Gene technology & biosafety

Do I need approval?

Depending on the risk group category your organism belongs to you will either need approval, or to submit a notification to the IBC.

1. Determine the risk group of your organism.
2. Check whether the organism is considered a Security Sensitive Biological Agent. If it is an SSBA, you must contact the IBC before obtaining the organism. 

• Risk Group 1 Agents (low risk) - notification

• Risk Group 2 Agents (low risk) – notification only unless:

a. Risk Group 2 agents are cultured in large volumes (> 25 Litres)
b. Risk Group 2 agents require special precautions associated with their use as highlighted in AS 2243.3.
c. they are to be used in humans or animals (NB: Human Research Ethics Application or an Animal Research Ethics Application must also be completed).

• IBC project approval is required for the following high risk projects:

a. Genetically Modified Organisms (i.e. genetically modified - microorganism, animals and plants)
b. Prions
c. Infectious / potentially infectious animals and plants (e.g. bats)
d. Poisonous or venomous animals and plants (e.g. snakes, spiders, mushrooms)
e. Biological agents and toxins on the Defence Strategic Goods List
f. Security Sensitive Biological Material
g. Goods that require the use of a Quarantine Approved Premises
h. Emerging new biohazards not captured within the above definition.

What do I need to submit? 

Application for Biosafety can be found at the forms page.  

• If it is Risk Group 1 (low risk) – application and copy of Risk Assessment 
• If it is Risk Group 2 (moderate risk) – application and a copy of Risk assessment and any Safe work procedures 
• If it is Risk Group 2 (high risk) – application and a copy of Risk assessment, research protocol & all safe work procedures relevant to this application. 
• Note: Risk Grade 3 and 4 are prohibited at UOW.

The use of human tissue, blood or bodily fluids, or animals and their tissue in research and teaching may require additional approval from the appropriate Human or Animal Ethics Committees prior to commencement of work. 

Where and when do I submit?

Submit the documentation to: uow-biosafety@uow.edu.au

Check the Committee Information section for the agenda deadline.

All projects for which have IBC approval is required – must submit:

• Amendment requests
• Annual reports
• Final reports detailing disposal procedures should be submitted within three months of the expiry date for the approval.

Failure to adhere to these requirements may result in an approval lapsing.

Access forms that are required.

Storage, handling, transport or disposal of Risk Group 2 agents must be conducted in accordance with the Australian New Zealand Standard, Safety in Laboratories, Part 3: Microbiological Safety and Containment (AS/NZS 2243.3). 

Any container of viable microorganisms, including any waste that may contain potentially infectious organisms, must be transported outside the laboratory within a second unbreakable and closed container, which shall first be decontaminated on all outer surfaces.  

See Clause 13.1 for further information on identification and management of contaminated material and waste.

All forms can be accessed from the forms page

Do I need approval?

All work involving “dealings” with a Genetically Modified Organism (GMO) requires written approval from the IBC before work can commence.

The facility (room or area) where the dealing is to be conducted may need to be certified by the OGTR.

If you are working with a genetically modified vertebrate animal, you will require approval by the IBC and Animal Ethics Committee.

What type of approval do I need?

The approval process will depend on the category of the GMO.

Exempt Dealings

Exempt Dealings pose negligible or very low risks i.e. contained research involving very well understood organisms and processes for creating and studying GMOs. They must not involve an intentional release of a GMO into the environment.

Research involving exempt dealings does not need to be carried out in a certified laboratory but the laboratory must meet a number of conditions. Refer to the OGTRs Guidance Notes for the Containment of Exempt Dealings (PDF).

Exempt Dealings are described in Parts 1 & 2 of Schedule 2 of the Gene Technology Regulations 2001 (the Regulations). For further information, refer to Gene Technology Regulations 2001 (legislation.gov.au).

Once you have identified that you are working with an Exempt Dealing you will need to complete an Exempt Dealing Form and submit it to the IBC for review at the next meeting.

Notifiable Low Risk Dealings

Notifiable Low Risk Dealings (NLRDs) are activities with GMOs undertaken in containment i.e. not released into the environment that have been assessed as posing low risk to the health and safety of people and the environment provided certain risk management conditions are met.

NLRDs are divided into those that should be conducted in a certified PC1 Laboratory and those that should be conducted in a certified PC2 laboratory.

UOW does not have any PC3 facilities. Risk Group 3 and 4 organisms cannot be brought to UOW.

Once you have identified that you are working with an NLRD, you will need to complete a Notification of NLRD Form and submit it to the IBC for review at the next meeting.

Dealings Not Involving an Intentional Release/Licensed Dealings

Dealings with GMOs in contained facilities which are classified as DNIR (Dealing NOT involving an Intentional Release):

• are not intended to be released into the environment; and
• do not meet the criteria for classification as Types of GMO dealings | Office of the Gene Technology Regulator (ogtr.gov.au) or NLRDs

DNIRs are higher risk dealings than Notifiable Low Risk Dealings (NLRD). In general, DNIRs involve work with GM pathogenic [disease-causing] organisms, or GMOs containing higher risk genes from pathogens or genes that:

• encode toxins; or
• confer an oncogenic [cancer-causing] modification or immuno-modulatory [changing the immune system] function.

Research involving DNIRs must be carried out in a laboratory certified to at least Physical Containment Level 2 (PC2). Apply for a DNIR licence | Office of the Gene Technology Regulator (ogtr.gov.au).

Once you have identified that you are working with a DNIR you will need to complete an Application for a DNIR form and submit it to the IBC for review at the next meeting.  This will then be sent to the OGTR, who must approve the dealing before research can commence.

Dealings involving Intentional Release (DIR)

If you wish to conduct research that involves intentional release, please contact uow-biosafety@uow.edu.au.

Making changes to an Approved “Dealing”

Any variation to an approved GMO Dealing needs to be submitted to the IBC for approval. This may include changes to key personnel, addition of similar GMOs, altered facility conditions or storage locations.

The applicable form will need to be completed and submitted to the IBC for review at the next meeting:

• Exempt Dealings: Notification of Changes to Exempt Dealing Form
• Licensed Dealings: Notification of Variation to a DNIR/DIR Protocol Form

Submitting Annual Reports

It is a condition of approval that Annual Progress Reports are provided to the IBC for review using the Annual Report on Approved Protocol form.

Failure to adhere to this requirement may mean an approval is revoked.

Final reports should be submitted within three months the approval expiry date.

All GMOs must be labelled and stored safely and securely in a manner preventing unauthorised access, mix-up or inadvertent release. Specific requirements for storage are detailed in the OGTR Explanatory Information - Guide to Physical Containment Levels and Facility Types | Office of the Gene Technology Regulator (ogtr.gov.au) and the OGTR Guidelines for the Transport, Storage and Disposal of GMOs | Office of the Gene Technology Regulator (ogtr.gov.au).

Disposal of NDIRs must be in accordance with the requirements of the licence.

The GMO storage database

The GMO storage database records storage details of GMOs held at the University of Wollongong.  It is accessible online and provides a record of the exact location the GMO is stored in.  Storage arrangements must be compliant with the containment category of the organism. GMOs for which the minimum permitted physical containment level is PC2 must be packed inside a sealed, unbreakable secondary container.  In the case of a small storage unit, such as a refrigerator, freezer, or cryogenic storage container, the storage unit is permitted to be the secondary container. 

Note: The GMO storage database is under review and while current users may still use it new users are unable to be added at present. A new database is being developed.

There are specific conditions covering transport and packaging, covering details such as who can pack and transport materials, and the specific packaging used.  All packaging and paperwork for the transportation of GMOs must meet the relevant transport codes, (e.g., road, rail, and air) whether the material is being self-delivered, or sent by courier via the Distribution Centre.

Contact your laboratory manager for advice before making any arrangements.

Refer to the following for additional information:

• The Australian Dangerous Goods Code
• Australia Post – Prohibited and Dangerous Goods
• Gene Technology Regulations 2001
• Guidelines for the Transport, Storage and Disposal of GMOs | Office of the Gene Technology Regulator (ogtr.gov.au)

Microorganisms are classified into Risk Groups based on their potential impact on humans and the environment.

See Australian New Zealand Standard, Safety in Laboratories, Part 3: Microbiological Safety and Containment (AS/NZS 2243.3) for a listing. 

These lists are not exhaustive, and microorganisms are generally classified as follows:

Risk Group 1 (RG1): Low individual and low community risk. These microorganisms are unlikely to cause disease.

Risk Group 2 (RG2): Moderate individual risk, limited community risk. These microorganisms are unlikely to be a significant risk to laboratory workers or the environment, but exposure may cause infection. 

Risk Group 3 (RG3): High individual risk, limited/moderate community risk. These microorganisms usually cause serious disease and may present a significant risk to laboratory workers, but may only present a moderate risk of spreading amongst a community. 

Risk Group 4 (RG4): High individual and high community risk. These microorganisms usually cause life-threatening disease and may be readily transmissible. Effective treatments are not usually available.

Risk Groups correlate with Physical Containment (PC) facility requirements, ie. RG2 organisms should only be used in a PC2 (or higher) facility.

A facility - laboratory, animal facility etc - will need to be certified by the OGTR before it can be used for work conducted under an NLRD or DNIR authorisation.  Facilities that have been certified by the OGTR will display signage on all entrances to the facility.

Facilities in which only exempt dealings are conducted do not need to be certified, but must meet some minimum containment requirements.

PC facilities are classified according to the ability of the structure and operational arrangements to contain GMOs.

Physical Containment Level 1 (PC1)

A PC1 laboratory or facility is suitable for work with microorganisms where the hazard levels are low, and where laboratory or facility personnel can be adequately protected by standard laboratory practice.

Physical Containment Level 2 (PC2)

A PC2 laboratory or facility with appropriate practices and infrastructure is appropriate for research involving material likely to contain Risk Group (RG) 2 microorganisms. If activities involving material which is likely to aerosolise, or with microorganisms transmissible by the respiratory route are performed, they must be done so in a biosafety cabinet (BSC).

Physical Containment Level 3 (PC3) and Level 4 (PC4)

PC3 and PC4 facilities provides additional building features and services to minimise the risk of infection or release appropriate to the use of RG3 and RG4 microorganisms.

Note: There are no certified PC3 or PC4 facilities at the University of Wollongong. For more comprehensive information, see the Guidelines for the certification of physical containment facilities | Office of the Gene Technology Regulator.

The Commonwealth Department of Health monitors a list of Security Sensitive Biological Agents (SSBAs) which may pose significant risk to human health, the environment and the Australian economy if deliberately released.

The list of Tier 1 (highest security risk) and Tier 2 (high security risk) SSBAs is below. The use of SSBAs is regulated, with conditions attached to their storage, transport and end uses. Further information can be obtained from the Department of Health SSBA Guidelines and SSBA Fact Sheets.

If you intend to use any agent on the SSBA List, you must contact the Integrity and Ethics Unit prior to obtaining the agent.

The List of Security Sensitive Biological Agents (March 2016)

Notes

1. The agents above only refer to infectious, viable and pathogenic organisms or active toxins.

2. ‘Highly pathogenic influenza virus infecting humans’ includes influenza viral strains that fulfil all the criteria listed below:

• considered highly pathogenic in usual host animal;
• proven infection of humans; and
• involved in an outbreak of human disease.

Examples of such viral strains include the 1918 pandemic Influenza virus A and Influenza virus A H5N1.

3. 'Botulinum toxin’ does not refer to a form approved for therapeutic use under the Therapeutic Goods Act 1989. For example, the forms of Botulinum toxin approved for therapeutic use and known under their commercial names Botox^™ or Dysport^™.

WHS has released a number of guidelines to support safe work practice.  Key guidelines relevant to working with biological hazards are viewable on the safe at work webpage. These include:

• Biosafety Manual and Guidelines
• Biological Waste Disposal Guide
• Preventing the Transmission of Blood and Bodily Fluid Pathogen Guidelines
• PPE Guidelines
• Immunisation guidelines

• Work Health and Safety Act 2011
• Gene Technology Act 2000
• Biosecurity Act 2015
• National Health Security Act, 2007
• AS/NZS 2243.3:2010 Safety in Laboratories - Microbiological Safety and Containment
• AS/NZS 2243.1 Safety in laboratories—Planning and operational aspects

• Biosafety contact: rso-biosafety@uow.edu.au / Ph: 4221 3350
• WHS: whs-admin@uow.edu.au / Ph: 4221 3931
• Complaints or concerns: research-integrity@uow.edu.au