Genetically Modified Organism Project Classification

What is a GMO?

A GMO is a Genetically Modified Organism. The Gene Technology Act 2000 defines a GMO as:

an organism that has been modified by gene technology; or
an organism that has inherited particular traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology; or
anything declared by the regulations to be a genetically modified organism, or that belongs to a class of things declared by the regulations to be genetically modified organisms;

but does not include:

a human being, if the human being is covered by paragraph (a) only because the human being has undergone somatic cell gene therapy; or
an organism declared by the regulations not to be a genetically modified organism, or that belongs to a class or organisms declared by the regulations not to be genetically modified organisms.

Organisms that are not Genetically Modified Organisms

If your project involves organisms that are not genetically modified organisms as defined by Schedule 1 of the Gene Technology Regulations 2001, or techniques that are not deemed as gene technology techniques as defined by Schedule 1A of the Gene Technology Regulation then a project application is not required to be submitted to the Griffith University Biosafety Committee (UBC) or OGTR.

Exempt Dealings

Schedule 2 of the Gene Technology Regulations 2001 provides information regarding Exempt Dealing categories and exempt host/vector systems. Exempt Dealings are those considered to be of minimal risk and this category of dealing includes:

dealings of a kind mentioned in Part 1 of Schedule 2; and
does not involve a genetic modification other than a modification described in Part 1 of Schedule 2; and
does not involve an intentional release of the GMO to the environment; and
does not involve a retroviral vector that is able to transduce human cells.

Exempt Dealings are monitored by the Griffith University Biosafety Committee (UBC). Work can only begin on Exempt Dealing projects once the Griffith University-IBC recommendation has been received. Project applicants and/or principal research leaders must inform the UBC when exempt dealing projects are completed or abandoned.

These dealings must be undertaken in a minimum PC1 facility as set out in the Australian Standard 2243.3:2002. These facilities are not required to be certified by the OGTR.

Notifiable Low Risk Dealings

NLRDs are dealings that have been assessed as having minimal risk to the health and safety of people and the environment and as such these risks can be managed in certified containment facilities. There are two classes of NLRD categories, PC1 NLRD which are required to be undertaken in a minimum of an OGTR certified PC1 facility and PC2 NLRD required to be undertaken in a minimum of an OGTR certified PC2 facility.

PC1 NLRDs are those dealings as defined in Part 1 of Schedule 3 of the Gene Technology Regulations 2001 and PC2 NLRD's are those dealings as defined in Part 2 of Schedule 3 of the Gene Technology Regulations 2001.

NLRDs are recommended by the Griffith University Biosafety Committee (UBC) and then reported to the OGTR in the organisation's Annual Report. Work can only begin on NLRD projects once the recommendation has been received by the project leader.

Dealings Not Involving Intentional Release of Genetically Modified Organisms

DNIR of GMOs are dealings that may pose significant risks to the health and safety of people or the environment but are typically laboratory-based research projects. These dealings must be licensed by the Regulator. Part 3 of Schedule 3 of the Gene Technology Regulation 2001 provides prescribed information regarding application for a licence.

DNIR applications are submitted to the Griffith University Biosafety Committee (UBC) for consideration and then forwarded to the OGTR for approval. Work can not begin until the OGTR has issued a licence. Licence approval can take up to 90 days once the OGTR has receipted the application.

These dealings must be undertaken in OGTR certified PC2 facilities as set out in the OGTR Guidelines for Certification of PC2 Facilities/Physical Containment 2 Requirements.