Summary of this Part


This Part describes the system of regulation for:
  • very low risk contained activities (notifiable low risk dealings); and
  • dealings that have undergone a period of licensing, monitoring of any risks and a determination that the GMO no longer requires licensing based on the fact that the dealings with the GMO present minimal risk (dealings on the GMO Register).
This recognises that different types of dealings with GMOs present varying levels of risk, and that different levels of assessment and regulatory oversight are appropriate in relation to each.

Key provisions in this Part and major changes as a result of consultation on the draft Bill

Notifiable low risk dealings (Division 2)


In summary, the system of regulation for notifiable low risk dealings will operate as follows:
  • regulations will be made describing types of dealings with GMOs that are ‘notifiable low risk dealings’ for the purposes of this Bill. Before prescribing certain dealings with GMOs as being notifiable low risk dealings the GTR must take into account:
    • whether the GMO is ‘biologically contained’ (because it has a reduced ability to survive or reproduce without human intervention);
    • whether the dealing involves minimal risk (taking into account such things as the properties of the GMO as a pathogen or pest and its capacity to produce toxic proteins); and
    • whether proposed conditions will be adequate to manage any risk associated with the proposed dealing.
A dealing with a GMO may not be prescribed as a notifiable low risk dealing if the dealing involves release of the GMO into the environment – notifiable low risk dealings may only be dealings that are conducted within contained facilities.

It is anticipated that the dealings prescribed in the regulations as notifiable low risk dealings will be based on the existing GMAC Category B activities.
  • regulations will also set out conditions which must be complied with by people undertaking notifiable low risk dealings. The regulations will require that the activities be notified to the GTR; that they be supervised by an Institutional Biosafety Committee and that the activities occur within a certified containment facility.
    Example:
    If a person is proposing to carry out low risk research activities they would check the Schedule to the Gene Technology Regulations to determine whether the activity proposed to be undertaken is a notifiable low risk dealing. If the proponent believes that the activity is a notifiable low risk dealing (in accordance with the regulations) they would go to their IBC for verification that the dealing is a notifiable low risk and for the IBC’s consideration of whether the proposed work will be carried out in accordance with the conditions set in the regulations in relation to notifiable low risk dealings.
    If the IBC is satisfied that the work is a notifiable low risk dealing and is to be undertaken in accordance with the prescribed conditions then the work may proceed. The IBC and the proponent must, however, notify the GTR providing information about the work being undertaken. This provides for an extra checking mechanism and if the GTR is not satisfied that the work has been appropriately classified as a notifiable low risk dealing, the GTR may take appropriate action (including requiring the work to cease and the applicant to seek a licence to undertake the work). The GTR may also monitor compliance with the conditions prescribed in the regulations through reporting requirements, auditing and/or spot checks.

The proposed system for regulation of notifiable low risk dealings with GMOs was discussed in some detail during consultations on the draft Bill. Generally, there was considerable support, particularly in the research community, for the way that GMAC has dealt with low risk research involving GMOs.

There was also a strong call from researchers that the existing system for contained work be maintained so that unnecessary costs were not incurred for work that is largely low risk. The assessment process proposed for notifiable low risk dealings and dealings with GMOs that do not involve a deliberate release into the environment, was generally supported. It was seen as a streamlined way for dealing with low risk activities, based on the current GMAC processes, but with capacity for more comprehensive assessment where necessary.

The GMO Register (Division 3)

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The purpose of the GMO Register is to enable certain dealings with GMOs to be undertaken without the requirement for a licence to be held by a named individual or organisation. Dealings with GMOs may be entered on the GMO Register once they have been licensed for a certain period of time, and once the GTR is satisfied that the dealings with the GMO are sufficiently safe that they can be undertaken by anyone without the safety of the dealings being dependent on oversight by a licence holder.
    Example:
    A company who wished to market a flower that had been genetically modified to extend vase life would initially apply for a licence to do so. If any risks posed by the flower could be managed, the GTR would grant the applicant a licence subject to, as a minimum, conditions requiring provision of any further information about risks or unintended effects by the licence holder and a requirement that the GTR be allowed to enter premises to undertake auditing and monitoring.

    After a period of time (for example, 5 years), the GTR could re-examine the licence and determine that, on the basis of the absence of risks posed by the flower, it is no longer appropriate for the flower to be subject to the licensing regime and that the flower should be entered on the Register, enabling unrestricted use.

The concept of a GMO Register was not included in the consultation draft of the Gene Technology Bill. The provisions were however included to address concerns raised by stakeholders in relation to the licensing system.

One of the concerns raised was that if a GMO has been growing in Australia for a long period of time, was used by a very large number of people (for example, a GM flower that was grown and sold in Australia and would be “dealt with” by millions of people including those who sell the flower and buy the cut flower) and had been demonstrated to be safe, then it was unreasonable to expect one company (the licence holder) to continue to have to hold a licence to enable the flower to be grown, sold and used by millions of people. Particularly if there were no longer any conditions that were necessary to be observed to manage any risks posed by the flower and hence no direct oversight of dealings necessary by the licence holder. The point was raised that if the licence holder chose to surrender the licence, then all of the dealings with the GMO by millions of people would be “illegal” under the Bill.

The GMO Register was developed to address this concern by enabling the GTR to enter GMOs on the Register after a period of licensing and demonstration of the absence of risk. The effect of entry on the Register is that anyone may deal with the GMO (without the need for there to be a single licence holder).

For a clause by clause explanation of this Part please refer to the Explanatory Memorandum to the Gene Technology Bill 2000