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] effect.
The contained facilities used for conducting DNIRs are generally certified by the Regulator, 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) AND the risk(s) identified for dealings with the specific GMO. DNIR licences issued by the Regulator specify the facilities in which the dealings my be conducted.
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 guidance on the classification of contained dealings with viral vectors.