must
be
available,
and
worn
properly
fastened
by
all
personnel
including
visitors,
trainees,
and
others
entering
or
working
in
the
laboratory.
Protective
laboratory
clothing
must
not
be
worn
in
non‐laboratory
areas.
4. Suitable
footwear
with
closed
toes
and
heels
and
preferably
with
non‐slip
soles
must
be
worn
in
all
laboratory
areas.
5. Gloves
must
be
worn
for
all
procedures
that
might
involve
direct
skin
contact
with
toxins,
blood,
infectious
materials
or
infected
animals.
Rings
or
hand
jewellery
which
interfere
with
glove
use
must
be
removed
before
gloving.
The
wearing
of
jewellery
in
the
laboratory
should
be
discouraged.
Gloves
must
be
removed
carefully
and
decontaminated
with
other
laboratory
wastes
before
disposal.
Reusable
gloves
(e.g.
insulated,
chemical
resistant,
etc.)
may
be
used
where
necessary
and
must
be
appropriately
decontaminated
after
use.
6. Face
and
eye
protection
(e.g.,
glasses,
goggles,
face
shields,
or
other
protective
devices)
must
be
worn
when
necessary
to
protect
the
face
and
eyes
from
splashes,
impacting
objects,
harmful
substances,
UV
light,
or
other
rays.
25
|
P a g e 7. Eating,
drinking,
smoking,
storing
food
or
utensils,
applying
cosmetics,
and
inserting
or
removing
contact
lenses
are
not
permitted
in
any
laboratory
work
area.
Contact
lenses
are
not
protective
devices,
and
must
be
used
only
in
conjunction
with
appropriate
protective
eyewear
in
eye
hazard
areas.
8. Oral
pipetting
is
prohibited
in
any
laboratory.
9. Long
hair
must
be
tied
back
or
restrained.
10. Hands
must
be
washed
after
gloves
are
removed,
before
leaving
the
laboratory,
and
after
handling
materials
known
or
suspected
to
be
contaminated,
even
when
gloves
have
been
worn.
11. Work
surfaces
must
be
cleaned
and
decontaminated
with
the
appropriate
disinfectant
at
the
end
of
the
day
and
after
any
spill
of
potentially
hazardous
material.
Loose
or
cracked
work
surfaces
must
be
repaired
or
replaced.
12. All
technical
procedures
must
be
performed
in
a
manner
that
minimizes
the
creation
of
aerosols.
13. All
contaminated
or
infectious
liquid
or
solid
materials
must
be
decontaminated
before
disposal
or
reuse.
Contaminated
materials
that
are
to
be
autoclaved
or
incinerated
at
a
site
away
from
the
laboratory
must
be
double‐bagged
or
placed
into
containers,
the
outsides
of
which
are
disinfected.
14. Access
to
Level
1
and
2
laboratories
must
be
at
the
discretion
of
the
laboratory
director
/
principal
investigator
(e.g.
only
persons
who
have
been
advised
of
the
potential
hazards
and
meet
any
specific
entry
requirements
such
as
immunization
should
be
allowed
to
enter
the
laboratory
area).
Persons
under
the
age
of
16
years
should
not
be
permitted
in
the
laboratory
or
support
areas.
Pregnant
women
and
immunocompromised
people
who
work
in
or
enter
the
laboratory
must
be
advised
of
the
associated
risks.
15. Hazard
warning
signs,
indicating
the
containment
level
or
the
risk
group
of
the
agent
used,
must
be
posted
outside
each
laboratory
operating
at
Containment
Level
2.
Where
the
infectious
agent
used
in
the
laboratory
requires
special
provisions
for
entry,
the
relevant
information
must
be
included
in
the
door
sign.
The
agent(s)
must
be
identified
in
the
information
provided
for
signing
along
with
the
names
of
the
laboratory
supervisor
and
other
responsible
person(s),
and
any
special
conditions
for
staff
entry.
16. The
use
of
needles
and
syringes
and
other
sharp
objects
must
be
strictly
limited.
Hypodermic
needles
and
syringes
must
be
used
only
for
parenteral
injection
and
aspiration
of
fluids
from
26
|
P a g e laboratory
animals
and
diaphragm
bottles.
Extreme
caution
must
be
used
when
handling
needles
and
syringes
to
avoid
autoinoculation
and
the
generation
of
aerosols
during
use
and
disposal.
Needles
must
not
be
bent
or
sheared.
Disposable
needles
and
syringes
must
not
be
replaced
in
their
sheath
or
guard.
They
must
be
placed
into
a
puncture‐resistant
yellow
container
and
autoclaved,
if
contaminated,
before
disposal,
or
incinerated.
Sharps
containers
are
available
at
both
the
Biological
Sciences
Stockroom
and
Chemical
Control
Centre.
17. All
spills,
accidents
(needlesticks,
punctures,
cuts,
etc.)
and
overt
or
potential
exposures
must
be
reported
in
writing
to
the
laboratory
supervisor
or
acting
alternate
as
soon
as
circumstances
permit.
This
person
must
file
this
report
with
the
University
of
Windsor,
Office
of
Occupational
Health
&
Safety.
Appropriate
medical
evaluation,
surveillance,
and
treatment
must
be
sought
and
provided
as
required.
Actions
taken
to
prevent
future
occurrences
should
be
documented.
18. Baseline
serum
or
other
specimens
shall
be
collected
from
laboratory
and
other
at‐risk
personnel
and
stored
when
deemed
necessary.
Additional
serum
specimens
may
be
collected
periodically,
depending
on
the
agent
handled
or
the
function
of
the
facility.
Baseline
and
periodic
serum
or
other
specimens
shall
be
collected
and
maintained
by
the
University's
Occupational
Health
Service
or
an
equivalent
health
service.
Confidentiality
will
be
maintained
according
to
the
legal
obligations
of
the
Regulated
Health
Disciplines
Act,
or
its
subsequent
revision.
Tests
will
not
be
performed
without
the
informed
consent
of
the
donor.
19. Laboratory
workers
should
be
protected
by
appropriate
immunization
where
possible.
Levels
of
antibody
considered
to
be
effective
should
be
documented.
Appropriate
immunization
or
evidence
of
exposure
should
be
maintained
in
a
confidential
manner.
Particular
attention
must
be
given
to
individuals
who
are
or
may
become
immunocompromised,
as
vaccine
administration
may
be
different
than
for
immunologically
competent
adults.
For
more
information
on
various
types
of
safety
equipment
use
in
preventing
infection
from
biological
agents,
please
refer
to
Appendix
C
–
Safety
Equipment
3.2 Working
with
Laboratory
Animals
Animals
can
harbour
infectious
organisms
which
are
acquired
naturally.
Some
infectious
agents
can
give
rise
to
a
chronic
carrier
state,
or
an
agent
might
be
shed
intermittently.
If
the
possibility
that
such
an
agent
may
be
excreted,
secreted,
exhaled
or
shed
by
an
animal
during
the
course
of
an
experiment
cannot
be
excluded,
then
all
those
animals
should
be
kept
at
the
containment
level
appropriate
to
the
risk.
27
|
P a g e Animals
may
also
be
intentionally
inoculated
with
viruses
or
other
organisms
in
any
of
the
four
Risk
Groups
or
with
viable
materials
(e.g.,
transformed
cells)
suspected
of
containing
these
agents.
Under
these
circumstances,
the
animals
should
be
kept
at
the
containment
level
appropriate
to
the
risk
of
the
agent,
recognizing
that
in
some
cases,
in
vivo
work
may
increase
that
risk.
Naturally
occurring
or
experimentally
induced
infections
in
laboratory
animals
may
be
transmitted
to
other
laboratory
animals,
invertebrates
and
laboratory
workers.
Laboratory
animals
and
insects
may
scratch
or
bite
or
may
be
the
source
of
an
aerosol.
Besides
the
risk
from
an
infection
that
the
animal
or
insect
may
be
harbouring,
there
is
also
a
risk
that
some
of
the
material
being
injected
may
adhere
to
the
fur
or
exoskeleton
and
remain
as
a
potential
hazard.
In
all
situations,
it
is
the
responsibility
of
the
principal
investigator,
laboratory
supervisor
and
the
University
of
Windsor’s
Biological
Safety
Committee,
in
consultation
with
Government
agencies
and
the
animal
care
authorities,
to
determine
the
risk
levels
inherent
in
the
proposed
activity.
The
requirements
for
the
maintenance
of
animals
may
differ
in
scale
and
degree,
but
the
basic
principles
for
microbiological
safety
will
be
similar
to
those
outlined
in
Section
3.1
‐
General
Laboratory
Safety
Practices
and
should
include
the
following
precautions.
1. Infected
animals
and
insects
should
be
segregated
from
uninfected
animals
wherever
possible,
and
it
is
preferable
to
separate
any
handling
area
from
the
holding
area.
2. Animals
or
insects
in
use
in
an
experiment
must
be
maintained
at
a
level
of
containment
that
is
at
least
equivalent
to
the
containment
level
for
the
biological
agent
with
which
it
has
been
infected
or
treated.
3. Provision
must
be
made
to
ensure
that
inoculated
animals
or
insects
cannot
escape.
4. Dead
animals
or
insects
and
the
refuse
from
the
animal
room
and
cages
(e.g.
bedding,
faeces
and
food)
must
be
placed
in
a
leakproof
container
and
autoclaved
or
incinerated.
5. All
cages
must
be
properly
labelled,
and
procedures
in
the
holding
area
must
minimize
the
dispersal
of
dander
and
dust
from
the
animals
and
cage
refuse.
6. Protective
clothing,
including
scratch/bite
resistant
gloves,
eye
protection,
appropriate
chemical
restraint
and
proper
handling
equipment
are
recommended
for
the
handling
of
non‐human
primates.
7. Disposable
latex
gloves
should
be
worn
by
animal
care
providers
while
feeding
and
watering
animals
or
cleaning
cages.
8. Non‐disposable
gloves,
boots,
floors,
walls
and
cage
racks
should
be
disinfected
frequently.
28
|
P a g e In
addition
to
the
preceding,
the
following
must
also
be
satisfied:
9. All
aspects
of
the
proposed
use
of
animals
in
research
&
teaching
must
meet
the
current
veterinary
standards
and
regulations
for
the
care
and
maintenance
of
experimental
animals
as
described
by
the
Canadian
Council
on
Animal
Care,
relevant
provincial
legislation,
and
local
animal
care
authorities.
10. The
appropriate
species
must
be
selected
for
the
animal
experiments.
11. The
investigator
and
/
or
person(s)
responsible
for
the
animal
experiment
must
ensure
that
all
those
having
contact
with
the
animals
and
waste
materials
are
familiar
with
and
aware
of
any
special
precautions
and
procedures
that
may
be
required.
Where
possible,
personnel
should
be
protected
by
immunization
with
appropriate
vaccines.
12. All
incidents,
including
animal
bites
and
scratches
or
cuts
from
cages
or
other
equipment
must
be
documented
and
the
employee
should
report
to
the
Occupational
Health
Service
for
medical
assessment
and
follow‐up.
13. Small
laboratory
rodents
or
other
small
animals
that
escape
from
their
cages
should
be
killed
when
captured,
their
carcasses
incinerated,
and
the
area
should
be
thoroughly
decontaminated.
In
the
event
that
animals
escape
through
the
containment
perimeter,
the
relevant
authorities
must
be
notified
promptly
and
appropriate
action
initiated.
Unexpected
illness
or
deaths
among
animals
must
be
reported
to
the
principal
investigator
and
the
veterinarian,
who
will
be
responsible
for
final
disposition.
Animals
should
not
be
touched
until
instructions
are
given
by
the
person‐in‐charge.
3.3 Working
with
Human
Pathogens
Some
micro‐organisms
(viruses,
bacteria,
fungi,
etc.)
are
species
specific,
selectively
infecting
and
causing
disease
in
a
limited
number
of,
or
only
one,
host
species.
Unrelated
and
distantly
related
species
may
not
be
similarly
affected
by
the
same
infectious
micro‐organism
due
to
differences
in
physiology,
metabolism,
biochemistry,
etc.
In
general,
the
risk
to
a
laboratory
technician
working
with
a
virus
that
only
infects
and
causes
disease
in
rodents
is
lower
than
the
risk
to
a
laboratory
technician
working
with
tissues
and
cells
from
humans
or
other
primates.
If
the
human
material
contains
a
viable
pathogen,
it
will
likely
be
a
human
pathogen,
with
the
potential
to
infect
and
cause
disease
in
another
human.
Although
a
single
mode
of
transmission
may
predominate,
disease
causing
micro‐organisms
can
be
spread
or
transmitted
from
one
host
to
the
next,
directly
or
indirectly,
by
a
number
of
methods,
including
aerosol
generation
and
inhalation,
ingestion
of
contaminated
food
and
water,
skin
and
mucous
29
|
P a g e membrane
contact
with
contaminated
surfaces,
contact
contamination
of
an
open
wound
or
lesion,
and
autoinoculation
via
a
cut,
laceration
or
puncture
with
a
contaminated
instrument.
3.3.1 Human
Bloodborne
Pathogens
Human
blood
is
recognized
as
a
potential
source
of
pathogenic
micro‐organisms
that
may
present
a
risk
to
workers
who
are
exposed
during
the
performance
of
their
duties.
Although
the
hepatitis
B
virus
(HBV)
and
the
human
immunodeficiency
virus
(HIV)
are
often
cited
as
examples,
a
"bloodborne
pathogen"
is
any
pathogenic
micro‐organism
that
is
present
in
human
blood
or
other
potentially
infectious
materials
and
that
can
infect
and
cause
disease
in
persons
who
are
exposed
to
blood
containing
this
pathogen.
"Other
potentially
infectious
materials"
means
material
which
has
the
potential
to
transmit
bloodborne
pathogens.
This
includes
infected
human
tissues
and
the
following
body
fluids:
semen,
vaginal
secretions,
cerebrospinal
fluid,
synovial
fluid,
pleural
fluid,
peritoneal
fluid,
pericardial
fluid,
amniotic
fluid,
saliva
in
dental
procedures,
and
any
other
body
fluid
that
is
visibly
contaminated
with
blood.
The
biosafety
requirements
identified
for
research
&
teaching
laboratories
may
not
always
be
applicable
to
all
workplace
settings
where
workers
handle
or
are
exposed
to
human
blood,
body
fluids
or
other
materials
potentially
containing
biological
agents.
Between
1982
and
1988,
the
Centers
for
Disease
Control
(Atlanta,
Georgia)
published
a
series
of
recommendations
and
precautions
for
the
protection
of
healthcare
workers
(physicians,
nurses,
phlebotomists,
dentists,
laboratory
workers,
etc.)
who
have,
or
are
likely
to
have,
contact
with
human
blood
and
certain
body
fluids
and
may
be
at
risk
of
exposure
to
bloodborne
pathogens
such
as
hepatitis
B
virus
(HBV)
and
human
immunodeficiency
virus
(HIV).
These
recommendations
became
known
as
"Universal
Blood
and
Body
Fluid
Precautions"
or
simply,
"Universal
Precautions".
3.3.2 Universal
Blood
and
Body
Fluid
Precautions
The
possibility
of
undiagnosed
infection
combined
with
the
increasing
prevalence
of
HBV
and
HIV
led
the
Center
for
Disease
Control
(Atlanta,
Georgia)
to
recommend
that
blood
and
certain
other
body
fluids
from
all
humans
be
considered
potentially
infectious
and
that
precautions
be
taken
to
minimize
the
risk
of
exposure.
This
approach,
called
"Universal
Precautions",
is
a
method
of
infection
control,
intended
to
prevent
parenteral,
mucous
membrane,
and
non‐intact
skin
exposure
of
workers
to
bloodborne
pathogens.
All
human
blood,
certain
human
body
fluids,
and
other
materials
are
considered
potentially
infectious
for
hepatitis
B
virus
(HBV),
human
immunodeficiency
virus
(HIV),
and
other
bloodborne
pathogens.
Precautions
must
be
consistently
used.
Body
fluids
to
which
universal
precautions
apply
include
blood,
body
fluids
containing
visible
blood,
semen,
vaginal
secretions,
cerebrospinal
fluid,
synovial
fluid,
pleural
fluid,
peritoneal
fluid,
pericardial
fluid,
and
amniotic
fluid.
30
|
P a g e Universal
precautions
generally
do
not
apply
to
faeces,
breast
milk,
nasal
secretions,
sputum
and
saliva,
sweat,
tears,
urine,
and
vomitus
unless
they
contain
visible
blood.
Although
these
materials
are
not
implicated
in
the
transmission
of
bloodborne
pathogens,
it
is
prudent
to
minimize
non‐intact
skin
and
mucous
membrane
contact
with
these
materials.
Hepatitis
B
immunization
is
recommended
as
an
adjunct
to
universal
precautions
for
workers
who
have
occupational
exposure
to
human
blood
or
other
potentially
infectious
materials.
This
immunization
is
provided
to
employees
at
risk
is
performed
by
the
employee’s
personal
physician
and
is
covered
by
the
University
of
Windsor’s
extended
health
plan.
Individuals
who
do
not
have
extended
health
coverage
will
be
reimbursed
by
the
University
of
Windsor
to
facilitate
immunization.
In
the
hospital
setting,
HBV
immunization
is
recommended
for
personnel
in
these
occupational
groups:
medical
technologists,
operating
room
staff,
phlebotomists
and
intravenous
therapy
nurses,
surgeons
and
pathologists,
dialysis
unit
staff,
emergency
room
staff,
nursing
personnel,
physicians,
and
students
in
schools
of
medicine,
dentistry,
nursing,
laboratory
technology
and
other
allied
health
professions.
Outside
the
hospital
setting,
HBV
immunization
is
recommended
for
healthcare
workers
who
may
have
exposure
to
human
blood
and
other
potentially
infectious
materials,
such
as
dental
professionals,
laboratory
and
blood
bank
technicians,
dialysis
centre
staff,
emergency
medical
technicians,
morticians,
workers
in
clinical
/
diagnostic
laboratories,
and
workers
in
research
&
teaching
facilities
that
study,
produce
or
manipulate
human
blood
which
may
contain
HBV
and
HIV.
General
Precautions
All
workers
should
routinely
use
appropriate
barrier
precautions
to
prevent
skin
and
mucous
membrane
exposure
when
contact
with
human
blood
or
other
body
fluids
is
anticipated.
Eating,
drinking,
smoking,
applying
cosmetics
or
lip
balm,
and
handling
contact
lenses
are
prohibited.
Gloves
should
be
worn
when
touching
blood
and
body
fluids,
mucous
membranes,
or
non‐intact
skin,
for
handling
items
or
surfaces
soiled
with
blood
or
body
fluids,
and
for
performing
venipuncture
and
other
vascular
access
procedures.
If
a
glove
is
torn
or
damaged
during
use,
it
should
be
removed
and
a
new
glove
used
as
promptly
as
safety
permits.
Disposable
gloves
should
not
be
washed
or
disinfected
for
reuse.
Washing
with
surfactants
may
enhance
penetration
of
liquids
through
undetected
holes
in
the
glove.
Disinfecting
agents
may
cause
deterioration
of
the
glove
material.
Masks
and
protective
eyewear
or
face
shields
should
be
worn
during
procedures
that
are
likely
to
generate
droplets
of
blood
or
other
body
fluids
to
prevent
exposure
of
mucous
membranes
of
the
mouth,
nose,
and
eyes.
31
|
P a g e Gowns
or
aprons
should
be
worn
during
procedures
that
are
likely
to
generate
splashes
of
blood
or
other
body
fluids.
Protective
clothing
should
be
removed
before
leaving
the
area.
Hands
and
other
skin
surfaces
should
be
washed
immediately
and
thoroughly
if
contaminated
with
blood
or
other
body
fluids.
Hands
should
be
washed
immediately
after
gloves
are
removed
since
no
barrier
is
100%
effective.
Alternatively,
the
University
of
Windsor’s
Biological
Safety
Program
provides
Hand
Sanitizer
stations
in
all
BSL‐1
and
BSL‐2
facilities
to
be
used
in
the
decontamination
of
hands
and
other
skin
surfaces.
Workers
should
take
precautions
to
prevent
injuries
caused
by
needles,
scalpels,
and
other
sharp
instruments
or
devices
during
procedures,
when
cleaning
used
instruments,
during
disposal
of
used
needles,
and
when
handling
sharp
instruments
after
procedures.
Needles
and
syringes
should
be
used
only
in
those
situations
when
there
is
no
alternative.
To
prevent
needlestick
injuries,
needles
should
not
be
recapped,
purposely
bent
or
broken
by
hand,
removed
from
disposable
syringes,
or
otherwise
manipulated
by
hand.
After
they
are
used,
disposable
syringes
and
needles,
scalpel
blades,
and
other
sharp
items
should
be
placed
in
puncture‐resistant
containers
for
disposal.
The
puncture‐resistant
container
should
be
located
as
close
to
the
use
area
as
practical.
Contaminated
reusable
pointed
and
sharp
objects
such
as
large
bore
needles
and
scalpels
should
be
placed
in
a
puncture
resistant
container
for
transport
to
the
reprocessing
area.
Mouthpieces,
resuscitation
bags,
or
other
ventilation
devices
should
be
available
for
use
in
areas
in
which
the
need
for
resuscitation
is
predictable.
Workers
who
have
exudative
lesions,
weeping
dermatitis,
cuts,
open
wounds
or
other
breaks
in
the
skin
should
either
refrain
from
all
direct
contact
with
blood
and
other
body
fluids
until
the
condition
resolves,
or
utilise
protective
barriers
to
reduce
the
risk
of
exposure.
Pregnant
workers
should
be
especially
familiar
with
and
strictly
adhere
to
precautions
to
minimize
the
risk
of
perinatal
transmission
of
bloodborne
pathogens.
Additional
Precautions
for
Clinical
Laboratories
All
blood
and
body
fluid
specimens
should
be
in
a
well
constructed
container
with
a
secure
lid
to
prevent
leaking
during
transport.
Gloves
should
be
worn
by
all
persons
processing
blood
and
body
fluid
specimens.
Gloves
should
be
removed
and
replaced
and
hands
should
be
washed
upon
completion
of
specimen
processing
since
no
barrier
is
100%
effective.
32
|
P a g e Masks
and
protective
eyewear
or
a
face
shield
should
be
worn
if
mucous
membrane
contact
with
blood
or
body
fluids
is
anticipated.
A
biological
safety
cabinet
is
not
necessary
for
routine
procedures
such
as
histologic
and
pathologic
studies
or
microbiological
culturing.
However,
biological
safety
cabinets
should
be
used
whenever
procedures
involve
activities
that
have
a
high
potential
for
generating
aerosol
droplets
(blending,
sonicating,
vigorous
mixing,
etc.)
Mouth
pipetting
is
prohibited.
Mechanical
pipetting
devices
should
be
used
for
manipulating
all
liquids
in
the
laboratory.
Laboratory
work
surfaces
should
be
decontaminated
with
an
appropriate
chemical
germicide
after
a
spill
of
blood
or
other
body
fluids
and
when
work
activities
are
completed.
Hands
should
be
washed
after
completing
laboratory
activities
and
protective
clothing
should
be
removed
before
leaving
the
laboratory
area.
Equipment
and
instruments
should
be
decontaminated
and
cleaned
before
being
repaired
in
the
laboratory
or
transported
to
the
manufacturer
or
repair
shop.
Contaminated
materials
should
be
decontaminated
before
processing
for
reuse.
Disposable
contaminated
wastes
must
be
collected
in
the
appropriate
containers.
Additional
Precautions
for
Autopsies
or
Morticians’
Services
These
additional
precautions
are
applicable
for
work
completed
at
the
Schulich
School
of
Medicine
–
Windsor
program.
All
persons
performing
or
assisting
in
postmortem
procedures
should
wear
gloves,
masks,
protective
eyewear,
gowns,
and
waterproof
aprons.
Instruments
and
surfaces
contaminated
during
postmortem
procedures
should
be
decontaminated
with
an
appropriate
chemical
germicide.
Gloves
should
be
worn
during
the
cleaning
and
decontaminating
procedure.
3.4 Physical
Containment
Levels
Four
levels
of
containment
(1
‐
4),
appropriate
to
the
four
risk
groups
for
potentially
hazardous
biological
agents,
are
defined.
These
levels
of
containment
are
to
be
regarded
as
adequate
for
most
laboratory
uses
of
the
listed
agents.
It
remains
the
responsibility
of
the
principal
investigator
or
33
|
P a g e laboratory
director
and
the
University
of
Windsor
to
require
a
higher
level
of
containment
for
specific
manipulations,
if
these
appreciably
increase
the
possibility
of
infection.
Classification
of
organisms
according
to
risk
group
is
not
meant
to
establish
the
actual
handling
of
biological
hazards
in
the
laboratory
setting.
For
example,
the
risk
group
system
does
not
take
into
account
the
procedures
that
are
to
be
employed
during
the
manipulation
of
a
particular
organism.
Therefore,
all
researchers
who
are
working
with
biological
agents
need
to
develop
site
specific
instructions
which
are
to
be
followed
by
all
individuals
within
their
laboratory,
such
as
personal
protective
equipment
requirements,
spill
response,
and
methods
to
reduce
exposure.
Containment
levels
are
selected
to
provide
the
end‐user
with
a
description
of
the
minimum
containment
required
for
handling
the
organism
safely
in
a
laboratory
setting.
In
addition
to
the
inherent
characteristics
of
each
organism
as
described
in
Appendix
B
–
Risk
Group
Categorization
of
Agents
the
containment
system
includes
the
engineering,
operational,
technical
and
physical
requirements
for
manipulating
a
particular
pathogen.
These
containment
levels
are
applicable
to
facilities
such
as
diagnostic,
research,
clinical,
teaching
and
production
facilities
that
are
working
at
a
laboratory
scale.
3.4.1 Laboratory
Requirements
–
Biological
Containment
Level
1
University
of
Windsor’s
Biological
Safety
Committee
has
defined
well‐characterized
agents
that
are
not
known
to
consistently
cause
disease
in
healthy
adult
humans
and/or
pose
a
minimal
potential
hazard
to
laboratory
personnel
and
the
environment
as
requiring
Biological
Safety
Level
1
containment.
A
Biological
Safety
Certificate
is
required
for
all
BSL‐1
work
The
following
operational
procedures
must
be
followed
at
the
University
of
Windsor
for
all
certified
laboratories
that
handle
infectious
substances
that
require
a
Level
1
Containment
Level
(BSL‐1),
including:
1. Each
laboratory
must
obtain
and
post
in
a
conspicuous
location
a
valid
copy
of
their
University
of
Windsor
Biological
Safety
Certificate
which
lists
all
substances
that
the
laboratory
is
approved
to
utilize
as
part
of
their
research
and/or
teaching
program.
2. A
copy
of
the
University
of
Windsor’s
Biological
Safety
Manual
must
be
made
available
for
all
individuals
working
within
the
laboratory.
A
copy
of
this
manual
can
be
downloaded
from
the
University
of
Windsor’s
Biological
Safety
Program
website
(www.uwindsor.ca/biosafety)
or
requested
from
the
Chemical
Control
Centre
(p:
519.253.3000.3523
/
e:
[email protected]).
3. Personnel
must
receive
training
on
the
potential
hazards
associated
with
the
work
involved
and
the
necessary
precautions
to
prevent
exposure
to
infectious
agents
and
release
of
contained
material;
personnel
must
show
evidence
that
they
understood
the
training
provided;
training
34
|
P a g e must
be
documented
and
signed
by
both
the
employee
and
supervisor;
retraining
programs
should
also
be
implemented.
The
University
of
Windsor’s
Biological
Safety
Program
is
currently
developing
general
biological
safety
training
programs
to
be
delivered
electronically
within
a
web‐based
format
on
the
following
topics:
(1)
General
Biological
Safety;
(2)
Biological
Containment
–
Level
1;
(3)
Biological
Containment
–
Level
2;
and
(4)
Safe
and
effective
utilization
of
a
Biological
Safety
Cabinet.
Principle
Investigators
are
responsible
for
providing
and
documenting
laboratory
and
agent
specific
training.
Physical
Requirements
•
•
•
•
•
•
A
room
separated
from
public
areas
by
a
door
is
required.
There
are
no
particular
restrictions
on
locating
the
facility
near
public
or
heavily
travelled
corridors;
however,
doors
should
remain
closed.
Coatings
on
walls,
ceilings,
furniture,
and
floors
should
be
cleanable.
Windows
that
can
be
opened
should
not
be
near
working
areas
or
containment
equipment
and
should
be
equipped
with
fly
screens.
There
are
no
special
air
handling
requirements
beyond
those
concerned
with
proper
functioning
of
the
biological
safety
cabinets,
if
used,
and
those
required
by
building
codes.
Handwashing
facilities
must
be
provided,
preferably
near
the
point
of
exit
to
public
areas.
Separate
locations
should
be
provided
for
hanging
street
clothing
and
laboratory
coats
at
the
entrance/exit.
Eye
wash
stations
should
be
available.
Operational
Requirements
•
•
•
•
•
•
•
•
The
basic
laboratory
safety
practices
described
in
Section
3
must
be
followed.
In
addition,
where
chemical
disinfection
procedures
are
employed,
effective
concentrations
and
contact
times
must
be
used.
Chemical
disinfectants
used
to
decontaminate
materials
to
be
removed
from
the
laboratory
must
be
replaced
regularly.
Eating,
drinking,
smoking,
storing
of
food,
personal
belongings,
or
utensils,
applying
cosmetics,
and
inserting
or
removing
contact
lenses
are
not
permitted
in
any
laboratory;
the
wearing
of
contact
lenses
is
permitted
only
when
other
forms
of
corrective
eyewear
are
not
suitable;
wearing
jewelry
is
not
recommended
in
the
laboratory.
Oral
pipetting
of
any
substance
is
prohibited
in
any
laboratory.
Long
hair
is
to
be
tied
back
or
restrained
so
that
it
cannot
come
into
contact
with
hands,
specimens,
containers
or
equipment.
Access
to
laboratory
and
support
areas
is
limited
to
authorized
personnel.
Doors
to
laboratories
must
not
be
left
open
(this
does
not
apply
to
an
open
area
within
a
laboratory).
Open
wounds,
cuts,
scratches
and
grazes
should
be
covered
with
waterproof
dressings.
35
|
P a g e 3.4.2
Laboratory
Requirements
–
Biological
Containment
Level
2
University
of
Windsor’s
Biological
Safety
Committee
has
defined
well‐characterized
agents
that
have
a
moderate
potential
hazard
to
personnel
and
the
environment
as
requiring
Biological
Safety
Level
2
containment.
It
differs
from
BSL‐1
in
that
(1)
laboratory
personnel
have
specific
training
in
handling
pathogenic
agents
and
are
directed
by
competent
scientists;
(2)
access
to
the
laboratory
is
limited
when
work
is
being
conducted;
(3)
extreme
precautions
are
taken
with
contaminated
sharp
items;
and
(4)
certain
procedures
in
which
infectious
aerosols
or
splashes
may
be
created
are
conducted
in
biological
safety
cabinets
or
other
physical
containment
equipment.
A
Biological
Safety
Certificate
is
required
for
all
BSL‐2
work
In
addition
to
the
laboratory
requirements
stipulated
in
Section
3.4.1
–
Laboratory
Requirements
–
Biological
Safety
Level
1,
the
following
operational
procedures
must
be
followed
at
the
University
of
Windsor
for
all
certified
laboratories
that
handle
infectious
substances
that
require
a
Level
2
Containment
Level
(BSL‐2),
including:
1. Each
laboratory
must
obtain
and
post
in
a
conspicuous
location
a
valid
copy
of
their
University
of
Windsor
Biological
Safety
Certificate
which
lists
all
substances
that
the
laboratory
is
approved
to
utilize
as
part
of
their
research
and/or
teaching
program.
2. Good
microbiological
laboratory
practices
intended
to
avoid
the
release
of
infectious
agents
are
to
be
employed.
3. Appropriate
signage
indicating
the
nature
of
the
hazard
being
used
(e.g.,
biohazard
sign,
containment
level)
must
be
posted
outside
each
laboratory;
if
infectious
agents
used
in
the
laboratory
require
special
provisions
for
entry,
the
relevant
information
must
be
included
on
the
sign;
the
contact
information
of
the
laboratory
supervisor
or
other
responsible
person(s)
must
also
be
listed.
4. Entry
must
be
restricted
to
laboratory
staff,
animal
handlers,
maintenance
staff
and
others
on
official
business.
5. All
people
working
in
the
containment
area
must
be
trained
in
and
follow
the
operational
protocols
for
the
project
in
process.
Trainees
must
be
accompanied
by
a
trained
staff
member.
Visitors,
maintenance
staff,
janitorial
staff
and
others,
as
deemed
appropriate,
must
also
be
provided
with
training
and/or
supervision
commensurate
with
their
anticipated
activities
in
the
containment
area.
36
|
P a g e 6. Emergency
procedures
for
spill
clean‐up,
BSC
failure,
fire,
animal
escape
and
other
emergencies
must
be
written,
easily
accessible
and
followed.
A
record
must
be
made
of
other
people
entering
the
facility
during
an
emergency.
For
more
information
on
each
of
these
areas,
please
see
Section
4
–
Emergency
Procedures
within
this
manual.
Operational
Requirements:
• Class
I
or
II
biological
safety
cabinets
(see
Appendix
D
–
Biological
Safety
Cabinets)
are
required
for
all
manipulations
of
agents
which
may
create
an
aerosol.
The
biological
safety
cabinet
must
have
been
tested
and
certified
within
the
previous
12
months
according
to
accepted
standards
(see
Section
3.8).
• Inspection
and
retesting
is
mandatory
if
the
cabinet
is
relocated.
Moves
of
a
minor
nature
may
be
exempt
if
the
move
is
supervised
by
the
testing
technologist
to
ensure
that
the
equipment
has
not
been
subjected
to
undue
stress.
At
the
time
certification
is
carried
out,
the
testing
technologist
should
ascertain
that
the
users
are
familiar
with
the
containment
capability
of
the
equipment
under
various
operating
conditions
and
familiarize
such
individuals
with
precautions
to
be
taken
in
its
use.
• Air
from
these
cabinets
may
be
recirculated
to
the
room
only
after
passage
through
a
high
efficiency
particulate
air
(HEPA)
filter.
• Good
microbiological
laboratory
practices
intended
to
avoid
the
release
of
biological
agents
are
to
be
employed.
Centrifugation
must
be
conducted
with
closed
containers
or
aerosol
proof
safety
heads
or
cups.
These
should
be
opened
only
in
the
biological
safety
cabinet.
• Organisms
which
have
been
experimentally
infected
must
remain
in
the
laboratory
or
appropriate
animal
containment
facility.
• An
emergency
plan
for
handling
spills
of
infectious
materials
must
be
provided
as
part
of
the
principle
investigators
application
for
a
University
of
Windsor
Biological
Safety
Certificate
(UWinBSC)
and
be
ready
for
use
whenever
needed.
Laboratory
workers
must
be
educated
about
the
emergency
plans.
A
record
must
be
made
of
other
people
entering
the
facility
during
an
emergency.
• Vacuum
lines
used
for
work
involving
the
agent
must
be
protected
from
contamination
by
HEPA
filters
or
equivalent
equipment.
37
|
P a g e •
Laboratory
coats
should
be
worn
only
in
the
laboratory
area.
Either
front‐button
coats
or
wrap
around
gowns
are
acceptable.
These
coats
shall
not
be
worn
outside
the
containment
laboratory.
•
Special
care
should
be
taken
to
avoid
contamination
of
the
skin
with
infectious
materials.
Gloves
must
be
worn
when
handling
infected
organisms
or
when
hands
may
be
exposed
to
biological
agents.
•
Contaminated
glassware
must
not
leave
the
facility.
Decontamination
must
be
carried
out
using
procedures
demonstrated
to
be
effective.
If
there
is
no
autoclave
or
incinerator
in
the
laboratory,
contaminated
materials
must
be
disinfected
chemically
or
be
double
bagged
and
transported
to
the
autoclave
or
incinerator
in
durable,
leakproof
containers
which
are
closed
and
wiped
on
the
outside
with
disinfectant
before
leaving
the
laboratory.
Periodic
intensive
cleaning
must
be
done
at
regular
intervals.
Cleaning
and
maintenance
staff
should
receive
appropriate
immunization
and
medical
surveillance.
•
38
|
P a g e 4 EMERGENCY
PROCEDURES
4.1 Biological
Spill
Response
Spills,
accidents
or
exposures
to
infectious
materials
and
losses
of
containment
must
be
reported
immediately
to
the
laboratory
supervisor;
written
records
of
such
incidents
must
be
maintained,
and
the
results
of
incident
investigations
should
be
used
for
continuing
education.
Emergency
plans
and
procedures
to
be
readily
available
and
to
include
appropriate
equipment
and
training
for
emergency
response
to
spills
or
accidental
release
of
organisms
(i.e.,
personal
protective
equipment,
disinfectants);
training
to
be
documented.
Laboratory
bench
tops
and
surfaces
are
to
be
decontaminated
after
any
spill
of
potentially
infectious
materials
and
at
the
end
of
the
working
day.
If
there
is
a
spill
during
use,
surface
decontaminate
all
objects
in
the
cabinet;
disinfect
the
working
area
of
the
cabinet
while
it
is
still
in
operation
(do
not
turn
the
cabinet
off).
Decontamination
of
the
laboratory
space,
its
furniture
and
its
equipment
requires
a
combination
of
liquid
and
gaseous
disinfectants.
Surfaces
can
be
decontaminated
using
a
solution
of
sodium
hypochlorite
(NaOCl);
a
solution
containing
1
g/l
available
chlorine
may
be
suitable
for
general
environmental
sanitation,
but
stronger
solutions
(5
g/l)
are
recommended
when
dealing
with
high‐risk
situations.
For
environmental
decontamination,
formulated
solutions
containing
3%
hydrogen
peroxide
(H2O2)
make
suitable
substitutes
for
bleach
solutions.
Whenever
possible,
suitable
gloves
should
be
worn
when
handling
biohazardous
materials.
However,
this
does
not
replace
the
need
for
regular
and
proper
hand‐washing
by
laboratory
personnel.
Hands
must
be
washed
after
handling
biohazardous
materials
and
animals,
and
using
the
toilet,
and
before
leaving
the
laboratory,
and
eating.
In
most
situations,
thorough
washing
of
hands
with
ordinary
soap
and
water
is
sufficient
to
decontaminate
them,
but
the
use
of
germicidal
soaps
is
recommended
in
high‐risk
situations.
Hands
should
be
thoroughly
lathered
with
soap,
using
friction,
for
at
least
10
minutes,
rinsed
in
clean
water
and
dried
using
a
clean
paper
or
cloth
towel
(if
available,
warm‐air
hand‐dryers
are
also
recommended).
39
|
P a g e 4.1.1
Classification
of
Spills
A
MINOR
BIOLOGICAL
SPILL
is
one
that
can
be
handled
safely
by
laboratory
personnel
without
the
assistance
of
safety
and
emergency
personnel.
Minor
spills
include:
• The
release
of
BSL‐1
organisms
without
splashing
or
agitation
• The
release
of
a
small
volume
of
BLS‐1
organisms
without
splashing
or
agitation
A
MAJOR
BIOLOGICAL
SPILL
is
one
that
requires
outside
assistance.
These
include:
• Any
spill
involving
a
biological
agent
that
an
individual
does
not
feel
confident
in
their
ability
to
effectively
mitigate
the
spill
• The
release
of
any
organisms
resulting
in
excessive
splashing
and
agitation
• The
release
of
any
BSL‐2
organisms
• The
release
of
a
large
volume
of
BSL‐1
organisms
(there
is
enough
present
to
seek
its
own
level
or
in
other
words,
to
run
to
a
low
point)
4.1.2
Biohazardous
Spill
Procedure
–
Minor
Biological
Spill
This
procedure
is
applicable
to
spills
on
a
nonporous
surface
such
as
a
tile
floor
or
concrete
floor.
1. Notify
others
in
the
area
immediately,
to
limit
potential
of
further
contamination
to
additional
personnel
or
the
environment.
2. Assess
the
situation
and
determine
classification
of
the
spill:
A
MINOR
BIOLOGICAL
SPILL
is
one
that
can
be
handled
safely
by
laboratory
personnel
without
the
assistance
of
safety
and
emergency
personnel.
Minor
spills
include:
• The
release
of
BSL‐1
organisms
without
splashing
or
agitation
• The
release
of
a
small
volume
of
BLS‐1
organisms
without
splashing
or
agitation
A
MAJOR
BIOLOGICAL
SPILL
is
one
that
requires
outside
assistance.
These
include:
• Any
spill
involving
a
biological
agent
that
an
individual
does
not
feel
confident
in
their
ability
to
effectively
mitigate
the
spill
• The
release
of
any
organisms
resulting
in
excessive
splashing
and
agitation
• The
release
of
any
BSL‐2
organisms
• The
release
of
a
large
volume
of
BSL‐1
organisms
(there
is
enough
present
to
seek
its
own
level
or
in
other
words,
to
run
to
a
low
point)
3. For
a
minor
spill,
proceed
to
Step
4.
For
major
biological
spills,
immediately
evacuate
area,
secure
area,
and
call
for
assistance
(see
Major
Spill
Response).
40
|
P a g e 4. Remove
any
contaminated
clothing
and
lab
coats.
Wash
exposed
skin
with
antiseptic
soap
and
water.
Get
your
biohazard
spill
kit
and
review
spill
procedure
before
proceeding
with
cleanup.
5. Remove
spill
supplies
from
kit
and
line
bucket/container
with
a
biohazard
bag.
(Retrieve
a
sharps
container
for
disposal
of
sharps
if
necessary.)
6. At
a
minimum,
wear
two
pairs
of
gloves
and
splash
goggles.
7. If
applicable,
using
mechanical
means
(i.e.
dustpan/broom,
tongs),
pick
up
any
contaminated
sharp
items
(needles,
broken
glass,
etc.)
and
place
them
in
an
approved
sharps
container
for
disposal.
8. Cover
the
spill
with
an
absorbent
material
and
carefully
apply
decontamination
solution
pour
around
the
spill
allowing
it
to
mix
with
the
material
(i.e.
10%
Bleach
‐
sodium
hypochlorite
solution
containing
5000‐6000
parts
per
million,
ppm).
If
using
a
proprietary
disinfectant
product,
follow
the
manufacturer’s
instructions
for
proper
use
concentration
and
contact
time.
Make
sure
the
disinfectant
is
not
beyond
the
expiration
date.
9. Allow
a
contact
time
of
20
minutes
10. Remove
the
absorbent
material
by
using
a
mechanical
means
(i.e.
dustpan
and
broom,
plastic
scrapers)
and
deposit
it
along
with
the
mechanical
tool
into
a
biohazard
bag.
11. Remove
residual
disinfectant
with
fresh
paper
towels.
Dispose
of
the
towels
in
the
biohazard
bag.
12. Repeat
steps
8
and
9
for
sufficient
disinfection
of
contaminated
surfaces,
if
necessary.
13. Clean
the
surface
with
an
EPA‐registered
disinfectant
and
allow
to
air
dry.
If
bleach
is
used,
wipe
up
bleach
residue
with
water.
14. Remove
outer
pair
of
gloves
only
and
dispose
of
them
in
the
biohazard
bag.
15. Remove
splash
goggles
with
inner
gloves
still
on,
and
clean
the
goggles
by
autoclaving.
16. Remove
inner
pair
of
gloves
and
place
them
in
the
biohazard
bag
for
disposal.
17. Close
the
bag
and
dispose
of
as
biohazardous
waste.
(Please
refer
to
“Safe
Operations
of
Autoclaves
in
the
Treatment
of
Biomedical
Waste”
manual)
18. Wash
your
hands
with
soap
&
water
and/or
by
using
hand‐sanitization
solution
as
soon
as
possible.
41
|
P a g e 19. Return
spill
kit
to
designated
location.
Ensure
that
the
spill
kit
is
restocked
for
next
use.
20. Notify
immediate
supervisor,
if
you
have
not
already
done
so.
Complete
an
Incident
/
Accident
form
to
ensure
that
the
incident
is
reported
and
medically
managed
in
accordance
with
reporting
requirements
4.1.3
Biohazardous
Spill
Procedure
–
Major
Biological
Spill
This
procedure
is
applicable
to
spills
on
a
nonporous
surface
such
as
a
tile
floor
or
concrete
floor.
1. Notify
others
in
the
area
immediately,
to
limit
potential
of
further
contamination
to
additional
personnel
or
the
environment.
2. Assess
the
situation
and
determine
classification
of
the
spill:
A
MINOR
BIOLOGICAL
SPILL
is
one
that
can
be
handled
safely
by
laboratory
personnel
without
the
assistance
of
safety
and
emergency
personnel.
Minor
spills
include:
o The
release
of
organisms
without
splashing
or
agitation
o The
release
of
a
small
volume
of
organisms
without
splashing
or
agitation
(i.e.
few
milliliters)
o Type
of
equipment
which
is
being
utilized
(i.e.
sonication,
vortex,
etc.)
o Contaminated
area
A
MAJOR
BIOLOGICAL
SPILL
is
one
that
requires
outside
assistance.
These
include:
o The
release
of
organisms
resulting
in
excessive
splashing
and
agitation
o The
release
of
a
large
volume
of
biological
materials
(500ML)
o Type
of
Agent
(i.e.
risk
group
2,
2+,
or
above)
3. For
major
biological
spills,
immediately
evacuate
area,
secure
area,
and
contact
Campus
Community
Police
(dial
911)
for
assistance.
4.1.4
Biohazardous
Spill
Procedure
–
On
Body
1. Immediately
remove
contaminated
clothing.
All
contaminated
materials
must
be
treated
of
as
biohazardous.
(Please
refer
to
“Safe
Operations
of
autoclaves
in
the
Treatment
of
Biomedical
Waste”
manual)
2. Vigorously
wash
exposed
area
with
soap
&
water
for
at
least
10
minutes.
Alternative,
an
approved
hand‐sanitizer
which
contains
65%
isopropanol
can
be
used.
42
|
P a g e 3. If
eye
exposure
occurs,
use
eye
wash
per
instructions
(at
least
15
minutes).
4. Obtain
medical
attention
by
contacting
Campus
Community
Police
(dial
911),
if
necessary.
4.1.5 Biohazardous
Spill
Procedure
–
Inside
a
Biological
Safety
Cabinet
1. Allow
BSC
to
operate
unattended
for
five
(5)
minutes
to
facilitate
aerosol
purification.
2. Call
for
assistance
if
needed.
It
is
useful
to
have
a
second
person
with
“clean”
hands
get
all
the
materials
for
clean
up.
3. While
wearing
PPE
(gown,
safety
glasses
and
gloves)
cover
the
spill
with
an
absorbent
material
and
carefully
apply
decontamination
solution
pour
around
the
spill
allowing
it
to
mix
with
the
material
(i.e.
10%
Bleach
‐
sodium
hypochlorite
solution
containing
5000‐6000
parts
per
million,
ppm).
If
using
a
proprietary
disinfectant
product,
follow
the
manufacturer’s
instructions
for
proper
use
concentration
and
contact
time.
Make
sure
the
disinfectant
is
not
beyond
the
expiration
date.
Do
not
place
your
head
inside
the
cabinet
to
clean
the
spill.
Keep
your
face
behind
the
front
view
screen.
If
necessary,
flood
the
work
surface,
as
well
as
the
drain
pans
and
catch
basins
below
the
work
surface,
with
disinfectant.
4. Spray
or
wipe
cabinet
walls,
work
surfaces,
and
inside
the
front
view
sash
with
disinfectant.
Assume
everything
in
the
cabinet
is
contaminated.
a. Lift
exhaust
grill
and
tray
and
wipe
all
surfaces.
b. Discard
contaminated
disposable
materials
using
appropriate
biohazardous
waste
disposal
procedures.
(Please
refer
to
“Safe
Operations
of
Autoclaves
in
the
Treatment
of
Biomedical
Waste”
manual)
c. Wipe
down
contaminated
reusable
items
with
disinfectant
then
place
in
biohazard
bags
or
autoclave
pans
with
lids
for
autoclaving.
d. Those
items
that
are
non‐autoclavable
should
be
wiped
down
with
disinfectant
and
kept
wet
for
a
minimum
of
20
minutes
before
removal
from
BSC.
5. After
20
minutes
of
contact
time,
soak
up
the
disinfectant
and
discard
the
absorbent
materials
into
a
biohazard
bag
and
handle
as
regulated
medical
waste.
6. Remove
outer
pair
of
gloves
only
and
dispose
of
them
in
the
biohazard
bag.
43
|
P a g e 7. Remove
splash
goggles
with
inner
gloves
still
on,
and
clean
the
goggles
by
autoclaving.
8. Remove
inner
pair
of
gloves
and
place
them
in
the
biohazard
bag
for
disposal.
9. Close
the
bag
and
dispose
of
as
biohazardous
waste.
(Please
refer
to
“Safe
Operations
of
Autoclaves
in
the
Treatment
of
Biomedical
Waste”
manual)
10. Wash
your
hands
with
soap
&
water
and/or
by
using
hand‐sanitization
solution
as
soon
as
possible.
11. Allow
the
cabinet
to
run
for
15
minutes
after
cleaning
and
before
shut
off
or
re‐use.
12. If
you
have
not
already
done
so,
notify
your
immediate
supervisor
of
the
spill.
The
supervisor
should
be
notified
if
the
spill
overflows
into
the
interior
of
the
cabinet.
It
may
be
necessary
to
perform
a
more
extensive
decontamination
of
the
cabinet.
4.1.6
1.
2.
Biohazardous
Spill
Procedure
–
within
a
Centrifuge
Shut
down
the
centrifuge
Wait
five
(5)
minutes
before
opening
the
centrifuge
following
the
end
of
a
run
with
potentially
hazardous
biological
material.
This
will
allow
any
aerosols
to
settle
prior
to
opening
secondary
containment.
3.
If
a
tube
breaks
within
a
centrifuge
bucket
and
the
containment
has
not
been
breached,
open
the
centrifuge
bucket
in
a
Biological
Safety
Cabinet
and
proceed
to
decontaminate
the
spill
per
the
Minor
Spill
protocol.
If
there
is
no
containment
of
the
spill
or
the
containment
has
been
breached:
1. If
centrifuge
contamination
is
identified
after
the
safety
bucket
lid
is
opened,
carefully
close
the
centrifuge
lid
and
allow
aerosols
to
settle
for
at
least
30
minutes.
2. Remove
any
contaminated
protective
clothing
and
place
it
in
a
biohazard
bag.
Wash
hands
and
any
exposed
skin
surfaces
with
soap
and
water.
3. Evacuate
the
laboratory
for
at
least
30
minutes.
Post
a
warning
sign
on
the
laboratory
door.
Notify
your
supervisor.
44
|
P a g e 4. After
thirty
(30)
minutes,
enter
the
laboratory
with
personal
protective
equipment
and
spill
clean‐up
materials.
Fullf‐ace
protection,
a
lab
coat
and
utility
gloves
should
be
worn.
A
respirator
may
also
be
recommended
to
be
worn.
5. Transfer
rotors
and
buckets
into
a
biological
safety
cabinet.
Immerse
within
70%
ethanol
or
a
non‐corrosive
appropriate
disinfectant
effective
against
the
agent
in
use.
A
one‐hour
contact
time
is
recommended.
Uncapped
or
unbroken
tubes
may
be
wiped
down
with
disinfectant
after
the
soak
and
placed
in
a
new
container.
Handle
broken
glass
with
forceps
and
place
in
biohazardous
sharps
container.
6. Carefully
retrieve
any
broken
glass
from
inside
the
centrifuge
with
forceps
and
place
in
a
sharps
container.
Smaller
pieces
of
glass
may
be
collected
with
cotton
or
paper
towels
held
between
the
forceps.
Place
all
broken
glass
within
biohazardous
sharps
container.
7. Carefully
wipe
the
inside
of
the
centrifuge
with
papers
towels
soaked
in
an
appropriate
disinfectant.
Spray
the
inside
of
the
centrifuge
with
an
appropriate
disinfectant
and
allow
to
air
dry.
Avoid
the
use
of
sodium
hypochlorite
if
at
all
possible
because
of
the
corrosive
nature
of
sodium
hypochlorite
solutions.
If
sodium
hypochlorite
solutions
are
used,
rinse
thoroughly
with
copious
amounts
of
water.
8. Remove
outer
pair
of
gloves
only
and
dispose
of
them
in
the
biohazard
bag.
9. Remove
splash
goggles
with
inner
gloves
still
on,
and
clean
the
goggles
by
autoclaving.
10. Remove
inner
pair
of
gloves
and
place
them
in
the
biohazard
bag
for
disposal.
11. Close
the
bag
and
dispose
of
along
with
the
biohazardous
sharps
container
(if
used)
as
biohazardous
waste.
(Please
refer
to
“Safe
Operations
of
Autoclaves
in
the
Treatment
of
Biomedical
Waste”
manual)
12. Wash
your
hands
with
soap
&
water
and/or
by
using
hand‐sanitization
solution
as
soon
as
possible.
4.1.7 Biohazardous
Spill
Procedure
–
during
Transportation
This
procedure
is
applicable
to
spills
on
a
nonporous
surface
such
as
a
tile
floor
or
concrete
floor.
1. Notify
others
in
the
area
immediately,
to
limit
potential
of
further
contamination
to
additional
personnel
or
the
environment.
2. Assess
the
situation
and
determine
classification
of
the
spill:
45
|
P a g e A
MINOR
BIOLOGICAL
SPILL
is
one
that
can
be
handled
safely
by
laboratory
personnel
without
the
assistance
of
safety
and
emergency
personnel.
Minor
spills
include:
• The
release
of
BSL‐1
organisms
without
splashing
or
agitation
• The
release
of
a
small
volume
of
BLS‐1
organisms
without
splashing
or
agitation
A
MAJOR
BIOLOGICAL
SPILL
is
one
that
requires
outside
assistance.
These
include:
• Any
spill
involving
a
biological
agent
that
an
individual
does
not
feel
confident
in
their
ability
to
effectively
mitigate
the
spill
• The
release
of
any
organisms
resulting
in
excessive
splashing
and
agitation
• The
release
of
any
BSL‐2
organisms
• The
release
of
a
large
volume
of
BSL‐1
organisms
(there
is
enough
present
to
seek
its
own
level
or
in
other
words,
to
run
to
a
low
point)
3. If
minor,
follow
clean‐up
steps
outlined
within
the
Minor
Spill
Response
Section.
For
major
biological
spills,
immediately
evacuate
area,
secure
area,
and
contact
Campus
Community
Police
(dial
911)
for
assistance.
4.1.8
Biohazardous
Spill
Procedure
–
Involving
Prions
Prions,
also
referred
to
as
“unconventional”
infectious
agents
or
“agents
of
transmissible
spongiform
encephalopathies”,
are
believed
to
contain
protein
only.
As
mentioned
previously,
they
can
cause
Creutzfeldt‐Jakob
disease
in
humans,
scrapie
in
sheep,
bovine
spongiform
encephalopathy
in
cattle,
etc.
These
infectious
agents
are
unusually
resistant
to
inactivation
by
most
physical
and
chemical
agents
and
materials
suspected
of
containing
them
require
special
processing
before
reuse
or
disposal.
To
date,
available
data
indicate
that
prions
can
be
inactivated
by
a
solution
of
2
mol/l
sodium
hydroxide
(NaOH)
containing
4.0
mol/l
guanidinium
hydrochloride
(HNC(NH2)2.HCl)
or
guanidinium
isocyanate
(HNC(NH2)2.HNCO)
and
sodium
hypochlorite
(NaOCl)
(>
2%
available
chlorine)
followed
by
steam
autoclaving
at
132
°C
for
4.5
h.
Incineration
is
also
an
effective
means
of
dealing
with
prion‐contaminated
materials
4.1.9
Disposal
of
Spill
Materials
The
disposal
of
laboratory
and
medical
waste
is
subject
to
various
regional,
national
and
international
regulations
and
the
latest
versions
of
such
relevant
documents
must
be
consulted
before
designing
and
implementing
a
programme
for
handling,
transportation
and
disposal
of
biohazardous
waste.
In
general,
ash
from
incinerators
may
be
handled
as
normal
domestic
waste
and
removed
by
local
authorities.
46
|
P a g e Autoclaved
waste
may
be
disposed
of
by
off‐site
incineration
or
in
licensed
landfill
sites
4.1.10 Biological
Spill
Reporting
MINOR
BIOLOGICAL
SPILLS:
Spills
and
accidents
that
result
in
exposures
to
organisms
to
be
immediately
reported
to
your
supervisor
with
an
incident
report
forwarded
to
the
University
of
Windsor’s
Biological
Safety
Officer
(ext.
3523).
Written
records
to
be
maintained
(see
Pathogen
Accountablity).
Medical
attention
and
surveillance
will
be
provided
as
appropriate.
MAJOR
BIOLOGICAL
SPILLS:
Emergency
procedures
for
spill
clean‐up,
BSC
failure,
fire,
animal
escape
and
other
emergencies
must
be
written,
easily
accessible
and
followed.
A
record
must
be
made
of
other
people
entering
the
facility
during
an
emergency.
The
University’s
Biological
Safety
Officer
(ext.
3523)
must
be
immediately
notified.
Medical
attention
and
surveillance
will
be
provided
as
appropriate.
Biological
Spill
Kit
The
kit
should
be
maintained
in
a
white
6‐gallon
leak‐proof
bucket
and
contain
the
following:
• Concentrated
household
bleach
–
check
expiration
date
• Spray
bottle
for
making
10%
bleach
solution
• Forceps
or
tongs
for
handling
sharps
• Paper
towels
or
other
suitable
absorbent
• Biohazard
bags
of
various
sizes
• Disposable
gloves
• Disposable
foot
covers
• Face
protection
–
at
a
minimum
safety
glasses
and
mask
• Spill
sign
to
post
on
door
Biohazardous
Spill
Kits
are
available
at
the
Chemical
Control
Centre.
4.2 Emergency
Medical
Procedures
In
life‐threatening
situations
requiring
immediate
medical
attention,
telephone
the
University
of
Windsor’s
Campus
Community
Police
(Dial
911)
and
they
will
contact
the
appropriate
authorities
and
co‐
ordinate
the
response.
47
|
P a g e 4.2.1
Medical
Surveillance
&
Immunioprophylaxis
Laboratory
personnel
should
be
protected
against
laboratory‐acquired
infections
by
appropriate
immunization
with
relevant,
licensed
vaccines
unless
documented
to
have
pre‐existing
immunity.
Hepatitis
B
immunization
is
strongly
recommended
for
all
persons
who
handle
or
are
exposed
to
human
blood,
body
fluids,
organs
or
tissues.
Immunoprophylaxis
and
information
pertaining
to
the
availability
and
the
advisability
of
immunizing
agents
are
available
through
the
following:
Windsor
Essex
Health
Unit
–
Immunization
Unit,
1005
Ouellette
Avenue,
Windsor,
Ontario
N9A
4J8
(519)
258‐2416
ext.
1222.
Immunizing
agents
are
available
to
protect
laboratory
workers
against:
Anthrax
Botulism
Cholera
Diphtheria
Hemophilus
influenzae
type
b
Hepatitis
A
Hepatitis
B
Influenza
A
Japanese
encephalitis
Lyme
disease
Measles
Meningococcus
Mumps
Pertussis
Plague
Pneumococcus
Polio
Rabies
Rubella
Tetanus
Tuberculosis
(BCG)
Typhoid
Vaccinia
Varicella
Yellow
fever
4.2.2 Animal
Bites
and
Scratches
The
following
emergency
response
procedures
shall
be
followed
when
a
worker
has
been
exposed
to
zoonotic
agents
via
animal
bite
or
scratch,
via
mucous
membrane
contact,
or
via
non‐intact
skin
contact.
Laboratory
Worker,
Student,
and
Visitors
The
exposed
site
must
be
washed
immediately.
A. Wash
with
soap
and
water
after
allowing
the
wound
to
bleed
freely.
B. If
mucous
(eyes,
nose,
mouth)
membrane
or
non‐intact
(cuts,
rash,
eczema
or
dermatitis)
skin
contact,
flush
with
water
at
the
nearest
faucet
or
eye
wash
station.
The
individual
must
immediately
inform
the
supervisor
/
principal
investigator
of
the
exposure
incident.
The
individual
must
seek
prompt
medical
attention
at
the
nearest
hospital
emergency
department
or
emergency
clinic,
a
medical
practitioner
of
their
choosing.
The
individual
must
provide
information
for
a
University
of
Windsor
Accident/Incident
(obtained
from
her
/
his
supervisor
/
principal
investigator),
48
|
P a g e describing
the
incident
in
detail,
including
the
route
of
exposure
and
the
emergency
actions
taken,
and
a
description
of
the
individual’s
duties
as
they
relate
to
the
exposure
incident.
4.2.3 Exposure
to
Human
Blood
and
Body
Fluids
The
following
emergency
response
procedures
shall
be
followed
when
a
worker
has
been
exposed
to
blood
or
body
fluids
via
a
needlestick,
cut
or
puncture
wound,
via
mucous
membrane
contact,
or
via
non‐intact
skin
contact.
Laboratory
Worker,
Student,
Visitors
The
exposed
site
must
be
washed
immediately.
A. Wash
with
soap
and
water
after
allowing
the
wound
to
bleed
freely.
B. If
mucous
(eyes,
nose,
mouth)
membrane
or
non‐intact
(cuts,
rash,
eczema
or
dermatitis)
skin
contact,
flush
with
water
at
the
nearest
faucet
or
eye
wash
station.
The
laboratory
worker,
student,
or
visitor
must
immediately
inform
the
supervisor
/
principal
investigator
of
the
exposure
incident.
4.2.4 Exposure
to
Infectious
and
Communicable
Disease
Agents
The
following
emergency
response
procedures
shall
be
followed
when
a
worker
has
been
exposed
to
infectious
or
communicable
disease
agents
via
inhalation,
a
needlestick,
cut
or
puncture
wound,
via
ingestion
or
mucous
membrane
contact,
or
via
non‐intact
skin
contact.
Laboratory
Worker,
Student,
Visitors
The
exposed
site
must
be
washed
immediately.
A. Wash
with
soap
and
water
after
allowing
the
wound
to
bleed
freely.
B. If
mucous
(eyes,
nose,
mouth)
membrane
or
non‐intact
(cuts,
rash,
eczema
or
dermatitis)
skin
contact,
flush
with
water
at
the
nearest
faucet
or
eye
wash
station.
The
laboratory
worker,
student,
or
visitor
must
immediately
inform
the
supervisor
/
principal
investigator
of
the
exposure
incident.
4.2.5
Important
Medical
Emergency
Numbers
&
Contacts
Emergency
Number
(Fire,
Police,
Ambulance)
Hospitals:
Hotel‐Dieu
Grace
Hospital
49
|
P a g e 911
(519)
973‐4444
Windsor
Regional
Hospital
(Metropolitan
Campus)
Windsor
Regional
Hospital
(Western
Campus)
Poison
Control
Centre
(519)
254‐1661
(519)
257‐5100
(800)
268‐9017
UNIVERSITY
CAMPUS
EMERGENCY
NUMBERS
Campus
Community
Police
(Emergency)
Campus
Community
Police
(Non‐Emergency)
Chemical
Control
Centre
(24hrs/day)
Office
of
Occupational
Health
and
Safety
University
Medical
Office
Located:
(2nd
Floor,
CAW
Student
Centre)
Monday‐Thursday
9:00
a.m.
‐
5:00
p.m.
Friday
9:00
a.m.
‐12:00
p.m.
&
1:00
p.m.
‐
5:00
p.m.
ext.
911
ext.
1234
ext.
3523
ext.
2055
ext.
7002
4.3 Medical
Incident
Reporting
Requirements
4.3.1
Individual:
The
laboratory
worker,
student,
or
visitor
must
seek
prompt
medical
attention
at
the
nearest
hospital
emergency
department
or
emergency
clinic,
a
medical
practitioner
of
their
choosing.
The
laboratory
worker,
student,
or
visitor
must
provide
information
for
a
University
of
Windsor
Accident/Incident
(obtained
from
her
/
his
supervisor
/
principal
investigator),
describing
the
incident
in
detail,
including
the
route
of
exposure
and
the
emergency
actions
taken,
and
a
description
of
the
individual’s
duties
as
they
relate
to
the
exposure
incident.
4.3.2
Supervisor/Principle
Investigators:
1. The
supervisor
must
refer
the
affected
individual(s)
to
the
nearest
hospital
emergency
department
or
medical
practitioner
of
their
choosing.
2. Supervisors
and/or
Principle
Investigators
must
complete
and
sign
the
University
of
Windsor’s
Accident
/
Incident
report
(www.uwindsor.ca/safety)
under
“Report
an
Accident”.
3. The
supervisor
must
ensure
that
the
exposure
incidents
are
reported
within
24‐hours
to
both
the
Chemical
Control
Centre
(519.973.7013
‐
fax)
and
the
Office
of
Occupational
Health
and
Safety
(519.971.3671
–
fax).
50
|
P a g e 4.3.3
Chemical
Control
Centre
–
Laboratory
Safety,
Compliance,
and
Assurance:
The
Chemical
Control
Centre’s
Laboratory
Safety,
Compliance
and
Assurance
division
shall
be
forwarded
a
copy
of
the
Accident
/
Incident
Investigation
Report
by
Occupational
Health
and
Safety.
If
the
individual
refuses
appropriate
post‐exposure
prophylaxis
and
/
or
testing,
this
shall
be
documented
in
the
medical
record
by
the
Occupational
Health
and
Safety
and
countersigned
by
the
individual,
or
a
refusal
document
should
be
signed
and
forwarded
to
Occupational
Health
and
Safety.
Counselling
regarding
potential
exposure
and
infection,
immunoprophylaxis
and
follow‐up
testing
shall
be
offered
to
anyone
if
her
/
his
exposure
is
determined
to
be
of
a
nature
that
may
transmit
zoonotic
agents.
4.3.4
Office
of
Occupational
Health
&
Safety
The
Office
of
Occupational
Health
&
Safety
shall
confer
with
the
affected
individual(s)
and
/
or
attending
physician(s)
/
caregiver(s)
to
determine
whether
the
exposure
is
of
a
nature
that
may
transmit
the
biological
agent
HBV,
HIV
or
any
other
bloodborne
pathogens.
Counselling
regarding
potential
HBV,
HIV
or
other
bloodborne
pathogen
exposure
and
infection,
chemo
/
immunoprophylaxis
and
follow‐up
testing
shall
be
offered
to
any
individual
if
her
/
his
exposure
is
determined
to
be
of
a
nature
that
may
transmit
HBV,
HIV
or
other
bloodborne
pathogens.
A
hepatitis
B
vaccine
or
other
appropriate
post‐exposure
prophylaxis
shall
be
offered
if
the
individual
has
not
been
immunized
previously
or
does
not
demonstrate
adequate
antibodies.
If
the
individual
refuses
appropriate
post‐exposure
prophylaxis
and
/
or
testing,
this
shall
be
documented
in
the
medical
record
by
the
Office
of
Occupational
Health
&
Safety
and
countersigned
by
the
employee,
or
a
refusal
document
should
be
signed
retained.
The
Office
of
Occupational
Health
&
Safety
will
act
as
the
point
of
contact
for
all
employee
related
WSIB
claims.
In
addition,
they
will
prepare
or
have
prepared
prescribed
reports
concerning
occupational
exposures,
occupational
hygiene,
and/or
occupational
health
surveillance
programs
related
to
biological
agents.
These
reports
shall
be
presented
as
prescribed
to
managers,
supervisors,
employees,
and
the
appropriate
Joint
Health
and
Safety
Committee.
51
|
P a g e 5 CLASSIFICATION
OF
BIOLOGICAL
AGENTS
5.1 General
Information
The
standards
and
practices
described
in
this
manual
apply
to
all
laboratory
research
and
teaching
activities
conducted
within
the
University
of
Windsor
and
its
affiliated
institutions
where
such
activities
involve
the
use
of
known
biological
agents
or
cultures,
or
when
an
agent
has
been
recently
isolated
or
is
suspected
to
be
present
in
the
material
handled.
Judgements
of
the
inherent
risks
of
a
pathogen
are
made
on
the
basis
of
a
variety
of
factors,
including:
(1)
severity
of
the
disease
it
causes;
(2)
the
routes
of
infection;
and
(3)
its
virulence
and
infectivity.
This
judgement
should
take
into
account
the
existence
of
effective
therapies,
immunization,
the
presence
or
absence
of
vectors,
quantity
of
agent
and
whether
the
agent
is
indigenous
to
Canada,
as
well
as
possible
effects
on
other
species,
including
plants
and
animals.
Due
to
their
unknown
characteristics,
emerging
pathogens
and
novel
agents
may
require
more
stringent
specialized
practices
and
procedures
for
their
safe
handling.
Biological
agents
are
classified
according
to
Risk
Groups,
which
are
analogous
to
the
Containment
Levels
described
in
Section
1.4.2.
These
classifications
presume
ordinary
circumstances
in
the
laboratory,
or
growth
in
small
volumes
for
experimental,
diagnostic
or
teaching
purposes.
The
classifications
of
biological
agents
reflect
the
judgements
made
on
their
inherent
risks.
Large
volumes
and
high
concentrations
of
a
biological
agent
in
growth
media
may
pose
greater
risks
than
smears
of
the
same
agent
on
a
microscope
slide.
Other
unusual
manipulations
may
also
increase
the
hazard.
5.2 Genetically
Engineered
Organisms
and
Cell
Lines
The
biological
hazards
associated
with
the
use
of
mammalian
or
other
cells
in
culture,
and
an
appropriate
Risk
Group,
will
be
influenced
by
the
following
criteria.
Micro‐organisms
that
are
demonstrated
to
be
nonpathogenic,
containing
no
adventitious
agents
and
having
a
long
history
of
safe
industrial
use
are
not
considered
here.
1. Primary
cultures
of
mammalian
or
other
cells
may
harbour
infectious
agents
or
integrated
DNA
originally
present
in
the
animal
or
human
from
which
the
cultures
were
derived.
Whenever
possible,
the
donor
should
be
tested
for
suspect
pathogens
prior
to
the
preparation
of
the
culture,
and
the
culture
should
be
considered
to
be
contaminated
until
proven
to
be
free
of
the
suspect
agents.
Such
primary
cultures
should
be
handled
in
a
manner
appropriate
to
the
Risk
52
|
P a g e Group
of
the
suspected
contaminant,
and
precautions
should
be
taken
to
protect
laboratory
personnel.
2. Cell
lines
known
to
contain
infectious
agents
or
integrated
DNA
should
be
handled
in
a
manner
appropriate
to
the
Risk
Group
for
the
agent.
3. Cell
lines
that
are
deemed
to
be
free
of
infectious
agents
rarely
pose
a
biological
hazard.
If
there
is
unintentional
parenteral
inoculation,
normal
immune
response
should
provide
protection,
prevent
progressive
growth,
and
cause
rejection
of
accidentally
transplanted
cells.
For
activities
involving
genetically
engineered
organisms,
•
the
host
organism
should
be
non‐pathogenic,
with
no
adventitious
agents,
a
history
of
safe
use,
and
limited
ability
to
survive
in
the
environment,
•
vectors
with
known
inserts
should
be
well
characterized
and
free
of
sequences
that
result
in
adverse
effects
to
humans,
animals,
plants,
or
the
environment,
and
•
the
genomic
insert
should
be
limited
in
size
to
the
smallest
sequence
required
and
should
not
increase
the
stability
of
the
gene
product
in
the
environment.
Resistance
markers
should
be
transferred
with
caution,
to
prevent
acquisition
of
resistance
that
might
compromise
the
therapeutic
use
of
antimicrobial
agents.
The
resulting
recombinant
organism
should
be
non‐pathogenic
or
alternatively
posses
limited
survival
characteristics
and
be
without
adverse
environmental
consequences.
5.2.1 Recombinant
DNA
and
Genetic
Manipulation
Genetic
methods
such
as
selection,
cross
breeding,
conjugation
and
transformation
have
been
used
for
many
years
to
alter
animals,
plants
and
microorganisms.
These
methods
have
recently
been
supplemented
with
newer
and
much
more
efficient
ones,
of
which
the
best
known
are
the
techniques
of
recombinant
DNA.
Some
newer
techniques
include:
•
the
production
of
transgenic
plants
and
animals,
•
the
cloning
of
microbial
toxin
or
other
virulence
genes
in
an
expression
vector
or
in
a
host
background
in
which
it
may
be
expressed,
and
•
the
production
of
full‐length
infectious
viral
clones,
including
the
reconstruction
of
infectious
virions
from
recombinant
constructs
(reverse
genetic
engineering).
For
the
purposes
of
this
document,
recombinant
DNA
includes:
•
DNA
molecules
produced
outside
living
cells
by
joining
natural
or
synthetic
DNA
segments
to
DNA
molecules
capable
of
replication
in
living
cells,
•
DNA
molecules
produced
in
living
cells
by
joining
enriched
or
natural
segments
to
intracellular
DNA,
and,
53
|
P a g e •
DNA
molecules
resulting
from
replication
of
such
recombinant
molecules.
Guidance
in
assessing
potential
risks
in
recombinant
DNA
research
can
only
be
very
general;
each
case
requires
individual
assessment.
It
is
unrealistic
to
define
all
of
the
genetically
engineered
organisms
which
might
be
created
or
used
in
the
laboratory.
The
vast
majority
of
this
research
involves
only
the
remotest
possibility
of
creating
a
hazard
because
the
source
of
the
DNA
being
transferred,
the
vector
and
the
host
are
all
innocuous
or
have
low
risk
characteristics.
However,
some
genetic
manipulation
does
raise
a
significant
possibility
of
risk.
Factors
to
consider
when
determining
the
containment
level
of
a
recombinant
organism
should
include:
•
containment
level
of
the
recipient
organism
•
containment
level
of
the
donor
organism
•
replication
competency
of
the
recombinant
organism
•
property
of
the
donor
protein
to
become
incorporated
into
the
recombinant
particle
•
potential
pathogenic
factors
associated
with
the
donor
protein
In
general,
containment
levels
for
activities
involving
recombinant
DNA
will
be
assigned
according
to
the
following
criteria
and
considerations:
1. If
none
of
the
components
of
the
genetic
manipulation
(DNA,
vector,
host)
presents
any
known
hazard
and
none
can
be
reasonably
foreseen
in
their
combination,
then
no
restrictions
beyond
the
requirements
of
Containment
Level
1
are
necessary.
2. If
one
of
the
components
used
in
the
procedure
is
hazardous,
then,
in
general,
determination
of
the
containment
level
required
will
begin
at
the
level
appropriate
to
the
known
hazard.
The
level
of
containment
may
be
increased
or
decreased
depending
on
the
particular
gene
transferred,
the
expression
of
the
gene
in
the
recombinant
organism,
the
envisaged
interactions
between
the
transferred
gene
and
the
host‐vector
system,
and
other
relevant
factors.
3. In
any
activity
involving
genes
coding
for
hazardous
products,
host‐vector
systems
with
limited
ability
to
survive
outside
of
the
laboratory
(affording
biological
containment)
should
be
used.
Their
use
may
reduce
the
level
of
physical
containment
required.
4. The
containment
level
may
be
reduced
if
it
is
known
that
the
DNA
or
vector
is
mutant
and
defective
in
their
disease‐causing
or
replication
characteristics.
5. In
the
case
of
animal
virus
vectors,
including
retroviruses,
one
must
consider
the
nature
of
the
helper
cells
and
the
likelihood
that
replication‐competent
viruses
may
be
produced.
Each
case
needs
to
have
a
risk
assessment,
as
it
is
not
realistic
to
try
to
define
in
advance
all
the
possible
genetically
engineered
organisms
that
might
be
created
or
used
in
the
laboratory.
Assistance
with
the
54
|
P a g e risk
assessment
can
be
provided
by
the
Public
Health
Agency
of
Canada’s
Office
of
Laboratory
Security,
telephone
(613)
957‐1779.
The
vast
majority
of
recombinant
research
involves
only
the
remotest
possibility
of
creating
a
hazard,
because
the
source
of
the
DNA
being
transferred,
the
vector
and
the
host
are
all
innocuous.
However,
some
genetic
manipulation
does
raise
significant
possibility
of
risk.
5.2.2 Transgenic
Plants
There
is
considerable
potential
for
commercial
production
of
biological
products
in
transgenic
plants
and
animals.
The
potential
release
of
transgenic
organisms
into
the
environment
and
transmission
of
novel
genes
to
other
plants
and
animals
must
be
considered
when
designing
both
the
production
system
and
facilities
to
contain
the
transgenic
organisms.
In
each
case,
the
risk
level
should
be
determined
in
consultation
with
the
appropriate
Government
agency.
Transgenic
plants
may
transmit
novel
characteristics
to
other
plants,
thereby
modifying
the
gene
pool
of
existing
species.
Since
this
transmission
is
mediated
by
pollen,
transgenic
plants
should
be
made
sterile
or
contained
in
a
growth
chamber
or
greenhouse
designed
to
prevent
pollen
release
via
air
or
insects.
If
plants
are
allowed
to
mature,
care
must
be
taken
to
contain
seeds
in
the
growth
chamber
or
greenhouse.
Transgenic
animals
should
be
handled
according
to
the
Guidelines
of
the
Canadian
Council
for
Animal
Care
and
the
University
of
Windsor’s
Animal
Care
Committee
guidelines
(www.uwindsor.ca/acc).
An
important
consideration
is
the
ability
of
the
animal
to
transmit
genes
by
breeding
with
another
animal
of
the
same
or
a
related
species.
Transgenic
animals
must
be
adequately
contained
to
prevent
the
unintentional
spread
of
genetic
modifications.
It
is
recommended
that
transgenic
animals
be
produced
using
methodology
which
restricts
the
potential
for
transmission
of
genes
to
another
host.
If
viable
micro‐organisms
are
used
as
vehicles
for
transfection,
the
containment
level
for
the
plants
or
animals
inoculated
with
these
viable
recombinant
micro‐organisms
must
be
at
least
as
high
as
that
required
for
work
with
that
specific
micro‐organism.
Transgenic
plants
and
animals
produced
by
microinjection,
by
use
of
replication
defective
vectors,
or
other
sequences
that
are
not
normally
horizontally
transmitted,
generally
may
be
handled
at
Containment
Level
1.
The
following
recommendations
should
be
considered
prior
to
the
initiation
of
transgenic
experiments.
•
Complete
copies
of
the
replication
competent
genome
should
not
be
used.
•
The
constructs
should
not
contain
genes
capable
of
causing
neoplastic
transformation
in
animals.
•
The
probability
of
recombination
with
extraneous
micro‐organisms
should
be
minimal
or
nonexistent.
55
|
P a g e 5.3 Animal
Cells,
Blood
and
Body
Fluids,
and
Fixed
Tissues
The
biological
hazards
of
animal
cells,
tissues,
blood
and
body
fluids
arise
from
the
possibility
that
they
might
contain
or
transmit
infectious
agents.
It
is
prudent
to
consider
all
cell
lines
to
be
potentially
infectious.
Cells
known
or
suspected
to
contain
such
agents,
or
primary
cultures
from
animals
and
humans
known
or
reasonably
suspected
to
be
infected,
should
be
assigned
to
the
risk
group
for
the
suspected
agent.
The
following
should
be
handled
at
Containment
Level
2:
Primate
cell
lines
derived
from
lymphoid
or
tumour
tissue,
all
cell
lines
exposed
to
or
transformed
by
a
primate
oncogenic
virus,
all
samples
of
human
tissues
and
fluids,
all
primate
tissues,
all
cell
lines
new
to
the
laboratory
(until
proven
to
be
free
of
adventitious
agents),
all
virus‐containing
primate
cell
lines,
and
all
mycoplasma‐containing
cell
lines.
These
are
factors
that
influence
the
containment
level
required:
•
•
•
•
•
•
•
particular
source
of
the
material
the
volume
and
concentration
of
the
agent
the
extent
of
culturing
and
incubation
the
types
of
manipulations
to
be
conducted
the
use
of
additional
precautions
Non‐recombinant
cell
lines
•
•
•
•
•
For
every
new
cell
line
that
is
manipulated
in
a
laboratory,
a
detailed
risk
assessment
must
be
done
in
order
to
determine
the
appropriate
level
of
precautions
to
be
taken.
A
detailed
risk
assessment
should
include,
but
is
not
limited,
to
the
following:
•
•
•
•
•
•
•
•
source
of
cell
line:
the
closer
phylogenetically
to
humans,
the
greater
the
potential
risk
(highest
to
lowest
risk:
human
autologous,
human
heterologous,
primate,
other
mammalian,
avian,
invertebrate);
source
tissue:
provides
an
indication
of
possible
contaminants
and
latent
(oncogenic)
viruses;
type
of
cell
line
highest
to
lowest
risk:
primary
cell
cultures,
continuous
cell
cultures,
intensivelycharacterized
cell
cultures;
quantity
of
cells
per
culture;
source
population
of
the
specimen
from
which
the
cell
line
was
derived.
recombinant
cell
lines
(in
addition
to
the
above
criteria)
properties
of
the
host
cell
line
(in
the
case
of
hybridomas,
the
properties
of
each
of
the
contributing
cells
must
be
considered);
56
|
P a g e vector
used
for
transformation
(may
increase
containment
level
requirements);
transfer
of
viral
sequences
(may
increase
containment
level
requirements);
transfer
of
virulence
factors
(may
increase
containment
level
requirements);
activation
of
endogenous
viruses
(may
increase
containment
level
requirements);
recombinant
gene
product
(may
increase
containment
level
requirements);
helper
virus
presence
(may
increase
containment
level
requirements).
Once
all
the
relevant
information
regarding
the
cell
line
has
been
obtained,
including
any
hazards
associated
with
the
media
to
be
used
during
manipulation
of
the
cell
culture,
it
can
be
assessed
to
ascertain
the
hazards
posed
by
manipulating
the
particular
cell
line.
The
cell
line
is
to
be
handled
at
the
containment
level
appropriate
to
the
level
of
risk
determined
by
the
assessment.
•
•
•
•
•
•
5.3.1 Primary
Cell
Cultures
and
Animal
Iissues
The
following
containment
requirements
apply
to
primary
cell
cultures
and
tissues
from
human,
non‐
human
primate
and
non‐primate
animal
sources
when
handled
in
the
laboratory
or
used
for
animal
passage.
Cells
and
tissues
known
or
suspected
to
be
contaminated
or
infected
with
any
of
the
agents
included
in
Appendix
B
–
Risk
Group
Categorization
of
Agents
must
be
handled
at
the
containment
level
appropriate
to
those
agents.
Human
and
non‐human
primate
material:
Containment
Level
2
Non‐primate
animal
material:
Containment
Level
1
5.3.2 Established
Cell
Lines
Human
or
other
animal
cell
lines
known
not
to
be
contaminated
or
infected
with
any
of
the
agents
included
in
Appendix
B
–
Risk
Group
Categorization
of
Agents
(under
level
1)
may
be
handled
at
Containment
Level
1.
Cultures
known
or
suspected
to
be
contaminated
or
infected
with
any
of
the
agents
included
in
Appendix
A
–
Agents
not
indigenous
to
Canada
or
under
Risk
Groups
2
and
above
must
be
handled
at
the
containment
level
appropriate
to
those
agents.
5.3.3 Blood
and
Body
Fluids
The
need
for
precautionary
measures
extends
also
to
situations
in
which
human
blood,
saliva,
urine
and
other
body
fluids
or
faeces
must
be
handled.
The
precautions
required
may
be
more
stringent
when
the
specimens
are
used
for
culturing
purposes,
but
initially,
their
handling
should
be
consistent
with
Containment
Level
2.
Reduction
of
the
containment
level
may
be
acceptable
if
potential
hazards
associated
with
the
material
are
expected
to
be
diminished
because
of
dilution,
use
of
chemical
or
other
treatments
or
additional
protective
measures
and
practices.
Culturing
of
specimens
in
research
laboratory
Blood
or
blood
fractions
and
other
body
fluid
specimens
of
human
or
animal
origin
that
are
known
or
suspected
to
contain
any
of
the
agents
included
in
Appendix
A
–
Agents
not
indigenous
to
Canada
must
57
|
P a g e be
handled
at
the
containment
level
appropriate
to
those
agents
when
these
specimens
are
cultured
in
volumes
greater
than
that
which
is
necessary
for
routine
diagnostic
work.
Routine
clinical
diagnostic
work
in
laboratory
For
routine
clinical
diagnostic
work
with
specimens
of
human
blood,
serum
and
other
body
fluids
(urine,
cerebrospinal
fluid,
etc.)
from
the
general
population,
Containment
Level
1
may
be
acceptable
if
the
activity
does
not
involve
culturing
of
the
specimen
beyond
the
volumes
necessary
to
allow
clinical
analysis.
However,
in
such
cases
the
workers
must
be
made
fully
aware
of
the
potential
hazards
and
should
take
additional
precautions.
Pre‐exposure
immunization
against
Hepatitis
A
and
B
viruses
and
the
use
of
appropriate
face
and
eye
protection
and
gloves
are
recommended.
For
routine
clinical
diagnostic
work
with
specimens
which
are
known
to
be
from
infected
individuals,
the
containment
level
appropriate
to
the
agent
must
be
maintained.
5.3.4 Fixed
Tissues
and
Tissue
Sections
Tissues
and
tissue
sections
from
human
and
animal
sources
are
routinely
fixed
by
treatment
with
chemical
agents
to
preserve
structures
for
later
examination
and
study.
Generally,
these
chemical
treatments
inhibit
all
biological
activity.
Most,
but
not
all,
intracellular
and
intercellular
biological
agents
are
inactivated
during
this
treatment.
A
notable
exception
is
the
group
of
unconventional
agents
known
as
‘prions’.
In
general,
fixed
tissues
and
tissue
specimens
should
be
handled
under
at
least
Containment
Level
1
conditions.
A
higher
level
of
containment
may
be
required
depending
on
the
source
of
the
material,
the
nature
of
the
agent
and
whether
or
not
it
is
inactivated.
Where
a
biological
agent
which
usually
requires
a
higher
level
of
containment
is
present
in
the
tissue,
the
laboratory
director
/
principal
investigator
should
provide
documentation
to
the
University
of
Windsor’s
Biosafety
Committee
to
support
a
request
for
a
lower
level
of
containment.
5.4 Cell
Line
Contamination
with
Infectious
Agents
Bacteria
and
fungi
Cell
lines
contaminated
with
bacteria
and
fungi
are
readily
identified
when
grown
in
antibiotic‐free
media
because
they
quickly
overgrow
the
cells.
Viral
contamination
Unlike
bacteria
and
fungi,
viruses
are
not
readily
identified
and
so
can
pose
a
significant
hazard
to
those
manipulating
primary
cell
lines.
Because
of
the
varying
risks
associated
with
cell
line
material,
the
World
Health
Organization
proposed
a
classification
of
cell
lines
based
on
each
line’s
likelihood
of
carrying
viruses
pathogenic
to
humans.
Low
likelihood:
58
|
P a g e cell
lines
derived
from
avian
and
invertebrate
tissues.
Medium
likelihood:
mammalian
nonhematogenous
cells,
such
as
fibroblasts
and
epithelial
cells.
High
likelihood:
blood
and
bone
marrow
cells
derived
from
human
or
non‐human
primates;
human
pituitary
cells,
caprine
and
ovine
cells,
especially
those
of
neural
origin;and
hybridoma
cells
when
at
least
one
fusion
partner
is
of
human
or
non‐human
primate
origin.
Both
viral
and
cellular
oncogenes
have
been
recognized,
most
notably
the
human
T‐cell
leukemia
virus
(HTLV‐I).
HTLV‐I
is
a
human
oncogenic
virus
that
transforms
normal
cells
into
malignant
cells.
Cell
lines
with
known
or
potential
viral
contaminants
are
to
be
handled
at
the
containment
level
appropriate
for
the
contaminating
agent
of
the
highest
risk.
One
of
the
primary
hazards
of
manipulating
cell
cultures
is
the
expression
of
latent
viruses.
Endogenous
viral
sequences
have
been
found
in
a
variety
of
cell
lines
derived
from
mammalian
species,
including
humans.
Cell
lines
can
be
grown
in
an
altered
manner
by
applying
various
treatments
(e.g.,
change
in
pH,
serum
level,
temperature,
medium
supplements,
cocultivation).
These
treatments
may
cause
altered
expression
of
oncogenes,
expression
of
latent
viruses,
interactions
between
recombinant
genomic
segments
or
altered
expression
of
cell
surface
proteins.
Manipulations
that
may
alter
the
"normal"
behaviour
of
cell
lines
to
a
more
hazardous
state
are
to
be
conducted
at
a
containment
level
appropriate
to
the
new
hazardous
state.
The
biological
hazards
associated
with
primate
cell
lines
must
also
be
taken
into
consideration
when
determining
the
level
of
containment
required.
Primary
cell
lines
derived
from
the
genus
Macaca
may
harbour
herpesvirus
simiae
(Cercopithecine
herpes
virus,
B‐virus),
and
therefore
tissues
from
Macaca
must
be
manipulated
as
follows:
Containment
level
2
is
to
be
used
when
handling
tissues
or
body
fluids
from
macaques.
If
material
is
suspected
or
known
to
contain
herpesvirus
simiae,
containment
level
3
is
required.
In
vitro
primary
diagnostic
tests
are
to
be
done
at
containment
level
3.
No
culturing
/
propagation
(culturing)
of
the
virus
is
allowed
to
be
completed
at
the
University
of
Windsor.
Prions
The
protein‐only
infectious
particle,
or
prion,
is
accepted
as
the
causative
agent
of
transmissible
spongiform
encephalopathies,
such
as
bovine
spongiform
encephalopathy
(BSE).
Cell
cultures
derived
from
bovine
sources
known
or
suspected
to
be
BSE
positive,
and
in
vitro
primary
diagnostic
tests
of
cell
cultures
derived
from
bovine
sources
known
or
suspected
to
be
BSE
positive
are
to
be
handled
using
TSE
specific
guidelines.
Information
and
the
TSE
guidelines
can
be
found
by
contacting:
Canadian
Food
Inspection
Agency
(CFIA),
Biohazard
Containment
and
Safety
Division
P:
(613)
221‐7074
W:
http://www.inspection.gc.ca/english/sci/bio/bioe.shtml
59
|
P a g e Mycoplasmas
Although
mycoplasmas
have
commonly
been
identified
as
sources
of
cell
culture
contamination,
mycoplasma‐contaminated
cultures
have
not
yet
been
reported
as
a
source
of
a
laboratory‐acquired
infection.
However,
because
of
the
presence
of
biologically
active
mycoplasma
products
and
the
stability
of
mycoplasma
antigens
as
well
as
the
fact
that
a
number
of
mycoplasmas
are
human
pathogens,
they
are
considered
hazardous
in
cell
cultures.
Cell
lines
with
mycoplasma
contaminants
are
to
be
handled
atthe
containment
level
appropriate
for
the
contaminating
agent
of
the
highest
risk.
Parasites
Freshly
prepared
primary
cell
lines
may
be
at
risk
of
parasite
contamination
if
the
cell
line
was
obtained
from
a
specimen
known
or
suspected
to
be
infected
with
a
human
parasite.
Parasites
have
many
lifecycle
stages,
and
not
all
stages
are
infective.
This
must
be
taken
into
consideration
when
determining
the
appropriate
level
of
containment.
Cell
lines
in
which
the
life‐cycle
stage
of
the
infecting
parasite
is
not
known
are
to
be
manipulated
at
the
containment
level
appropriate
for
the
contaminating
agent
of
the
highest
risk.
5.5 Biological
Agent
Risk
Group
Criteria
and
Categories
A
risk
group
classification
has
traditionally
been
used
to
categorize
the
relative
hazards
of
infective
organisms.
The
factors
used
to
determine
which
risk
group
an
organism
falls
into
is
based
upon
the
particular
characteristics
of
the
organism,
such
as
pathogenicity;
infectious
dose;
mode
of
transmission;
host
range;
availability
of
effective
preventive
measures
and
the
availability
of
effective
treatment.
These
classifications
presume
ordinary
circumstances
in
the
research
&
teaching
laboratories
or
growth
in
small
volumes
for
diagnostic
and
experimental
purposes.
Four
levels
of
risk
have
been
defined
as
follows.
Risk
Group
l
(low
individual
and
community
risk)
A
biological
agent
that
is
unlikely
to
cause
disease
in
healthy
workers
or
animals.
Risk
Group
2
(moderate
individual
risk,
limited
community
risk)
A
pathogen
that
can
cause
human
or
animal
disease,
but
under
normal
circumstances
is
unlikely
to
be
a
serious
hazard
to
healthy
laboratory
workers,
the
community,
livestock
or
the
environment.
Laboratory
exposures
rarely
cause
infection
leading
to
serious
disease.
Effective
treatment
and
preventive
measures
are
available
and
the
risk
of
spread
is
limited.
Risk
Group
3
(high
individual
risk,
low
community
risk)
60
|
P a g e A
pathogen
that
usually
causes
serious
human
or
animal
disease,
or
which
can
result
in
serious
economic
consequences
but
does
not
ordinarily
spread
by
casual
contact,
from
one
individual
to
another,
or
that
can
be
treated
by
antimicrobial
or
antiparasitic
agents.
Risk
Group
4
(high
individual
risk,
high
community
risk)
A
pathogen
that
usually
produces
very
serious
human
or
animal
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.
Appendix
B
–
Risk
Group
Categorization
of
Agents
contains
a
listing
of
Risk
Group
categories
for
biohazardous
agents.
For
the
current
risk
group
classification
of
an
agent,
contact
Office
of
Laboratory
Security
directly
at:
Public
Health
Agency
of
Canada
Office
of
Laboratory
Security
P:
(613)
957‐1779
W:
http://www.phac‐aspc.gc.ca/ols‐bsl/.
Or
for
agents
which
can
infect
animal,
contact
the
Biohazard
Containment
and
Safety
Division
of
CFIA
at:
Canadian
Food
Inspection
Agency
(CFIA),
Biohazard
Containment
and
Safety
Division
P:
(613)
221‐7074
W:
http://www.inspection.gc.ca/english/sci/bio/bioe.shtml
NOTE:
Risk
Group
4
agents
are
not
approved
for
use
at
the
University
of
Windsor
and
shipments
including
such
agents
should
not
be
accepted.
As
a
general
precaution,
agents
should
be
elevated
to
the
next
risk
group
when
manipulation
may
result
in
the
production
of
infectious
droplets
and
aerosols.
Agents
with
similar
pathogenic
characteristics
but
which
are
not
included
in
the
following
lists,
should
be
considered
to
belong
in
the
same
risk
group.
Certain
biological
agents
which
are
animal
pathogens
are
considered
not
indigenous
to
Canada
and
are
subject
to
control
by
the
CFIA.
Appendix
A
–
Agents
not
indigenous
to
Canada
contains
a
partial
listing
of
agents
not
indigenous
to
Canada.
61
|
P a g e 6 SECURITY
6.1 General
Biological
agents
have
a
dual‐use
potential.
They
can
be
used
in
research
&
teaching
for
the
advancement
of
science
and
the
diagnosis
of
disease,
but
can
also
be
misused,
stolen
or
intentionally
released.
The
handling
of
infectious
disease
agents
requires
a
security
plan
to
ensure
that
biological
agents
are
used
as
intended
and
stored
securely.
6.2 Physical
Protection
The
physical
protection
risk
assessment
should
include
all
levels
of
a
security
review:
perimeter
security,
facility
security,
laboratory
security
and
agent
specific
security,
and
outline
procedures
for
securing
the
area,
e.g.,
card
access,
key
pads,
locks
etc.
All
laboratories
should
adopt
security
practices
to
minimize
opportunities
for
unauthorized
entry
into
laboratories,
animal
and
storage
areas,
as
well
as
the
unauthorized
removal
of
infectious
materials
from
their
facility.
The
aim
is
to
have
a
dedicated
and
controlled
access
into
the
laboratory
limited
to
authorized
personnel,
laboratory
staff,
and
maintenance
staff.
Within
the
laboratory,
access
to
biological
agents
should
be
controlled
as
well.
The
containment
perimeter
(i.e.,
doors,
windows)
should
provide
the
required
level
of
security
and
should
be
kept
closed.
6.3 Personnel
Reliability
&
Suitability
For
all
laboratories
which
have
been
designated
as
Containment
Level
3,
Background
checks
and
security
clearances
may
be
required
before
employees
are
granted
access
to
containment
facilities.
It
may
be
appropriate
to
use
photo
identification
badges
for
employees
and
temporary
badges
for
escorted
visitors
to
identify
individuals
with
clearance
to
enter
restricted
areas.
Procedures
must
be
developed
for
approving
and
granting
visitors
access
to
controlled
areas.
In
this
capacity
the
access
to
agents
and
storage
facilities
is
limited
to
legitimate
use/individuals
only.
Biosafety
training
should
include
address
security
issues
and
must
be
provided
to
all
personnel
who
are
given
access.
Personnel
must
demonstrate
that
they
have
understood
the
biosecurity
training
provided.
62
|
P a g e 6.4 Pathogen
Accountablity
The
University
of
Windsor
is
required
to
use
a
system
to
properly
label,
track
of
internal
possession,
inactivation
and
disposal
of
cultures
after
use,
and
transfers
within
and
outside
the
facility.
These
controls
also
assist
in
the
tracking
of
pathogen
storage
locations
and
in
clarifying
under
whose
responsibility
the
pathogens
lie.
The
institution
requires
all
permit
holders
to
update
their
inventories
within
the
University
of
Windsor’s
Hazardous
Materials
Information
system,
including
any
new
additions
as
a
result
of
diagnosis,
verification
of
proficiency
testing,
or
receipt
from
other
locations
as
well
as
to
remove
agents
after
transfers
or
appropriate
inactivation
and
disposal
mechanisms
have
been
used.
Disposal
of
agents
after
use
should
include
all
sub‐cultures
of
that
agent
as
well.
Laboratories
are
required
to
keep
records
of
all
pathogen
inventories,
who
has
access
to
agents,
who
has
access
to
areas
where
agents
are
stored
or
used,
as
well
as
transfer
documents.
A
record
of
culture
collections
and
other
agents
not
currently
used
for
research
should
be
included
in
inventory
lists
as
well.
A
notification
process
for
identifying,
reporting,
and
remediation
of
security
problems,
i.e.,
inventory
discrepancy,
equipment
failure,
breach
of
security,
release
of
agents,
etc.,
should
be
in
place.
6.5 Storage
Agents
stored
and
maintained
for
on‐going
research,
teaching,
or
as
part
of
a
culture
collection
should
have
adequate
physical
protection.
Agents
should
be
stored
securely,
in
consideration
of
the
containment
level
of
the
agent
itself
and
should
have
restricted
access.
An
inventory
of
stored
agents
should
also
be
maintained
so
that
pathogen
storage
locations
are
tracked,
and
also
so
that
it
is
clear
who
is
responsible
for
the
pathogens.
Documentation
procedures
should
include
proper
labelling,
tracking
of
internal
possession,
inactivation
and
disposal
of
cultures
after
use
and
transfers
within
and
outside
the
facility.
Other
records
on
who
has
access
to
the
agents,
who
has
access
to
where
the
agents
are
stored
or
used
and
transfer
documents,
should
also
be
kept.
63
|
P a g e Appendixes
Appendix
A
–
Agents
not
indigenous
to
Canada
The
following
partial
list
is
provided
as
an
example
of
animal
pathogens
which
are
not
indigenous
to
Canada
and
which
are
subject
to
control
by
the
Canadian
Food
Inspection
Agency
(CFIA).
The
CFIA
will
determine
the
conditions
under
which
these
agents
are
used
and
maintained.
This
list
of
non‐indigenous
agents
is
not
complete.
BACTERIA
Mycoplasma
agalactiae
Mycoplasma
mycoides
Rickettsia
ruminantium
PARASITES
Besnoitia
besnoiti
Theileria
annulata
Theileria
bovis
Theileria
hirci
Theileria
lawrencei
Theileria
parva
Trypanosoma
equiperdum
Trypanosoma
evansi
Trypanosoma
vivax
VIRUSES
Bornaviridae
Borna
disease
virus
Bunyaviridae
Nairobi
sheep
disease
virus
Rift
Valley
fever
virus
Caliciviridae
Swine
vesicular
disease
virus
Vesicular
exanthema
virus
Flaviviridae
Hog
cholera
virus
Herpesviridae
Pseudorabies
virus
Iridoviridae
African
swine
fever
virus
64
|
P a g e Orthomyxoviridae
Fowl
plague
virus
Paramyxoviridae
Rinderpest,
Newcastle
disease
virus:
mesogenic,
velogenic
strains
Peste
des
petits
ruminants
Picornaviridae
Genus
Aphthovirus
Foot‐and‐mouth
disease
virus
Genus
Enterovirus
Teschen
disease
virus
Poxviridae
Chordopoxvirinae
(poxviruses
of
vertebrates)
Genus
Orthopoxvirus
Smallpox
(Alastrim)
virus
Genus
Capripoxvirus
Sheeppox
virus
Goatpox
virus
Lumpy
skin
disease
virus
Genus
Suipoxvirus
Swinepox
virus
Camelpox
virus
Reoviridae
Genus
Orbivirus
Bluetongue
virus
African
horsesickness
virus
Rhabdoviridae
Genus
Vesiculovirus
Ephemeral
fever
virus
Vesicular
stomatitis
virus
(animal
inoculation)
Togaviridae
Louping
ill
virus
(animal
inoculation)
Wesselsbron
disease
virus
Venezuelan
equine
encephalitis
(VEE)
virus
65
|
P a g e Appendix
B
–
Risk
Group
Categorization
of
Agents
Risk
Group
1
–
Low
individual
and
community
risk
This
group
includes
those
micro‐organisms,
bacteria,
fungi,
viruses
and
parasites
which
are
unlikely
to
cause
disease
in
healthy
workers
or
animals.
Many
agents
are
referred
to
in
the
literature
by
a
variety
of
names
and,
before
assuming
that
an
unlisted
agent
is
assigned
to
Risk
Group
1,
its
characteristics
and
pathogenicity
must
be
verified
in
consultation
with
the
University
of
Windsor’s
Biological
Safety
Committee
or
the
Office
of
Biosafety,
Public
Health
Agency
of
Canada.
66
|
P a g e Risk
Group
2
–
Moderate
individual
risk
and
limited
community
risk
A
pathogen
that
can
cause
human
or
animal
disease
but,
under
normal
circumstances,
is
unlikely
to
be
a
serious
hazard
to
healthy
laboratory
workers,
the
community,
livestock
or
the
environment.
Laboratory
exposures
rarely
cause
infection
leading
to
serious
disease.
Effective
treatment
and
preventive
measures
are
available
and
the
risk
of
spread
is
limited.
BACTERIA,
CHLAMYDIA,
MYCOPLASMA
Actinobacillus:
all
species
Actinomyces
pyogenes
(C.
pyogenes)
Bacillus
cereus
Bartonella
bacilliformis,
B.
henselae,
B.
quintana,
B.
elizabethae
Bordetella
pertussis,
B.
parapertussis
and
B.
bronchiseptica
Borrelia
recurrentis,
B.
burgdorferi
Campylobacter
spp:
C.
coli,
C.
fetus,
C.
jejuni
Chlamydia
pneumoniae,
C.
psittaci
(non‐avian
strains),
C.
trachomatis
Clostridium
botulinum,
Cl.
chauvoei,
Cl.
difficile,
Cl.
haemolyticum,
Cl.
histolyticum,
Cl.
novyi,
Cl.
perfringens,
Cl.
septicum,
Cl.
sordellii,
Cl.
tetani
Corynebacterium
diphtheriae,
C.
haemolyticum,
C.
pseudotuberculosis,
C.
pyogenes
(A.
pyogenes)
Edwardsiella
tarda
Erysipelothrix
rusiopathae
(insidiosa)
Escherichia
coli:
enterotoxigenic
/
invasive
/
hemorrhagic
strains
Francisella
tularensis
Type
B,
(biovar
palaearctica),
F.
novocida
Fusobacterium
necrophorum
Haemophilus
influenzae,
H.
ducreyi
Helicobacter
pylori
Legionella
spp.
Leptospira
interrogans:
all
serovars
Listeria
monocytogenes
Mycobacteria:
all
species
except
M.
tuberculosis
and
M.
bovis
(non‐BCG
strain),
which
are
in
Risk
Group
3
Mycoplasma
pneumoniae,
M.
hominis
Neisseria
gonorrhoeae,
N.
meningitidis
Nocardia
asteroides,
N.
brasiliensis
Pasteurella:
all
species
except
P.
multocida
type
B,
which
is
in
Risk
Group
3
Pseudomonas
aeruginosa
Salmonella
enterica
(S.
choleraesuis)
Salmonella
enterica
serovar
arizonae
(Arizona
hinshawii)
Salmonella
enterica
serovar
gallinarum‐pullorum
(S.
gallinarum‐pullorum)
Salmonella
enterica
serovar
meleagridis
(S.
meleagridis)
Salmonella
enterica
serovar
paratyphi
B
(S.
paratyphi
B)
(Schottmulleri)
Salmonella
enterica
serovar
typhi
(S.
typhi)
Salmonella
enterica
serovar
typhimurium
(S.
typhimurium)
Shigella
boydii,
S.
dysenteriae,
S.
flexneri,
S.
sonnei
Staphylococcus
aureus
Streptobacillus
moniliformis
67
|
P a g e Streptococcus
spp:
Lancefield
Groups
A,
B,
C,
D,
G
Treponema
carateum,
T.
pallidum
(including
T.
pertenue),
T.
vincentii
Ureaplasma
urealyticum
Vibrio
cholerae
(including
El
Tor),
V.
parahaemolyticus,
V.
vulnificus
Yersinia
enterocolitica,
Y.
pseudotuberculosis
FUNGI
Cryptococcaceae
Candida
albicans
Cryptococcus
neoformans
Moniliaceae
Aspergillus
flavus
Aspergillus
fumigatus
Epidermophyton
floccosum
Microsporum
spp.
Sporothrix
schenckii
Trichophyton
spp.
VIRUSES
Arthropod‐borne
viruses
are
identified
with
an
asterisk
(*).
Only
those
viruses
which
may
be
associated
with
human
or
animal
disease
have
been
included
in
this
list.
Agents
listed
in
this
group
may
be
present
in
blood,
CSF,
central
nervous
system
and
other
tissues,
and
infected
arthropods,
depending
on
the
agent
and
the
stage
of
infection.
Adenoviridae
Adenoviruses:
all
serotypes
Arenaviridae
Lymphocytic
choriomeningitis
virus:
laboratory
adapted
strains
Tacaribe
virus
complex:
Tamiami,
Tacaribe,
Pichinde
Bornaviridae
Borna
disease
virus
Bunyaviridae*
Genus
Bunyavirus
Bunyamwera
and
related
viruses
California
encephalitis
group,
including
LaCrosse,
Lumbo
and
Snowshoe
hare
virus
Genus
Phlebovirus:
all
species
except
Rift
Valley
fever
virus
(see
Appendix
A
–
Agents
not
indigenous
to
Canada)
Caliciviridae:
all
isolates,
including
Hepatitis
E
and
Norwalk
virus
Coronaviridae
Human
coronavirus:
all
strains
Genus
Torovirus
Transmissible
gastroenteritis
virus
of
swine
Hemagglutinating
encephalomyelitis
virus
of
swine
Mouse
hepatitis
virus
68
|
P a g e Bovine
coronavirus
Feline
infectious
peritonitis
virus
Avian
infectious
bronchitis
virus
Canine,
Rat
and
Rabbit
coronaviruses
Flaviviridae*
Yellow
fever
virus:
17D
vaccine
strain
Dengue
virus:
serotypes
1,
2,
3,
4
Kunjin
virus
Hepatitis
C
virus
Hepadnaviridae
Hepatitis
B
virus,
including
Delta
agent
Herpesviridae
Alphaherpesvirinae
Genus
Simplexvirus:
all
isolates
including
HHV
1
and
HHV
2,
except
Herpes
B
virus
which
is
in
Risk
Group
4
Genus
Varicellavirus:
all
isolates
including
varicella
/
zoster
virus
(HHV
3)
and
pseudorabies
virus
(see
Appendix
A
–
Agents
not
indigenous
to
Canada)
Betaherpesvirinae
Genus
Cytomegalovirus:
all
isolates
including
CMV
(HHV
5)
Genus
Muromegalovirus:
all
isolates
Gammaherpesvirinae
Genus
Lymphocryptovirus:
Epstein
Barr
Virus
(HHV
4)
and
EB‐like
isolates
Genus
Rhadinovirus:
all
isolates
except
H.
ateles
and
H.
saimiri
in
Risk
Group
3
Genus
Thetalymphocryptovirus:
all
isolates
Unassigned
Herpesviruses:
includes
HHV
6
(human
B‐lymphotrophic
virus),
HHV
7,
HHV
8,
etc.
Orthomyxoviridae
Genus
Influenzavirus:
Influenza
virus
type
A:
all
isolates
Influenza
virus
type
B:
all
isolates
Influenza
virus
type
C:
all
isolates
Papovaviridae
Genus
Papillomavirus:
all
isolates
Genus
Polyomavirus:
all
isolates
Paramyxoviridae
Genus
Morbillivirus:
all
isolates
except
Rinderpest
virus
(see
Appendix
A
–
Agents
not
indigenous
to
Canada)
Genus
Paramyxovirus:
all
isolates
Genus
Pneumovirus:
all
isolates
Parvoviridae
Genus
Parvovirus:
all
isolates
Picornaviridae
Genus
Aphthovirus:
(see
Appendix
A
–
Agents
not
indigenous
to
Canada)
Genus
Cardiovirus:
all
isolates
Genus
Enterovirus:
all
isolates
Genus
Hepatovirus:
all
isolates
(Hepatitis
A)
Genus
Rhinovirus:
all
isolates
69
|
P a g e Poxviridae
(see
Table
1
for
restrictions)
Chordopoxvirinae
(poxviruses
of
vertebrates)
Genus
Avipoxvirus:
all
isolates
Genus
Capripoxvirus:
(see
Appendix
A
–
Agents
not
indigenous
to
Canada)
Genus
Leporipoxvirus:
all
isolates
Genus
Molluscipoxvirus
Genus
Orthopoxvirus:
all
isolates
except
Variola
virus
and
Monkeypox
virus
which
are
in
Risk
Group
4
Genus
Parapoxvirus:
all
isolates
Genus
Suipoxvirus:
Swinepox
virus
(see
Appendix
A
–
Agents
not
indigenous
to
Canada)
Genus
Yatapoxvirus
All
other
ungrouped
poxviruses
of
vertebrates
Reoviridae
Genus
Orbivirus:
all
isolates
(see
Appendix
A
–
Agents
not
indigenous
to
Canada)
Genus
Orthoreovirus:
types
1,
2
and
3
Genus
Rotavirus:
all
isolates
Retroviridae
Oncovirinae
Genus
Oncornavirus
C
Subgenus
Oncornavirus
C
avian:
all
isolates
Subgenus
Oncornavirus
C
mammalian:
all
isolates
except
HTLV‐I
and
HTLV‐II
Genus
Oncornavirus
B:
all
isolates
Lentivirinae:
all
isolates
except
HIV‐I
and
HIV‐II
Spumavirinae:
all
isolates
Rhabdoviridae
Genus
Vesiculovirus:
all
laboratory
adapted
strains
(see
Appendix
A
–
Agents
not
indigenous
to
Canada)
Genus
Lyssavirus:
Rabies
virus
(fixed
virus)
Togaviridae
Genus
Alphavirus*
Semliki
forest
virus
Sindbis
virus
Chikungunya
virus:
high‐passage
strains
O'Nyong‐Nyong
virus
Ross
river
virus
Venezuelan
equine
encephalitis
virus:
only
strain
TC‐83,
no
animal
inoculation
(see
Appendix
C)
Genus
Rubivirus
Rubella
virus
Genus
Pestivirus
Bovine
diarrhoea
virus
Border
disease
virus
Genus
Arterivirus
Equine
arteritis
virus
Unclassified
viruses
Other
Hepatitis
viruses
Astro
viruses
70
|
P a g e Chronic
infectious
neuropathic
agents
(CHINAs):
Scrapie,
BSE
(except
Kuru
and
Creutzfeldt‐Jakob
Disease
agents
in
Risk
Group
3)
PARASITES
Infective
stages
of
the
following
parasites
have
caused
laboratory
infections
by
ingestion,
skin
or
mucosal
penetration
or
accidental
injection.
Preparations
of
these
parasites
known
to
be
free
of
infective
stages
do
not
require
this
level
of
containment.
PROTOZOA
Babesia
microti
Babesia
divergens
Balantidium
coli
Cryptosporidium
spp.
Entamoeba
histolytica
Giardia
spp.
(mammalian)
Leishmania
spp.
(mammalian)
Naegleria
fowleri
Plasmodium
spp.
(human
or
simian)
Pneumocystis
carinii
Toxoplasma
gondii
Trypanosoma
brucei,
T.
cruzi
HELMINTHS
Nematodes
Ancylostoma
duodenale
Angiostrongylus
spp.
Ascaris
spp.
Brugia
spp.
Loa
loa
Necator
americanus
Onchocerca
volvulus
Strongyloides
spp.
Toxocara
canis
Trichinella
spp.
Trichuris
trichiura
Wuchereria
bancrofti
Cestodes
Echinococcus
(gravid
segments)
Hymenolepis
diminuta
Hymenolepis
nana
(human
origin)
Taenia
saginata
Taenia
solium
Trematodes
Clonorchis
sinensis
Fasciola
hepatica
71
|
P a g e Opisthorchis
spp.
Paragonimus
westermani
Schistosoma
haematobium
Schistosoma
japonicum
Schistosoma
mansoni
72
|
P a g e Risk
Group
3
–
High
individual
and
low
community
risk
A
pathogen
that
usually
causes
serious
human
or
animal
disease,
or
which
can
result
in
serious
economic
consequences
but
does
not
ordinarily
spread
by
casual
contact,
from
one
individual
to
another,
or
that
can
be
treated
by
antimicrobial
or
antiparasitic
agents.
BACTERIA,
CHLAMYDIA,
RICKETTSIA
Bacillus
anthracis
Brucella:
all
species
Burkholderia
(Pseudomonas)
mallei,
B.
pseudomallei
Chlamydia
psittaci:
avian
strains
only
Coxiella
burnetti
Francisella
tularensis
type
A
(biovar
tularensis)
Mycobacterium
bovis:
non‐BCG
strains
Mycobacterium
tuberculosis1
Pasteurella
multocida,
type
B
Rickettsia:
all
species
(see
see
Appendix
A
–
Agents
not
indigenous
to
Canada)
Yersinia
pestis
1
Preparation
of
smears
and
primary
culture
of
M.
tuberculosis
may
be
performed
at
Level
2
physical
containment
using
Level
3
operational
procedures
and
conditions.
All
other
manipulations
of
M.
tuberculosis
require
Containment
Level
3
physical
and
operational
conditions.
FUNGI
Moniliaceae
Ajellomyces
capsulatus
(Histoplasma
capsulatum,
including
H.
capsulatum
var.
duboisii)
Ajellomyces
dermatitidis
(Blastomyces
dermatitidis)
Coccidioides
immitis
Paracoccidioides
brasiliensis
VIRUSES
Arthropod‐borne
viruses
are
identified
with
an
asterisk
(*).
Arenaviridae
Lymphocytic
choriomeningitis
virus:
neurotropic
strains
Bunyaviridae
Unclassified
Bunyavirus
Hantaan,
Korean
haemorrhagic
fever
and
epidemic
nephrosis
viruses
including
Hantavirus
pulmonary
syndrome
virus
Rift
Valley
fever
virus
Flaviviridae*
73
|
P a g e Yellow
fever
virus:
wild
type
St.
Louis
encephalitis
virus
Japanese
encephalitis
virus
Murray
Valley
encephalitis
virus
Powassan
encephalitis
virus
Herpesviridae
Gammaherpesvirinae
Genus
Rhadinovirus:
Herpesvirus
ateles,
Herpesvirus
saimiri
Retroviridae
Oncovirinae
Genus
Oncornavirus
C
Human
T‐cell
leukemia
/
lymphoma
virus2
Genus
Oncornavirus
D
Mason‐Pfizer
monkey
virus
Viruses
from
non‐human
primates
Lentivirinae
Human
immunodeficiency
viruses
(HIV):
all
isolates2
Rhabdoviridae
Genus
Vesiculovirus:
wild
type
strains
(see
Appendix
A
–
Agents
not
indigenous
to
Canada)
Genus
Lyssavirus
Rabies
virus
(street
virus)
Togaviridae
Genus
Alphavirus*
Eastern
equine
encephalitis
virus
Chikungunya
virus
Venezuelan
equine
encephalitis
virus
(except
Strain
TC‐83;
see
Appendix
A
–
Agents
not
indigenous
to
Canada)
Western
equine
encephalitis
virus
Unclassified
Viruses
Chronic
infectious
neuropathic
agents:
Kuru,
Creutzfeldt‐Jakob
Disease
agents
(level
of
precautions
depends
on
the
nature
of
the
manipulations
and
the
amount
of
sera,
biopsy
/
necropsy
materials
handled)
2
Laboratories
engaging
in
primary
isolation
and
identification
of
HTLV
or
HIV
may
perform
these
activities
in
Containment
Level
2
laboratories
(physical
conditions)
using
Containment
Level
3
operational
procedures
and
conditions.
All
research
and
production
activities
require
Containment
Level
3
physical
and
operational
conditions.
PARASITES
None
74
|
P a g e Risk
Group
4
–
High
individual
and
community
risk
A
pathogen
that
usually
produces
very
serious
human
or
animal
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.
NOTE:
Risk
Group
4
agents
are
not
approved
for
use
at
the
University
of
Windsor.
BACTERIA
None
FUNGI
None
VIRUSES
Arthropod‐borne
viruses
are
identified
with
an
asterisk
(*).
Arenaviridae
Lassa,
Junin,
Machupo,
Sabia,
Guanarito
viruses
Bunyaviridae*
Genus
Nairovirus
Crimean‐Congo
hemorrhagic
fever
virus
Filoviridae
Marburg
virus
Ebola
virus
Flaviviridae*
Tick‐borne
encephalitis
complex
including
Russian
Spring‐Summer
encephalitis
virus
Kyasanur
forest
virus
Omsk
hemorrhagic
fever
virus
Herpesviridae
Alphaherpesvirinae
Genus
Simplexvirus:
Herpes
B
virus
(Cercopithecine
herpesvirus
1)
Poxviridae
Genus
Orthopoxvirus
Variola
virus
Monkeypox
virus
PARASITES
None
75
|
P a g e Appendix
C
–
Safety
Equipment
An
essential
element
in
maintaining
personal
safety
and
environmental
protection
is
the
correct
selection,
use
and
maintenance
of
safety
equipment
in
the
laboratory.
Safety
equipment
must
be
maintained
and
regularly
serviced.
There
must
also
be
a
regular
program
of
testing
and
inspection,
and
accurate
records
must
be
kept.
The
following
is
a
list
of
safety
devices
appropriate
to
the
containment
laboratory:
Type
Application
Animal
cages
or
boxes
partial
to
total
containment
of
aerosols;
provide
protection
from
cross‐
contamination
and
personnel
and
environmental
protection
high
temperature
steam
sterilization
aerosol‐free
blenders
provide
containment
of
aerosols
See
Appendix
D
–
Biological
Safety
Cabinets
safety
cups
with
sealed
heads
provide
containment
of
aerosols
device
for
flushing
face
and
eyes
with
water
in
event
of
splash
or
spray
of
biological
or
chemical
agents
safety
glasses,
goggles
and
full‐face
shields
provide
protection
from
flying
objects
and
splashes
provide
personnel
and
environmental
protection;
for
removal
or
control
of
gases
and
vapours.
provide
hand
protection
of
varying
degrees;
check
technical
specifications
to
determine
degree
of
protection
high
efficiency
particulate
air
filters
available
in
various
sizes,
including
cartridges;
disposable;
provide
99.97%
removal
of
0.3
μM
particulates
electric
or
gas
with
side‐arm
to
contain
splatters
when
flaming
inoculation
and
transfer
loops
head
covers,
shoe
covers,
coats,
gowns
or
ventilated
suits
appropriate
to
hazard
variety
of
containers,
preferably
of
stainless
steel
and
autoclavable,
with
tight‐fitting
lids,
and
which
may
be
used
for
transporting
waste
materials
to
an
autoclave
variety
of
devices
which
eliminate
need
to
pipette
by
mouth
partial
or
full‐face
protection;
provided
with
variety
of
filters
autoclavable,
puncture‐resistant
containers
which
are
used
for
collection
and
disposal
of
used
hypodermic
syringes
and
needles,
blades
and
other
sharp
waste
Autoclaves
Blenders
and
mixers
Biological
Safety
Cabinet
Centrifuge
equipment
Face
/
eye
wash
station
Face
and
eye
protection
Fume
hoods
Gloves
HEPA
filters
Incinerators
–
micro
Laboratory
clothing
Leakproof
containers
Pipetting
devices
Respiratory
protection
Sharps
waste
containers
76
|
P a g e Appendix
D
–
Biological
Safety
Cabinets
A
biological
safety
cabinet
is
a
ventilated
cabinet
which
uses
a
variety
of
combinations
of
HEPA
filtration,
laminar
air
flow
and
containment
to
provide
personnel,
product
or
environmental
protection
or
protection
of
all
components
against
particulates
or
aerosols
from
biohazardous
agents.
It
is
distinguished
from
a
chemical
fume
hood
by
the
presence
of
HEPA
filtration
and
the
laminar
nature
of
the
airflow.
There
are
three
kinds
of
biological
safety
cabinets,
designated
as
Class
I,
II,
and
III
have
been
developed
to
meet
various
research,
teaching,
and
clinical
applications.
Class
I:
Open
fronted
cabinets
with
laminar
airflow
directed
away
from
the
user
through
a
HEPA
filter.
The
cabinet
may
be
ducted
to
exhaust
system
or
may
exhaust
into
the
room.
Class
I
cabinets
provide
personnel
and
environmental
protection,
but
no
product
protection.
It
is
similar
to
the
air
movement
within
a
chemical
fume
hood,
but
has
a
HEPA
filter
in
the
exhaust
system
to
protect
the
environment.
Suitable
for
some
work
procedures
at
Containment
1
and
2.
Class
II
types
A,
B1,
B2,
and
B3:
A
Class
II
biological
safety
cabinet
provides
personnel,
environmental,
and
product
protection.
They
utilize
a
re‐circulated
HEPA
filtered
vertical
laminar
airflow
within
a
partially
contained
cabinet
with
a
glass
sash
leaving
8‐10
inch
work
opening.
The
component
of
the
airflow
that
is
exhausted
through
HEPA
filters
may
be
ducted
to
the
outside
or
re‐circulated
to
the
room.
Class
II
cabinets
provide
a
high
degree
of
protection
to
the
worker,
the
work
and
the
environment.
Suitable
for
work
at
Containment
Level
1,
2
and
3.
Class
III:
These
cabinets
were
designed
for
working
with
microbiological
agents
assigned
to
Biosafety
level
4
and
provide
maximum
protection
to
both
the
environment
and
the
worker.
These
enclosed
cabinets
contain
a
HEPA
filtered
supplied
air,
non‐recirculated
HEPA
filtered
laminar
flow
air
over
the
work
surface
and
hard
ducted
to
outside.
The
work
surface
is
accessed
only
through
glove
ports
or
sealed
air
locks.
These
cabinets
provide
a
totally
contained
area
to
protect
the
worker,
the
work
and
the
environment.
Suitable
for
work
at
Containment
Level
1,
2,
3,
and
4.
77
|
P a g e HIGH
EFFICIENCY
PARTICULATE
AIR
FILTERS
(HEPA):
HEPA
filters
are
using
the
exhaust
and/or
supply
systems
of
biological
safety
cabinets.
A
typical
HEPA
filter
is
a
single
sheet
of
borosilicate
fibers
which
has
been
treated
with
a
wet‐strength
water‐repellant
binder.
The
filter
medium
is
pleated
to
increase
the
overall
surface
area
inside
the
filter
frame,
and
the
pleats
are
often
divided
by
corrugated
aluminum
separators
HORIZONTAL/VERTICAL
LAMINAR
FLOW
“CLEAN
BENCH”:
These
units
discharge
HEPA‐filtered
air
across
a
work
surface
towards
the
user.
These
devices
only
provide
product
protection
and
can
be
used
for
certain
clean
activities,
include
the
dust‐free
assembly
of
sterile
equipment.
These
units
are
not
biological
safety
cabinets
and
should
not
bused
used
when
handling
cell
culture
materials
or
drug
formulations
as
individuals
can
be
exposed
to
materials
which
can
cause
hypersensitivity.
Use
of
Biological
Safety
Cabinets:
To
help
facilitate
the
registration
and
certification
of
any
biological
safety
cabinet,
it
is
requested
that
you
notify
the
University
of
Windsor’s
Biological
Safety
Cabinet
Coordinator
(Chemical
Control
Centre,
ext.
3523
Option
4)
if
a
biological
safety
cabinet
is
to
be
ordered,
installed,
moved
or
relocated
from
another
institution.
The
proposed
location
for
the
cabinet
must
be
known.
Cabinets
acquired
from
another
institution
or
from
another
laboratory
on
campus,
must
be
decontaminated
before
being
moved
to
University
of
Windsor
laboratories.
Documentation
will
be
required.
New
cabinets
or
cabinets
which
have
been
moved
must
be
recertified
after
they
are
installed
in
the
new
location.
All
Class
II
biological
safety
cabinets
must
be
recertified
annually
by
an
approved
testing
service
A
University
of
Windsor
Biological
Safety
Certificate
must
have
been
completed
for
all
of
the
agents
that
will
be
used
in
the
cabinet.
Facilities
must
be
consulted
for
installation
requirements.
78
|
P a g e Use
of
Natural
gas
and
propane
is
not
permitted
inside
Class
II
cabinets
and
is
not
recommended
inside
Class
I
cabinets.
For
more
information
on
Biological
Safety
Cabinets
please
see
the
University
of
Windsor’s
guidelines
on
the
“Safe
operation
of
Biological
Safety
Cabinets”
(www.uwindsor.ca/biosafety)
79
|
P a g e Appendix
E
–
Laboratory
Design
This
section
is
designed
to
provide
guidance
on
the
design
and
layout
required
to
achieve
the
four
containment
levels
detailed
in
Section
3.
This
section
divided
into
five
matrices:
Laboratory
Location
and
Access;
Surface
(i.e.,
floors,
walls,
ceilings,
sealants)
Finishes
and
Casework;
Heating,
Ventilation
and
Air
Conditioning
(HVAC);
Containment
Perimeter;
and
Laboratory
Services
(i.e.,
water,
drains,
gas,
electricity
and
safety
equipment).
Information
on
commissioning,
certification
and
recertification
of
the
containment
features
detailed
in
the
matrices
can
be
found
in
Section
1.
Legend:
‐
Mandatory
(Laboratory
Biosafety
Guidelines,
3rd
edition,
2004)
‐
Recommended
(Laboratory
Biosafety
Guidelines,
3rd
edition,
2004)


1
2
1

Level
2 3
 
 
4















3
4
5

6
7

8
9





10

11
12
13
80
|
P a g e 



Laboratory Location & Access
Separated from public areas by door.
Access limited to authorized personnel.
Laboratory room doors to have appropriate signage (e.g.,
biohazard sign, containment level, contact information, entry
requirements).
Size of door openings to allow passage of all anticipated
equipment.
Doors to the containment laboratory lockable (this does not apply
to areas within the containment laboratory).
Doors to provide restricted access by installation of a controlled
access system (e.g., card key) or equivalent.
Electronic locking systems to be backed up with a physical keylock system.
Office areas to be located outside of containment laboratory.
Paperwork stations for data collection can be within containment
laboratory provided they are located away from laboratory work
areas.
Entry to laboratory to be provided via an anteroom.
Anteroom door(s) located between the clean and dirty change
rooms not to be opened simultaneously with either the
containment laboratory door or the clean change entry door.
(Interlock, visual or audible alarms, or protocols are all
acceptable means.)
Anteroom door(s) located between the clean and dirty change
rooms not to be opened simultaneously with either the
containment laboratory door or the clean change entry door
(interlock only).
Interlocked doors, if present, to have manual overrides for
emergency exit.
Entry to laboratory zone to be provided with clothing change
areas separating personal and laboratory clothing dedicated to
that zone (i.e., "clean" change area separated from "dirty"
change area).

14
Exit from laboratory to be provided with a walk-through shower
on the containment barrier (i.e., between “dirty” and "clean"
change anterooms). (CL3 laboratories manipulating organisms,
such as HIV, that are not infectious via inhalation, are not
required to fulfil this criterion.)

15
Entry to laboratory to be provided via anteroom with airtight
doors (e.g., inflatable or compression seal); for laboratories using
only a Class III BSC biological safety cabinet line, airtight doors
are not required.

16
Entry to laboratory zone to be provided with a suit change area, a
chemical shower on the containment barrier (i.e., between the
laboratory and suit change area) and water shower on exit from
the zone (i.e., between "dirty" and "clean" change areas); for
laboratories using only a Class III biological safety cabinet line,
suit change area and chemical shower are not required.







Level
2 3
4














17
18
19
Containment laboratories to be located in close proximity to
supporting mechanical services to limit the amount of potentially
contaminated services.
Containment laboratories to be located away from external
building envelope walls.
A laboratory support area to be provided adjacent to the
containment facility for all supporting laboratory manipulations.
1
1
2
3
4











5
6
7


8
9
81
|
P a g e Surfaces, Finishes, and Casework
Doors, frames, casework and bench tops to be nonabsorptive
(i.e., the use of organic materials should be avoided).
Working surfaces of bench tops to be non-absorptive.
Surfaces to be scratch, stain, moisture, chemical and heat
resistant in accordance with laboratory function.
Surfaces to provide impact resistance in accordance with
laboratory function.
Surfaces to be continuous and compatible with adjacent and
overlapping materials (i.e., to maintain adhesion and a
continuous perimeter); wall and floor welded seams are
acceptable in level 3 laboratories.
Continuity of seal to be maintained between the floor and wall (a
continuous cove floor finish up the wall is recommended).
Interior surfaces to minimize movement of gases and liquid
through perimeter membrane.
Interior coatings to be gas and chemical resistant in accordance
with laboratory function (e.g., will withstand chemical
disinfection, fumigation).
Interior coatings to be cleanable.

10
11
12
13
14
15
16
17
18





























1
Level
2 3 4
  
Structural stability to withstand 1.25 times maximum design
pressure under supply and exhaust fan failure conditions (i.e., no
wall distortion or damage).
Bench tops to have no open seams.
Bench tops to contain spills of materials (e.g., with marine edges
and drip stops).
Benches, doors, drawers, door handles, etc. to have rounded rims
and corners.
Backsplashes, if installed tight to wall, to be sealed at wall-bench
junction.
Reagent shelving to be equipped with lip edges.
Drawers to be equipped with catches, i.e., to prevent the drawer
from being pulled out of the cabinet.
Drawers to be of one piece construction.
Cabinet doors not to be self-closing.
1
2
3




Room pressure differential monitoring lines penetrating the
containment barrier to be provided with filters of efficiency equal
to that of HEPA filtration.

Alarm (visual or audible) to be provided in the laboratory and
outside laboratory area (i.e., to warn others and maintenance
personnel) to signal air handling systems failure.
5

6
7





Supply air system to be interlocked (i.e., fans, dampers,
electrical) with exhaust air system, to prevent sustained
laboratory positive pressurization.


9
82
|
P a g e Where determined necessary by a local risk assessment, supply
air duct to be provided with backdraft protection (i.e., HEPA filter;
bubble tight backdraft damper).
Supply air to be HEPA filtered.
Supply air system to be independent of other laboratory areas.
CL3 supply can be combined with areas of lower containment
when provided with backdraft protection (i.e., HEPA filter, bubble
tight backdraft damper) downstream from the connection. (For
CL3 laboratories manipulating organisms, such as HIV, that are
not infectious via inhalation this criterion is only recommended.)
8
10
11
100% outside air to be supplied.
Directional inward airflow provided such that air will always flow
towards areas of higher containment (e.g., ± 25 Pa differential).
Visual pressure differential monitoring devices to be provided at
entry to containment laboratory.

4

Containment perimeter

Exhaust air to be HEPA filtered. (CL3 laboratories manipulating
organisms, such as HIV, that are not infectious via inhalation are
not required to fulfil this criterion.)
Exhaust air to be passed through two stages of HEPA filtration.
12



13

14






15
16
17
HEPA filters installed into the supply and exhaust system to
conform to the requirements of IEST-RP-CC001.3(1).
Supply HEPA filter housings to be designed to withstand structural
change at applied pressure of 2500 Pa [10 in. w.g.].
Where HEPA filters are used for backdraft protection in
accordance with local risk assessment, supply HEPA filter housings
to be designed to withstand structural change at applied pressure
of 2500 Pa [10 in. w.g.].
Exhaust HEPA filter housings to be designed to withstand
structural change at applied pressure of 2500 Pa [10 in. w.g.] and
to be provided with a method of isolation and decontamination.
(For CL3 laboratories manipulating organisms, such as HIV, that
are not infectious via inhalation this criterion is only
recommended.)
Exhaust air system to be independent of other laboratory areas.
CL3 exhaust can be combined with areas of lower containment
when provided with a HEPA filter upstream from the connection.
(For CL3 laboratories manipulating organisms, such as HIV, that
are not infectious via inhalation this criterion is only
recommended.)
Supply and exhaust systems located outside of containment to be
accessible for repairs, maintenance, cleaning and inspection.
18
Supply air ductwork that is outside the containment perimeter
(e.g., between containment perimeter and HEPA filter or bubble
tight backdraft damper) to be sealed airtight in accordance with
Sheet Metal and Air Conditioning Contractors National Association
(SMACNA) Seal Class A(2).

19
Where backdraft protection is required in accordance with local
risk assessment, supply air ductwork that is outside the
containment perimeter (e.g., between containment perimeter and
HEPA filter or bubble tight backdraft damper) to be sealed airtight
in accordance with SMACNA Seal Class A(2).


20
Exhaust air ductwork that is outside the containment perimeter
(e.g., between containment perimeter and HEPA filter or bubble
tight backdraft damper) to be sealed airtight in accordance with
SMACNA Seal Class A(2). (CL3 laboratories manipulating
organisms, such as HIV, that are not infectious via inhalation are
not required to fulfil this criterion.)

21
Airflow control devices and duct sensors to be located
downstream of the exhaust HEPA filter and upstream of the
supply bubble tight backdraft damper or HEPA filter, or if located
upstream, duct penetrations to be sealed in accordance with
SMACNA Seal Class A(2). (CL3 laboratories manipulating
organisms, such as HIV, that are not infectious via inhalation are
not required to fulfil this criterion.)

22
Bubble tight backdraft dampers and HEPA filters to be located in
close proximity to the containment perimeter. (CL3 laboratories
manipulating organisms, such as HIV, that are not infectious via
inhalation are not required to fulfil this criterion.)



83
|
P a g e 1
1
Level
2 3


4
Autoclave or other acceptable means of waste treatment/disposal
to be provided.


2
Double-door barrier autoclave with bioseal to be located on
containment barrier; body of autoclave to be preferably located
outside of containment for ease of maintenance. (For CL3
laboratories manipulating organisms, such as HIV, that are not
infectious via inhalation it is not mandatory that the autoclave be
a double-door barrier model.)
Barrier autoclave to be equipped with interlocking doors, or visual
or audible alarms to prevent both doors from opening at the
same time.

3

4
Barrier autoclave to be equipped with interlocking doors, and
visual or audible alarms to prevent both doors from opening at
the same time.










For materials that cannot be autoclaved (e.g., heat sensitive
equipment, samples, film) other proven technologies for waste
treatment (e.g., incineration, chemical, or gas) to be provided at
containment barrier.
All penetrations to be sealed with nonshrinking sealant at
containment barrier.
All conduit and wiring to be sealed with nonshrinking sealant at
the containment barrier.
Windows, if they can be opened, to be protected by fly screens.
Windows positioned on containment barrier to be sealed in place;
window glazing material to provide required level of security.
Observation windows to be installed on containment barrier.
1
Level
2 3
4
Laboratory Services (i.e., water, drains, gas, electricity,
and safety equipment)











5
6
7
8
Laboratory Services (i.e., water, drains, gas, electricity,
and safety equipment)


9
10
1
2
3
4
Hooks
to
be
provided
for
laboratory
coats
at
laboratory
exit;
street
and
laboratory
clothing
areas
to
be
separated.
BSCs
and
other
primary
containment
devices
to
be
provided.
Examples
for
use
include
procedures
with
the
potential
for
producing
aerosols
and
those
involving
high
concentrations,
large
volumes
or
particular
types
of
agents.

5
6

84
|
P a g e Handwashing
sinks
to
be
located
near
the
point
of
exit
from
the
laboratory
or
in
anteroom.
Not
applicable
to
CL4
suit
laboratories.
Handwashing
sinks
to
be
provided
with
"hands‐free"
capability.
BSCs
and
other
primary
containment
devices
to
be
provided.

Emergency
eyewash
facilities
to
be
provided
in
accordance
with
applicable
regulations
(i.e.,
ANSI
Z358.1‐1998(3)).
7
Emergency
shower
equipment
to
be
provided
in
accordance
with
applicable
regulations
(i.e.,
ANSI
Z358.1‐1998(3)).

When
it
is
not
possible
to
limit
the
quantities
of
hazardous
chemicals
within
the
laboratory,
emergency
shower
equipment
to
be
provided
in
accordance
with
applicable
regulations
(i.e.,
ANSI
Z358.1‐1998(3)).

8


9

10
Domestic
water
branch
piping
serving
laboratory
area(s)
to
be
provided
with
backflow
prevention,
in
accordance
with
CAN/CSA‐B64.10‐01/B64.10.1‐01(4)
,and
isolation
valve,
to
be
located
in
close
proximity
to
the
containment
barrier.
Drain
lines
and
associated
piping
(including
autoclave
condensate)
to
be
separated
from
lower
containment
laboratory
areas
and
to
go
directly
to
main
building
sanitary
sewer
at
point
of
exit
from
building
(downstream
of
all
other
connections).

11
Drain
lines
and
associated
piping
(including
autoclave
condensate)
to
be
separated
from
areas
of
lower
containment
and
to
be
connected
to
an
effluent
sterilization
system.

12
Drains
connected
to
effluent
sterilization
to
be
sloped
towards
sterilization
system
to
ensure
gravity
flow;
consideration
should
be
given
to
the
installation
of
valves
to
isolate
sections
of
piping
for
in
situ
decontamination;
the
effluent
sterilization
system
(e.g.,
piping,
valves,
tank)
to
be
heat
and
chemical
resistant
consistent
with
application.


Autoclave
condensate
drain
to
have
a
closed
connection.
For
CL3,
open
connection
is
allowable
if
located
within
containment
barrier.


Drainage
traps
to
be
provided
to
required
deep
seal
depth
in
consideration
of
air
pressure
differentials.


Floor
drains
not
to
be
provided,
except
when
essential
(e.g.,
body
shower
and
animal
rooms).

16
Plumbing
vent
lines
(including
effluent
sterilization
system)
to
be
provided
with
filter
of
efficiency
equivalent
to
that
of
HEPA
and
provided
with
a
means
of
isolation
and
decontamination.
17
18
Plumbing
vent
lines
to
be
independent
of
lower
containment
plumbing
vent
lines,
or
combined
with
lines
from
lower
containment
when
provided
with
a
filter
of
efficiency
equivalent
to
that
of
HEPA
upstream
from
the
connection.
(CL3
laboratories
manipulating
organisms,
such
as
HIV,
that
are
not
infectious
via
inhalation
are
not
required
to
fulfil
this
criterion.)
Compressed
gas
cylinder(s)
to
be
located
outside
the
laboratory.
13
14
15




Laboratory
supply
gas
piping
(e.g.,
carbon
dioxide,
compressed
air)
to
be
provided
with
backflow
prevention.

20
Portable
vacuum
pump
to
be
provided
in
the
laboratory.
Internal
contamination
of
vacuum
pump
to
be
minimized
(e.g.,
HEPA
filtration
of
vacuum
line,
use
of
disinfectant
traps).
21
22
Compressed
breathing
air
to
be
provided
to
positive‐pressure
personal
protective
equipment
(i.e.,
for
connection
to
the
air
hose
of
suits),
equipped
with
breathing
air
compressors
and
back‐up
cylinders
(sufficient
for
30
minutes
per
person);
air
hose
connections
to
be
provided
in
all
areas
where
suits
are
worn,
including
chemical
shower
and
suit
change
room.
Emergency
lighting
to
be
provided.
19


85
|
P a g e 

23
24
25
26







Laboratory
to
be
equipped
with
a
communication
system
between
containment
area
and
outside
support
area.

System
(e.g.,
fax,
computer)
to
be
provided
for
electronic
transfer
of
information
and
data
from
laboratory
area
to
outside
laboratory
perimeter.
(Note:
paperwork
from
the
containment
laboratory
may
be
removed
after
appropriate
decontamination,
i.e.,
autoclaving,
irradiation,
microwaving;
such
practices
are
generally
not
recommended
for
use
on
a
routine
basis).

Work
area
to
be
monitored
(e.g.,
closed
circuit
TV)
from
outside
laboratory
perimeter
(e.g.,
security/biosafety
office).

27
28
86
|
P a g e Life
safety
systems,
lighting,
HVAC
systems,
BSCs,
security
systems
and
other
essential
equipment
to
be
supported
with
emergency
back‐up
power.
Circuit
breakers
to
be
located
outside
biocontainment
area.
Fluorescent
light
ballasts
and
starters
to
be
located
outside
containment
area.

Appendix
F
–
References
Canadian Council on Animal Care. Guide to the Care and Use of Experimental Animals. 2nd edition. Vol.
1, 1993; Vol. 2. Ottawa, Ontario.
Canadian Standards Association. 1995. Biological Containment Cabinets: Installation and Field Testing.
Etobicoke, Ontario.
Canadian Standards Association. 1995. Evaluation of Single Use Medical Sharps Containers for
Biohazardous and Cytotoxic Waste. Etobicoke, Ontario.
Canadian Standards Association. 1994. Fume Hoods and Associated Exhaust Systems. Rexdale,
Ontario.
Canadian Standards Association. 1988. Handling of Waste Materials within Health Care Facilities.
Rexdale, Ontario.
CRC Handbook of Laboratory Animal Science. Vol. 1. 1974. Melby EC Jr, Altman NH, eds. CRC Press,
Cleveland, Ohio.
CRC Handbook of Laboratory Safety. 1989. Furr AK, ed. CRC Press, Boca Raton, Florida.
Government of Canada. Biotechnology Regulations: A Users Guide. 1991. Supply and Services Canada,
Hull, Quebec.
Laboratory Centre for Disease Control. 2003. Laboratory Biosafety Guidelines. 3nd edition. Health
Canada, Ottawa, Ontario.
National Institutes of Health. 1974. Biohazards Safety Guide. Washington, D.C.
National Institutes of Health. 1986. Guidelines for Research Involving Recombinant DNA Molecules.
Federal Register 51: 16958.
National Institutes of Health. 1979. Laboratory Safety Monograph: a supplement to the NIH Guidelines for
Recombinant DNA Research. US Dept. of Health and Human Services, Public Health Service.
Washington, D. C.
National Institutes of Health. 1984. Recombinant DNA Research: Actions under Guidelines. Guidelines
for Research involving Recombinant DNA Molecules. Federal Register, parts V & VI, 46256-46291.
National Research Council. 1989. Biosafety in the Laboratory: Prudent Practices for the Handling and
Disposal of Infectious Materials. National Academy Press, Washington, D.C.
Ontario Ministry of the Environment. 1986. Guidelines for the Handling and Disposal of Biomedical
Wastes from Health Care Facilities and Laboratories. Toronto, Ontario.
Recombinant DNA Advisory Committee. National Institutes of Health. 1989. Minutes of Meeting, October
6. Recombinant DNA Technical Bulletin 12: 213-252.
Transportation of Dangerous Goods Act and Regulations. 1992. Ottawa.
World Health Organization. 1993. Laboratory Biosafety Manual. 2nd edition. WHO, Geneva.
87
|
P a g e APPLICATION
FOR
BIOLOGICAL
SAFETY
CERTIFICATE
The
University
of
Windsor
requires
that
all
Researchers
possess
a
valid
biological
safety
certificate
when
performing
research
that
involves
biological
agents.
Failure
to
acquire
a
biological
safety
certificate
will
lead
to
the
withholding
of
funding
until
the
application
process
is
completed.
Section
A:
Applicant
Information:
Principle
Investigator:
Department:
Mailing
Address:
Building:
Email
Address:
Telephone
Ext.:
Section
B:
Project
Title(s)
/
Funding
Sponsor
and/or
Agency
Information:
Title
Agency
Grant
No.
Start
/
End
Dates
Agency
Grant
No.
Start
/
End
Dates
Grant
No.
Start
/
End
Dates
Title
Title
Agency
Section
C:
Facilities
/
Project
Location
Building
Room
Containment
Level
(1
‐3)1
Biosafety
Office
Use
Only
Last
Site
Visit
–
Based
on
Health
Canada’s
“Laboratory
Biosafety
Guidelines”,
3rd
Edition,
2004.
1
Site
Specific
Handling
&
Emergency
Response:
Please list the site specific instructions and safety protocols, including
waste handling and spills response, that all lab workers will follow when handling the biohazardous materials specified
in this application.
Section
D:
Biological
Safety
Cabinet(s):
Please
attach
a
copy
of
report(s)
on
testing
and
certification
performed
within
the
last
twelve
months.
UWin
ID
#
Building
Room
Biosafety
Office
Use
Only
DBase
Updated
Section
E:
Animal
Utilization:
Indicate
if
biological
agents
are
to
be
used
on
animals.
Provide
attachment
which
briefly
outlines
procedures
which
involve
animals
used
in
conjunction
with
biological
agents.
None
–
No
animals
will
be
used
in
the
projects
outlined
in
“Section
B”
Non‐primate
mammals
Other
animals:
specify
Approved
by
Animal
Care
Committee
(ACC)
Animal
Research
Protocol
No:
Pending
Approval
from
Animal
Care
Committee
(ACC)
‐
application
submitted
For
more
information
please
visit
the
University
of
Windsor’s
Animal
Care
Committee
website:
www.uwindsor.ca/acc
Section
F:
Radiation
Utilization:
Indicate
if
biological
agents
are
to
be
used
in
conjunction
with
radioisotopes.
None
–
No
radioisotopes
will
be
used
in
the
projects
outlined
in
“Section
B”
Radioisotope
Other
type
of
radiation
Approved
by
Radiation
Safety
Committee
(UWinRSC)
Internal
Radiation
Permit
No.
Pending
Approval
from
Radiation
Safety
Committee
(UWinRSC)
‐
application
submitted
For
more
information
please
visit
the
University
of
Windsor’s
Radiation
Safety
Program
website:
www.uwindsor.ca/radiation
Section
G:
Biological
Agent
Utilization:
Provide
an
attachment
which
briefly
outlines
the
procedures
which
involve
the
use
of
biological
agents.
Use
of
Microorganisms:
If
no,
please
proceed
to
next
section.
Human
pathogen
Yes
No
Name
of
microbe
or
parasite
Known
to
be
a
Animal
Plant
pathogen
pathogen
Yes
No
Yes
No
Max
Qty
Cultured
Source
PHAC
Recommended
Containment
Level:
CFIA
Use
of
Cell
Culture:
If
no,
please
proceed
to
next
section.
Human
Will
be
used
Yes
No
Established/
Primary
Non‐human
primate
Rodent
Other
(specify)
Cell
Type
Specific
cell
lines
Recommended
Containment
Level:
Supplier
PHAC
CFIA
Use
of
Human
Source
Materials:
If
no,
please
proceed
to
next
section.
Will
be
used
Material
Yes
Specify
source
/
use
No
Human
blood
(whole)
Human
blood
(fraction)
Human
tissue/organs
(preserved)
Human
tissue/organs
(unpreserved)
Any
human
source
known
to
have
an
infectious
agent
PHAC
CFIA
Recommended
Containment
Level:
Does
your
Research
Proposal
also
require
approval
through
the
Research
Ethics
Board.
If
yes,
provide
your
REB
file
no:
___________________________
For
more
information
please
visit
the
University
of
Windsor’s
Research
Ethics
Board
website:
www.uwindsor.ca/reb
Use
of
Genetically
Modified
Organisms
/
Cell
Lines:
If
no,
please
proceed
to
next
section.
Will
the
genetic
sequences
be
from
the
following:
Yes
A
human
or
animal
pathogen
and
their
toxin?
A
Risk
Group
One
microorganism?
A
Risk
Group
Two
microorganism?
Known
oncogenes?
Gene
transduction
Yes
Will
you
use
a
live
vector(s)?
If
yes,
specify
source/origin(s):_______________________________
If
viral,
is
it
(are
they)
replication
defective?
If
no,
specify
source/origin(s):_______________________________
Is
the
virus
infectious
to
humans
or
animals?
No
No
Section
H:
Regulatory
Oversight:
Does
any
of
the
work
conducted
within
the
specified
locations
require
any
additional
approvals
or
permits.
If
yes,
please
attach
a
copy
of
the
approval
and/or
permit
for
all
applicable
biological
agents.
Permit
Required
(Yes/No/Unsure):
Canadian
Food
Inspection
Agency2
Permit
No:
2
–
CFIA
regulates
activities
which
may
cause
infections
within
animals.
For
more
information,
please
visit
their
website
at
http://www.inspection.gc.ca
Public
Health
Agency
of
Canada3
Permit
Required
(Yes/No/Unsure):
Permit
No:
3
–
Public
Health
Agency
regulates
activities
which
may
cause
infections
within
humans.
For
more
information,
please
visit
their
website
at
http://www.phac‐aspc.gc.ca
Section
I:
Personnel:
Please
list
all
personnel,
regardless
of
employment
status,
who
will
be
using
biological
agents
listed
within
this
application;
provide
attachment
if
space
is
insufficient.
Name
Title
Student
/
Employee
ID
Biosafety
Office
Use
Only
DBase
Updated
Section
J:
Immunization:
If answering ‘no’ to any of these questions, please provide explanation on an attachment to
this application form.
Question
Yes
No
Do all of the above persons demonstrate antibody titres against those hazardous biological agents
identified above for which a licensed immunizing agent is available to protect workers against
infection?
Are medical certificates available to attest to the immunizations and / or adequate antibody titres?
Unless known to have pre-existing immunity, are these persons encouraged to obtain relevant
immunization with a licensed immunizing agent to protect against infection by the identified
hazardous biological agent?
Will this work require medical surveillance? If yes, please describe what type of medical
surveillance is required:
Section
K:
Declaration:
I declare that I am familiar with the contents of Health Canada’s Laboratory Biosafety Guidelines, 3rd Edition (2004) and
that the above describes my research program, insofar as this includes the use of hazardous biological agents and
materials, in its entirety.
As the legally responsible individual, I will ensure that all research conducted under my direction in the above
laboratories and by the above personnel conforms to the requirements of the University of Windsor’s Biological Safety
Program. In addition, I understand that if either myself and/or designated personal are found to be in breach of either
institutional and/or Health Canada guidelines all funding maybe frozen until corrective action is taken.
Signature of Principle Investigator
Date
Biological Safety Program Use Only:
Institutional Responsible Official (RO):
Select and circle: AP (Approved);
CA (Conditionally Approved);
Signature of Institutional Responsible Official (RO)
RS (Review & Resubmit)
Date
Conditions/Comments:
University of Windsor Biological Safety Committee – Chair (UWinBSC):
Select and circle: AP (Approved);
CA (Conditionally Approved);
Signature of Chair - UWBSC
Date
Conditions/Comments:
Biological
Safety
Certificate
No:
Issued
Date:
Expiry
Date:
Classification:
Restrictions:
RS (Review & Resubmit)
NOTES:
A valid University of Windsor Biological Safety Certificate is required for all University laboratory activities which involve
the use or manipulation of potentially hazardous biological agents and materials containing such agents, including
bacteria, viruses, fungi, parasites, recombinant DNA, human and animal tissues and cells, and human and animal
blood and body fluids. This requirement applies to activities which are either supervised by University employees or
conducted within the University, irrespective of the source of the funds used to support this activity. Biological agents
need not be overtly pathogenic; even agents which are “unlikely to cause disease in healthy workers or animals” are
assigned to Risk Group 1 and require Containment Level 1 conditions for their manipulation.
The required information must be typed or printed clearly and as completely as possible on the application form.
Illegible applications and those lacking the required information will be returned unsigned. In general, a single
application form may be used to identify all projects requiring the same Containment Level.
Information attachments may be required and are acceptable if space is insufficient on the application form. Since
attachments will not be returned, photocopies should be provided. The original documents should be retained by the
Principal Investigator.
A. Applicant Information:
One name is allowed per application form. In the case of projects which are supervised collaboratively, one individual
must be responsible for ensuring that the conditions of the permit are maintained. Generally, only one Biological Safety
Certificate is required for each Principle Investigator (P.I.).
B. Project Title(s)/Funding Sponsor and/or Agency Information:
Project titles must be matched with the corresponding sponsor or agency which is funding the activity. All sources of
financial support for the identified activities, whether internal or external, should be listed. Financial details are not
required. Activities involving potentially hazardous biological agents and materials which are not directly supported by
grants or contracts must also be reported on a University of Windsor Biological Safety Certificate.
C. Facilities / Project Location:
All laboratory facilities used by the Principal Investigator and her / his group for activities involving hazardous biological
agents and materials must be listed, whether or not these are shared with others. The required Containment Level of
individual rooms may be determined by referring to Health Canada’s Laboratory Biosafety Guidelines, 3rd edition
(2004). The submission of an application for a University of Windsor Biological Safety Certificate implies willingness to
allow the University of Windsor Responsible Official, Biological Officer, and/or his or her designate to visit the
laboratory sites used by the Biological Safety Certificate holder in order to determine compliance with the requirements
of the Biological Safety Program.
D. Biological Safety Cabinet(s):
Biological safety cabinets used in laboratory activities requiring Containment Level 2 and higher containment must be
tested and approved for use annually, unless otherwise noted. For each such biological safety cabinet, attach a copy of
the report on the testing and certification performed during the previous 12 month period. If cabinet testing was not
performed within the past year or the report is more than 12 months old, please make the necessary arrangements and
indicate the scheduled retesting date. For information about arranging this testing, consult the University of Windsor’s
Responsible Officer (RO) – Biological Safety or the Biological Safety website.
E. Identification of Animal Usage with Biological Agents:
Indicate by marking the appropriate boxes, whether or not animals will be used in conjunction with biological agents in
the identified project(s). Provide a brief outline identifying those activities involving both animals and biological agents,
and the Animal Research Protocol Number(s). For more information, please visit the University of Windsor’s Animal
Care Committee website.
F. Identification of Radiological Usage with Biological Agents:
Indicate by marking the appropriate boxes, whether or not radioisotopes will be used in conjunction with biological
agents in the identified project(s). Provide a brief outline identifying those activities involving both radiological and
biological agents, and the University of Windsor Radiation Safety Number(s). For more information, please visit the
University of Windsor’s Radiation Safety Committee website.
G. Identification of Biological Agent Usage:
Indicate by marking the appropriate boxes and then specifying the biological agents and materials to be used. Provide
and attach a brief outline identifying those procedures, activities and manipulations which involve the use of biological
agents in each project. Health Canada has identified four Risk Groups and assigned biological agents to these groups.
Descriptions of cell and tissue cultures must indicate the species, whether they are primary or established lines, and
whether they contain, or may contain, oncogenic or other viruses.
In general, activities involving human blood, organs, tissues and cells must be conducted at a minimum of
Containment Level 2. In some circumstances, such work may be conducted at a lower Containment level. However, if
such is desired, documentation to justify this request must be attached to the application form for review by the
Biological Safety Committee. When standard recombinant DNA techniques are used and the source of the genetic
material being transferred, the vector (if any), and the recipient host are all innocuous or have low risk characteristics,
no additional details are required. If there is potential for producing recombinant microorganisms with a significantly
elevated level of risk, or if any of the constituent parts pose a higher risk, then disclosure is required on an attachment
for review.
H. Other Agency Approval or Permit:
If the proposed activity requires the approval of any other agency (e.g., Public Safety, Canadian Food Inspection
Agency, and Agriculture and Agri-Food Canada), evidence of such approval must be provided as an attachment.
Provide and attach a copy of the approval or permit.
I. Personnel:
All personnel, including undergraduate and summer research students, directly involved in the identified
project(s) of the Principal Investigator and working within the identified facilities must be listed. If new personnel start
working on the project during the validity period of the certificate, the University of Windsor’s Responsible Officer (RO)
– Biological Safety must be notified and provided with the information so that the certificate may be amended.
J. Immunization:
Laboratory personnel should be protected against laboratory-acquired infections by appropriate immunization with
relevant, licensed vaccines unless documented to have pre-existing immunity. Hepatitis B immunization is strongly
recommended for all persons who handle or are exposed to human blood, body fluids, organs or tissues.
Immunoprophylaxis and information pertaining to the availability and the advisability of immunizing agents are available
through the following: Windsor Essex Health Unit – Immunization Unit, 1005 Ouellette Avenue, Windsor, Ontario N9A
4J8 (519) 258-2416 ext. 1222.
Immunizing agents are available to protect laboratory workers against:
Anthrax
Botulism
Cholera
Diphtheria
Hemophilus influenzae type b
Hepatitis A
Hepatitis B
Influenza A
Japanese encephalitis
Lyme disease
Measles
Meningococcus
Mumps
Pertussis
Plague
Pneumococcus
Polio
Rabies
Rubella
Tetanus
Tuberculosis (BCG)
Typhoid
Vaccinia
Varicella
Yellow fever
K. Declaration:
By signing this declaration, the Principal Investigator acknowledges full responsibility for the activities under her /his
supervision, and agrees to maintain and operate her / his laboratory facilities in compliance with the University of
Windsor’s Biological Safety Program.
Review and Approval: The completed, signed application form must be submitted to the University of Windsor’s
Responsible Officer (RO) / Biosafety Officer for review and approval. If the proposed activity requires a permit or the
approval of any other agency (e.g., Health Canada, Agriculture and Agri-Food Canada, Canadian Food Inspection
Agency), evidence of such approval must be provided.
Biological Safety Certificate Validity, Expiration, and Amendments: University Biological Safety Certificates for
activities requiring Containment Level 1 are valid for 2 calendar years from the date of approval by the University
Biological Safety Committee Chair or, in the case of renewals, from the expiration date of the previous Certificate.
Similarly, University Biological Safety Certificates for activities requiring Containment Level 2 or Containment Level 3
are valid for 1 year only. Only those activities and agents identified on the application form and attachments are
covered. Significant changes (e.g., use of additional hazardous biological agents and materials, new personnel, animal
use) must be reported to the University of Windsor’s Responsible Officer (RO) – Biological Safety so that an
appropriate amendment may be made to the Biological Safety Certificate. The submission of another application form
may not be necessary. In most cases, amendments will be recorded as an attachment to the current Certificate on file.
Requests for an amendment must include the following information: (A) Principal Investigator’s name; (B) Principal
Investigator’s signature; (C) Current University of Windsor Biological Safety Certificate number; and (D) Description of
the requested amendment.
This information must be provided to:
Chemical Control Centre
University of Windsor
Essex Hall – B37
401 Sunset Avenue
Windsor, Ontario N9B 3P4
(519) 253-3000 ext. 3523 (p)
(519) 973-7013 (f)
[email protected] (e)
Assistance, Information, and the World Wide Web:
The University of Windsor’s Biological Safety Program is available at: http://www.uwindsor.ca/biosafety
This site contains the text of the University of Windsor’s Biological Safety Program, reference guides, contact
information, MSDS information, and other biological safety related information.
Questions remaining unanswered after accessing this site, and requests for assistance should be directed to:
University of Windsor’s Responsible Officer – Biological Safety
Chemical Control Centre
University of Windsor
Essex Hall – B37
401 Sunset Avenue
Windsor, Ontario N9B 3P4
(519) 253-3000 ext. 3523 (p)
(519) 973-7013 (f)
[email protected] (e)