An Act to regulate activities involving gene technology, and for
related purposes
Part 1—Preliminary
1
Short title [see
Note 1]
This Act may be cited as the Gene
Technology Act 2000.
2
Commencement [see
Note 1]
(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.
3
Object of Act
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.
4
Regulatory framework to achieve object
The object of this Act is to be achieved
through a regulatory framework which:
(aa) provides
that where there are threats of serious or irreversible environmental damage, a
lack of full scientific certainty should not be used as a reason for postponing
cost‑effective measures to prevent environmental degradation; and
(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.
5
Nationally consistent scheme
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.
6 Act
to bind the Crown
(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.
7 External
Territories
This Act extends to every external
Territory other than Norfolk Island.
8
Offences
(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.
Part 2—Interpretation and operation of Act
Division 1—Simplified outline
9
Simplified outline
The following is a simplified outline of
this Part:
This Part contains the definitions
used in this Act.
This Part contains provisions to facilitate
the conferral of functions and powers on the Regulator under State legislation,
in order to facilitate a nationally consistent regulatory scheme.
This Part contains provisions to
enable the concurrent operation of certain State legislation in relation to
GMOs, and gives the capacity for this Act to have a more limited operation when
corresponding State legislation is in force.
This Part also enables the Ministerial
Council to issue policy principles, policy guidelines and codes of practice.
Division 2—Definitions
10
Definitions
(1) In this Act, unless the contrary
intention appears:
Account means the Gene Technology Account
established by section 129.
accredited organisation means an organisation
accredited under Division 3 of Part 7.
aggravated offence has the meaning given by
section 38.
Australian Health Ethics Committee means the
Australian Health Ethics Committee established under the National Health and
Medical Research Council Act 1992.
Commonwealth authority means the following:
(a) a body corporate established for a
public purpose by or under an Act;
(b) a company in which a controlling
interest is held by any one of the following persons, or by 2 or more of the
following persons together:
(i) the Commonwealth;
(ii) a body covered by paragraph (a);
(iii) a body covered by
either of the above subparagraphs.
confidential commercial information means
information declared by the Regulator to be confidential commercial information
under section 185.
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;
(h) transport the GMO;
(i) dispose of the GMO;
and includes the possession, supply or use of the GMO for
the purposes of, or in the course of, a dealing mentioned in any of
paragraphs (a) to (i).
eligible person, in relation to a reviewable
decision, has the meaning given by section 179.
emergency dealing determination means a
determination in force under section 72B.
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 and Community Committee means the Gene
Technology Ethics and Community Consultative Committee established by
section 106.
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 Agreement made for the purposes of this Act between the Commonwealth
and at least 4 States, 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.
inadvertent dealings application means an
application for a GMO licence to which Division 3 or 4 of Part 5 does
not apply because of the operation of section 46A or 49.
Institutional Biosafety Committee means a committee
established as an Institutional Biosafety Committee in accordance with written
guidelines issued by the Regulator under section 98.
jurisdiction means the following:
(a) the Commonwealth;
(b) a State.
licence holder means the holder of a GMO licence.
Ministerial Council means the Ministerial
Council within the meaning of the Gene Technology Agreement.
notifiable low risk dealing has the meaning
given by section 74.
officer, in relation to the Commonwealth,
includes the following:
(a) a Minister;
(b) a person who holds:
(i) an office established
by or under an Act; or
(ii) an appointment made
under an Act; or
(iii) an appointment made by
the Governor‑General or a Minister but not under an Act;
(c) a person who is a member or
officer of a Commonwealth authority;
(d) a person who is in the service or
employment of the Commonwealth or of a Commonwealth authority, or is employed
or engaged under an Act.
organism means any biological entity that is:
(a) viable; or
(b) capable of reproduction; or
(c) capable of transferring genetic
material.
person covered by a GMO licence means a
person authorised by a GMO licence to deal with a GMO.
premises includes the following:
(a) a building;
(b) a place (including an area of
land);
(c) a vehicle;
(d) a vessel;
(e) an aircraft;
(f) a facility;
(g) any part of premises (including
premises referred to in paragraphs (a) to (f)).
Record means the Record of GMO and GM Product
Dealings mentioned in section 138.
Regulator means the Gene Technology Regulator
appointed under section 118.
reviewable decision has the meaning given by
section 179.
State includes the Australian Capital
Territory and the Northern Territory.
State agency means the following:
(a) the Crown in right of a State;
(b) a Minister of a State;
(c) a State Government Department;
(d) an instrumentality of a State,
including a body corporate established for a public purpose by or under a law
of a State;
(e) a company in which a controlling
interest is held by any one of the following persons, or by 2 or more of the
following persons together:
(i) the Crown in right of
a State;
(ii) a person or body
covered by paragraph (b) or (d);
(iii) a person or body
covered by either of the above subparagraphs.
thing includes a substance, and a thing in
electronic or magnetic form.
(2) If this Act requires or permits the
Ministerial Council to do a thing, the Ministerial Council must do the thing in
accordance with any requirements specified in the Gene Technology Agreement.
11
Meaning of intentional release of a GMO into the environment
For the purposes of this Act, a dealing
with a GMO involves the intentional release of the GMO into the
environment if the GMO is intentionally released into the open
environment, whether or not it is released with provision for limiting the
dissemination or persistence of the GMO or its genetic material in the
environment.
12
Meaning of corresponding State law
(1) For the purposes of this Act, corresponding
State law means a State law that is declared by the Minister, by notice
in the Gazette, to correspond to this Act and the regulations, including
such a law as amended from time to time.
(2) The Minister may revoke a Gazette notice
under subsection (1) in relation to a State law only if:
(a) the Minister is requested by the
State concerned to revoke the notice; or
(b) the State law has been amended
otherwise than as agreed by a majority of the members of the Ministerial
Council (being a majority that includes the Commonwealth) under the Gene
Technology Agreement; or
(c) amendments of the State law have
been agreed by a majority of the members of the Ministerial Council (being a
majority that includes the Commonwealth) under the Gene Technology Agreement,
and the State law has not been amended in accordance with that agreement within
a reasonable period after the agreement.
Division 3—Operation of Act
13
Operation of Act
(1) This Act applies as follows:
(a) to things done, or omitted to be
done, by constitutional corporations;
(b) to things done, or omitted to be
done, in the course of constitutional trade or commerce;
(c) to things done, or omitted to be
done, by a person that may cause the spread of diseases or pests;
(d) for purposes relating to the
collection, compilation, analysis and dissemination of statistics;
(e) to the Commonwealth and
Commonwealth authorities;
(f) to things authorised by the
legislative power of the Commonwealth under paragraph 51(xxxix) of the
Constitution, so far as it relates to the matters mentioned in paragraphs (a)
to (e) of this subsection.
(2) In this section:
constitutional corporation means a trading,
foreign or financial corporation within the meaning of paragraph 51(xx) of the
Constitution.
constitutional trade or commerce means trade
or commerce:
(a) between Australia and places
outside Australia; or
(b) among the States; or
(c) by way of the supply of services
to the Commonwealth or to a Commonwealth authority.
14
Wind‑back of reach of Act
(1) This section applies to a State (the notifying
State) at a particular time if:
(a) a corresponding State law is in
force in the notifying State at that time; and
(b) a wind‑back notice in
relation to that State is in force at that time.
(2) This Act applies as a law of the
Commonwealth in the notifying State with the following modifications:
(a) this Act applies as if paragraph
13(1)(c) (which deals with the spread of pests and diseases) had not been
enacted;
(b) this Act does not apply to a
dealing with a GMO undertaken:
(i) by a higher education
institution or a State agency; or
(ii) by a person authorised
to undertake the dealing by a licence held under the corresponding State law by
a higher education institution or a State agency.
(3) In this section:
wind‑back notice, in
relation to a State, means a notice given by the State to the Minister, under
the Gene Technology Agreement, stating that this section is to apply to the
State.
15
Relationship to other Commonwealth laws
The provisions of this Act are in
addition to, and not in substitution for, the requirements of any other law of
the Commonwealth (whether passed or made before or after the commencement of
this section).
Division 4—Provisions to facilitate a nationally consistent scheme
Subdivision A—General provisions
16
State laws may operate concurrently
(1) This Act is not intended to exclude the
operation of any State law, to the extent that the State law is capable of
operating concurrently with this Act, other than a State law prescribed by the
regulations for the purposes of this section.
(2) The Governor‑General may prescribe
a State law under subsection (1) only if:
(a) there is no corresponding State
law in effect in relation to that State; and
(b) either:
(i) the State law relates
specifically to dealings with GMOs; or
(ii) for the purposes of a
decision under the State law as to whether or not a licence, authority or
approval (however described) is granted under the State law, the State law
distinguishes between dealings with GMOs and dealings with other things.
17
Conferral of functions on Commonwealth officers and bodies
(1) A corresponding State law may confer
functions, powers and duties on the following:
(a) the Regulator or another officer
of the Commonwealth;
(b) a Commonwealth authority;
(c) the Ethics and Community
Committee;
(e) the Gene Technology Technical
Advisory Committee.
(2) If a function, power or duty is conferred
on a person or body under subsection (1), the person or body may perform
the function or duty or exercise the power, as the case requires.
(3) If a corresponding State law is expressed
to confer on the Regulator the power to determine that dealings be included on
the GMO Register, the Regulator may include the dealings on the GMO Register in
accordance with the corresponding State law.
(4) If a corresponding State law is expressed
to confer on the Regulator the power to vary the GMO Register, the Regulator
may vary the GMO Register in accordance with the corresponding State law.
(5) If a corresponding State law is expressed
to confer on the Regulator the power to enter information on the Record of GMO
and GM Product Dealings, the Regulator may enter the information on the Record
in accordance with the corresponding State law.
(6) The Regulator may:
(a) make any notations in the GMO
Register that the Regulator considers necessary to identify entries that relate
to dealings included on the Register as mentioned in subsection (3) or
(4); and
(b) make any notations in the Record
of GMO and GM Product Dealings that the Regulator considers necessary to identify
entries that relate to information entered on the Record as mentioned in subsection (5).
18 No
doubling‑up of liabilities
(1) If:
(a) an act or omission is an offence
against this Act and is also an offence against a corresponding State law; and
(b) the offender has been punished for
the offence under the corresponding State law;
the offender is not liable to be punished for the offence
under this Act.
(2) If a person has been ordered to pay a
pecuniary penalty under a corresponding State law, the person is not liable to
a pecuniary penalty under this Act in respect of the same conduct.
19
Review of certain decisions
(1) Application may be made to the
Administrative Appeals Tribunal for review of a reviewable State decision.
(2) A decision made by the Regulator in the
performance of a function or the exercise of a power conferred by a
corresponding State law is a reviewable State decision for the
purposes of this section if:
(a) the law under which the decision
was made provides for review by the Administrative Appeals Tribunal; and
(b) the decision is declared by the
regulations to be a reviewable State decision for the purposes of this section.
(3) For the purposes of this section, the Administrative
Appeals Tribunal Act 1975 has effect as if a corresponding State law were
an enactment.
20
Things done for multiple purposes
The validity of a licence, certificate
or other thing issued, given or done for the purposes of this Act is not
affected only because it was issued, given or done also for the purposes of a
corresponding State law.
Subdivision B—Policy principles, policy guidelines and codes of practice
21
Ministerial Council may issue policy principles
(1) The Ministerial Council may issue policy
principles in relation to the following:
(a) ethical issues relating to
dealings with GMOs;
(aa) recognising areas, if any,
designated under State law for the purpose of preserving the identity of one or
both of the following:
(i) GM crops;
(ii) non‑GM crops;
for marketing purposes;
(b) matters relating to dealings with
GMOs prescribed by the regulations for the purposes of this paragraph.
Note 1: Section 57 provides that the Regulator
must not issue a licence if to do so would be inconsistent with a policy
principle.
Note 2: Subsection 33(3) of the Acts Interpretation
Act 1901 confers power to revoke or amend an instrument issued under an
Act.
(2) Before issuing a policy principle, the
Ministerial Council must be satisfied that the policy principle was developed
in accordance with section 22.
(3) Regulations for the purposes of paragraph (1)(b)
may relate to matters other than the health and safety of people or the
environment, but must not derogate from the health and safety of people or the
environment.
(4) Policy principles are disallowable
instruments for the purposes of section 46A of the Acts Interpretation
Act 1901.
22
Consultation on policy principles
(1) Policy principles are to be developed in
consultation with the following:
(a) the Gene Technology Technical
Advisory Committee;
(b) the Regulator;
(c) the Ethics and Community
Committee;
(e) such Commonwealth and State
agencies and such regulatory agencies as the Ministerial Council considers
appropriate;
(f) such industry groups as the
Ministerial Council considers appropriate;
(g) such environmental, consumer and
other groups as the Ministerial Council considers appropriate.
(2) Consultation under subsection (1)
must be in accordance with guidelines (if any) issued by the Ministerial
Council for the purposes of this section.
23
Ministerial Council may issue policy guidelines
The Ministerial Council may issue policy
guidelines in relation to matters relevant to the functions of the Regulator.
Note 1: Section 56 requires the Regulator to have
regard to policy guidelines when deciding an application for a GMO licence.
Section 30 provides that the Regulator is not subject to direction in
relation to individual decisions.
Note 2: Subsection 33(3) of the Acts Interpretation
Act 1901 confers power to revoke or amend an instrument issued under an
Act.
24
Ministerial Council may issue codes of practice
(1) The Ministerial Council may issue codes
of practice in relation to gene technology.
Note: Subsection 33(3) of the Acts Interpretation
Act 1901 confers power to revoke or amend an instrument issued under an
Act.
(2) The Ministerial Council must not issue a
code of practice unless the code of practice was developed by the Regulator in
consultation with the following:
(a) the Gene Technology Technical
Advisory Committee;
(b) the Ethics and Community
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.
Part 3—The Gene Technology Regulator
25
Simplified outline
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.
26 The
Gene Technology Regulator
There is to be a Gene Technology
Regulator.
27
Functions of the 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.
28
Powers of the Regulator
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.
29
Delegation
(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.
30 Independence
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.
Part 4—Regulation of dealings with GMOs
Division 1—Simplified outline
31
Simplified outline
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
(aa) the dealing
is specified in an emergency dealing determination; 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.
Division 2—Dealings with GMOs must be licensed
32
Person not to deal with a GMO without a licence
(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 the person knows or is reckless
as to that fact; and
(c) the dealing with the GMO is not
specified in an emergency dealing determination, and the person knows or is
reckless as to that fact; and
(d) the dealing is not a notifiable
low risk dealing, and the person knows or is reckless as to that fact; and
(e) the dealing is not an exempt
dealing, and the person knows or is reckless as to that fact; and
(f) the dealing is not included on
the GMO Register, and the person knows or is reckless as to that fact.
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 whichever of the following applies:
(a) in the case of an aggravated
offence— imprisonment for 5 years or 2,000 penalty units;
(b) in any other case— imprisonment
for 2 years or 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.
33
Person not to deal with a GMO without a licence—strict liability offence
(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
(ba) the dealing with the GMO is not
specified in an emergency dealing determination; 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),
(ba), (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.
34
Person must not breach conditions of a GMO licence
(1) The holder of a GMO licence is guilty of
an offence if:
(a) the holder intentionally takes an
action or omits to take an action; and
(b) the action or omission contravenes
the licence, and the holder knows or is reckless as to that fact.
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 has knowledge of the
conditions of the licence; and
(c) the action or omission contravenes
a condition of the licence, and the person knows or is reckless as to that
fact.
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 whichever of the following applies:
(a) in the case of an aggravated
offence— imprisonment for 5 years or 2,000 penalty units;
(b) in any other case— imprisonment
for 2 years or 500 penalty units.
Note: Section 38 defines aggravated
offence.
(4) A person who is guilty of an offence
under subsection (1) or (2) is guilty of a separate offence in respect of
each day (including the day of a conviction for the offence or any later day)
on which the person is guilty of the offence.
35
Person must not breach conditions of a GMO licence—strict liability 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.
35A
Person must not breach conditions of emergency dealing determination
(1) A person is guilty of an offence if:
(a) the person intentionally takes an
action or omits to take an action; and
(b) the person has knowledge of the
conditions to which an emergency dealing determination is subject; and
(c) the action or omission contravenes
such a condition, and the person knows or is reckless as to that fact.
Note: Chapter 2 of the Criminal Code
sets out the general principles of criminal responsibility.
(2) An offence under this section is
punishable on conviction by whichever of the following applies:
(a) in the case of an aggravated
offence—imprisonment for 5 years or 2,000 penalty units;
(b) in any other case—imprisonment for
2 years or 500 penalty units.
Note: Section 38 defines aggravated
offence.
35B
Person must not breach conditions of emergency dealing determination—strict
liability offence
(1) A person is guilty of an offence if:
(a) the person takes an action or omits
to take an action; and
(b) the person has knowledge of the
conditions to which an emergency dealing determination is subject; and
(c) the action or omission by the
person contravenes such a condition.
Note: Chapter 2 of the Criminal Code
sets out the general principles of criminal responsibility.
(2) Strict liability applies to
paragraphs (1)(a) and (c).
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.
36
Person must not breach conditions on GMO Register
(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).
37
Offence relating to notifiable low risk dealings
(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).
38
Aggravated offences—significant damage to health or safety of people or to the
environment
(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.
Part 5—Licensing system
Division 1—Simplified outline
39
Simplified outline
The following is a simplified outline of
this Part:
This Part provides a licensing system
under which a person can apply to the Regulator for a licence authorising
dealings with GMOs.
This Part sets out the processes to be
followed by the Regulator in relation to applications involving 2 kinds of
dealings:
(a) those that
involve the intentional release of a GMO into the environment; and
(b) those that
do not involve the intentional release of a GMO into the environment.
A licence can cover dealings by
persons other than the licence holder. The licence holder is required to inform
such persons of any conditions of the licence that apply to them.
Division 2—Licence applications
40
Person may apply for a licence
(1) A person may apply to the Regulator for a
licence authorising specified dealings with one or more specified GMOs by a
person or persons.
(2) The application must be in writing, and
must contain:
(a) such information as is prescribed
by the regulations (if any); and
(b) such information as is specified
in writing by the Regulator.
(3) The application must specify whether any
of the dealings proposed to be authorised by the licence would involve the
intentional release of a GMO into the environment.
(4) The dealings in respect of which a person
may apply for a licence may be:
(a) all dealings with a GMO, or with a
specified class of GMOs; or
(b) a specified class of dealings with
a GMO, or with a specified class of GMOs; or
(c) one or more specified dealings
with a GMO, or with a specified class of GMOs.
(5) The applicant may apply for a licence
authorising such dealings by:
(a) a specified person or persons; or
(b) a specified class of person; or
(c) all persons.
(6) The application must be accompanied by
the application fee (if any) prescribed by the regulations.
40A
Licences relating to inadvertent dealings
(1) If the Regulator is satisfied that a
person has come into possession of a GMO inadvertently the Regulator may, with
the agreement of the person, treat the person as having made an inadvertent dealings
application.
(2) To avoid doubt, subsection (1) does
not prevent a person from making an application under section 40 in
respect of a GMO that has inadvertently come into the person’s possession.
Note: Sections 46A and 49 have the effect that
the Regulator may expedite consideration of an application to dispose of a GMO
that has come into a person’s possession inadvertently. These sections have
effect whether the application is made under section 40, or is taken to
have been made under this section.
41
Application may be withdrawn
(1) The applicant may withdraw the
application at any time before the licence is issued.
(2) The application fee is not refundable if
the applicant withdraws the application.
42
Regulator may require applicant to give further information
(1) The Regulator may, by notice in writing,
require an applicant for a licence to give the Regulator such further
information in relation to the application as the Regulator requires.
(2) The notice may specify the period within
which the information is to be provided.
(3) The Regulator may require information to
be given under this section at any time before the Regulator decides the
application, whether before or after the Regulator has begun to consider the
application.
43
Regulator must consider applications except in certain circumstances
(1) The Regulator must consider an
application under section 40 for a licence in accordance with this Part.
(2) However, the Regulator is not required to
consider the application, or may cease considering the application, if:
(a) the application does not contain
the information specified by the Regulator or prescribed by the regulations; or
(b) the application does not satisfy
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; or
(f) the Regulator is satisfied
(having regard to the matters specified in section 58) that the applicant
is not a suitable person to hold a licence.
(3) The Regulator must issue the licence, or
refuse to issue the licence, within the period (if any) prescribed by the
regulations.
44
Regulator may consult with applicant
Before considering an application in
accordance with the requirements of this Part, the Regulator may consult the
applicant, or another regulatory agency, on any aspect of the application.
45
Regulator must not use certain information in considering licence application
If:
(a) a person (the first person)
applies for a GMO licence; and
(b) the first person provides
information to the Regulator for the purposes of the Regulator’s consideration
of the application; and
(c) the information is confidential
commercial information;
the Regulator must not take that information into account
for the purposes of considering an application by another person for a GMO
licence, unless the first person has given written consent for the information
to be so taken into account.
Division 3—Initial consideration of licences for dealings not involving
intentional release of a GMO into the environment
46
Applications to which this Division applies
This Division applies to an application
for a GMO licence if the Regulator is satisfied that none of the dealings
proposed to be authorised by the licence would involve the intentional release
of a GMO into the environment.
46A
Division does not apply to an application relating to inadvertent dealings
Despite section 46, this Division
does not apply to an application for a GMO licence if the Regulator is
satisfied that:
(a) the dealings proposed to be
authorised by the licence are limited to dealings to be undertaken for the
purposes of, or for purposes relating to, disposing of a GMO; and
(b) the applicant for the licence came
into possession of the GMO inadvertently.
47
What the Regulator must do in relation to application
(1) Before issuing the licence, the Regulator
must prepare a risk assessment and a risk management plan in relation to the
dealings proposed to be authorised by the licence.
(2) In preparing the risk assessment, the
Regulator must take into account the risks posed by the dealings proposed to be
authorised by the licence, including any risks to the health and safety of
people or risks to the environment.
(3) In preparing the risk management plan,
the Regulator must take into account the means of managing any risks posed by
the dealings proposed to be authorised by the licence in such a way as to
protect:
(a) the health and safety of people;
and
(b) the environment.
(4) The Regulator may consult:
(a) the States; and
(b) the Gene Technology Technical
Advisory Committee; and
(c) relevant Commonwealth authorities
or agencies; and
(d) any local council that the
Regulator considers appropriate; and
(e) any other person the Regulator
considers appropriate;
on any aspect of the application.
Division 4—Initial consideration of licences for dealings involving
intentional release of a GMO into the environment
48
Applications to which this Division applies
This Division applies to an application for
a GMO licence if the Regulator is satisfied that at least one of the dealings
proposed to be authorised by the licence would involve the intentional release
of a GMO into the environment.
49
Division does not apply to an application relating to inadvertent dealings
Despite section 48, this Division
does not apply to an application for a GMO licence if the Regulator is
satisfied that:
(a) the dealings proposed to be
authorised by the licence are limited to dealings to be undertaken for the
purposes of, or for purposes relating to, disposing of a GMO; and
(b) the applicant for the licence came
into possession of the GMO inadvertently.
50
Regulator must prepare risk assessment and risk management plan
(1) Before issuing the licence, the Regulator
must prepare a risk assessment and a risk management plan in relation to the
dealings proposed to be authorised by the licence.
(3) Unless section 50A applies in
relation to the application for the licence, the Regulator must seek advice on
matters relevant to the preparation of the risk assessment and the risk
management plan from:
(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.
50A
Limited and controlled release applications
(1) This section applies to an application
for a licence if the Regulator is satisfied that:
(a) the principal purpose of the
application is to enable the licence holder, and persons covered by the
licence, to conduct experiments; and
(b) the application proposes, in
relation to any GMO in respect of which dealings are proposed to be authorised:
(i) controls to restrict
the dissemination or persistence of the GMO and its genetic material in the
environment; and
(ii) limits on the proposed
release of the GMO; and
(c) the Regulator is satisfied that
the controls and limits are of such a kind that it is appropriate for the
Regulator not to seek the advice referred to in subsection 50(3).
(2) For the purposes of subsection (1):
controls, in relation to a GMO and its
genetic material, include the following:
(a) methods to restrict the
dissemination or persistence of the GMO or its genetic material in the
environment;
(b) methods for disposal of the GMO or
its genetic material;
(c) data collection, including studies
to be conducted about the GMO or its genetic material;
(d) the geographic area in which the
proposed dealings with the GMO or its genetic material may occur;
(e) compliance, in relation to
dealings with the GMO or its genetic material, with:
(i) a code of practice
issued under section 24; or
(ii) a technical or
procedural guideline issued under section 27.
(3) For the purposes of
subsection (1):
limits, in relation to the release of a GMO
that is proposed to be authorised by a licence, includes limits on any of the
following:
(a) the scope of the dealings with the
GMO;
(b) the scale of the dealings with the
GMO;
(c) the locations of the dealings with
the GMO;
(d) the duration of the dealings with
the GMO;
(e) the persons who are to be
permitted to conduct the dealings with the GMO.
(4) In deciding whether the principal purpose
of an application is to enable the licence holder, and persons covered by the
licence, to conduct experiments, the Regulator:
(a) must have regard to whether the
applicant proposes that any or all of the following be authorised by, and done
under, the licence:
(i) testing hypotheses;
(ii) gaining scientific or
technical knowledge;
(iii) gaining data for
regulatory purposes, or for product development or marketing; and
(b) may have regard to any other
matter that the Regulator considers to be relevant.
51
Matters Regulator must take into account in preparing risk assessment and risk
management plan
(1) In preparing the risk assessment in
relation to the dealings proposed to be authorised by the licence, the
Regulator must take into account the following:
(a) the risks posed by those dealings,
including any risks to the health and safety of people or risks to the
environment, having regard to the matters prescribed by the regulations;
(c) any advice in relation to the risk
assessment provided by a State or a local council in response to a request
under 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;
(c) any advice in relation to the risk
management plan provided by a State or a local council in response to a request
under subsection 50(3);
(d) any advice in relation to the risk
management plan provided by the Gene Technology Technical Advisory Committee in
response to a request under subsection 50(3);
(e) any advice in relation to the risk
management plan provided by a Commonwealth authority or agency in response to a
request under subsection 50(3);
(f) any advice in relation to the
risk management plan provided by the Environment Minister in response to a
request under subsection 50(3);
(g) any other matter prescribed by the
regulations for the purposes of this paragraph.
(3) For the avoidance of doubt, in taking
into account the means of managing risks as mentioned in paragraph (2)(a),
the Regulator:
(a) is not limited to considering
submissions or advice mentioned in paragraphs (2)(b), (c), (d), (e) and
(f); and
(b) subject to section 45, may
take into account other information, including, but not limited to, relevant
independent research.
52
Public notification of risk assessment and risk management plan
(1) After taking the steps referred to in
sections 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
(ba) if the Regulator is satisfied that
one or more dealings proposed to be authorised by the licence may pose a
significant risk to the health and safety of people or to the environment—state
that the Regulator is so satisfied; and
(c) invite written submissions in
relation to the risk assessment and the risk management plan; and
(d) specify the closing date for
submissions, which must not be earlier than:
(i) if the notice states
that the Regulator is satisfied that the dealings proposed to be authorised by
the licence may pose a significant risk to the health and safety of people or
to the environment—50 days after the date on which the notice was published; or
(ii) in any other case—30
days after the date on which the notice was published.
(3) The Regulator must also seek advice on
the risk assessment and the risk management plan from:
(a) the States; and
(b) the Gene Technology Technical
Advisory Committee; and
(c) each Commonwealth authority or
agency prescribed by the regulations for the purposes of this paragraph; and
(d) the Environment Minister; and
(e) any local council that the
Regulator considers appropriate.
53
Regulator may take other actions
(1) In addition to satisfying the
requirements of this Division in relation to an application for a licence to
which this Division applies, the Regulator may take any other action the
Regulator considers appropriate for the purpose of deciding the application,
including holding a public hearing.
(2) If the Regulator holds a public hearing,
the Regulator may, having regard to the requirements of this Act in relation to
confidential commercial information, direct that any part of the hearing be
held in private, and may determine who can attend.
(3) The Regulator may give directions
prohibiting or restricting the publication of evidence given, or material
contained in documents produced, at a public hearing.
(4) A person must not contravene a direction
given under subsection (3).
Maximum penalty: 30 penalty units.
Note: Chapter 2 of the Criminal Code
sets out the general principles of criminal responsibility.
54
Person may request copies of certain documents
(1) A person may request that the Regulator
provide the person with a copy of the following documents:
(a) an application to which this
Division applies;
(b) a risk assessment or a risk
management plan prepared under section 50.
(2) If a person makes a request under subsection (1),
the Regulator must provide to the person a copy of the documents, other than:
(a) any confidential commercial
information contained in the documents; and
(b) any information contained in the
documents about relevant convictions (within the meaning of section 58) of
the applicant for the licence.
Note 1: In order for information to be confidential
commercial information, it must be covered by a declaration under
section 185.
Note 2: The Privacy Act 1988 also contains
provisions relevant to the disclosure of information.
Division 5—Decision on licence etc.
55
Regulator must make a decision on licence and licence conditions
After taking any steps required by
Division 3 or 4 of this Part in relation to an application for a GMO
licence, the Regulator:
(a) must decide whether to issue or
refuse to issue the licence; and
(b) if the Regulator decides to issue
the licence—may impose conditions to which the licence is subject.
56
Regulator must not issue the licence unless satisfied as to risk management
(1) The Regulator must not issue the licence
unless the Regulator is satisfied that any risks posed by the dealings proposed
to be authorised by the licence are able to be managed in such a way as to
protect:
(a) the health and safety of people;
and
(b) the environment.
(2) For the purposes of subsection (1),
the Regulator must have regard to the following:
(a) the risk assessment prepared under
section 47 or 50 in relation to the dealings;
(b) the risk management plan prepared
under section 47 or 50 in relation to the dealings;
(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.
Note: Paragraphs (2)(a), (b) and (c) do not
apply to an inadvertent dealings application.
57
Other circumstances in which Regulator must not issue the licence
(1) The Regulator must not issue the licence
if the Regulator is satisfied that issuing the licence would be inconsistent
with a policy principle in force under section 21.
(2) The Regulator must not issue the licence
unless the Regulator is satisfied that the applicant is a suitable person to
hold the licence.
(3) Subsection (2) does not apply to an
inadvertent dealings application.
58
Matters to be taken into account in deciding whether a person is suitable to
hold a licence
(1) Without limiting the matters to which the
Regulator may have regard in deciding whether a natural person is a suitable
person to hold a licence, the Regulator must have regard to:
(a) any relevant conviction of the
person; and
(b) any revocation or suspension of a
licence or permit (however described) held by the person under a law of the
Commonwealth, a State or a foreign country, being a law relating to the health
and safety of people or the environment; and
(c) the capacity of the person to meet
the conditions of the licence.
(2) Without limiting the matters to which the
Regulator may have regard in deciding whether a body corporate is a suitable
person to hold a licence, the Regulator must have regard to the following:
(a) any relevant conviction of the
body corporate; and
(b) if there is a relevant conviction
of the body corporate:
(i) whether the offence
concerned was committed at a time when any person who is presently a director
of the body corporate was a director; and
(ii) whether that offence
was committed at a time when any officer or shareholder of the body corporate
who is presently in a position to influence the management of the body
corporate was such an officer or shareholder; and
(c) any revocation or suspension of a
licence or permit (however described) held by the body corporate under a law of
the Commonwealth, a State or a foreign country, being a law relating to the health
and safety of people or the environment; and
(d) the capacity of the body corporate
to meet the conditions of the licence.
(3) In this section:
relevant conviction means a conviction for an
offence against a law of the Commonwealth, a State or a foreign country, being
a law relating to the health and safety of people or the environment, if:
(a) the offence was committed within
the period of 10 years immediately before the making of the application for the
licence; and
(b) the offence was punishable on
conviction by a fine of $5,000 or more, or by a term of imprisonment of one
year or more.
(4) Nothing in this section affects the
operation of Part VIIC of the Crimes Act 1914 (which includes
provisions that, in certain circumstances, relieve persons from the requirement
to disclose spent convictions and require persons aware of such convictions to
disregard them).
59
Notification of licence decision
The Regulator must notify the applicant
in writing of the Regulator’s decision (including any conditions imposed by the
Regulator, if applicable).
60
Period of licence
(1) A licence continues in force:
(a) if the licence is expressed to be
in force for a particular period—until the end of that period; or
(b) otherwise—until it is cancelled or
surrendered.
(2) A licence is not in force throughout any
period of suspension.
(3) A licence issued as a result of an
inadvertent dealings application must not be expressed to be in force for a
period of longer than 12 months.
Division 6—Conditions of licences
61
Licence is subject to conditions
A GMO licence is subject to the
following conditions:
(a) the conditions set out in sections 63,
64 and 65;
(b) any conditions prescribed by the
regulations;
(c) any conditions imposed by the
Regulator at the time of issuing the licence;
(d) any conditions imposed by the
Regulator under section 71 after the licence is issued.
62
Conditions that may be prescribed or imposed
(1) Licence conditions may include conditions
that impose obligations in relation to GM products that are derived from a GMO
in respect of which particular dealings are licensed.
(2) Licence conditions may relate to, but are
not limited to, the following:
(a) the scope of the dealings
authorised by the licence;
(b) the purposes for which the
dealings may be undertaken;
(c) variations to the scope or
purposes of the dealings;
(d) documentation and record‑keeping
requirements;
(e) the required level of containment
in respect of the dealings, including requirements relating to the certification
of facilities to specified containment levels;
(f) waste disposal requirements;
(g) measures to manage risks posed to
the health and safety of people, or to the environment;
(h) data collection, including studies
to be conducted;
(i) auditing and reporting;
(j) actions to be taken in case of
the release of a GMO from a contained environment;
(k) the geographic area in which the
dealings authorised by the licence may occur;
(l) requiring compliance with a code
of practice issued under section 24, or a technical or procedural
guideline issued under section 27;
(m) supervision by, and monitoring by,
Institutional Biosafety Committees;
(n) contingency planning in respect of
unintended effects of the dealings authorised by the licence;
(o) limiting the dissemination or
persistence of the GMO or its genetic material in the environment.
(3) Licence conditions may also include
conditions requiring the licence holder to be adequately insured against any
loss, damage, or injury that may be caused to human health, property or the
environment by the licensed dealing.
63
Condition about informing people of obligations
(1) It is a condition of a licence that the
licence holder inform any person covered by the licence, to whom a particular
condition of the licence applies, of the following:
(a) the particular condition,
including any variations of it;
(b) the cancellation or suspension of
the licence;
(c) the surrender of the licence.
(2) Requirements in relation to the manner in
which information is provided under subsection (1) may be:
(a) prescribed by the regulations; or
(b) specified by the Regulator.
(3) Such requirements may include, but are
not limited to, measures relating to labelling, packaging, conducting training
and providing information.
(4) If such requirements are prescribed or
specified, it is a condition of a licence that the licence holder comply with
the requirements.
64
Condition about monitoring and audits
(1) It is a condition of a licence that if:
(a) a person is authorised by the
licence to deal with a GMO; and
(b) a particular condition of the
licence applies to the dealing by the person;
the person must allow the Regulator, or a person
authorised by the Regulator, to enter premises where the dealing is being
undertaken, for the purposes of auditing or monitoring the dealing.
(2) Subsection (1) does not limit the
conditions that may be imposed by the Regulator or prescribed by the
regulations.
65
Condition about additional information to be given to the Regulator
(1) It is a condition of a licence that the
licence holder inform the Regulator if he or she:
(a) becomes aware of additional
information as to any risks to the health and safety of people, or to the
environment, associated with the dealings authorised by the licence; or
(b) becomes aware of any
contraventions of the licence by a person covered by the licence; or
(c) becomes aware of any unintended
effects of the dealings authorised by the licence.
(2) For the purposes of subsection (1):
(a) the licence holder is taken to
have become aware of additional information of a kind mentioned in subsection (1)
if he or she was reckless as to whether such information existed; and
(b) the licence holder is taken to
have become aware of contraventions, or unintended effects, of a kind mentioned
in subsection (1) if he or she was reckless as to whether such
contraventions had occurred, or such unintended effects existed.
66
Person may give information to Regulator
A person covered by a licence may inform
the Regulator if he or she:
(a) becomes aware of additional
information as to any risks to the health and safety of people, or to the
environment, associated with the dealings authorised by the licence; or
(b) becomes aware of any
contraventions of the licence by a person covered by the licence; or
(c) becomes aware of any unintended
effects of the dealings authorised by the licence.
67
Protection of persons who give information
A person (the first person)
does not incur any civil liability in respect of loss, damage or injury of any
kind suffered by another person because the first person gave information to
the Regulator under section 65, 66 or paragraph 72D(2)(h).
Division 7—Suspension, cancellation and variation of licences
68
Suspension and cancellation of licence
The Regulator may, by notice in writing
given to the holder of a GMO licence, suspend or cancel the licence if:
(a) the Regulator believes on
reasonable grounds that a condition of the licence has been breached, whether
by the licence holder or by a person covered by the licence; or
(b) the Regulator believes on
reasonable grounds that the licence holder, or a person covered by the licence,
has committed an offence against this Act or the regulations; or
(c) any annual charge payable in
respect of the licence remains unpaid after the due date; or
(d) the licence was obtained
improperly; or
(e) the Regulator becomes aware of
risks associated with the continuation of the dealings authorised by the
licence, and is satisfied that the licence holder has not proposed, or is not
in a position to implement, adequate measures to deal with those risks; or
(f) the Regulator is satisfied that
the licence holder is no longer a suitable person to hold the licence.
69
Surrender of licence
The licence holder may, with the consent
of the Regulator, surrender the licence.
70
Transfer of licences
(1) The licence holder and another person
(the transferee) may jointly apply to the Regulator for the
licence to be transferred from the licence holder to the transferee.
(2) The application must be in writing, and
must contain:
(a) such information as is prescribed
by the regulations (if any); and
(b) such information as is specified
in writing by the Regulator.
(3) The Regulator must not transfer the
licence unless the Regulator is satisfied that, if the licence is transferred,
any risks posed by the dealings authorised by the licence will continue to be
able to be managed in such a way as to protect:
(a) the health and safety of people;
and
(b) the environment.
(4) The Regulator must not transfer the
licence unless the Regulator is satisfied that the transferee is a suitable
person to hold the licence.
(5) The Regulator must give written notice of
his or her decision on the application to the licence holder and the
transferee.
(6) If the Regulator decides to transfer the
licence:
(a) the transfer takes effect on the
date specified in the notice; and
(b) the licence continues in force as
mentioned in section 60; and
(c) the licence is subject to the same
conditions as those in force immediately before the transfer.
71
Variation of licence
(1) The Regulator may vary a licence, by
notice in writing given to the licence holder:
(a) at any time, on the Regulator’s
own initiative; or
(b) on application by the licence‑holder.
(1A) An application for a variation 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.
(2) 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.
(2A) The
Regulator must not vary a licence if the original application for the licence
was an application to which section 50A applied, unless:
(a) the Regulator is satisfied that
the principal purpose of the licence as proposed to be varied is to enable the
licence holder, and persons covered by the licence, to conduct experiments; and
(b) the application for variation proposes,
in relation to any GMO in respect of which dealings are proposed to be
authorised as a result of the variation:
(i) controls to restrict
the dissemination or persistence of the GMO and its genetic material in the
environment; and
(ii) limits on the proposed
release of the GMO; and
(c) the Regulator is satisfied that
the controls and limits are of such a kind that it is appropriate for the
Regulator not to seek the advice referred to in subsection 50(3).
Note: Section 50A applies to an application
that proposes controls and limits on the dissemination, persistence and release
of the GMO concerned and is for the purpose of conducting experiments.
(2B) The Regulator must not vary a licence if
the Regulator is satisfied that the risk assessment and the risk management
plan in respect of the original application for the licence did not cover the
risks posed by the dealings proposed to be authorised by the licence as varied.
(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) The Regulator must not vary a 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.
(5) The Regulator must not vary a licence
unless any local council that the Regulator considers appropriate has been
consulted on the proposed variation.
(6) The Regulator must not vary a licence in
the circumstances (if any) prescribed by the regulations.
(7) If an application has been made for variation
of a licence, the Regulator must vary the licence, or refuse to vary the
licence, within the period (if any) prescribed by the regulations.
(8) For the purposes of subsection (2A):
controls has the same meaning as in
subsection 50A(2).
limits has the same meaning as in subsection
50A(3).
72
Regulator to notify of proposed suspension, cancellation or variation
(1) Before suspending, cancelling or varying
a licence under this Division, the Regulator must give written notice of the
proposed suspension, cancellation or variation to the licence holder.
(2) The notice:
(a) must state that the Regulator
proposes to suspend, cancel or vary the licence; and
(b) may require the licence holder to
give to the Regulator any information of a kind specified in the notice that is
relevant to the proposed suspension, cancellation or variation; and
(c) may invite the licence holder to
make a written submission to the Regulator about the proposed suspension,
cancellation or variation.
(3) The notice must specify a period within
which the licence holder:
(a) must give the information referred
to in paragraph (2)(b); and
(b) may make a submission under paragraph (2)(c).
The period must not end earlier than 30 days after the day
on which the notice was given.
(4) In considering whether to suspend, cancel
or vary a licence, the Regulator must have regard to any submission made under paragraph (2)(c).
(5) This section does not apply to a
suspension, cancellation or variation requested by the licence holder.
(6) This section does not apply to a
suspension, cancellation or variation of a licence if the Regulator considers
that the suspension, cancellation or variation is necessary in order to avoid
an imminent risk of death, serious illness, serious injury or serious damage to
the environment.
(7) This section does not apply to a
variation of a licence if the Regulator is satisfied that the variation is of
minor significance or complexity.
Part 5A—Emergency dealing determinations
Division 1—Simplified outline
72A Simplified
outline
The following is a simplified outline of
this Part:
This Part provides a system under
which the Minister can make determinations relating to dealings with GMOs in
emergencies.
Division 2—Making of emergency dealing determination
72B Minister
may make emergency dealing determination
(1) The Minister may, by legislative
instrument (an emergency dealing determination), specify dealings
with a GMO for the purposes of this Part.
(2) The Minister may make an emergency
dealing determination only if:
(a) the Minister has received advice
from:
(i) the Commonwealth Chief
Medical Officer; or
(ii) the Commonwealth Chief
Veterinary Officer; or
(iii) the Commonwealth Chief
Plant Protection Officer; or
(iv) a person prescribed by
the regulations;
that there is an actual or
imminent threat to the health and safety of people or to the environment, and
that the dealings proposed to be specified in the emergency dealing
determination would, or would be likely to, adequately address the threat; and
(b) the Minister is satisfied that
there is an actual or imminent threat to the health and safety of people or to
the environment, and that the dealings proposed to be specified in the
emergency dealing determination would, or would be likely to, adequately
address the threat; and
(c) the Minister has received advice
from the Regulator that any risks posed by the dealings proposed to be
specified in the emergency dealing determination are able to be managed in such
a way as:
(i) to protect the health
and safety of people; and
(ii) to protect the
environment; and
(d) the Minister is satisfied that any
risks posed by the dealings proposed to be specified in the emergency dealing
determination are able to be managed in such a way as:
(i) to protect the health
and safety of people; and
(ii) to protect the
environment; and
(e) the States have been consulted in
relation to the making of the proposed emergency dealing determination.
(3) An actual or imminent threat of a kind
mentioned in paragraph (2)(a) or (b) may include, but is not limited to,
any of the following:
(a) a threat from the outbreak of a
plant, animal or human disease;
(b) a threat from a particular plant
or animal, such as a pest or an alien invasive species;
(c) a threat from an industrial
spillage.
(4) The dealings in respect of which the
Minister may make an emergency dealing determination 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.
72C
Period of effect of emergency dealing determination
(1) An emergency dealing determination takes
effect:
(a) on the day on which the emergency
dealing determination is made; or
(b) on a later day that is specified
in the emergency dealing determination.
(2) An emergency dealing determination ceases
to have effect:
(a) subject to subsection (3), at
the end of the period of 6 months starting when the emergency dealing
determination takes effect; or
(b) at the end of the period specified
by the Minister in the emergency dealing determination; or
(c) when the emergency dealing
determination is revoked;
whichever occurs first.
(3) The Minister may, by legislative
instrument, extend the period of effect of an emergency dealing determination.
(4) The Minister may extend the period of
effect of an emergency dealing determination under subsection (3) more
than once, but each single such extension must not exceed 6 months.
(5) The Minister may extend the period of
effect of an emergency dealing determination only if:
(a) the Minister has received advice
from the original adviser in relation to the emergency dealing determination
that the threat to which the determination relates still exists, and that the
proposed extension would, or would be likely to, adequately address the threat;
and
(b) the Minister is satisfied that the
threat still exists, and that the proposed extension would, or would be likely
to, adequately address that threat; and
(c) the Minister has received advice
from the Regulator that any risks posed by the proposed extension are able to
be managed in such a way as:
(i) to protect the health
and safety of people; and
(ii) to protect the environment;
and
(d) the Minister is satisfied that any
risks posed by the proposed extension are able to be managed in such a way as:
(i) to protect the health
and safety of people; and
(ii) to protect the
environment; and
(e) a majority of jurisdictions agree
to the extension.
(6) A legislative instrument extending the
period of effect of an emergency dealing determination takes effect at the time
when the determination would have ceased to have effect but for the extension.
(7) In subsection (5):
original adviser, in relation to an emergency
dealing determination, means the person who gave the advice mentioned in
paragraph 72B(2)(a) in relation to the determination.
Division 3—Effect and conditions of emergency dealing determination
72D
Emergency dealing determination authorises dealings, subject to conditions
(1) If an emergency dealing determination is
in force in respect of dealings with a GMO, those dealings are authorised,
subject to the conditions (if any) specified in the emergency dealing determination.
(2) Conditions may relate to, but are not
limited to, the following:
(a) the quantity of GMO in relation to
which dealings are covered;
(b) the scope of the dealings covered;
(c) the purposes for which the
dealings may be undertaken;
(d) variations to the scope or
purposes of the dealings;
(e) the source of the GMO;
(f) the persons who may deal with the
GMO;
(g) the information that is required
to be given by a person and the person to whom that information is to be given;
(h) obligations about informing the
Regulator if:
(i) a person becomes aware
of additional information as to any risks to the health and safety of people,
or to the environment, associated with the dealings specified in the emergency
dealing determination; or
(ii) a person becomes aware
of any contraventions of the conditions to which the emergency dealing
determination is subject by any person; or
(iii) a person becomes aware
of any unintended effects of the dealings specified in the emergency dealing
determination;
(i) the storage and security of the
GMO;
(j) the required level of containment
in respect of the dealings, including requirements relating to the
certification of facilities to specified containment levels;
(k) waste disposal requirements;
(l) the manner in which any quantity
of the GMO is to be dealt with if a condition of the emergency dealing
determination is breached;
(m) measures to manage risks posed to
the health and safety of people, or to the environment;
(n) data collection, including studies
to be conducted;
(o) auditing and reporting;
(p) the keeping and disclosure of, and
access to, records about the GMO;
(q) actions to be taken in case of the
release of a GMO from a contained environment;
(r) the geographic area in which the
dealings specified in the emergency dealing determination may occur;
(s) requirements for compliance with
a code of practice issued under section 24, or a technical or procedural
guideline issued under section 27;
(t) supervision by, and monitoring
by, Institutional Biosafety Committees;
(u) contingency planning in respect of
unintended effects of the dealings specified in the emergency dealing
determination;
(v) limiting the dissemination or
persistence of the GMO or its genetic material in the environment;
(w) any other matters that the Minister
thinks appropriate.
(3) A condition under paragraph (2)(f)
may permit dealings with a GMO by, or may impose obligations upon:
(a) a specified person or persons; or
(b) a specified class of person.
(4) It is a condition of an emergency dealing
determination that if:
(a) a dealing with a GMO is specified
in the emergency dealing determination; and
(b) a particular condition of the
emergency dealing determination applies to the dealing by a 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.
(5) Subsection (4) does not limit the
conditions that may be specified in an emergency dealing determination.
Division 4—Variation, suspension and revocation of emergency dealing
determination
72E
Variation, suspension and revocation of emergency dealing determination
(1) The Minister may, by legislative
instrument, vary the conditions to which an emergency dealing determination is
subject, including by imposing new conditions.
(2) The Minister may, by legislative
instrument, suspend or revoke an emergency dealing determination if:
(a) the Minister becomes aware of
risks to the health and safety of people, or to the environment, associated
with the continuation of the dealings authorised by the emergency dealing
determination, and is satisfied that adequate measures to address those risks
are not able to be implemented; or
(b) the Minister is satisfied that the
threat to which the emergency dealing determination relates:
(i) no longer exists; or
(ii) is no longer
sufficiently actual or imminent as to require the determination to be in force
to address that threat; or
(c) the Minister is no longer
satisfied that the dealings specified in the emergency dealing determination
adequately address the threat.
(3) The Minister must not:
(a) vary an emergency dealing
determination (unless the variation is of a minor technical nature); or
(b) suspend or revoke an emergency
dealing determination;
unless the States have been consulted in relation to the
variation, suspension or revocation, as the case requires.
(4) A variation, suspension or revocation of
an emergency dealing determination takes effect:
(a) if the Minister states in the
variation, suspension or revocation that the variation, suspension or
revocation is necessary to prevent imminent risk of death, serious illness,
serious injury or serious environmental damage—on the day on which the
variation, suspension or revocation is made; or
(b) in any other case—on the day
specified by the Minister in the variation, suspension or revocation.
(5) The day specified as mentioned in
paragraph (4)(b) must not be earlier than 30 days after the day on which
the variation, suspension or revocation is made.
Part 6—Regulation of notifiable low risk dealings and dealings on
the GMO Register
Division 1—Simplified outline
73
Simplified outline
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.
Division 2—Notifiable low risk dealings
74
Notifiable low risk dealings
(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.
75
Regulation of notifiable low risk dealings
(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.
Division 3—The GMO Register
76 GMO
Register
(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.
77
Contents of Register
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.
78
Regulator may include dealings with GMOs on GMO Register
(1) The Regulator may, by writing, determine
that a dealing with a GMO is to be included on the GMO Register if the
Regulator is satisfied that:
(a) the dealing is, or has been,
authorised by a GMO licence; or
(b) the GMO concerned:
(i) is a GM product; and
(ii) is a genetically
modified organism only because of regulations made under paragraph (c) of
the definition of genetically modified organism.
(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.
(4) A determination under subsection (1)
is a disallowable instrument for the purposes of section 46A of the Acts
Interpretation Act 1901.
79
Regulator not to make determination unless risks can be managed
(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.
80
Variation of GMO Register
(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.
81
Inspection of Register
The Regulator must permit any person to
inspect any part of the GMO Register.
Part 7—Certification and accreditation
Division 1—Simplified outline
82
Simplified outline
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, or conditions to which an emergency dealing determination
is subject, 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, or conditions to which
an emergency dealing determination is subject, can specify that dealings must
be supervised by an Institutional Biosafety Committee established by an
accredited organisation.
Division 2—Certification
83
Application for certification
(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, or conditions to
which an emergency dealing determination is subject, 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.
84
When the Regulator may certify the facility
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.
85
Regulator may require applicant to give further information
(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.
86 Conditions
of certification
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.
87
Variation of certification
(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.
88
Suspension or cancellation of certification
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.
89
Regulator to notify of proposed suspension, cancellation or variation
(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.
(7) This section does not apply to a
variation of a certification if the Regulator is satisfied that the variation
is of minor significance or complexity.
89A
Transfer of certification
(1) The holder of a certification and another
person (the transferee) may jointly apply to the Regulator for
the certification to be transferred from the holder of the certification 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
certification unless the Regulator is satisfied that, if the certification is
transferred, any conditions to which the certification is subject will continue
to be met.
(4) The Regulator must give written notice of
his or her decision on the application to the holder of the certification and
the transferee.
(5) If the Regulator decides to transfer the
certification:
(a) the transfer takes effect on the
date specified in the notice; and
(b) the certification continues in
force; and
(c) the certification is subject to
the same conditions as those in force immediately before the transfer.
90
Guidelines
(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.
Division 3—Accredited organisations
91
Application for accreditation
(1) A person may apply to the Regulator for
accreditation of an organisation as an accredited organisation under this
Division.
Note 1: 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)).
Note 2: The conditions to which an emergency dealing
determination is subject may require supervision of dealings by an Institutional
Biosafety Committee established by an accredited organisation (see paragraph
72D(2)(t)).
(2) The application must be in writing, and
must contain such information as the Regulator requires.
92
Regulator may accredit organisations
(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 an Institutional Biosafety Committee in accordance with written
guidelines issued by the Regulator under section 98; and
(b) if the organisation has
established an Institutional Biosafety Committee—whether the organisation will
be able to maintain the Institutional Biosafety Committee in accordance with
such guidelines; and
(c) if the organisation has
established an Institutional Biosafety Committee—whether the organisation has
appropriate indemnity arrangements for its Institutional Biosafety Committee
members; and
(ca) if the organisation has not
established an Institutional Biosafety Committee as mentioned in
paragraph (a)—whether the organisation will be in a position to use an
Institutional Biosafety Committee established by an accredited organisation;
and
(d) any other matters specified in
such guidelines.
93
Regulator may require applicant to give further information
(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.
94
Conditions of accreditation
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.
95
Variation of accreditation
(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.
96
Suspension or cancellation of accreditation
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.
97
Regulator to notify of proposed suspension, cancellation or variation
(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.
(7) This section does not apply to a
variation of an accreditation if the Regulator is satisfied that the variation
is of minor significance or complexity.
98 Guidelines
(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.
Part 8—The Gene Technology Technical Advisory Committee and the
Gene Technology Ethics and Community Consultative Committee
Division 1—Simplified outline
99
Simplified outline
The following is a simplified outline of
this Part:
This Part provides for the
establishment of the Gene Technology Technical Advisory Committee and the Gene
Technology Ethics and Community Consultative Committee.
The Part sets out the membership of
these bodies, and their functions.
Division 2—The Gene Technology Technical Advisory Committee
100
The Gene Technology Technical Advisory Committee
(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 subsections (6) and (7A),
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).
(7A) The Minister must ensure that the Committee
includes at least one person who is a member of the Ethics and Community
Committee. The Minister is not required to be satisfied that this person has
skills or experience in an area 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.
101
Function of the Gene Technology Technical Advisory Committee
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.
102
Expert advisers
(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.
103
Remuneration
(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.
104
Members and procedures
(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.
105
Subcommittees
(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.
Division 3—The Gene Technology Ethics and Community Consultative
Committee
106
The Gene Technology Ethics and Community Consultative Committee
The Gene Technology Ethics and Community
Consultative Committee (the Ethics and Community Committee) is
established.
107
Function of Ethics and Community Committee
The function of the Ethics and Community
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;
(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;
(e) community consultation in respect
of the process for applications for licences covering dealings that involve the
intentional release of a GMO into the environment;
(f) risk communication matters in
relation to dealings that involve the intentional release of a GMO into the
environment;
(g) matters of general concern identified
by the Regulator in relation to applications made under this Act;
(h) matters of general concern in
relation to GMOs.
108
Membership
(1) The Minister is to appoint up to 12
members of the Ethics and Community Committee, and must appoint one of the members
to chair the Ethics and Community Committee.
(2) Before appointing a member of the Ethics
and Community 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.
(3) The Minister must not appoint a person as
a member of the Ethics and Community Committee (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) community consultation;
(b) risk communication;
(c) the impact of gene technology on
the community;
(d) issues relevant to businesses
developing or using biotechnology;
(e) issues relevant to gene technology
research;
(f) issues relevant to local
government;
(g) issues of concern to consumers;
(h) law;
(i) religious practices;
(j) human health;
(k) animal health and welfare;
(l) primary production;
(m) ethics;
(n) environmental issues;
(o) issues specified by the
regulations for the purposes of this paragraph.
(4) The Minister must ensure that the Ethics
and Community 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.
(5) The members of the Ethics and Community
Committee hold office on a part‑time basis.
(6) The Minister must not appoint a member to
chair the Ethics and Community Committee unless a majority of jurisdictions
agree to the appointment.
109
Remuneration
(1) A person who is a member of the Ethics
and Community 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
and Community 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.
110
Membership and Procedures
(1) The regulations may prescribe matters
relating to the members of the Ethics and Community Committee, 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 and Community Committee, including, but
not limited to, the following:
(a) procedures for convening meetings
of the Ethics and Community Committee;
(b) the constitution of a quorum for a
meeting of the Ethics and Community Committee;
(c) the way in which matters are to be
resolved by the Ethics and Community Committee;
(d) Ethics and Community Committee
records;
(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 and Community Committee must operate in the way
determined in writing by the Regulator.
(4) If no regulations are in force under
subsection (2) and no determination is in force under subsection (3),
the Ethics and Community Committee may operate in the way determined in writing
by the Ethics and Community Committee.
(5) A determination made under
subsection (3) or (4) is not a legislative instrument.
111
Subcommittees
(1) The Ethics and Community 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.
112
Expert advisers
(1) The Minister may appoint one or more
persons (expert advisers) to give expert advice to the Ethics and
Community Committee to assist it in the performance of its functions. Expert
advisers may be appointed on a continuing or an ad hoc basis.
(2) Expert advisers are not members of the
Ethics and Community Committee.
Part 9—Administration
Division 1—Simplified outline
117
Simplified outline
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.
Division 2—Appointment and conditions of Regulator
118
Appointment of the Regulator
(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.
(5) The Governor‑General must not
appoint a person as the Regulator if, at any time during the period of 2 years
immediately before the proposed period of appointment, the person was employed
by a body corporate whose primary commercial activity relates directly to the
development and implementation of gene technologies.
(6) The Governor‑General must not
appoint a person as the Regulator if the person has a pecuniary interest in a
body corporate whose primary commercial activity relates directly to the
development and implementation of gene technologies.
119
Termination of 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; or
(c) an ordinary employer‑sponsored
member of PSSAP, within the meaning of the Superannuation Act 2005;
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 Board (within the meaning of
the Superannuation Act 1976) gives a certificate under section 54C
of that Act.
(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 Board (within the meaning of
the Superannuation Act 1990) gives a certificate under section 13
of that Act.
(7) For the purposes of the Superannuation
Act 2005, 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 Board (within the meaning of
the Superannuation Act 2005) gives an approval and certificate under
section 43 of that Act.
120
Disclosure of interests
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.
121
Acting appointment
(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.
122
Terms and conditions
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.
123
Outside employment
The Regulator must not engage in paid
employment outside the duties of the Regulator’s office without the approval of
the Minister.
124
Remuneration
(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.
125
Leave of absence
(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.
126
Resignation
The Regulator may resign his or her
appointment by giving the Governor‑General a written resignation.
Division 3—Money
127
Regulator may charge for services
The Regulator may charge for services
provided by, or on behalf of, the Regulator in the performance of the
Regulator’s functions.
128
Notional payments by the Commonwealth
(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.
129
Gene Technology Account
(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.
130
Credits to Account
(1) There must be credited to the Account the
following:
(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 amounts standing to the credit of
the Account;
(f) amounts equal to money received
by the Commonwealth in relation to property paid for with amounts standing to
the credit of 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 debited from the Account;
(h) amounts equal to amounts of any
gifts given or bequests made for the purposes of the Account.
Note: An Appropriation Act provides for amounts to
be credited to a Special Account if any of the purposes of the Account is a
purpose that is covered by an item in the Appropriation Act.
(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.
131
Recovery of amounts
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.
132
Purposes of Account
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.
Division 4—Staffing
133
Staff assisting the Regulator
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.
134
Consultants
(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.
135
Seconded officers
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.
Division 5—Reporting requirements
136
Annual Report
(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.
136A
Quarterly reports
(1) As soon as practicable after the end of
each quarter, the Regulator must prepare and give to the Minister a report on
the operations of the Regulator during that quarter.
(2) The report must include information about
the following:
(a) GMO licences issued during the
quarter;
(b) any breaches of conditions of a
GMO licence that have come to the Regulator’s attention during the quarter;
(ba) emergency dealing determinations
made by the Minister during the quarter;
(bb) any breaches of conditions of an
emergency dealing determination that have come to the Regulator’s attention
during the quarter;
(c) auditing and monitoring of
dealings with GMOs under this Act by the Regulator or an inspector during the
quarter.
Note: Auditing and monitoring may include spot checks.
(3) 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.
(4) In this section:
quarter means a period of 3 months beginning
on 1 January, 1 April, 1 July or 1 October of any year.
137
Reports to Parliament
(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.
Division 6—Record of GMO and GM Product Dealings
138
Record of GMO and GM Product Dealings
(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).
(3A) The Record must contain the following
information, other than confidential commercial information, in relation to
each emergency dealing determination made under section 72B:
(a) the dealings specified in the
emergency dealing determination and the GMO to which those dealings relate;
(b) any conditions to which the
emergency dealing determination is subject;
(c) the date on which the emergency
dealing determination takes effect;
(d) the date on which the emergency
dealing determination will cease to have effect.
(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 Food Standards Australia
New Zealand 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.
139
Inspection of Record
The Regulator must permit any person to
inspect any part of the Record.
Division 7—Reviews of notifiable low risk dealings and exemptions
140
Regulator may review notifiable low risk dealings
(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).
141
Regulator may review exemptions
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.
142
Regulator may give notice of consideration
(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.
143
What Regulator may do after consideration
(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.
144
Regulator not required to review matters
Nothing in this Division requires the
Regulator to consider a matter under section 140 or 141.
Part 10—Enforcement
145
Simplified outline
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, or for certain other
reasons.
This Part enables the Regulator to
give directions to a person permitted by an emergency dealing determination to
deal with a GMO, 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 or for certain other
reasons.
The Part also empowers the Federal
Court to issue injunctions, and contains a forfeiture provision.
146 Regulator
may give directions
(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) either of the following applies:
(i) it is necessary to
exercise powers under this section in order to protect the health and safety of
people or to protect the environment;
(ii) it is desirable in the
public interest, having regard to the matters specified in
subsection (2A), for the Regulator to exercise powers under this section;
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) one of the following kinds of
persons is not complying with this Act or the regulations in respect of a
thing:
(i) a person covered by a
GMO licence;
(ii) a person dealing with,
or who has dealt with, a GMO specified in an emergency dealing determination;
and
(b) either of the following applies:
(i) it is necessary to
exercise powers under this section in order to protect the health and safety of
people or to protect the environment;
(ii) it is desirable in the
public interest, having regard to the matters specified in
subsection (2A), for the Regulator to exercise powers under this section;
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.
(2A) For the purposes of deciding under
subparagraph (1)(b)(ii) or (2)(b)(ii) whether it is desirable to exercise
powers under this section to give directions to a licence holder or another
person, the Regulator must have regard to the following:
(a) the types of dealings with GMOs
authorised by the licence or specified in the emergency dealing determination
concerned, and, in particular, whether the dealings are ongoing;
(b) whether measures have been, or are
being, taken to address the non‑compliance with this Act or the regulations
that the Regulator believes is occurring (the suspected non‑compliance);
(c) the likelihood of the licence
holder or other person not complying with this Act or the regulations at a
future time;
(d) the severity of the suspected non‑compliance;
(e) whether, on one or more occasions,
the licence holder or the other person:
(i) has been charged with
or convicted of an offence against this Act; or
(ii) has been given a
direction under this section;
(f) other means available to the
Regulator to address the suspected non‑compliance (including, but not
limited to, by cancelling, varying or suspending a licence, accreditation or
certification);
(g) whether, in the Regulator’s
opinion, the suspected non‑compliance was deliberate;
(h) the desirability of deterring
future non‑compliance 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.
147
Injunctions
(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.
148
Forfeiture
(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.
Part 11—Powers of inspection
Division 1—Simplified outline
149
Simplified outline
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 or an emergency dealing determination can be subject, and
section 64 imposes a condition in relation to monitoring dealings with
GMOs.
Division 2—Appointment of inspectors and identity cards
150
Appointment of inspectors
(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.
151
Identity card
(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.
Division 3—Monitoring powers
152
Powers available to inspectors for monitoring compliance
(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; or
(d) the occupier of the premises is a
person dealing with, or who has dealt with, a GMO specified in an emergency
dealing determination, and the entry is at a reasonable time.
153
Monitoring powers
(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.
Division 4—Offence‑related powers
154
Searches and seizures related to offences
(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.
155
Offence‑related powers of inspectors in relation to premises
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.
156
Use of equipment at 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.
Division 5—Expert assistance
157
Expert assistance to operate a thing
(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.
Division 6—Emergency powers
158
Powers available to inspectors for dealing with dangerous situations
(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.
Division 7—Obligations and incidental powers of inspectors
159
Inspector must produce identity card on request
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.
160
Consent
(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.
161
Details of warrant to be given to occupier etc.
(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.
162
Announcement before entry
(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.
163
Compensation for damage
(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.
Division 8—Power to search goods, baggage etc.
164
Power to search goods, baggage etc.
(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.
165
Seizure of goods
An inspector may seize goods mentioned
in section 164 if the inspector has reasonable grounds to suspect that the
goods are evidential material.
Division 9—General provisions relating to search and seizure
166
Copies of seized things to be provided
(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.
167
Occupier entitled to be present during search
(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.
168
Receipts for things seized
(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.
169
Retention of seized things
(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.
170
Magistrate may permit a thing to be retained
(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.
171
Disposal of goods if there is no owner or owner cannot be located
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.
Division 10—Warrants
172
Monitoring warrants
(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.
173
Offence‑related warrants
(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.
174
Offence‑related warrants by telephone, telex, fax etc.
(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.
175
Offences relating to warrants
(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.
Division 11—Other matters
176
Part not to abrogate privilege against self‑incrimination
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.
177
Part does not limit power to impose conditions
This Part is not to be taken to limit
the Regulator’s power to impose licence conditions or the Minister’s power to
impose conditions on an emergency dealing determination.
Part 12—Miscellaneous
Division 1—Simplified outline
178
Simplified outline
The following is a simplified outline of
this Part:
This Part provides for miscellaneous
matters, including the following:
(a) review of
decisions;
(b) provisions
relating to confidential commercial information;
(c) the making
of regulations;
(d) transitional
provisions;
(e) review of
the operation of the Act.
Division 2—Review of decisions
179
Meaning of terms
The following table sets out:
(a) decisions that are reviewable
decisions; and
(b) each eligible person
in relation to a reviewable decision:
|
Reviewable decisions and eligible persons
|
|
Item
|
Decision
|
Provision under which decision made
|
Eligible person in relation to decision
|
|
1A
|
To refuse to consider an application on the basis that the
applicant is not a suitable person to hold a licence
|
paragraph 43(2)(f)
|
the applicant
|
|
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
|
|
3A
|
To refuse to transfer a licence
|
section 70
|
an applicant for the transfer
|
|
4
|
To vary a licence
|
section 71
|
the licence holder
|
|
4A
|
To refuse 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
|
|
7A
|
To refuse to transfer a certification
|
section 89A
|
an applicant for the transfer
|
|
8
|
To suspend or cancel a certification
|
section 88
|
the holder of the certification
|
|
9
|
To refuse to accredit an organisation
|
section 92
|
the applicant for accreditation
|
|
10
|
To specify a condition of an accreditation
|
section 94
|
the holder of the accreditation
|
|
11
|
To vary an accreditation
|
section 95
|
the holder of the accreditation
|
|
12
|
To suspend or cancel an accreditation
|
section 96
|
the holder of the accreditation
|
|
13
|
To refuse to declare information to be confidential
commercial information
|
section 185
|
the person who made an application under section 184
in relation to the information
|
|
14
|
To revoke a declaration that information is confidential
commercial information
|
section 186
|
the person who made an application under section 184
in relation to the information
|
180
Notification of decisions and review rights
(1) The Regulator must, as soon as
practicable after making a reviewable decision, cause a notice in writing to be
given to each eligible person in relation to the decision, containing:
(a) the terms of the decision; and
(b) the reasons for the decision; and
(c) a statement setting out
particulars of the person’s review rights.
(2) A failure to comply with the requirements
of subsection (1) in relation to a decision does not affect the validity of
the decision.
181
Internal review
(1) An eligible person in relation to a
reviewable decision (other than a decision made by the Regulator personally)
may apply in writing to the Regulator for review (internal review)
of the decision.
(2) An application for internal review must
be made within 30 days after the day on which the decision first came to the
notice of the applicant, or within such period (if any) as the Regulator,
either before or after the end of that period, allows.
(3) The Regulator must, on receiving an
application, review the reviewable decision personally.
(4) The Regulator may:
(a) make a decision affirming, varying
or revoking the reviewable decision; and
(b) if the Regulator revokes the
decision, make such other decision as the Regulator thinks appropriate.
182
Deadlines for making reviewable decisions
If:
(a) this Act provides for a person to
make an application of any kind to the Regulator; 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 reviewable decision to reject the application, and the person may
seek internal review of the reviewable decision under section 181.
183
Review of decisions by Administrative Appeals Tribunal
(1) Subject to the Administrative Appeals
Tribunal Act 1975, an application may be made by an eligible person in relation
to:
(a) a reviewable decision made by the
Regulator personally; or
(b) a decision made by the Regulator
under section 181 (which provides for internal review).
(2) In this section:
decision has the same meaning as in the Administrative
Appeals Tribunal Act 1975.
183A
Extended standing for judicial review
(1) This section extends (and does not limit)
the meaning of the term person aggrieved in the Administrative
Decisions (Judicial Review) Act 1977 for the purposes of the application of
that Act in relation to:
(a) a decision made under this Act or
the regulations; or
(b) a failure to make a decision under
this Act or the regulations; or
(c) conduct engaged in for the purpose
of making a decision under this Act or the regulations.
(2) A State is taken to be a person aggrieved
by the decision, failure or conduct.
(3) A term (except person aggrieved)
used in this section and in the Administrative Decisions (Judicial Review)
Act 1977 has the same meaning in this section as it has in that Act.
Division 3—Confidential commercial information
184
Application for protection of confidential commercial information
(1) A person may apply to the Regulator for a
declaration that specified information to which this Act relates is
confidential commercial information for the purposes of this Act.
(2) An application under subsection (1)
must be in writing in the form approved by the Regulator.
185
Regulator may declare that information is confidential commercial information
(1) Subject to subsection (2), if the
person satisfies the Regulator that the information specified in the
application is:
(a) a trade secret; or
(b) any other information that has a
commercial or other value that would be, or could reasonably be expected to be,
destroyed or diminished if the information were disclosed; or
(c) other information that:
(i) concerns the lawful
commercial or financial affairs of a person, organisation or undertaking; and
(ii) if it were disclosed,
could unreasonably affect the person, organisation or undertaking;
the Regulator must declare that the information is
confidential commercial information for the purposes of this Act.
(2) The Regulator may refuse to declare that
the information is confidential commercial information if the Regulator is
satisfied that the public interest in disclosure outweighs the prejudice that
the disclosure would cause to any person.
(2A) The Regulator must refuse to declare that
information is confidential commercial information if the information relates
to one or more locations at which field trials involving GMOs are occurring, or
are proposed to occur, unless the Regulator is satisfied that significant
damage to the health and safety of people, the environment or property would be
likely to occur if the locations were disclosed.
Note: This means that, in general, information about
sites where dealings with GMOs are occurring will be required to be disclosed
under sections 54 and 138, unless the Regulator is satisfied that
disclosure would involve significant risks to health and safety.
(3) The Regulator must give the applicant
written notice of the Regulator’s decision about the application.
(3A) If:
(a) the Regulator declares that
particular information is confidential commercial information; and
(b) the information relates to one or
more locations at which field trials involving GMOs are occurring, or are
proposed to occur;
the Regulator must make publicly available a statement of
reasons for the making of the declaration, including, but not limited to:
(c) the reasons why the Regulator was
satisfied as mentioned in subsection (1); and
(d) the reasons why the Regulator was
not satisfied under subsection (2) that the public interest in disclosure
of the information outweighed the prejudice that the disclosure would cause;
and
(e) the reasons why the Regulator was
satisfied under subsection (2A) that significant damage to the health and
safety of people, the environment or property would be likely to occur if the
locations were disclosed.
(3B) If:
(a) a person has made an application
under section 184 for a declaration that specified information is
confidential commercial information; and
(b) the Regulator has not yet made a
decision on the application;
the information is to be treated as confidential
commercial information until the Regulator makes a decision on 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.
186
Revocation of declaration
(1) The Regulator may, by written notice
given to the applicant, revoke a declaration under section 185 if the
Regulator is satisfied:
(a) that the information concerned no
longer satisfies paragraph 185(1)(a), (b) or (c); or
(b) that the public interest in
disclosure of the information outweighs the prejudice that disclosure would
cause to any person.
(2) A revocation by the Regulator under subsection (1)
does not take effect until any review rights under section 181 or 183 in
relation to the revocation are exhausted.
187
Confidential commercial information must not be disclosed
(1) A person who:
(a) has confidential commercial
information; and
(b) has it only because of performing
duties or functions under this Act or under a corresponding State law; and
(c) knows that the information is
confidential commercial information;
must not disclose the information except:
(d) to any of the following in the
course of carrying out duties or functions under this Act or under a
corresponding State law:
(i) the Commonwealth or a
Commonwealth authority;
(ii) a State agency;
(iii) the Gene Technology
Technical Advisory Committee; or
(e) by order of a court; or
(f) with the consent of the person
who applied to have the information treated as confidential commercial
information.
Maximum penalty: Imprisonment for 2 years or 120 penalty
units.
Note 1: Chapter 2 of the Criminal Code sets
out the general principles of criminal responsibility.
Note 2: Information to which subsection (1)
applies is information to which section 38 of the Freedom of
Information Act 1982 applies, because subsection (1) is listed in
Schedule 3 to that Act.
(2) A person
who:
(a) has confidential commercial
information; and
(b) has it because of a disclosure
under subsection (1) or under this subsection; and
(c) knows that the information is
confidential commercial information;
must not disclose the information except:
(d) to any of the following in the
course of carrying out duties or functions under this Act or under a
corresponding State law:
(i) the Commonwealth or a
Commonwealth authority;
(ii) a State agency;
(iii) the Gene Technology
Technical Advisory Committee; or
(e) by order of a court; or
(f) with the consent of the person
who applied to have the information treated as confidential commercial
information.
Maximum penalty: Imprisonment for 2 years or 120 penalty
units.
Note 1: Chapter 2 of the Criminal Code sets
out the general principles of criminal responsibility.
Note 2: Information to which subsection (2)
applies is information to which section 38 of the Freedom of
Information Act 1982 applies, because subsection (2) is listed in
Schedule 3 to that Act.
(3) In this section:
court includes a tribunal, authority or
person having power to require the production of documents or the answering of
questions.
disclose, in relation to information, means
give or communicate in any way.
Division 4—Conduct by directors, employees and agents
188
Conduct by directors, employees and agents
(1) If, in proceedings for an offence against
this Act or the regulations, or an ancillary offence in relation to this Act or
the regulations, it is necessary to establish the state of mind of a body
corporate in relation to particular conduct, it is sufficient to show:
(a) that the conduct was engaged in by
a director, employee or agent of the body corporate within the scope of his or
her actual or apparent authority; and
(b) that the director, employee or
agent had the state of mind.
(2) Any conduct engaged in on behalf of a
body corporate by a director, employee or agent of the body corporate within
the scope of his or her actual or apparent authority is taken, for the purposes
of a prosecution for:
(a) an offence against this Act or the
regulations; or
(b) an ancillary offence relating to
this Act or the regulations;
to have been engaged in also by the body corporate, unless
the body corporate establishes that the body corporate took reasonable
precautions and exercised due diligence to avoid the conduct.
(3) If, in proceedings for an ancillary
offence relating to this Act or the regulations, it is necessary to establish
the state of mind of a person other than a body corporate in relation to
particular conduct, it is sufficient to show:
(a) that the conduct was engaged in by
an employee or agent of the person within the scope of his or her actual or
apparent authority; and
(b) that the employee or agent had the
state of mind.
(4) Any conduct engaged in on behalf of a
person (the first person), other than a body corporate, by an
employee or agent of the first person, within the scope of the actual or
apparent authority of the employee or agent is taken, for the purposes of a
prosecution for:
(a) an offence against this Act or the
regulations; or
(b) an ancillary offence relating to
this Act or the regulations;
to have been engaged in also by the first person unless
the first person establishes that he or she took reasonable precautions and
exercised due diligence to avoid the conduct.
(5) If:
(a) a person other than a body
corporate is convicted of an offence; and
(b) the person would not have been
convicted of the offence if subsections (3) and (4) had not been enacted;
the person is not liable to be punished by imprisonment
for that offence.
189
Meaning of terms
(1) A reference in subsection 188(1) or (3)
to the state of mind of a person includes a reference to:
(a) the knowledge, intention, opinion,
belief or purpose of the person; and
(b) the person’s reasons for the
intention, opinion, belief or purpose.
(2) A reference in section 188 to a
director of a body corporate includes a reference to a constituent member of a
body corporate incorporated for a public purpose by a law of the Commonwealth
or a State.
(3) A reference in section 188 to
engaging in conduct includes a reference to failing or refusing to engage in
conduct.
(4) A reference in section 188 to an
ancillary offence relating to this Act or the regulations is a reference to an
offence created by section 5, 6, 7 or 7A or subsection 86(1) of the Crimes
Act 1914 that relates to this Act or the regulations.
Division 5—Transitional provisions
190
Transitional provision—dealings covered by Genetic Manipulation Advisory
Committee advice to proceed
(1) The prohibitions in this Act apply to a
dealing with a GMO by a person at a particular time during the transition
period (the dealing time) with the modifications set out in subsection (2),
if:
(a) immediately before the
commencement of Part 4 of this Act, an advice to proceed was in force in
relation to the dealing with the GMO by the person; and
(b) the advice to proceed is in force
at the dealing time; and
(c) the dealing is in accordance with
the advice to proceed.
(2) Unless the dealing is a notifiable low
risk dealing, an exempt dealing or a dealing on the GMO Register:
(a) the advice to proceed is taken for
the purposes of this Act to be a GMO licence; and
(b) the holder of the advice to
proceed is taken to be the licence holder; and
(c) the licence is taken to be subject
to any conditions to which the advice to proceed is subject; and
(d) the licence is taken to remain in
force for the period ending at the earliest of the following times:
(i) the time when the
advice to proceed expires;
(ii) the end of the
transition period;
(iii) when the licence is
cancelled under section 68 or surrendered under section 69.
(3) In this section:
advice to proceed means an advice to proceed
issued by the Genetic Manipulation Advisory Committee, in accordance with
Guidelines issued by that Committee.
transition period means the period of 2 years
beginning at the commencement of Part 4 of this Act.
191
Regulations may relate to transitional matters
Regulations may be made in relation to
transitional matters arising from the enactment of this Act.
Division 6—Other
192
False or misleading information or document
A person must not:
(a) in connection with an application
made to the Regulator under this Act or the regulations; or
(b) in compliance or purported
compliance with this Act or the regulations;
do either of the following:
(c) give information (whether orally
or in writing) that the person knows to be false or misleading in a material
particular;
(d) produce a document that the person
knows to be false or misleading in a material particular without:
(i) indicating to the
person to whom the document is produced that it is false or misleading, and the
respect in which it is false or misleading; and
(ii) providing correct
information to that person, if the person producing the document is in
possession of, or can reasonably acquire, the correct information.
Maximum penalty: Imprisonment for 1 year or 60 penalty
units.
Note: Chapter 2 of the Criminal Code
sets out the general principles of criminal responsibility.
192A
Interference with dealings with GMOs
(1) A person is guilty of an offence if:
(a) the person engages in conduct; and
(b) the conduct:
(i) results in damage to,
destruction of, or interference with, premises at which dealings with GMOs are
being undertaken; or
(ii) involves damaging,
destroying, or interfering with, a thing at, or removing a thing from, such
premises; and
(c) the owner or occupier of the
premises, or the owner of the thing (as the case requires), has not consented
to the conduct; and
(d) in engaging in the conduct, the
person intends to prevent or hinder authorised GMO dealings that are being
undertaken at the premises or facility; and
(e) the person knows, or is reckless
as to, the matters mentioned in paragraphs (b) and (c).
Maximum penalty: Imprisonment for 2 years or 120 penalty
units.
Note: Chapter 2 of the Criminal Code
sets out the general principles of criminal responsibility.
(2) In this section:
authorised GMO dealings, in relation to
premises or a facility, means dealings with GMOs being undertaken at the
premises or facility:
(a) that are authorised to be
undertaken at the premises or facility by a GMO licence; or
(aa) that are specified in an emergency
dealing determination and are not prohibited from being undertaken at the
premises or facility by a condition of the determination; or
(b) that are notifiable low risk
dealings; or
(c) that are exempt dealings; or
(d) that are dealings included on the
GMO Register.
193
Regulations
(1) The Governor‑General may make
regulations prescribing matters:
(a) required or permitted by this Act
to be prescribed; or
(b) necessary or convenient to be
prescribed for carrying out or giving effect to this Act.
(2) Without limiting subsection (1), the
regulations may require a person to comply with codes of practice or guidelines
issued under this Act as in force at a particular time or from time to time.
194
Review of operation of Act
(1) The
Ministerial Council must cause an independent review of the operation of this
Act, including the structure of the Office of the Gene Technology Regulator, to
be undertaken as soon as possible after the fourth anniversary of the
commencement of this Act.
(2) A
person who undertakes such a review must give the Ministerial Council a written
report of the review.
(3) The
Minister, on behalf of the Ministerial Council, must cause a copy of the report
of the review to be tabled in each House of the Parliament within 12 months
after the fourth anniversary of the commencement of this Act.
(4) In
this section:
independent
review means a review
undertaken by persons who:
(a) in
the opinion of a majority of the Ministerial Council possess appropriate
qualifications to undertake the review; and
(b) include
one or more persons who are not employed by the Commonwealth or a Commonwealth
authority.