Biosafety and Defence
Find out more about requirements for ensuring biosafety is maintained and whether your research complies with the Defence Trade Control Act.
Research involving biohazardous materials, genetically modified organisms (GMOs) 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).
What does this mean for me?
The Swinburne Biosafety Committee (SBC) oversees compliance to The Gene Technology Act (2000) and the Gene Technology Regulations (2001) as well as assesses, approves, inspects and monitors research facilities to ensure that potential biological hazardous materials cause no harm to human, animal and environmental health.
If you are working with biohazards such as GMOs, blood products or venoms you will need to apply to the SBC 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.
Find out more about Defence Trade Control compliance here.
What biosafety matters require approval or notification?
The Swinburne Biosafety Committee (SBC) requires approval or notification for:
- Genetically modified organisms (GMO) and certification of physical containment facilities in which GMO dealings will be conducted — more information can be found here
- Security Sensitive Biological Agents (SSBAs)
- Organisms in Risk Group 2, 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 contain a hazard to humans such as toxins, allergens or prions
- Quarantine materials in any of the above categories
- The safety of major clinical and research equipment, such as MEG or MRI machines.
Note: SBC responsibility does not extend to general laboratory risks and procedures involving the use of chemicals that are otherwise covered by Swinburne Occupational Health and Safety Policies or Procedures.
How do I submit an application for approval?
- Go to the Swinburne Ethics Review Management website.
- Click ‘Log in’ in the top right-hand corner of the menu bar and enter your Swinburne email address and password.
- Select ‘Create project’ from the left-hand sidebar, add in the Project Title and select ‘Biosafety Clearance’ from the drop-down menu, then click ‘Create’.
- Complete the application — you can invite your collaborators to review and work on the form too.
- Create and attach relevant additional documents as requested in the form.
- Obtain the sign-offs requested in the form.
- Submit the form.
- Respond to any queries posed by the committee.
- Approval will be granted once all outstanding queries are satisfied. You will receive formal notification of this approval.
- To modify your existing biosafety application, refer to the ERM applicant guide.
Note: Work cannot commence until written approval has been received. Please contact firstname.lastname@example.org for more information.
Further information about biosafety matters
The Swinburne Biosafety Committee has approved a number of generic risk assessments and standard operating procedures that are available for use across Swinburne:
- Standard operating procedure and risk assessment — working with human blood, plasma, tissue and other body fluids
- 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)
- 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 or more information about the above documents.
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, that reviews research applications and monitors certified facilities.
The IBC for Swinburne 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 and biohazardous materials.
Exempt dealings are a category of dealings with genetically modified organisms (GMOs) that have been assessed over time as posing a very low risk, such as contained research involving very well understood organisms and processes for creating and studying GMOs.
More information about exempt dealings can be found on the Office of the Gene Technology Regulator website.
Notifiable Low Risk Dealings (NLRDs) are dealings with genetically modified organisms that have been assessed as posing a low risk to the health and safety of people and the environment provided certain risk management conditions are met.
NLRDs must be:
- conducted by persons with appropriate training and experience within a facility certified to either Physical Containment level 1 (PC1) or level 2 (PC2)
- assessed by the Swinburne Biosafety Committee
- transported in accordance with the Regulator's Guidelines for the Transport of GMOs.
Defence Trade Control Compliance
The Defence Trade Control Act (2012), Customs Act (1901) and Weapons of Mass Destruction (Prevention of Proliferation) Act (1995) control the export of certain goods and technologies. The purpose of the Act is to protect national security by preventing sensitive goods and technologies from falling into the wrong hands. To achieve this, the DTCA regulates the intangible supply, publication and brokering of goods that are directly or indirectly linked to military or Defence activity.
Under the Act, controlled goods and technology are sorted into two categories:
- Munitions (or military) items
- Dual-use items that may be used for civilian/commercial purposes but may also be used in military systems or for weapons of mass destruction.
These items include but are not limited to:
- Nuclear materials — facilities and equipment, nuclear reactors, gas centrifuges and materials designed for nuclear use
- Materials, chemicals, micro-organisms and toxins — powdered metals, ceramics, composite materials, toxic chemicals and pathogens, protective and detection equipment, and body armour
- Materials processing — machine tools (CNC machines), crucibles, valves, robots, vibration test systems, vacuum pumps, chemical processing and handling equipment
- Electronics — radiation hardened electronics, Field Programable Gate Arrays (FPGA), microwave electronics, electronic test equipment, high energy storage devices and fast switching devices
- Computers — radiation hardened computers, high performance computers, tools for development and delivery of intrusion software
- Telecommunications and information security — telecommunications systems, jamming equipment, RF monitoring equipment, IP network surveillance equipment, as well as cryptographic and cryptanalytic equipment, and cryptographic activation equipment
- Sensors and lasers — marine acoustic systems, imaging detector systems, optical mirrors, lasers and magnetometers
- Navigation and avionics — gyroscopes, accelerometers, inertial navigation systems and flight control systems
- Marine — submersible vehicles, remotely controlled manipulators, noise reduction systems and air independent power systems
- Aerospace and propulsion — aero gas turbine engines, rocket propulsion systems, UAVs, sounding rockets, wind tunnels and turbine blade production equipment.
How do I know if my research comes under the Defence Trade Control Act (DTCA)?
You must be exporting the controlled goods or technology out of Australia and the goods or technology must be listed on the Defence and Strategic Goods List (DSGL).
If you are unsure whether your research is a controlled good or technology, we recommend you use the Online DSGL Tool or look at the scenarios and case studies provided by the Defence Export Controls.
This flowchart also outlines what does and does not come under the DTCA.
Need to apply for a permit? Find out how here.
Frequently asked questions
Brokering is where a person or organisation acts as an agent or intermediary and arranges the supply of controlled technology outside of Australia. A permit is not required to broker dual use technology.
Publication refers to information that is made available to the public or a section of the public via the internet, journal articles, conference papers, blogs, websites and/or social media. Except where a general exemption applies, a permit is required when the information published is about military use technology. A permit is not required for the publication of dual use technology.
Scenario: My research is listed on the Defence and Strategic Goods List (DSGL). I wish to publish my new findings in a scientific journal based in the US. Do I need a permit to send a copy to the editor?
If your technology is listed on Part 1 of the DSGL and is part of applied research, you will need a supply permit to send a copy to your publisher abroad, and to send a draft copy to co-authors located overseas.
If your technology is listed on Part 2 of the DSGL (dual use), a permit is not needed to send a paper to a publisher or co-authors located overseas as it is exempted as a ‘pre-publication activity’.
Intangible supply refers to non-physical methods such as email, fax or providing a password to access electronic files. This does not include instances where the supply is a pre-publication activity (such as emailing an article to an overseas journal or to a colleague for review prior to publication) and some verbal supplies.
Scenario: My research is a controlled DSGL technology. At teleconference project meeting, I discuss the DSGL technology with collaborators in Malaysia.
The oral supply exception applies and you do not need a permit.
Scenario: My research is a controlled DSGL technology. At a teleconference project meeting, I provide my collaborators in Malaysia ongoing access to the project folders containing the DSGL controlled technology.
As your collaborators can now share the controlled technology, you have supplied the technology and a permit is required. An oral exemption does not apply.
Scenario: My research is a controlled DSGL technology. At a project meeting, I provide my collaborators at the Australian National University access to the project folders containing the DSGL technology.
A permit is not required, as supply has occurred wholly within Australia.
The question to ask is whether or not the technology is available in the public domain. If the answer is ‘yes’ — even if there’s a requirement to pay to access the technology — then it is a publication. If access is restricted to particular groups or users, then it’s not in the public domain and will be covered by ‘supply’.
Certain types of research are exempt from controls. This applies if:
- you are supplying technology that is already “in the public domain” — that means that it is “technology or software which has been made available without restrictions upon its further dissemination”
- your work is “basic scientific research” — that means that your work is experimental or theoretical work undertaken principally to acquire new knowledge of the fundamental principles of phenomena or observable facts
- your work is on medical equipment that incorporates dual use goods and technology
- the supply is for the purpose of seeking a patent application, except if your work is in nuclear technology
- you are supplying to government or security agency employees.
You must have a permit if you are engaging in an international collaboration that will either:
- involve the supply, publication or brokerage of tangible or intangible goods and technologies on the Defence and Strategic Goods List (DSGL) which are being developed for military use; or
- involve the supply of intangible goods that are intended to be commercial but could be used in military systems or for weapons of mass destruction (dual use).
The only exception is if you fall under one of the general exemptions, listed here.
Researchers should follow these steps to find out whether their work could be affected by the Defence Trade Control Act:
- Use the online DSGL Tool provided by the Defence Export Controls Office to assess whether you need a permit or are exempt from the DTC scheme.
- Save a copy of the assessment report generated by the DSGL Tool.
- If you need to apply for a permit, or are unsure if you need to, email email@example.com outlining your research. Please also include a copy of the assessment report generated by the DSGL Online Tool.
- The Research Ethics, Integrity & Biosafety team will coordinate the next steps.
The Defence Export Controls Office within the Department of Defence is responsible for the administration of the Defence Trade Control Act (2012). Their website has information and tools to help exporters and researchers comply with the Act. Some particularly useful resources include:
For further information please email firstname.lastname@example.org.
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Contact us for more information
If you would like to know more about our Biosafety and Defence compliance, please contact the Research Ethics, Integrity and Biosafety team via email@example.com.