About Genetically Modified Organisms

What is a GMO?

A genetically modified organism (GMO) is defined as:

1. an organism that has been modified by gene technology, or
2. 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
3. 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

This does not include:

1. A human being, if the human being has undergone somatic cell gene therapy; or
2. an organism declared by the Schedule 1 of the Regulations not to be a genetically modified organism, or that belongs to a class of organism declared by Schedule 1 of the Regulations not to be genetically modified organisms

In order to understand the definition of a GMO it is important that two further terms are understood - 'organism' and 'gene technology'. 'Organism' is defined in the Gene Technology Act as a biological entity that is viable, capable of reproduction or capable of transferring genetic material.

'Gene Technology' is defined as any technique for the modification of genes or other genetic material, but does not include sexual reproduction, homologous recombination or any other technique specified in Schedule 1A of the Gene Technology Regulations.

Gene Technology legislation prohibits all dealings with GMOs unless they are 'approved' in one of the following ways.

What is a dealing with a GMO?

A dealing with a GMO means to:

1. conduct experiments with a GMO; or
2. make, develop, produce or manufacture a GMO; or
3. breed a GMO; or
4. propagate a GMO; or
5. use a GMO in manufacturing even though the prodct is not a GMO; or
6. grow, raise or culture a GMO; or
7. import or export a GMO; or
8. transport a GMO; or
9. dispose of a GMO

Exempt dealings »

These are dealings with GMOs that have been assessed over time as posing negligible risk. Exempt dealings must be contained within a facility and must not involve the intentional release of a GMO into the environment.  The facility does not need to be certified by the OGTR. Please refer to the guidance notes for containment of exempt dealings.

A dealing with a GMO is exempt if:

1. it is a dealing of a kind mentioned in Schedule 2, Part 1 of the Gene Technology Regulations 2001; and
2. it does not involve a genetic modification other than a modification described in Schedule 2, Part 1 of the Gene Technology Regulations 2001; and
3. it does not involve the intentional release of the GMO into the environment

PC1 standards are recommended for the conduct of exempt dealings.

Notifiable Low Risk Dealings (NLRDs) »

These are dealings with GMOs that have been assessed as posing low risks provided there is compliance with certain risk management conditions. NLRDs must be conducted within a facility certified to be at least Physical Containment (PC) Level 1 or 2, depending on the type of GMO involved. GMOs produced/used as part of an NLRD must not be released into the environment. If GMOs produced/used by an NLRD are to be transported, they must be transported in accordance with the Guidelines for transport, storage and disposal of GMOs issued by the Regulator.  Please note that all NLRDs are limited to 5 years. No variations to NLRDs are permitted. If the scope of work changes, a new NLRD application must be submitted to the IBC. If there is any doubt about whether work is within the scope of an existing NLRD, the IBC must be consulted for advice. For more information about NLRDs refer to Schedule 3, Parts 1 and 2 of the Gene Technology Regulations 2001.

A dealing with a GMO is a Notifiable Low Risk Dealing (NLRD) if:

1. it is a dealing of a kind mentioned in Schedule 3, Parts 1 and 2 of the Gene Technology Regulations 2001; and
2. it is not a dealing of a kind mentioned in Schedule 3, Part 3 of the Gene Technology Regulations 2001; and
3. it does not involve the intentional relase of the GMO into the environment

NLRD's mentioned in Part 1 may be undertaken in certified PC1 facilities and those mentioned in Part 2 may be undertaken in Certified PC2 facilites (or in certified facilities with higher levels of containment).

OGTR guides

The OGTR has several guidance documents on the 2011 changes to NLRDs and the classification of contained dealings with viral vectors.

• Fact Sheet: Changes to the conduct of Notifiable Low Risk Dealings
• Guidance tables for the classification of contained dealings with viral vectors as at 1 September 2011
• Guidance flowchart for the classification of contained dealings with viral vectors as at 1 September 2011
• Guidance tables on the changes to the classification of contained dealings with viral vectors 1 September 2011

Licenced dealings (DNIRs and DIRs) »

All dealings with GMOs that are not Exempt Dealings or NLRDs need to be licenced by the Regulator. There are two types of licences that may be issued by the Regulator - licences for dealings with GMOs that do not involve the intentional release of a GMO into the environment (DNIRs), and licences for dealings with GMOs that do involve the intentional release of a GMO into the environment (DIRs). For more information about licenced dealings refer to Schedule 3, Part 3 of the Gene Technology Regulations 2001.

Approval for dealings

To undertake any dealings with GMOs at The Australian National University, you need to apply for approval from the University Recombinant DNA Monitoring Committee for Exempt, Notifiable Low Risk Dealings and Licences and then approval from the OGTR for Licenced Dealings. 

At The Australian National University, Biological Safety and Gene Technology training are COMPULSORY for supervisors and personnel working on a Notifiable Low Risk Dealing (NLRD), Dealing Not Involving Release (DNIR) or Dealing Involving Release (DIR).  Additional in-house training MAY be required for personnel working on a NLRD and WILL be required for personnel working on a Licenced Dealing or in a PC3 facility.

Physical Containment Facility certification is required for NLRDs or Licenced Dealings.

PC facility levels

There are four levels of physical containment (PC) applied to facilities certified by the Regulator. For more information on PC levels, please see the Guide to Physical Containment Levels and Facility Types on the OGTR website.