Containment Facilities Requirements
- DNIRs must be conducted in a facility that is certified to at least PC2 level by the OGTR
Resources
- List of DNIRs - (Schedule 3, Part 3 of OGTR Regulations 2001)
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.