Exempt dealings are a category of dealings with GMOs that have been assessed over time as posing a very low risk (i.e. contained research involving very well understood organisms and processes for creating and studying GMOs). The only legislative requirement for exempt dealings is that they must not involve an intentional release of a GMO into the environment.

Exempt dealings are described in Schedule 2 of the Gene Technology Regulations 2001 (the Regulations).

As of 8 October 2019, the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 amend the Commonwealth Gene Technology Regulations 2001 (the Regulations). Changes to Schedule 2 include the addition of two new bacterial species to the list of host/vector systems for exempt dealings, and listing dealings with cloned full length viral genomes as exempt if they are unable to produce infectious agents in any potential host species. These changes will be adopted in the gene technology legislation of States and Territories at different times, and organisations operating under those laws (e.g. state agencies of those jurisdictions) must continue to follow the earlier legislation until this has occurred. For further information on the amendments, see the 2019 Amendments to the Regulations web page.

The following links contain an excerpt of Schedule 2 of the Regulations incorporating the above amendments:

Types of Dealings with GMOs classified as Exempt dealings – October 2019 (PDF 310 KB)
Types of Dealings with GMOs classified as Exempt dealings – October 2019 (DOCX 52 KB)

The following links contain an excerpt of Schedule 2 of the Regulations prior to the above amendments:

Types of Dealings with GMOs classified as Exempt dealings – September 2011 (PDF 250 KB)
Types of Dealings with GMOs classified as Exempt dealings – September 2011 (DOCX 94 KB)
    Exempt dealings do not require a specified level of containment. The Regulator has released Guidance Notes for the Containment of Exempt Dealings, that are effectively equivalent to those for facilities certified by the Regulator to Physical Containment Level 1 (PC1). These notes are provided as guidance only to persons conducting exempt dealings pursuant to regulation 6 of the Regulations as currently in force and/or pursuant to any applicable corresponding law. They may be of assistance to organisations or persons in determining how to undertake exempt dealings to satisfy themselves with regard to avoiding intentional release. Please note that these guidance notes are not Guidelines for Certification of a PC1 Facility.

    There are no requirements to report exempt dealings to the Regulator and exempt dealings are not included in the GMO Record.


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