GMO Dealings

The Gene Technology Act 2000 (the Act) prohibits all dealings with genetically modified organisms (GMOs) unless they are:

  • an exempt dealing (confirmed by an IBC)
  • a notifiable low risk dealing (NLRD, assessed and authorised by an IBC)
  • included on the GMO Register
  • an emergency dealing determination (EDD)
  • authorised by a license.

There are 3 types of GMO dealings that need a licence from the Gene Technology Regulator:

  • dealings not involving intentional release (DNIR)
  • dealings involving intentional release (DIR)
  • inadvertent dealings.

  • Exempt dealings

    Exempt dealings are dealings with GMOs that pose a very low risk. They cannot involve any release of a GMO into the environment, such as field trials or commercial releases.  

    Schedule 2 of the Gene Technology Regulations 2001 lists dealings considered exempt. Exempt dealings do not need a licence if the activity stays within specified criteria. The IBC must confirm if a dealing is exempt.  

    To apply for approval for an exempt dealing, submit a GMO dealing application form to the IBC.

  • Notifiable low risk dealings (NLRD)

    A notifiable low risk dealing (NLRD) is an activity with GMOs that is:

    • undertaken in containment, in a facility certified by the Regulator or approved in writing by the Regulator
    • assessed as posing low risk to the health and safety of people and the environment provided certain risk management conditions are met.

    Schedule 3 of the Gene Technology Regulations 2001 (the Regulations) specifies the types of dealings with GMOs classified as NLRDs.

    An Institutional Biosafety Committee (IBC) must assess a dealing as an NLRD before it can be undertaken. 

    To apply for approval for an NLRD dealing, submit a GMO dealing application form to the IBC. If a research project includes both exempt dealings and NLRDs, they can be included in a single application.

    Details about an IBC’s assessment of an NLRD is notified to the Regulator and published in the List of notifiable low risk dealings. You should notify the Research Compliance Officer if any information in your application is required to be kept confidential.

     

  • Dealings not involving intentional release (DNIR)

    A DNIR is a dealing not involving the intentional release of a GMO into the environment. These are dealings with GMOs in containment which do not meet the criteria for classification as exempt dealings or notifiable low risk dealings (NLRDs).

    Dealings with a GMO licensed as a DNIR:

    • must not involve release into the environment
    • must be licensed by the Regulator.

    Schedule 3, Part 3 of the Regulations describes which dealings with GMOs cannot be authorised by NLRDs. These dealings need to be authorised by DNIR licences.

    DNIRs often involve genetically modified, disease-causing (pathogenic) organisms, or GMOs containing higher risk genes from pathogens or genes that:

    • encode toxins
    • encode genetic elements for gene drive mechanisms
    • confer a cancer-causing (oncogenic) modification or immuno-modulatory effect (changing the immune system).

    The holder of a licence is the OGTR accredited organisation, which is the University of Adelaide. A licence cannot be held by a researcher. The researcher can be listed as the Project Supervisor or an authorised person. To apply for a DNIR licence, contact the Research Compliance Officer.

  • Dealings involving intentional release (DIR)

    A DIR is a dealing involving the intentional release of GMOs. These are dealings with GMOs which take place outside of containment. Most DIR licences issued have been for:

    • experimental field trials of GM plants (limited and controlled releases)
    • general/commercial releases of GM plants.

    Some DIR licences have been issued for GMOs for medical or veterinary use, either for trial (limited and controlled release) or general/commercial release. The release of GM animals would also require a DIR licence.

    The holder of a licence is the OGTR accredited organisation, which is the University of Adelaide. A licence cannot be held by a researcher. The researcher can be listed as the Project Supervisor or an authorised person. To apply for a DIR licence, contact the Research Compliance Officer.

  • Clinical trials

    The type of approval required for a trial depends on the nature of the GMO and its likely fate once introduced into the trial participant. Clinical trials where patient cells are removed, genetically modified and replaced may not need a licence if they meet specific requirements.

    Clinical trials involving any other type of GMO will need a licence. If participants can shed, excrete or transmit the GMO, the trial needs a DIR licence. Otherwise, the trial needs a DNIR licence.

    For more information, refer to the guidance for conducting human clinical trials involving GMOs

    If you are not sure about the appropriate category, ask the IBC before submitting an application.

  • Viral vectors

    Dealings with viral vectors can be classified in the DNIR, NLRD and Exempt categories. The Regulator has developed guidance on the classification of contained dealings with viral vectors.

     

    Genetic modifications conferring an immunomodulatory effect

    The Regulator has clarified that when considering whether a genetic modification confers an immunomodulatory effect, the intention is to only include proteins, nucleic acid sequences or other molecules which either up-regulate or down-regulate the normal host immune response following exposure to an antigen.

    Cytokines that alter the normal immune response would be considered immunomodulatory. An example would be an oncolytic virus that expresses a cytokine intended to amplify an anti-tumour immune response.

    Antigens expressed for the purpose of vaccination are not considered immunomodulatory, as they initiate a normal immune response.

    Allergens inducing an allergic response would also not be immunomodulatory, as that response is normal in a susceptible person. A GM microorganism expressing a common allergen could still require a licence under Schedule 3.1 (f) as the genetic modification would increase the capacity of the organism to cause harm.

  • Gene drives

    Gene drives are genetic elements that are favoured for inheritance. An organism that contains a gene drive due to gene technology will be a GMO. It will be subject to regulation under the Act.

    Contained dealings with GMOs containing functional gene drives need a DNIR licence.

    Dealings with viral vectors that can change an organism to produce an engineered gene drive also need a DNIR licence.

     

  • Genome editing technology

    Site directed nuclease 1 (SDN-1) gene editing involves the application of a site-directed nuclease (SDN) to cause breaks in the genome, where a nucleic acid template is not supplied to guide genome repair. SDNs include, but are not limited to, CRISPR/Cas9, zinc finger nucleases, meganucleases and TALENs. Site-directed nucleases can be used in a variety of ways to produce SDN-1 organisms.

    The GMO status of SDN-1 gene edited organisms, and the IBC approval required prior to commencing work with them, is shown in this gene editing table .

    • Scenarios in green are not GMO dealings, and do not require IBC approval. However, you should contact the IBC to confirm the GMO status of organisms you are dealing with.
    • Scenarios in red constitute GMO dealings and a GMO dealing application must have been submitted to, and assessed and authorised by, the IBC before dealings with the GMO can commence.
    • Scenarios in yellow arise when nucleic acid was introduced into the initial organism as a transgene, but the initial organism or its offspring may subsequently be classed as “not a GMO” under certain circumstances. A gene edited organism release application form  must be assessed and authorised by the IBC before you can remove these organisms from approved physical containment facilities. This is to prevent inadvertent release of a GMO without a licence, which is a serious breach of the Gene Technology Act 2000.

    GMOs which may subsequently by classed as "not a GMO"

    • Example 1: A plant line with stably integrated Cas9 and gRNA transgenes is a GMO, but those of its segregating offspring which carry a SDN-1 modification and that lack Cas9 and gRNA transgenes or other traits from gene technology would not be GMOs.
    • Example 2: Cas9 and gRNA are transiently expressed in an organism. The organism is a GMO while the transgenes and their products are present. If the transient transgene and its expressed products have degraded over time and only SDN-1 modifications remain, the organism and its offspring are not GMOs.

    In both of these examples, Cas9 and gRNA transgenes are introduced, so a GMO dealing application form must be submitted, assessed and approved before commencing any work with the GMOs. If the transgene is subsequently degraded in the organism, or not inherited by its offspring, and you intend to handle these organisms as non-GMOs (e.g. to conduct a field trial of the plants in the environment), you need to apply to the IBC using the gene edited organism release application form  to obtain approval to remove these organisms from containment facilities.

    Prime editing

    The prime editing technique relies upon a site-directed nuclease with an additional enzymatic function (reverse transcriptase) engineered in.  The regulation of template-mediated genome editing equally applies to prime editing, and the resulting organisms would be GMOs, unless another exclusion under Schedule 1 applies.

    Base editing

    The regulation of base editing differs from other SDN genome editing methodologies as base editing requires additional enzyme activity, e.g. cytidine deaminase or adenine deaminase to achieve changes to nucleic acids in addition to nuclease activity. The Gene Technology Regulator has determined at this time that the use of base editing remains regulated, and the resulting organisms would be GMOs, unless another exclusion under Schedule 1 applies. 

  • RNA interference

    Some RNA interference (RNAi) techniques are not gene technology

    The Gene Technology Regulations list RNAi techniques involving directly applying RNAs to temporarily induce RNAi, as a technique that is not gene technology (see item 11 of Schedule 1A).

    As a result, organisms modified using these techniques will not be classified as GMOs.

    The RNAs could be introduced to the organism by any method including, but not limited to:

    • the organism taking up an externally applied RNA (e.g. by spraying with or dipping in an RNA solution)
    • injecting RNA into the organism
    • electroporation, and
    • methods leading to the organism consuming material to which the RNA has been applied (e.g. insects consuming RNA by feeding on plant material sprayed with RNA).

    To ensure that only short-lived RNAi techniques are excluded, this exclusion only applies if:

    • the organism’s genomic DNA sequence cannot be changed by the technique (this requirement can be met even if changes to genomic DNA methylation can occur), and
    • the introduced RNA cannot be translated into a protein or lead to the production of infectious agents.

    Provided the above requirements are met, the applied RNAs could potentially include small interfering RNAs, artificial microRNAs, short or long double-stranded RNAs and hairpin RNAs, with sequence of any origin. It is the responsibility of proponents to comply with the law and ensure that the requirements above have been met.

    This Regulation does not change the status of organisms to which other RNAi techniques have been applied, e.g. where an organism is stably or transiently transformed with a transgene able to express RNA that can induce gene silencing, this remains a GMO.

After requesting any amendments, you must receive approval in writing from the IBC before any changes to dealings can commence.

  • Amending exempt dealings

    What can be amended
    Any changes to the dealings that do not affect the exempt dealing classification.

    How to apply
    Provide a summary of the proposed changes to the Research Compliance Officer. If possible, making tracked changes on the original dealing application form is preferred.

  • Amending NLRDs

    What can be amended

    • Addition of facilities of the same class as those listed in the Record of Assessment
    • Addition of personnel of the same class as those listed in the Record of Assessment
    • Addition of dealings with GMOs that fall within the scope of approved GMOs in the Record of Assessment. 

    How to apply

    • Provide a summary of the proposed changes to the Research Compliance Officer. If possible, making tracked changes on the original dealing application form is preferred.

  • Varying a licenced dealing

    What can be amended/varied

    Please refer to the OGTRs Policy on scope for variation of GMO licences.

    How to apply

    The Research Compliance Officer will submit a licence variation request to the OGTR. A decision on a variation request is usually made by the Regulator within 90 working days.

  • Transport, storage and disposal of exempt GMOs

    Transport, storage and disposal of all exempt GMOs outside of a facility should be conducted in such a way to prevent intentional release of GMOs into the environment. Refer to Part 2 of the Guidance notes for the containment of exempt dealings , and any other requirements specified by the IBC in their assessment of the dealing.

  • Transport, storage and disposal of PC1 or PC2 notifiable low risk dealing (NLRD) GMOs

    Any NLRD involving transportation, storage or disposal of a GMO, outside of certified facilities, must adhere to the Guidelines for the Transport, Storage and Disposal of GMOs .

    Storing PC1 or PC2 GMOs outside of an OGTR certified facility

    Approval for storage:

    • The IBC must approve any storage of PC1 or PC2 GMOs outside of a certified facility, and the approval must be noted in the NLRD Record of Assessment. When applying for an NLRD, consider where GMOs will be stored after your experiments are completed.
    • Whole, viable GM animals or plants must not be stored outside of an authorised physical containment facility. This restriction does not apply to the pollen, seeds, tubers, bulbs, corms or dormant stems of GM plants.

    Containment:

    • All GMOs, including organisms containing GMOs, being stored must be wholly contained inside a sealed, unbreakable primary container.
    • PC2 GMOs must also 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.

    Loss, spill or escape of GMOs during storage:

    • In the event of the escape, unintentional release, spill, leak or loss of GMOs from storage:
      • efforts must be implemented as soon as reasonably practicable to locate and/or retrieve the GMOs and return the GMOs to containment or render them non-viable; and
      • the incident must be reported to the IBC as soon as reasonably practicable.
    • A supply of decontamination agents effective against the GMOs being stored must be readily available for decontamination purposes. All containers of decontamination agents, including any solutions for decontaminating hands, must be labelled with the contents and the expiry date. Decontamination agents must not be used after their expiry date. 
    • A spill kit, or other means of containing GMOs (e.g. traps for capturing escaped GM mice, a dustpan and broom for clean-up of spilled GM seed), and appropriate PPE should be accessible by personnel in the storage area.  

    Labelling:

    • You must label the stored material as being, or containing, a GMO.
    • The primary container must be labelled to clearly show the name and IBC ID number or licence number of the GMO being stored.
    • The storage unit, or any other secondary container, must be labelled to clearly show the name and contact details of the person responsible for the dealings, so that the person can be contacted should any GMOs be spilled or lost. A template is provided.
    • A biohazard label must be attached to the storage unit when storing any GM micro-organisms that satisfy the criteria for classification as a Risk Group 2 organism under Section 3.2 of AS/NZS 2243.3:2010.

    Accounting requirements:

    • Procedures must be in place to ensure that all GMOs stored can be accounted for.
    • A record(s) of GMOs being stored must be maintained and made available to the IBC or the Regulator upon request.
    • The record(s) of GMOs being stored must allow the person storing the GMOs to find the exact location of where the GMO is being stored.

    Security:

    • During the storage of GMOs outside of an authorised physical containment facility, access to the GMOs must be restricted, by any means that is effective, to only authorised persons as stated in the IBC’s record of assessment. Such means include swipe card, pin code or key access to the storage area, or having a key operated lock on a storage cupboard or drawer. 

    Transporting PC1 or PC2 GMOs outside of an OGTR certified facility

    There are detailed guidelines for transport of different types of PC1 and PC2 GMOs, and animals or plants containing GMOs. Refer to the Requirements for Transport of GMOs 

    Disposing of PC1 or PC2 GMOs in medical biohazard waste streams

    • The NLRD Record of Assessment or licence must approve waste service providers or external personnel as authorised persons for the dealings.
    • Medical waste bins containing viable GMOs being collected for destruction and disposal by a waste service provider must be labelled as containing GMOs. The IBC recommends securing the lid of the bin with a red cable tie labelled with “GMO waste” to comply with this requirement. Contact the Research Compliance Officer for details on how to purchase approved cable ties.
    • Medical waste bins containing viable GMOs must not be left unattended outside of a building while awaiting collection. 

  • Importing GMOs into Australia

    If you want to import any GMOs into Australia, you must have IBC authorisation. For PC1 and PC2 GMOs, the NLRD Record of Assessment must specifically permit import of the GMOs and transport of the GMO.

    Transport during import of a GMO authorised under an NLRD must comply with the Guidelines for the Transport, Storage and Disposal of GMOs . You must ensure the package containing the GMO meets any packaging and labelling requirements included in the Guidelines and the dealing Record of Assessment or licence.

    You should also consult the Department of Agriculture, Water and the Environment (DAWE)  to find out whether you need an import permit.

  • Exporting GMOs out of Australia

    If you want to export any GMOs out of Australia, you must have IBC authorisation. For PC1 and PC2 GMOs, the NLRD Record of Assessment must specifically permit transport of the GMO.

    Transport during export of a GMO authorised under an NLRD must comply with the Guidelines for the Transport, Storage and Disposal of GMOs . You must ensure the package containing the GMO meets any packaging and labelling requirements included in the Guidelines and the dealing Record of Assessment or licence.

    You should also ensure that you have the relevant approvals from the Department of Agriculture, Water and the Environment  and other Australian regulators (eg. approval from the Department of Defence, if your organisms are on the Defence & Strategic Goods list ) and from the receiving country(ies).

Schedule 1

  • Schedule 1A: Techniques not gene technology
    Item Description of technique

    1

    Somatic cell nuclear transfer, if the transfer does not involve genetically modified material.

    2

    Electromagnetic radiation-induced mutagenesis.

    3

    Particle radiation-induced mutagenesis.

    4

    Chemical-induced mutagenesis.

    5

    Fusion of animal cells, or human cells, if the fused cells are unable to form a viable whole animal or human.

    6

    Protoplast fusion, including fusion of plant protoplasts.

    7

    Embryo rescue.

    8

    In vitro fertilisation.

    9

    Zygote implantation.

    10

    A natural process, if the process does not involve genetically modified material.

    Examples
    Examples of natural processes include conjugation, transduction, transformation and transposon mutagenesis.

    11

    Introduction of RNA into an organism, if:
     a. the RNA cannot be translated into a polypeptide; and
     b. the introduction of the RNA cannot result in an alteration of the organism's genome sequence; and
     c. the introduction of the RNA cannot give rise to an infectious agent.

  • Schedule 1B: Genetically modified organisms
    Item Description of technique

    1

    An organism that has had its genome modified by oligonucleotide-directed mutagenesis.

    2

    An organism modified by repair of single-strand or double-strand breaks of genomic DNA induced by a site-directed nuclease, if a nucleic acid template was added to guide homology-directed repair.

  • Schedule 1: Organisms not genetically modified
    Item Description of organism

    1

    (Item 1 repealed 8 October 2020)

    2

    A whole animal, or a human being, modified by the introduction of naked recombinant nucleic acid (such as a DNA vaccine) into its somatic cells, if the introduced nucleic acid is incapable of giving rise to infectious agents.

    3

    Naked plasmid DNA that is incapable of giving rise to infectious agents when introduced into a host cell.

    4

    An organism modified by repair of single-strand or double-strand breaks of genomic DNA induced by a site-directed nuclease, if a nucleic acid template was not added to guide homology-directed repair.

    6

    		 An organism that results from an exchange of DNA if:
     a. the donor species is also the host species; and
     b. the vector DNA does not contain any heterologous DNA.

    7

    An organism that results from an exchange of DNA between the donor species and the host species if:
     a. such exchange can occur by naturally occurring processes; and
     b. the donor species and the host species are micro-organisms that:
         i. satisfy the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 1; and
        ii. are known to exchange nucleic acid by a natural physiological process; and
     c. the vector used in the exchange does not contain heterologous DNA from any organism other than an organism that is involved in the exchange.

    8

    An organism that is descended from a genetically modified organism (the initial organism), if none of the traits it has inherited from the initial organism are traits that occurred in the initial organism because of gene technology.

    9

    		 An organism that has inherited particular traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology, if:
     a. the initial organism was not a genetically modified organism (because of the application of regulation 5); or
     b. all such inherited traits are traits that occurred in the initial organism as a result of a modification described in an item in this Schedule.

    10

    An organism that was modified by gene technology but in which the modification, and any traits that occurred because of gene technology, are no longer present.

    11

    Agrobacterium radiobacter strain K1026.

    12

    Pasteurella multocida strain PMP1.

Schedule 2

  • Schedule 2 Part 1: Exempt dealings

     Note: Subregulation 6(1) sets out other requirements for exempt dealings.

    Item Description of dealing

    2

    		 A dealing with a genetically modified Caenorhabditis elegans, unless:
     a. an advantage is conferred on the animal by the genetic modification; or
     b. as a result of the genetic modification, the animal is capable of secreting or producing an infectious agent.

    3

    		 A dealing with an animal into which genetically modified somatic cells have been introduced, if:
     a. the somatic cells are not capable of giving rise to infectious agents as a result of the genetic modification; and
     b. the animal is not infected with a virus that is capable of recombining with the genetically modified nucleic acid in the somatic cells.​​​​

    3A

    		 A dealing with an animal whose somatic cells have been genetically modified in vivo by a replication defective viral vector, if:
     a. the in vivo modification occurred as part of a previous dealing; and
     b. the replication defective viral vector is no longer in the animal; and
     c. no germ line cells have been genetically modified; and
     d. the somatic cells cannot give rise to infectious agents as a result of the genetic modification; and
     e. the animal is not infected with a virus that can recombine with the genetically modified nucleic acid in the somatic cells of the animal.

    4

    (1) Subject to subitem (2), a dealing involving a host/vector system mentioned in Part 2 of this Schedule and producing no more than 25 litres of GMO culture in each vessel containing the resultant culture.

    (2) The donor nucleic acid:
     a. must meet either of the following requirements:
         i. it must not be derived from organisms implicated in, or with a history of causing, disease in otherwise healthy:
            A. human beings;
            B. animals;
            C. plants; or
            D. fungi

        ii. it must be characterised and the information derived from its characterisation show that it is unlikely to increase the capacity of the host or vector to cause harm*; and

     b. must not code for a toxin with an LD50 of less than 100 micrograms/kg; and
     c. must not code for a toxin with an LD50 of 100 micrograms/kg or more, if the intention is to express the toxin at high levels; and
     d. must not be uncharacterised nucleic acid from a toxin-producing organism; and
     e. if the donor nucleic acid includes a viral sequence - cannot give rise to infectious agents when introduced into any potential host species, without additional non-host genes or gene products that:
        i. are not available in the host cell into which the nucleic acid is introduced as part of the dealing; and
       ii. will not become available during the dealing; and

     f. if the donor nucleic acid includes a viral sequence - cannot restore replication competence to the vector.

    * Example
    Donor nucleic acid would not comply with subparagraph (ii) if its characterisation shows that, in relation to the capacity of the host or vector to cause harm, it:
    (a) provides an advantage; or
    (b) adds a potential host species or mode of transmission; or
    (c) increases its virulence, pathogenicity or transmissibility.

    5

    		 A dealing involving shot-gun cloning, or the preparation of a cDNA library, in a host/vector system mentioned in items 1 to 6 of the table in Part 2 of this Schedule, if the donor nucleic acid is not derived from either:
     a. a pathogen; or
     b. a toxin-producing organism.

  • Schedule 2 Part 2: Host/vector systems for exempt dealings
    Item Class Host Vector

    1

    Bacteria

    		 Escherichia coli K12, E. coli B, E. coli C or E. coli Nissle 1917 - any derivative that does not contain:
     a. generalised transducing phages; or
     b. genes able to complement the conjugation defect in a non-conjugative plasmid​​​​​    		 Any of the following:
     a. non-conjugative plasmids
     b. lambda bacteriophage;
     c. lambdoid bacteriophage;
     d. Fd, F1 or M13 bacteriophage

     

    2

    Bacteria

    		 Bacillus-asporogenic strains of the following species with a reversion frequency of less than 10^-7:
     a. B. amyloliquefaciens
     b. B. licheniformis
     c. B. pumilus
     d. B. subtilis
     e. B. thuringiensis​​​​    		 Any of the following:
     a. non-conjugative plasmids
     b. Other plasmids and phages whose host range does not include B. cereus, B. anthracis or any other pathogenic strain of Bacillus

     

    3

    Bacteria

    Pseudomonas putida strain KT2440

    Non-conjugative plasmids

    4

    Bacteria

    		 The following Streptomyces species:
     a. S. aureofaciens
     b. S. coelicolor
     c. S. cyaneus
     d. S. griseus
     e. S. lividans
     f. S. parvulus
     g. S. rimosus
     h. S. venezuelae

     

    		 Any of the following:
     a. non-conjugative plasmids
     b. plasmids SCP2, SLP1, SLP2, pIJ101 and derivatives
     c. actinophage phi C31 and derivatives​​​​​​

    5

    Bacteria

    		 Any of the following:
     a. Agrobacterium radiobacter
     b. Agrobacterium rhizogenes (disarmed strains only)
     c. Agrobacterium tumefaciens (disarmed strains only)​​​​​​

    Disarmed Ri or Ti plasmids

    6

    Bacteria

    		 Any of the following:
     a. Allorhizobium species
     b. Corynebacterium glutamicum
     c. Lactobacillus species
     d. Lactococcus lactis
     e. Oenococcus oeni syn. Leuconostoc oeni
     f. Pediococcus species
     g. Photobacterium angustum
     h. Pseudoalteromonas tunicata
     i. Rhizobium species
     j. Sphingopyxis alaskensis syn. Sphingomonas alaskensis
     k. Streptococcus thermophilus
     l. Synechococcus species strains PCC 7002, PCC 7942 & WH 8102
     m. Synechocystis species strain PCC 6803
     n. Vibrio cholerae CVD103-HgR
     o. Zymomonas mobilis

     

    Non-conjugative plasmids

    7

    Fungi

    		 Any of the following:
     a. Kluyveromyces lactis
     b. Neurospora crassa (laboratory strains)
     c. Pichia pastoris
     d. Saccharomyces cerevisiae
     e. Schizosaccharomyces pombe
     f. Trichoderma reesei
     g. Yarrowia lipolytica

     

    All vectors

    8

    Slime moulds

    Dictyostelium species

    Dictyostelium shuttle vectors, including those based on the endogenous plasmids Ddp1 & Ddp2

    9

    Tissue Culture

    Any of the following if they cannot spontaneously generate a whole animal:
     a. animal or human cell cultures (including packaging cell lines)
     b. isolated cells, isolated tissues or isolated organs, whether animal or human
     c. early non-human mammalian embryos cultured in vitro

    		 Any of the following:
     a. plasmids
     b. replication defective viral vectors unable to transduce human cells
     c. polyhedrin minus forms of the baculovirus Autographa californica nuclear polyhedrosis virus (ACNPV)​​​​​​

    10

    Tissue Culture

    		 Either of the following if they are not intended, and are not likely without human intervention, to vegetatively propagate, flower or regenerate into a whole plant:
     a. plant cell cultures
     b. isolated plant tissues or organs​​​​​​    		 Any of the following:
     a. Disarmed Ri or Ti plasmids in Agrobacterium radiobacter, Agrobacterium rhizogenes (disarmed strains only) or Agrobacterium tumefaciens (disarmed strains only)
     b. non-pathogenic viral vectors​​​​​​

  • Schedule 2 Part 3: Definitions

    Refer to the Gene Technology Resources page for a comprehensive list of gene-tech terms.

    Code for: in relation to a toxin, means to specify the amino acid sequence of the toxin.

    Non-conjugative plasmid: a plasmid that is not self-transmissible, and includes, but is not limited to, non-conjugative forms of the following plasmids:
     a. bacterial artificial chromosomes (BACs)
     b. cosmids
     c. P1 artificial chromosomes (PACs)
     d. yeast artificial chromosomes (YACs).

    Non-vector system: a system in which donor nucleic acid is or was introduced into a host cell:
     a. in the absence of a nucleic acid-based vector; or
     b. using a nucleic acid-based vector in the course of a previous dealing and the vector is:
         i. no longer present; or
        ii. present but cannot be remobilised from a host cell.

    Example 1
    A system mentioned in paragraph (a) might involve the use of electroporation or particle bombardment.

    Example 2
    A system mentioned in paragraph (b) might involve cells that were transduced with a replication defective retroviral vector in which no vector particles remain.

Schedule 3

NLRD = Notifiable Low Risk Dealing

  • Schedule 3 Part 1: NLRDs suitable for at least physical containment lvl 1

    Because of subregulation 12(1) a dealing mentioned in this Part is not a notifiable low risk dealing if it is also a dealing of a kind mentioned in Part 3 of this Schedule.

    The following kinds of notifiable low risk dealings must be undertaken, unless paragraph 13(2)(c) or subregulation 13(3) applies, in facilities certified to at least physical containment level 1 and that are appropriate for the dealings:

    Item Description of dealing

    (a)

    		 a dealing involving a genetically modified laboratory guinea pig, a genetically modified laboratory mouse, a genetically modified laboratory rabbit or a genetically modified laboratory rat, unless:
     a. an advantage is conferred on the animal by the genetic modification; or
     b. the animal is capable of secreting or producing an infectious agent as a result of the genetic modification;​​​​​​
      Note there is no Item (b) in the current version of Schedule 3 Part 1
    (c) a dealing involving virions of a replication defective vector derived from Human adenovirus or from Adeno-associated virus, either without a host or with a host mentioned in item 9 of Part 2 of Schedule 2, if the donor nucleic acid:
     a. cannot restore replication competence to the vector; and
     b. does not confer an oncogenic modification or immunomodulatory effect in humans.​​​​​​

  • Schedule 3 Part 2: NLRDs suitable for at least physical containment lvl 2 & 3

    Because of subregulation 12(1) a dealing mentioned in this Part is not a notifiable low risk dealing if it is also a dealing of a kind mentioned in Part 3 of this Schedule.

    The following kinds of notifiable low risk dealings must be undertaken, unless paragraph 13(2)(c) or subregulation 13(3) applies, in facilities certified to at least physical containment level 2 and that are appropriate for the dealings:

    2.1 Kinds of dealings suitable for at least physical containment level 2
    Item Description of dealing
    (a) a dealing involving whole animals (including non-vertebrates) that:
       i. involves genetic modification of the genome of the oocyte or zygote or early embryo by any means to produce a novel whole organism; and
      ii. does not involve any of the following:
         A. a genetically modified laboratory guinea pig;
         B. a genetically modified laboratory mouse;
         C. a genetically modified laboratory rabbit;
         D. a genetically modified laboratory rat;
         E. a genetically modified Caenorhabditis elegans;
    (aa) a dealing involving a genetically modified laboratory guinea pig, a genetically modified laboratory mouse, a genetically modified laboratory rabbit, a genetically modified laboratory rat or a genetically modified Caenorhabditis elegans, if:
       i. the genetic modification confers an advantage on the animal; and
      ii. the animal is not capable of secreting or producing an infectious agent as a result of the genetic modification;​​​​​
    (b)

    a dealing involving a genetically modified plant
    (c)

    a dealing involving a host/vector system not mentioned in paragraph 1.1(c) or Part 2 of Schedule 2, if neither host nor vector has been implicated in, or has a history of causing, disease in otherwise healthy:
       i. human beings; or
      ii. animals; or
     iii. plants; or
     iv. fungi;
    (d)

    a dealing involving a host/vector system not mentioned in Part 2 of Schedule 2, if:
       i. the host or vector has been implicated in, or has a history of causing, disease in otherwise healthy:
         A. human beings; or
         B. animals; or
         C. plants; or
         D. fungi; and

      ii. the genetic modification is characterised; and
     iii. the characterisation of the genetic modification shows that it is unlikely to increase the capacity of the host or vector to cause harm;

    Example:
    A genetic modification would not comply with subparagraph (iii) if, in relation to the capacity of the host or vector to cause harm, it:
    • provides an advantage; or
    • adds a potential host species or mode of transmission; or
    • increases its virulence, pathogenicity or transmissibility.
    (e)

    a dealing involving a host/vector system mentioned in Part 2 of Schedule 2, if the donor nucleic acid:
       i. is characterised, and the characterisation shows that it may increase the capacity of the host or vector to cause harm; or
      ii. is uncharacterised nucleic acid from an organism that has been implicated in, or has a history of causing, disease in otherwise
         A. human beings; or
         B. animals; or
         C. plants; or
         D. fungi;
    (f) a dealing involving a host/vector system mentioned in Part 2 of Schedule 2 and producing more than 25 litres of GMO culture in each vessel containing the resultant culture, if:
       i. the dealing is undertaken in a facility that is certified by the Regulator as a large scale facility; and
      ii. the donor nucleic acid satisfies the conditions set out in subitem 4(2) of Part 1 of Schedule 2;​​​​​
    (g)

    a dealing involving complementation of knocked-out genes, if the complementation is unlikely to increase the capacity of the GMO to cause harm compared to the capacity of the parent organism before the genes were knocked out;

    Example
    A dealing would not comply with paragraph (g) if it involved complementation that, in relation to the parent organism:
    • provides an advantage; or
    • adds a potential host species or mode of transmission; or
    • increases its virulence, pathogenicity or transmissibility.
    (h) a dealing involving shot-gun cloning, or the preparation of a cDNA library, in a host/vector system mentioned in items 1 to 6 of the table in Part 2 of Schedule 2, if the donor nucleic acid is derived from either:
       i. a pathogen; or
      ii. a toxin-producing organism;​​​​​​
    (i)

    a dealing involving virions of a replication defective viral vector unable to transduce human cells and a host not mentioned in Part 2 of Schedule 2, if the donor nucleic acid cannot restore replication competence to the vector;
    (j) a dealing involving virions of a replication defective non-retroviral vector able to transduce human cells, either without a host or with a host mentioned in Part 2 of Schedule 2, if:
       i. the donor nucleic acid cannot restore replication competence to the vector; and
      ii. the dealing is not a dealing mentioned in paragraph 1.1(c)​​​​​​
    (k) a dealing involving virions of a replication defective non-retroviral vector able to transduce human cells and a host not mentioned in Part 2 of Schedule 2, if:
       i. the donor nucleic acid cannot restore replication competence to the vector; and
      ii. the donor nucleic acid does not confer an oncogenic modification or immunomodulatory effect in humans​​​​​​
    (l) a dealing involving virions of a replication defective retroviral vector able to transduce human cells, either without a host or with a host mentioned in Part 2 of Schedule 2, if:
       i. all viral genes have been removed from the retroviral vector so that it cannot replicate or assemble new virions without these functions being supplied in trans; and
      ii. viral genes needed for virion production in the packaging cell line are expressed from independent, unlinked loci with minimal sequence overlap with the vector to limit or prevent recombination; and
     iii. either:
         A. the retroviral vector includes a deletion in the Long Terminal Repeat sequence of DNA that prevents transcription of genomic RNA following integration into the host cell DNA; or
         B. the packaging cell line and packaging plasmids express only viral genes gagpol, rev and an envelope protein gene, or a subset of these;
    (m) a dealing involving virions of a replication defective retroviral vector able to transduce human cells and a host not mentioned in Part 2 of Schedule 2, if:
       i. the donor nucleic acid does not confer an oncogenic modification or immunomodulatory effect in humans; and
      ii. all viral genes have been removed from the retroviral vector so that it cannot replicate or assemble new virions without these functions being supplied in trans; and
     iii. viral genes needed for virion production in the packaging cell line are expressed from independent, unlinked loci with minimal sequence overlap with the vector to limit or prevent recombination; and
     iv. either:
         A. the retroviral vector includes a deletion in the Long Terminal Repeat sequence of DNA that prevents transcription of genomic RNA following integration into the host cell DNA; or
         B. the packaging cell line and packaging plasmids express only viral genes gagpol, rev and an envelope protein gene, or a subset of these.

     

    2.2 Kinds of dealings suitable for at least physical containment level 3
    Item Description of dealing
    (1)

    A kind of dealing that:
     a. is a kind mentioned in clause 2.1; and
     b. involves a micro-organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3

    ​​​must be undertaken, unless paragraph 13(2)(c) or subregulation 13(3) applies, in facilities certified to at least physical containment level 3 and that are appropriate for the dealings.
    (2)

    For the purposes of paragraph (1)(b), a genetically modified micro-organism is taken to satisfy the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3 if the unmodified parent micro-organism satisfies those criteria.
    (3)

    However, subclause (2) does not apply in relation to a replication defective retroviral vector that meets the criteria in paragraph 2.1(l) or (m).

  • Schedule 3 Part 3: Dealings not NLRDs

    Note 1 The following list qualifies the list in Parts 1 and 2, and is not an exhaustive list of dealings that are not notifiable low risk dealings.

    Note 2 If a dealing is not a notifiable low risk dealing, or an exempt dealing, as provided by these regulations, a person undertaking the dealing must be authorised by a GMO licence unless the dealing is within one of the other exceptions to licensing provided by the Act: see section 32 of the Act.

    3.1 Kinds of dealings

    A dealing of any of the following kinds, or involving a dealing of the following kinds, is not a notifiable low risk dealing:

    Item Description of dealing
    (a) a dealing (other than a dealing mentioned in paragraph 2.1(h)) involving cloning of nucleic acid encoding a toxin having an LD50 of less than 100 micrograms per kg;
    (b) a dealing involving high level expression of toxin genes, even if the LD50 is 100 micrograms per kg or more;
    (c) a dealing (other than a dealing mentioned in paragraph 2.1 (h)) involving cloning of uncharacterised nucleic acid from a toxin-producing organism;
    (d) a dealing involving virions of a replication defective viral vector and a host not mentioned in Part 2 of Schedule 2, if:
       i. the donor nucleic acid confers an oncogenic modification or immunomodulatory effect in humans; and
      ii. the dealing is not a dealing mentioned in paragraph 2.1(i)​​​​​​
    (e)

    a dealing involving a replication competent virus or viral vector, other than a vector mentioned in Part 2 of Schedule 2, if the genetic modification confers an oncogenic modification or immunomodulatory effect in humans;
    (f)

    a dealing involving, as host or vector, a micro-organism, if:
       i. the micro-organism has been implicated in, or has a history of causing, disease in otherwise healthy:
          A. human beings; or
          B. animals; or
          C. plants; or
          D. fungi; and

      ii. none of the following sub-subparagraphs apply:
          A. the host/vector system is a system mentioned in Part 2 of Schedule 2;
          B. the genetic modification is characterised and its characterisation shows that it is unlikely to increase the capacity of the host or vector to cause harm;
          C. the dealing is a dealing mentioned in paragraph 2.1 (g);

    Example:
    a genetic modification would not comply with sub-subparagraph (B) if, in relation to the capacity of the host or vector to cause harm, it:
    • provides an advantage; or
    • adds a potential host species or mode of transmission; or
    • increases its virulence, pathogenicity or transmissibility.
    (g) a dealing involving the introduction, into a micro-organism, of nucleic acid encoding a pathogenic determinant, unless:
       i. the dealing is a dealing mentioned in paragraph 2.1 (g); or
      ii. the micro-organism is a host mentioned in Part 2 of Schedule 2;​​​​​​
    (h)

    a dealing involving the introduction into a micro-organism, other than a host mentioned in Part 2 of Schedule 2, of genes whose expressed products are likely to increase the capacity of the micro-organisms to induce an autoimmune response;
    (i)

    a dealing involving use of a viral or viroid genome, or fragments of a viral or viroid genome, to produce a novel replication competent virus with an increased capacity to cause harm compared to the capacity of the parent or donor organism;

    Example
    A dealing would comply with paragraph (i) if it produces a novel replication competent virus that has a higher capacity to cause harm to any potential host species than the parent organism because the new virus has:
    • an advantage; or
    • a new potential host species or mode of transmissibility; or
    • increased virulence, pathogenicity or transmissibility.
    (j)

    a dealing, other than a dealing mentioned in paragraph 2.1 (l) or (m), with a replication defective retroviral vector (including a lentiviral vector) able to transduce human cells;
    (k) a dealing involving a genetically modified animal, plant or fungus that is capable of secreting or producing infectious agents as a result of the genetic modification;
    (l)

    a dealing producing, in each vessel containing the resultant GMO culture, more than 25 litres of that culture, other than a dealing mentioned in paragraph 2.1 (f);
    (m) a dealing that is inconsistent with a policy principle issued by the Ministerial Council;
    (n) a dealing involving the intentional introduction of a GMO into a human being, unless the GMO:
       i. is a human somatic cell; and
      ii. cannot secrete or produce infectious agents as a result of the genetic modification; and
     iii. if it was generated using viral vectors:
         A. has been tested for the presence of viruses likely to recombine with the genetically modified nucleic acid in the somatic cells; and
         B. the testing did not detect a virus mentioned in sub-subparagraph (A); and
         C. the viral vector used to generate the GMO as part of a previous dealing is no longer present in the somatic cells;

     
    (o)

    a dealing involving a genetically modified pathogenic organism, if the practical treatment of any disease or abnormality caused by the organism would be impaired by the genetic modification;
    (p) a dealing involving a micro-organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 4;
    (q) a dealing involving a micro-organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3 and that is not undertaken:
       i. in a facility that is certified by the Regulator to at least physical containment level 3 and that is appropriate for the dealing; or
      ii. in a facility that the Regulator has agreed in writing is a facility in which the dealing may be undertaken​​​​​
    (r) a dealing involving a GMO capable of sexual reproduction, the sexual progeny of which are, as a result of the genetic modification, more likely to inherit a particular nucleotide sequence or set of nucleotide sequences (when compared to inheritance from the unmodified parent organism);
    (s)

    a dealing involving a viral vector that can modify an organism capable of sexual reproduction, so that the sexual progeny of the organism are more likely to inherit a particular nucleotide sequence or set of nucleotide sequences (when compared to inheritance from the unmodified parent organism).

    Note: A modification that increases the likelihood of inheritance of a nucleotide sequence or sequences, as described in paragraphs (r) and (s), is generally known as an engineered gene drive.

    • For the purposes of 3.1 (p), a genetically modified micro organism is taken to satisfy the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 4 if the unmodified parent micro organism satisfies those criteria.

    • For the purposes of 3.1 (q), a genetically modified micro organism is taken to satisfy the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3 if the unmodified parent micro organism satisfies those criteria. However, this clause does not apply in relation to a replication defective retroviral vector that meets the criteria in paragraph 2.1(l) or (m).

Incidents in relation to GMOs include, either intentional or accidental:

  • breaches of containment and/or release of GMOs from containment
  • spills of GMO material
  • non-compliance with OGTR Guidelines
  • non-compliance with institutional requirements

Your efficient and effective response to an incident is vital. All incidents must be reported.

Any spill, accident, or unintentional release involving GMOs must be reported to the IBC as soon as possible, and within 24 hours. Email the IBC, or call one of the Research Compliance Officers:

  • Dr Amanda Highet, Senior Research Compliance Officer - T:(08) 8313 6105.
  • Dr Jess Hall, Research Compliance Officer - T: (08) 8313 3059.

All personnel working with GMOs should be familiar with the protocols in place for dealing with and reporting incidents and for emergency responses.

In the event of an incident or emergency involving GMOs, the following general principles apply:

  1. Notify others in the area so that they are aware of any hazards present and can assist with incident response.
  2. Where required, alert Emergency Services and/or seek first-aid or medical assistance.
  3. Alert the Facility Manager of the incident.
  4. Notify Security if the area needs to be isolated or locked down.
  5. Consult the area safety manuals, standard operating procedures and risk management plan and, where safe to do so, take emergency actions to manage the risk and contain GMOs as soon as possible.
  6. Alert other relevant personnel including the principal investigator, your supervisor, Head of School, etc.
  7. Notify the IBC as soon as possible, and within 24 hours. The IBC shall notify external regulators where required (e.g., OGTR, Department of Agriculture).
  8. Prepare and submit incident reports as relevant, including a report to UniSafe where the incident involved a risk to the health and safety of people.

All personnel that deal with GMOs should be familiar with the area safety manuals, standard operating procedures and emergency plan and the protocols for an emergency response. These reference documents should be reviewed regularly and updated as required, particularly when new/different GMOs are introduced to an area and when a new or varied containment facility is established. Facility Managers should ensure that all personnel are aware of and have access to the relevant documentation.

Areas should ensure that emergency contact numbers (eg. Facility Manager, Principal Investigators) are easily identifiable to all personnel entering a facility and that appropriate 'after hours' emergency contact details are also included.

 

Spill and unintentional release procedures

The following spill procedures and posters provide step-by-step procedures for cleaning up different categories of spills involving GMOs and biological materials, as required by the OGTR.

Spills involving microorganisms, viral vectors, or samples containing these:

Spills involving GM animal materials including sperm, ova, embryos and isolated tissues:

Spills involving material derived from GM aquatic organisms, including water spills that may contain GM eggs, larvae or fry:

Spills involving GM plant material, soil and seed spills, and spills from plants infected with experimental microorganisms:

Unintentional release procedures:

 

Further information

Contact us

For regulatory compliance or Institutional Biosafety Committee enquiries contact E: ibc@adelaide.edu.au

Contact

  • Amanda Highet