Gene technology

Work involving the manipulation of genetic material must follow the legislative requirements of the Office of the Gene Technology Regulator (OGTR).

Laboratory and Biosafety Committee (LBC) approval is required for all dealings (work) involving Genetically Modified Organisms (GMOs) before work commences.

  • The approval process varies depending on the class of dealing with GMOs
  • LBC and Animal Ethics Committee (AEC) approval is required for projects involving GM animals.
  • In addition to project approval, the dealing may need to be conducted in a facility (room) that has been certified by the Office of the Gene Technology Regulator (OGTR).

There are four classes of dealings involving Genetically Modified Organisms (GMOs), based on the level of risk to the community and environment: Exempt Dealings, Notifiable Low Risk Dealings (NLRDs), Dealings Not involving Intentional Release (DNIRs) and Dealings involving an Intentional Release (DIRs).

Exempt dealings

Exempt dealings are a category of dealing that pose a very low risk to the health and safety of people and the environment.

Exempt dealings must be:

  • contained within a facility and must not be released into the environment
  • approved by the Laboratory and Biosafety Committee (LBC)

Exempt dealings do not need to be conducted in an OGTR certified facility.

To determine if the dealing is exempt, check:

Read an overview of exempt dealing approval process (PDF, 55.0 KB) .

Notifiable Low Risk Dealings (NLRDs)

Notifiable Low Risk Dealings (NLRDs) pose a low risk to the health and safety of people and the environment provided certain risk management conditions are met.

NLRDS must be:

  • conducted by persons with appropriate training and experience
  • conducted within a facility certified to OGTR Physical Containment Level (PC) 1, PC2 or PC3
  • approved by the LBC
  • transported, stored and disposed of in accordance with OGTR Guidelines for Transport, Storage and Disposal of GMOs

To determine if the dealing is an NLRD, check:

Overview of NLRD approval process (PDF, 55.0 KB) .

Dealings NOT involving an Intentional Release (DNIR) of a GMO into the environment

Dealings NOT involving an Intentional Release (DNIR) of a GMO into the environment pose a higher risk than exempt dealings and NLRDs. If a dealing cannot be classified as an exempt dealing or an NLRD then a licence is required.

DNIRs:

  • must not involve the release of the GMO into the environment
  • must be conducted in a facility certified to OGTR Physical Containment Level (PC) 2, PC3 or PC4
  • must be licensed by the OGTR
    • the LBC performs an initial assessment of the DNIR application
    • work can only be conducted if the OGTR issues a DNIR licence for the work
    • the OGTR assessment process can take 90 working days
  • changes or variations to the DNIR licence must be approved by the OGTR
  • must be transported, stored and disposed of in accordance any specific licence requirements and in accordance with OGTR  Guidelines for Transport, Storage and Disposal of GMOs.

To determine if the dealing is a DNIR, check:

Overview of DNIR approval process (PDF, 59.7 KB) .

Dealings involving Intentional Release (DIR) into the environment

A license is required for dealings involving an intentional release (DIR) of a GMO into the Australian environment. If you think you may require a DIR licence, please contact Deakin Biosafety.

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