Biosafety

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.