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Gene Technology Bill 2000

Part 5 Licensing system

Division 1 Simplified outline

39   Simplified outline

                   The following is a simplified outline of this Part:

This Part provides a licensing system under which a person can apply to the Regulator for a licence authorising dealings with GMOs.

This Part sets out the processes to be followed by the Regulator in relation to applications involving 2 kinds of dealings:

               (a)     those that involve the intentional release of a GMO into the environment; and

              (b)     those that do not involve the intentional release of a GMO into the environment.

A licence can cover dealings by persons other than the licence holder. The licence holder is required 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:

                     (a)  such information as is prescribed by the regulations (if any); and

                     (b)  such information as is specified in writing by the Regulator.

             (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.

41   Application may be withdrawn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.

             (2)  The notice may specify the period within which the information is to be provided.

43   Regulator must consider applications except in certain circumstances

             (1)  The Regulator must consider an application under section 40 for a licence in accordance with this Part.

             (2)  However, the Regulator is not required to consider 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 subsection 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.

             (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.

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:

                     (a)  the health and safety of people; and

                     (b)  the environment.

             (4)  The Regulator may consult:

                     (a)  the States; and

                     (b)  the Gene Technology Technical Advisory Committee; and

                     (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   Dealings that may pose significant risks to the health and safety of people or the environment

             (1)  If the Regulator is satisfied that at least one of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment, the Regulator must publish a notice in respect of the application:

                     (a)  in the Gazette ; and

                     (b)  in a newspaper circulating generally in all States; and

                     (c)  on the Regulator’s website (if any).

             (2)  For the purpose of satisfying himself or herself as to whether the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment, the Regulator must have regard to the following:

                     (a)  the properties of the organism to which the dealings relate before it became, or will become, a GMO;

                     (b)  the effect, or the expected effect, of genetic modification that has occurred, or will occur, on the properties of the organism;

                     (c)  provisions for limiting the dissemination or persistence of the GMO or its genetic material in the environment;

                     (d)  the potential for spread or persistence of the GMO or its genetic material in the environment;

                     (e)  the extent or scale of the proposed dealings;

                      (f)  any likely impacts of the proposed dealings on the health and safety of people;

                     (g)  any other matter prescribed by the regulations for the purposes of this paragraph.

             (3)  The notice mentioned in subsection (1) must:

                     (a)  state that the application has been made; and

                     (b)  state that a person may request further information about the application under section 54; and

                     (c)  invite written submissions on whether the licence should be issued, being submissions about matters that the Regulator is required to take into account:

                              (i)  under paragraph 51(1)(a) in preparing a risk assessment in relation to the dealings proposed to be authorised by the licence; and

                             (ii)  under paragraph 51(2)(a) in preparing a risk management plan in relation to those dealings; and

                     (d)  specify the closing date for submissions, which must not be earlier than 30 days after the date on which the notice was published.

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.

             (2)  The Regulator must prepare a risk assessment and a risk management plan whether or not the Regulator was required to publish a notice in relation to the application under section 49.

             (3)  The Regulator must seek advice on matters relevant to the preparation of the risk assessment and the risk management plan from:

                     (a)  the States; and

                     (b)  the Gene Technology Technical Advisory Committee; and

                     (c)  each Commonwealth authority or agency prescribed by the regulations for the purposes of this paragraph; and

                     (d)  the Environment Minister; and

                     (e)  any local council that the Regulator considers appropriate.

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 mentioned in paragraphs 49(2)(a) to (f);

                     (b)  any submission made under paragraph 49(3)(c) in relation to such risks;

                     (c)  any advice in relation to the risk assessment provided by a State or a local council in response to a request under subsection 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 subsection 50(3);

                     (e)  any advice in relation to the risk assessment provided by a Commonwealth authority or agency in response to a request under subsection 50(3);

                      (f)  any advice in relation to the risk assessment provided by the Environment Minister in response to a request under subsection 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;

                     (b)  any submission made under paragraph 49(3)(c) in relation to the means of managing such risks;

                     (c)  any advice in relation to the risk management plan provided by a State or a local council in response to a request under subsection 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 subsection 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 subsection 50(3);

                      (f)  any advice in relation to the risk management plan provided by the Environment Minister in response to a request under subsection 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 paragraph (2)(a), the Regulator:

                     (a)  is not limited to considering submissions or advice mentioned in paragraphs (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 49 (if applicable), 50 and 51, the Regulator must publish a notice:

                     (a)  in the Gazette ; and

                     (b)  in a newspaper circulating generally in all States; and

                     (c)  on the Regulator’s website (if any).

             (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

                     (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 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:

                     (a)  the States; and

                     (b)  the Gene Technology Technical Advisory Committee; and

                     (c)  each Commonwealth authority or agency prescribed by the regulations for the purposes of this paragraph; and

                     (d)  the Environment Minister; 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: 30 penalty units.

Note:          Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility.

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.

Note 1:       In order for information to be confidential commercial information , it must be covered by a declaration under section 185.

Note 2:       The Privacy Act 1988 also contains provisions relevant to the disclosure of information.



 

Division 5 Decision on licence etc.

55   Regulator must make a decision on licence and licence conditions

                   After taking any steps required by Division 3 or 4 of this Part in relation to an application for a GMO licence, the Regulator:

                     (a)  must decide whether to issue or refuse to issue the licence; and

                     (b)  if the Regulator decides to issue the licence—may impose conditions to which the licence is subject.

56   Regulator must not issue the licence unless satisfied as to risk management

             (1)  The Regulator must not issue the licence unless the Regulator is satisfied that any risks posed by the dealings proposed to be authorised by the licence are able to be managed in such a way as to protect:

                     (a)  the health and safety of people; and

                     (b)  the environment.

             (2)  For the purposes of subsection (1), the Regulator must have regard to the following:

                     (a)  if a risk assessment has been prepared under section 50 in relation to those dealings—the risk assessment;

                     (b)  if a risk management plan has been prepared under section 50 in relation to those dealings—the risk management plan;

                     (c)  any submissions received under section 52 in relation to the licence;

                     (d)  any policy guidelines in force under section 23 that relate to:

                              (i)  risks that may be posed by the dealings proposed to be authorised by the licence; or

                             (ii)  ways of managing such risks so as to protect the health and safety of people or to protect the environment.

57   Other circumstances in which Regulator must not issue the licence

             (1)  The Regulator must not issue the licence if the Regulator is satisfied that issuing the licence would be inconsistent with a policy principle in force under section 21.

             (2)  The Regulator must not issue the licence unless the Regulator is satisfied that the applicant is a suitable person to hold the licence.

58   Matters to be taken into account in deciding whether a person is suitable to hold a licence

             (1)  Without limiting the matters to which the Regulator may have regard in deciding whether a natural person is a suitable person to hold a licence, the Regulator must have regard to:

                     (a)  any relevant conviction of the person; and

                     (b)  any revocation or suspension of a licence or permit (however described) held by the person under a law of the Commonwealth, a State or a foreign country, being a law relating to the health and safety of people or the environment; and

                     (c)  the capacity of the person to meet the conditions of the licence.

             (2)  Without limiting the matters to which the Regulator may have regard in deciding whether a body corporate is a suitable person to hold a licence, the Regulator must have regard to the following:

                     (a)  any relevant conviction of the body corporate; and

                     (b)  if there is a relevant conviction of the body corporate:

                              (i)  whether the offence concerned was committed at a time when any person who is presently a director of the body corporate was a director; and

                             (ii)  whether that offence was committed at a time when any officer or shareholder of the body corporate who is presently in a position to influence the management of the body corporate was such an officer or shareholder; and

                     (c)  any revocation or suspension of a licence or permit (however described) held by the body corporate under a law of the Commonwealth, a State or a foreign country, being a law relating to the health and safety of people or the environment; and

                     (d)  the capacity of the body corporate to meet the conditions of the licence.

             (3)  In this section:

relevant conviction means a conviction for an offence against a law of the Commonwealth, a State or a foreign country, being a law relating to the health and safety of people or the environment, if:

                     (a)  the offence was committed within the period of 10 years immediately before the making of the application for the licence; and

                     (b)  the offence was punishable on conviction by a fine of $5,000 or more, or by a term of imprisonment of one year or more.

             (4)  Nothing in this section affects the operation of Part VIIC of the Crimes Act 1914 (which includes provisions that, in certain circumstances, relieve persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them).

59   Notification of licence decision

                   The Regulator must notify the applicant in writing of the Regulator’s decision (including any conditions imposed by the Regulator, if applicable).

60   Period of licence

             (1)  A licence continues in force:

                     (a)  if the licence is expressed to be in force for a particular period—until the end of that period; or

                     (b)  otherwise—until it is cancelled or surrendered.

             (2)  A licence is not in force throughout any period of suspension.



 

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.

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 he or she:

                     (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 he or she 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 he or she 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 he or she:

                     (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 or 66.



 

Division 7 Suspension, cancellation and variation of licences

68   Suspension and cancellation of licence

                   The Regulator may, by notice in writing given to the holder of a GMO licence, suspend or cancel the licence if:

                     (a)  the Regulator believes on reasonable grounds that a condition of the licence has been breached, whether by the licence holder or by a person covered by the licence; or

                     (b)  the Regulator believes on reasonable grounds that the licence holder, or a person covered by the licence, has committed an offence against this Act or the regulations; or

                     (c)  any annual charge payable in respect of the licence remains unpaid after the due date; or

                     (d)  the licence was obtained improperly; or

                     (e)  the Regulator becomes aware of risks associated with the continuation of the dealings authorised by the licence, and is satisfied that the licence holder has not proposed, or is not in a position to implement, adequate measures to deal with those risks; or

                      (f)  the Regulator is satisfied that the licence holder is no longer a suitable person to hold the licence.

69   Surrender of licence

                   The licence holder may, with the consent of the Regulator, surrender the licence.

70   Transfer of licences

             (1)  The licence holder and another person (the transferee ) may jointly apply to the Regulator for the licence to be transferred from the licence holder to the transferee.

             (2)  The application must be in writing, and must contain:

                     (a)  such information as is prescribed by the regulations (if any); and

                     (b)  such information as is specified in writing by the Regulator.

             (3)  The Regulator must not transfer the licence unless the Regulator is satisfied that, if the licence is transferred, any risks posed by the dealings authorised by the licence will continue to be able to be managed in such a way as to protect:

                     (a)  the health and safety of people; and

                     (b)  the environment.

             (4)  The Regulator must not transfer the licence unless the Regulator is satisfied that the transferee is a suitable person to hold the licence.

             (5)  The Regulator must give written notice of his or her decision on the application to the licence holder and the transferee.

             (6)  If the Regulator decides to transfer the licence:

                     (a)  the transfer takes effect on the date specified in the notice; and

                     (b)  the licence continues in force as mentioned in section 60; and

                     (c)  the licence is subject to the same conditions as those in force immediately before the transfer.

71   Variation of licence

             (1)  The Regulator may, at any time, by notice in writing given to the licence holder, vary a licence.

             (2)  However, the Regulator must not vary a licence to authorise dealings involving the intentional release of a GMO into the environment if the application for the licence was originally considered under Division 3 of this Part.

Note:          Applications can only be considered under Division 3 if none of the dealings proposed to be authorised by the licence would involve the intentional release of a GMO into the environment.

             (3)  Without limiting subsection (1), the Regulator may:

                     (a)  impose licence conditions or additional licence conditions; or

                     (b)  remove or vary licence conditions that were imposed by the Regulator; or

                     (c)  extend or reduce the authority granted by the licence.

             (4)  However, the Regulator must not vary the licence unless the Regulator is satisfied that any risks posed by the dealings proposed to be authorised by the licence as varied are able to be managed in such a way as to protect:

                     (a)  the health and safety of people; and

                     (b)  the environment.

72   Regulator to notify of proposed suspension, cancellation or variation

             (1)  Before suspending, cancelling or varying a licence under this Division, the Regulator must give written notice of the proposed suspension, cancellation or variation to the licence holder.

             (2)  The notice:

                     (a)  must state that the Regulator proposes to suspend, cancel or vary the licence; and

                     (b)  may require the licence holder to give to the Regulator any information of a kind specified in the notice that is relevant to the proposed suspension, cancellation or variation; and

                     (c)  may invite the licence holder to make a written submission to the Regulator about the proposed suspension, cancellation or variation.

             (3)  The notice must specify a period within which the licence holder:

                     (a)  must give the information referred to in paragraph (2)(b); and

                     (b)  may make a submission under paragraph (2)(c).

The period must not end earlier than 30 days after the day on which the notice was given.

             (4)  In considering whether to suspend, cancel or vary a licence, the Regulator must have regard to any submission made under paragraph (2)(c).

             (5)  This section does not apply to a suspension, cancellation or variation requested by the licence holder.

             (6)  This section does not apply to a suspension, cancellation or variation of a licence if the Regulator considers that the suspension, cancellation or variation is necessary in order to avoid an imminent risk of death, serious illness, serious injury or serious damage to the environment.