Gene Technology Act 2001
Div 6Conditions of licences
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Division 6—Conditions of licences 61—Licence is subject to conditions A GMO licence is subject to the following conditions: (a) the conditions set out in sections 63, 64 and 65; (b) any conditions prescribed by the regulations; (c) any conditions imposed by the Regulator at the time of issuing the licence; (d) any conditions imposed by the Regulator under section 71 after the licence is issued. 62—Conditions that may be prescribed or imposed (1) Licence conditions may include conditions that impose obligations in relation to GM products that are derived from a GMO in respect of which particular dealings are licensed. (2) Licence conditions may relate to, but are not limited to, the following: (a) the scope of the dealings authorised by the licence; (b) the purposes for which the dealings may be undertaken; (c) variations to the scope or purposes of the dealings; (d) documentation and record-keeping requirements; (e) the required level of containment in respect of the dealings, including requirements relating to the certification of facilities to specified containment levels; (f) waste disposal requirements; (g) measures to manage risks posed to the health and safety of people, or to the environment; (h) data collection, including studies to be conducted; (i) auditing and reporting; (j) actions to be taken in case of the release of a GMO from a contained environment; (k) the geographic area in which the dealings authorised by the licence may occur; (l) requiring compliance with a code of practice issued under section 24, or a technical or procedural guideline issued under section 27; (m) supervision by, and monitoring by, Institutional Biosafety Committees; (n) contingency planning in respect of unintended effects of the dealings authorised by the licence; (o) limiting the dissemination or persistence of the GMO or its genetic material in the environment. (3) Licence conditions may also include conditions requiring the licence holder to be adequately insured against any loss, damage or injury that may be caused to human health, property or the environment by the licensed dealing. 63—Condition about informing people of obligations (1) It is a condition of a licence that the licence holder inform any person covered by the licence, to whom a particular condition of the licence applies, of the following: (a) the particular condition, including any variations of it; (b) the cancellation or suspension of the licence; (c) the surrender of the licence. (2) Requirements in relation to the manner in which information is provided under subsection (1) may be— (a) prescribed by the regulations; or (b) specified by the Regulator. (3) Such requirements may include, but are not limited to, measures relating to labelling, packaging, conducting training and providing information. (4) If such requirements are prescribed or specified, it is a condition of a licence that the licence holder comply with the requirements. 64—Condition about monitoring and audits (1) It is a condition of a licence that if— (a) a person is authorised by the licence to deal with a GMO; and (b) a particular condition of the licence applies to the dealing by the person, the person must allow the Regulator, or a person authorised by the Regulator, to enter premises where the dealing is being undertaken, for the purposes of auditing or monitoring the dealing. (2) Subsection (1) does not limit the conditions that may be imposed by the Regulator or prescribed by the regulations. 65—Condition about additional information to be given to the Regulator (1) It is a condition of a licence that the licence holder inform the Regulator if the licence holder— (a) becomes aware of additional information as to any risks to the health and safety of people, or to the environment, associated with the dealings authorised by the licence; or (b) becomes aware of any contraventions of the licence by a person covered by the licence; or (c) becomes aware of any unintended effects of the dealings authorised by the licence. (2) For the purposes of subsection (1)— (a) the licence holder is taken to have become aware of additional information of a kind mentioned in subsection (1) if the licence holder was reckless as to whether such information existed; and (b) the licence holder is taken to have become aware of contraventions, or unintended effects, of a kind mentioned in subsection (1) if the licence holder was reckless as to whether such contraventions had occurred, or such unintended effects existed. 66—Person may give information to Regulator A person covered by a licence may inform the Regulator if the person— (a) becomes aware of additional information as to any risks to the health and safety of people, or to the environment, associated with the dealings authorised by the licence; or (b) becomes aware of any contraventions of the licence by a person covered by the licence; or (c) becomes aware of any unintended effects of the dealings authorised by the licence. 67—Protection of persons who give information A person (the first person) does not incur any civil liability in respect of loss, damage or injury of any kind suffered by another person because the first person gave information to the Regulator under section 65, 66 or 72D(2)(h).