Biosafety

If your research or teaching involves using genetically modified organisms (GMOs), quarantined materials, infectious microorganisms or biological hazards, you’ll need to work in accordance with all the relevant legislative requirements and at a standard that ensures the safety of staff, students, the wider community and the environment.

Microbiological safety and containment standard

The Australian/New Zealand Standard 2243.3:2010 Safety in laboratories Part 3: Microbiological safety and containment is your first source of information about biosafety and microbiological lab safety. It’s the Standard that Australia uses to describe the management of biohazards of all kinds. All Curtin’s biosafety systems have been developed from this Standard, and you should always refer to it for guidance.

Curtin students and staff have access to the Standard through Curtin Library’s SAI Global account. Search for ‘2243.3:2010’ to get the Standard. Your downloaded copy of the Standard will self-erase after a couple of days, and you’ll need to go back to SAI Global to get another copy each time you need it.

Biosafety Awareness Statement

The Biosafety Awareness Statement [.pdf 190kB] details the biosafety systems you need to comply with at Curtin if you want to work with genetically modified organisms, quarantined materials, microorganisms in Risk Groups 2 and 3, tissues or body fluids from humans or animals, or any living creatures that could harm you while you study them, or damage local ecosystems.

It contains the full set of information in the feedback from the Biosafety Section of the Hazard Identification Tool (HIT).

Genetically Modified Organisms (GMOs) training course

If you work with Genetically Modified Organisms (GMOs), or within a research facility Certified by the Office of the Gene Technology Regulator (OGTR), you need to complete the compulsory Gene Technology Training. This training is given every second month by the Chair of Curtin’s Institutional Biosafety Committee (IBC).

The date and time will be advertised by Facility Managers and School Managers in the biosciences areas, so look out for the email announcement.

Alternatively, you can get a group together and request a special session by contacting the biosafety advisor.

Quarantine training course

Biosafety training on the web

Which class of GMO do I want to work with?

There are four classes of GM Dealings and the approval process is different for each class. Read the Australian Government documents below for more information.

Exempt Dealings

Exempt Dealings (EDs) pose the lowest level of risk. Curtin is therefore exempt from having to notify the Office of the Gene Technology Regulator (OGTR) that EDs are being done (like for an NLRD), or from seeking a Licence from the OGTR (like for a DNIR or DIR). EDs must be contained within a research or teaching facility, and must not involve the release of the organism into the environment. To check if your work is an ED, read Dealings classified as exempt dealings.

If you want to perform an ED, before you begin you must advise the IBC by filling in the GM Dealing Application Form on InfoEd. The Biosafety Advisor will get back to you within a couple of days to confirm that you are planning to perform an ED or to ask you to submit an application to perform a different kind of dealing.

Notifiable Low Risk Dealings (NLRDs)

These GM dealings pose a low level of risk. Curtin must notify the OGTR about each NLRD that is being done. NLRDs must be contained within an OGTR-certified research facility, and must not involve the release of the organism into the environment. To check if your work is an NLRD, read Types of dealings with GMOs classified as Notifiable Low Risk Dealings (NLRDs) [.pdf 291kB].

If you want to perform an NLRD, before you begin you must apply to the IBC for permission by filling in the GM Dealing Application Form on InfoEd. The IBC will assess your planned work, and either issue an Approval or ask you to submit an application to perform a different kind of dealing. You cannot commence your work until you receive Approval, which can take up to two months, so apply early to avoid delays.

Dealings Not involving an Intentional Release (DNIRs)

These GM dealings pose a higher level of risk. This class includes all dealings that are not EDs or NLRDs, and which do not involve an intentional release of the organism into the environment. DNIRs must be licenced to Curtin University by the OGTR. To check if your work is a DNIR, read What are Dealings NOT involving an Intentional Release (DNIR) of a GMO into the environment?

If you want to perform a DNIR, contact the biosafety advisor. They will help you through the application process. This involves applying to the IBC for approval, then the IBC will apply to the OGTR for a licence to do the dealing. You cannot commence your work until you receive a licence, which can take up to six months, so apply early to avoid delays.

Dealings involving an Intentional Release (DIRs)

These GM Dealings pose a higher level of risk. This class includes all dealings involving the release of the organism into the environment, usually field trials of plants. DIRs must be licenced to Curtin by the OGTR. To check if your work is a DIR, read What are Dealings involving an Intentional Release (DIR) of a GMO into the environment?

If you want to perform a DIR, contact the biosafety advisor. They will help you through the application process. This involves applying to the IBC for approval, then the IBC will apply to the OGTR for a licence to do the dealing. You cannot commence your work until you receive a licence, which can take between nine and fourteen months, so apply early to avoid delays.

Legislation governing the use of GMOs in Australia

The Gene Technology Act 2000 and Regulations 2001 describe a national scheme for the regulation of GMOs in Australia. The legislation aims to make GM techniques safe for researchers, the public and the environment. However, the safety of recombinant DNA work ultimately depends on the individuals conducting it.

The object of this Act is to protect the health and safety of people and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with GMOs.

The Office of the Gene Technology Regulator (OGTR) is the administrative body under the Act. The OGTR has awarded Curtin status as an Accredited Organisation, enabling us to perform gene technology Dealings, and maintain several OGTR-Certified research facilities.

Working with GMOs training course

How do I import biological materials or soil/sand/rock into Curtin?

There are two levels of quarantine that apply to Western Australia:

State quarantine between WA and the Eastern States of Australia
Federal quarantine between Australia and overseas

You might need import permits from both Federal and State quarantine, or you might just need a Federal quarantine import permit, or you might not need any permits at all.

Follow the steps below to figure out which kinds of permit(s) you need to apply for, and contact the biosafety advisor for assistance.

To import from overseas:

Step 1: Search the Department of Agriculture BICON database for Federal quarantine import requirements.

Step 2: Read the import conditions for your commodity to figure out if you need to apply for an Import Permit. If you don’t require an Import Permit then just follow the import conditions.

Step 3: If you do require an Import Permit then you must register (top right of the BICON webpage) to join the existing Curtin multiple user account. The Organisation Name is â€œCurtin Universityâ€ and the Account Administrator’s Email is â€œbernadette.bradley@curtin.edu.auâ€.

Step 4: Once you’ve been confirmed as a user, you can apply for an Import Permit. You’ll need a credit card. Sometimes you may need to bring the materials into a Quarantine Approved Premises (QAP) – ask your lab manager and/or contact the biosafety advisor for assistance to either get access to a QAP or to get the approval for your own lab.

Western Australian quarantine:

Step 1: Search the WA Organisms List to find the legal status of the organism you want to import. If it’s listed, you’ll be able to see any control requirements required. If it’s unlisted or requires a permit then you’ll need to apply for an Import Permit.

Step 2. Check the Import Requirements associated with the organism. Fulfil all the listed requirements.

If you need more information, call Quarantine WA on +61 8 9334 1800. Curtin’s Biosafety Advisor may also be able to assist you.

Legislation governing the use of quarantined materials in Australia

There are several Federal and State Acts of law that cover quarantine, and it’s illegal to import any biological material without adhering to all the Guidelines and Regulations associated with those Acts.

The key legislation is the:

Biosecurity Act 2015 which replaced the Quarantine Act 1908
Biosecurity and Agriculture Management Act 2007 (State) and Regulations (2013)

These Acts are administered by the:

Department of Agriculture (Commonwealth)
Department of Agriculture and Food (State)

Approved Arrangements Accredited Person training

Appropriately handling samples

All microorganisms in Risk Groups (RG) 2, 3 or 4 need to be handled at the appropriate corresponding Physical Containment (PC) level (eg. PC2 for RG2).

For information about how to handle the samples, refer to Sections 3-5 of the Australian/New Zealand Standard 2243.3:2010 Safety in laboratories Part 3: Microbiological safety and containment. Curtin staff and students have access to the Standard through Curtin Library’s SAI Global account. Search for ‘2243.3:2010’ to get the Standard. Your downloaded copy of the Standard will self-erase after a couple of days, and you’ll need to go back to SAI Global to get another copy each time you need it.

If you can handle your microorganism at the same PC level as their RG then you don’t need Institutional Biosafety Committee (IBC) approval. This includes handling the microorganism entirely within a Class II Biosafety Cabinet if it can be infective via the respiratory route. However, if you need to use non-Standard methods, contact the biosafety advisor. They will help you to seek IBC assessment and approval of your methods before you can begin work.

We recommended you get the appropriate immunisations listed in The Australian Immunisation Handbook 10th Edition 2015. There may be other vaccinations available that are relevant to the samples you are handling.

What are SSBAs?

SSBAs are weaponisable pathogens or toxins that could be used to make a bioweapon.

Tier 1 Agents

Abrin (reportable quantity 5 mg)
Bacillus anthracis (Anthraxvirulent strains)
Botulinum toxin (non-therapeutic forms, reportable quantity 0.5 mg)
Ebolavirus
Foot-and-mouth disease virus
Highly pathogenic influenza virus, infecting humans
Marburgvirus
Ricin (reportable quantity 5 mg)
Rinderpest virus
SARS coronavirus
Variola virus (Smallpox)
Yersinia pestis (Plague)

Tier 2 Agents

African swine fever virus
Capripoxvirus (Sheep pox virus and Goat pox virus)
Classical swine fever virus
Clostridium botulinum (Botulism; toxin-producing strains)
Francisella tularensis (Tularaemia)
Lumpy skin disease virus
Peste-des-petits-ruminants virus
Yellow fever virus (non-vaccine strains)

How do I begin working with SSBAs at Curtin?

All activities related to SSBAs are regulated by the National Health Security Act (2007) – Part 3. It’s illegal to have any SSBA unless it’s being held following all the requirements of the SSBA regulatory system. Curtin is not registered to work with SSBAs, so it’s illegal for any of our people to store or work with SSBAs.

If you want to work with any SSBA in the future, then you must contact the biosafety advisor and the Chair of the IBC R.Steuart@curtin.edu.au immediately to discuss the possibility once the proper registration has been gained from the Federal Government Department of Health and Aging.

It’s possible to culture an SSBA from an environmental sample or a biological sample without specifically meaning to do so. If you become aware that you have cultured a presumptive SSBA, you must immediately contact the biosafety advisor or the Chair of the IBC R.Steuart@curtin.edu.au.

Legislation governing the use of SSBAs in Australia

Part 3 of the National Health Security Act 2007 and Regulations 2008 describes a national scheme for the regulation of SSBAs in Australia and builds on Australia’s obligations under the Biological and Toxin Weapons Convention (1975) and UN Security Council Resolution 1540 (2004).

The Department of Health and Ageing (DoHA) is the administrative body under the Act. Any institution that intends to store or perform research with, SSBAs must be registered with DoHa before the agent is imported into their site.

See the Department of Health’s page about SSBAs for more information.

Transport guidelines

Transport regulations

The IATA Dangerous Goods Regulations
The Australia Post Dangerous and Prohibited Goods guidelines
Australian Code for the Transport of Dangerous Goods by Road and Rail
International Maritime Dangerous Goods Code (IMDG Code)
The Office of the Gene Technology Regulator (OGTR), Guidelines for the transport of GMOs
Australian Standard for packaging for surface transport of biological material that may cause disease in humans, animals and plants (AS 4834). (All Australian Standards are accessible through the library)
United Nations Recommendations on the Transport of Dangerous Goods – Model Regulations

Biological containment facilities

Curtin has several biological containment facilities used to contain its biohazardous microbiological/plant/animal research and teaching activities.

We have a number of research facilities that are certified by the Office of the Gene Technology Regulator (OGTR), in which teaching and research with genetically modified organisms can be undertaken. There are PC2-level lab, plant, and animal facilities available.

We have a number of research facilities that are Approved Arrangements by the Department of Agriculture, in which teaching and research with quarantined biosecurity materials can be undertaken. There are QC2-level lab, plant, and animal facilities available.

Accessing research facilities

Dr Bernadette Bradley

Mobile:

0401 103 655

Phone:

+61 8 9266 1383

Email:

HazardousMaterials@curtin.edu.au

Institutional Biosafety Committee

Curtin’s Institutional Biosafety Committee (IBC) oversees all the research and teaching at Curtin involving the use of genetically modified organisms (GMOs), quarantined biological materials, infectious microorganisms, and other biohazardous materials.

Biosafety training and guidelines

Biosafety training

Genetically modified organisms

Quarantined materials and biosecurity

To import from overseas:

Western Australian quarantine:

Pathogenic microorganisms

Security Sensitive Biological Agents (SSBAs)

Tier 1 Agents

Tier 2 Agents

Transporting and storing biological materials

Storing biological materials

Biosafety advisor and committee

Dr Bernadette Bradley

Institutional Biosafety Committee