Biosafety

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

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 Office of the Gene Technology Regulator (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.
 

Microorganisms

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.

Research or teaching activities involving the use of Risk Group 2 microorganisms or higher must be approved by the Institutional Biosafety Committee (IBC) before commencement.

Please note that facilities within Flinders University are not currently equipped for work with Risk Group 3 and 4 microorganisms.

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.

• IBC terms of reference
• IBC membership 2020

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 Institutional Biosafety Committee (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.

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 biosecurity 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 Office of the Gene Technology Regulator (OGTR).

Internal inspections of PC facilities are regularly conducted to ensure compliance.

To request a PC facility certification, or to discuss renewal, variation or suspension of an existing certification, please contact the IBC Executive Officer, Dr Jess Hall.

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.

Genetically Modified Organisms (GMOs)

The IBC is subject to the following legislation, regulations and amendments governing the practices and procedures involving GMOs:

• The Gene Technology Act 2000 (current compilation)
• The Gene Technology Regulations 2001 (current compilation)
• The Gene Technology (Consequential Amendments) Act 2000
• The Gene Technology (Licence Charges) Act 2000
• Gene Technology Act 2001 - South Australia
• Gene Technology Regulations 2017 - South Australia
• The Criminal Code Act 1995

The following legislation and regulations are also relevant to work with biohazardous materials, including GMOs:

• SA Work, Health, Safety Act 2012
• SA Work, Health, Safety Regulations 2012

Microorganisms

In Australia, safety and containment aspects of work with microorganisms are governed by Australian and New Zealand Standard 2243.3 ‘Safety in Laboratories - Part 3: Microbiological Safety and Containment'. The Standard may be accessed via the SAI Global website, Standards Online (access is available on campus).

If you are working with clinical or environmental samples, remember that any specimen has the potential to be infectious, and precautions should be taken when handling these samples.

In the Australian Guidelines for the Prevention and Control of Infection in Healthcare (2010), the National Health and Medical Research Council (NHMRC) adopts the term ‘standard precautions’ as the basic risk minimisation strategy for handling human “blood (including dried blood); all other body substances, secretions and excretions (excluding sweat), regardless of whether they contain visible blood; non-intact skin; and mucous membranes”. These precautions should also be followed when working with potentially infectious environmental samples, such as untreated water, sewerage samples, animal faecal matter, soil, etc.

‘Standard precautions’ are the work practices required for basic infection control and include:

• Good microbiological practices (aseptic technique);
• Good hygiene practices (hand washing and drying, both before and after contact);
• Appropriate use of personal protective equipment (gloves, gowns, face masks, safety glasses);
• Waterproof coverings over any break in skin integrity (cuts, abrasions, etc.);
• Routine decontamination of surfaces at completion of work (benches and equipment used in direct contact with sample);
• Appropriate procedures for the handling and disposal of waste;
• Appropriate procedures for the handling and disposal of sharps;
• Following behavioural practices applied in physical containment level 2 facilities;
• Performing all work in a biosafety cabinet with any human-derived samples or cell lines known or reasonably expected to be infected with a pathogenic microorganism;
• Avoiding/minimising the creation of aerosols and performing work in a biosafety cabinet whenever there is a likelihood that aerosols may be produced (regardless of infectious status of the sample);
• Do not use a laminar flow for any work involving potentially infectious samples; and
• Receiving vaccination(s) where necessary - for example, when working with human body fluids, tissue samples, etc., immunisation against Hepatitis B is recommended if antibody titre is low.

A risk assessment must always be performed before beginning any work with these types of samples.

• SOP - Storage of genetically modified organisms
• SOP - Transport of genetically modified animals 
• SOP - Transport of genetically modified microorganisms
• SOP - Transport of genetically modified plants
• SOP - Disposal of genetically modified organisms, Risk group 2 microorganisms and biohazardous waste
• Storage labels template for GMOs
• Storage labels template for risk group 2 microorganisms

• Spill or unintentional release flowchart - Flinders University PC Laboratories
• Spill or unintentional release flowchart - Flinders Medical Centre PC Laboratories
• Spill or unintentional release flowchart - PC Animal Facilities
• Spill or unintentional release flowchart - PC Plant Facilities

These documents provide guidance and examples on preparing Standard Operating Procedures for work with lentiviral vectors. The documents are a guide only, and should be modified for your own project.

• Recombinant adenovirus and lentivirus safety - SWMS
• Ultracentrifugation of Lentivirus - SWMS 

The Office of the Gene Technology Regulator (OGTR) have prepared a guidance document on classification of contained dealings with viral vectors. This document may be helpful when trying to determine which classification your viral vector dealings fall under within the Gene Technology Regulations 2001.

• Guidance notes on classification of viral vector dealings

The Office of the Gene Technology Regulator (OGTR) is an Australian Government department that oversees the Commonwealth Gene Technology Act, 2000 and the associated Gene Technology Regulations, 2001. The OGTR website provides a range of important and useful information in this area.

Download a copy of the OGTR’s Guidance flowchart for the classification of contained dealings with viral vectors.

For an indicative listing of microbiological organisms in each of the risk groups, refer to AS/NZS 2243.3 ‘Safety in Laboratories: Part 3: Microbiological Safety and Containment’. The standard may be accessed via the SAI Global website, standards online (access is available on campus)”    

Where researchers wish to send or receive materials to or from external organisations for use in their research, a Material Transfer Agreement (MTA), will often be required. MTAs are appropriate where the owner of the material wishes to formalise the permitted uses of the material, the ownership or sharing of ownership of the material, (and any research outputs arising from the use of the material), and also where it is desirable to clearly establish with which party the risk and liability in relation to the use of the material will lie.

At Flinders, MTAs are overseen by Research Development and Support - please refer to the contracts section for more information.