Dealings with Genetically Modified Organisms (GMOs)

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

Exempt Dealings

These are dealings with GMOs that are known to pose low risk.  Exempt dealings must be contained within a facility of PC1 standard and must not involve the intentional release of a GMO into the environment.  The OGTR has issued non compulsory guidance notes for the containment of exempt dealings (link). For more information about exempt dealings with GMOs please refer to Schedule 2 of the Gene Technology Regulations 2001.

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 Level 1 or Physical Containment Level 2 depending on the type of GMO involved and if GMOs produced/used by an NLRD are to be transported, they must be transported in accordance with the Guidelines issued by the Regulator for the transport of GMOs.  GMOs produced/used as part of an NLRD must not be released into the environment. For more information about NLRDs refer to Schedule 3, Parts 1 and 2 of the Gene Technology Regulations 2001.

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.

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

• Applications for Approval of Dealings with GMOs

At the ANU, Biological Safety and Gene Technology training is COMPULSORY for anyone working on a dealing with a GMO or in a certified Physical Containment Facility.  Additional in-house training MAY be required for anyone working on an Exempt Dealing or a NLRD and WILL be required for anyone working on a Licenced Dealing or in a PC3 facility

• Biological Safety Training Course
• Gene Technology Practices Training Course

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

• Certification of a Physical Containment Facility

Further Information:

• What is a GMO?
• What is a Dealing with a GMO?
• What is an Exempt Dealing?
• What is a Notifiable Low Risk Dealing?
• How do I know what type of approval I need under the legislation to deal with a GMO?
• How do I apply?