Transcript Biosafety training manual [Powerpoint, 1.0MB]

Swinburne Biosafety Committee
• Presentation title
Biosafety Training Module
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Swinburne Biosafety Committee (SBC)
The SBC is responsible for reviewing and
approving Swinburne activity (research
and teaching) or facilities involving:
Genetically
Modified Organisms
(GMOs)
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Biohazardous
materials/hazardous
biological agents
Swinburne Biosafety Committee
You will need SBC approval for matters involving
• GMOs & certification of physical containment facilities in
which GMO dealings will be conducted
• Organisms in Risk Group 2, 3 or 4 (AS/NZS 2243.3:2010) or
procedures that may result in the isolation or enrichment
of such organisms
• All human tissue or blood products
• Cultured primary mammalian cells or mammalian cell lines
likely to contain infectious agents
• Material of biological origin that may be or may contain a
hazard to humans e.g. toxins, allergens, prions
• Security Sensitive Biological Agents (SSBAs)
• Quarantine materials in any of the above categories
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Topics to be covered
• Presentation title
Genetically Modified Organisms
(GMOs)
Biologically hazardous
microorganisms
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Microorganisms
Topics:
modes of disease transmission
standard precautions
biological safety cabinets
spill & waste management
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Transmission
Escape from the
host or reservoir
of infection
Entry to the new
host
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Transport to the
new host via
ingestion,
inhalation or
skin penetration
Standard precautions
personal hygiene practices, particularly handwashing
use of personal protective equipment (gloves, gowns and protective eyewear)
use of 70% alcohol-based chlorhexidine (0.5%) hand rub solutions as an adjunct to hand
washing
appropriate handling and disposal of sharps and other infectious waste
adequate sterilisation of reusable equipment
environmental controls, including design and maintenance of premises
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Biological safety cabinets
Biological safety cabinets (BSC) are used when working with specimens containing
micro-organisms transmissible by the respiratory route or when work produces a
significant risk from aerosol production.
Class I
• exhaust-ventilated, protection is
afforded by an inward flow of air
away from the user and a HEPA
(high efficiency particulate air)
filter is used before exhaust air is
discharged from the cabinet
Class II
• provide protection by inducing
an inflow of room air through the
work access opening, by passing
recirculated, HEPA-filtered,
laminar flow air over the work
zone to prevent it becoming
contaminated. A HEPA filter is
used before exhaust air is
discharged from the cabinet.
Class III
• completely enclosed unit and
the user is physically separated
from the work. Both incoming
and outgoing air passes via HEPA
filters.
• This class of safety cabinet is
used for work with high-hazard
micro-organisms
* Bunsen burners should not be used in Class II cabinets as they disrupt the laminar flow and the barrier air.
* Laminar flow benches must never be used when handling pathogenic materials as any aerosols formed will
be directed at the user.
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Spills & waste management
Spills
PC2 facility
• risk assessment determine
the hazard level & identify
the proper clean-up
procedure
Biosafety cabinets
• small and contained
• aerosols removed
*All spills must be reported.
Waste
Decontaminate
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Dispose of carefully
Microorganisms
The basic approach to
working with
microorganisms is to
regard them as
potential pathogens
and to handle them
with standard
microbiological
techniques
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AS/NZS 2243.3:2010
Safety in laboratories
Part 3: Microbiological
safety and
containment classifies
microorganisms into
four risk groups and
specifies work
requirements for the
corresponding four
physical containment
levels
PC labs according to
AS/NZS 2243.3:2010
are not the same as
OGTR-certified PC labs
– so please ensure you
know which you are
referring.
Microorganisms
Risk Group categories
Risk Group 1
(low individual and
community risk) unlikely to
cause human or animal
disease.
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Risk Group 2
Risk Group 3
(moderate individual risk, limited
community risk)
unlikely to be a significant risk to
laboratory workers, the
community, livestock, or the
environment; laboratory
exposures may cause infection,
but effective treatment and
preventive measures are
available, and the risk of spread is
limited.
(high individual risk, limited to
moderate community risk)
usually causes serious human or
animal disease and may present a
significant risk to laboratory workers.
It could present a limited to
moderate risk if spread in the
community or the environment, but
there are usually effective
preventive measures or treatment
available.
Risk Group 4
(high individual and community risk)
usually produces life-threatening
human or animal disease, represents
a significant risk to laboratory
workers and may be readily
transmissible from one individual to
another. Effective treatment and
preventive measures are not usually
available.
Microorganisms
Risk Group
1
Risk Group
2
Risk Group
3
Risk Group
4
PC1
PC2
PC3
PC4
Human and animal clinical and diagnostic specimens would normally be regarded as Risk Group 2 and
shall be handled in PC2 facilities unless a higher risk group is indicated by the clinical notes.
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Microorganisms
Some
important
points:
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• Persons who are immuno-suppressed,
immuno-compromised, or vulnerable to
infection, should inform their supervisor or
laboratory manager of their condition so that
appropriate action may be taken.
• All female employees should be warned of the
risk to the unborn child or the pregnant woman
of occupational exposure to certain
microorganisms, e.g., Listeria monocytogenes,
rubella virus, human immunodeficiency virus
(HIV), hepatitis B, C and E viruses.
Microorganisms
Examples of Risk Group 2 bacteria
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Examples of Risk Group 2 parasites
(reproduced from AS/NZS 2243.3:2010)
Microorganisms
Examples of Risk Group 3 viruses
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Examples of Risk Group 4 viruses
Genetically Modified Organisms
Definition
Legislation
GMOs at
Swinburne
- handling
- storage
- containment
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Definition: What is a GMO?
An organism that has
been modified by GT*
An organism that has
inherited traits from an
organism that occurred
in the initial organism
because of GT*
*GT (Gene Technology) any
• sexual reproduction
technique for the modification
• homologous recombination
of genes or other genetic
material, but does not include: • any other technique specified in the regulations.
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What is not a GMO?
Naturally occurring
mutations
Fusion of animal cells
(unless the product can
form an animal)
Plants formed by
protoplast fusion,
embryo rescue or in
vitro fertilisation or
zygote implantation
Organisms formed by
natural DNA transfer
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(reproduced and modified with permission from Curtin University
Health and Safety)
GMO Regulation
Gene Technology
(GT) Act 2000
Gene Technology
Regulations 2001
Federal Administration via
the Office of the Gene
Technology Regulator
(OGTR)
States have mirror
regulations
Regulations reviewed and
updated regularly
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Object of the GT Act (2000)
to protect the health and safety of people and the
environment:
• by identifying risks posed by or as a result of
gene technology, and
• by managing those risks through regulating
certain dealings with GMOs.
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Role of the Office of the Gene
Technology Regulator (OGTR)
Accreditation of
organisations
• Ensures that
sufficient oversight
is in place
• Institutional
Biosafety
Committee (IBC)*
•At Swinburne, IBC = Swinburne
Biosafety Committee
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Certification of
facilities
Certification of
dealings
• Ensures conditions
necessary to
minimise risk are
maintained
• Ensures that GMO
dealings are
undertaken safely,
in appropriate
facilities, considers
ethics and ensures
there is a record
• Ensures
researchers are
appropriately
trained/responsible
What is a GMO ‘dealing’?
Defined in the
regulations
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• conduct experiments with the GMO
• make, develop, produce or manufacture the
GMO
• breed the GMO
• propagate the GMO
• use the GMO in the course of manufacture of
a thing that is not a GMO
• grow, raise or culture the GMO
• import the GMO
• transport the GMO
• dispose of the GMO
• includes the possession, supply or use of the
GMO for the purposes of, or in the course of,
a dealing mentioned above
Types of ‘Dealings’
Exempt
dealings
Low risk, negligible
consequences from
release
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Notifiable
low risk
dealings
(NLRDs)
Low risk as long as
certain conditions
are adhered to.
Dealings not
involving
release (DNIRs)
- Medium risk, mostly due
to potential for harm (to
people or environment)
from unintentional release
– allows the OGTR to
impose conditions to
manage risk
Dealings
involving
release
(DIRs)
High risk
Emergency
Dealing
Determination
(EDD)
Regulating GMO dealings
Regulations
Regulations contain detailed Schedules
Schedules define the category to which a dealing belongs
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Schedules
Schedule 1A: Techniques that are not GT
Schedule 1: Organisms that are not GM
Schedule 2: Dealings exempt from licensing
• Part 1 Exempt dealings
• Part 2 Host/vector systems for exempt dealings
• Part 3 Definitions
Schedule 3: NLRDs in relation to a GMO
• Part 1 NLRDs suitable for at least PC1 containment
• Part 2 NLRDs suitable for at least PC2 or PC3 containment
• Part 3 Dealings that are not NLRDs
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Physical Containment (PC)
facilities
The OGTR has adopted the four-tier
classification system based on AS/NZS 2243.3 for
certifying facilities suitable for GMO dealings
PC1
PC2
PC3
PC4
Physical Containment (PC)
facilities
Dealings must be conducted in a facility certified by the OGTR
at a level appropriate to the potential risk posed by the
dealing.
Exempt
not necessary,
but recommend
PC1 →PC2
NLRD
DNIR
PC1→PC3
PC2 → PC4
NB: PC4 is not applicable in the Swinburne context.
DIR
outside
containment
facilities
Dealings at Swinburne
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Exempt
NLRD
DNIR
DIR
NB: DNIR not applicable in
the Swinburne context
NB: DIR not applicable in the
Swinburne context.
Exempt dealings (examples)
GM
C. elegans
Dealings using
host/vectors
from Schedule 2
e.g.
E. coli/
non-conjugative
plasmids
GM of the
somatic cells
of an animal
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Note: devil’s in
the detail
– read the fine
print
Exempt dealings (at Swinburne)
The Swinburne
Biosafety Committee
must be notified
May be undertaken in a
non-OGTR certified
facility but recommend
PC2
Best practice
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• Maintain good laboratory practice
• GMOs should not be released into the
environment
NLRD - PC1 dealings (examples)
GM mouse, rat, guinea pig, rabbit
Replication defective adenoviral vectors
• Must not restore competence of the vector
• No genes that confer oncogenic modifications
in humans
• No genes that encode proteins with
immunomodulatory activity in humans
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NLRD – PC2 dealings (examples)
GM of whole animals (except mouse etc)
GM of plants
exempt host/vectors where the conditions for exempt status are not met
Non-exempt host/vectors
Volumes >25L
Viral vectors (assorted subcategories)
Note: devil’s in the detail – read the fine print!
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Working with NLRDs?
You must
Must have SBC approval BEFORE the
dealing starts
Must notify the OGTR (via SBC)
Must be undertaken in OGTR certified
PC2 labs
Undertake OGTR PC2 training (see your
Laboratory Manager)
Observe Part C: Behavioural
requirements Guidelines for Certification
of a Physical Containment Level 2
Laboratory
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OGTR-Certified PC2 behavioural
guidelines
Access and
Egress
• Restricted to authorised personnel
• All doors and windows must be closed
Non GMO
• Procedures must be in place to prevent
cross contamination
Aerosols
• Work that produces an aerosol must be
performed in a Biological Safety Cabinet
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PC2 behavioural guidelines
Decontamination
All decontamination procedures must be carried out by trained personnel.
GMOs must be rendered non-viable prior to disposal.
Wastes containing GMOs must be decontaminated prior to disposal.
Work benches, surfaces and equipment must be decontaminated when the
dealings are completed.
Equipment must be decontaminated before being removed from the facility.
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PC2 behavioural guidelines
Decontamination can be effected by
Autoclave
Chemical
Bleach (5000ppm sodium
hypochlorite = 0.5%) [Household
bleach = 4% sodium hypochlorite
1/8 dilution = final concentration
of 0.5% hypochlorite]
Freshly prepared (same day)
Do not autoclave bleach
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Transport
Between laboratories, buildings, campuses
Double contained
• Sealed unbreakable
containers
• Labelled
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Decontaminate (e.g.
80% ethanol spray)
• Primary container
prior to packing
• Secondary (outer)
container prior to
leaving the lab
Spills
If a spill occurs outside the facility:
All spilt material must be recovered and
contaminated surfaces decontaminated
Any real or suspected unintentional release must
be reported to the SBC and OGTR as soon as
reasonably possible.
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Your responsibilities
Everyone
• Work safely
• Look after yourself and those around
you
• Wear/use appropriate PPE
• Attend training sessions
• Keep accurate records of your GM
work
• Know which regulations affect your
work (and comply with them)
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Chief Investigators/Project leaders
• Get approval for GM work from
the Swinburne Biosafety
Committee
• Ensure work is undertaken in an
appropriately certified facility
• Ensure GM records are kept
• Ensure all people working with
GMOs have appropriate training
• Ensure appropriate supervision is
maintained
• Are responsible for staff and
students working on project
• Provide annual reports
Penalties – defined in GT Act
Breach of NLRDs
• 50 penalty units
($5,500)
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Breach of GMO licence (DNIR/DIR)
• Each day the breach occurs is
considered a separate offence!
• Aggravated offence = significant
damage to health and safety of
people or the environment
• 5 years imprisonment or 2000
penalty units ($1.1 million)
• Other cases
• 2 years imprisonment or 500
penalty units ($55,000)
Swinburne Biosafety Committee
You will need SBC approval for matters involving the following,
through the Research Integrity Office, prior to commencing.
• GMOs & certification of physical containment facilities in
which GMO dealings will be conducted
• Organisms in Risk Group 2, 3 or 4 or procedures that may
result in the isolation or enrichment of such organisms
• All human tissue or blood products
• Cultured primary mammalian cells or mammalian cell lines
likely to contain infectious agents
• Material of biological origin that may be or may contain a
hazard to humans e.g. toxins, allergens, prions
• Security Sensitive Biological Agents (SSBAs)
• Quarantine materials in any of the above categories
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Research Integrity Office
Advice on regulatory
and institutional
requirements for the
use of GMOs and
biological hazardous
materials.
Third (after Supervisor
and Lab Manager) point
of contact for queries
regarding applications
to use GMOs and/or
biological hazardous
materials
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Secretariat support to
the Swinburne
Biosafety Committee
(SBC)
Contact details:
Executive Officer, SBC
Research Integrity
Office
Swinburne Research
Regulating GMO dealings – extra info
• Exempt Dealings - certain types of dealings with GMOs which involve a very low risk (i.e. contained
research involving very well understood organisms and processes for creating and studying GMOs).
Other then listing in the Regulations, the only legislative requirement for exempt dealings is that they
must not involve an intentional release of a GMO into the environment.
• Notifiable Low Risk Dealings - the regulations also set out categories of dealings with GMOs which
are low risk and which may proceed provided that certain conditions spelt out in the regulations are
observed. This includes requirements that the specified dealings be undertaken only in certified
contained facilities, overseen by Institutional Biosafety Committees (IBCs) and notified annually to the
Regulator. The conditions under which such dealings must be conducted are clearly set out in the
regulations. An NLRD must not involve the intentional release of a GMO into the environment.
• Licences - all dealings with GMOs (that are not exempt or NLRDs or on the GMO Register) need to be
licensed by the Regulator. The licensing system is based on rigorous scientific risk assessment and
extensive consultation with expert advisory committees, Government agencies and, for intentional
releases of GMOs into the environment, the public.
• GMO Register - dealings with GMOs may be entered on the GMO Register once they have been
licensed for a certain period of time. Dealings will not be entered onto the Register until the Regulator
is satisfied that the dealings are sufficiently safe that they can be undertaken by anyone, and that
safety does not depend on oversight by a licence holder.
• Emergency Dealing Determination (EDD) - the Minister may make an EDD authorising dealings with
GMOs for a limited period in an emergency. The Minister must be satisfied that there is an actual or
imminent threat to people or the environment, that the EDD would adequately address the threat
and that risks posed are able to be managed so as to protect people and the environment. The
Minister must receive advice from the Regulator to management of risks.
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