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