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This is a Bill, not an Act. For current law, see the Acts databases.
GENE TECHNOLOGY AMENDMENT BILL 2007
2007
THE LEGISLATIVE ASSEMBLY
FOR THE AUSTRALIAN CAPITAL
TERRITORY
(As presented)
(Minister for Health)
Gene
Technology Amendment Bill 2007
Contents
Page
2007
THE LEGISLATIVE ASSEMBLY
FOR THE AUSTRALIAN CAPITAL
TERRITORY
(As presented)
(Minister for Health)
Gene Technology
Amendment Bill 2007
A Bill for
An Act to amend the
Gene Technology Act
2003
The Legislative Assembly for the Australian Capital Territory enacts as
follows:
This Act is the Gene Technology Amendment Act 2007.
This Act commences on a day fixed by the Minister by written
notice.
Note 1 The naming and commencement provisions automatically commence
on the notification day (see Legislation Act, s 75 (1)).
Note 2 A single day or time may be fixed, or different days or times
may be fixed, for the commencement of different provisions (see Legislation Act,
s 77 (1)).
Note 3 If a provision has not commenced within 6 months beginning on
the notification day, it automatically commences on the first day after that
period (see Legislation Act, s 79).
This Act amends the Gene Technology Act 2003.
4 Simplified
outline—pt 4New section 31 (b)
(ia)
insert
(ia) the dealing is specified in an emergency dealing determination;
or
substitute
32 Person not to deal with GMO without
licence
A person commits 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 about that fact; and
(c) the dealing with the GMO is not specified in an emergency dealing
determination, and the person knows or is reckless about that fact;
and
(d) the dealing is not a notifiable low risk dealing, and the person knows
or is reckless about that fact; and
(e) the dealing is not an exempt dealing and the person knows or is
reckless about that fact; and
(f) the dealing is not included on the GMO Register, and the person knows
or is reckless about that fact.
Maximum penalty:
(a) for an aggravated offence—2 000 penalty units, imprisonment for
5 years or both; or
(b) in any other case—500 penalty units, imprisonment for 2 years or
both.
Note 1 Aggravated offence is defined in s 38.
Note 2 For provisions corresponding to the Commonwealth Act,
s 32 (4), see the Legislation Act, s 48.
6 Person
not to deal with GMO without licence—strict liability
offenceNew section 33 (1)
(ba)
insert
(ba) the dealing with the GMO is not specified in an emergency dealing
determination; and
after
subsection (1) (b),
insert
(ba),
8 Person
must not breach conditions of GMO
licenceSection 34 (1)
substitute
(1) The holder of a GMO licence commits 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 about that fact.
Maximum penalty:
(a) for an aggravated offence—2 000 penalty units, imprisonment for
5 years or both; or
(b) in any other case—500 penalty units, imprisonment for 2 years or
both.
9 Section
34 (2) (b) and (c)
substitute
(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 about that fact.
10 New
sections 35A and 35B
insert
35A Person must not breach conditions of emergency
dealing determination
A person commits 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 about that fact.
Maximum penalty:
(a) for an aggravated offence—2 000 penalty units, imprisonment for
5 years or both; or
(b) in any other case—500 penalty units, imprisonment for 2 years or
both.
Note This section differs from the Commonwealth Act, s
35A.
35B Person must not breach conditions of emergency
dealing determination—strict liability offence
(1) A person commits 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.
Maximum penalty:
(a) for an aggravated offence—200 penalty units; or
(b) in any other case—50 penalty units.
(2) Strict liability applies to subsection (1) (a) and (c).
Note This section differs from the Commonwealth Act, s
35B.
insert
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 remove any doubt, subsection (1) does not prevent a person from
making an application under section 40 in relation to a GMO that has
inadvertently come into the person’s possession.
Note Section 46A and s 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 s 40, or is taken to have been made under this
section.
12 Regulator
may require applicant to give further
informationNew section 42
(3)
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 begun to consider the application.
13 Regulator
must consider applications except in certain
circumstancesSection 43
(2)
omit
application if—
substitute
application, or may cease considering the application, if—
14 New
section 43 (2) (f)
insert
(f) the regulator is satisfied (having regard to the matters mentioned in
section 58) that the applicant is not a suitable person to hold a
licence.
insert
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.
substitute
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.
17 Regulator
must prepare risk assessment and risk management
planSection 50 (2)
omit
omit
The
substitute
Unless section 50A applies in relation to the application for the licence,
the
insert
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 people covered by the licence, to conduct experiments; and
(b) the application proposes in relation to any GMO for 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 mentioned
in section 50 (3).
(2) In deciding whether the principal purpose of an application is to
enable the licence holder, and people 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 anything else the regulator considers to be
relevant.
(3) In this section:
controls, in relation to restricting the dissemination or
persistence of a GMO and its genetic material in the environment, include the
following:
(a) stated methods for disposal of the GMO or its genetic
material;
(b) data collection requirements, including studies to be conducted about
the GMO or its genetic material;
(c) a restricted geographic area in which the proposed dealings with the
GMO or its genetic material may occur;
(d) 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.
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 people who are to be permitted to conduct of the dealings with the
GMO.
Note This section differs from the Commonwealth Act, s
50A.
20 Matters
regulator must take into account in preparing risk assessment and risk
management planSection 51 (1)
(a)
omit everything after
matters
substitute
prescribed by regulation;
omit
omit
23 Public
notification of risk assessment and risk management
planSection 52 (1)
omit
sections 49 (if applicable), 50 and 51
substitute
section 50 and section 51
24 New
section 52 (2) (ba)
insert
(ba) if the regulator is satisfied that 1 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
omit everything after
earlier
substitute
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.
26 Regulator
must not issue the licence unless satisfied as to risk
managementSection 56 (2) (a) and
(b)
substitute
(a) the risk assessment prepared under section 47 or section 50 in
relation to the dealings;
(b) the risk management plan prepared under section 47 or section 50
in relation to the dealings;
27 Section
56 (2), new note
insert
Note Subsections (2) (a) to (c) do not apply to an inadvertent
dealings application.
28 Other
circumstances in which regulator must not issue the
licenceNew section 57
(3)
insert
(3) Subsection (2) does not apply to an inadvertent dealings
application.
29 Period
of licenceNew section 60
(3)
insert
(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.
30 Protection
of persons who give informationSection
67
omit
or section 66
substitute
, section 66 or the Commonwealth Act, section 72D (2) (h)
31 Variation
of licenceSection 71
(1)
substitute
(1) The regulator may vary a licence, by written notice 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) any information prescribed by regulation; and
(b) any information specified in writing by the regulator.
omit
However, the
substitute
The
insert
(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 people covered by
the licence, to conduct experiments; and
(b) the application for variation proposes, in relation to any GMO for
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 mentioned
in section 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 relation to the
original application for the licence did not cover the risks posed by the
dealings proposed to be authorised by the licence as varied.
omit
However, the regulator must not vary the
substitute
The regulator must not vary a
35 New
section 71 (5) to (8)
insert
(5) The regulator must not vary a licence unless any local council that
the regulator considers appropriate has been consulted about the proposed
variation.
(6) The regulator must not vary a licence in the circumstances (if any)
prescribed by regulation.
(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 regulation.
(8) In this section:
controls—see section 50A (3).
limits—see section 50A (3).
36 Regulator
to notify of proposed suspension, cancellation or
variationNew section 72
(8)
insert
(8) 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.
37 GMO
licence—annual chargeSection
72A
renumber as section 72AA
insert
Part 5A Emergency dealing
determinations
Note to pt 5A
This part differs from the Commonwealth Act, pt 5A.
72A Application of Commonwealth emergency dealing
determinations
An emergency dealing determination in force under the Commonwealth Act,
section 72B applies, as far as applicable, as a law of the Territory.
Note This section differs from the Commonwealth Act, s
72A.
72B Minister may make emergency dealing
determination
Note The Commonwealth Act, s 72B permits the Commonwealth Minister
to make emergency dealing determinations with a GMO for the purposes of the
Commonwealth Act, part 5A.
72C Period of effect of emergency dealing
determination
Note The Commonwealth Act, s 72C provides for when an emergency
dealing determination takes effect, when it ceases to have effect and how the
period of effect may be extended by the Commonwealth Minister responsible for
emergency dealing determinations.
Division 5A.3 Effect and conditions of
emergency dealing determination
72D Emergency dealing determination authorises
dealings, subject to conditions
Note The Commonwealth Act, s 72D authorises dealings with a GMO
subject to conditions, including those referred to in s 72D (2).
Division 5A.4 Variation, suspension and
revocation of emergency dealing determination
72E Variation, suspension and revocation of emergency
dealing determination
Note Under the Commonwealth Act, s 72E, the Commonwealth Minister
responsible for emergency dealing determinations may suspend an emergency
dealing determination, revoke an emergency dealing determination or vary the
conditions to which an emergency dealing determination is subject.
39 Regulator
may include dealings with GMOs on GMO
registerSection 78 (4)
omit
40 Simplified
outline—pt 7Section 82 (2) and
(4)
after
Licence conditions
insert
, or conditions to which an emergency dealing determination is
subject,
41 Application
for certificationSection 83 (2),
note
after
licence
insert
, or conditions to which an emergency dealing determination is
subject,
42 Regulator
to notify of proposed suspension, cancellation or
variationNew section 89
(8)
insert
(8) 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.
insert
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) any information prescribed by regulation; and
(b) any information required, in writing, by the regulator.
(3) The regulator must not transfer the certification unless 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 stated 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.
44 Application
for accreditationSection 91 (1), note
substitute
Note 1 The conditions of a licence may require supervision of
dealings by an institutional biosafety committee (see s 62 (2) (m)), and a
regulation may require such supervision of notifiable risk dealings
(see s 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 (see the Commonwealth Act, s 72D (2) (t)).
45 Regulator
may accredit organisationsSection 92 (2)
(a)
omit
, or proposes to establish,
46 Section
92 (2) (b) and (c)
substitute
(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 the 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
47 Regulator
to notify of proposed suspension, cancellation or
variationNew section 97
(8)
insert
(8) 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.
substitute
Part 8 Gene technology technical advisory
committee and gene technology ethics and community consultative
committee
49 Simplified
outline—pt 8Section 99 (b) and
(c)
substitute
(b) gene technology ethics and community consultative committee.
substitute
Division 8.3 Gene technology ethics and
community consultative committee
substitute
Gene technology ethics and community consultative
committee
after
technology
insert
ethics and
substitute
107 Function of ethics and community
committee
The function of the ethics and community committee under this Act is to
provide advice, on 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
for 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 about the process for applications for licences
covering dealings that involve 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.
54 Sections
108 and 109, notes
omit
consultative
substitute
ethics and community
55 RegulationsSection
110, note
omit everything after
membership
substitute
and procedures of the ethics and community committee.
56 SubcommitteesSection
110A
omit
57 New
sections 111 and 112
in division 8.3, insert
111 Subcommittees
Note The Commonwealth Act, s 111 deals with the establishment of
subcommittees by the ethics and community committee.
112 Expert advisers
Note The Commonwealth Act, s 112 provides for the appointment of
expert advisers to the ethics and community committee.
58 Gene
technology ethics committeeDivision
8.4
omit
59 Quarterly
reportsNew sections 136A (2) (ba) and
(bc)
insert
(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;
60 Record
of GMO and GM product dealingsNew section
138 (1A)
insert
(1A) The GM 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.
after
(1),
insert
(1A),
62 Simplified
outline—pt 10Section 145 (a)
(ii)
after
environment
insert
, or for certain other reasons
insert
(aa) authorises the regulator to give directions to a person permitted by
an emergency dealing determination to deal with a GMO if—
(i) the regulator believes that the person is not complying with this Act;
and
(ii) 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; and
64 Regulator
may give directionsSection 146 (1)
(b)
substitute
(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
mentioned in subsection (2A), for the regulator to exercise powers under this
section;
substitute
(a) 1 of the following kinds of people is not complying with this Act in
relation to 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
substitute
(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
mentioned in subsection (2A), for the regulator to exercise powers under this
section;
insert
(2A) For the purposes of deciding under subsection (1) (b) (ii) or
subsection (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 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 at a future time;
(d) the severity of the suspected noncompliance;
(e) whether, on 1 or more occasions, the licence holder or 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
noncompliance (including, but not limited to, by cancelling, varying or
suspending a licence, accreditation or certification);
(g) whether, in the regulator’s opinion, the suspected noncompliance
was deliberate;
(h) the desirability of deterring future noncompliance with this Act or
the regulations.
68 Simplified
outline—pt 11Section 149
(e)
after
licence
insert
or an emergency dealing determination
69 Powers
available to inspectors for monitoring
complianceNew section 152 (2)
(d)
insert
(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.
omit
subsection (2) (c) does not
substitute
subsection (2) (c) or (d) does not
substitute
177 Pt 11 does not limit power to impose
conditions
This part does not limit the regulator’s power to impose licence
conditions or the Minister’s power to impose conditions on an emergency
dealing determination.
72 Meaning
of reviewable decision and eligible
personSection 179, table, new item
1A
before item 1, insert
1A
|
to refuse to consider an application on the basis that the applicant is not
a suitable person to hold a licence under section 43 (2) (f)
|
the applicant
|
73 Section
179, table, new item 5A
insert
5A
|
to refuse to vary a licence under section 71
|
the licence holder
|
74 Section
179, table, new item 7A
insert
7A
|
to refuse to transfer a certification under section 89A
|
an applicant for the transfer
|
75 Deadlines
for making reviewable decisionsSection 182
(a)
substitute
(a) this Act provides for a person to make an application of any kind to
the regulator; and
omit
decision to refuse the application
substitute
reviewable decision to refuse the application, and the person may seek
internal review of the reviewable decision under section 181
77 Regulator
may declare information is confidential commercial
informationNew section 185
(5A)
insert
(5A) If—
(a) a person has made an application under section 184 for a declaration
that stated 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.
78 Interference
with dealings with GMOsSection 192A (2),
definition of authorised GMO dealings, new paragraph
(aa)
insert
(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
79 Section
192A (2), definition of authorised GMO dealings, paragraph
(d)
after
are
insert
dealings
80 Dictionary,
definition of consultative committee
omit
81 Dictionary,
definition of deal with
omit everything after paragraph (g), substitute
(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).
82 Dictionary,
new definition of ethics and community committee
insert
ethics and community committee means the gene technology
ethics and community consultative committee established by the Commonwealth Act,
section 106.
83 Dictionary,
definition of ethics committee
omit
84 Dictionary,
new definition of inadvertent dealings application
insert
inadvertent dealings application means an application for a
GMO licence to which division 5.3 or division 5.4 does not apply because of the
operation of section 46A or section 49.
85 Dictionary,
definition of institutional biosafety committee
substitute
institutional biosafety committee means a committee
established as an institutional biosafety committee in accordance with the
guidelines issued by the regulator under section 98.
Endnotes
1 Presentation speech
Presentation speech made in the Legislative Assembly on 2007.
2 Notification
Notified under the Legislation Act on 2007.
3 Republications of amended laws
For the latest republication of amended laws, see
www.legislation.act.gov.au.
© Australian Capital Territory
2007
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