Procedure for
Working with
Biological Material
Version
2.0
TRIM file number
D09/13611
FoS document
Biological Procedure
Short description
Procedure for the management of biological materials.
Relevant to
All workers
Authority
This Procedure has been approved by Dean Faculty of Science
under the Governance (Policy and Procedures) Rule 2005 of the
Council and sections 20 and 32 of the CSU Act.
Responsible officer
Manager, University Laboratories
Responsible office
Faculty of Science
Date introduced
November 2013
Next scheduled review date
November 2016
Related University documents
CSU Administration Manual, CSU Legislative Manual, CSU
Accident and Incident Guidelines, CSU Biosafety Manual, CSU
Code of Conduct, CSU Health and Safety Policy, CSU risk
Management Policy, FoS Risk Assessment Procedure, FoS Risk
Register Procedure, FoS Waste Management Procedure, FoS
Biological Agents Register Form, FoS Quarantine Goods Record
Form, FoS Autoclave Log Register, FoS Biological Legislation
Register
Related legislation
Commonwealth:
Biological Control Act 1984
Crimes (Biological Weapons) Act 1976
Gene Technology Act 2000
Quarantine Act 1908
National Health Security Act 2007
NSW:
Animal Diseases Act 1991
Animal Research Act 1985
Biological Control Act 1985
Gene Technology Act 2003
Human Tissue Act 1983
Plant Diseases Act 1924
Protection of the Environment Operations Act 1997
Public Health Act 1991
Work Health and Safety Act 2011
Key words
Procedure, biological, storage, risk , physical containment,
teaching, research, science
Procedure for Working with Biological Material
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1.
PURPOSE
In accordance with the CSU Occupational Health and Safety Policy and the Work
Health and Safety Act 2011 the Faculty of Science (FoS) will do whatever is
reasonably practicable to ensuring health and safety. Central to achieving this is all
workers understanding their duty of care responsibilities and the specialised risks
associated with the FoS Facilities.
This procedure outlines the requirements for the safe and compliant acquisition,
production and use of biological material including, but not limited to, microorganisms
in the FoS Facilities.
2.
SCOPE
This procedure applies to all workers conducting or intending to conduct work or
research with microorganisms or other biological material in the FoS Facilities where
workers may potentially be exposed to:
 Human blood, tissue, body fluid and excreta
 Animals and their tissues, blood, body fluids and excreta
 Material contaminated or potentially contaminated with infectious organisms
 Imported biological material
 Biological material with restrictions on movement administered by State
Departments of Primary Industry
 Microorganisms
 Diseased plant/plant material and soil material, noxious weeds, invasive plants,
herbicide resistant plant and seed loaded soil
 Viruses
 Prions
3.
DEFINITIONS
Biological Material: Bacteria, viruses, protozoa, fungi, parasites, or molecules derived
from these which are capable of causing infection or disease in humans, animals, and
plants. Plant material and soil material, noxious weeds, invasive plants, and herbicide
resistant plants and seeds and seed loaded soil.
Biosafety Manual: Procedures, guidelines and policies written by the Institutional
Biosafety Committee that govern the use of biological material at CSU.
Institutional Biosafety Committee: Advisory committee that oversees the use and
research of biological agents in the university (IBC).
Procedure for Working with Biological Material
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Physical Containment (PC1 to PC4): Is the level of ranking that is given to a
laboratory or facility that handles biological material. It reflects the risks involved with
the agents that can be handled as per AS/NZS 2243.3, DAFF Biosecurity, SSBA Act
and the Guide to Physical Containment Levels and Facility Types (OGTR).
Risk Groups (risk groups 1-4): Is the ranking level given to biological material by the
AS/NZS 2243.3. Generally the grouping means the organism must be worked with in a
facility with the same level of physical containment e.g. risk group 2 organisms are
usually worked with in a PC2 facility, however with approval a risk group 2 organism
can be worked with in a PC1 facility in a biological safety cabinet .
4.
4.1
PROCEDURE
Responsibilities
Workers - CSU Institutional Biosafety Committee:
 Approve acquisition and maintain a list of Risk Group 2 organisms kept within
university facilities
 Inspect annually physical containment facilities certified by the Office of Gene
Technology Regulator (OGTR), laboratories classified at PC2 or above and clinics
 Review CSU Biosafety policies, procedures and guidelines in accordance with
relevant national and state legislation and guidelines
Worker – Manager, University Laboratories:
 Register all physical containment laboratories, facilities and quarantine facilities
 Ensuring Managers of containment facility are adequately trained and qualified
 Allocating areas deemed high or medium risk in relation to biological material
Worker - Head of School (HoS):
 Ensure all biological risks associated with research and/or teaching are managed in
accordance with national and state legislation and guidelines, and FoS and IBC
procedures and guidelines
 Ensure workers vaccinations are in accordance with the Australian Immunisation
Handbook
 Work with individual workers or cohorts to assess and implement vaccination
requirements for specific occupational risks
Worker - Principle Researcher and/or Academic Staff Member using material requiring
IBC approval for teaching:
 Ensure that all biological material and any subcultures thereof, are identifiable by
means of an appropriate and approved nomenclature
 Complete all essential risk documentation
 Check that an appropriately classified laboratory, in accordance with AS/NZS2243.3
is available
Procedure for Working with Biological Material
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Apply for approvals/licenses from CSU and regulatory bodies (see Table 1)
Submit risk documentation and all approvals/licenses to the Facility/Laboratory
Manager
Notify Facility/Laboratory Manager of changes to the risk register
Maintain biological materials register
Maintain microorganism register
Ensure all biological waste generated on site is disposed in accordance with FoS
Waste Management Procedure and relevant legislative requirements
Ensure workers vaccinations are in accordance with the Australian Immunisation
Handbook
Work with individual workers or cohorts to assess and implement vaccination
requirements for specific occupational risks
Provide adequate staff training
Provide Facility/Laboratory Manager with documentation of staff training for training
records
Participate in training when requested
Inform all female employees of the potential risk to themselves and their unborn child
as a result of occupational exposure to certain microorganisms
Participate in IBC inspections when requested
Comply with CSU Accident/Incident Policy
Worker - The Facility/Laboratory Manager:
 Review and approve, as appropriate, risk documentation
 Ensure the register of all biological materials is maintained
 Ensure the register of all microorganisms is maintained
 Maintain worker training records
 Implement Waste Management Procedure
 Ensure autoclave register is maintained
 Ensure laboratory manual is maintained
 Ensure, in date, SDS sheets for biologicals are available
 Ensure workers vaccinations are in accordance with the Australian Immunisation
Handbook
 Work with individual workers or cohorts to assess and implement vaccination
requirements for specific occupational risks
 Inform all female employees of the potential risk to themselves and their unborn from
occupational exposure to certain microorganisms
 Participate in IBC inspections
 Comply with CSU Accident/Incident Policy and maintain records
Workers – Technical Staff:
 Ensure that all biological material and any subcultures thereof, are identifiable by
means of an appropriate and approved nomenclature
 Ensure the register of all biological materials is maintained
 Ensure the register of all microorganisms is maintained
Procedure for Working with Biological Material
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Comply with all risk documentation
Participate in training as required
Report any hazards, spill or containment issues to the Principle Researcher and/or
the Facility/Laboratory Manager
Complete SWPs as directed by the Facility/Laboratory Manager
Notify the Principle Researcher and/or the Facility/Laboratory Manager if you are at
risk
Work with the Principle Researcher and/or the Facility/Laboratory Manager to ensure
your safety
Workers – Students:
 Ensure that all biological material and any subcultures thereof, are identifiable by
means of an appropriate and approved nomenclature
 Ensure the register of all biological materials is maintained
 Ensure the register of all microorganisms is maintained
 Comply with all risk documentation
 Participate in training as required
 Report any hazards, spill or containment issues to the Principle Researcher and/or
the Facility/Laboratory Manager
 Complete SWPs as directed by the Principle Researcher, the Facility/Laboratory
Manager or Academic in Charge
 Notify the Principle Researcher, Facility/Laboratory Manager or Academic in Charge
if you are at risk
 Work with the Principle Researcher, the Facility/Laboratory Manager or the Academic
in Charge to ensure your safety
4.2
Requirements
Before commencing work with biological material all workers must complete all
essential risk documentation, check that an appropriately classified laboratory, in
accordance with AS/NZS2243.3 is available, apply for approvals/licenses from CSU
and regulatory bodies (see Table 1) and submit risk documentation and all
approvals/licenses to the Facility/Laboratory Manager.
4.2.1 General Requirements for working with Biological Material
Signage
All FoS Facilities are required to display the FoS door signage on all entrances
or in the near vicinity. The sign includes symbol notification of any known
dangerous good or hazards. FoS Facilities used for work with biological material
or microorganisms must display the biological and infectious substances symbol.
Facility Microorganism Register
A register of all microorganisms introduced into a facility must be kept. This
register is to contain the microorganisms:
Procedure for Working with Biological Material
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 Date of arrival
 Scientific name and common name
 Risk group level
 Collection number/culture collection number or relevant identifying code
 Name, asset number and location (Bd and Rm) of the refrigerator or freezer
being used for storage
 Date and method of destruction
Facility Biological Material Register
A register of all biological material introduced into a facility must be kept. This
register is to contain:
 Date of arrival
 Scientific name and common name
 Risk group level
 Collection number/culture collection number or relevant identifying code
 Name, asset number and location (Bd and Rm) of the refrigerator or freezer
being used for storage
 Date and method of destruction
Labelling
Refrigerator or freezer being used for storage must display:
 Name and/or number of the refrigerator or freezer
 Asset number
 Microorganisms Register
 Biological Material Register
 Contains biological material sign
 Contains infectious material sign (when appropriate)
 Must not store any items for human consumption sign
Containers storing microorganisms must be labelled with:
 Organism name
 Worker responsible and their contact details
 Risk group
 Date Cultured/Expiry date
If the worker is unable to label individual container (e.g. due to size restriction)
then the rack or container they are being stored in must be labelled
appropriately.
Autoclave Register
An Autoclave Log Register shall be kept of all autoclaved material with the
following information:
 Date
 Operator
 Cycle Used
Procedure for Working with Biological Material
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Origin and type of load
Attach thermolog – this indicates if sterilisation was successful.
Autoclave must be compliance tested annually and a spore test must be
completed at least every month.
Human and Animal Diagnostic Specimens
Handling diagnostic specimens must be in accordance with Australian Standard
2243.3 (section 3.4). Diagnostic specimens from humans or animals are usually
classed as Risk Group 2 and shall be worked with in a PC2 or above Facility.
Any organism isolated from the specimen shall be handled with care in an
appropriately levelled facility.
4.2.2 Additional Requirements for Working with Biological Material
Gene Technology
The transport, possession, handling manipulation and storage of genetically
modified material is to be carried out in accordance with the Gene Technology
Act 2001 and is regulated by the Office of the Gene Technology Regulator.
Any dealings with genetically modified organisms requires approval from the
Institutional Biosafety Committee (IBC).
Information about the class of dealing or appropriate application procedures can
be found on the IBC website or the OGTR website.
Australian Quarantine and Inspection Service (AQIS)
Any research involving imported material must be done in accordance with DAFF
Biosecurity: AQIS regulations.
Infection Control
Teaching and/or research involving patients or patient/student scenario’s in FoS
Facilities and Specialist Teaching Spaces and off campus localities used for
work, research or study (e.g. field sites and placement facilities) must follow the
Australian Guidelines for the Prevention and Control of Infection in Healthcare
(2010) and NSW Health Infection Control Guidelines.
Animals, Plants and Aquatic Materials Biosecurity
Any biosecurity sensitive dealings with animals, plants or aquatic material must
be in accordance with NSW Department of Primary Industries (DPI) and relevant
legislation e.g. movement of grapevines, fruit, vegetable and bees both intrastate
and interstate.
Procedure for Working with Biological Material
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Noxious Weeds
Dealings with any noxious weed must be in accordance with NSW DPI, weed
control orders and the Noxious Weed Act (1993). Information regarding permits
to have and cultivate weeds for research and education can be found on the
NSW DPI website.
Herbicide Resistant Seeds
Dealings with any herbicide resistant seed require IBC approval.
Security Sensitive Biological Agents (SSBA)
Dealings with SSBA’s must be in accordance with National Health Security Act
2007, the National Health Security Regulations 2008 and the SSBA Standards.
Before commencing work with SSBA’s consent must be obtained from the IBC,
the Dean of Science and the Manager of University Laboratories. All licenses
and containment arrangements must be in place before any work on SSBA’s
commences. A list of SSBA’s (current) can be found at:
http://www.health.gov.au/SSBA#list
4.3
Risk Management Summary
1) Complete all essential risk documentation
2) Check that an appropriately classified laboratory, in accordance with
AS/NZS2243.3 is available
3) Apply for approvals/licenses from CSU and regulatory bodies (see Table 1)
4) Submit risk documentation and all approvals/licenses to the
Facility/Laboratory Manager
5) Update Risk Register
6) Maintain Biological Agents Register
7) Maintain Microorganism Register
8) Provide staff training
9) Provide all training records to the Facility/Laboratory Manager
10) Participate in training when requested
11) Participate in IBC inspections when requested
12) Comply with CSU Accident/Incident Policy
Table 1 Approval Requirements
Biological Hazard
Microorganism Risk group 1
Microorganism Risk group 2
Microorganism Risk group 3
CSU approval
 Facility/Laboratory Manager
 IBC (required to keep a record)
 Facility/Laboratory Manager
 IBC
 Dean of Science, HoS, Manager
Compliance requirements
 AS2243.3
 AS2243.3
 AS2243.3
Procedure for Working with Biological Material
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Microorganism Risk group 4
Genetically modified organism
Animal tissue, blood or body
fluids (excludes procurement
from suppliers e.g. abattoirs,
pharmaceutical companies)
Human tissue, blood or body
fluids
Import or export of biological
material (general)
of University Laboratories
 Facility/Laboratory Manager
Not able to be approved
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Import or export of biological
material (risk group organisms)
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Security Sensitive Biological
Agents
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Noxious weeds
Herbicide resistant seed
4.4
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IBC
HoS
Facility/Laboratory Manager
Animal Care and Ethics
Committee
IBC if they may contain RG2
organisms
School Ethics Committee (low
risk) or Ethics in Human
Research Committee
IBC
As per Quarantine Goods
Records Form
As per licensing requirements
IBC
As per Quarantine Goods
Records Form
As per licensing requirements
IBC
Dean of Science, Manager of
University Laboratories
Facility/Laboratory Manager
Research Supervisor
HoS
IBC
 No facility at CSU
 AS2243.3
 Gene Technology
Legislation
 Animal Research Act
 NHMRC
 AS2243.3
 Dept Foreign Affairs and
Trade
 AQIS approval
 Dept Foreign Affairs and
Trade
 AQIS approval
 AS2243.3
 National Health Security
Act
 AS2243.3
 Noxious Weeds Act
Immunisation
Workers are at increased risk of vaccine preventable diseases when:

Working with infectious organisms
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Working with body fluids or human blood
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Working with animals
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Working with soil

Working in childcare

First Aid Officer

Conducting fieldwork

Laboratory cleaners

Travelling overseas
Vaccinations should be in accordance with the recommendations of the Australian
Immunisation Handbook. Additional vaccinations may be required as a result of
specific occupational risks e.g. clinical training. The HoS and/or the Facility/Laboratory
Procedure for Working with Biological Material
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Manager will work with individual workers or cohorts to assess and implement
vaccination requirements as necessary.
4.5
At Risk Workers
Workers who are immuno-suppressed or immuno-compromised and are handling human
pathogens as part their duties should inform their supervisor. The Facility/Laboratory
Manager and worker, seeking medical advice when necessary, will work together to assess
and implement vaccination requirements as necessary.
4.6
Precautions for Women
Workers who are pregnant will be informed of the risk to themselves and their unborn child
from occupational exposure to some infectious material, Medical opinion may be required
when determining protection methods. The Facility/Laboratory Manager and worker, seeking
medical advice when necessary, will work together to ensure the safety of the worker and
their unborn child.
Organisms as per AS2243.3 of concern include:
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5.0
Toxoplasma gondii
Listeria monocytogenes
Cytomegalo virus
parvovirus B19
rubella virus
human immunodeficiency virus
Coxiella burnetii
hepatitis B,C and E viruses
some fungi
REFERENCES and UNIVERSITY RELATED DOCUMENTS
Australian Government - National Health Security Regulations 2008
Australian Standard AS/NZS 2243.3:2010 Safety in Laboratories part 3 Microbiological
aspects and containment facilities
Department of Health - Office of the Gene Technology Regulator
Department of Health and Aging - Australian Immunisation Handbook
Department of Health and Aging Office of the Gene Technology - Explanatory Information –
Guide to Physical Containment Levels and Facility Types
Department of Heath and Aging - SSBA Guidelines
Health and Medical Research Council (NHMRC) - Australian Guidelines for the Prevention
and Control of Infection in Healthcare (2010)
NSW Health - Infection Control Policy
Procedure for Working with Biological Material
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Commonwealth Legislation:
Biological Control Act 1984
Crimes (Biological Weapons) Act 1976
Gene Technology Act 2000
Quarantine Act 1908
National Health Security Act 2007
NSW Legislation:
Animal Diseases Act 1991
Animal Research Act 1985
Biological Control Act 1985
Gene Technology Act 2003
Human Tissue Act 1983
Plant Diseases Act 1924
Protection of the Environment Operations Act 1997
Public Health Act 1991
Work Health and Safety Act 2011
CSU Administrative Manual
CSU Legislative Guide
CSU Accident and Incident Guidelines
CSU Biosafety Manual
CSU Code of Conduct
CSU Health and Safety Policy
FoS Risk Assessment Procedure
FoS Risk Register Procedure
FoS Waste Management Procedure
FoS Biological Agents Register Form
FoS Quarantine Goods Record Form
FoS Autoclave Log Register
FoS Biological Legislation Register
6.0
Table of amendments
Version
number
1.0
2.0
Date
08/2011
11/2013
Short description of amendment
Original document
Updated after Faculty of Science Review 2013.
Procedure for Working with Biological Material
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