Part 6Regulation of notifiable low risk dealings and dealings on the GMO Register

Part 6—Regulation of notifiable low risk dealings and dealings on the GMO Register 73—Simplified outline (a) establishes a mechanism for the regulations to regulate certain dealings with GMOs (notifiable low risk dealings) that do not involve the intentional release of GMOs into the environment (see Division 2); (b) provides that the regulations may (among other things) require that the Regulator be notified of such dealings; (c) enables the Regulator to determine that certain dealings previously authorised by a licence be included on the GMO Register; (d) ensures that, if a dealing is included on the GMO Register, anyone may undertake the dealing, subject to specified conditions. This section differs from section 73 of the Commonwealth Act. Division 2—Notifiable low risk dealings 74—Notifiable low risk dealings (1) The regulations may declare a dealing with a GMO to be a notifiable low risk dealing for the purposes of this Act. (2) Before the Governor makes regulations declaring a dealing with a GMO to be a notifiable low risk dealing, the Regulator must be satisfied that the dealing would not involve the intentional release of a GMO into the environment. (3) Before the Governor makes regulations declaring a dealing with a GMO to be a notifiable low risk dealing, the Regulator must consider— (a) whether the dealing with the GMO would involve any risk to the health and safety of people, or to the environment, taking into account— (i) the properties of the GMO as a pathogen or pest; and (ii) the toxicity of any proteins produced by the GMO; and (b) if there is such a risk—whether 1 or more of the requirements prescribed in the regulations for the purposes of subsection (2) would be sufficient to manage that risk; and (c) any other matter the Regulator considers appropriate. (4) Regulations under subsection (1) may be expressed to apply to— (c) one or more specified dealings with a GMO or with a specified class of GMOs. 75—Regulation of notifiable low risk dealings (1) The regulations may regulate— (a) a specified notifiable low risk dealing; or (b) a specified class of notifiable low risk dealings, for the purpose of protecting the health and safety of people or the environment. (2) The regulations may prescribe different requirements to be complied with in different situations or by different persons, including requirements in relation to the following: (a) the class of person who may undertake notifiable low risk dealings; (b) notifying the Regulator of notifiable low risk dealings; (c) supervision by Institutional Biosafety Committees of notifiable low risk dealings; (d) the containment level of facilities in which notifiable low risk dealings may be undertaken. Division 3—The GMO Register 76—GMO Register Section 76 of the Commonwealth Act provides for the establishment and maintenance of the GMO Register. 77—Contents of Register If the Regulator determines under section 78 that a dealing with a GMO is to be included on the GMO Register, the Regulator must specify in the GMO Register— (a) a description of the dealing with the GMO; and (b) any condition to which the dealing is subject. 78—Regulator may include dealings with GMOs on GMO Register (1) The Regulator may, by writing, determine that a dealing with a GMO is to be included on the GMO Register if the Regulator is satisfied that— (a) the dealing is, or has been, authorised by a GMO licence; or (b) the GMO concerned— (i) is a GM product; and (ii) is a genetically modified organism only because of regulations made under paragraph (c) of the definition of genetically modified organism. (2) A determination under subsection (1) may be made— (a) on application by the holder of a licence that authorises the dealing; or (b) on the initiative of the Regulator. (3) A determination under subsection (1) comes into effect on the day specified in the determination. Section 78(4) of the Commonwealth Act provides for determinations to be disallowable instruments. 79—Regulator not to make determination unless risks can be managed (1) The Regulator must not make a determination under section 78(1) in respect of a dealing with a GMO unless the Regulator is satisfied— (a) that any risks posed by the dealing are minimal; and (b) that it is not necessary for persons undertaking the dealing to hold, or be covered by, a GMO licence, in order to protect the health and safety of people or to protect the environment. (2) For the purposes of subsection (1), the Regulator must have regard to the following: (a) any data available to the Regulator about adverse effects posed by the dealing; (b) any other information as to risks associated with the dealing of which the Regulator is aware, including information provided to the Regulator by a licence holder under section 65 or by another person under section 66; (c) whether there is a need for the dealing to be subject to conditions; (d) any other information in relation to whether the dealing should be authorised by a GMO licence. (3) The Regulator may have regard to such other matters as the Regulator considers relevant. 80—Variation of GMO Register (1) The Regulator may vary the GMO Register by written determination. (2) A variation may— (a) remove a dealing from the GMO Register; or (b) revoke or vary conditions to which a dealing on the GMO Register is subject; or (c) impose additional conditions to which a dealing on the GMO Register is subject. 81—Inspection of Register Section 81 of the Commonwealth Act requires the Regulator to permit any person to inspect the GMO Register.