MELBOURNE BIORISK STANDARDS PROCEDURE
RELEVANT LEGISLATION
Occupational Health and Safety Act 2004 (Vic)
Gene Technology Act 2000
Quarantine Act 1908
National Health Security Act 2007
Regulation 17.1.R8 - Code of Conduct for Research
GOVERNING POLICY
Biorisk Policy
SCOPE
This procedure applies to all work areas of the University where regulated biological material (RBM) is
stored, used, handled, transported or disposed.
The procedure applies to all staff and students of the University, including visiting and honorary staff.
PROCEDURE
1. Principles
1.1 The University seeks to protect the health and safety of people, animals and the
environment by identifying and managing risks posed by work with RBMs.
2. Purpose of the Melbourne Biorisk Standards (MBSs)
2.1 The MBSs will guide the conduct and approval of work involving RBM.
2.2 Staff and students who work with RBM will refer to the MBSs when making applications to
the Gene Technology and Biosafety Committee (GTBC).
2.3 The GTBC will refer to the MBSs when reviewing and making decisions about
applications.
2.4 The MBSs should be evidence-based, will reflect current or accepted best practice and
will allow for flexibility that is required in work with RBMs.
2.5 The MBSs may be prepared by anyone involved in work with RBMs at the University.
2.6 The MBSs will be developed in consultation with relevant stakeholders.
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3. Proposal to create a Draft MBSs
3.1 Before drafting a MBS author(s) must first submit a proposal to the GTBC.
3.2 The GTBC or its delegate will assess the proposal to determine the suitability of the
proposed MBS.
3.3 The GTBC will advise the author(s) if the proposed MBS should proceed to drafting or if it
is unsuitable.
4. Creation of Draft MBSs
4.1 Draft MBSs must be prepared in line with the principles described herein and using the
template provide by the Office for Research Ethics and Integrity (OREI).
4.2 The GTBC will assess the draft MBS to determine its suitability and advise the author(s) if
the draft should proceed to consultation or if it requires redrafting or if it is unsuitable.
5. Consultation of Draft MBSs
5.1 The OREI will manage the consultation process. As part of this,
5.1.1
OREI will undertake sufficient checks including but not limited to those to ensure:
5.1.1.1 Compliance with all relevant regulatory requirements,
5.1.1.2 Compliance with University regulations, policies and procedures,
5.1.1.3 Compliance with the MBS template.
5.1.2
OREI will enable University-wide consultation of the draft MBS with relevant
stakeholders.
5.1.3
The period of consultation of the draft MBS will be at least four weeks.
5.1.4
Feedback will be sent directly to the author(s) of the draft MBS.
5.2 The author(s) of the draft MBS will redraft the document in consideration of the feedback
received during the consultation period.
6. Approval of Draft MBSs
6.1 The GTBC will assess the post-consultation draft MBS and either:
6.1.1
Approve it for promulgation as an MBS; or
6.1.2
Advise the author(s) that the post-consultation draft MBS requires further
redrafting or consultation; or
6.1.3
Advise the author(s) that the post-consultation draft MBS is unsuitable.
6.2 The GTBC will determine when a MBS comes into effect.
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7. Promulgation of MBSs
7.1 OREI will promulgate the MBSs.
8. Use of MBSs
8.1 Staff and students who work with RBM will refer to the MBSs when making applications to
the GTBC.
8.2 The GTBC will refer to the MBSs when reviewing and making decisions about
applications.
9. Review of MBSs
9.1 Anyone involved in work with biological material at the University may recommend that a
MBS should be replaced, refined or removed.
9.2 Recommendations for the replacement, refinement or removal of a MBSs must be made
to GTBC.
9.3 The GTBC will consider recommendations for the replacement, refinement or removal of
a MBSs. Following consideration of a recommendation:
9.3.1
The GTBC may remove a MBS it deems unsuitable.
9.3.2
The GTBC may approve replacement or refinement of a MBS. Any replaced or
refined MBS shall be prepared in accordance with steps 4, 5 and 6 of this
procedure.
9.4 Minor amendments for clarity or to correct errors may be made by OREI and do not need
to go through this process.
10. Evaluation
10.1
OREI will establish an implementation evaluation plan, evaluation measures and
reporting requirements as appropriate.
RELATED DOCUMENTS
Australian/New Zealand Standards 2243.3: Safety in Laboratories Part 3: Microbiological safety and
containment
Containment Facility Internal Certification Procedure
Infectious Agent Project Approval Procedure
Infectious Agent Reporting Procedure
Melbourne Biorisk Standards
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DEFINITIONS
Term
Definition
Infectious agent
An infectious agent is a bacterium, fungus, virus or other agent
that is able to invade and replicate in a host organism (for
example, human, animal or plant) and which may or may not
cause a disease.
RBM
Includes but is not limited to:
 infectious agents (as above)
 hazardous infectious agents i.e. infectious agents able to
cause disease in an otherwise healthy host (for example
human, animal or plant).
Designated Work
Group

Biological material such as blood, tissues, cell lines or
body fluids sourced from a living organism that might
reasonably be expected to contain hazardous infectious
agents.

Genetically modified organisms, including viable
organisms that have been modified by gene technology;
or that have inherited particular traits from an initial
organism that occurred because of gene technology

Imported material requiring containment in a Quarantine
Approved Premise (QAP) due to the biosecurity risk. This
is based on the probability of a disease or pest being
introduced to Australia that may cause harm.
A Designated Work Group (DWG) is a negotiated and agreed
grouping of workers who share similar workplace health and
safety interests and conditions
RESPONSIBLE OFFICER
The Deputy Vice-Chancellor (Research) is responsible for the development, compliance monitoring
and review of this policy and any associated schedules, procedures and guidelines.
IMPLEMENTATION OFFICER
The Director, Office for Research Ethics and Integrity is responsible for the promulgation and
implementation of this policy in accordance with the scope outlined above. Enquiries about
interpretation of this policy should be directed to the Implementation Officer.
REVIEW
This policy is to be reviewed by XX/XX/XXXX.
VERSION HISTORY
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Version
Approved By
Approval Date
1.0
Director, OREI
26 May 2014
Effective Date
Sections Modified
Consultation version
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Keywords
Facility, hazardous, biosafety, microorganism, laboratory, high risk, biorisk
management, gene technology, biosecurity
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