The purpose of this Appendix is to:

  • provide background to the development of the current gene technology regulatory system
  • outline the types of dealings that are defined by the Act and the Regulations and corresponding State laws
  • provide the procedure followed for each type of application
  • indicate other administrative factors, such as certification and accreditation,
    which help the Regulator manage risk.

Development of the regulatory system

Voluntary oversight


Oversight of gene technology in Australia began on a voluntary basis with formation of the Committee on Recombinant DNA set up by the Australian Academy of Science in the mid-1970s. In 1981 the Recombinant DNA Monitoring Committee was established in the federal Department of Science. These two committees comprised a range of scientific experts who effectively provided a peer review assessment of proposals to conduct experiments with GMOs between 1975 and 1987.

The work of these committees was consolidated into the Genetic Manipulation Advisory Committee (GMAC) in 1987. GMAC was an administrative body founded on the initiative of the then Minister for Industry, Technology and Commerce. It was funded federally and charged with assessing risks to human health and the environment in connection with gene technology and providing advice to proponents on how risks associated with work with GMOs could be managed. It also provided advice to statutory agencies responsible for product approvals that contained GMOs, or contained things that were derived from GMOs. While GMAC had no statutory powers or functions, Australian researchers consistently sought and complied with its advice. Although GMAC had no enforcement powers, compliance with its recommendations was a condition of research and development funding from the Australian Government.

Development of legislation


With the advent of significant advances in the application of the technology, increased commercial involvement and elevated community concern about GMOs, the Australian Government, together with the States, initiated a cooperative process to develop a uniform national approach to regulating gene technology in November 1998. Public and other stakeholder comment was sought on a paper entitled ‘Regulation of gene technology’ prepared by the Commonwealth State Consultative Group on Gene Technology (CSCG). These consultations contributed to preparation of a discussion paper entitled ‘Proposed national regulatory system for genetically modified organisms—how should it work?’

The discussion paper was advertised widely in 1999 in national, State and regional newspapers; mailed directly to over 2500 individuals and organisations representing a wide range of interests and all Members of Parliament and Senators in the Australian Parliament; and posted on the interim OGTR website. More than 200 written submissions were received. Initial development of the regulatory scheme was informed by Australia’s first consensus conference where a range of community representatives were invited to comment on the management of GMOs (Clark & Brinkley 2001).

In December 1999 a draft Gene Technology Bill 2000 and accompanying Explanatory Memorandum were released for public comment. Public forums were held in all capital cities and a number of regional centres. Over 750 people attended and more than 160 written submissions were received. Such extensive consultation on the development of the regulatory scheme reflects the emphasis the government placed on community input and participation in the decision-making process relating to gene technology. This process generated strong agreement about what should be included and excluded from the scope of the legislation. In setting up the regulatory scheme the government sought to recognise and balance the potential of gene technology to contribute to society with community concerns over development and deployment of the technology.

Some outcomes of the public consultation relevant to risk analysis include:
  • a focus on science-based risk assessment
  • availability of a range of advice to the Regulator from scientific experts, government agencies and others
  • openness and transparency in decision making
  • opportunities for public input as part of the decision-making process
  • that broader issues, such as ethical concerns, should be taken into account.
On 21 June 2001 the national legislative scheme for regulation of gene technology in Australia commenced with enactment of the Gene Technology Act 2000 (the Act) and the Gene Technology Regulations 2001 (the Regulations). The system is underpinned by the Intergovernmental Agreement on Gene Technology (Gene Technology Agreement) signed in 2001 by all Australian jurisdictions, which commits the States to pass corresponding laws.

Reviews of legislation


In 2005–06, as required by section 194 of the Act, the Gene Technology Ministerial Council (now the Legislative and Governance Forum on Gene Technology [LGFGT]) commissioned an independent review of the Act and of the Gene Technology Agreement. The review panel conducted extensive public and stakeholder consultation, and found that the Act and the national regulatory scheme had worked well in the five years following its introduction, and that no major changes were needed. However, it suggested a number of minor changes, aimed at improving operation of the Act.

The Gene Technology Amendment Act 2007 implemented the changes agreed in the All Governments’ Response to the recommendations of the review. The Gene Technology Amendment Regulations Bill 2007 gave effect to changes directly affecting the Regulations, and made consequential amendments necessitated by amendments to the Act. The majority of these amendments commenced on 1 July 2007, amending the Gene Technology Act 2000 and the Gene Technology Regulations 2001, respectively.

The Gene Technology Amendment Act 2007 introduced changes in six main areas, namely:
  • assessment of applications for intentional release - streamlining the process for the initial consideration, and introducing limited and controlled release provisions
  • licence variations - providing clarification on the circumstances in which licence variations can be made
  • a new provision - Emergency Dealing Determination (EDD) - giving the minister the ability to expedite approval of a dealing with a GMO in an emergency
  • committees - improving the mechanism for providing advice to the Regulator and the LGFGT on ethical issues and issues of concern to the community
  • Regulator’s powers to direct - clarifying the circumstances under which the Regulator can direct a person to comply with the Act
  • inadvertent dealings - providing a streamlined process for the Regulator to issue a licence to persons who find themselves inadvertently dealing with an unlicensed GMO, for the purpose of disposing of that GMO.
The Regulator conducted a technical review and subsequently introduced the Gene Technology Amendment Regulations Bill 2006, which amended the Regulations. The review was based on the operational experience of the OGTR in implementing the legislation between 2001 and 2005 and extensive consultation with accredited organisations. The amendments resulted in changes to the classification and containment requirements for some low-risk dealings with GMOs.

The LGFGT initiated a second independent review of the Act in June 2011, including inviting public submissions. The report of the 20118. Independent Review of the Gene Technology Act 2000 was made publicly available in December 2011. The Review investigated emerging trends and international developments in biotechnology and their regulation, the efficiency and effectiveness of the operation of the Act consistently across the national scheme for gene technology regulation in Australia, and the interface between the Act and other regulation. The Review found that the Act was working well and that the OGTR was operating in an effective and efficient manner. The Review considered that the current consultation processes in relation to applications under the Act were working well.

Three sets of amendments to the Regulations have been made: Amendment Regulations 2006 (as a result of the 2004–06 Regulator’s review), Amendment Regulations 2007 (consequential amendments due to the review of the Gene Technology Act 2000) and Amendment Regulations 2011, which included requirements for transport, storage and disposal of GMOs.

Operation of the regulatory system


The Gene Technology Act 2000 (the Act) and the Gene Technology Regulations 2001 (the Regulations) and corresponding State laws provide a nationally consistent system to regulate use of gene technology in Australia. This legislation establishes an independent statutory office holder, the Gene Technology Regulator (the Regulator), who is charged with administering the Act and making decisions about development and use of GMOs under the Act.
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The Regulator is a statutory office holder reporting directly to the Australian Parliament and is supported by staff in the Office of the Gene Regulator (OGTR). The LGFGT, comprising representatives from all Australian jurisdictions, oversees implementation of the regulatory system (see Figure A1). The Act establishes two committees whose role is to give advice to the Regulator and the LGFGT on matters relating to gene technology. These are the Gene Technology Technical Advisory Committee (GTTAC) and the Gene Technology Ethics and Community Consultative Committee (GTECCC)9.

Figure A1: Governance arrangements for the Gene Technology Regulator

Figure A1: Governance arrangements for the Gene Technology Regulator

Notes: APVMA = Australian Pesticides and Veterinary Medicines Authority; DAFF = Department of Agriculture, Fisheries and Forestry; FSANZ = Food Standards Australia New Zealand; GTECCC = Gene Technology Ethics and Community Consultative Committee; GTTAC = Gene Technology Technical Advisory Committee; NICNAS = National Industrial Chemicals Notification and Assessment Scheme; TGA = Therapeutic Goods Administration.

Legislative and Governance Forum on Gene Technology


The Legislative and Governance Forum on Gene Technology (LGFGT) oversees implementation of the legislation and the role of the Regulator. The LGFGT was established by the Gene Technology Agreement 2001 between the Australian Government and the governments of all States. The Agreement commits State governments to enact corresponding State legislation.

The role of the LGFGT is to provide policy input into implementing and operating the regulatory scheme. In addition, the LGFGT provides advice to the Australian Government Minister for Health and Ageing on the appointment of the Regulator and appointment of members of the Gene Technology committees (see below). The LGFGT is supported by the Gene Technology Standing Committee.

The Act provides for the LGFGT to issue policy principles on ethical issues relating to GMOs and recognition of areas designated under State law for the purpose of preserving the identity of either GM crops or non-GM crops for marketing purposes (section 21). In relation to the latter, on 31 July 2003 the LGFGT issued its first policy principle: Gene Technology (Recognition of Designated Areas) Principle 2003 which came into effect on 5 September 2003.

Gene Technology advisory committees


The legislation creates two committees to provide advice to the Regulator and the LGFGT: the GTTAC and the GTECCC. Membership of the committees consists of persons with expertise in one or more scientific fields (GTTAC) or with skills and experience in areas relevant to gene technology as specified in the Act (GTECCC).

GTTAC—provides scientific and technical advice, at the request of the Regulator or the LGFGT, on:
  • gene technology
  • GMOs and GM products
  • applications made under the Act
  • biosafety aspects of gene technology
  • the need for and content of policy principles, policy guidelines, codes of practice,
    and technical and procedural guidelines.
GTECCC—provides advice at the request of the Regulator or the LGFGT, on:
  • ethical issues relating to gene technology
  • the need for, and content of, codes of practice in relation to ethics in respect of conducting dealings with GMOs
  • the need for, and content of, policy principles in relation to dealings with GMOs that should not be conducted for ethical reasons
  • the need for policy principles, policy guidelines, codes of practice, and technical and procedural guidelines in relation to GMOs and GM products and the content of such principles, guidelines and codes
  • community consultation in respect of the process for applications for licences covering dealings that involve the intentional release of a GMO into the environment
  • risk communication matters in relation to dealings that involve the intentional release of a GMO into the environment
  • matters of general concern identified by the Regulator in relation to applications made under the Act
  • matters of general concern in relation to GMOs.

Types of dealings


To ‘deal with’ a GMO is defined in section 10(1) of the Act as:
        conduct experiments with, make, develop, produce or manufacture, breed, propagate, use in the course of manufacture of a thing that is not the GMO, grow, raise or culture, import, transport, 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 the above.

A GMO is defined as any organism that has been modified by gene technology, or offspring of such an organism that has inherited the introduced trait, or anything declared as a GMO in the Regulations.

Section 31 of the Act prohibits dealings with GMOs unless it is:
  • an exempt dealing
  • a notifiable low-risk dealing (NLRD)
  • authorised by a licence
  • included on the GMO Register
  • specified in an emergency dealing determination (EDD).
Exempt dealings and NLRDs are not considered to pose risks that require direct scrutiny by the Regulator in the form of case-by-case risk assessment. These kinds of dealings are routine laboratory techniques involving GMOs that have been used safely for many years or pose minimal risks when performed in contained conditions.
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The Regulator may issue three types of licences under the Act, namely:
  • dealings not involving intentional release (DNIR)
  • dealings involving intentional release (DIR), or
  • inadvertent dealings.
The DIR licence applications may also qualify for a streamlined process for limited and controlled releases (such as field trials) that involve research and incorporate measures to restrict dissemination and persistence of the GMO and its introduced genetic material in the environment (section 50A).

The Act states that the Regulator must prepare a risk assessment and risk management plan (RARMP) for all DIR and DNIR applications, as part of the process of making a decision on whether to issue a licence (sections 47 and 50).

The Act (Part 5) allows the Regulator to grant a temporary licence to a person inadvertently dealing with an unlicensed GMO for the purpose of disposing of the GMO. This does not require preparation of an RARMP before issuing the licence (section 49).

Dealings on the GMO Register (Part 6, Division 3 of the Act) are dealings that have been authorised by a licence previously, have a history of safe use, and no longer require a licence from the Regulator to protect the health and safety of people or the environment.

The minister may issue an EDD to exempt specified dealings from the licensing requirements for a limited period, where the GMO is likely to address an actual or imminent threat to the health and safety of people or to the environment, and any risks associated with using the GMO for that purpose could be adequately managed.

A representation of the classes of dealings, outlining the predetermined management conditions (such as containment), which are based on the level of risk, is set out in Table A1.

Table A1: Classes of GMO dealings under the Gene Technology Act 2000

CategoryLicence requiredContainment
ExemptNoNo intentional release to the environment
NLRDNo, dealings must be assessed by IBC; notified in annual reportYes
PC1 or PC2 (usually)
DNIRYes, applications must be reviewed by IBC; RARMP prepared and licence decision by the Regulator Yes
³PC2 (usually) and other conditions will apply
DIR
(except for limited and controlled releases)
Yes, applications must be reviewed by IBC; consultation on application, RARMP prepared, consultation on RARMP and licence decision by the RegulatorContainment measures may be required, determined on a case-by-case basis, and other licence conditions will apply
DIR
(limited and controlled)
Yes, applications must be reviewed by IBC; RARMP prepared, consultation on RARMP and licence decision by the RegulatorContainment measures will be required based on size/scope of release sought by applicant; and other licence conditions will apply
Inadvertent dealingYes, licence decision by the Regulator only for the purposes of disposal of
the GMO
Containment and/or disposal measures will apply
GMO RegisterNo, but must be previously licensed;
review of related RARMPs
Containment measures may be required
EDDNo, determination by the minister, subject to advice of threat and utility of GMO from competent authorities and risk assessment advice from the Regulator Containment and/or disposal measures may be included in EDD conditions

Notes: DIR = dealings involving intentional release; DNIR = dealings not involving intentional release; EDD = emergency dealing determination; GMO = genetically modified organism; IBC = Institutional Biosafety Committee; NLRD = notifiable low-risk dealing; PC = physical containment; RARMP = risk assessment and risk management plan.

The licensing system is based on a rigorous process of risk assessment using science-based evidence. For those dealings that involve an intentional release of a GMO into the environment (DIR), the legislation requires extensive consultation with experts, agencies and authorities, and the public. More data must be submitted for assessment and a more rigorous assessment process is set out than is required for dealings not involving intentional release of a GMO into the environment (DNIR).

The Regulator may adapt the risk assessment method described in Chapter 4 that is prepared in relation to inadvertent dealings (section 40A of the Act), proposed emergency dealing determinations (section 72B), inclusion of dealings on the GMO Register (section 79) or variations to existing licences (section 71), as well as to review of NLRDs (section 140) and exempt dealings (section 141).

Timeframes


Under section 43(3) of the Act, the Regulator must issue or refuse to issue a licence within a time limit prescribed by the Regulations. Similarly, the Regulations prescribe timeframes for consideration of applications to vary licences, to accredit organisations and to certify facilities. These statutory timeframes are shown in Table A2. They do not include weekends or public holidays in the Australian Capital Territory or periods where the Regulator has requested more information from the applicant, including resolving a Commercially Confidential Information claim, and cannot continue assessment until that information has been provided.

Table A2: Timeframes under the Gene Technology Act 2000

CategoryTimeframe
DNIR90 working days (Regulation 8)
DIR (except for limited and controlled releases)255 working days (Regulation 8)
DIR—limited and controlled, no significant risk150 working days (Regulation 8)
DIR—limited and controlled, significant risk170 working days (Regulation 8)
Licence variation90 working days (Regulation 11A)
Accreditation90 working days (Regulation 16)
Certification90 working days (Regulation 14)

Notes: DIR = dealings involving intentional release; DNIR = dealings not involving intentional release.

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Dealings involving minimal risks


The GMO Register10 is a mechanism provided by the Act (Part 6, Division 3) for authorisation of dealings with GMOs that have a history of safe use. The Regulator may make a determination to include dealings with a GMO on the GMO Register only if the dealings have previously been authorised by a GMO licence, and the Regulator must be satisfied that risks posed by the specific dealings are minimal and that it is not necessary for anyone conducting the dealings to be covered by a licence in order to protect the health and safety of people or the environment (sections 78 and 79 of the Act). The principles of risk analysis set out in this framework are applicable to determining whether a GMO should be included on the GMO Register. After inclusion on the Register, the dealings no longer require authorisation by a licence but may still have conditions attached to their registration. A determination to include dealings with a GMO on the GMO Register is a disallowable instrument, meaning that the determination is subject to scrutiny, and may be disallowed by the Australian Parliament.

One GMO dealing has so far been placed on the GMO Register.

Exempt dealings are dealings with GMOs that have been assessed over time as posing negligible11 risks to people or to the environment, and are therefore exempt from licensing and do not require a case-by-case risk assessment. The types of dealings that are exempt are specified in the Regulations (Schedule 2). These dealings comprise basic molecular biology techniques and activities that have been conducted extensively in laboratories worldwide. Exempt dealings do not require a specified level of containment but must not involve intentional release of a GMO into the environment. Guidance on appropriate containment measures for exempt dealings is provided on the OGTR website. Examples of exempt dealings include dealings with:
  • an animal into which GM somatic cells have been introduced, where the introduced somatic cells do not produce infectious agents
  • small volumes (<25L) of an approved host/vector system into which low-risk genetic material has been introduced (eg the gene must not be uncharacterised, it must not be derived from a pathogenic organism, nor code for a toxin
Notifiable low-risk dealings (NLRDs) are dealings with GMOs that have been assessed over time as posing negligible risks provided certain management conditions are met. The types of dealings that may be conducted as NLRDs are specified in the Regulations (Parts 1 and 2 of Schedule 3). Before a type of dealing is listed in these Parts of Schedule 3, the Regulator must have considered whether the GMOs involved are biologically contained, whether the dealings involve minimal risks to people and the environment, and whether no or minimal conditions would be needed to manage any such risks (section 74 of the Act). NLRDs must not involve intentional release of a GMO into the environment.NLRDs may only be undertaken in a facility meeting appropriate technical guidelines issued by the Regulator (usually PC1 or PC2 certified facilities). Before being conducted, the dealings must be assessed by an IBC as an NLRD, in accordance with regulation 13. Details of all new NLRDs that have been assessed by an IBC must be reported to the Regulator annually. NLRDs are included on the Record of GMO and GM Product Dealings but do not require case-by-case risk assessment.

An example of an NLRD which may be conducted in PC1 facilities include dealings with:
  • GM mice/rats
Examples of NLRDs that may be conducted in PC2 facilities include dealings with:
  • a genetically modified animal (other than a mouse or rat) including invertebrates
  • a genetically modified plant, provided the dealing occurs in a facility designed to prevent release of its pollen and seed
  • an approved host/vector system into which a gene that may pose a higher level of risk has been introduced (eg the gene may encode a pathogenic determinant or uncharacterised gene from a pathogen).
Licensed dealings

Any dealing that is not exempt, or on the GMO Register or specified in an EDD, or an NLRD, must not be conducted unless licensed.

The Regulator considers licence applications on a case-by-case basis, based on whether the risks posed by the dealing can be managed to protect human health and safety and the environment. The Regulator must decide whether to issue a licence for that dealing, and the management conditions to be imposed to manage any risks (if a licence is issued).

The legislation sets out a series of actions the Regulator must take in relation to applications for licences, both for intentional releases (DIRs) and contained releases (DNIRs). The Act details the steps the Regulator must take when assessing the application, while the application forms detail the information the applicant must provide.

The application forms issued by the Regulator for both DIRs and DNIRs require the applicant to identify risks that the dealings may pose to human health and safety and the environment and any measures proposed to manage those risks. Both also require the IBC to review and support the application.

Preparing an RARMP

For DIRs and DNIRs, the Act specifies to take into account ‘the risks posed by the dealings proposed to be authorised by the licence’ (sections 47(2) and 51(1a)) and ‘the means of managing any risks posed by those dealings in such a way as to protect: (i) the health and safety of people; and (ii) the environment (sections 47(3) and 51(2a)), as well as advice from any consultation and any matter prescribed by the Regulations.

Requirements for the RARMPs of all DIR applications are specified in section 51 of the Act as well as in Regulations 9A and 10.

The Regulator must take into account the risks posed by the proposed dealings, including any risks to the health and safety of people or to the environment as prescribed by the Regulations. Regulation 9A prescribes that the Regulator, when preparing a risk assessment, must have regard to:
  • the properties of the organism to which dealings proposed to be authorised by a licence relate before it became, or will become, a GMO
  • the effect, or the expected effect, of the genetic modification that has occurred, or will occur, on the properties of the organism
  • provisions for limiting dissemination or persistence of the GMO or its genetic material in the environment
  • the potential for spread or persistence of the GMO or its genetic material in the environment
  • the extent or scale of the proposed dealings
  • any likely impacts of the proposed dealings on the health and safety of people.
Regulation 10(1) requires the Regulator to consider:
  • any previous assessment by a regulatory authority, in Australia or overseas, in relation to allowing or approving dealings with the GMO
and the potential of the GMO concerned to:
  • be harmful to other organisms
  • adversely affect any ecosystems
  • transfer genetic material to another organism
  • spread or persist in the environment
  • be toxic, allergenic or pathogenic to other organisms.
In taking into account any risk or potential capacity mentioned above, the Regulator must consider both the short term and the long term (Regulation 10(2)).

Information required under Regulations 9A and 10 provides essential parameters for the risk context and serves as terms of reference for the entire risk analysis process. The first two considerations of Regulation 9A, in combination with the object of the Act, form the basis for using comparative risk assessment.

Consulting on the RARMP

The Regulator may consult on any aspect of a DNIR application with:
  • the States/Territories
  • Gene Technology Technical Advisory Committee (GTTAC)
  • relevant Commonwealth authorities or agencies
  • any local council the Regulator considers appropriate
  • any other person the Regulator considers appropriate (section 47(4)).
When preparing a risk assessment and risk management plan (RARMP) (section 50(3)) for a DIR, the Regulator must, unless satisfied that it is a limited and controlled release application under section 50A, seek advice from:
  • the States/Territories
  • GTTAC
  • each Commonwealth authority or agency prescribed by the Regulations
  • the Environment Minister
  • any local council the Regulator considers appropriate.
In addition, the public must be consulted after preparing an RARMP and before making a decision whether to issue a licence (section 52). Regulation 9 specifies the Commonwealth authorities and agencies that must be consulted.
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Considering whether to issue a licence

Applicant suitability is an important consideration in the Regulator’s consideration on whether to issue a licence. Section 58 specifies the particulars for assessing applicant suitability. In addition, certification of facilities and accreditation of organisations, as specified in Part 7 of the Act, form part of the risk context. The statutory licence conditions set out in sections 63, 64 and 65 of the Act provide context for both risk assessment and risk management. In addition, the Regulator may prescribe or impose additional conditions on the licence to manage risk to a tolerable level.

Deciding whether to issue a licence and notifying the decision

Section 56(1) specifies that the Regulator must not issue a licence unless satisfied that any risks posed by the dealings proposed to be authorised by the licence are able to be managed in such a way as to protect the health and safety of people and the environment. When the Regulator has made a decision whether to issue a licence, he or she must notify the applicant or licence holder (section 180).

After a licence has been issued

Once a licence is issued, the licence holder must comply with the conditions of the licence. A substantive part of the legislation (including Parts 10 and 11 of the Act) concerns the topics ‘enforcement’ and ‘powers of inspection’. The Act also specifies that the Regulator may suspend, cancel or vary existing licences (sections 68 and 71).

In addition, the Act provides for substantive penalties for undertaking unlawful dealings (for an outline, see section 31) and for interference with authorised dealings with a GMO (section 192A).

The legislation requires the Regulator to prepare an RARMP for both DNIR and DIR applications. The risk assessment takes account of any risks to human health and safety or to the environment posed by the dealing, and the risk management plan outlines how these risks can be managed.

The requirements of the legislation have been framed to place greater scrutiny on dealings that involve release of GMOs into the environment (DIRs). The Regulator may impose conditions on all licences. Measures will be imposed to restrict the persistence and spread of the GMO and its genetic material in the environment for all DIRs determined to be limited and controlled releases. Non-compliance with conditions placed on licences issued under the Act is a criminal offence.

For both DNIR and DIR applications the applicant must provide information specified in the application forms as to their suitability to hold a licence. This information includes any relevant convictions, revocations or suspensions of licences under laws relating to human health and safety or to the environment and an assessment of the applicant’s capacity to manage any risks posed by the proposed dealings.

Dealings not involving intentional releases


DNIRs usually take place under specified physical containment conditions in certified facilities, which minimises risks to the environment. The Act requires preparation of an RARMP for DNIR applications (section 47). The application form specifies the information the Regulator requires.

This Risk Analysis Framework outlines the approach taken to risk analysis and to preparation of RARMPs. As a guide to the legislative and administrative requirements, the five-stage process adopted in respect of DNIR applications is shown in Figure A2 and is described below.

Stage 1 - The applicant must prepare information about the proposed dealings with the GMO, possible risks posed by the dealings and proposed ways that each risk would be managed. The applicant must ensure all responses to the Regulator’s information requirements are supported by appropriate data and literature citations.

Stage 2 –The IBC reviews the application and appends an evaluation report setting out its advice as to the completeness of the application form. The IBC’s role is to ensure the quality of applications submitted to the Regulator. If there is not sufficient information, the application is rejected.

Stage 3 - Section 47 of the Gene Technology Act 2000 requires the Regulator to prepare a risk assessment and risk management plan (RARMP). The information provided in the application is used to prepare the RARMP in relation to the proposed dealings.

The actual risk assessment process is, to some extent, shaped by the data requirements set out in the DNIR application form; however, the Regulator can require submission of any data required to comprehensively identify and evaluate risks posed by the dealing. The Regulator is specifically permitted by the legislation to seek and take into account any other relevant information such as independent research, independent literature searches, and the advice of any person or group. The Regulator may also request more information from the applicant.

Preparation of the risk assessment involves developing risk scenarios that describe how risks that may be posed by the dealings with the GMO could result in harm, identifying risks that require more detailed characterisation and estimating the level of risk based on the likelihood of the event occurring and the likely consequences of that occurrence. Risks are then evaluated to determine which require treatment in order to protect people and the environment.

The risk management plan considers how risks to human health and safety or to the environment posed by the dealing with the GMO that require management may be able to be managed. This, then, provides the basis for conditions that may be applied to the licence, and draft conditions are included in the consultation version of the RARMP.

Stage 4 –The Regulator may consult experts, agencies or authorities about the RARMP, such as the GTTAC, the States and Territories, prescribed Australian Government agencies, the Environment Minister, and appropriate local government authorities.

Stage 5 - The Regulator makes the decision on whether to issue a licence or not, and if agreeing to issue the licence, any conditions to be imposed. This decision is based upon the RARMP, having regard to any policy principles issued by the LGFGT. The Regulator must notify the applicant in writing that a licence decision has been made. The Regulator also advises all experts, agencies and authorities that were consulted.

The statutory timeframe allowed for consideration of a DNIR application is 90 days.

Figure A2: DNIR assessment process

Figure A2: DNIR assessment process as described above

Dealings involving intentional release


The Regulator will use information submitted by the applicant (as specified in the application form) to determine which consultation process will apply and the timeframe allowed under the Act for processing the application, on a case-by-case basis.
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This Risk Analysis Framework outlines the approach taken to risk analysis and to preparation of RARMPs. As a guide to the legislative and administrative requirements, the eight-stage process adopted in respect of DIR applications is shown in Figure A3 and is described below.

Stage 1 - The applicant must prepare comprehensive information about the proposed dealings with the GMO, possible risks posed by the dealings and proposed ways that each risk will be managed. The Regulator’s information requirements are set out in detail on the application form. The applicant must ensure all responses are supported by appropriate data and literature citations, providing quantitative data where appropriate. It is expected that the applicants will collect relevant data during contained work and early trials to support applications for dealings involving intentional releases of GMOs.

Stage 2 - The IBC reviews the application and appends an evaluation report setting out its advice as to the completeness of the application form. The IBC’s role is to ensure the quality of applications submitted to the Regulator.

Stage 3—Section 50A of the Act allows the Regulator to make a determination on the application as to whether it is for a limited and controlled release, which would follow a shorter process.

Section 50A(1) of the Act specifies limited and controlled release applications as applying, if the Regulator is satisfied that:
  1. the principal purpose of the application is to enable the licence holder, and persons covered by the licence to conduct experiments
  2. the application proposes, in relation to any GMO in respect of which dealings are proposed to be authorised:
    1. controls to restrict dissemination or persistence of the GMO and its genetic material in the environment
    2. limits on the proposed release of the GMO
  1. the Regulator is satisfied that the controls and limits are of such a kind that it is appropriate for the Regulator not to seek the advice referred to in subsection 50(3).

Section 50A(2) of the Act describes the term ‘controls’ as including:
  1. methods to restrict the dissemination or persistence of the GMO or its genetic material into the environment
  2. methods for disposal of the GMO or its genetic material
  3. data collection, including studies to be conducted about the GMO or its genetic material
  4. the geographic area in which the proposed dealings with the GMO or its genetic material may occur
  5. compliance, in relation to dealings with the GMO or its genetic material, with:
    1. a code of practice issued under section 24, or
    2. a technical or procedural guideline issued under section 27.
Section 50A(3) describes the term ‘limits’ as including:
  1. the scope of the dealings with the GMO
  2. the scale of the dealings with the GMO
  3. the locations of the dealings with the GMO
  4. the duration of the dealings with the GMO
  5. the persons who are to be permitted to conduct the dealings with the GMO.
Stage 4 - A ‘Notification of Application’ is sent out for all DIR applications to those on the OGTR mailing list and placed on the website advising when the consultation RARMP is expected to be released for comment. This is not a requirement of the Act but increases the transparency of the regulatory system and aims to increase participation in the consultation process.

The Regulator must provide a copy of the application (excluding any information that the Regulator has declared to be, or is under consideration as, confidential commercial information) to anyone who requests a copy (section 54 of the Act).

Stage 5 - The Regulator must seek advice on the application regarding matters relevant to preparation of the RARMP, under section 50 of the Act, from the GTTAC, the States, prescribed Australian Government agencies, the Environment Minister, and appropriate local government authorities. The Regulator usually consults with local government authorities on where the release is proposed to occur. In addition, the Regulator also routinely seeks advice from other relevant Australian Government agencies such as the Department of Agriculture, Fisheries and Forestry and the Department of Foreign Affairs and Trade. If the application is for a limited and controlled release, this consultation step is not required.

Stage 6 - Section 51 of the Act requires the Regulator to prepare an RARMP (consultation version), and to take account of submissions received during any consultation on the application under section 50 of the Act.

The actual risk assessment process is, to some extent, shaped by the data requirements set out in the DIR application form; however, the Regulator can require submission of any data required to comprehensively identify and evaluate risks posed by the dealing. The Regulator is specifically permitted by the legislation to seek and take into account any other relevant information such as independent research, independent literature searches, and the advice of any person or group. The Regulator may also request more information from the applicant or hold a public hearing.

Preparation of the risk assessment involves developing risk scenarios that describe how risks that may be posed by the dealings with the GMO could result in harm, identifying risks that require more detailed characterisation and estimating the level of risk based on the likelihood of the event occurring and the likely consequences of that occurrence. Risks are then evaluated to determine which require treatment in order to protect people and the environment.

The risk management plan considers how risks to human health and safety or to the environment posed by the dealing with the GMO that require management may be able to be managed. This, then, provides the basis for conditions that may be applied to the licence, and draft conditions are included in the consultation version of the RARMP.

Stage 7 - Once the consultation version of the RARMP is prepared for a DIR application, the Regulator must determine if any of the proposed dealings pose a significant risk to the health and safety of people or to the environment. The minimum consultation period specified in the Act is 50 days if the Regulator is satisfied that the dealings may pose a significant risk to the health and safety of people or to the environment. If the Regulator considers that the proposed dealings do not pose significant risks, a minimum 30-day consultation period is specified (section 52(2)).

The statutory timeframe allowed for consideration of a DIR application, except for a limited and controlled release application, is 255 days. For a limited and controlled release application this timeframe is either 170 days (for dealings that may pose a significant risk) or 150 days (for dealings that do not pose a significant risk).

The Regulator is required to seek public comment on the consultation RARMP via advertisements in a national newspaper and the Australian Government Gazette and notices placed on the Regulator’s website. In practice, the Regulator advertises more broadly, including metropolitan and regional newspapers and special interest press, and advises by mail or email all persons and organisations that have registered their interest in receiving such information on the OGTR mailing lists. Under section 52(3) of the Act the Regulator must also seek advice on the RARMP from the expert groups, agencies and authorities mentioned above (for consultation on the application).

The Regulator is required to consult with the Australian Government Environment Minister on DIR licence applications.

Stage 8 - The Regulator then finalises the RARMP, taking into account the advice provided in relation to the consultation version of the RARMP, in accordance with section 56(2) of the Act. The Regulator then makes the decision on issuing the licence, and any conditions to be imposed, based upon the finalised RARMP, having regard to any policy principles issued by the LGFGT. The Regulator must notify the applicant in writing that a licence decision has been made. The Regulator also publishes the finalised RARMP on the OGTR website, advises all experts, agencies and authorities that were consulted and people or organisations that made submissions, and notifies registered recipients on the OGTR mailing list.

Figure A3: DIR assessment process

Figure A3: DIR assessment process as described above

Inadvertent dealings

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The Act (Part 5) allows the Regulator to grant a temporary licence (no longer than 12 months) to a person inadvertently dealing with an unlicensed GMO. The licence may be issued to the person for the purposes of disposing of the GMO. There is no requirement to prepare an RARMP or consult in relation to inadvertent dealing applications, but the Regulator must not issue a licence unless satisfied that the risks posed by the dealings are able to be managed in such a way as to protect the health and safety of people and the environment.

Emergency dealing determinations


The EDD provision in the Act (section 72A–E) provides the relevant minister with the power to expedite an approval of a dealing with a GMO in an emergency. This recognises that situations may arise in which a rapid assessment of a proposed dealing with a GMO may be required. An EDD can only be made for a limited period (up to six months) but may be extended by the minister. Before making an EDD, the minister must be satisfied that:
  • there is an actual or imminent threat to the health and safety of people or to the environment
  • the dealings proposed to be specified in the EDD would, or would be likely to, adequately address the threat
  • any risks posed by the dealings proposed to be specified in the EDD are able to be managed in such a way as to protect the health and safety of people and the environment.
The minister must receive advice in relation to the threat and addressing the threat from the Commonwealth Chief Medical Officer, the Commonwealth Chief Veterinary Officer or the Commonwealth Chief Plant Protection Officer, and in relation to managing those risks from the Gene Technology Regulator. The States must also be consulted.

In developing the risk assessment advice for the minister, the Regulator will apply the principles embodied in the Risk Analysis Framework, but is not required to follow the consultation processes that apply to DIR applications.

GMO Record


The Act requires the Regulator to maintain a record of approved GMOs and GM product dealings (the GMO Record, section 138). Details of licences issued (DNIR, DIR, inadvertent dealings), information about NLRDs, GMO dealings included on the GMO Register, EDDs, and information about GM products approved by other regulatory authorities are included on the GMO Record.

The GMO Record12 is currently divided into separate sections for recording:
  • GM products—those used in food processing, therapeutics, and pesticides and veterinary medicines
  • contained dealings—notifiable low-risk dealings (NLRD) and DNIR licences
  • intentional releases—DIR licences
  • inadvertent dealing licences
  • GMO Register
  • emergency dealing determinations (EDDs).

Accreditation and certification


Accreditation of organisations and certification of individual physical containment facilities help manage risk that may be associated with dealings with GMOs by providing an administrative system by which to monitor and oversee the development and use of these facilities.

An organisation undertaking licensed dealings with GMOs will be required to be accredited by the Regulator (sections 91–98). The process of accreditation enables the Regulator to assess if the organisation has the resources and the internal processes in place to enable it to effectively oversee work with GMOs. Before an organisation can be accredited, it must have established, or have access to, an appropriately constituted IBC.

IBCs provide on-site evaluation of low-risk contained dealings that do not require case-by-case consideration by the Regulator. IBCs are required to comprise a range of suitable experts and an independent person, and they provide a quality assurance mechanism that reviews the information applicants submit to the Regulator. The Guidelines for the accreditation of organisations and the [Guidelines for the certification of facilities/physical containment requirements are available from the OGTR website.

The legislation allows the Regulator to certify containment facilities (sections 83–90) to ensure that they meet appropriate standards for containment of GMOs and that trained and competent staff carry out those procedures and practices. Guidelines for certification of each type of facility (laboratory, plant house, aquaria, etc.) to physical containment (PC) levels 1, 2, 3 or 4 have been developed by the Regulator and must be complied with before a facility can be certified. All certified facilities must be inspected before certification, and annually, by the IBC. The OGTR inspects all high-level facilities (large-scale PC2, PC3 and PC4) before certification and re-certification.

Coordination with other regulatory agencies


Australia’s gene technology regulatory system does not operate in isolation, but is part of an integrated legislative framework. While the Regulator must consider risks to human health and safety and to the environment relating to development and use of GMOs, other agencies have responsibility for regulating GMOs or GM products as part of a broader or different mandate. In addition, these agencies have relevant and complementary expertise.

During development of the gene technology legislation it was determined that the activities of the Regulator should not override existing legislation or result in duplication. Hence, the Act incorporates a requirement for the Regulator to consult with other agencies on DIR applications, and was accompanied by consequential amendments to the other relevant legislation relating to mutual consultation and exchange of information regarding their assessments and approvals.

Accordingly, where other agencies approve non-viable products derived from GMOs, advice on these decisions is supplied to the Regulator for placing on the GMO Record.

Situations arise where approval of particular dealings with a GMO requires approval by both the Regulator and another regulatory body; the respective roles of these agencies are listed, along with relevant legislation, in Table A3.

For example, while the Regulator must license general release of a GMO into the environment that is used as a human therapeutic, the TGA would have to authorise its administration to people.

Similarly, while the Regulator must approve the environmental release of GM insecticidal or herbicide tolerant plants into the environment, the APVMA, which is responsible for regulating agricultural chemicals, must register the insecticidal gene product or approve application of the herbicide to which the GM plants are tolerant.

Although the focus and responsibility of other agencies that regulate products that are, or are derived from, GMOs are distinct from those of the Regulator, where there is a requirement for regulation, the Regulator has a policy of aligning the decision-making processes as far as is practicable. The OGTR and other regulatory agencies work closely together to ensure thorough coordinated assessments of applications are undertaken and, wherever possible, that the timing of decisions by both agencies coincide.

An example of where this cannot apply is when FSANZ is asked to assess the safety of a GM product that will be imported for use in human food before an application to grow the GMO from which it was derived in Australia is submitted to the Regulator.

Table A3: Regulatory agencies in Australia with a role in regulating gene technology

GMO/GM productsScopeRelevant legislation
Office of the Gene Technology Regulator (OGTR) - Portfolio of Health and Ageing
GMO dealingsOGTR provides a national scheme for the regulation of GMOs in Australia, in order to protect human health and safety and the environment by identifying risks posed by or as a result of gene technology, and to manage those risks by regulating certain dealings with GMOs.Gene Technology Act 2000
Therapeutic Goods Administration (TGA) - Portfolio of Health and Ageing
Medicines, medical devices, blood and tissuesTGA administers legislation that provides a national framework for the regulation of medicines, medical devices, blood and tissues in Australia, including GM and GM-derived therapeutic products, and ensures their quality, safety and efficacy.Therapeutic Goods Act 1989
Food Standards Australia and New Zealand (FSANZ) - Portfolio of Health and Ageing
FoodFSANZ is responsible for the Australia New Zealand Food Standards Code, which prohibits use of food products produced using gene technology in Australia unless there is specific approval for sale of these foods following a safety assessment. The Code also contains provisions for labelling certain GM foods.Food Standards Australia New Zealand Act 1991
Australian Pesticides and Veterinary Medicines Authority (APVMA) - Portfolio of Agriculture, Fisheries and Forestry
Agricultural and Veterinary ChemicalsAPVMA operates the national system that evaluates, registers and regulates all agricultural chemicals (including those that are, or are used on, GM crops) and veterinary therapeutic products. Assessments consider human and environmental safety, product efficacy (including insecticide and herbicide resistance management) and trade issues relating to residues.Agricultural and Veterinary Chemicals (Code) Act 1994;
Agricultural and Veterinary Chemicals Administration Act 1994
National Industrial Chemicals Notification and Assessment Scheme (NICNAS) - Portfolio of Health and Ageing
Industrial ChemicalsNICNAS provides a national notification and assessment scheme to protect the health of the public, workers and the environment from the harmful effects of industrial chemicals.Industrial Chemicals (Notification and Assessment) Act 1989
DAFF Biosecurity - Portfolio of Agriculture, Fisheries and Forestry
Quarantine DAFF Biosecurity regulates importation into Australia of all animal, plant and biological products that may pose a quarantine pest and/or disease risk. Quarantine Act 1908;
Imported Food Control
Act 1992

Notes: Further details of the Australian gene technology regulatory system are available on the OGTR website. Specific queries can be addressed to the OGTR freecall number (1800 181 030) or the OGTR email inbox.

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8Review of the Gene Technology Act 2000 - Final Report

9Amendments to the legislation replaced the Gene Technology Ethics Committee and Gene Technology Community Consultative Committee with the GTECCC from 1 January 2008.

10It is important to note the difference between the GMO Register and the GMO Record. Inclusion of a dealing with a GMO on the GMO Register authorises that dealing, which therefore no longer requires a licence. The GMO Record provides a listing of authorised dealings with GMOs, including licensed dealings, NLRDs, EDDs and dealings on the GMO Register, as well as dealings with GM products.

11The term ‘negligible’ is defined in Chapter 4 and is used here for consistency.

12The GMO Record can be accessed through the Regulator’s website.