Dealing NOT involving an Intentional Release (DNIR) of genetically modified organisms (GMOs) into the environment are dealings with GMOs in contained facilities which do not meet the criteria for classification as Exempt Dealings or Notifiable Low Risk Dealings (NLRDs).
Dealings with a GMO licensed as a DNIR must not involve release into the environment.
These dealings must be licensed by the Gene Technology Regulator (the Regulator).
Schedule 3, Part 3, of the Gene Technology Regulations 2001 (the Regulations) describe DNIRs as higher risk dealings than Notifiable Low Risk Dealings (NLRD).
In general, DNIRs often involve work with GM pathogenic [disease-causing] organisms, or GMOs containing higher risk genes from pathogens or genes that:
- encode toxins or
- confer an oncogenic [cancer-causing] modification or immuno-modulatory [changing the immune system] function.
The contained facilities used for conducting DNIRs must be certified, and typically range from Physical Containment Level 2 to Physical Containment Level 4.
The appropriate level of containment is determined by the risk group classification of the non-genetically modified parent organism (‘wild type’) as outlined in the Australian/New Zealand Standard (AS/NZS 2243.3:2010) AND the risk(s) identified for dealings with the specific GMO.
Dealings with viral vectors—classifying them correctly
Because dealings with viral vectors can be classified in the DNIR, NLRD and Exempt categories, the Regulator has developed guidelines, guidance tables and guidance flow charts about the correct classification of contained dealings with viral vectors.
For dealings covered by the Gene Technology Regulations 2001, the Regulator has developed:
- Guidelines on classification of contained dealings with viral vectors, as amended 1 July 2007 [HTML]
- Guidance tables for the classification of contained dealings with viral vectors, as amended 1 September 2011 [HTML]
- Guidance flow charts for the classification of contained dealings with viral vectors, as amended 1 September 2011 [HTML]
- The Regulator also gives guidance for Institutional Biosafety Committees about considerations that may be appropriate when assessing dealings with viral vectors as an NLRD.
Guidance for IBCs assessing NLRDs involving retroviral (including lentiviral) vectors [HTML]