Details regarding biosafety-related activities, approval requirements, and all related matters, are contained within the Biosafety Manual. The information provided on these Biosafety webpages is a summary only, and the Manual must be consulted for complete details.
Do I need biosafety approval?
If you are planning to conduct research or teaching activities involving:
- Gene technology, including Genetically Modified Organisms (GMOs), no matter which species;
- Microorganisms that meet criteria as Risk Group 2 or higher;
- Procedures that are likely to result in the isolation or enrichment of risk group 2 or higher microorganisms from clinical or environmental samples;
- Genome editing technologies such as CRISPR/Cas9;
- the use of naked nucleic acid (e.g. siRNAs or oligonucleotides) in exempt or non-exempt hosts,
You must seek and receive biosafety approval before commencing.
Gene Technology Dealings
Gene technology activities are referred to as 'dealings'. There are several classes of dealings, which are fully described on the OGTR website, and in the Biosafety Manual. The major classes are:
- Exempt Dealing;
- Notifiable Low Risk Dealing (NLRD);
- Dealing Not involving an Intentional Release (DNIR); and
- Dealing Involving an Intentional Release (DIR).
You must understand these classes of dealings, and decide which dealing is appropriate for the activity that you are undertaking.
In Australia and New Zealand, microorganisms are classified into Risk Groups 1 to 4, based on the pathogenicity of the agent, the mode of transmission, and the availability of preventative measures and treatment.
Please note that facilities within Flinders University are not currently equipped for work with Risk Group 3 and 4 microorganisms.
Who grants biosafety approval?
The University's Institutional Biosafety Committee (IBC) approves applications to conduct research and teaching activities with gene technology and Risk Group 2 or higher microorganisms.
For work involving gene technology, the IBC operates under the Commonwealth Gene Technology Act 2000 and the associated Gene Technology Regulations 2001, overseen by the Office of the Gene Technology Regulator (OGTR), as well as corresponding State-based legislation. A full listing of relevant legislation and regulations can be found at Legislation and Guidelines.
The IBC also has responsibility for overseeing the following biosafety-related activities:
Security Sensitive Biological Agents (SSBAs)
The University must notify the Australian Government Department of Health regarding all research involving the use of Security Sensitive Biological Agents (SSBAs).
Therefore, all use of SSBAs must be notified to the IBC, via the IBC Executive Officer, Dr Jess Hall, on 08 7221 8353 or firstname.lastname@example.org
Information relating to SSBAs can be found on the Department of Health's SSBA website.
Physical Containment (PC) Facilities
There are four types of Physical Containment (PC) Facilities: PC1, PC2, PC3 and PC4.
At Flinders, certified PC facilities include: laboratory, animal and plant. PC2 microbiology and quarantine facilities are also available.
All work performed in a certified facility of a specific PC level must follow the procedures set out for that level of containment. PC facilities used for gene technology work must be certified by the OGTR.
Internal inspections of PC facilities are regularly conducted to ensure compliance.
To request a PC facility certification, or to discuss renewal or suspension of an existing certification, please contact the IBC Executive Officer, Dr Jess Hall, on 08 7221 8353 or email@example.com
Please note that the IBC is unable to provide financial assistance for PC facility maintenance or for equipment and reagent purchases. Facility supervisors are expected to maintain PC facilities in a compliant status as a requirement of retaining facility certification. The IBC’s role is to oversee compliance of the facilities by performing inspections, assisting with training, and providing advice about PC facility and biosafety requirements to facility operators.