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Gene Technology Bill 2000

Part 12 Miscellaneous

Division 1 Simplified outline

178   Simplified outline

                   The following is a simplified outline of this Part:

This Part provides for miscellaneous matters, including the following:

               (a)     review of decisions;

               (b)     provisions relating to confidential commercial information;

               (c)     the making of regulations;

               (d)     transitional provisions;

               (e)     review of the operation of the Act.



 

Division 2 Review of decisions

179   Meaning of terms

                   The following table sets out:

                     (a)  decisions that are reviewable decisions ; and

                     (b)  each eligible person in relation to a reviewable decision:

 

Reviewable decisions and eligible persons

Item

Decision

Provision under which decision made

Eligible person in relation to decision

1

To refuse to issue a licence

section 55

the applicant for the licence

2

To impose a licence condition

section 55

the licence holder

3

To suspend or cancel a licence

section 68

the licence holder

4

To vary a licence

section 71

the licence holder

5

To refuse to certify a facility

section 84

the applicant for certification

6

To specify a condition of a certification

section 86

the holder of the certification

7

To vary a certification

section 87

the holder of the certification

8

To suspend or cancel a certification

section 88

the holder of the certification

9

To refuse to accredit an organisation

section 92

the applicant for accreditation

10

To specify a condition of an accreditation

section 94

the holder of the accreditation

11

To vary an accreditation

section 95

the holder of the accreditation

12

To suspend or cancel an accreditation

section 96

the holder of the accreditation

13

To refuse to declare information to be confidential commercial information

section 185

the person who made an application under section 184 in relation to the information

14

To revoke a declaration that information is confidential commercial information

section 186

the person who made an application under section 184 in relation to the information

180   Notification of decisions and review rights

             (1)  The Regulator must, as soon as practicable after making a reviewable decision, cause a notice in writing to be given to each eligible person in relation to the decision, containing:

                     (a)  the terms of the decision; and

                     (b)  the reasons for the decision; and

                     (c)  a statement setting out particulars of the person’s review rights.

             (2)  A failure to comply with the requirements of subsection (1) in relation to a decision does not affect the validity of the decision.

181   Internal review

             (1)  An eligible person in relation to a reviewable decision (other than a decision made by the Regulator personally) may apply in writing to the Regulator for review ( internal review ) of the decision.

             (2)  An application for internal review must be made within 30 days after the day on which the decision first came to the notice of the applicant, or within such period (if any) as the Regulator, either before or after the end of that period, allows.

             (3)  The Regulator must, on receiving an application, review the reviewable decision personally.

             (4)  The Regulator may:

                     (a)  make a decision affirming, varying or revoking the reviewable decision; and

                     (b)  if the Regulator revokes the decision, make such other decision as the Regulator thinks appropriate.

182  Deadlines for making reviewable decisions

                   If:

                     (a)  this Act provides for a person to apply to the Regulator to make a reviewable decision; and

                     (b)  a period is specified under this Act or the regulations for giving notice of the decision to the applicant; and

                     (c)  the Regulator has not notified the applicant of the Regulator’s decision within that period;

the Regulator is taken, for the purposes of this Act, to have made a decision to reject the application.

183   Review of decisions by Administrative Appeals Tribunal

             (1)  Subject to the Administrative Appeals Tribunal Act 1975 , an application may be made by an eligible person in relation to:

                     (a)  a reviewable decision made by the Regulator personally; or

                     (b)  a decision made by the Regulator under section 181 (which provides for internal review).

             (2)  In this section:

decision has the same meaning as in the Administrative Appeals Tribunal Act 1975 .

183A   Extended standing for judicial review

             (1)  This section extends (and does not limit) the meaning of the term person aggrieved in the Administrative Decisions (Judicial Review) Act 1977 for the purposes of the application of that Act in relation to:

                     (a)  a decision made under this Act or the regulations; or

                     (b)  a failure to make a decision under this Act or the regulations; or

                     (c)  conduct engaged in for the purpose of making a decision under this Act or the regulations.

             (2)  A State is taken to be a person aggrieved by the decision, failure or conduct.

             (3)  A term (except person aggrieved ) used in this section and in the Administrative Decisions (Judicial Review) Act 1977 has the same meaning in this section as it has in that Act.



 

Division 3 Confidential commercial information

184   Application for protection of confidential commercial information

             (1)  A person may apply to the Regulator for a declaration that specified information to which this Act relates is confidential commercial information for the purposes of this Act.

             (2)  An application under subsection (1) must be in writing in the form approved by the Regulator.

185   Regulator may declare that information is confidential commercial information

             (1)  Subject to subsection (2), if the person satisfies the Regulator that the information specified in the application is:

                     (a)  a trade secret; or

                     (b)  any other information that has a commercial or other value that would be, or could reasonably be expected to be, destroyed or diminished if the information were disclosed; or

                     (c)  other information that:

                              (i)  concerns the lawful commercial or financial affairs of a person, organisation or undertaking; and

                             (ii)  if it were disclosed, could unreasonably affect the person, organisation or undertaking;

the Regulator must declare that the information is confidential commercial information for the purposes of this Act.

             (2)  The Regulator may refuse to declare that the information is confidential commercial information if the Regulator is satisfied that the public interest in disclosure outweighs the prejudice that the disclosure would cause to any person.

          (2A)  The Regulator must refuse to declare that information is confidential commercial information if the information relates to one or more locations at which field trials involving GMOs are occurring, or are proposed to occur, unless the Regulator is satisfied that significant damage to the health and safety of people, the environment or property would be likely to occur if the locations were disclosed.

Note:          This means that, in general, information about sites where dealings with GMOs are occurring will be required to be disclosed under sections 54 and 138, unless the Regulator is satisfied that disclosure would involve significant risks to health and safety.

             (3)  The Regulator must give the applicant written notice of the Regulator’s decision about the application.

          (3A)  If:

                     (a)  the Regulator declares that particular information is confidential commercial information; and

                     (b)  the information relates to one or more locations at which field trials involving GMOs are occurring, or are proposed to occur;

the Regulator must make publicly available a statement of reasons for the making of the declaration, including, but not limited to:

                     (c)  the reasons why the Regulator was satisfied as mentioned in subsection (1); and

                     (d)  the reasons why the Regulator was not satisfied under subsection (2) that the public interest in disclosure of the information outweighed the prejudice that the disclosure would cause; and

                     (e)  the reasons why the Regulator was satisfied under subsection (2A) that significant damage to the health and safety of people, the environment or property would be likely to occur if the locations were disclosed.

             (4)  If the Regulator refuses an application under subsection 184(1) in relation to information, the information is to be treated as confidential commercial information until any review rights under section 181 or 183 in relation to the application are exhausted.

186   Revocation of declaration

             (1)  The Regulator may, by written notice given to the applicant, revoke a declaration under section 185 if the Regulator is satisfied:

                     (a)  that the information concerned no longer satisfies paragraph 185(1)(a), (b) or (c); or

                     (b)  that the public interest in disclosure of the information outweighs the prejudice that disclosure would cause to any person.

             (2)  A revocation by the Regulator under subsection (1) does not take effect until any review rights under section 181 or 183 in relation to the revocation are exhausted.

187   Confidential commercial information must not be disclosed

             (1)  A person who:

                     (a)  has confidential commercial information; and

                     (b)  has it only because of performing duties or functions under this Act or under a corresponding State law; and

                     (c)  knows that the information is confidential commercial information;

must not disclose the information except:

                     (d)  to any of the following in the course of carrying out duties or functions under this Act or under a corresponding State law:

                              (i)  the Commonwealth or a Commonwealth authority;

                             (ii)  a State agency;

                            (iii)  the Gene Technology Technical Advisory Committee; or

                     (e)  by order of a court; or

                      (f)  with the consent of the person who applied to have the information treated as confidential commercial information.

Maximum penalty:    Imprisonment for 2 years or 120 penalty units.

Note 1:       Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility.

Note 2:       Information to which subsection (1) applies is information to which section 38 of the Freedom of Information Act 1982 applies, because subsection (1) is listed in Schedule 3 to that Act.

             (2)  A person who:

                     (a)  has confidential commercial information; and

                     (b)  has it because of a disclosure under subsection (1) or under this subsection; and

                     (c)  knows that the information is confidential commercial information;

must not disclose the information except:

                     (d)  to any of the following in the course of carrying out duties or functions under this Act or under a corresponding State law:

                              (i)  the Commonwealth or a Commonwealth authority;

                             (ii)  a State agency;

                            (iii)  the Gene Technology Technical Advisory Committee; or

                     (e)  by order of a court; or

                      (f)  with the consent of the person who applied to have the information treated as confidential commercial information.

Maximum penalty:    Imprisonment for 2 years or 120 penalty units.

Note 1:       Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility.

Note 2:       Information to which subsection (2) applies is information to which section 38 of the Freedom of Information Act 1982 applies, because subsection (2) is listed in Schedule 3 to that Act.

             (3)  In this section:

court includes a tribunal, authority or person having power to require the production of documents or the answering of questions.

disclose , in relation to information, means give or communicate in any way.



 

Division 4 Conduct by directors, employees and agents

188   Conduct by directors, employees and agents

             (1)  If, in proceedings for an offence against this Act or the regulations, or an ancillary offence in relation to this Act or the regulations, it is necessary to establish the state of mind of a body corporate in relation to particular conduct, it is sufficient to show:

                     (a)  that the conduct was engaged in by a director, employee or agent of the body corporate within the scope of his or her actual or apparent authority; and

                     (b)  that the director, employee or agent had the state of mind.

             (2)  Any conduct engaged in on behalf of a body corporate by a director, employee or agent of the body corporate within the scope of his or her actual or apparent authority is taken, for the purposes of a prosecution for:

                     (a)  an offence against this Act or the regulations; or

                     (b)  an ancillary offence relating to this Act or the regulations;

to have been engaged in also by the body corporate, unless the body corporate establishes that the body corporate took reasonable precautions and exercised due diligence to avoid the conduct.

             (3)  If, in proceedings for an ancillary offence relating to this Act or the regulations, it is necessary to establish the state of mind of a person other than a body corporate in relation to particular conduct, it is sufficient to show:

                     (a)  that the conduct was engaged in by an employee or agent of the person within the scope of his or her actual or apparent authority; and

                     (b)  that the employee or agent had the state of mind.

             (4)  Any conduct engaged in on behalf of a person (the first person ), other than a body corporate, by an employee or agent of the first person, within the scope of the actual or apparent authority of the employee or agent is taken, for the purposes of a prosecution for:

                     (a)  an offence against this Act or the regulations; or

                     (b)  an ancillary offence relating to this Act or the regulations;

to have been engaged in also by the first person unless the first person establishes that he or she took reasonable precautions and exercised due diligence to avoid the conduct.

             (5)  If:

                     (a)  a person other than a body corporate is convicted of an offence; and

                     (b)  the person would not have been convicted of the offence if subsections (3) and (4) had not been enacted;

the person is not liable to be punished by imprisonment for that offence.

189   Meaning of terms

             (1)  A reference in subsection 188(1) or (3) to the state of mind of a person includes a reference to:

                     (a)  the knowledge, intention, opinion, belief or purpose of the person; and

                     (b)  the person’s reasons for the intention, opinion, belief or purpose.

             (2)  A reference in section 188 to a director of a body corporate includes a reference to a constituent member of a body corporate incorporated for a public purpose by a law of the Commonwealth or a State.

             (3)  A reference in section 188 to engaging in conduct includes a reference to failing or refusing to engage in conduct.

             (4)  A reference in section 188 to an ancillary offence relating to this Act or the regulations is a reference to an offence created by section 5, 6, 7 or 7A or subsection 86(1) of the Crimes Act 1914 that relates to this Act or the regulations.



 

Division 5 Transitional provisions

190   Transitional provision—dealings covered by Genetic Manipulation Advisory Committee advice to proceed

             (1)  The prohibitions in this Act apply to a dealing with a GMO by a person at a particular time during the transition period (the dealing time ) with the modifications set out in subsection (2), if:

                     (a)  immediately before the commencement of Part 4 of this Act, an advice to proceed was in force in relation to the dealing with the GMO by the person; and

                     (b)  the advice to proceed is in force at the dealing time; and

                     (c)  the dealing is in accordance with the advice to proceed.

             (2)  Unless the dealing is a notifiable low risk dealing, an exempt dealing or a dealing on the GMO Register:

                     (a)  the advice to proceed is taken for the purposes of this Act to be a GMO licence; and

                     (b)  the holder of the advice to proceed is taken to be the licence holder; and

                     (c)  the licence is taken to be subject to any conditions to which the advice to proceed is subject; and

                     (d)  the licence is taken to remain in force for the period ending at the earliest of the following times:

                              (i)  the time when the advice to proceed expires;

                             (ii)  the end of the transition period;

                            (iii)  when the licence is cancelled under section 68 or surrendered under section 69.

             (3)  In this section:

advice to proceed means an advice to proceed issued by the Genetic Manipulation Advisory Committee, in accordance with Guidelines issued by that Committee.

transition period means the period of 2 years beginning at the commencement of Part 4 of this Act.

191   Regulations may relate to transitional matters

                   Regulations may be made in relation to transitional matters arising from the enactment of this Act.



 

Division 6 Other

192   False or misleading information or document

                   A person must not:

                     (a)  in connection with an application made to the Regulator under this Act or the regulations; or

                     (b)  in compliance or purported compliance with this Act or the regulations;

do either of the following:

                     (c)  give information (whether orally or in writing) that the person knows to be false or misleading in a material particular;

                     (d)  produce a document that the person knows to be false or misleading in a material particular without:

                              (i)  indicating to the person to whom the document is produced that it is false or misleading, and the respect in which it is false or misleading; and

                             (ii)  providing correct information to that person, if the person producing the document is in possession of, or can reasonably acquire, the correct information.

Maximum penalty:    Imprisonment for 1 year or 60 penalty units.

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

192A  Interference with dealings with GMOs

             (1)  A person is guilty of an offence if:

                     (a)  the person engages in conduct; and

                     (b)  the conduct:

                              (i)  results in damage to, destruction of, or interference with, premises at which dealings with GMOs are being undertaken; or

                             (ii)  involves damaging, destroying, or interfering with, a thing at, or removing a thing from, such premises; and

                     (c)  the owner or occupier of the premises, or the owner of the thing (as the case requires), has not consented to the conduct; and

                     (d)  in engaging in the conduct, the person intends to prevent or hinder authorised GMO dealings that are being undertaken at the premises or facility; and

                     (e)  the person knows, or is reckless as to, the matters mentioned in paragraphs (b) and (c).

Maximum penalty:    Imprisonment for 2 years or 120 penalty units.

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

             (2)  In this section:

authorised GMO dealings , in relation to premises or a facility, means dealings with GMOs being undertaken at the premises or facility:

                     (a)  that are authorised to be undertaken at the premises or facility by a GMO licence; or

                     (b)  that are notifiable low risk dealings; or

                     (c)  that are exempt dealings; or

                     (d)  that are deregulated GMO dealings.

192B   Cloning of human beings is prohibited

             (1)  A person is guilty of an offence if:

                     (a)  the person engages in conduct; and

                     (b)  the person knows that, or is reckless as to whether, the conduct will result in the cloning of a whole human being.

Maximum penalty:    2,000 penalty units or imprisonment for 10 years.

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

             (2)  In this section:

cloning of a whole human being means the use of technology for the purpose of producing, from one original, a duplicate or descendant that is, or duplicates or descendants that are, genetically identical to the original.

192C   Certain experiments involving animal eggs prohibited

                   A person is guilty of an offence if:

                     (a)  the person engages in conduct; and

                     (b)  the person knows that, or is reckless as to whether, the conduct involves carrying out experiments or research that involves putting human cells, or a combination of human cells and animal cells, into animal eggs.

Maximum penalty:    2,000 penalty units or imprisonment for 10 years.

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

192D   Certain experiments involving putting human and animal cells into a human uterus prohibited

                   A person is guilty of an offence if:

                     (a)  the person engages in conduct; and

                     (b)  the person knows that, or is reckless as to whether, the conduct involves carrying out experiments or research that involves putting a combination of human cells and animal cells into a human uterus.

Maximum penalty:    2,000 penalty units or imprisonment for 10 years.

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

193   Regulations

             (1)  The Governor-General may make regulations prescribing matters:

                     (a)  required or permitted by this Act to be prescribed; or

                     (b)  necessary or convenient to be prescribed for carrying out or giving effect to this Act.

             (2)  Without limiting subsection (1), the regulations may require a person to comply with codes of practice or guidelines issued under this Act as in force at a particular time or from time to time.

194   Review of operation of Act

             (1)  The Ministerial Council must cause an independent review of the operation of this Act, including the structure of the Office of the Gene Technology Regulator, to be undertaken as soon as possible after the fourth anniversary of the commencement of this Act.

             (2)  A person who undertakes such a review must give the Ministerial Council a written report of the review.

             (3)  The Minister, on behalf of the Ministerial Council, must cause a copy of the report of the review to be tabled in each House of the Parliament within 12 months after the fourth anniversary of the commencement of this Act.

             (4)  In this section:

independent review means a review undertaken by persons who:

                     (a)  in the opinion of a majority of the Ministerial Council possess appropriate qualifications to undertake the review; and

                     (b)  include one or more persons who are not employed by the Commonwealth or a Commonwealth authority.