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PARLIAMENT OF VICTORIA
Gene Technology Amendment Bill 2007
TABLE OF PROVISIONS
Clause Page
PART 1--PRELIMINARY 1
1 Purpose 1
2 Commencement 2
3 Principal Act 3
4 Notes 3
PART 2--EMERGENCY DEALING DETERMINATIONS 4
5 Definitions 4
6 Simplified outline (Part 4) 4
7 Person not to deal with a GMO without a licence 5
8 Person not to deal with a GMO without a licence--strict liability
offence 5
9 Person must not breach conditions of a GMO licence 6
10 New sections 35A and 35B inserted 6
35A Person must not breach conditions of emergency
dealing determination 6
35B Person must not breach conditions of emergency
dealing determination--strict liability offence 7
11 Protection of persons who give information 8
12 Renumbering of section 72A 8
13 New Part 5A inserted 8
PART 5A--EMERGENCY DEALING DETERMINATIONS 8
Division 1--Simplified outline 8
72A Simplified outline 8
Division 2--Making of emergency dealing determination 9
72B Minister may make emergency dealing determination 9
72C Period of effect of emergency dealing determination 10
Division 3--Effect and conditions of emergency dealing
determination 11
72D Emergency dealing determination authorises dealings,
subject to conditions 11
561126B.I-18/7/2007 i BILL LA INTRODUCTION 18/7/2007
Clause Page
Division 4--Variation, suspension and revocation of
emergency dealing determination 14
72E Variation, suspension and revocation of emergency
dealing determination 14
14 Simplified outline (Part 7) 15
15 Application for certification 16
16 Application for accreditation 16
17 Quarterly reports 16
18 Record of GMO and GM Product Dealings 16
19 Simplified outline (Part 10) 17
20 Regulator may give directions 17
21 Simplified outline (Part 11) 18
22 Powers available to inspectors for monitoring compliance 18
23 Part does not limit power to impose conditions 18
24 Interference with dealings with GMOs 18
PART 3--GENE TECHNOLOGY ETHICS AND COMMUNITY
CONSULTATIVE COMMITTEE 20
25 Definitions 20
26 Heading to Part 8 20
27 Simplified outline (Part 8) 20
28 The Gene Technology Ethics and Community Consultative
Committee 20
29 New section 107 substituted 21
107 Function of Ethics and Community Committee 21
30 New sections 111 and 112 inserted 22
111 Subcommittees 22
112 Expert advisers 22
PART 4--ASSESSMENT OF APPLICATIONS: LIMITED AND
CONTROLLED RELEASE AND CONSULTATION ON
SIGNIFICANT RISK 23
31 Repeal of section 49 23
32 Regulator must prepare risk assessment and risk management
plan 23
33 New section 50A inserted 23
50A Limited and controlled release applications 23
34 Matters Regulator must take into account in preparing risk
assessment and risk management plan 26
35 Public notification of risk assessment and risk management
plan 26
561126B.I-18/7/2007 ii BILL LA INTRODUCTION 18/7/2007
Clause Page
PART 5--PROVISIONS RELATING TO VARIATION 27
36 Variation of licence 27
37 Review of decisions 29
PART 6--REGULATOR'S POWER TO DIRECT 30
38 Simplified outline (Part 10) 30
39 Regulator may give directions 30
PART 7--INADVERTENT DEALINGS 33
40 Definition 33
41 New section 40A inserted 33
40A Licences relating to inadvertent dealings 33
42 New section 46A inserted 34
46A Division does not apply to an application relating to
inadvertent dealings 34
43 New section 49 inserted 34
49 Division does not apply to an application relating to
inadvertent dealings 34
44 Regulator must not issue the licence unless satisfied as to risk
management 35
45 Other circumstances in which Regulator must not issue the
licence 35
46 Period of licence 35
PART 8--TECHNICAL AMENDMENTS 36
47 Definitions 36
48 Regulator may require applicant to give further information 36
49 Regulator must consider applications except in certain
circumstances 37
50 Regulator must not issue the licence unless satisfied as to risk
management 37
51 Regulator to notify of proposed suspension, cancellation or
variation 37
52 Regulator may include dealings with GMOs on GMO register 37
53 Regulator to notify of proposed suspension, cancellation or
variation 38
54 New section 89A inserted 38
89A Transfer of certification 38
55 Regulator may accredit organisations 39
56 Regulator to notify of proposed suspension, cancellation or
variation 39
57 Review of decisions 40
58 Deadlines for making reviewable decisions 40
59 Regulator may declare that information is confidential
commercial information 41
561126B.I-18/7/2007 iii BILL LA INTRODUCTION 18/7/2007
Clause Page
PART 9--REPEAL OF AMENDING ACT 42
60 Repeal of amending Act 42
ENDNOTES 43
561126B.I-18/7/2007 iv BILL LA INTRODUCTION 18/7/2007
PARLIAMENT OF VICTORIA
Introduced in the Assembly
Gene Technology Amendment Bill 2007
A Bill for an Act to amend the Gene Technology Act 2001 and for
other purposes.
The Parliament of Victoria enacts:
PART 1--PRELIMINARY
1 Purpose
The purpose of this Act is to improve the
operation of the regulatory scheme for gene
5 technology by making nationally agreed
amendments to the legislative framework of the
scheme (set out for Victoria in the Gene
Technology Act 2001) including--
(a) introducing emergency powers giving the
10 Minister the ability to expedite the approval
of a dealing with a GMO in an emergency
(Part 2);
561126B.I-18/7/2007 1 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 1--Preliminary
s. 2
(b) improving the mechanism for providing
advice to the Gene Technology Regulator
and the Gene Technology Ministerial
Council on ethics and community
5 consultations (Part 3);
(c) streamlining the process for the initial
consideration of licences and reducing the
regulatory burden for low risk dealings
(Part 4);
10 (d) providing clarification on the circumstances
in which licence variations can be made
(Part 5);
(e) clarifying the circumstances under which the
Regulator can direct a person to comply with
15 the Act (Part 6);
(f) providing the Regulator with the power to
issue a licence to persons who find
themselves inadvertently dealing with an
unlicensed GMO, for the purpose of
20 disposing of that organism (Part 7);
(g) making technical amendments to improve
the operation of the Act (Part 8).
2 Commencement
(1) Subject to subsection (3), this Act (other than
25 section 43) comes into operation on a day or days
to be proclaimed.
(2) Section 43 comes into operation immediately after
section 31 comes into operation.
(3) If a provision of this Act to which subsection (1)
30 applies does not come into operation before
1 January 2008, it comes into operation on that
day.
561126B.I-18/7/2007 2 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 1--Preliminary
s. 3
3 Principal Act
In this Act, the Gene Technology Act 2001 is See:
Act No.
called the Principal Act. 67/2001
and
amending
Act Nos
11/2003 and
108/2004.
LawToday:
www.
legislation.
vic.gov.au
4 Notes
5 Section 8B of the Principal Act is repealed.
__________________
561126B.I-18/7/2007 3 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 2--Emergency Dealing Determinations
s. 5
PART 2--EMERGENCY DEALING DETERMINATIONS
5 Definitions
(1) Insert the following definitions in section 10(1) of
the Principal Act--
5 "corresponding Commonwealth emergency
dealing determination, in relation to an
emergency dealing determination under this
Act, means a determination under section
72B of the Commonwealth Act that specifies
10 the same kind of dealings as those proposed
to be specified in, or specified in, the
emergency dealing determination under this
Act;
emergency dealing determination means a
15 determination in force under section 72B;".
(2) Insert the following note at the foot of section 10
of the Principal Act--
"Note
This section differs from section 10 of the Commonwealth
20 Act.".
6 Simplified outline (Part 4)
In section 31 of the Principal Act after "GMO
licence; or" insert--
" the dealing is specified in an emergency
25 dealing determination; or".
561126B.I-18/7/2007 4 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 2--Emergency Dealing Determinations
s. 7
7 Person not to deal with a GMO without a licence
For section 32(1) of the Principal Act
substitute--
"(1) A person is guilty of an offence if--
5 (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
10 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
15 (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
20 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.".
8 Person not to deal with a GMO without a licence--
25 strict liability offence
(1) After section 33(1)(b) of the Principal Act
insert--
"(ba) the dealing with the GMO is not specified in
an emergency dealing determination; and".
30 (2) In section 33(2) of the Principal Act after "(1)(b),"
insert "(ba),".
561126B.I-18/7/2007 5 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 2--Emergency Dealing Determinations
s. 9
9 Person must not breach conditions of a GMO
licence
(1) For section 34(1) of the Principal Act
substitute--
5 "(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
10 licence, and the holder knows or is
reckless as to that fact.".
(2) For section 34(2)(b) and (c) of the Principal Act
substitute--
"(b) the person has knowledge of the conditions
15 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.".
10 New sections 35A and 35B inserted
20 After section 35 of the Principal Act insert--
"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
25 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
30 a condition, and the person knows or is
reckless as to that fact.
561126B.I-18/7/2007 6 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 2--Emergency Dealing Determinations
s. 10
(2) An offence under this section is punishable
on conviction by whichever of the following
applies--
(a) in the case of an aggravated offence--
5 imprisonment for a term not exceeding
5 years or a fine not exceeding
$220 000;
(b) in any other case--imprisonment for a
term not exceeding 2 years or a fine not
10 exceeding $55 000.
Notes
1 Section 38 defines aggravated offence.
2 This section differs from section 35A of
the Commonwealth Act.
15 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
20 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
25 contravenes such a condition.
(2) Strict liability applies to subsection (1)(a)
and (c).
(3) An offence under this section is punishable
on conviction by a fine of not more than
30 whichever of the following amounts
applies--
(a) in the case of an aggravated offence--
$22 000;
561126B.I-18/7/2007 7 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 2--Emergency Dealing Determinations
s. 11
(b) in any other case--$5500.
Notes
1 Section 38 defines aggravated offence.
2 This section differs from section 35B of
5 the Commonwealth Act.".
11 Protection of persons who give information
In section 67 of the Principal Act for "or 66"
substitute ", 66 or 72D(2)(h)".
12 Renumbering of section 72A
10 For the provision number at the beginning of
section 72A of the Principal Act substitute
"72AA".
13 New Part 5A inserted
After Part 5 of the Principal Act insert--
15 "PART 5A--EMERGENCY DEALING
DETERMINATIONS
Division 1--Simplified outline
72A Simplified outline
In outline, this Part provides a system under
20 which the Minister can make determinations
relating to dealings with GMOs in
emergencies.
Note
This section differs from section 72A of the
25 Commonwealth Act.
561126B.I-18/7/2007 8 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 2--Emergency Dealing Determinations
s. 13
Division 2--Making of emergency dealing
determination
72B Minister may make emergency dealing
determination
5 (1) The Minister may, by Order published in the
Government Gazette (an emergency dealing
determination), specify dealings with a
GMO for the purposes of this Part.
(2) The Minister may make an emergency
10 dealing determination only if the Minister
administering section 72B of the
Commonwealth Act has made, or is
proposing to make, a corresponding
Commonwealth emergency dealing
15 determination.
Note
Section 72B of the Commonwealth Act includes a
subsection (3) dealing with threats of a kind
mentioned in subsection (2) of that section.
20 (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
25 (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
30 GMOs.
Note
This section differs from section 72B of the
Commonwealth Act.
561126B.I-18/7/2007 9 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 2--Emergency Dealing Determinations
s. 13
72C Period of effect of emergency dealing
determination
(1) An emergency dealing determination takes
effect--
5 (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
10 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
15 (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--
20 whichever occurs first.
(3) The Minister may, by Order published in the
Government Gazette, extend the period of
effect of an emergency dealing
determination.
25 (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.
30 (5) The Minister may extend the period of effect
of an emergency dealing determination only
if the Minister administering section 72C of
the Commonwealth Act has under that
section extended, or is proposing to extend
561126B.I-18/7/2007 10 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 2--Emergency Dealing Determinations
s. 13
under that section, the period of effect of the
corresponding Commonwealth emergency
dealing determination.
(6) An Order extending the period of effect of an
5 emergency dealing determination takes
effect at the time when the determination
would have ceased to have effect but for the
extension.
Note
10 This section differs from section 72C of the
Commonwealth Act.
Division 3--Effect and conditions of emergency
dealing determination
72D Emergency dealing determination
15 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
20 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;
25 (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;
30 (e) the source of the GMO;
(f) the persons who may deal with the
GMO;
561126B.I-18/7/2007 11 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 2--Emergency Dealing Determinations
s. 13
(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
5 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,
10 associated with the dealings
specified in the emergency dealing
determination; or
(ii) a person becomes aware of any
contraventions of the conditions to
15 which the emergency dealing
determination is subject by any
person; or
(iii) a person becomes aware of any
unintended effects of the dealings
20 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
25 requirements relating to the
certification of facilities to specified
containment levels;
(k) waste disposal requirements;
(l) the manner in which any quantity of the
30 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
35 environment;
561126B.I-18/7/2007 12 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 2--Emergency Dealing Determinations
s. 13
(n) data collection, including studies to be
conducted;
(o) auditing and reporting;
(p) the keeping and disclosure of, and
5 access to, records about the GMO;
(q) actions to be taken in case of the release
of the GMO from a contained
environment;
(r) the geographic area in which the
10 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
15 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
20 specified in the emergency dealing
determination;
(v) limiting the dissemination or
persistence of the GMO or its genetic
material in the environment;
25 (w) any other matters that the Minister
thinks appropriate.
(3) A condition under subsection (2)(f) may
permit dealings with a GMO by, or may
impose obligations upon--
30 (a) a specified person or persons; or
(b) a specified class of person.
561126B.I-18/7/2007 13 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 2--Emergency Dealing Determinations
s. 13
(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;
5 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
10 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
15 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
20 emergency dealing determination
(1) The Minister may, by Order published in the
Government Gazette, vary the conditions to
which an emergency dealing determination is
subject, including by imposing new
25 conditions, if the Minister administering
section 72E of the Commonwealth Act has
made, or is proposing to make, the same
variation to the corresponding
Commonwealth emergency dealing
30 determination.
(2) The Minister may, by Order published in the
Government Gazette, suspend or revoke an
emergency dealing determination if the
Minister administering section 72E of the
35 Commonwealth Act has suspended or
561126B.I-18/7/2007 14 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 2--Emergency Dealing Determinations
s. 14
revoked, or is proposing to suspend or
revoke, (as the case requires) the
corresponding Commonwealth emergency
dealing determination.
5 Note
Section 72E of the Commonwealth Act includes a
subsection (3) dealing with consultation with the
States in relation to the variation, suspension or
revocation of an emergency dealing determination.
10 (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
15 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
20 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
25 subsection (4)(b) must not be earlier than
30 days after the day on which the variation,
suspension or revocation is made.
Note
This section differs from section 72E of the
30 Commonwealth Act.".
14 Simplified outline (Part 7)
In section 82 of the Principal Act after "Licence
conditions" (where twice occurring) insert
", or conditions to which an emergency dealing
35 determination is subject,".
561126B.I-18/7/2007 15 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 2--Emergency Dealing Determinations
s. 15
15 Application for certification
In the note at the foot of section 83(2) of the
Principal Act after "licence" insert
", or conditions to which an emergency dealing
5 determination is subject,".
16 Application for accreditation
For the note at the foot of section 91(1) of the
Principal Act substitute--
Notes
10 1 The conditions of a licence may require supervision of
dealings by an Institutional Biosafety Committee (see
section 62(2)(m)), and the regulations may require such
supervision of notifiable low risk dealings (see section
75(2)(c)).
15 2 The conditions to which an emergency dealing
determination is subject may require supervision of
dealings by an Institutional Biosafety Committee (see
section 72D(2)(t)).".
17 Quarterly reports
20 After section 136A(2)(b) of the Principal Act
insert--
"(ba) emergency dealing determinations made by
the Minister during the quarter;
(bb) any breaches of conditions of an emergency
25 dealing determination that have come to the
Regulator's attention during the quarter;".
18 Record of GMO and GM Product Dealings
(1) After section 138(1) of the Principal Act insert--
"(1A) The Record must contain the following
30 information, other than confidential
commercial information, in relation to each
emergency dealing determination made
under section 72B--
561126B.I-18/7/2007 16 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 2--Emergency Dealing Determinations
s. 19
(a) the dealings specified in the emergency
dealing determination and the GMO to
which those dealings relate;
(b) any conditions to which the emergency
5 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
10 have effect.".
(2) In section 138(5) of the Principal Act after "(1),"
insert "(1A),".
19 Simplified outline (Part 10)
In section 145 of the Principal Act after "protect
15 the environment;" insert--
"· enables the Regulator to give directions to a
person permitted by an emergency dealing
determination to deal with a GMO if--
the Regulator believes that the person is
20 not complying with this Act or the
regulations; and
the Regulator believes that it is
necessary to do so in order to protect the
health and safety of people or to protect
25 the environment or for certain other
reasons;".
20 Regulator may give directions
For section 146(2)(a) of the Principal Act
substitute--
30 "(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;
561126B.I-18/7/2007 17 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 2--Emergency Dealing Determinations
s. 21
(ii) a person dealing with, or who has dealt
with, a GMO specified in an emergency
dealing determination; and".
21 Simplified outline (Part 11)
5 In section 149 of the Principal Act after
"a licence" insert "or an emergency dealing
determination".
22 Powers available to inspectors for monitoring
compliance
10 (1) In section 152(2)(c) of the Principal Act for
"time." substitute "time; or".
(2) After section 152(2)(c) of the Principal Act
insert--
"(d) the occupier of the premises is a person
15 dealing with, or who has dealt with, a GMO
specified in an emergency dealing
determination, and the entry is at a
reasonable time.".
23 Part does not limit power to impose conditions
20 (1) In the heading to section 177 of the Principal Act
omit "licence".
(2) In section 177 of the Principal Act after
"conditions" insert "or the Minister's power to
impose conditions on an emergency dealing
25 determination".
24 Interference with dealings with GMOs
(1) In section 192A(2) of the Principal Act after
paragraph (a) of the definition of authorised
GMO dealings insert--
30 "(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".
561126B.I-18/7/2007 18 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 2--Emergency Dealing Determinations
s. 24
(2) In section 192A(2) of the Principal Act in
paragraph (d) of the definition of authorised
GMO dealings after "are" insert "dealings".
__________________
561126B.I-18/7/2007 19 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 3--Gene Technology Ethics and Community Consultative Committee
s. 25
PART 3--GENE TECHNOLOGY ETHICS AND COMMUNITY
CONSULTATIVE COMMITTEE
25 Definitions
(1) In section 10(1) of the Principal Act omit the
5 definitions of Consultative Committee and Ethics
Committee.
(2) Insert the following definition in section 10(1) of
the Principal Act--
"Ethics and Community Committee means the
10 Gene Technology Ethics and Community
Consultative Committee established by
section 106 of the Commonwealth Act;".
26 Heading to Part 8
For the heading to Part 8 of the Principal Act
15 substitute--
"PART 8--THE GENE TECHNOLOGY
TECHNICAL ADVISORY COMMITTEE AND
THE GENE TECHNOLOGY ETHICS AND
COMMUNITY CONSULTATIVE
20 COMMITTEE".
27 Simplified outline (Part 8)
In section 99 of the Principal Act for ", the Gene
Technology Community Consultative Committee
and the Gene Technology Ethics Committee"
25 substitute "and the Gene Technology Ethics and
Community Consultative Committee".
28 The Gene Technology Ethics and Community
Consultative Committee
(1) In the heading to Division 3 of Part 8 of the
30 Principal Act after "Technology" insert "Ethics
and".
561126B.I-18/7/2007 20 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 3--Gene Technology Ethics and Community Consultative Committee
s. 29
(2) In the heading to section 106 of the Principal Act
after "Technology" insert "Ethics and".
(3) In the note at the foot of section 106 of the
Principal Act after "Technology" insert "Ethics
5 and".
(4) In the note at the foot of sections 108, 109 and
110 of the Principal Act for "Consultative
Committee" substitute "Ethics and Community
Committee".
10 (5) In the note at the foot of section 110 of the
Principal Act for "operation" substitute
"procedures".
(6) Section 110A of the Principal Act is repealed.
(7) Division 4 of Part 8 of the Principal Act is
15 repealed.
29 New section 107 substituted
For section 107 of the Principal Act substitute--
"107 Function of Ethics and Community
Committee
20 The function of the Ethics and Community
Committee under this Act is to provide
advice, on the request of the Regulator or the
Ministerial Council, on the following--
(a) ethical issues relating to gene
25 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
30 principles in relation to dealings with
GMOs that should not be conducted for
ethical reasons;
561126B.I-18/7/2007 21 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 3--Gene Technology Ethics and Community Consultative Committee
s. 30
(d) the need for policy principles, policy
guidelines, codes of practice and
technical and procedural guidelines in
relation to GMOs and GM products and
5 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
10 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;
15 (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.".
20 30 New sections 111 and 112 inserted
After section 110 of the Principal Act insert--
"111 Subcommittees
Note
Section 111 of the Commonwealth Act deals with the
25 establishment of subcommittees by the Ethics and
Community Committee.
112 Expert advisers
Note
Section 112 of the Commonwealth Act provides for
30 the appointment of expert advisers to the Ethics and
Community Committee.".
__________________
561126B.I-18/7/2007 22 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 4--Assessment of Applications: Limited and Controlled Release and
s. 31
Consultation on Significant Risk
PART 4--ASSESSMENT OF APPLICATIONS: LIMITED AND
CONTROLLED RELEASE AND CONSULTATION ON
SIGNIFICANT RISK
31 Repeal of section 49
5 Section 49 of the Principal Act is repealed.
32 Regulator must prepare risk assessment and risk
management plan
(1) Section 50(2) of the Principal Act is repealed.
(2) In section 50(3) of the Principal Act for "The"
10 substitute "Unless section 50A applies in relation
to the application for the licence, the".
33 New section 50A inserted
After section 50 of the Principal Act insert--
"50A Limited and controlled release
15 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
20 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--
25 (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
30 the GMO; and
561126B.I-18/7/2007 23 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 4--Assessment of Applications: Limited and Controlled Release and
s. 33
Consultation on Significant Risk
(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
5 section 50(3).
(2) For the purposes of subsection (1)--
controls, in relation to restricting the
dissemination or persistence of a GMO
and its genetic material in the
10 environment, include the following--
(a) specified methods for disposal of
the GMO or its genetic material;
(b) data collection requirements,
including studies to be conducted
15 about the GMO or its genetic
material;
(c) a restricted geographic area in
which the proposed dealings with
the GMO or its genetic material
20 may occur;
(d) compliance, in relation to dealings
with the GMO or its genetic
material, with--
(i) a code of practice issued
25 under section 24; or
(ii) a technical or procedural
guideline issued under
section 27.
(3) For the purposes of subsection (1)--
30 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--
561126B.I-18/7/2007 24 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 4--Assessment of Applications: Limited and Controlled Release and
s. 33
Consultation on Significant Risk
(a) the scope of the dealings with the
GMO;
(b) the scale of the dealings with the
GMO;
5 (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
10 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
15 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--
20 (i) testing hypotheses;
(ii) gaining scientific or technical
knowledge;
(iii) gaining data for regulatory
purposes, or for product
25 development or marketing; and
(b) may have regard to any other matter
that the Regulator considers to be
relevant.
Note
30 This section differs from section 50A of the Commonwealth
Act.".
561126B.I-18/7/2007 25 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 4--Assessment of Applications: Limited and Controlled Release and
s. 34
Consultation on Significant Risk
34 Matters Regulator must take into account in
preparing risk assessment and risk management
plan
(1) In section 51(1)(a) of the Principal Act for
5 "mentioned in section 49(2)(a) to (f)" substitute
"prescribed by the regulations".
(2) Section 51(1)(b) of the Principal Act is repealed.
(3) Section 51(2)(b) of the Principal Act is repealed.
35 Public notification of risk assessment and risk
10 management plan
(1) In section 52(1) of the Principal Act omit
"49 (if applicable),".
(2) After section 52(2)(b) of the Principal Act
insert--
15 "(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
20 satisfied; and".
(3) In section 52(2)(d) of the Principal Act for "than
30 days after the date on which the notice was
published." substitute--
"than--
25 (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
30 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.".
__________________
561126B.I-18/7/2007 26 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 5--Provisions Relating to Variation
s. 36
PART 5--PROVISIONS RELATING TO VARIATION
36 Variation of licence
(1) For section 71(1) of the Principal Act
substitute--
5 "(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.
10 (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
15 writing by the Regulator.".
(2) In section 71(2) of the Principal Act for
"However, the" substitute "The".
(3) After section 71(2) of the Principal Act insert--
"(2A) The Regulator must not vary a licence if the
20 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
25 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,
30 in relation to any GMO in respect of
which dealings are proposed to be
authorised as a result of the variation--
561126B.I-18/7/2007 27 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 5--Provisions Relating to Variation
s. 36
(i) controls to restrict the
dissemination or persistence of the
GMO and its genetic material in
the environment; and
5 (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
10 not to seek the advice referred to in
section 50(3).
Note
Section 50A applies to an application that
proposes controls and limits on the
15 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
20 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.".
25 (4) In section 71(4) of the Principal Act for
"However, the Regulator must not vary the"
substitute "The Regulator must not vary a".
(5) After section 71(4) of the Principal Act insert--
"(5) The Regulator must not vary a licence unless
30 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
35 regulations.
561126B.I-18/7/2007 28 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 5--Provisions Relating to Variation
s. 37
(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
5 regulations.
(8) For the purposes of subsection (2A)--
controls has the same meaning as in
section 50A(2);
limits has the same meaning as in
10 section 50A(3).".
37 Review of decisions
After item 4 in the table in section 179 of the
Principal Act insert--
"4A To refuse to vary a section 71 the licence
licence holder".
__________________
561126B.I-18/7/2007 29 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 6--Regulator's Power to Direct
s. 38
PART 6--REGULATOR'S POWER TO DIRECT
38 Simplified outline (Part 10)
In section 145 of the Principal Act after
"environment" insert ", or for certain other
5 reasons".
39 Regulator may give directions
(1) For section 146(1)(b) of the Principal Act
substitute--
"(b) either of the following applies--
10 (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,
15 having regard to the matters specified
in subsection (2A), for the Regulator to
exercise powers under this section--".
(2) For section 146(2)(b) of the Principal Act
substitute--
20 "(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;
25 (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--".
561126B.I-18/7/2007 30 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 6--Regulator's Power to Direct
s. 39
(3) After section 146(2) of the Principal Act insert--
"(2A) For the purposes of deciding under
subsection (1)(b)(ii) or (2)(b)(ii) whether it is
desirable to exercise powers under this
5 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
10 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
15 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
20 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
25 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
30 this section;
(f) other means available to the Regulator
to address the suspected
non-compliance (including, but not
limited to, by cancelling, varying or
561126B.I-18/7/2007 31 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 6--Regulator's Power to Direct
s. 39
suspending a licence, accreditation or
certification);
(g) whether, in the Regulator's opinion, the
suspected non-compliance was
5 deliberate;
(h) the desirability of deterring future
non-compliance with this Act or the
regulations.".
__________________
561126B.I-18/7/2007 32 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 7--Inadvertent Dealings
s. 40
PART 7--INADVERTENT DEALINGS
40 Definition
Insert the following definition in section 10(1) of
the Principal Act--
5 "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;".
10 41 New section 40A inserted
After section 40 of the Principal Act insert--
"40A Licences relating to inadvertent dealings
(1) If the Regulator is satisfied that a person has
come into possession of a GMO
15 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
20 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
25 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
30 section 40, or is taken to have been made under this
section.".
561126B.I-18/7/2007 33 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 7--Inadvertent Dealings
s. 42
42 New section 46A inserted
After section 46 of the Principal Act insert--
"46A Division does not apply to an application
relating to inadvertent dealings
5 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
10 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.".
15 43 New section 49 inserted
After section 48 of the Principal Act insert--
"49 Division does not apply to an application
relating to inadvertent dealings
Despite section 48, this Division does not
20 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
25 for purposes relating to, disposing of a
GMO; and
(b) the applicant for the licence came into
possession of the GMO inadvertently.".
561126B.I-18/7/2007 34 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 7--Inadvertent Dealings
s. 44
44 Regulator must not issue the licence unless satisfied
as to risk management
At the foot of section 56 of the Principal Act
insert--
5 "Note
Subsections (2)(a), (2)(b) and (2)(c) do not apply to an
inadvertent dealings application.".
45 Other circumstances in which Regulator must not
issue the licence
10 After section 57(2) of the Principal Act insert--
"(3) Subsection (2) does not apply to an
inadvertent dealings application.".
46 Period of licence
After section 60(2) of the Principal Act insert--
15 "(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.".
__________________
561126B.I-18/7/2007 35 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 8--Technical Amendments
s. 47
PART 8--TECHNICAL AMENDMENTS
47 Definitions
(1) In the definition of deal with in section 10(1) of
the Principal Act--
5 (a) for paragraph (g) substitute--
"(g) import the GMO;
(h) transport the GMO;
(i) dispose of the GMO--";
(b) for the expression commencing "and
10 includes" and ending at the end of the
definition substitute--
"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
15 paragraphs (a) to (i);".
(2) In the definition of Institutional Biosafety
Committee in section 10(1) of the Principal Act
for "by an accredited organisation as an
Institutional Biosafety Committee" substitute
20 "as an Institutional Biosafety Committee in
accordance with written guidelines issued by the
Regulator under section 98".
48 Regulator may require applicant to give further
information
25 After section 42(2) of the Principal Act insert--
"(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
30 begun to consider the application.".
561126B.I-18/7/2007 36 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 8--Technical Amendments
s. 49
49 Regulator must consider applications except in
certain circumstances
(1) In section 43(2) of the Principal Act after
"application" (where first occurring) insert
5 ", or may cease considering the application,".
(2) In section 43(2)(e) of the Principal Act for "21."
substitute "21; or".
(3) After section 43(2)(e) of the Principal Act
insert--
10 "(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.".
50 Regulator must not issue the licence unless satisfied
15 as to risk management
For section 56(2)(a) and (b) of the Principal Act
substitute--
"(a) the risk assessment prepared under
section 47 or 50 in relation to the dealings;
20 (b) the risk management plan prepared under
section 47 or 50 in relation to the dealings;".
51 Regulator to notify of proposed suspension,
cancellation or variation
After section 72(6) of the Principal Act insert--
25 "(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.".
52 Regulator may include dealings with GMOs on
30 GMO register
In section 78(3) of the Principal Act omit the
second sentence.
561126B.I-18/7/2007 37 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 8--Technical Amendments
s. 53
53 Regulator to notify of proposed suspension,
cancellation or variation
After section 89(6) of the Principal Act insert--
"(7) This section does not apply to a variation of
5 a licence if the Regulator is satisfied that the
variation is of minor significance or
complexity.".
54 New section 89A inserted
After section 89 of the Principal Act insert--
10 "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
15 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
20 (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
25 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.
30 (5) If the Regulator decides to transfer the
certification--
(a) the transfer takes effect on the date
specified in the notice; and
561126B.I-18/7/2007 38 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 8--Technical Amendments
s. 55
(b) the certification continues in force; and
(c) the certification is subject to the same
conditions as those in force
immediately before the transfer.".
5 55 Regulator may accredit organisations
(1) In section 92(2)(a) of the Principal Act omit
", or proposes to establish,".
(2) For section 92(2)(b) and (c) of the Principal Act
substitute--
10 "(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
15 (c) if the organisation has established an
Institutional Biosafety Committee--whether
the organisation has appropriate indemnity
arrangements for its Institutional Biosafety
Committee members; and
20 (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
25 established by an accredited organisation;
and".
56 Regulator to notify of proposed suspension,
cancellation or variation
After section 97(6) of the Principal Act insert--
30 "(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.".
561126B.I-18/7/2007 39 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 8--Technical Amendments
s. 57
57 Review of decisions
(1) Before item 1 in the table in section 179 of the
Principal Act insert--
"1A To refuse to consider section the
an application on the 43(2)(f) applicant".
basis that the applicant
is not a suitable
person to hold a
licence
(2) After item 3 in the table in section 179 of the
5 Principal Act insert--
"3A To refuse to transfer a section 70 an applicant
licence for the
transfer".
(3) After item 7 in the table in section 179 of the
Principal Act insert--
"7A To refuse to transfer a section an applicant
certification 89A for the
transfer".
58 Deadlines for making reviewable decisions
(1) For section 182(a) of the Principal Act
10 substitute--
"(a) this Act provides for a person to make an
application of any kind to the Regulator;
and".
(2) In section 182 of the Principal Act for "decision to
15 reject the application" substitute "reviewable
decision to reject the application, and the person
may seek internal review of the reviewable
decision under section 181".
561126B.I-18/7/2007 40 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 8--Technical Amendments
s. 59
59 Regulator may declare that information is
confidential commercial information
After section 185(3A) of the Principal Act
insert--
5 "(3B) If--
(a) a person has made an application under
section 184 for a declaration that
specified information is confidential
commercial information; and
10 (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
15 application.".
__________________
561126B.I-18/7/2007 41 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Part 9--Repeal of Amending Act
s. 60
PART 9--REPEAL OF AMENDING ACT
60 Repeal of amending Act
This Act is repealed on 1 January 2009.
561126B.I-18/7/2007 42 BILL LA INTRODUCTION 18/7/2007
Gene Technology Amendment Bill 2007
Endnotes
ENDNOTES
By Authority. Government Printer for the State of Victoria.
561126B.I-18/7/2007 43 BILL LA INTRODUCTION 18/7/2007
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