The provision for emergency dealing determinations (EDDs) gives the Minister the power to expedite an approval of dealings with a GMO in an emergency (Part 5A of the Act). Table 1 summarises the categories of GMO authorisations, their authorisation requirements and the extent of containment required to conduct the dealings. The Regulator may, directly or on application, vary an issued licence or GMO Register or other instrument. Variations may involve changes to conditions applied to a licence or to the GMO Register entry or other instrument. The Regulator must not vary a licence unless satisfied that any risks posed by the dealings to be varied are able to be managed to protect the health and safety of people and the environment. The Regulator cannot vary a DNIR licence to authorise dealings for intentional release of a GMO into the environment. More information on the various categories of and their is available on the OGTR website. and certification of physical containment facilities helps to manage risks that may be associated with GMO dealings. Conditions of licences for GMO dealings include a requirement for the organisation conducting the dealings to maintain accreditation. Table 1: Categories of authorisations for GMO dealings under the Gene Technology Act 2000 Authorisation requirements Controls Category Licence required Controls may be required, determined DIR (except for Review of applications by IBC case by case, and other licence limited and Consultation on application conditions will apply controlled Preparation of RARMP releases) Consultation on RARMP and licence decision by Regulator DIR (limited and Licence required Controls will be required, based on controlled Review of applications by IBC size and scope of release sought by releases) Preparation of RARMP applicant, and other licence conditions Consultation on RARMP and licence will apply decision by Regulator DNIR Licence required Usually PC2 (or higher) certified Review of applications by IBC physical containment facilities Preparation of RARMP Licence decision by Regulator EDD Licence not required Containment measures may be Determination by minister, subject to included in EDD conditions advice of threat and utility of GMO from competent authorities, and risk assessment advice from Regulator Legislative instrument Exempt Licence not required No intentional release to the Dealings classified as exempt are environment scheduled in the Regulations
The provision for emergency dealing determinations (EDDs) gives the Minister the power to expedite an approval of dealings with a GMO in an emergency (Part 5A of the Act). Table 1 summarises the categories of GMO authorisations, their authorisation requirements and the extent of containment required to conduct the dealings. The Regulator may, directly or on application, vary an issued licence or GMO Register or other instrument. Variations may involve changes to conditions applied to a licence or to the GMO Register entry or other instrument. The Regulator must not vary a licence unless satisfied that any risks posed by the dealings to be varied are able to be managed to protect the health and safety of people and the environment. The Regulator cannot vary a DNIR licence to authorise dealings for intentional release of a GMO into the environment. More information on the various categories of and their is available on the OGTR website. and certification of physical containment facilities helps to manage risks that may be associated with GMO dealings. Conditions of licences for GMO dealings include a requirement for the organisation conducting the dealings to maintain accreditation. Table 1: Categories of authorisations for GMO dealings under the Gene Technology Act 2000 Category Authorisation requirements Controls DIR (except for limited and controlled releases) Licence required Review of applications by IBC Consultation on application Preparation of RARMP Consultation on RARMP and licence decision by Regulator Controls may be required, determined case by case, and other licence conditions will apply DIR (limited and controlled releases) Licence required Review of applications by IBC Preparation of RARMP Consultation on RARMP and licence decision by Regulator Controls will be required, based on size and scope of release sought by applicant, and other licence conditions will apply DNIR Licence required Review of applications by IBC Preparation of RARMP Licence decision by Regulator Usually PC2 (or higher) certified physical containment facilities EDD Licence not required Determination by minister, subject to advice of threat and utility of GMO from competent authorities, and risk assessment advice from Regulator Legislative instrument Containment measures may be included in EDD conditions Exempt Licence not required Dealings classified as exempt are scheduled in the Regulations No intentional release to the environment