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This is a Bill, not an Act. For current law, see the Acts databases.
1998-1999-2000
The Parliament
of the
Commonwealth of
Australia
HOUSE OF
REPRESENTATIVES
Presented and read a first
time
Gene
Technology Bill 2000
No. ,
2000
(Health and Aged
Care)
A Bill for an Act to regulate
activities involving gene technology, and for related
purposes
ISBN: 0642
436630
Contents
A Bill for an Act to regulate activities involving gene
technology, and for related purposes
The Parliament of Australia enacts:
This Act may be cited as the Gene Technology Act 2000.
(1) Sections 1 and 2 of this Act commence on the day on which this
Act receives the Royal Assent.
(2) Subject to subsection (3), the other provisions of this Act
commence on a day or days to be fixed by Proclamation.
(3) If a provision of this Act does not commence under subsection (2)
within 6 months after the day on which this Act receives the Royal Assent, it
commences on the first day after the end of that period.
The object of this Act is to protect the health and safety of people, and
to protect the environment, by identifying risks posed by or as a result of gene
technology, and by managing those risks through regulating certain dealings with
GMOs.
The object of this Act is to be achieved through a regulatory framework
which:
(a) provides an efficient and effective system for the application of gene
technologies; and
(b) operates in conjunction with other Commonwealth and State regulatory
schemes relevant to GMOs and GM products.
Note: Examples of the schemes mentioned in
paragraph (b) are those that regulate food, agricultural and veterinary
chemicals, industrial chemicals and therapeutic goods.
It is the intention of the Parliament that this Act form a component of a
nationally consistent scheme for the regulation of certain dealings with GMOs by
the Commonwealth and the States.
(1) This Act binds the Crown in each of its capacities.
(2) Nothing in this Act renders the Crown liable to be prosecuted for an
offence.
This Act extends to every external Territory other than Norfolk
Island.
(1) Chapter 2 of the Criminal Code applies to all offences
against this Act.
Note: Chapter 2 of the Criminal Code sets out
the general principles of criminal responsibility.
(2) If a maximum penalty is specified:
(a) at the foot of a section of this Act (other than a section that is
divided into subsections); or
(b) at the foot of a subsection of this Act;
then:
(c) a person who contravenes the section or subsection is guilty of an
offence punishable, on conviction, by a penalty not exceeding the specified
penalty; or
(d) the offence referred to in the section or subsection is punishable, on
conviction, by a penalty not exceeding the specified penalty.
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.
(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.
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.
(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.
(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.
(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.
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).
(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.
(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).
(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.
(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.
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.
(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.
(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.
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.
(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.
The following is a simplified outline of this Part:
This Part establishes the office of the Gene Technology Regulator (the
Regulator), and specifies the Regulator’s functions and
powers.
There is to be a Gene Technology Regulator.
The Regulator has the following functions:
(a) to perform functions in relation to GMO licences as set out in
Part 5;
(b) to develop draft policy principles and policy guidelines, as requested
by the Ministerial Council;
(c) to develop codes of practice;
(d) to issue technical and procedural guidelines in relation to
GMOs;
(e) to provide information and advice to other regulatory agencies about
GMOs and GM products;
(f) to provide information and advice to the public about the regulation
of GMOs;
(g) to provide advice to the Ministerial Council about:
(i) the operations of the Regulator and the Gene Technology Technical
Advisory Committee; and
(ii) the effectiveness of the legislative framework for the regulation of
GMOs, including in relation to possible amendments of relevant
legislation;
(h) to undertake or commission research in relation to risk assessment and
the biosafety of GMOs;
(i) to promote the harmonisation of risk assessments relating to GMOs and
GM products by regulatory agencies;
(j) to monitor international practice in relation to the regulation of
GMOs;
(k) to maintain links with international organisations that deal with the
regulation of gene technology and with agencies that regulate GMOs in countries
outside Australia;
(l) such other functions as are conferred on the Regulator by this Act,
the regulations or any other law.
Subject to this Act, the Regulator has power to do all things necessary
or convenient to be done for or in connection with the performance of the
Regulator’s functions.
(1) The Regulator may, by instrument in writing, delegate any of the
Regulator’s powers or functions to any of the following:
(a) an employee of the Department;
(b) an employee of another Department or of a Commonwealth authority, if
the functions of the other Department or Commonwealth authority relate, whether
directly or indirectly, to GMOs or GM products;
(c) an officer or employee of a State agency, if the functions of the
State agency relate, whether directly or indirectly, to GMOs or GM
products.
(2) In exercising powers or functions under a delegation, the delegate
must comply with any directions of the Regulator.
Subject to this Act and to other laws of the Commonwealth, the Regulator
has discretion in the performance or exercise of his or her functions or powers.
In particular, the Regulator is not subject to direction from anyone in relation
to:
(a) whether or not a particular application for a GMO licence is issued or
refused; or
(b) the conditions to which a particular GMO licence is
subject.
The following is a simplified outline of this Part:
This Part deals with the regulation of dealings with GMOs.
This Part prohibits dealings with GMOs unless:
(a) the person undertaking the dealing is authorised to do so by a GMO
licence; or
(b) the dealing is a notifiable low risk dealing (see Division 2 of
Part 6); or
(c) the dealing is an exempt dealing; or
(d) the dealing is included in the GMO Register (see Division 3 of
Part 6).
This Part imposes heavier penalties on unlawful dealings that cause, or are
likely to cause, significant damage to the health and safety of people or to the
environment.
(1) A person is guilty of an offence if:
(a) the person deals with a GMO, knowing that it is a GMO; and
(b) the person knows that the dealing with the GMO by the person is not
authorised by a GMO licence or is reckless as to whether or not the dealing is
so authorised; and
(c) the person knows that the dealing is not a notifiable low risk dealing
or is reckless as to whether or not the dealing is a notifiable low risk
dealing; and
(d) the person knows that the dealing is not an exempt dealing or is
reckless as to whether or not the dealing is an exempt dealing; and
(e) the person knows that the dealing is not included on the GMO Register
or is reckless as to whether or not the dealing is included on the GMO
Register.
Note: Chapter 2 of the Criminal Code sets out
the general principles of criminal responsibility.
(2) An offence under subsection (1) is punishable on conviction by a
fine of not more than whichever of the following amounts applies:
(a) in the case of an aggravated offence—2,000 penalty
units;
(b) in any other case—500 penalty units.
Note: Section 38 defines aggravated
offence.
(3) In this section:
exempt dealing means a dealing specified by the regulations
to be an exempt dealing.
(4) Regulations under subsection (3) may be expressed to
exempt:
(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.
(1) A person is guilty of an offence if:
(a) the person deals with a GMO, knowing that it is a GMO; and
(b) the dealing with the GMO by the person is not authorised by a GMO
licence; and
(c) the dealing is not a notifiable low risk dealing; and
(d) the dealing is not an exempt dealing; and
(e) the dealing is not included on the GMO Register.
Note: Chapter 2 of the Criminal Code sets out
the general principles of criminal responsibility.
(2) Strict liability applies to paragraphs (1)(b), (c), (d) and
(e).
Note: For strict liability, see
section 6.1 of the Criminal Code.
(3) An offence under this section is punishable on conviction by a fine of
not more than whichever of the following amounts applies:
(a) in the case of an aggravated offence—200 penalty
units;
(b) in any other case—50 penalty units.
Note: Section 38 defines aggravated
offence.
(4) In this section:
exempt dealing has the same meaning as in
section 32.
(1) The holder of a GMO licence is guilty of an offence if the
holder:
(a) intentionally takes an action or omits to take an action;
and
(b) knows that the action or omission contravenes the licence or is
reckless as to whether or not the action or omission contravenes the
licence.
Note: Chapter 2 of the Criminal Code sets out
the general principles of criminal responsibility.
(2) A person covered by a GMO licence is guilty of an offence
if:
(a) the person intentionally takes an action or omits to take an
action; and
(b) the person knows that the action or omission contravenes the licence
or is reckless as to whether or not the action or omission contravenes the
licence; and
(c) the person has knowledge of the conditions of the licence.
Note: Chapter 2 of the Criminal Code sets out
the general principles of criminal responsibility.
(3) An offence under this section is punishable on conviction by a fine of
not more than whichever of the following amounts applies:
(a) in the case of an aggravated offence—2,000 penalty
units;
(b) in any other case—500 penalty units.
Note: Section 38 defines aggravated
offence.
(1) The holder of a GMO licence is guilty of an offence if the
holder:
(a) takes an action or omits to take an action; and
(b) the action or omission contravenes the licence.
Note: Chapter 2 of the Criminal Code sets out
the general principles of criminal responsibility.
(2) A person covered by a GMO licence is guilty of an offence
if:
(a) the person takes an action or omits to take an action;
and
(b) the action or omission contravenes the licence; and
(c) the person has knowledge of the conditions of the licence.
Note: Chapter 2 of the Criminal Code sets out
the general principles of criminal responsibility.
(3) Strict liability applies to paragraphs (1)(a) and (b) and (2)(a)
and (b).
Note: For strict liability, see
section 6.1 of the Criminal Code.
(4) An offence under this section is punishable on conviction by a fine of
not more than whichever of the following amounts applies:
(a) in the case of an aggravated offence—200 penalty
units;
(b) in any other case—50 penalty units.
Note: Section 38 defines aggravated
offence.
(1) A person is guilty of an offence if the person:
(a) deals with a GMO, knowing that it is a GMO; and
(b) the dealing is on the GMO Register; and
(c) the dealing contravenes a condition relating to the dealing that is
specified in the GMO Register.
Maximum penalty: 50 penalty units.
Note: Chapter 2 of the Criminal Code sets out
the general principles of criminal responsibility.
(2) Strict liability applies to paragraphs (1)(b) and (c).
(1) A person is guilty of an offence if:
(a) the person deals with a GMO, knowing that it is a GMO; and
(b) the dealing is a notifiable low risk dealing; and
(c) the dealing by the person was not undertaken in accordance with the
regulations.
Maximum penalty: 50 penalty units.
Note 1: Notifiable low risk dealings are
specified in the regulations—see Part 6.
Note 2: Chapter 2 of the Criminal Code sets out
the general principles of criminal responsibility.
(2) Strict liability applies to paragraphs (1)(b) and (c).
(1) An offence is an aggravated offence if the commission of
the offence causes significant damage, or is likely to cause significant damage,
to the health and safety of people or to the environment.
(2) In order to prove an aggravated offence, the prosecution must prove
that the person who committed the offence:
(a) intended his or her conduct to cause significant damage to the health
and safety of people or to the environment; or
(b) was reckless as to whether that conduct would cause significant damage
to the health and safety of people or to the environment.
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.
(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.
(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.
(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.
(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.
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.
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.
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.
(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.
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.
(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.
(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.
(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.
(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.
(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.
(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.
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.
(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.
(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.
(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).
The Regulator must notify the applicant in writing of the
Regulator’s decision (including any conditions imposed by the Regulator,
if applicable).
(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.
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.
(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.
(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.
(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.
(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.
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.
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.
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.
The licence holder may, with the consent of the Regulator, surrender the
licence.
(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.
(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.
(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.
The following is a simplified outline of this Part:
Division 2 of this Part establishes a mechanism for the regulations to
regulate certain dealings with GMOs that do not involve the intentional release
of GMOs into the environment (notifiable low risk
dealings).
The regulations may (among other things) require that the Regulator be
notified of such dealings.
Division 3 of this Part establishes the GMO Register.
The Regulator may determine that certain dealings previously authorised by
a licence be included on the GMO Register.
If a dealing is included on the GMO Register, anyone may undertake the
dealing, subject to any specified conditions.
(1) The regulations may declare a dealing with a GMO to be a notifiable
low risk dealing for the purposes of this Act.
(2) Before the Governor-General makes regulations declaring a dealing with
a GMO to be a notifiable low risk dealing, the Regulator must be satisfied that
the dealing would not involve the intentional release of a GMO into the
environment.
(3) Before the Governor-General makes regulations declaring a dealing with
a GMO to be a notifiable low risk dealing, the Regulator must consider the
following matters:
(a) whether the GMO is biologically contained so that it is not able to
survive or reproduce without human intervention;
(b) whether the dealing with the GMO would involve minimal risk to the
health and safety of people and to the environment, taking into account the
properties of the GMO as a pathogen or pest and the toxicity of any proteins
produced by the GMO;
(c) whether no conditions, or minimal conditions, would be necessary to be
prescribed to manage any risk referred to in paragraph (b).
(4) Regulations under subsection (1) may be expressed to apply
to:
(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.
(1) The regulations may regulate:
(a) a specified notifiable low risk dealing; or
(b) a specified class of notifiable low risk dealings;
for the purpose of protecting the health and safety of people or the
environment.
(2) The regulations may prescribe different requirements to be complied
with in different situations or by different persons, including requirements in
relation to the following:
(a) the class of persons who may undertake notifiable low risk
dealings;
(b) notifying the Regulator of notifiable low risk dealings;
(c) supervision by Institutional Biosafety Committees of notifiable low
risk dealings;
(d) the containment level of facilities in which notifiable low risk
dealings may be undertaken.
(1) There is to be a Register known as the GMO Register.
(2) The GMO Register is to be maintained by the Regulator.
(3) The GMO Register may be kept in a computerised form.
If the Regulator determines under section 78 that a dealing with a
GMO is to be included on the GMO Register, the Regulator must specify in the GMO
Register:
(a) a description of the dealing with the GMO; and
(b) any condition to which the dealing is subject.
(1) If a dealing with a GMO is, or has been, authorised by a GMO licence,
the Regulator may, by writing, determine that the dealing with the GMO is to be
included on the GMO Register.
(2) A determination under subsection (1) may be made:
(a) on application by the holder of a licence that authorises the dealing;
or
(b) on the initiative of the Regulator.
(3) A determination under subsection (1) comes into effect on the day
specified in the determination. If the determination was made on application by
the holder of a GMO licence that authorises the dealing, the day must not be
before the licence ceases to be in force.
(4) A determination under subsection (1) is a disallowable instrument
for the purposes of section 46A of the Acts Interpretation Act
1901.
(1) The Regulator must not make a determination under subsection 78(1) in
respect of a dealing with a GMO unless the Regulator is satisfied:
(a) that any risks posed by the dealing are minimal; and
(b) that it is not necessary for persons undertaking the dealing to hold,
or be covered by a GMO licence, in order to protect the health and safety of
people or to protect the environment.
(2) For the purposes of subsection (1), the Regulator must have
regard to the following:
(a) any data available to the Regulator about adverse effects posed by the
dealing;
(b) any other information as to risks associated with the dealing of which
the Regulator is aware, including information provided to the Regulator by a
licence holder under section 65 or by another person under
section 66;
(c) whether there is a need for the dealing to be subject to
conditions;
(d) any other information in relation to whether the dealing should be
authorised by a GMO licence.
(3) The Regulator may have regard to such other matters as the Regulator
considers relevant.
(1) The Regulator may vary the GMO Register by written
determination.
(2) A variation may:
(a) remove a dealing from the GMO Register; or
(b) revoke or vary conditions to which a dealing on the GMO Register is
subject; or
(c) impose additional conditions to which a dealing on the GMO Register is
subject.
(3) A determination under subsection (1) is a disallowable instrument
for the purposes of section 46A of the Acts Interpretation Act
1901.
The Regulator must permit any person to inspect any part of the GMO
Register.
The following is a simplified outline of this Part:
Division 2 of this Part establishes a system under which the Regulator
may certify facilities to specified containment levels in accordance with
guidelines issued by the Regulator. Licence conditions can require that
facilities be certified to specified containment levels.
Division 3 of this Part enables the Regulator to accredit
organisations in accordance with accreditation guidelines issued by the
Regulator. Licence conditions can specify that dealings must be supervised by an
Institutional Biosafety Committee established by an accredited
organisation.
(1) A person may apply to the Regulator for certification of a facility to
a particular containment level under this Division.
(2) The application must be in writing, and must contain such information
as the Regulator requires.
Note: The conditions of a licence may require that a
facility be certified under this Division.
(3) The application must be accompanied by the application fee (if any)
prescribed by the regulations.
The Regulator may, by written instrument, certify the facility to a
specified containment level if the facility meets the containment requirements
specified in guidelines issued by the Regulator under section 90.
(1) The Regulator may, by notice in writing, require an applicant for
certification of a facility 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.
The certification of a facility is subject to the following
conditions:
(a) any conditions imposed by the Regulator at the time of
certification;
(b) any conditions imposed by the Regulator under section 87 after
certification;
(c) any conditions prescribed by the regulations.
(1) The Regulator may, at any time, by notice in writing given to the
holder of the certification, vary the certification of a facility.
(2) Without limiting subsection (1), the Regulator may:
(a) impose additional conditions; or
(b) remove or vary conditions that were imposed by the
Regulator.
The Regulator may, by notice in writing, suspend or cancel the
certification of a facility if the Regulator believes on reasonable grounds that
a condition of the certification has been breached.
(1) Before suspending, cancelling or varying a certification under this
Division, the Regulator must give written notice of the proposed suspension,
cancellation or variation to the holder of the certification.
(2) The notice:
(a) must state that the Regulator proposes to suspend, cancel or vary the
certification; and
(b) may require the holder of the certification 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 holder of the certification 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 holder of the
certification:
(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 certification, 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 holder of the certification.
(6) This section does not apply to a suspension, cancellation or variation
of a certification 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.
(1) The Regulator may, by written instrument, issue technical or
procedural guidelines about the requirements for the certification of facilities
to specified containment levels.
(2) The Regulator may, by written instrument, vary or revoke the
guidelines.
(1) A person may apply to the Regulator for accreditation of an
organisation as an accredited organisation under this Division.
Note: The conditions of a licence may require supervision of
dealings by an Institutional Biosafety Committee established by an accredited
organisation (see paragraph 62(2)(m)), and the regulations may require such
supervision of notifiable low risk dealings (see paragraph
75(2)(c)).
(2) The application must be in writing, and must contain such information
as the Regulator requires.
(1) The Regulator may, by written instrument, accredit an organisation as
an accredited organisation.
(2) In deciding whether to accredit an organisation, the Regulator must
have regard to:
(a) whether the organisation has established, or proposes to establish, an
Institutional Biosafety Committee in accordance with written guidelines issued
by the Regulator under section 98; and
(b) whether the organisation will be able to maintain an Institutional
Biosafety Committee in accordance with such guidelines; and
(c) whether the organisation has, or will have, appropriate indemnity
arrangements for its Institutional Biosafety Committee members; and
(d) any other matters specified in such guidelines.
(1) The Regulator may, by notice in writing, require an applicant for
accreditation of an organisation 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.
The accreditation of an accredited organisation is subject to the
following conditions:
(a) any conditions imposed by the Regulator at the time of
accreditation;
(b) any conditions imposed by the Regulator under section 95 after
accreditation;
(c) any conditions prescribed by the regulations.
(1) The Regulator may, at any time, by notice in writing given to an
accredited organisation, vary the organisation’s accreditation.
(2) Without limiting subsection (1), the Regulator may:
(a) impose additional conditions; or
(b) remove or vary conditions that were imposed by the
Regulator.
The Regulator may, by notice in writing, suspend or cancel the
accreditation of an organisation if the Regulator believes on reasonable grounds
that a condition of the accreditation has been breached.
(1) Before suspending, cancelling or varying an accreditation under this
Division, the Regulator must give written notice of the proposed suspension,
cancellation or variation to the holder of the accreditation.
(2) The notice:
(a) must state that the Regulator proposes to suspend, cancel or vary the
accreditation; and
(b) may require the holder of the accreditation 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 holder of the accreditation 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 holder of the
accreditation:
(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 an accreditation,
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 holder of the accreditation.
(6) This section does not apply to a suspension, cancellation or variation
of an accreditation 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.
(1) The Regulator may, by written instrument, issue technical or
procedural guidelines in relation to requirements that must be met in order for
an organisation to be accredited under this Division.
(2) The guidelines may relate to, but are not limited to, matters
concerning the establishment and maintenance of Institutional Biosafety
Committees.
(3) The Regulator may, by written instrument, vary or revoke the
guidelines.
The following is a simplified outline of this Part:
This Part provides for the establishment of the Gene Technology Technical
Advisory Committee, the Gene Technology Community Consultative Group and the
Gene Technology Ethics Committee.
The Part sets out the membership of these bodies, and their
functions.
(1) The Gene Technology Technical Advisory Committee is
established.
(2) The Minister is to appoint up to 20 members of the Committee, and must
appoint one of the members to chair the Committee.
(3) The members hold office on a part-time basis.
(4) Before appointing a member of the Committee, the Minister must consult
the following:
(a) the States;
(b) the Regulator;
(c) such scientific, consumer, health, environmental and industry groups
as the Minister considers appropriate;
(d) such other Ministers as the Minister considers appropriate.
(5) Subject to subsection (6), the Minister must not appoint a person
as a member of the Committee unless the Minister is satisfied that the person
has skills or experience in one or more of the following areas:
(a) molecular biology;
(b) ecology;
(c) plant, microbial, animal or human genetics;
(d) virology;
(e) entomology;
(f) agricultural or aquacultural systems;
(g) biosafety engineering;
(h) public health;
(i) occupational health and safety;
(j) risk assessment;
(k) clinical medicine;
(l) biochemistry;
(m) pharmacology;
(n) plant or animal pathology;
(o) botany;
(p) microbiology;
(q) animal biology;
(r) immunology;
(s) toxicology;
(t) an area specified by the regulations for the purposes of this
paragraph.
(6) The Minister must appoint a layperson as a member of the Committee.
The Minister is not required to be satisfied that the person has skills or
experience in an area mentioned in subsection (5).
(7) In appointing the members of the Committee, the Minister must ensure,
as far as practicable, that among the members as a whole there is a broad range
of skills and experience in the areas mentioned in
subsection (5).
(8) The Minister must not appoint a member to chair the Committee unless a
majority of jurisdictions agree to the appointment.
The function of the Gene Technology Technical Advisory Committee is to
provide scientific and technical advice, on the request of the Regulator or the
Ministerial Council, on the following:
(a) gene technology, GMOs and GM products;
(b) applications made under this Act;
(c) the biosafety aspects of gene technology;
(d) the need for policy principles, policy guidelines, codes of practice
and technical and procedural guidelines in relation to GMOs and GM products, and
the content of such principles, guidelines and codes.
(1) The Minister may appoint one or more persons (expert
advisers) to give expert advice to the Gene Technology Technical
Advisory Committee to assist it in the performance of its functions. Expert
advisers may be appointed on a continuing or an ad hoc basis.
(2) For the avoidance of doubt, expert advisers are not Committee
members.
(1) A person who is a member of the Gene Technology Technical Advisory
Committee or an expert adviser is to be paid the remuneration that is determined
by the Remuneration Tribunal. If no determination of that remuneration by the
Tribunal is in operation, the member is to be paid the remuneration that is
prescribed by the regulations.
(2) A person who is a member of the Gene Technology Technical Advisory
Committee or an expert adviser is to be paid the allowances that are prescribed
by the regulations.
(3) This section has effect subject to the Remuneration Tribunal Act
1973.
(1) The regulations may prescribe matters relating to the members of the
Gene Technology Technical Advisory Committee and expert advisers, including, but
not limited to, the following:
(a) term of appointment;
(b) resignation;
(c) disclosure of interests;
(d) termination of appointment;
(e) leave of absence.
(2) The regulations may prescribe matters relating to the operation of the
Gene Technology Technical Advisory Committee, including, but not limited
to:
(a) procedures for convening meetings of the Committee; and
(b) the constitution of a quorum for a meeting of the Committee;
and
(c) the way in which matters are to be resolved by the Committee;
and
(d) Committee records; and
(e) reporting requirements, including, but not limited to, reports to the
Regulator and to the public.
(3) If no regulations are in force under subsection (2), the
Committee must operate in the way determined by the Regulator in
writing.
(4) If no regulations are in force under subsection (2) and no
determination is in force under subsection (3), the Committee may operate
in the way it determines.
(1) The Gene Technology Technical Advisory Committee may, with the
Regulator’s consent, establish subcommittees to assist in the performance
of its functions.
(2) The regulations may prescribe matters relating to the constitution and
operation of subcommittees.
The Gene Technology Community Consultative Group (the Consultative
Group) is established.
The function of the Consultative Group is to provide advice, on the
request of the Regulator or the Ministerial Council, on the following:
(a) matters of general concern in relation to GMOs;
(b) the need for policy principles, policy guidelines, codes of practice
and technical and procedural guidelines in relation to GMOs and GM products and
the content of such principles, guidelines and codes.
(1) The Minister is to appoint up to 12 members of the Consultative Group,
and must appoint one of the members to chair the Consultative Group.
(2) Before appointing a member of the Consultative Group, the Minister
must consult the following:
(a) the States;
(b) the Regulator;
(c) such scientific, consumer, health, environmental and industry groups
as the Minister considers appropriate;
(d) such other Ministers as the Minister considers appropriate.
(3) The Minister must not appoint a person as a member of the Consultative
Group (other than as a member mentioned in subsection (4)) unless the
Minister is satisfied that the person has skills or experience of relevance to
gene technology in relation to one or more of the following:
(a) environmental issues;
(b) consumer issues;
(c) the impact of gene technology on the community;
(d) issues relevant to the biotechnology industry;
(e) issues relevant to gene technology research;
(f) public health issues;
(g) issues relevant to primary production;
(h) issues relevant to local government;
(i) issues specified by the regulations for the purposes of this
paragraph.
(4) The Minister must ensure that the Consultative Group includes the
following members:
(a) a person who is a member of the Gene Technology Technical Advisory
Committee;
(b) a person who is a member of the Ethics Committee.
(5) The members of the Consultative Group hold office on a part-time
basis.
(6) The Minister must not appoint a member to chair the Consultative Group
unless a majority of jurisdictions agree to the appointment.
(1) A person who is a member of the Consultative Group is to be paid the
remuneration that is determined by the Remuneration Tribunal. If no
determination of that remuneration by the Tribunal is in operation, the member
is to be paid the remuneration that is prescribed by the regulations.
(2) A person who is a member of the Consultative Group is to be paid the
allowances that are prescribed by the regulations.
(3) This section has effect subject to the Remuneration Tribunal Act
1973.
(1) The regulations may prescribe matters relating to the members of the
Consultative Group, including, but not limited to, the following:
(a) term of appointment;
(b) resignation;
(c) disclosure of interests;
(d) termination of appointment;
(e) leave of absence.
(2) The regulations may prescribe matters relating to the operation of the
Consultative Group, including:
(a) procedures for convening meetings of the Consultative Group;
and
(b) the constitution of a quorum for a meeting of the Consultative Group;
and
(c) the way in which matters are to be resolved by the Consultative Group;
and
(d) Consultative Group records; and
(e) reporting requirements, including, but not limited to, reports to the
Regulator and to the public.
(3) If no regulations are in force under subsection (2), the
Consultative Group must operate in the way determined by the Regulator in
writing.
(4) If no regulations are in force under subsection (2) and no
determination is in force under subsection (3), the Consultative Group may
operate in the way it determines.
(1) The Gene Technology Ethics Committee (the Ethics
Committee) is established.
(2) The Minister is to appoint up to 12 members of the Ethics Committee,
and must appoint one of the members to chair the Committee.
(3) The members hold office on a part-time basis.
(4) Before appointing a member of the Ethics Committee, the Minister must
consult the following:
(a) the States;
(b) the Regulator;
(c) such scientific, consumer, health, environmental and industry groups
as the Minister considers appropriate;
(d) such other Ministers as the Minister considers appropriate.
(5) The Minister must not appoint a person as a member of the Ethics
Committee (other than as a member mentioned in subsection (6)) unless the
Minister is satisfied that the person has skills or experience in one or more of
the following areas:
(a) ethics and the environment;
(b) health ethics;
(c) applied ethics;
(d) law;
(e) religious practices;
(f) population health;
(g) agricultural practices;
(h) animal health and welfare;
(i) issues of concern to consumers in relation to gene
technology;
(j) environmental systems.
(6) The Minister must ensure that the Ethics Committee includes the
following members:
(a) a person who is a member of the Gene Technology Technical Advisory
Committee;
(b) a person who is a member of the Australian Health Ethics Committee and
who has expertise in medical research.
(7) The Minister must not appoint a member to chair the Ethics Committee
unless a majority of jurisdictions agree to the appointment.
The function of the Ethics Committee is to provide advice, on the request
of the Regulator or the Ministerial Council, on the following:
(a) ethical issues relating to gene technology;
(b) the need for, and content of, codes of practice in relation to ethics
in respect of conducting dealings with GMOs;
(c) the need for, and content of, policy principles in relation to
dealings with GMOs that should not be conducted for ethical reasons.
(1) The Minister may appoint one or more persons (expert
advisers) to give expert advice to the Ethics Committee to assist it in
the performance of its functions. Expert advisers may be appointed on a
continuing or an ad hoc basis.
(2) For the avoidance of doubt, expert advisers are not Committee
members.
(1) A person who is a member of the Ethics Committee or an expert adviser
is to be paid the remuneration that is determined by the Remuneration Tribunal.
If no determination of that remuneration by the Tribunal is in operation, the
member is to be paid the remuneration that is prescribed by the
regulations.
(2) A person who is a member of the Ethics Committee or an expert adviser
is to be paid the allowances that are prescribed by the regulations.
(3) This section has effect subject to the Remuneration Tribunal Act
1973.
(1) The regulations may prescribe matters relating to the members of the
Ethics Committee and expert advisers, including, but not limited to, the
following:
(a) term of appointment;
(b) resignation;
(c) disclosure of interests;
(d) termination of appointment;
(e) leave of absence.
(2) The regulations may prescribe matters relating to the operation of the
Ethics Committee, including, but not limited to:
(a) procedures for convening meetings of the Committee; and
(b) the constitution of a quorum for a meeting of the Committee;
and
(c) the way in which matters are to be resolved by the Committee;
and
(d) Committee records; and
(e) reporting requirements, including but not limited to reports to the
Regulator and to the public.
(3) If no regulations are in force under subsection (2), the Ethics
Committee must operate in the way determined by the Regulator in
writing.
(4) If no regulations are in force under subsection (2) and no
determination is in force under subsection (3), the Ethics Committee may
operate in the way it determines.
(1) The Ethics Committee may, with the Regulator’s consent,
establish subcommittees to assist in the performance of its functions.
(2) The regulations may prescribe matters relating to the constitution and
operation of subcommittees.
The following is a simplified outline of this Part:
This Part provides for various administrative matters.
Division 2 sets out matters relating to the appointment, conditions
and remuneration of the Regulator.
Division 3 provides for financial matters, including the establishment
of a Special Account, called the Gene Technology Account.
Division 4 provides for matters relating to staffing.
Division 5 sets out reporting requirements.
Division 6 requires the Regulator to maintain a record of GMOs and GM
products.
Division 7 permits the Regulator to review notifiable low risk
dealings and exemptions.
(1) The Regulator is to be appointed by the Governor-General by written
instrument.
(2) The Regulator holds office for the period specified in the instrument
of appointment. The period specified must not be less than 3 years or more than
5 years.
(3) The Regulator holds office on a full-time basis.
(4) The Governor-General must not appoint a person as the Regulator unless
a majority of jurisdictions agree to the appointment.
(1) The Governor-General may terminate the appointment of the Regulator
for misbehaviour or physical or mental incapacity.
(2) If the Regulator:
(a) becomes bankrupt, applies to take the benefit of any law for the
relief of bankrupt or insolvent debtors, compounds with his or her creditors or
makes an assignment of his or her remuneration for their benefit; or
(b) fails to comply with his or her obligations under section 120;
or
(c) without the consent of the Minister, engages in any paid employment
outside the duties of his or her office; or
(d) is absent from duty, except on leave of absence, for 14 consecutive
days or for 28 days in any 12 months;
the Governor-General must terminate his or her appointment.
(3) The Governor-General must not terminate the appointment of the
Regulator under subsection (1) unless a majority of jurisdictions agree to
the termination of the appointment.
(4) If the Regulator is:
(a) an eligible employee for the purposes of the Superannuation Act
1976; or
(b) a member of the superannuation scheme established by deed under the
Superannuation Act 1990;
the Governor-General may, with the consent of the Regulator, retire the
Regulator from office on the grounds of physical or mental incapacity.
(5) For the purposes of the Superannuation Act 1976, the Regulator
is taken to have been retired from office on the grounds of invalidity
if:
(a) the Regulator is removed or retired from office on the grounds of
physical or mental incapacity; and
(b) the Commonwealth Superannuation Board of Trustees No. 2 gives a
certificate under section 54C of the Superannuation Act
1976.
(6) For the purposes of the Superannuation Act 1990, the Regulator
is taken to have been retired from office on the grounds of invalidity
if:
(a) the Regulator is removed or retired from office on the grounds of
physical or mental incapacity; and
(b) the Commonwealth Superannuation Board of Trustees No. 1 gives a
certificate under section 13 of the Superannuation Act
1990.
The Regulator must give written notice to the Minister of all interests,
pecuniary or otherwise, that the Regulator has or acquires and that could
conflict with the proper performance of the Regulator’s
functions.
(1) The Minister may appoint a person to act as the Regulator:
(a) during a vacancy in the office of Regulator, (whether or not an
appointment has previously been made to the office); or
(b) during any period, or during all periods, when the Regulator is absent
from duty or from Australia, or is, for any reason, unable to perform the duties
of the office.
(2) Anything done by or in relation to a person purporting to act under an
appointment is not invalid merely because:
(a) the occasion for the appointment had not arisen; or
(b) there was a defect or irregularity in connection with the appointment;
or
(c) the appointment had ceased to have effect; or
(d) the occasion to act had not arisen or had ceased.
The Regulator holds office on the terms and conditions (if any) in
relation to matters not covered by this Act that are determined by the
Governor-General.
The Regulator must not engage in paid employment outside the duties of
the Regulator’s office without the approval of the Minister.
(1) The Regulator is to be paid the remuneration that is determined by the
Remuneration Tribunal. If no determination of that remuneration by the Tribunal
is in operation, the Regulator is to be paid the remuneration that is prescribed
by the regulations.
(2) The Regulator is to be paid the allowances that are prescribed by the
regulations.
(3) This section has effect subject to the Remuneration Tribunal Act
1973.
(1) The Regulator has the recreation leave entitlements that are
determined by the Remuneration Tribunal.
(2) The Minister may grant the Regulator leave of absence, other than
recreation leave, on the terms and conditions as to remuneration or otherwise
that the Minister determines.
The Regulator may resign his or her appointment by giving the
Governor-General a written resignation.
The Regulator may charge for services provided by, or on behalf of, the
Regulator in the performance of the Regulator’s functions.
(1) The purpose of this section is to ensure that fees and charges under
this Act and the regulations, and charges under the Gene Technology (Licence
Charges) Act 2000, are notionally payable by the Commonwealth (or parts of
the Commonwealth).
(2) The Minister responsible for administering the Financial Management
and Accountability Act 1997 may give written directions for the purpose
of this section, including directions relating to the transfer of amounts
within, or between, accounts operated by the Commonwealth.
(1) The Gene Technology Account is established.
(2) The Account is a Special Account for the purposes of the Financial
Management and Accountability Act 1997.
(1) There must be credited to the Account the following:
(a) all money appropriated by the Parliament for the purposes of the
Account;
(b) amounts equal to money from time to time received by the Commonwealth
under the Gene Technology (Licence Charges) Act 2000;
(c) amounts equal to fees received by the Commonwealth under subsections
40(6) and 83(3);
(d) amounts equal to amounts received by the Commonwealth in connection
with the performance of the Regulator’s functions under this Act, the
regulations or a corresponding State law;
(e) amounts equal to interest received by the Commonwealth from the
investment of money from the Account;
(f) amounts equal to money received by the Commonwealth in relation to
property paid for with money from the Account;
(g) amounts equal to amounts recovered by the Commonwealth under
subsection 146(5) or 158(4), to the extent that they are referable to amounts
paid out of the Account;
(h) amounts equal to amounts of any gifts given or bequests made for the
purposes of the Account.
(2) The purposes of the Account are to make payments:
(a) to further the object of this Act (as set out in section 3);
and
(b) otherwise in connection with the performance of the Regulator’s
functions under this Act, the regulations or a corresponding State
law.
The following amounts may be recovered in a court of competent
jurisdiction as debts due to the Commonwealth:
(a) amounts payable to the Commonwealth under the Gene Technology
(Licence Charges) Act 2000;
(b) fees payable to the Commonwealth under this Act, the regulations or a
corresponding State law;
(c) amounts payable to the Commonwealth in connection with the performance
of the Regulator’s functions.
Amounts standing to the credit of the Account may be expended:
(a) in payment or discharge of the costs, expenses and other obligations
incurred:
(i) by the Regulator in the performance of the Regulator’s functions
or in the exercise of the Regulator’s powers under this Act, the
regulations or a corresponding State law; or
(ii) by an inspector under paragraph 158(2)(e) or under a corresponding
State law; and
(b) in payment of any remuneration and allowances payable to any person
under this Act or the regulations.
The staff assisting the Regulator are to be persons engaged under the
Public Service Act 1999 and made available for the purpose by the
Secretary of the Department.
(1) The Regulator may engage persons with suitable qualifications and
experience as consultants to the Regulator.
(2) The terms and conditions of engagement of consultants are such as the
Regulator determines.
The Regulator may be assisted by the following:
(a) persons engaged under the Public Service Act 1999;
(b) officers and employees of Commonwealth authorities;
(c) officers and employees of State agencies;
whose services are made available to the Regulator in connection with the
performance or exercise of any of the Regulator’s functions or
powers.
(1) As soon as practicable after the end of each financial year, the
Regulator must prepare and give to the Minister a report on the operations of
the Regulator during that year.
(2) The Minister must cause a copy of the report to be laid before each
House of the Parliament within 15 sitting days of the day on which the report
was given to the Minister.
(3) The Regulator must give a copy of the report to each State.
(1) The Regulator may at any time cause a report about matters relating to
the Regulator’s functions to be tabled in either House of the
Parliament.
(2) The Regulator must give a copy of the report to the Minister and to
each State.
(1) The Regulator must maintain a Record of GMO and GM Product Dealings
(the Record).
(2) The purpose of the Record is to maintain a comprehensive record of all
dealings in Australia that involve GMOs or GM products.
(3) The Record must contain the following information, other than
confidential commercial information, in relation to each licence issued under
section 55:
(a) the name of the licence holder;
(b) the persons covered by the licence;
(c) the dealings authorised by the licence and the GMO to which those
dealings relate;
(d) any licence conditions;
(e) the date on which the licence was issued, and its expiry date (if
any).
(4) The Record must contain the following information, other than
confidential commercial information, in relation to each notifiable low risk
dealing that is notified to the Regulator in accordance with regulations under
section 75:
(a) the name of the person who notified the dealing;
(b) such particulars of the dealing as are prescribed by the regulations
for the purposes of this paragraph.
(5) The Record must contain such information as is prescribed by the
regulations, other than confidential commercial information, in relation to GM
products mentioned in designated notifications given to the Regulator under the
following Acts:
(a) the Agricultural and Veterinary Chemicals (Administration) Act
1992;
(b) the Australia New Zealand Food Authority Act 1991;
(c) the Industrial Chemicals (Notification and Assessment) Act
1989;
(d) the Therapeutic Goods Act 1989.
(6) The Record must also contain:
(a) a description of each dealing on the GMO Register; and
(b) any condition to which the dealing is subject.
(7) The Record may be kept in a computerised form.
(8) The Regulator must ensure that information mentioned in
subsection (3), (4), (5) or (6) is entered on the Record as soon as
reasonably practicable.
(9) In this section:
designated notification means a notification required because
of the amendments made by the Gene Technology (Consequential Amendments) Act
2000.
The Regulator must permit any person to inspect any part of the
Record.
(1) The Regulator may, at any time, in accordance with this Division,
consider the following matters:
(a) whether a dealing with a GMO should be a notifiable low risk
dealing;
(b) whether an existing notifiable low risk dealing should no longer be a
notifiable low risk dealing.
(2) The basis of the Regulator’s consideration must relate
to:
(a) the matters of which the Regulator must be satisfied under subsection
74(2); or
(b) the matters the Regulator must consider under subsection
74(3).
The Regulator may, at any time, in accordance with this Division,
consider the following matters:
(a) whether a dealing that is an exempt dealing within the meaning of
subsection 32(3) should not be an exempt dealing;
(b) whether a dealing should be an exempt dealing within the meaning of
that subsection.
(1) The Regulator may publish a notice inviting written submissions in
relation to any matter that the Regulator may consider under section 140 or
141. The notice must:
(a) specify the matters to which submissions are to relate; and
(b) specify the closing date for submissions, which must not be earlier
than 30 days after the date on which the notice was published.
(2) If the Regulator publishes a notice under subsection (1), the
Regulator must also give written notice, stating the matters mentioned in
subsection (1), to:
(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.
(3) A notice under this section may relate to a single matter or to a
class of matters.
(1) If:
(a) the matter relates to whether a dealing should be a notifiable low
risk dealing; and
(b) the Regulator is satisfied as mentioned in subsection 74(2);
and
(c) the Regulator has considered the matters mentioned in subsection
74(3);
the Regulator may recommend to the Ministerial Council that the dealing be
declared to be a notifiable low risk dealing.
(2) If:
(a) the matter relates to whether an existing notifiable low risk dealing
be reconsidered; and
(b) after having had regard to the matters mentioned in section 74,
the Regulator considers that the dealing should not be a notifiable low risk
dealing;
the Regulator may recommend to the Ministerial Council that the regulations
be amended accordingly.
(3) If the matter relates to whether a dealing:
(a) should be an exempt dealing; or
(b) should cease to be an exempt dealing;
the Regulator may recommend to the Ministerial Council that the regulations
be amended accordingly.
Nothing in this Division requires the Regulator to consider a matter
under section 140 or 141.
The following is a simplified outline of this Part:
This Part enables the Regulator to give directions to a licence holder or
to a person covered by a licence, if:
(a) the Regulator believes that the person is not complying with this Act
or the regulations; and
(b) the Regulator believes that it is necessary to do so in order to
protect the health and safety of people or to protect the environment.
The Part also empowers the Federal Court to issue injunctions, and contains
a forfeiture provision.
(1) If the Regulator believes, on reasonable grounds, that:
(a) a licence holder is not complying with this Act or the regulations in
respect of a thing; and
(b) it is necessary to exercise powers under this section in order to
protect the health and safety of people or to protect the environment;
the Regulator may give directions to the licence holder, by written notice,
requiring the licence holder, within the time specified in the notice, to take
such steps in relation to the thing as are reasonable in the circumstances for
the licence holder to comply with this Act or the regulations.
(2) If the Regulator believes on reasonable grounds that:
(a) a person covered by a GMO licence is not complying with this Act or
the regulations in respect of a thing; and
(b) it is necessary to exercise powers under this section in order to
protect the health and safety of people or to protect the environment;
the Regulator may give directions to the person, by written notice,
requiring the person, within the time specified in the notice, to take such
steps in relation to the thing as are reasonable in the circumstances for the
person to comply with this Act or the regulations.
(3) A person commits an offence if he or she does not take the steps
specified in a notice under subsection (1) or (2) within the time specified
in the notice.
Maximum penalty:
(a) in the case of an aggravated offence—2,000 penalty
units;
(b) in
any other case—500 penalty units.
Note 1: Chapter 2 of the Criminal Code sets out
the general principles of criminal responsibility.
Note 2: Aggravated offence is defined in
section 38.
(4) If the licence holder or the person, as the case requires, does not
take the steps specified in the notice within the time specified in the notice,
the Regulator may arrange for those steps to be taken.
(5) If the Regulator incurs costs because of arrangements made by the
Regulator under subsection (4), the licence holder or the person, as the
case requires, is liable to pay to the Commonwealth an amount equal to the cost,
and the amount may be recovered by the Commonwealth as a debt due to the
Commonwealth in a court of competent jurisdiction.
(6) Section 4K of the Crimes Act 1914 does not apply to an
offence against subsection (3).
(7) A time specified in a notice under subsection (1) or (2) must be
reasonable having regard to the circumstances.
(1) If a person has engaged, is engaging, or is about to engage in any
conduct that is or would be an offence against this Act or the regulations, the
Federal Court of Australia (the Court) may, on the application of
the Regulator or any other aggrieved person, grant an injunction restraining the
person from engaging in the conduct.
(2) If:
(a) a person has refused or failed, is refusing or failing, or is about to
refuse or fail, to do a thing; and
(b) the refusal or failure is, or would be, an offence against this Act or
the regulations;
the Court may, on the application of the Regulator or any other aggrieved
person, grant an injunction requiring the person to do the thing.
(3) The power of the Court to grant an injunction may be
exercised:
(a) whether or not it appears to the Court that the person intends to
engage, or to continue to engage, in conduct of that kind; and
(b) whether or not the person has previously engaged in conduct of that
kind.
(4) The Court may discharge or vary an injunction granted under this
section.
(5) The Court may grant an interim injunction pending a determination of
an application under subsection (1).
(6) The powers granted by this section are in addition to, and not in
derogation of, any other powers of the Court.
(1) If a court:
(a) convicts a person of an offence against this Act or the regulations;
or
(b) makes an order under section 19B of the Crimes Act 1914 in
respect of a person charged with an offence against this Act or the
regulations;
the court may order forfeiture to the Commonwealth of any thing used or
otherwise involved in the commission of the offence.
(2) A thing ordered by a court to be forfeited under this section becomes
the property of the Commonwealth and may be sold or otherwise dealt with in
accordance with the directions of the Regulator.
(3) Until the Regulator gives a direction, the thing must be kept in such
custody as the Regulator directs.
The following is a simplified outline of this Part:
This Part provides for powers of inspection in relation to monitoring and
offences.
Division 2 provides for the appointment of inspectors.
Divisions 3 to 9 deal with the powers and obligations of inspectors,
and the rights and responsibilities of an occupier of premises when an inspector
seeks to exercise powers.
Division 10 sets out procedures relating to monitoring warrants and
offence-related warrants.
This Part does not limit the conditions to which a licence can be subject,
and section 64 imposes a condition in relation to monitoring dealings with
GMOs.
(1) The Regulator may, by instrument in writing, appoint any of the
following persons as inspectors:
(a) a person who is appointed or employed by the Commonwealth;
(b) a person who is appointed or employed by a State.
(2) In exercising powers or performing functions as an inspector, an
inspector must comply with any directions of the Regulator.
(1) The Regulator must issue an identity card to an inspector.
(2) The identity card:
(a) must be in the form prescribed by the regulations; and
(b) must contain a recent photograph of the inspector.
(3) If a person to whom an identity card has been issued ceases to be an
inspector, the person must return the identity card to the Regulator as soon as
practicable.
Maximum penalty: 1 penalty unit.
Note: Chapter 2 of the Criminal Code sets out
the general principles of criminal responsibility.
(4) An inspector must carry his or her identity card at all times when
exercising powers or performing functions as an inspector.
(1) For the purpose of finding out whether this Act or the regulations
have been complied with, an inspector may:
(a) enter any premises; and
(b) exercise the monitoring powers set out in section 153.
(2) An inspector is not authorised to enter premises under
subsection (1) unless:
(a) the occupier of the premises has consented to the entry; or
(b) the entry is made under a warrant under section 172; or
(c) the occupier of the premises is a licence holder, or a person covered
by a licence, and the entry is at a reasonable time.
(1) The monitoring powers that an inspector may exercise
under paragraph 152(1)(b) are as follows:
(a) to search the premises and any thing on the premises;
(b) to inspect, examine, take measurements of, conduct tests on, or take
samples of, any thing on the premises that relates to a GMO;
(c) to take photographs, make video or audio recordings or make sketches
of the premises or any thing on the premises;
(d) if the inspector was authorised to enter the premises by a warrant
under section 172—to require any person in or on the premises
to:
(i) answer any questions put by the inspector; and
(ii) produce any book, record or document requested by the
inspector;
(e) to inspect any book, record or document on the premises;
(f) to take extracts from or make copies of any such book, record or
document;
(g) to take onto the premises such equipment and materials as the
inspector requires for the purpose of exercising powers in relation to the
premises;
(h) to secure a thing, until a warrant is obtained to seize it, being a
thing:
(i) that the inspector finds during the exercise of monitoring powers on
the premises; and
(ii) that the inspector believes on reasonable grounds is evidential
material; and
(iii) that the inspector believes on reasonable grounds would be lost,
destroyed or tampered with before the warrant can be obtained.
(2) For the purposes of this Part, monitoring powers include
the power to operate equipment at premises to see whether:
(a) the equipment; or
(b) a disk, tape or other storage device that:
(i) is at the premises; and
(ii) can be used with the equipment or is associated with it;
contains information that is relevant to determining whether there has been
compliance with the Act or the regulations.
(3) If the inspector, after operating equipment at the premises, finds
that the equipment, or that a tape, disk or other storage device at the
premises, contains information mentioned in subsection (2), the inspector
may:
(a) operate facilities at the premises to put the information in
documentary form and copy the document so produced; or
(b) if the information can be transferred to a tape, disk or other storage
device that:
(i) is brought to the premises; or
(ii) is at the premises and the use of which for the purpose has been
agreed to in writing by the occupier of the premises;
operate the equipment or other facilities to copy the information to the
storage device, and remove the storage device from the premises.
(1) This section applies if an inspector has reasonable grounds for
suspecting that there may be evidential material on any premises.
(2) The inspector may:
(a) enter the premises, with the consent of the occupier or under a
warrant issued under section 173; and
(b) exercise the powers set out in subsection (3) and
section 155; and
(c) if the entry is under a warrant—seize the evidential material,
if the inspector finds it on the premises.
(3) If:
(a) in the course of searching, in accordance with a warrant, for a
particular thing, an inspector finds another thing that the inspector believes
on reasonable grounds to be evidential material; and
(b) the inspector believes, on reasonable grounds, that it is necessary to
seize that other thing in order to prevent its concealment, loss or destruction,
or its use in committing, continuing or repeating an offence against this Act or
the regulations;
the warrant is taken to authorise the inspector to seize that other
thing.
The powers an inspector may exercise under paragraph 154(2)(b) are as
follows:
(a) to search the premises and any thing on the premises for the
evidential material;
(b) to inspect, examine, take measurements of, conduct tests on, or take
samples of the evidential material;
(c) to take photographs, make video or audio recordings or make sketches
of the premises or the evidential material;
(d) to take onto the premises such equipment and materials as the
inspector requires for the purpose of exercising powers in relation to the
premises.
(1) The inspector may operate equipment at the premises to see whether
evidential material is accessible by doing so, if the inspector believes on
reasonable grounds that the operation of the equipment can be carried out
without damage to the equipment.
(2) If the inspector, after operating the equipment, finds that evidential
material is accessible by doing so, the inspector may:
(a) seize the equipment and any disk, tape or other associated device;
or
(b) if the material can, by using facilities at the premises, be put in
documentary form—operate the facilities to put the material in that form
and seize the documents so produced; or
(c) if the material can be transferred to a disk, tape or other storage
device that:
(i) is brought to the premises; or
(ii) is at the premises and the use of which for the purpose has been
agreed to in writing by the occupier of the premises;
operate the equipment or other facilities to copy the material to the
storage device and take the storage device from the premises.
(3) An inspector may seize equipment under paragraph (2)(a) only
if:
(a) it is not practicable to put the material in documentary form as
mentioned in paragraph (2)(b) or to copy the material as mentioned in
paragraph (2)(c); or
(b) possession by the occupier of the equipment could constitute an
offence.
(4) An inspector may seize equipment under paragraph (2)(a) or
documents under paragraph (2)(b) only if the inspector entered the premises
under a warrant.
(1) If an inspector believes on reasonable grounds that:
(a) information relevant to determining whether there has been compliance
with this Act or the regulations, or evidential material, may be accessible by
operating a thing at particular premises; and
(b) expert assistance is required to operate the thing; and
(c) if he or she does not take action under this subsection, the
information or material may be destroyed, altered or otherwise interfered
with;
he or she may do whatever is necessary to secure the thing, whether by
locking it up, placing a guard or otherwise.
(2) The inspector must give notice to the occupier of the premises of his
or her intention to secure the thing and of the fact that the thing may be
secured for up to 24 hours.
(3) The thing may be secured:
(a) for a period not exceeding 24 hours; or
(b) until the thing has been operated by the expert;
whichever happens first.
(4) If the inspector believes on reasonable grounds that the expert
assistance will not be available within 24 hours, he or she may apply to the
magistrate for an extension of that period.
(5) The inspector must give notice to the occupier of the premises of his
or her intention to apply for an extension, and the occupier is entitled to be
heard in relation to the application.
(1) This section applies if:
(a) an inspector has reasonable grounds for suspecting that there may be
on any premises a particular thing in respect of which this Act or the
regulations have not been complied with; and
(b) the inspector considers that it is necessary to exercise powers under
this section in order to avoid an imminent risk of death, serious illness,
serious injury, or to protect the environment.
(2) The inspector may do any of the following:
(a) enter the premises;
(b) search the premises for the thing;
(c) secure the thing, if the inspector finds it on the premises, until a
warrant is obtained to seize the thing;
(d) if the inspector has reasonable grounds for suspecting that a person
has not complied with this Act or the regulations in respect of the
thing—require the person to take such steps as the inspector considers
necessary for the person to comply with this Act or the regulations;
(e) take such steps, or arrange for such steps to be taken, in relation to
the thing as the inspector considers appropriate.
(3) The inspector may exercise the powers in subsection (2) only to
the extent that it is necessary for the purpose of avoiding an imminent risk of
death, serious illness, serious injury or serious damage to the
environment.
(4) If the Regulator incurs costs because of steps reasonably taken or
arranged to be taken by an inspector under paragraph (2)(e), the person is
liable to pay to the Commonwealth an amount equal to the costs, and the amount
may be recovered by the Commonwealth as a debt due to the Commonwealth in a
court of competent jurisdiction.
An inspector is not entitled to exercise any powers under this Part in
relation to premises if:
(a) the occupier of the premises has required the inspector to produce his
or her identity card for inspection by the occupier; and
(b) the inspector fails to comply with the requirement.
(1) Before obtaining the consent of a person for the purposes of paragraph
152(2)(a) or 154(2)(a), the inspector must inform the person that he or she may
refuse consent.
(2) An entry of an inspector by virtue of the consent of a person is not
lawful unless the person voluntarily consented to the entry.
(1) If a warrant in relation to premises is being executed and the
occupier of the premises or another person who apparently represents the
occupier is present at the premises, the inspector must make available to that
person a copy of the warrant.
(2) The inspector must identify himself or herself to that
person.
(3) The copy of the warrant referred to in subsection (1) need not
include the signature of the magistrate who issued the warrant.
(1) An inspector must, before entering premises under a warrant:
(a) announce that he or she is authorised to enter the premises;
and
(b) give any person at the premises an opportunity to allow entry to the
premises.
(2) An inspector is not required to comply with subsection (1) if he
or she believes on reasonable grounds that immediate entry to the premises is
required:
(a) to ensure the safety of a person; or
(b) to prevent serious damage to the environment; or
(c) to ensure that the effective execution of the warrant is not
frustrated.
(1) The owner of a thing is entitled to compensation for damage to the
thing if:
(a) the damage was caused to the thing as a result of it being operated as
mentioned in this Part; and
(b) the damage was caused as a result of:
(i) insufficient care being exercised in selecting the person who was to
operate the thing; or
(ii) insufficient care being exercised by the person operating the
thing.
(2) Compensation is payable out of money appropriated by the
Parliament.
(3) In determining the amount of compensation payable, regard is to be had
to whether the occupier of the premises and his or her employees and agents, if
they were available at the time, had provided any warning or guidance as to the
operation of the thing that was appropriate in the circumstances.
(1) This section applies to any goods that are to be, are being, or have
been, taken off a ship that voyages, or an aircraft that flies,
between:
(a) a place outside Australia and a place in Australia; or
(b) a place outside an external territory and a place in that
territory.
(2) If an inspector believes, on reasonable grounds, that goods are goods
to which this section applies, and that the goods may be, or may contain,
evidential material, the inspector may:
(a) examine the goods; or
(b) if the goods are baggage—open and search the baggage;
or
(c) if the goods are in a container—open and search the
container.
(3) An inspector may ask a person who owns, is carrying or is otherwise
associated with, or appears to the inspector to be associated with, goods to
which this section applies, any question in respect of the goods.
(4) A person must not refuse or fail to answer a question put to the
person under subsection (3).
Maximum penalty: 30 penalty units.
Note: Chapter 2 of the Criminal Code sets out
the general principles of criminal responsibility.
An inspector may seize goods mentioned in section 164 if the
inspector has reasonable grounds to suspect that the goods are evidential
material.
(1) Subject to subsection (2), if an inspector seizes, under a
warrant relating to premises:
(a) a document, film, computer file or other thing that can be readily
copied; or
(b) a storage device, the information in which can be readily
copied;
the inspector must, if requested to do so by the occupier of the premises,
or another person who apparently represents the occupier and who is present when
the warrant is executed, give a copy of the thing or the information to that
person as soon as practicable after the seizure.
(2) Subsection (1) does not apply if:
(a) the thing that has been seized was seized under paragraph 156(2)(b) or
(c); or
(b) possession by the occupier of the document, film, computer file, thing
or information could constitute an offence.
(1) If a warrant in relation to premises is being executed and the
occupier of the premises, or another person who apparently represents the
occupier is present at the premises, the person is entitled to observe the
search being conducted.
(2) The right to observe the search being conducted ceases if the person
impedes the search.
(3) This section does not prevent 2 or more areas of the premises being
searched at the same time.
(1) If a thing is seized under this Part, the inspector must provide a
receipt for the thing.
(2) If 2 or more things are seized, they may be covered in the one
receipt.
(1) Subject to any contrary order of a court, if an inspector seizes a
thing under this Part, the inspector must return it if:
(a) the reason for its seizure no longer exists or it is decided that it
is not to be used in evidence; or
(b) the period of 60 days after its seizure ends;
whichever first occurs, unless the thing is forfeited or forfeitable to the
Commonwealth.
(2) At the end of the 60 days specified in subsection (1), an
inspector must take reasonable steps to return the thing to the person from whom
it was seized, unless:
(a) proceedings in respect of which the thing may afford evidence were
instituted before the end of the 60 days and have not been completed (including
an appeal to a court in relation to those proceedings); or
(b) an inspector may retain the thing because of an order under
section 170; or
(c) to return the thing could cause an imminent risk of death, serious
illness, serious injury or serious damage to the environment; or
(d) an inspector is otherwise authorised (by a law, or an order of a
court, of the Commonwealth or of a State) to retain, destroy or dispose of the
thing.
(3) The thing may be returned under subsection (2) either
unconditionally or on such terms and conditions as the Regulator sees
fit.
(1) An inspector may apply to a magistrate for an order that he or she may
retain the thing for a further period if:
(a) before the end of 60 days after the seizure; or
(b) before the end of a period previously specified in an order of a
magistrate under this section;
proceedings in respect of which the thing may afford evidence have not
commenced.
(2) If the magistrate is satisfied that it is necessary for an inspector
to continue to retain the thing:
(a) for the purposes of an investigation as to whether an offence against
this Act has been committed; or
(b) to enable evidence of an offence against this Act to be secured for
the purposes of a prosecution;
the magistrate may order that an inspector may retain the thing for a
period (not being a period exceeding 3 years) specified in the order.
(3) Before making the application, the inspector must:
(a) take reasonable steps to discover who has an interest in the retention
of the thing; and
(b) if it is practicable to do so, notify each person whom the inspector
believes to have such an interest of the proposed application.
If:
(a) a thing is seized under this Part; and
(b) apart from this section, the Commonwealth is required to return the
thing to the owner; and
(c) there is no owner or the Regulator cannot, despite making reasonable
efforts, locate the owner;
the Regulator may dispose of the thing in such manner as the Regulator
thinks appropriate.
(1) An inspector may apply to a magistrate for a warrant under this
section in relation to premises.
(2) Subject to subsection (3), the magistrate may issue the warrant
if the magistrate is satisfied, by information on oath, that it is reasonably
necessary that one or more inspectors should have access to the premises for the
purposes of finding out whether this Act or the regulations have been complied
with.
(3) The magistrate must not issue the warrant unless the inspector or some
other person has given to the magistrate, either orally or by affidavit, such
further information (if any) as the magistrate requires concerning the grounds
on which the issue of the warrant is being sought.
(4) The warrant must:
(a) authorise one or more inspectors (whether or not named in the
warrant), with such assistance and by such force as is necessary and
reasonable:
(i) to enter the premises; and
(ii) to exercise the powers set out in section 153 in relation to the
premises; and
(b) state whether the entry is authorised to be made at any time of the
day or night or during specified hours of the day or night; and
(c) specify the day (not more than 6 months after the issue of the
warrant) on which the warrant ceases to have effect; and
(d) state the purpose for which the warrant is issued.
(1) An inspector may apply to a magistrate for a warrant under this
section in relation to premises.
(2) Subject to subsection (3), the magistrate may issue the warrant
if the magistrate is satisfied, by information on oath, that there are
reasonable grounds for suspecting that there is, or there may be within the next
72 hours, evidential material in or on the premises.
(3) The magistrate must not issue the warrant unless the inspector or some
other person has given to the magistrate, either orally or by affidavit, such
further information (if any) as the magistrate requires concerning the grounds
on which the issue of the warrant is being sought.
(4) The warrant must:
(a) name one or more inspectors; and
(b) authorise the inspectors so named, with such assistance and by such
force as is necessary and reasonable:
(i) to enter the premises; and
(ii) to exercise the powers set out in subsection 154(3) and
section 155; and
(iii) to seize the evidential material; and
(c) state whether the entry is authorised to be made at any time of the
day or night or during specified hours of the day or night; and
(d) specify the day (not more than one week after the issue of the
warrant) on which the warrant ceases to have effect; and
(e) state the purpose for which the warrant is issued.
(1) If, in an urgent case, an inspector considers it necessary to do so,
the inspector may apply to a magistrate by telephone, telex, fax or other
electronic means for a warrant under section 173 in relation to
premises.
(2) The magistrate may require communication by voice to the extent that
it is practicable in the circumstances.
(3) Before applying for the warrant, the inspector must prepare an
information of the kind mentioned in subsection 173(2) in relation to the
premises that sets out the grounds on which the warrant is sought.
(4) If it is necessary to do so, the inspector may apply for the warrant
before the information is sworn.
(5) If the magistrate is satisfied:
(a) after having considered the terms of the information; and
(b) after having received such further information (if any) as the
magistrate requires concerning the grounds on which the issue of the warrant is
being sought;
that there are reasonable grounds for issuing the warrant, the magistrate
may complete and sign the same warrant that the magistrate would issue under
section 173 if the application had been made under that section.
(6) If the magistrate completes and signs the warrant:
(a) the magistrate must:
(i) tell the inspector what the terms of the warrant are; and
(ii) tell the inspector the day on which and the time at which the warrant
was signed; and
(iii) tell the inspector the day (not more than one week after the
magistrate completes and signs the warrant) on which the warrant ceases to have
effect; and
(iv) record on the warrant the reasons for issuing the warrant;
and
(b) the inspector must:
(i) complete a form of warrant in the same terms as the warrant completed
and signed by the magistrate; and
(ii) write on the form the name of the magistrate and the day on which and
the time at which the warrant was signed.
(7) The inspector must also, not later than the day after the day of
expiry or execution of the warrant, whichever is the earlier, send to the
magistrate:
(a) the form of warrant completed by the inspector; and
(b) the information referred to in subsection (3), which must have
been duly sworn.
(8) When the magistrate receives those documents, the magistrate
must:
(a) attach them to the warrant that the magistrate completed and signed;
and
(b) deal with them in the way in which the magistrate would have dealt
with the information if the application had been made under
section 173.
(9) A form of warrant duly completed under subsection (6) is
authority for any entry, search, seizure or other exercise of a power that the
warrant signed by the magistrate authorises.
(10) If:
(a) it is material, in any proceedings, for a court to be satisfied that
an exercise of a power was authorised by this section; and
(b) the warrant signed by the magistrate authorising the exercise of the
power is not produced in evidence;
the court must assume, unless the contrary is proved, that the exercise of
the power was not authorised by such a warrant.
(11) A reference in this Part to a warrant under section 173 includes
a reference to a warrant signed by a magistrate under this section.
(1) An inspector must not make, in an application for a warrant, a
statement that the inspector knows to be false or misleading in a material
particular.
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) An inspector must not:
(a) state in a document that purports to be a form of warrant under
section 174 the name of a magistrate unless that magistrate issued the
warrant; or
(b) state on a form of warrant under that section a matter that, to the
inspector’s knowledge, departs in a material particular from the form
authorised by the magistrate; or
(c) purport to execute, or present to another person, a document that
purports to be a form of warrant under that section that the inspector
knows:
(i) has not been approved by a magistrate under that section; or
(ii) departs in a material particular from the terms authorised by a
magistrate under that section; or
(d) give to a magistrate a form of warrant under that section that is not
the form of warrant that the inspector purported to execute.
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.
Nothing in this Part affects the right of a person to refuse to answer a
question, give information, or produce a document, on the ground that the answer
to the question, the information, or the production of the document, might tend
to incriminate him or her or make him or her liable to a penalty.
This Part is not to be taken to limit the Regulator’s power to
impose licence conditions.
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.
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 |
(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.
(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.
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.
(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.
(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.
(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.
(3) The Regulator must give the applicant written notice of the
Regulator’s decision about the application.
(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.
(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.
(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.
(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.
(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.
(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.
Regulations may be made in relation to transitional matters arising from
the enactment of this Act.
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.
(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.