What are Dealings NOT involving an Intentional Release (DNIR) of a GMO into the environment?
Dealing NOT involving an intentional release of 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. These dealings must be licensed by the Gene Technology Regulator (the Regulator).
The contained facilities used for conducting DNIRs must be certified and typically range from Physical Containment Level 2 (PC2) to PC4 level containment. The appropriate level of containment is determined by the risk group classification of the wild type (non-genetically modified parent) organism 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 a GMO licensed as a DNIR must not involve release into the environment.
The kinds of dealings with GMOs that are classified as DNIRs are described in Schedule 3, Part 3 of theGene Technology Regulations 2001 (the Regulations) and are higher risk dealings than NLRDs.
In general, DNIRs consist of dealings with GM pathogenic organisms, or GM organisms containing higher risk genes from pathogens or genes that encode toxins or confer an oncogenic modification or immuno-modulatory function.
Dealings with viral vectors can be classified in the DNIR, NLRD, and exempt categories, therefore guidance on the correct classification of contained dealings with viral vectors has been developed.
For dealings covered by the Gene Technology Regulations 2001 as amended 1 July 2007