Dealings Not Involving Intentional Release into the Environment (DNIR)

Containment Facilities Requirements

  • DNIRs must be conducted in a facility that is certified to at least PC2 level by the OGTR

Resources

DNIRs:

  • Have a higher level of risk than exempt dealings or NLRDs
  • Must NOT involve the release of the GMO into the environment
  • Must be conducted in a facility that is certified to at least PC2 level by the OGTR
  • Can only be conducted if a DNIR licence for the work is issued by the OGTR
  • Must be conducted in accordance with the specific conditions listed on the DNIR licence
  • The GTRC performs an initial assessment of DNIR applications but cannot authorise commencement of work. 
  • Work can only commence if the OGTR issues a DNIR licence. The entire assessement process can take up to 6 months, including a 90 working day OGTR assessment period.
  • DNIR Licences can only be varied or amended with the prior approval from the OGTR (a new licence is issued each time the DNIR is varied).

Does my work need a DNIR licence?

If a dealing cannot be classified as an exempt activity or a NLRD, then a licence is required.

Examples of dealings with GMOs that require a DNIR licence:

  • Cloning an expression of a full length toxin gene in any host/vector system
  • Creation of a novel replication competent virus that is more virulent than its parent strain
  • Creation of a GM animal or plant that is able to secrete or produce infectious agents as a result of the modification

Application process

  • Approval for DNIRs must be granted by the Office of the Gene Technology Regulator and the approval process is considerable and time consuming.
  • For further information please see the Applications page.
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