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GMO Dealing

The nationally consistent legislative scheme for gene technology is comprised of the Commonwealth Gene Technology Act 2000 and Gene Technology Regulations 2001, and corresponding State and Territory legislation.

The University of Adelaide Institutional Biosafety Committee (IBC) administers gene technology regulatory compliance at the University and acts as an interface with the Australian Government Office of the Gene Regulator (OGTR) for the University. All University personnel who propose to deal with GMOs must obtain the appropriate approvals for their GMO work from the IBC and where necessary the OGTR prior to commencing the work. All non-university personnel intending to work with GMOs in University premises must also obtain the appropriate approvals from the IBC.

  • What is a GMO?

    The Gene Technology Act 2000 Link to external website(Act) provides a definition of the meaning of genetically modified organism:

    A genetically modified organism is defined as:

    • an organism that has been modified by gene technology;
    • 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; or
    • anything declared by the Regulations to be a genetically modified organism, or that belongs to a class of things declared by the Regulations to be genetically modified organisms;

    A genetically modified organism does not include:

    • a human being, if the human being is covered by paragraph (a) only because the human being has undergone somatic cell gene therapy; or
    • an organism declared by the Regulations not to be a genetically modified organism, or that belongs to a class of organisms declared by the Regulations not to be genetically modified organisms.
  • What is NOT a GMO?

    In accordance with the Act, there are several techniques that do not constitute gene technology and several organisms that are not considered GMOs for the purposes of regulatory compliance.

    If the work you are undertaking involves only these techniques and/or organisms then you only need to record that you have determined that you are not required to apply for approval under the Act.

    For any concerns or queries regarding gene editing technology and regulatory compliance, please contact the Research Compliance Officer (Gene Technology).

    See also:

  • What is a Dealing?

    The Gene Technology Act 2000 (Act) provides a definition of the meaning ‘deal with’ in relation to a GMO, which is to:

    • (a) conduct experiments with the GMO;
    • (b) make, develop, produce or manufacture the GMO;
    • (c) breed the GMO;
    • (d) propagate the GMO;
    • (e) use the GMO in the course of manufacture of a thing that is not the GMO;
    • (f) grow, raise or culture the GMO;
    • (g) import the GMO;
    • (h) transport the GMO;
    • (i) dispose of the GMO;

    and includes the possession, supply or use of the GMO for the purposes of, or in the course of, a dealing mentioned in any of paragraphs (a) to (i).

  • Exempt Dealings

    An Exempt dealing is a very low risk dealing. The IBC policy is that the researcher must submit an application to the IBC for authorisation and registration of the dealing.

    The exempt refers to the fact that the research work involving GMOs does not require an OGTR Dealing licence or is not a Notifiable Low Risk Dealing (NLRD).

  • Notifiable Low Risk Dealings

    There are two 'kinds' of Notifiable Low Risk Dealings (NLRDs).

    Some NLRDs can be undertaken in OGTR certified PC1 level containment facilities, whilst all others must be undertaken in OGTR certified PC2 level containment facilities.

    The IBC policy is that the researcher must submit an application to the IBC for authorisation and registration of the dealing. NLRDs are registered in the Accredited Organisation's (University of Adelaide) annual report to the OGTR.

  • Licensed Dealings

    A dealing that is not a notifiable low risk dealing (NLRD), or an exempt dealing, requires a licence which is issued by the OGTR . The holder of the licence is the 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.

    There are two categories of licence:

    Dealings Not Involving an Intentional Release (DNIR)

    A dealing not involving the intentional release of a GMO into the environment

    Dealings involving Intentional Release (DIR)

    A dealing involving the intentional release of a GMO into the environment

Guidelines & Application Forms for all GMO Dealings

  • Exempt Dealings

    Which Dealings Are Exempt?

    Exempt dealings are described in Schedule 2 of the Gene Technology Regulations 2001 (the Regulations). The only further legislative requirement for Exempt Dealings is that they do not involve an intentional release of the GMO into the environment.

    Part 1 of Schedule 2 provides a description of an Exempt Dealing.

    Part 2 of Schedule 2 determines the host/vector system relevant to Item (4) of Part 1

    Part 3 of Schedule 2 outlines the definitions relevant to Schedule 2

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    Application Process & Forms

    An Exempt Dealing requires authorisation and registration with the IBC. The Dealing application submitted will be assessed by the IBC and the registration and authorisation will be confirmed to you in writing.

    Note: The IBC will assess and endeavour to process the registration within four weeks (investigators should allow for this when determining their proposed commencement date).

    You must not commence the work until you have received written confirmation from the IBC that you are authorised to do so.

    The IBC GMO Dealing Application Form word document is submitted to the IBC to authorise and register both Exempt Dealings and Notifiable Low Risk Dealings. If your work involves both kinds of dealings you can now include details of all work for the one project on the one form.

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    Conditions and Responsibilities

    The OGTR has released Guidance Notes for the Containment of Exempt Dealings pdf, which are for guidance only to persons conducting exempt dealings. They may be of assistance in determining how to undertake exempt dealings with regard to avoiding intentional release.

    Investigators are responsible for ensuring that:

    • work with an exempt dealing must not involve an intentional release of the GMO into the environment – any unintentional release of GMOs must be reported to the IBC immediately;
    • the IBC is notified as soon as possible of any changes to the work registered as an exempt dealing;
    • the IBC is notified if work on the exempt dealing ceases or never commences;
    • stored GMOs are authorised.
  • Notifiable Low Risk Dealing (NLRD)

    Notifiable Low Risk Dealings are described in Schedule 3 of the Gene Technology Regulations 2001 and are dealings with GMOs 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.

    Schedule 3 also refers to host/vector systems in Part 2 of Schedule 2

    Part 1 of Schedule 3 provides a description of NLRDs suitable for at least physical containment level 1

    Part 2 of Schedule 3 provides a description of NLRDs suitable for at least physical containment level 2

    Part 3 of Schedule 3 provides a description of Dealings that are not NLRDs.

    In addition the OGTR has issued a series of documents to assist researchers who are working with viral vectors to determine the class of Dealing they require.

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    Application Process & Forms

    A Notifiable Low Risk Dealing requires authorisation and registration with the IBC. This is known as the Record of Assessment (RoA).The Dealing application submitted will be assessed by the IBC and the RoA will be sent to the Project Supervisor via email.

    The IBC GMO Dealing Application Form word document is submitted to the IBC to authorise and register both Exempt Dealings and Notifiable Low Risk Dealings. If your work involves both kinds of dealings please include details of all work for the one project on the one form.

    In addition, please ensure:

    • GMOs that are stored outside of a certified PC2 facility are listed on the application to ensure storage is authorised by the IBC. Unauthorised storage of GMOs is an offence under the Act;
    • that all proposed transport, including importation or exportation, of GMOs is included in the dealing as these aspects of a dealing also require approval. In Australia, all dealings with live and viable genetically modified organisms (GMOs), including import, are illegal unless authorised under the Gene Technology Act 2000 (the Act).

    The IBC will assess and endeavour to process the submission within four weeks (investigators should allow for this when determining their proposed commencement date).

    You must not commence the work until you have received your Record of Assessment (RoA) from the IBC.

    Note:

    • NLRDs that have been authorised and registered with the IBC are now also registered in the Accredited Organisation's (University of Adelaide) annual report to the OGTR.
    • Refer to the Quarantine section of the website for details on Import permits and compliance with the Biosecurity Act 2015.
    • When obtaining an Import permit the OGTR licence number or NLRD identifier number and name of assessing IBC can be provided to Department of Agriculture (DA).
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    Conditions & Responsibilities

    • work must not involve an intentional release of the GMO into the environment – any unintentional release of GMOs must be reported to the IBC immediately;
    • NLRDs must be conducted within a contained facility certified to at least the correct PC level for the dealing and of appropriate design for containing the type of GMO;
    • any transport of GMOs must be conducted in accordance with the current OGTR Guidelines pdf for the Transport, Storage and Disposal of GMOs;
    • all personnel must undertake appropriate training before commencing the work and safe working procedures must be understood and enforced;
    • the IBC is notified as soon as possible of any changes to the work registered as an exempt dealing;
    • if work on an NLRD ceases or never commences you must advise the IBC accordingly;
    • stored GMOs require a Dealing authorisation
  • Licenced Dealings - DNIR (Contained)

    Schedule 3 of the Regulations outlines the kinds of dealings that require a licence. Note that some dealings previously requiring a DNIR licence may now be classified as NLRD.

    DNIRs Now Classified as NLRDs

    A DNIR licence for a dealing which now only requires an NLRD can be surrendered. You should make a request to the IBC to surrender the DNIR licence before the DNIR licence expires. However, if you wish, the licence can be retained, with all existing licence conditions being followed.

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    Application for a DNIR Licence

    To apply for a DNIR licence, you must complete the following OGTR forms:

    Please send the DNIR Application Form in hard-copy as well as electronic copy to the IBC Secretary:

    Institutional Biosafety Committee Secretary

    E ibc@adelaide.edu.au

    Research Services Level 4, Rundle Mall Plaza, 50 Rundle Mall, THE UNIVERSITY OF ADELAIDE SA 5005

    Note: the assessment process will only proceed on receipt of all completed forms.

    If relevant, also complete a declaration that specified information is confidential commercial information pdf(CCI) by completing the OGTR form.

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    Considerations when Completing an Application

    It is important to provide information that is as comprehensive as existing scientific knowledge permits, and supported by whatever data are available. When completing your application paperwork, refer also to the OGTR Risk Analysis Framework Link to external website which describes the principles of risk analysis used by the Regulator when determining whether a licence is to be issued.

    The OGTR also requires that all storage of GMOs is authorised and that the GMOs are stored safely. When submitting a DNIR application, investigators should include any proposed storage period in their considerations of the 'expected completion date' in order to keep any potential stored GMOs authorised.

    Investigators should also ensure that all proposed transport, including importation or exportation, of GMOs is included in the dealing as these aspects of a dealing also require approval.

    Defective Viral Vectors - Guidelines

    The OGTR has issued a series of documents to assist those investigators working with defective viral vectors to determine which category of dealing their work falls into:

    The IBC will assess the application, which may require the principal investigator providing additional information. The IBC will endeavour to process the application within four weeks. You will be advised in writing of the outcomes of the assessment. The University submits each licence dealing application including an IBC evaluation report to the OGTR upon endorsement by the IBC.

    The OGTR will then undertake an extensive risk analysis. Further information may be required by the OGTR from the principal investigator during the review process. The statutory time period for the Regulator to make a decision on a DNIR application is 90 working days. There are however, a number of ways in which the 90 day period could be extended (eg. additional information/clarification required). From receipt of the application paperwork by the IBC it could thus take up to 4 or 5 months for a decision to be made and a licence issued. Investigators should allow for this when determining their proposed commencement date.

    Licences are issued to the 'Applicant Organisation' (ie. the University, not the investigator) and specific conditions will apply for the work. A licence is generally issued for a maximum of 5 years. You must not commence licensed work until written confirmation has been received from the OGTR that you are authorised to do so. The licence will detail a number of conditions that must be complied with in relation to the dealings with the GMO.

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  • Licensed Dealings - DIR (Intentional Release)

    DIR - Licensed Dealings involving the Intentional Release of a GMO into the Environment

    DIR Licence Applications

    The Regulations streamline the DIR licence application process by separating the dealings involving release into two categories: 'limited and controlled' releases (such as field trials); and 'other' releases (such as commercial releases).

    The same DIR application form can be used for both categories and the Regulator will use information supplied by the applicant to determine the appropriate category, on a case-by-case basis

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    'Limited' & 'Controlled' Releases

    This category recognises that an application for release of a GMO for experimental purposes will usually be limited in terms of time, spatial scale and location. The consultation process for a 'limited and controlled' release is consequently simpler than for other (general) release applications.

    In order for an application to fit into the 'limited and controlled' category it must satisfy all the requirements of section 50A of the Act, including:

    • the principal purpose is to conduct experiments; and
    • it is limited in scope, size, location and duration; and
    • it has controls to prevent dissemination or persistence.

    The 'limited and controlled' DIR category has a:

    • statutory time limit for the decision on an application: 150 working days for a dealing which the Regulator considers does not pose significant risk; 170 working days for a dealing which the Regulator considers may pose significant risk;
    • minimum 30-day consultation with the public and prescribed experts, agencies and authorities on the Risk Assessment and Risk Management Plan (RARMP).
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    Other Releases

    Any DIR application that not does satisfy all the requirements of section 50A of the Act will fall into this category. This includes releases that are:

    • commercial; or
    • non-experimental such as seed increase; or
    • unlimited in size, location and/or duration; or
    • minimally controlled to prevent dissemination or persistence.

    This DIR category has:

    • statutory period of 255 working days for assessment;
    • two minimum 30-day consultation rounds - (i) a consultation with prescribed stakeholders on the application and (ii) a second consultation round with the public, prescribed experts, agencies and authorities on the RARMP.
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    State-Regulation of GM Crops

    Legislation is in place to control the cultivation of genetically modified crops in South Australia.Genetically Modified Crops Management Regulations 2008 (made under the Genetically Modified Crops Management Act 2004) designate the whole of the state of South Australia as an area in which no genetically modified food crops may be cultivated.

    However, the Act enables the Minister to confer an exemption for the limited scale cultivation of GM food crops, including experimental crops in areas where the cultivation of GM crops is otherwise prohibited. Exemption Notices issued by the Minister will have conditions attached to ensure that local production and supply chains are unaffected.

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    DIR Application Process & Forms

    The application process for this category of licence is involved and if you are planning an intentional release you should read carefully the information available on the OGTR web site and contact the IBC Secretary for further details.

    Relevant OGTR information:

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    Conditions & Responsibilities

    The application process for this category of licence is involved and if you are planning an intentional release you should read carefully the information available on the OGTR web site and contact the IBC Secretary for further details.

    Specific licence conditions are stipulated for each licensed dealing. In general however, investigators must ensure that:

    • only the dealings and experiments listed in the licence are undertaken
    • the dealings with GMOs are undertaken only in the facilities specified in the licence
    • for DNIRs, work must not involve an intentional release of the GMO into the environment - any unintentional release of GMOs must be reported to the IBC immediately
    • the dealings are properly supervised and a record of the details of the dealings retained
    • the IBC is notified in writing of any changes to personnel working on the licensed dealings
    • authorised personnel covered by the licence are informed of and understand their obligations and are appropriately trained
    • required records are maintained
    • stored GMOs are authorised
    • approval is sought in writing for any proposed changes to the dealing
    • the Institutional Biosafety Committee is notified immediately:
      • if any of the project supervisor's contact details change
      • of any additional information as to any risks to the health and safety of people or to the environment associated with dealings authorised by the licence
      • of any contraventions of the licence, including the unintentional release of a GMO
      • of any unintended effects of the dealings authorised by the licence
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  • Genome Editing Technology

    The IBC recognises the importance that the introduction of genetic change is a fundamental methodology in biomedical, biological research and a key method for crop and animal improvement through the addition or removal of particular features.

    Recent technological advances for the modification of DNA sequences, commonly referred to as genome editing, allow specific changes to be induced at defined locations in plant and animal genomes. The Guideline issued by the University of Adelaide Institutional Biosafety Committee (IBC) is to ensure:

    • University personnel (staff and students) whose research involves genome editing technology are informed of the regulatory compliance required by the IBC.
    • The IBC has records of any modified organism that have been made, developed, produced or manufactured using genome editing technology.

    Guideline for Regulatory Compliance of Genome Editing Technology pdf

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  • Transport, Storage & Disposal of GMOs

    Storage Policy | Authorisation Process | Transport of GMO's

    Storage Policy

    Although the risks posed by storage of GMOs may be negligible, the potential risks to human health and safety and the environment associated with their removal from storage, use and disposal fall within the responsibilities of the Act. Under the Act, unauthorised storage of GMOs is an offence. Storage of GMOs is prohibited unless it is authorised and the GMOs are stored safely in accordance with OGTR Guidelines:

    The storage of GMOs can be covered by: a GMO licence (eg. DNIR), a notifiable low risk dealing (NLRD), an exempt dealing, or as part of a dealing listed on the GMO register.

    Where storage of GMOs has been authorised by an NLRD, the GMOs must be stored in accordance with the Guidelines for the Certification of Facilities and the Guidelines for the Transport, Storage and Disposal of GMOs pdf. If GMOs are authorised by a licence, they must be stored in accordance with the licence conditions.

    In addition, the OGTR requires that at any time that you are storing GMOs you must ensure that:

    • a new dealing application (exempt, NLRD or licence as appropriate) must be submitted in order to seek approval to use the GMOs for the purposes of conducting future research or experiments;
    • any transport of the GMOs is conducted in accordance with the guidelines for the transport of GMOs;
    • the IBC is notified as soon as possible of any changes, or proposed changes, to the storage notification;
    • work must not involve the intentional release of a GMO into the environment - the IBC must be notified immediately in the event of any unintentional release of a GMO.

    Investigators are required to:

    • maintain their own records of all stored GMOs arising from their dealings;
    • advise the IBC when the status of stored GMOs changes due to disposal of the GMOs;
    • upon ceasing employment or study:
      1. advise the Facility Manager and/or Biosafety Officer of any stored GMOs; and
      2. ensure that the expected completion date for existing authorised dealings adequately covers the expected term of storage for the GMOs; and
      3. identify an investigator who will agree to take responsibility for the stored GMOs; and
      4. ensure that the IBC is notified with regard to the above.
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    Authorisation of Stored GMOs

    When registering an Exempt Dealing or NLRD include details of any potential/proposed storage in the application.

    Investigators should include any proposed storage period in their considerations of the expected completion date. Thus, whilst it may be anticipated that the work will be completed by for example, December 2015, the investigator may plan to store the GMOs for later comparative work - hence, put a later expected completion date eg. December 2020, in order to keep the stored GMOs authorised. Note also that expected completion dates can be revised as the need arises by contacting the IBC with relevant details.

    For storage of GMOs that otherwise require a licence, please complete the OGTR Application for DNIR (Storage) pdf and submit to the IBC.

    Transport of GMO's

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Please contact the Research Compliance Officer (Gene Technology) for amendments to Dealings.

NOTE: It is the Principal Investigators responsibility to advise the IBC:

  • of any changes to the dealing (this includes personnel and facility changes), and
  • when the dealing is completed

Gene Technology Regulations 2001 — Schedules

Statutory Rules 2001 No. 106 as amended made under the Gene Technology Act 2000. This compilation was prepared on 1 September 2011 taking into account amendments up to SLI 2011 No. 73.

Schedule 1

  • Schedule 1A: Techniques Not Gene Technology

    Refer to the Gene Technology Resources page for an A-Z definition of gene-tech terminology.

    Schedule 1A: Techniques that are not gene technology (regulation 4)
    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.

  • Schedule 1: Organisms Not Genetically Modified Organisms

    Refer to the Gene Technology Resources page for an A-Z definition of gene-tech terminology.

    Schedule 1: Organisms that are not genetically modified organisms (regulation 5)
    Item Description of Organism

    1

    A mutant organism in which the mutational event did not involve the introduction of any foreign nucleic acid (that is, non-homologous DNA, usually from another species).

    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.

    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.

Schedule 2

  • Schedule 2 Part 1: Exempt Dealings

    Refer to the Gene Technology Resources page for an A-Z definition of gene-tech terminology.

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

    Schedule 2: Dealings exempt from licensing (regulation 6)
    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; or
        • (B) animals; or
        • (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;

    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; and

    • (b) must not code for a toxin with an LD50 of less than 100 µg/kg; and
    • (c) must not code for a toxin with an LD50 of 100 µg/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) must not include a viral sequence, unless the donor nucleic acid:
      • (i) is missing at least 1 gene essential for viral multiplication that:
        • (A) is not available in the cell into which the nucleic acid is introduced; and
        • (B) will not become available during the dealing; and
      • (ii) cannot restore replication competence to the vector.

    5

    A dealing involving shot-gun cloning, or the preparation of a cDNA library, in a host/vector system mentioned in item 1 of Part 2 of this Schedule, if the donor nucleic acid is not derived from either:

    • (a) a pathogen; or
    • (b) a toxin-producing organism.
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  • Schedule 2 Part 2: Host/Vector Systems for Exempt Dealings

    Refer to the Gene Technology Resources page for an A-Z definition of gene-tech terminology.

    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
    • 1. Non-conjugative plasmids
    • 2. Bacteriophage
      • (a) lambda
      • (b) lambdoid
      • (c) Fd or F1 (eg M13)
    • 3. None (non-vector systems)

     

     

    Bacillus – specified species – asporogenic strains with a reversion frequency of less than 10^-7:

    • (a) B. amyloliquefaciens
    • (b) B. licheniformis
    • (c) B. pumilus
    • (d) B. subtilis
    • (e) B. thuringiensis
    • 1. Non-conjugative plasmids
    • 2. Plasmids and phages whose host range does not include B. cereus, B. anthracis or any other pathogenic strain of Bacillus
    • 3. None (non-vector systems)

     

     

    Pseudomonas putida – strain KT 2440

    • 1. Non-conjugative plasmids including certified plasmids: pKT 262, pKT 263, pKT 264
    • 2. None (non-vector systems)

     

     

    Streptomyces – specified 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
    • 1. Non-conjugative plasmids
    • 2. Certified plasmids: SCP2, SLP1, SLP2, PIJ101 and derivatives
    • 3. Actinophage phi C31 and derivatives
    • 4. None (non-vector systems)

     

     

    Agrobacterium radiobacter

    • 1. Non-tumorigenic disarmed Ti plasmid vectors, or Ri plasmid vectors
    • 2. None (non-vector systems)

     

     

    Agrobacterium rhizogenes – disarmed strains

     

     

    Agrobacterium tumefaciens – disarmed strains

        Lactobacillus
    • 1. Non-conjugative plasmids
    • 2. None (non-vector systems)
       

    Lactococcus lacti

       

    Oenococcus oeni syn. Leuconostoc oeni

       

    Pediococcus

     

     

    Photobacterium angustum

     

     

    Pseudoalteromonas tunicata

     

     

    Rhizobium (including the genus Allorhizobium)

     

     

    Sphingopyxis alaskensis syn. Sphingomonas alaskensis

     

     

    Streptococcus thermophilus

     

     

    • Synechococcus – specified strains:
      • (a) PCC 7002
      • (b) PCC 7942
      • (c) WH 8102

     

     

    Synechocystis species – strain PCC 6803

     

     

    Vibrio cholerae CVD103 – HgR

    2 Fungi

    Kluyveromyces lactis

    • 1. All vectors
    • 2. None (non-vector systems)

     

     

    Neurospora crassa – laboratory strains

     

     

    Pichia pastoris

     

     

    Saccharomyces cerevisiae

     

     

    Schizosaccharomyces pombe

     

     

    Trichoderma reesei

     

     

    Yarrowia lipolytica

    3

    Slime moulds

    Dictyostelium species

    • 1. Dictyostelium shuttle vectors, including those based on the endogenous plasmids Ddp1 and Ddp2
    • 2. None (non-vector systems)

    4

    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
    • 1. Non-conjugative plasmids
    • 2. Non-viral vectors, or replication defective viral vectors unable to transduce human cells
    • 3. Baculovirus (Autographa californica nuclear polyhedrosis virus), polyhedrin minus
    • 4. None (non-vector systems)

     

     

    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
    • 1. Non-tumorigenic disarmed Ti plasmid vectors, or Ri plasmid vectors, in Agrobacterium tumefaciens, Agrobacterium radiobacter or Agrobacterium rhizogenes
    • 2. Non-pathogenic viral vectors
    • 3. None non-vector systems)
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  • Schedule 2 Part 3: Definitions

    Definitions in use for this Schedule:

    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.

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

Schedule 3

NLRD = Notifiable Low Risk Dealing

  • Schedule 3 Part 1: NLRDs Suitable for at least Physical Containment Lvl 1

    Refer to the Gene Technology Resources page for an A-Z definition of gene-tech terminology.

    Note 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 13 (3) b) applies, in facilities certified to at least physical containment level 1 and that are appropriate for the dealings:

    1.1 Kinds of dealings suitable for at least physical containment level 1
    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:

    • (i) an advantage is conferred on the animal by the genetic modification; or
    • (ii) 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 a replication defective vector derived from Human adenovirus or Adeno associated virus in a host mentioned in item 4 of Part 2 of Schedule 2, if the donor nucleic acid:

    • (i) cannot restore replication competence to the vector; and
    • (ii) does not:
      • (A) confer an oncogenic modification in humans; or
      • (B) encode a protein with immunomodulatory activity in humans.
  • Schedule 3 Part 2: NLRDs Suitable for at least Physical Containment Lvl 2 & 3

    Refer to the Gene Technology Resources page for an A-Z definition of gene-tech terminology.

    Note: Necause 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 13 (3) (b) 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
    ItemDescription 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:

    • (ii) animals; or
    • (iii) plants; or
    • (iv) fungi;
    (d)

    a dealing involving a host and vector not mentioned as a host/vector system 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 donor nucleic acid is characterised; and
    • (iii) the characterisation of the donor nucleic acid shows that it is unlikely to increase the capacity of the host or vector to cause harm;

    Example:

    Donor nucleic acid would not comply with subparagraph (iii) if, 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.
    (e)

    a dealing involving a host/vector system mentioned in Part 2 of Schedule 2, if the donor nucleic acid:

    • (i) encodes a pathogenic determinant; or
    • (ii) is uncharacterised nucleic acid from an organism that 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;
    (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:

    • (a) provides an advantage; or
    • (b) adds a potential host species or mode of transmission; or
    • (c) 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 item 1 of 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 the introduction of a replication defective viral vector unable to transduce human cells into 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 the introduction of a replication defective non-retroviral vector able to transduce human cells, other than a dealing mentioned in paragraph 1.1 (c), into a host mentioned in Part 2 of Schedule 2, if the donor nucleic acid cannot restore replication competence to the vector;
    (k)

    a dealing involving the introduction of a replication defective non-retroviral vector able to transduce human cells into 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:
      • (A) confer an oncogenic modification in humans; or
      • (B) encode a protein with immunomodulatory activity in humans;
    (l)

    a dealing involving the introduction of a replication defective retroviral vector able to transduce human cells into 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 into a virion 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 the introduction of a replication defective retroviral vector able to transduce human cells into a host not mentioned in Part 2 of Schedule 2, if:

    • (i) the donor nucleic acid does not:
      • (A) confer an oncogenic modification in humans; or
      • (B) encode a protein with immunomodulatory activity in humans; and
    • (ii) all viral genes have been removed from the retroviral vector so that it cannot replicate or assemble into a virion 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
    (a)

    Any kind of dealing mentioned in this Part involving 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 (3) (b) applies, in facilities that are:

    • (a)certified to at least physical containment level 3; and
    • (b)appropriate for the dealing.
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  • Schedule 3 Part 3: Dealings Not NLRDs

    Refer to the Gene Technology Resources page for an A-Z definition of gene-tech terminology.

    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 A dealing that is not a notifiable low risk dealing, or an exempt dealing, can only be undertaken by a person who is licensed, under the Act, for the dealing (see Act, section 32).

    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:

    Schedule 3 Part 3: Dealings that are not notifiable low risk dealings
    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 100µg/kg;
    (b) a dealing involving high level expression of toxin genes, even if the LD50 is 100 µg/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 the introduction of a replication defective viral vector into a host not mentioned in Part 2 of Schedule 2, other than a dealing mentioned in paragraph 2.1 (i), if the donor nucleic acid:

    • (i) confers an oncogenic modification in humans; or
    • (ii) encodes a protein with immunomodulatory activity in humans;
    (e)

    a dealing involving a replication competent virus or viral vector, other than a vector mentioned in Part 2 of Schedule 2, if the donor nucleic acid:

    • (i) confers an oncogenic modification in humans; or
    • (ii) encodes a protein with immunomodulatory activity 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 donor nucleic acid 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:

    Donor nucleic acid would not comply with sub-subparagraph (B) if, 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.
    (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:

    • (a) an advantage; or
    • (b) a new potential host species or mode of transmissibility; or
    • (c) 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.
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Incidents in relation to GMOs include, either intentional or accidental:

  • breaches of containment and/or release of GMOs
  • 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.

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

It is impossible to produce a contingency plan that would deal with all possible incidents or emergency scenarios. Thus, in the event of an incident or emergency involving GMOs:

  • alert the Facility Manager
  • alert other relevant personnel - principal investigator, your supervisor, Head of School, Security, Emergency Services, etc
  • consult the area safety manuals, standard operating procedures or 'emergency plan' and where appropriate, take emergency action(s) to contain the risk
  • submit appropriate accident or incident reports as may be required
  • report the incident to the IBC and notify any other authorities as may be required (eg. Department of Agriculture, TGA)

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. 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.

Further Information

Need Help? Contact Us

Please contact the Research Compliance Officer (Gene Technology) for regulatory compliance and IBC enquiries.

Office of Research Ethics, Compliance and Integrity
Address

Research Services
THE UNIVERSITY OF ADELAIDE
SA 5005 AUSTRALIA

Contact

T: +61 8 8313 5137
F: +61 8 8313 7325
recu@adelaide.edu.au