What is a GMO?
A genetically modified organism (GMO) is defined 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
This does not include:
- A human being, if the human being has undergone somatic cell gene therapy; or
- 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 Regulations.
What is a dealing with a GMO?
A dealing with a GMO means to:
- conduct experiments with a GMO; or
- make, develop, produce or manufacture a GMO; or
- breed a GMO; or
- propagate a GMO; or
- use a GMO in manufacturing even though the prodct is not a GMO; or
- grow, raise or culture a GMO; or
- import or export a GMO; or
- transport a GMO; or
- dispose of a GMO
What is an Exempt Dealing?
A dealing with a GMO is exempt if:
- it is a dealing of a kind mentioned in Schedule 2, Part 1 of the Gene Technology Regulations 2001; and
- it does not involve a genetic modification other than a modification described in Schedule 2, Part 1 of the Gene Technology Regulations 2001; and
- it does not involve the intentional release of the GMO into the environment
PC1 standards are recommended for the conduct of exempt dealings. See Guidance Notes for the Containment of Exempt Dealings.
What is a notifiable low risk dealing (NLRD)?
A dealing with a GMO is a Notifiable Low Risk Dealing (NLRD) if:
- it is a dealing of a kind mentioned in Schedule 3, Parts 1 and 2 of the Gene Technology Regulations 2001; and
- it is not a dealing of a kind mentioned in Schedule 3, Part 3 of the Gene Technology Regulations 2001; and
- 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).
How do I remain compliant when undertaking an NLRD?
You will remain compliant if:
- The dealing is only conducted within a certified PC1 or PC2 facility (as appropriate for the type of GMO involved)
- The dealing is properly supervised (for example, by the IBC of the Accredited Organisation in which the work is conducted) - and a record of the details of the dealing retained
- Any transport of the GMO is conducted in accordance with the Regulator's Guidelines for the Transport, Storage and Disposal of GMOs; and
- If the dealing involves organisms that may produce disease in humans, the NLRD must be conducted in accordance with the vaccination requirements set out in the Australian Standard AS/NZS 2243:3:2010 2.6.4 (Safety in laboratories Part 3: Microbiological safety and containment).
What are PC levels?
There are four levels of physical containment (PC) applied to facilities certified by the Regulator. For more information on the PC levels, please see the Explanatory Information guide on the OGTR website.
What type of approval do I need under the legislation to deal with a GMO?
Refer to the answers to the FAQs 'What is an Exempt Dealing?' and 'What is a Notifiable Low Risk Dealing?'
If, after reading these answers and consulting the associated Schedules, you think your proposed experiments may be exempt or if you are unsure, you should email the Secretary of the University Recombinant DNA Monitoring Committee with a description of the proposed exempt dealing, including a description of the exempt host, the exempt vector and the genetic modification. This email should provide the University Recombinant DNA Monitoring Committee with sufficient information to evaluate whether your proposal is exempt or requires a NLRD or Licenced Dealing application. If your dealing is classified by the Committee as exempt, you will be advised in writing that the work is exempt and that you may commence experimentation. If your dealing is classified by the Committee as a NLRD or Licenced Dealing, then you will be advised that an application for a NLRD or Licenced Dealing will need to be prepared.
If you think your proposed experiments may be a NLRD, then fill out and submit the NLRD application form to the Secretary as described on the Applications for Approval of Dealings with GMOs webpage.
If you think your proposed experiments may require an application for a Licenced Dealing then you should contact the Secretary for further advice before preparing an application for a Licenced Dealing.
What can the Regulator do in the case of non-compliance with the legislation?
Depending on the type of non-compliance, the Regulator has the power to cancel licences, certifications or accreditation of organisations and in the event of continued non-compliance, in terms of possible risks to the health and safety of people or risks to the environment, the Regulator may approach the Director of Public Prosecutions to pursue a prosecution under the legislation which may result in a fine or imprisonment. The Regulator may undertake routine or unannounced visits to organisations to monitor compliance with the conditions of:
- Licences issued for Licenced Dealings