Part 5Licensing system

Part 5—Licensing system 39—Simplified outline (a) provides a licensing system under which a person can apply to the Regulator for a licence authorising dealings with GMOs; (b) sets out the processes to be followed by the Regulator in relation to applications involving two kinds of dealings— (i) those that involve the intentional release of a GMO into the environment; and (ii) those that do not involve the intentional release of a GMO into the environment; (c) provides that a licence can cover dealings by persons other than the licence holder and requires the licence holder to inform such persons of any conditions of the licence that apply to them. Division 2—Licence applications 40—Person may apply for a licence (1) A person may apply to the Regulator for a licence authorising specified dealings with one or more specified GMOs by a person or persons. (2) The application must be in writing, and must contain— (3) The application must specify whether any of the dealings proposed to be authorised by the licence would involve the intentional release of a GMO into the environment. (4) The dealings in respect of which a person may apply for a licence may be— (a) all dealings with a GMO, or with a specified class of GMOs; or (b) a specified class of dealings with a GMO, or with a specified class of GMOs; or (c) one or more specified dealings with a GMO, or with a specified class of GMOs. (5) The applicant may apply for a licence authorising such dealings by— (a) a specified person or persons; or (b) a specified class of person; or (c) all persons. (6) The application must be accompanied by the application fee (if any) prescribed by the regulations. 40A—Licences relating to inadvertent dealings (1) If the Regulator is satisfied that a person has come into possession of a GMO inadvertently, the Regulator may, with the agreement of the person, treat the person as having made an inadvertent dealings application. (2) To avoid doubt, subsection (1) does not prevent a person from making an application under section 40 in respect of a GMO that has inadvertently come into the person's possession. Sections 46A and 49 have the effect that the Regulator may expedite consideration of an application to dispose of a GMO that has come into a person's possession inadvertently. These sections have effect whether the application is made under section 40, or is taken to have been made under this section. 41—Application may be withdrawn (1) The applicant may withdraw the application at any time before the licence is issued. (2) The application fee is not refundable if the applicant withdraws the application. 42—Regulator may require applicant to give further information (1) The Regulator may, by notice in writing, require an applicant for a licence to give the Regulator such further information in relation to the application as the Regulator requires. (3) The Regulator may require information to be given under this section at any time before the Regulator decides the application, whether before or after the Regulator has begun to consider the application. 43—Regulator must consider applications except in certain circumstances (1) The Regulator must consider an application under this Division for a licence in accordance with this Part. (2) However, the Regulator is not required to consider the application, or may cease considering the application, if— (a) the application does not contain the information specified by the Regulator or prescribed by the regulations; or (b) the application does not satisfy section 40(3); or (c) the application is not accompanied by the application fee (if any) prescribed by the regulations; or (d) the applicant did not provide further information required by the Regulator by notice under section 42 within the period specified in the notice; or (e) the Regulator is satisfied that to issue the licence would be inconsistent with a policy principle in force under section 21; or (f) the Regulator is satisfied (having regard to the matters specified in section 58) that the applicant is not a suitable person to hold a licence. (3) The Regulator must issue the licence, or refuse to issue the licence, within the period (if any) prescribed by the regulations. 44—Regulator may consult with applicant Before considering an application in accordance with the requirements of this Part, the Regulator may consult the applicant, or another regulatory agency, on any aspect of the application. 45—Regulator must not use certain information in considering licence application If— (a) a person (the first person) applies for a GMO licence; and (b) the first person provides information to the Regulator for the purposes of the Regulator's consideration of the application; and (c) the information is confidential commercial information, the Regulator must not take that information into account for the purposes of considering an application by another person for a GMO licence, unless the first person has given written consent for the information to be so taken into account. Division 3—Initial consideration of licences for dealings not involving intentional release of a GMO into the environment 46—Applications to which this Division applies This Division applies to an application for a GMO licence if the Regulator is satisfied that none of the dealings proposed to be authorised by the licence would involve the intentional release of a GMO into the environment. 46A—Division does not apply to an application relating to inadvertent dealings Despite section 46, this Division does not apply to an application for a GMO licence if the Regulator is satisfied that— (a) the dealings proposed to be authorised by the licence are limited to 1 or more of the following for purposes relating to disposing of a GMO: (i) conducting experiments with the GMO; (ii) propagating the GMO; (iii) growing, raising or culturing the GMO; (iv) transporting the GMO; (v) any other dealings to be undertaken for the purposes of, or for purposes relating to, disposing of the GMO; and (b) the applicant for the licence came into possession of the GMO inadvertently. 47—What the Regulator must do in relation to application (1) Before issuing the licence, the Regulator must prepare a risk assessment and a risk management plan in relation to the dealings proposed to be authorised by the licence. (2) In preparing the risk assessment, the Regulator must take into account the risks posed by the dealings proposed to be authorised by the licence, including any risks to the health and safety of people or risks to the environment. (3) In preparing the risk management plan, the Regulator must take into account the means of managing any risks posed by the dealings proposed to be authorised by the licence in such a way as to protect— (4) The Regulator may consult— (c) relevant Commonwealth authorities or agencies; and (d) any local council that the Regulator considers appropriate; and (e) any other person the Regulator considers appropriate, on any aspect of the application. Division 4—Initial consideration of licences for dealings involving intentional release of a GMO into the environment 48—Applications to which this Division applies This Division applies to an application for a GMO licence if the Regulator is satisfied that at least one of the dealings proposed to be authorised by the licence would involve the intentional release of a GMO into the environment. 49—Division does not apply to an application relating to inadvertent dealings Despite section 48, this Division does not apply to an application for a GMO licence if the Regulator is satisfied that— (a) the dealings proposed to be authorised by the licence are limited to 1 or more of the following for purposes relating to disposing of a GMO: (i) conducting experiments with the GMO; (ii) propagating the GMO; (iii) growing, raising or culturing the GMO; (iv) transporting the GMO; (v) any other dealings to be undertaken for the purposes of, or for purposes relating to, disposing of the GMO; and (b) the applicant for the licence came into possession of the GMO inadvertently. 50—Regulator must prepare risk assessment and risk management plan (1) Before issuing the licence, the Regulator must prepare a risk assessment and a risk management plan in relation to the dealings proposed to be authorised by the licence. (3) Unless section 50A applies in relation to the application for the licence, the Regulator must seek advice on matters relevant to the preparation of the risk assessment and the risk management plan from— (c) each Commonwealth authority or agency prescribed by the regulations for the purposes of this paragraph; and (d) Environment Australia; and (e) any local council that the Regulator considers appropriate. 50A—Limited and controlled release applications (1) This section applies to an application for a licence if the Regulator is satisfied that— (a) the principal purpose of the application is to enable the licence holder, and persons covered by the licence, to conduct experiments; and (b) the application proposes, in relation to any GMO in respect of which dealings are proposed to be authorised— (i) controls to restrict the dissemination or persistence of the GMO and its genetic material in the environment; and (ii) limits on the proposed release of the GMO; and (c) the Regulator is satisfied that the controls and limits are of such a kind that it is appropriate for the Regulator not to seek the advice referred to in section 50(3). (2) For the purposes of subsection (1)— controls, in relation to restricting the dissemination or persistence of a GMO and its genetic material in the environment, include the following: (a) specified methods for disposal of the GMO or its genetic material; (b) data collection requirements, including studies to be conducted about the GMO or its genetic material; (c) a restricted geographic area in which the proposed dealings with the GMO or its genetic material may occur; (d) compliance, in relation to dealings with the GMO or its genetic material, with— (i) a code of practice issued under section 24; or (ii) a technical or procedural guideline issued under section 27. (3) For the purposes of subsection (1)— limits, in relation to the release of a GMO that is proposed to be authorised by a licence, includes limits on any of the following: (a) the scope of the dealings with the GMO; (b) the scale of the dealings with the GMO; (c) the locations of the dealings with the GMO; (d) the duration of the dealings with the GMO; (e) the persons who are to be permitted to conduct the dealings with the GMO. (4) In deciding whether the principal purpose of an application is to enable the licence holder, and persons covered by the licence, to conduct experiments, the Regulator— (a) must have regard to whether the applicant proposes that any or all of the following be authorised by, and done under, the licence: (i) testing hypotheses; (ii) gaining scientific or technical knowledge; (iii) gaining data for regulatory purposes, or for product development or marketing; and (b) may have regard to any other matter that the Regulator considers to be relevant. This section differs from section 50A of the Commonwealth Act. 51—Matters Regulator must take into account in preparing risk assessment and risk management plan (1) In preparing the risk assessment in relation to the dealings proposed to be authorised by the licence, the Regulator must take into account the following: (a) the risks posed by those dealings, including any risks to the health and safety of people or risks to the environment, having regard to the matters prescribed by the regulations; (c) any advice in relation to the risk assessment provided by a State or a local council in response to a request under section 50(3); (d) any advice in relation to the risk assessment provided by the Gene Technology Technical Advisory Committee in response to a request under section 50(3); (e) any advice in relation to the risk assessment provided by a Commonwealth authority or agency in response to a request under section 50(3); (f) any advice in relation to the risk assessment provided by Environment Australia in response to a request under section 50(3); (g) any other matter prescribed by the regulations for the purposes of this paragraph. (2) In preparing the risk management plan, the Regulator must take into account the following: (a) the means of managing any risks posed by those dealings in such a way as to protect— (i) the health and safety of people; and (ii) the environment; (c) any advice in relation to the risk management plan provided by a State or a local council in response to a request under section 50(3); (d) any advice in relation to the risk management plan provided by the Gene Technology Technical Advisory Committee in response to a request under section 50(3); (e) any advice in relation to the risk management plan provided by a Commonwealth authority or agency in response to a request under section 50(3); (f) any advice in relation to the risk management plan provided by Environment Australia in response to a request under section 50(3); (g) any other matter prescribed by the regulations for the purposes of this paragraph. (3) For the avoidance of doubt, in taking into account the means of managing risks as mentioned in subsection (2)(a), the Regulator— (a) is not limited to considering submissions or advice mentioned in subsection (2)(b), (c), (d), (e) and (f); and (b) subject to section 45, may take into account other information, including, but not limited to, relevant independent research. 52—Public notification of risk assessment and risk management plan (1) After taking the steps referred to in sections 50 and 51, the Regulator must publish a notice— (a) in the Gazette; and (b) in 1 or more newspapers that the Regulator considers appropriate, having regard to the geographic area in which the dealings proposed to be authorised by the licence may occur; and (c) on the Regulator's website. (2) The notice must— (a) state that a risk assessment and a risk management plan have been prepared in respect of dealings proposed to be authorised by the licence; and (b) state that a person may request further information about the risk assessment and the risk management plan under section 54; and (ba) if the Regulator is satisfied that 1 or more dealings proposed to be authorised by the licence may pose a significant risk to the health and safety of people or to the environment—state that the Regulator is so satisfied; and (c) invite written submissions in relation to the risk assessment and the risk management plan; and (d) specify the closing date for submissions, which must not be earlier than— (i) if the notice states that the Regulator is satisfied that the dealings proposed to be authorised by the licence may pose a significant risk to the health and safety of people or to the environment—50 days after the date on which the notice was published; or (ii) in any other case—30 days after the date on which the notice was published. (3) The Regulator must also seek advice on the risk assessment and the risk management plan from— (c) each Commonwealth authority or agency prescribed by the regulations for the purposes of this paragraph; and (d) Environment Australia; and (e) any local council that the Regulator considers appropriate. 53—Regulator may take other actions (1) In addition to satisfying the requirements of this Division in relation to an application for a licence to which this Division applies, the Regulator may take any other action the Regulator considers appropriate for the purpose of deciding the application, including holding a public hearing. (2) If the Regulator holds a public hearing, the Regulator may, having regard to the requirements of this Act in relation to confidential commercial information, direct that any part of the hearing be held in private, and may determine who can attend. (3) The Regulator may give directions prohibiting or restricting the publication of evidence given, or material contained in documents produced, at a public hearing. (4) A person must not contravene a direction given under subsection (3). Maximum penalty: $3 300. 54—Person may request copies of certain documents (1) A person may request that the Regulator provide the person with a copy of the following documents: (a) an application to which this Division applies; (b) a risk assessment or a risk management plan prepared under section 50. (2) If a person makes a request under subsection (1), the Regulator must provide to the person a copy of the documents, other than— (a) any confidential commercial information contained in the documents; and (b) any information contained in the documents about relevant convictions (within the meaning of section 58) of the applicant for the licence. In order for information to be confidential commercial information, it must be covered by a declaration under section 185.