What the amendments change

The amendments are now in force, they:
  • 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 the amendments came into force

Amendments to the Commonwealth Gene Technology Regulations 2001 (the Regulations) commenced 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 Federal Register of Legislation compilation of the Regulations incorporates the three stages of amendments.

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

These changes were 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, ACT and South Australia.

What do I need to do to meet the changed NLRD requirements?

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?

New authorisations must now be in place for dealings previously being conducted as exempt dealings or NLRDs but which, from 8 October 2019, required a higher level of authorisation, or where the requirements for undertaking a NLRD changed (e.g. the required containment level increased). The transitional period during which pre-existing authorisations continued has now finished, and those dealings must cease or a new authorisation be obtained.

Where the level of authorisation decreased (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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