Biosafety and gene technology

The Institutional Biosafety Committee (IBC), on behalf of UOW, co-ordinates compliance with the relevant legislation and standards and provides advice on risks associated with infectious organisms, biohazardous materials, genetically modified organisms and materials requiring biosecurity containment. These regulations cover the import/export, transport, storage and handling of biological materials.
A Biosafety Application must be submitted via REDCap for all research and teaching activities that involve the use of biological materials.
Refer to Approvals to Work with Biological Materials or Genetically Modified Organisms for further information.

IBC meeting dates, agenda deadlines and general information

The Institutional Biosafety Committee operates in accordance with the IBC Terms of Reference.
The IBC meets five times a year on a Thursday from 12:30pm – 2:30pm. The meetings are held via Zoom.

Agenda deadlines and meeting dates 2025

Members

• Professor Chao Deng (Chair)
• Darren Smith
• Professor Jeremy Cook
• Dr Eva Tomaskovic-Crook
• Professor Martina Sanderson-Smith
• Katie Cicero
• Mark Aikman
• Associate Professor Guangming Jiang
• Fiona Wells

All correspondence for the IBC is to be sent to uow-biosafety@uow.edu.au

The application process

If your research, teaching or service activities involve biological materials, you must submit a Biosafety Application via REDCap for review by the IBC.
Depending on the nature of the work and the microorganisms involved, the application will fall into one of two categories:

Notification
For low-risk activities involving Risk Group 1 biological materials. A risk assessment will also need to be attached to the application.

Approval
For higher-risk activities, including those involving Risk Group 2 biological materials and GMOs. The application must also include relevant risk assessments, safe work procedures and research protocols.

Determining the Risk Group of your material or organism

Biological materials are classified into Risk Groups (RG) based on their potential to cause harm. The following table is applicable to human and animal infectious microorganism risk groups. Refer to AS/NZS 2243.3 for plant, invertebrates and aquatic infectious microorganisms. 

Refer to Section 3 and Tables 3.1 to 3.12 in AS/NZS 2243.3 Safety in Laboratories, Part 3: Microbiological Safety and Containment (AS/NZS 2243.3) for indicative examples.
AS/NZS 2243.3 does not provide tables for microorganisms belonging in Risk Group 1, as the number of relevant microorganisms is large.

Examples of RG 2 materials and work requiring IBC approval

Examples of RG 2 materials and work requiring IBC approval include:

• Clinical or diagnostic samples
• Handling of animals, their tissues or body parts
• Genetically Modified Organisms (GMOs)
• Prions
• Infectious / potentially infectious animals and plants (e.g. bats)
• Poisonous or venomous animals and plants (e.g. snakes, spiders, mushrooms)
• Biological agents and toxins on the Defence Strategic Goods List
• Security Sensitive Biological Agents (SSBA)
• Goods that require the use of an Approved Arrangement Site
• Risk Group 2 agents cultured in large volumes (> 25 litres)
• Emerging new biohazards not captured within the above definition
• Sewerage and waste water

General requirements for working with Genetically Modified Organisms (GMOs)

• Work with GMOs is governed by the Office of the Gene Technology Regulator (OGTR).
• All work involving dealings with GMOs must be approved, in writing, by the IBC before work can commence.
• The facility where the dealing is going to be conducted must be OGTR certified.
• Work with genetically modified vertebrate animals must also be approved by the Animal Ethics Committee, in addition to the IBC.
• Depending on the GMO category, you may need additional approval from the OGTR before work can commence. These are summarised below:

Determining the type of GMO dealing
There are four main categories of GMO dealings. The criteria for their classification, application and licencing requirements are described in further detail below.

Exempt dealings
Exempt dealings are low-risk activities involving GMOs that do not involve intentional release into the environment (e.g., no field trials or commercial use). No licence is needed for Exempt dealings if the activity meets the criteria in Schedule 2 of the Gene Technology Regulations 2001. The OGTRs Guidance Notes for the Containment of Exempt Dealings must be followed.

Once you have identified that you are working with an Exempt dealing you will need to include this in your REDCap Biosafety Application for IBC approval:
Type of Dealing – Exempt
Description of Exempt Dealing – use the descriptions outlined in the OGTR document Types of dealings with GMOs classified as Exempt Dealings. Include the relevant descriptions from Schedule 2 – Part 1 (dealing type) and Schedule 2 – Part 2 (host/vector systems).

Notifiable Low Risk Dealings (NLRDs)
NLRDs are GMO activities that are conducted in OGTR-certified containment facilities, and pose low risk to people and the environment when managed under specific conditions. They must comply with Schedule 3 of the Gene Technology Regulations 2001, which outlines eligible NLRD dealings and the required containment levels (i.e., PC1 Laboratory, PC 2 Laboratory).

Once you have identified that you are working with an NLRD, you will need to include this in your REDCap Biosafety Application for IBC Approval:
- Type of Dealing – NLRD
- Select the appropriate Physical Containment level
- Enter the NLRD Subtype

Dealings Not Involving an Intentional Release/Licensed Dealings (DNIR)
DNIRs are GMO dealings that:
- Do not involve intentional release into the environment, and
- Do not meet the criteria for classification as an exempt dealing or NLRD.
- Require a licence from the OGTR.

These dealings often involve:
- Pathogenic GMOs
- Genes that encode toxins, cause cancer, or alter the immune system

These dealings:
- Must be conducted in a PC2-certified laboratory or higher
- Are governed by Schedule 3, Part 3 of the Gene Technology Regulations 2001

Once you have identified that you are working with a DNIR:
- Complete the DNIR Application for Licence,
- Attach it to your REDCap Biosafety Application
- The IBC will review and send the application to the OGTR
- OGTR approval is required before starting the research.

Dealings involving Intentional Release (DIR)
If you wish to conduct research that involves intentional release, please contact uow-biosafety@uow.edu.au.

Storage of GMOs
All GMOs must be clearly labelled and stored in a way that ensures:
- Security from unauthorised access
- Prevention of mix-ups or accidental release

Storage must comply with the OGTR Guidelines:
- Guide to Physical Containment Levels and Facility Types
- Guidelines for the Transport, Storage and Disposal of GMOs

Disposal of NDIRs must follow the conditions in the OGTR-issued licence.

Transport of GMOs
Transporting GMOs must follow strict rules to ensure safety and compliance.
- Only authorised personnel can pack and transport GMOs
- Packaging must meet the standards set by transport regulations (road, rail, air)
- Correct documentation must accompany all shipments
- Applies whether GMOs are delivered in person or sent via courier (through the Distribution Centre)
- Before transporting GMOs, speak with your laboratory manager for advice and guidance.

Useful Resources regarding the transport of GMOs:
- The Australian Dangerous Goods Code
- Australia Post – Prohibited and Dangerous Goods
- Gene Technology Regulations 2001
- Guidelines for the Transport, Storage and Disposal of GMOs (OGTR)

Is your organism a security sensitive biological agent (SSBA)?
Before obtaining any biological agent, you must check if it is classified as a Security Sensitive Biological Agent (SSBA).

Step 1 – Check the SSBA List
The Department of Health and Aged Care maintains the official SSBA List (Fact Sheet 5), which includes agents that may pose a significant risk to human health, the environment and the Australian economy, if deliberately released.
- Tier 1: Highest security risk
- Tier 2: High security risk

Step 2 – Contact the IBC
If your organism is listed, you must contact the IBC before acquiring it; uow-biosafety@uow.edu.au.

For further information regarding SSBAs, refer to:
- SSBA Guidelines
- SSBA Fact Sheets.

Amendments and Annual Reports
All projects with IBC approval - including approved GMO dealings – must meet the following reporting obligations:

Amendments
Any changes to an approved project must be submitted to the IBC for review. This includes:
- Adding similar GMOs
- Changes to facility conditions or research locations
- Updates to GMO storage locations

For changes to Biosafety Applications, including exempt dealings, NLRD, DNIR and DIR, the amendment process is as follows:
- Create a new instance within the relevant Biosafety Application (in Application Registration)
- Populate the required fields, including any changes
- Attach any new or updated documents where relevant.
   For DNIR Licenced Dealings complete and attach the Application to vary or surrender a DNIR licence.
   For DIR Licenced Dealing complete and attach the Application to vary or surrender a DIR licence
- Ensure "Yes" is selected for "Apply for IBC Approval"
- Once all details have been completed, mark the Form Status as "Complete" and save to submit the Biosafety Application for IBC review

Note: any changes to research personnel can be addressed as part of the annual reporting requirements.

Annual and final reports
- Annual Reports: Submit using the Annual Report on Approved Protocol Form
- Final Reports: Must be submitted within three months of project expiry and include disposal procedures.

Failure to submit reports may result in an approval being revoked or lapsing.

Physical Containment levels

Facilities that have been certified by the OGTR will display signage on all entrances to the facility and must meet 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.

Notes:
- There are no certified PC3 or PC4 facilities at the University of Wollongong.
- For more information refer to the Guidelines for the certification of physical containment facilities | Office of the Gene Technology Regulator.

Biosafety Applications are processed and stored in the REDCap Biosafety Database.
For REDCap Biosafety access requests, please submit the online Research Systems Access Request Form.

Refer to the REDCap Biosafety User Guide for further detail on how to use REDCap.

The UOW Biosafety and GMO training program must be completed prior to commencing your work or research and consists of two modules.

Module 1 – Biosafety
Required for anyone working with, or who could be potentially exposed to, biohazardous material during the course of their work, including those working in PC1 or PC2 facilities.

Module 2 – Genetically Modified Organisms (GMO)
Required for anyone working in an OGTR certified PC1 or PC2 facility. Note: Module 1 must be complete before Module 2 can be attempted.

The training program is available on Moodle and must be renewed every 5 years.

Guidelines

• Biosafety Manual
• Immunisation Guidelines
• Preventing the Transmission of Blood-borne Pathogens Guidelines
• Hazardous Waste Disposal Guidelines and Hazardous Waste Collection Dates
• REDCap Biosafety User Guide

Forms and templates

• Immunisation Declaration Form
• Biosafety Self-Assessment Checklist
• Laboratory Vacating/Decommissioning Checklist
• IBC Annual Report Template
• IBC Final Report Template

Licensed Dealing

• Application for a DNIR Licence (dealing not involving an intentional release of a GMO into the environment)
• Application for DNIR Storage (same form as above)

Making changes to a Protocol

• Application to vary or surrender a DNIR Licence
• Application to vary or surrender a DIR Licence

Signs

• PC2 Authorised Personnel Sign
• PC1 Laboratory Door Sign
• PC2 Laboratory Door Sign
• Biosecurity Containment Facility BC1 Sign
• Biosecurity Containment Facility BC2 Sign

Key standards and legislation

In addition to the WHS Act (2011) and the WHS regulations (2017), the following key pieces of legislation are applicable when working with biological materials and GMOs:

• Gene Technology Act 2000
• Biosecurity Act 2015>
• National Health Security Act, 2007
• AS/NZS 2243.3 Safety in Laboratories - Microbiological Safety and Containment - (access through Intertek SAI Global database)
• AS/NZS 2243.1 Safety in laboratories—Planning and operational aspects - (access through Intertek SAI Global database)

For any questions or concerns related to Biosafety, please contact Fiona Wells, WHS Advisor (Science) by emailing uow-biosafety@uow.edu.au or calling 02 4221 3614.

There are also local are biosafety representatives who can assist with your general biosafety enquiries.