Biosafety and defence
Research involving biohazardous materials, genetically modified organisms and/or the export of defence sensitive materials or technologies must comply with relevant legislation and guidelines. This legislation includes The Gene Technology Act 2000, The Gene Technology Regulations 2001 and the Defence Trade Control Act (2012).
Compliance to these important laws is overseen by the Swinburne Biosafety Committee and the Research Ethics, Integrity & Biosafety team.
What does this mean for me?
If you are working with biohazards such as genetically modified organisms, blood product or venoms you will need to apply to the Swinburne Biosafety Committee to ensure that any risks posed by your research are appropriately managed and contained.
Similarly, if through your research you are exporting information, materials or technologies that have the potential to be directly or indirectly used for defence activity, you will need to assess whether a permit is required from the Department of Defence before you send this overseas.
The information on these pages outline what you need to know and who to contact.
Swinburne’s Biosafety Committee (SBC) oversees the safety of Swinburne’s research. The committee assesses, approves, inspects and monitors research facilities to ensure that potential biological hazardous materials (biohazards) cause no harm to human, animal and environmental health.
Biohazardous organisms include:
- toxins, allergens and venoms
- infectious micro-organisms
- Security-Sensitive Biological Agents (SSBAs)
- Genetically Modified Organisms (GMOs)
- some recombinant DNA
- hazardous proteins (prions and toxins).
Genetically Modified Organisms (GMOs) and Biohazardous Materials
GMOs refers to organisms that have been altered using gene technology. In 2001 a national regulatory scheme was introduced to monitor all work involving GMOs. This regulatory system is administered by the Office of the Gene Technology Regulator (OGTR). Organisations dealing with GMOs must be accredited and must have an Institutional Biosafety Committee, or access to an IBC, which reviews research applications and monitors certified facilities.
The IBC for Swinburne University is the Swinburne Biosafety Committee (SBC). The SBC provides a quality assurance or risk management mechanism with respect to Swinburne activity (research and teaching) or facilities involving GMOs as well as biohazardous materials.
Matters that require approval or notification
The Swinburne Biosafety Committee (SBC) requires approval/notification for:
- GMOs & certification of physical containment facilities in which GMO dealings will be conducted
- Security Sensitive Biological Agents (SSBAs)
- Organisms in Risk Group 2 (Acquisition of RG2 Form [DOCX 654KB]), 3 or 4 in the Australia/New Zealand Standard 2243.3:2010 or procedures that may result in the isolation or enrichment of such organisms
- All human tissue or blood products
- High risk cell lines (Cell culture information [DOCX 17KB])
- Material of biological origin that may be or may contain a hazard to humans e.g. toxins, allergens, prions
- Quarantine materials in any of the above categories
- The safety of major clinical and research equipment, e.g. MEG, MRI
Please note: SBC responsibility does not extend to general laboratory risks and procedures involving the use of chemicals which are otherwise covered by Swinburne Occupational Health and Safety Policies or Procedures.
The approval process
To gain approval, complete the appropriate form and email to the Research Ethics Office at email@example.com:
If you are working with GMOs additional documentation include:
Dealings involving Intentional Release (DIR) and Dealings Not Involving Intentional Release (DNIR) are of the highest level of risk. These dealings require approval from both the SBC and the OGTR. Please contact the Research Office for more information if you intend to use organisms of these categories.
Please note that work cannot commence until written approval has been received.
SOPs and Risk Assessments
The SBC have approved a number of generic risk assessments and SOPs and are available for use across Swinburne:
- SOP and Risk Assessment: Working with human blood, plasma, tissue and other body fluids
- Risk Assessment: General Risk Assessment for working with Risk Level 2 Bacteria in all Swinburne PC2 laboratories (according to Australian and New Zealand standard AS 2243.3)
- Risk Assessment : Use and propagation of Risk Level 2 human and animal cells in all Swinburne PC2 laboratories (according to Australian and New Zealand Standard AS 2243.3)
Please contact the Research Ethics Office if you would like copies of the documents or for more information.