What will the amendments change?

The amendments:
  • clarify whether or not organisms modified using several new technologies are GMOs,
  • adjust some contained dealings classifications to better match risk level, including exempt, Notifiable Low Risk Dealing (NLRD) and Dealings Not involving Intentional Release (DNIR) classifications, and
  • adjust minor aspects of NLRD governance at the level of Institutional Biosafety Committees (IBCs) and organisations undertaking NLRDs.
The amendments also include small ‘housekeeping’ changes to keep the legislation up to date, but which do not change requirements for regulated organisations.

The full amendments and explanatory statement are available on the Federal Register of Legislation and OGTR has prepared an overview to assist regulated organisations to understand the amendments:

PDF version of Overview of amendments to the Gene Technology Regulations 2001 (PDF 201 KB)
DOCX version of Overview of amendments to the Gene Technology Regulations 2001 (DOCX 38 KB)

When do the amendments come into force?

Amendments to the Commonwealth Gene Technology Regulations 2001 (the Regulations) commence in three stages:
  • 8 October 2019: the majority of amendments commenced
  • 1 July 2020: minor changes to Notifiable Low Risk Dealing assessment and reporting requirements commenced
  • 8 October 2020: repeal of an item on the list of organisms that are not GMOs.
The current Federal Register of Legislation compilation of the Regulations incorporates amendments that commenced on 8 October 2019 and 1 July 2020.

Please contact OGTR if you require compilations showing the effect of the amendments in track changes.

These changes will be automatically adopted in the corresponding gene technology legislation of Tasmania, New South Wales, the Northern Territory and Queensland, and equivalent amendments have been made in Victoria and South Australia. The ACT is yet to amend its gene technology laws, and organisations operating under those laws (e.g. agencies of the ACT Government) can only implement the amendments once that process is complete.

What do the amendments that commenced 1 July 2020 mean for organisations doing NLRDs now?

The changes to the requirements for IBCs assessing NLRD proposals or for organisations reporting NLRDs to the Regulator post 1 July 2020 can be met simply by using the latest NLRD reporting form and record of assessment guidance documents provided by OGTR, available here.

Requirements have changed for my contained dealing, what do I need to do?

There are transitional arrangements for dealings being conducted as exempt dealings or NLRDs before 8 October 2019 but which, from 8 October 2029, require a higher level of authorisation, or where the requirements for undertaking a NLRD change (e.g. the required containment level increases). Dealings that were already underway on 8 October 2019 can continue until 8 October 2020 under the pre-existing authorisation, and after that time the dealings must cease or a new authorisation be obtained.

Those planning work impacted by the amendments should familiarise themselves with the changes and allow time to get a new authorisation in place. Any new GMO dealing commencing on or after 8 October 2019 must be authorised according to the amended requirements.

Where the level of authorisation is decreasing (e.g. from NLRD to exempt), there is no need to obtain a new authorisation unless you want to access the conditions of the new authorisation category.

What SDN-1 organisms are excluded?

The amendments mean SDN-1 organisms are not GMOs provided that:
  • no nucleic acid template was added to cells to guide genome repair following site-directed nuclease application
  • the organism has no other traits from gene technology (e.g. cas9 transgene, expressed SDN protein).
It is the responsibility of proponents to ensure they are complying with the law and that these requirements have been met. Some methods used to generate SDN-1 organisms produce GMOs in intermediate steps, and dealings with these GMOs will continue to require authorisation under the Gene Technology Act 2000.

What about other organisms with equivalent changes?

The method used to modify an organism is the central consideration in determining whether or not the organism is a GMO. Techniques that are similar to SDN-1 but do not meet the SDN-1 exclusion, for example base editing, are not excluded from regulation through that amendment. Similarly, the scale of resulting nucleotide changes, whether an insertion or deletion, or whether the resulting nucleotide sequence may be found in sexually compatible species, is not a deciding factor.

How do I use the Schedules in the Gene Technology Regulations 2001 to work out if an organism is a GMO?

How do I use the Schedules in the Gene Technology Regulations 2001 to work out if an organism is a GMO?

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