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Gene Technology Bill 2000

Part 2 Interpretation and operation of Act

Division 1 Simplified outline

9   Simplified outline

                   The following is a simplified outline of this Part:

This Part contains the definitions used in this Act.

This Part contains provisions to facilitate the conferral of functions and powers on the Regulator under State legislation, in order to facilitate a nationally consistent regulatory scheme.

This Part contains provisions to enable the concurrent operation of certain State legislation in relation to GMOs, and gives the capacity for this Act to have a more limited operation when corresponding State legislation is in force.

This Part also enables the Ministerial Council to issue policy principles, policy guidelines and codes of practice.



 

Division 2 Definitions

10   Definitions

             (1)  In this Act, unless the contrary intention appears:

Account means the Gene Technology Account established by section 129.

accredited organisation means an organisation accredited under Division 3 of Part 7.

aggravated offence has the meaning given by section 38.

Australian Health Ethics Committee means the Australian Health Ethics Committee established under the National Health and Medical Research Council Act 1992 .

Commonwealth authority means the following:

                     (a)  a body corporate established for a public purpose by or under an Act;

                     (b)  a company in which a controlling interest is held by any one of the following persons, or by 2 or more of the following persons together:

                              (i)  the Commonwealth;

                             (ii)  a body covered by paragraph (a);

                            (iii)  a body covered by either of the above subparagraphs.

confidential commercial information means information declared by the Regulator to be confidential commercial information under section 185.

Consultative Group means the Gene Technology Community Consultative Group established by section 106.

containment level , in relation to a facility, means the degree of physical confinement of GMOs provided by the facility, having regard to the design of the facility, the equipment located or installed in the facility and the procedures generally used within the facility.

corresponding State law has the meaning given by section 12.

deal with , in relation to a GMO, means the following:

                     (a)  conduct experiments with the GMO;

                     (b)  make, develop, produce or manufacture the GMO;

                     (c)  breed the GMO;

                     (d)  propagate the GMO;

                     (e)  use the GMO in the course of manufacture of a thing that is not the GMO;

                      (f)  grow, raise or culture the GMO;

                     (g)  import the GMO;

and includes the possession, supply, use, transport or disposal of the GMO for the purposes of, or in the course of, a dealing mentioned in any of paragraphs (a) to (g).

eligible person , in relation to a reviewable decision , has the meaning given by section 179.

environment includes:

                     (a)  ecosystems and their constituent parts; and

                     (b)  natural and physical resources; and

                     (c)  the qualities and characteristics of locations, places and areas.

Environment Minister means the Minister responsible for environment and conservation.

Ethics Committee means the Gene Technology Ethics Committee established by section 111.

evidential material means any of the following:

                     (a)  a thing with respect to which an offence against this Act or the regulations has been committed or is suspected, on reasonable grounds, to have been committed;

                     (b)  a thing that there are reasonable grounds for suspecting will afford evidence as to the commission of any such offence;

                     (c)  a thing that there are reasonable grounds for suspecting is intended to be used for the purpose of committing any such offence.

facility includes, but is not limited to, the following:

                     (a)  a building or part of a building;

                     (b)  a laboratory;

                     (c)  an aviary;

                     (d)  a glasshouse;

                     (e)  an insectary;

                      (f)  an animal house;

                     (g)  an aquarium or tank.

gene technology means any technique for the modification of genes or other genetic material, but does not include:

                     (a)  sexual reproduction; or

                     (b)  homologous recombination; or

                     (c)  any other technique specified in the regulations for the purposes of this paragraph.

Gene Technology Agreement means the Gene Technology Intergovernmental Agreement made between the Commonwealth, New South Wales, Victoria, Queensland, Western Australia, South Australia, Tasmania, the Australian Capital Territory and the Northern Territory, as in force from time to time.

Gene Technology Technical Advisory Committee means the Gene Technology Technical Advisory Committee established by section 100.

genetically modified organism means:

                     (a)  an organism that has been modified by gene technology; or

                     (b)  an organism that has inherited particular traits from an organism (the initial organism ), being traits that occurred in the initial organism because of gene technology; or

                     (c)  anything declared by the regulations to be a genetically modified organism, or that belongs to a class of things declared by the regulations to be genetically modified organisms;

but does not include:

                     (d)  a human being, if the human being is covered by paragraph (a) only because the human being has undergone somatic cell gene therapy; or

                     (e)  an organism declared by the regulations not to be a genetically modified organism, or that belongs to a class of organisms declared by the regulations not to be genetically modified organisms.

GMO means a genetically modified organism.

GMO licence means a licence issued under section 55.

GMO Register means the GMO Register established by section 76.

GM product means a thing (other than a GMO) derived or produced from a GMO.

higher education institution means an institution within the meaning of section 4 of the Higher Education Funding Act 1988 , but does not include the Australian National University.

Institutional Biosafety Committee means a committee established by an accredited organisation as an Institutional Biosafety Committee.

jurisdiction means the following:

                     (a)  the Commonwealth;

                     (b)  a State.

licence holder means the holder of a GMO licence.

Ministerial Council means the Ministerial Council within the meaning of the Gene Technology Agreement.

notifiable low risk dealing has the meaning given by section 74.

officer , in relation to the Commonwealth, includes the following:

                     (a)  a Minister;

                     (b)  a person who holds:

                              (i)  an office established by or under an Act; or

                             (ii)  an appointment made under an Act; or

                            (iii)  an appointment made by the Governor-General or a Minister but not under an Act;

                     (c)  a person who is a member or officer of a Commonwealth authority;

                     (d)  a person who is in the service or employment of the Commonwealth or of a Commonwealth authority, or is employed or engaged under an Act.

organism means any biological entity that is:

                     (a)  viable; or

                     (b)  capable of reproduction; or

                     (c)  capable of transferring genetic material.

person covered by a GMO licence means a person authorised by a GMO licence to deal with a GMO.

premises includes the following:

                     (a)  a building;

                     (b)  a place (including an area of land);

                     (c)  a vehicle;

                     (d)  a vessel;

                     (e)  an aircraft;

                      (f)  a facility;

                     (g)  any part of premises (including premises referred to in paragraphs (a) to (f)).

Record means the Record of GMO and GM Product Dealings mentioned in section 138.

Regulator means the Gene Technology Regulator appointed under section 118.

reviewable decision has the meaning given by section 179.

State includes the Australian Capital Territory and the Northern Territory.

State agency means the following:

                     (a)  the Crown in right of a State;

                     (b)  a Minister of a State;

                     (c)  a State Government Department;

                     (d)  an instrumentality of a State, including a body corporate established for a public purpose by or under a law of a State;

                     (e)  a company in which a controlling interest is held by any one of the following persons, or by 2 or more of the following persons together:

                              (i)  the Crown in right of a State;

                             (ii)  a person or body covered by paragraph (b) or (d);

                            (iii)  a person or body covered by either of the above subparagraphs.

thing includes a substance, and a thing in electronic or magnetic form.

             (2)  If this Act requires or permits the Ministerial Council to do a thing, the Ministerial Council must do the thing in accordance with any requirements specified in the Gene Technology Agreement.

11   Meaning of intentional release of a GMO into the environment

                   For the purposes of this Act, a dealing with a GMO involves the intentional release of the GMO into the environment if the GMO is intentionally released into the open environment, whether or not it is released with provision for limiting the dissemination or persistence of the GMO or its genetic material in the environment.

12   Meaning of corresponding State law

             (1)  For the purposes of this Act, corresponding State law means a State law that is declared by the Minister, by notice in the Gazette , to correspond to this Act and the regulations, including such a law as amended from time to time.

             (2)  The Minister may revoke a Gazette notice under subsection (1) in relation to a State law only if:

                     (a)  the Minister is requested by the State concerned to revoke the notice; or

                     (b)  the State law has been amended otherwise than as agreed by a majority of the members of the Ministerial Council (being a majority that includes the Commonwealth) under the Gene Technology Agreement; or

                     (c)  amendments of the State law have been agreed by a majority of the members of the Ministerial Council (being a majority that includes the Commonwealth) under the Gene Technology Agreement, and the State law has not been amended in accordance with that agreement within a reasonable period after the agreement.



 

Division 3 Operation of Act

13   Operation of Act

             (1)  This Act applies as follows:

                     (a)  to things done, or omitted to be done, by constitutional corporations;

                     (b)  to things done, or omitted to be done, in the course of constitutional trade or commerce;

                     (c)  to things done, or omitted to be done, by a person that may cause the spread of diseases or pests;

                     (d)  for purposes relating to the collection, compilation, analysis and dissemination of statistics;

                     (e)  to the Commonwealth and Commonwealth authorities;

                      (f)  to things authorised by the legislative power of the Commonwealth under paragraph 51(xxxix) of the Constitution, so far as it relates to the matters mentioned in paragraphs (a) to (e) of this subsection.

             (2)  In this section:

constitutional corporation means a trading, foreign or financial corporation within the meaning of paragraph 51(xx) of the Constitution.

constitutional trade or commerce means trade or commerce:

                     (a)  between Australia and places outside Australia; or

                     (b)  among the States; or

                     (c)  by way of the supply of services to the Commonwealth or to a Commonwealth authority.

14   Wind-back of reach of Act

             (1)  This section applies to a State (the notifying State ) at a particular time if:

                     (a)  a corresponding State law is in force in the notifying State at that time; and

                     (b)  a wind-back notice in relation to that State is in force at that time.

             (2)  This Act applies as a law of the Commonwealth in the notifying State with the following modifications:

                     (a)  this Act applies as if paragraph 13(1)(c) (which deals with the spread of pests and diseases) had not been enacted;

                     (b)  this Act does not apply to a dealing with a GMO undertaken:

                              (i)  by a higher education institution or a State agency; or

                             (ii)  by a person authorised to undertake the dealing by a licence held under the corresponding State law by a higher education institution or a State agency.

             (3)  In this section:

wind-back notice , in relation to a State, means a notice given by the State to the Minister, under the Gene Technology Agreement, stating that this section is to apply to the State.

15   Relationship to other Commonwealth laws

                   The provisions of this Act are in addition to, and not in substitution for, the requirements of any other law of the Commonwealth (whether passed or made before or after the commencement of this section).



 

Division 4 Provisions to facilitate a nationally consistent scheme

Subdivision A General provisions

16   State laws may operate concurrently

             (1)  This Act is not intended to exclude the operation of any State law, to the extent that the State law is capable of operating concurrently with this Act, other than a State law prescribed by the regulations for the purposes of this section.

             (2)  The Governor-General may prescribe a State law under subsection (1) only if:

                     (a)  there is no corresponding State law in effect in relation to that State; and

                     (b)  either:

                              (i)  the State law relates specifically to dealings with GMOs; or

                             (ii)  for the purposes of a decision under the State law as to whether or not a licence, authority or approval (however described) is granted under the State law, the State law distinguishes between dealings with GMOs and dealings with other things.

17   Conferral of functions on Commonwealth officers and bodies

             (1)  A corresponding State law may confer functions, powers and duties on the following:

                     (a)  the Regulator or another officer of the Commonwealth;

                     (b)  a Commonwealth authority;

                     (c)  the Consultative Group;

                     (d)  the Ethics Committee;

                     (e)  the Gene Technology Technical Advisory Committee.

             (2)  If a function, power or duty is conferred on a person or body under subsection (1), the person or body may perform the function or duty or exercise the power, as the case requires.

             (3)  If a corresponding State law is expressed to confer on the Regulator the power to determine that dealings be included on the GMO Register, the Regulator may include the dealings on the GMO Register in accordance with the corresponding State law.

             (4)  If a corresponding State law is expressed to confer on the Regulator the power to vary the GMO Register, the Regulator may vary the GMO Register in accordance with the corresponding State law.

             (5)  If a corresponding State law is expressed to confer on the Regulator the power to enter information on the Record of GMO and GM Product Dealings, the Regulator may enter the information on the Record in accordance with the corresponding State law.

             (6)  The Regulator may:

                     (a)  make any notations in the GMO Register that the Regulator considers necessary to identify entries that relate to dealings included on the Register as mentioned in subsection (3) or (4); and

                     (b)  make any notations in the Record of GMO and GM Product Dealings that the Regulator considers necessary to identify entries that relate to information entered on the Record as mentioned in subsection (5).

18   No doubling-up of liabilities

             (1)  If:

                     (a)  an act or omission is an offence against this Act and is also an offence against a corresponding State law; and

                     (b)  the offender has been punished for the offence under the corresponding State law;

the offender is not liable to be punished for the offence under this Act.

             (2)  If a person has been ordered to pay a pecuniary penalty under a corresponding State law, the person is not liable to a pecuniary penalty under this Act in respect of the same conduct.

19   Review of certain decisions

             (1)  Application may be made to the Administrative Appeals Tribunal for review of a reviewable State decision.

             (2)  A decision made by the Regulator in the performance of a function or the exercise of a power conferred by a corresponding State law is a reviewable State decision for the purposes of this section if:

                     (a)  the law under which the decision was made provides for review by the Administrative Appeals Tribunal; and

                     (b)  the decision is declared by the regulations to be a reviewable State decision for the purposes of this section.

             (3)  For the purposes of this section, the Administrative Appeals Tribunal Act 1975 has effect as if a corresponding State law were an enactment.

20   Things done for multiple purposes

                   The validity of a licence, certificate or other thing issued, given or done for the purposes of this Act is not affected only because it was issued, given or done also for the purposes of a corresponding State law.

Subdivision B Policy principles, policy guidelines and codes of practice

21   Ministerial Council may issue policy principles

             (1)  The Ministerial Council may issue policy principles in relation to the following:

                     (a)  ethical issues relating to dealings with GMOs;

                     (b)  matters relating to dealings with GMOs prescribed by the regulations for the purposes of this paragraph.

Note 1:       Section 57 provides that the Regulator must not issue a licence if to do so would be inconsistent with a policy principle.

Note 2:       Subsection 33(3) of the Acts Interpretation Act 1901 confers power to revoke or amend an instrument issued under an Act.

             (2)  Before issuing a policy principle, the Ministerial Council must be satisfied that the policy principle was developed in accordance with section 22.

             (3)  Regulations for the purposes of paragraph (1)(b) may relate to matters other than the health and safety of people or the environment, but must not derogate from the health and safety of people or the environment.

             (4)  Policy principles are disallowable instruments for the purposes of section 46A of the Acts Interpretation Act 1901 .

22   Consultation on policy principles

             (1)  Policy principles are to be developed in consultation with the following:

                     (a)  the Gene Technology Technical Advisory Committee;

                     (b)  the Regulator;

                     (c)  the Consultative Group;

                     (d)  the Ethics Committee;

                     (e)  such Commonwealth and State agencies and such regulatory agencies as the Ministerial Council considers appropriate;

                      (f)  such industry groups as the Ministerial Council considers appropriate;

                     (g)  such environmental, consumer and other groups as the Ministerial Council considers appropriate.

             (2)  Consultation under subsection (1) must be in accordance with guidelines (if any) issued by the Ministerial Council for the purposes of this section.

23   Ministerial Council may issue policy guidelines

                   The Ministerial Council may issue policy guidelines in relation to matters relevant to the functions of the Regulator.

Note 1:       Section 56 requires the Regulator to have regard to policy guidelines when deciding an application for a GMO licence. Section 30 provides that the Regulator is not subject to direction in relation to individual decisions.

Note 2:       Subsection 33(3) of the Acts Interpretation Act 1901 confers power to revoke or amend an instrument issued under an Act.

24   Ministerial Council may issue codes of practice

             (1)  The Ministerial Council may issue codes of practice in relation to gene technology.

Note:          Subsection 33(3) of the Acts Interpretation Act 1901 confers power to revoke or amend an instrument issued under an Act.

             (2)  The Ministerial Council must not issue a code of practice unless the code of practice was developed by the Regulator in consultation with the following:

                     (a)  the Gene Technology Technical Advisory Committee;

                     (b)  the Consultative Group;

                     (c)  the Ethics Committee;

                     (d)  such Commonwealth and State agencies and such regulatory agencies as the Ministerial Council considers appropriate;

                     (e)  such industry groups as the Ministerial Council considers appropriate;

                      (f)  such environmental, consumer and other groups as the Ministerial Council considers appropriate.

             (3)  Codes of practice are disallowable instruments for the purposes of section 46A of the Acts Interpretation Act 1901 .