This appendix outlines the classes of dealings with GMOs that are defined by the Act, the Regulations and corresponding state and territory laws, as well as the procedures followed for each type of application and other instruments that help the Regulator manage risks to health and safety of people and the environment. It also describes activities the OGTR undertakes to monitor dealings with GMOs for compliance with legislation and actions it takes in response to non-compliances.
The GMO Register
The GMO Register is a register provided by Part 6, Division 3 of the Act. The Regulator may make a determination to include dealings with GMOs on the GMO Register1 according to section 78 of the Act. To be included on the GMO Register, the dealings must first have been authorised by a GMO licence. Dealings will not be entered onto the GMO Register until the Regulator is satisfied that the risks posed by the 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. After inclusion on the Register these dealings would no longer require authorisation by a licence from the Regulator but may still have conditions attached to their registration. One GMO dealing (for a colour modified carnation) is currently on the GMO Register.
Exempt dealings are dealings with GMOs that have been assessed over time as posing negligible2 risks to people or to the environment. They comprise basic molecular biology techniques that are used extensively in laboratories worldwide. The criteria for exempt dealings are specified in the Regulations (Schedule 2). Exempt dealings must not involve intentional release into the environment but do not require a specified level of containment. Guidance on appropriate containment measures for exempt dealings is provided on the OGTR website. If dealings fall within the classification in the Regulations for exempt dealings they do not require a case-by-case risk assessment. 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 (less than 10 litres) of an approved host/vector system into which low risk genetic material has been introduced (for example, the gene must not be uncharacterised, be derived from a pathogenic organism, nor code for a toxin).
Notifiable low risk dealings
NLRDs are dealings with GMOs that have been assessed as posing negligible risks provided certain management conditions are met. The Regulations specify the GMO dealings that are classified as NLRDs (Schedule 3 Part 1 and 2) and requirements for undertaking NLRDs (Regulation 13). Such dealings may only be undertaken in a facility certified by the Regulator at least to a specified physical containment level (usually PC1 or PC2 certified facilities) and is of an appropriate design for the kind of dealing undertaken. Conducting NLRDs requires prior assessment by an IBC to confirm that proposed dealings with GMOs are properly classified as NLRDs and that personnel have the appropriate training or experience. Organisations must keep a record of all current NLRDs and include them in an annual report to the Regulator. NLRDs are included on the Record of GMO and GM Product Dealings (see below) but do not require case-by-case risk assessment by the Regulator.
An example of an NLRD that may be conducted in PC1 facilities is dealing with GM laboratory mice or rats. Examples of NLRDs that may be conducted in PC2 facilities include dealings with:
- a GM animal (other than a mouse or rat) including invertebrates
- a GM 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 (for example, the gene may encode a pathogenic determinant or uncharacterised gene from a pathogen).
Any dealing with a GMO not classified as exempt or as an NLRD or listed on the GMO Register must not be conducted unless licensed. The Regulator considers all licence applications on a case-by-case basis. The Regulator must consider whether the risks posed by the dealing can be managed in such a way as to protect human health and safety and the environment. The Regulator must make a decision on whether to issue a licence to allow dealing and (if a licence were to be issued) the management conditions to be imposed to manage any risks.
The legislation sets out a series of actions the Regulator must take in considering applications for licences both for contained dealings (DNIRs) and those involving intentional release (DIRs). The Act details steps that must be taken in assessing the application, and the application forms detail the information an applicant must provide.
For both DNIRs and DIRs, the Regulator requires an applicant to identify risks the dealings may pose to human health and safety and the environment and any measures proposed to manage those risks. Both also require the organisation’s IBC to support the application.
The Act requires the Regulator to prepare a RARMP for both DNIR and DIR applications. The risk assessment takes account of any risks to human health and safety and the environment posed by the dealing and the risk management plan determines how those risks can be managed.
The requirements of the legislation have been framed so as to place greater scrutiny on dealings that involve release to the environment (DIRs). The Regulator may impose conditions on all licences; for example, for all DIRs determined to be limited and controlled releases, measures will be imposed to restrict the persistence and spread of the GMO and its genetic material. 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 Act 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 the environment and an assessment of the applicant’s capacity to manage any risks posed by the proposed dealings.
While the Act is highly prescriptive about the process to be followed in assessing licence applications, it is not explicit in directing how the Regulator should undertake risk analyses. The Risk Analysis Framework was, therefore, developed to provide guidance on how the Regulator and the OGTR should apply internationally recognised risk analysis practice in the context of the legislation. The framework was applied to all licence applications processed during 2009–103.
Dealings not involving intentional release
DNIRs usually take place under specified physical containment conditions in certified facilities, which minimise risks to the environment. The Act requires preparation of a RARMP for DNIR applications (section 47). The application form specifies the information the Regulator requires.
The legislation provides that in relation to DNIR licences the Regulator may consult GTTAC, the states and territories, relevant Australian Government agencies, and any other person the Regulator considers appropriate.
The Regulator considers the RARMP in deciding whether to issue a licence and in determining the licence conditions that should be imposed (if a licence were to be issued). Typical licence conditions require the applicant to conduct the dealings in certified facilities, to follow particular handling requirements (such as avoiding use of ‘sharps’ and using biosafety cabinets), to train and supervise staff, to transport and dispose of the GMO appropriately, and to have, and if necessary implement, contingency plans.
As a guide to the legislative requirements, the process required in respect of DNIR applications is described in Figure 18.
Figure 18: DNIR assessment process
Dealings involving intentional release
The application form is the same for all DIRs (including limited and controlled releases) and the Regulator will, on a case-by-case basis, use information the applicant submitted (as specified in the application form) to determine which consultation process will apply and the timeframe allowed under the Act for processing the application.
This Risk Analysis Framework outlines the approach taken to risk analysis and preparing RARMPs. As a guide to the legislative and administrative requirements, the eight-stage process adopted in respect of DIR applications is shown in Figure 19 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 would 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. Wherever possible quantitative data should be provided. It is expected that 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:
- the principal purpose of the application is to enable the licence holder, and persons covered by the licence to conduct experiments
- the application proposes, in relation to any GMO in respect of which dealings are proposed to be authorised:
- controls to restrict dissemination or persistence of the GMO and its genetic material into the environment
- limits on the proposed release of the GMO
- 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 section 50(3).
Section 50A(2) of the Act describes the term ‘controls’ as including:
(a) methods to restrict the dissemination or persistence of the GMO or its genetic material into the environment
(b) methods for disposal of the GMO or its genetic material
(c) data collection, including studies to be conducted about the GMO or its genetic material
(d) the geographic area in which the proposed dealings with the GMO or its genetic material may occur
(e) compliance, in relation to dealings with the GMO or its genetic material, with:
i. a code of practice issued under section 24, or
ii. a technical or procedural guideline issued under section 27.
Section 50A(3) describes the term ‘limits’ as including:
(a) the scope of the dealings with the GMO
(b) the scale of the dealings with the GMO
(c) the locations of the dealings with the GMO
(d) the duration of the dealings with the GMO
(e) 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 the Regulator has declared to be, or is under consideration as, confidential commercial information) to anyone that 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 GTTAC, the states and territories, prescribed Australian Government agencies, the Environment Minister, and appropriate local government authorities. The Regulator usually consults local government authorities where the release is proposed to occur. In addition, the Regulator 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 a 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 through advertisements in a national newspaper, in the Australian Government Gazette, and from notices placed on the Regulator’s website. In practice the Regulator advertises more broadly, including in metropolitan and regional newspapers and specialist interest press and will advise 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 GTMC. 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 19: DIR eight-stage assessment process
Part 5 of the Act allows the Regulator to grant a temporary licence (no longer than 12 months) to a person who finds they are 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 a 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 can be managed in such as way as to protect the health and safety of people and the environment.
Emergency dealing determinations
The EDD provision in Part 5A (section 72A–E) of the Act provides the Minister with the power to expedite 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 needed. 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 about addressing the threat from the Commonwealth Chief Medical Officer, the Commonwealth Chief Veterinary Officer, or the Commonwealth Chief Plant Protection Officer, about managing risks from the Gene Technology Regulator. The states and territories 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.
The GMO Record
Section 138 of the Act requires the Regulator to maintain a record of approved GMOs and GM product dealings. 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 Record4.
The GMO Record is currently divided into separate sections for recording:
- Notifiable low risk dealings
- Contained dealings – DNIR licences
- Intentional releases – DIR licences
- Inadvertent dealing licences
- GMO Register
- Emergency Dealing Determinations
- GM products – those used in food processing, therapeutics, and pesticides and veterinary medicines authorised by other regulatory agencies.
Accreditation and certification
Accreditation of organisations and certification of individual physical containment facilities helps manage risk that may be associated with dealings with GMOs.
The Regulator will require an organisation undertaking certain dealings with GMOs to be accredited. 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 scrutiny 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.
Certain dealings must be undertaken in certified facilities that meet defined requirements to ensure adequate containment of GMOs. The legislation allows the Regulator to certify laboratory or production facilities to ensure appropriate standards are met for containment of GMOs and that trained and competent staff are carrying out procedures and practices. The Regulator has issued guidelines to help organisations meet certification requirements for certification of each type of facility (laboratory, plant and animal, etc.) to physical containment (PC) levels 1, 2, 3 or 4, and must be complied with before a facility can be certified. All certified facilities must be inspected before certification, and annually thereafter (except for those certified as a PC1 facility). The OGTR inspects all high-level facilities (large-scale PC2, PC3 and PC4) before certification and re-certification5.
Monitoring and compliance
The aim of OGTR monitoring and compliance activities is to ensure dealings with GMOs comply with legislative obligations and are consistent with the object of the Act, bearing in mind that non-compliance with conditions placed on licences issued under the Act is a criminal offence. The OGTR has adopted an operational philosophy that places strong emphasis on helping accredited organisations and licence holders comply with their legislative obligations.
In particular, monitoring activities focus on managing dealings at field trial sites and within certified physical containment facilities to ensure:
- dissemination of a GMO and its genetic material is minimised
- persistence of a GMO in the environment is managed
- effective management of the GMO is maintained.
OGTR monitoring activities comprise the functions of routine monitoring, including spot checks, assessment of monitoring findings and, where necessary, recommending corrective action and follow-up activities.
The OGTR Monitoring Section conducts routine monitoring visits to a minimum of 20 per cent of field trial sites each year. The OGTR strategy for conducting field trial monitoring draws on accumulated operational experience of risk profiling in relation to compliance. For example, OGTR field trial monitoring coincides, where possible, with periods or circumstances when non-compliance with licence conditions designed to limit the spread and persistence of the GMOs or their genetic material is more likely to occur (for example, during flowering and/or harvesting of GM crops).
The monitoring program for contained dealings involves inspecting DNIRs and the facilities in which those dealings are conducted, as well as monitoring a minimum of 20 per cent of PC4, PC3 and PC2 large-scale facilities per year. These inspections focus on the integrity of the physical structure of a facility and on the general laboratory practices followed in that facility, including those practices followed for DNIRs and NLRDs.
OGTR compliance activities comprise reviews of potential compliance risks, audits, investigations, and related enforcement activities.
The OGTR may initiate practice reviews in response to observations made during monitoring activities, or to follow up incident reports that may relate to non-compliance with licence conditions by accredited organisations. Their objective is to determine if licence conditions can be, and are being, effectively implemented. An accredited organisation may seek a practice review to assess the effectiveness of systems its IBCs use to ensure dealings are being conducted in accordance with the Act.
The OGTR or an accredited organisation can initiate an audit that can entail documentary evidence, observations and/or assessments of procedures and practices. These activities are conducted to:
- verify that an accredited organisation has relevant and effective management procedures and practices to meet requirements under the Act, including accreditation requirements, guidelines and any licence conditions applicable to a dealing
- assess whether procedures and practices provide mechanisms to identify and resolve emerging risks
- suggest improvements to procedures and practices, where appropriate.
An investigation is an inquiry into a suspected non-compliance with the Act and corresponding state or territory laws with the aim of gathering evidence. Such investigations are not restricted to purely criminal aspects – in the wider context they may include advice on detected flaws and vulnerability in policies, practices and procedures. An investigation may be initiated as a consequence of OGTR monitoring, self-reporting by an accredited organisation, or by third-party reporting.
1It is important to note the difference between the GMO Record and the GMO Register. The GMO Register lists GMOs that no longer require a licence and will only ever be a subset of dealings included on the GMO Record. The GMO Record is a comprehensive listing of all dealings with GMOs including licensed dealings, NLRDs and GM products.
2The term ‘negligible’ is defined in Chapter 3 of the Risk Analysis Framework and is used here for consistency.
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