Gene Technology Amendment Act 2007
No. 99, 2007
An Act to amend the law relating to gene technology, and for
related purposes
[Assented to 28 June 2007]
The Parliament of Australia enacts:
1
Short title
This Act may be cited as the Gene
Technology Amendment Act 2007.
2
Commencement
(1) Each provision of this Act specified in
column 1 of the table commences, or is taken to have commenced, in accordance with
column 2 of the table. Any other statement in column 2 has effect according to
its terms.
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Commencement
information
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Column 1
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Column 2
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Column 3
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Provision(s)
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Commencement
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Date/Details
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1. Sections 1 to 3 and anything in this Act not
elsewhere covered by this table
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The day on which this Act receives the Royal Assent.
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28 June 2007
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2. Part 1 of Schedule 1
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The later of:
(a) 1 July 2007; and
(b) the day after the day on which this Act receives the
Royal Assent.
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1 July 2007 (paragraph (a) applies)
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3. Part 2 of Schedule 1
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A single day to be fixed by Proclamation.
However, if any of the provision(s) do not commence before
1 January 2008, they commence on that day.
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1 January 2008
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4. Parts 3, 4, 5 and 6 of Schedule 1
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At the same time as the provision(s) covered by table item 2.
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1 July 2007
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5. Schedule 2
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At the same time as the provision(s) covered by table item 2.
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1 July 2007
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Note: This table
relates only to the provisions of this Act as originally passed by both Houses
of the Parliament and assented to. It will not be expanded to deal with
provisions inserted in this Act after assent.
(2) Column 3 of the table contains additional
information that is not part of this Act. Information in this column may be
added to or edited in any published version of this Act.
3
Schedule(s)
Each Act that is specified in a Schedule
to this Act is amended or repealed as set out in the applicable items in the
Schedule concerned, and any other item in a Schedule to this Act has effect
according to its terms.
Schedule 1—Gene Technology Act 2000
Part 1—Emergency dealing determinations
1 Subsection 10(1)
Insert:
emergency dealing determination means a
determination in force under section 72B.
2 Section 31
After:
(a) the person
undertaking the dealing is authorised to do so by a GMO licence; or
insert:
(aa) the dealing
is specified in an emergency dealing determination; or
3 Subsection 32(1) (not including the note)
Repeal the subsection, substitute:
(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.
4 After paragraph 33(1)(b)
Insert:
(ba) the dealing with the GMO is not
specified in an emergency dealing determination; and
5 Subsection 33(2)
After “paragraphs (1)(b),”, insert “(ba),”.
6 Subsection 34(1) (not including the note)
Repeal the subsection, substitute:
(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.
7 Paragraphs 34(2)(b) and (c) (not including the note)
Repeal the paragraphs, 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 as to that fact.
8 After section 35
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 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.
9 Section 67
Omit “or 66”, substitute “, 66 or paragraph 72D(2)(h)”.
10 After Part 5
Insert:
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.
11 Section 82 (first paragraph of the simplified
outline)
After “Licence conditions”, insert “, or conditions to which an
emergency dealing determination is subject,”.
12 Section 82 (second paragraph of the simplified
outline)
After “Licence conditions”, insert “, or conditions to which an
emergency dealing determination is subject,”.
13 Subsection 83(2) (note)
After “conditions of a licence”, insert “, or conditions to which
an emergency dealing determination is subject,”.
14 Subsection 91(1) (note)
Repeal the note, substitute:
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)).
15 After paragraph 136A(2)(b)
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;
16 After subsection 138(3)
Insert:
(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.
17 Section 145
Before:
The Part also empowers the Federal
Court to issue injunctions, and contains a forfeiture provision.
insert:
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.
18 Paragraph 146(2)(a)
Repeal the paragraph, substitute:
(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
19 Section 149 (fifth paragraph of the simplified
outline)
After “a licence”, insert “or an emergency dealing
determination”.
20 At the end of subsection 152(2)
Add:
; 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.
21 Section 177
After “licence conditions”, insert “or the Minister’s power to
impose conditions on an emergency dealing determination”.
Note: The heading to section 177 is altered by
omitting “licence”.
22 Subsection 192A(2) (after paragraph (a) of the
definition of authorised GMO dealings)
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
23 Subsection 192A(2) (paragraph (d) of the definition
of authorised GMO dealings)
Omit “deregulated GMO dealings”, substitute “dealings included on
the GMO Register”.
Part 2—Creation of Gene Technology Ethics and Community
Consultative Committee
24 Subsection 10(1) (definition of Consultative Committee)
Repeal the definition.
25 Subsection 10(1)
Insert:
Ethics and Community Committee means the Gene
Technology Ethics and Community Consultative Committee established by section 106.
26 Subsection 10(1) (definition of Ethics Committee)
Repeal the definition.
27 Paragraphs 17(1)(c) and (d)
Repeal the paragraphs, substitute:
(c) the Ethics and Community Committee;
28 Paragraphs 22(1)(c) and (d)
Repeal the paragraphs, substitute:
(c) the Ethics and Community Committee;
29 Paragraphs 24(2)(b) and (c)
Repeal the paragraphs, substitute:
(b) the Ethics and Community Committee;
30 Part 8 (heading)
Repeal the heading, substitute:
Part 8—The Gene
Technology Technical Advisory Committee and the Gene Technology Ethics and
Community Consultative Committee
31 Section 99 (first paragraph of the simplified
outline)
Omit “, the Gene Technology Community Consultative Committee and
the Gene Technology Ethics Committee”, substitute “and the Gene Technology
Ethics and Community Consultative Committee”.
32 Subsection 100(5)
Omit “subsection (6)”, substitute “subsections (6) and
(7A)”.
33 Subsection 100(7A)
Repeal the subsection, substitute:
(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).
34 Divisions 3
and 4 of Part 8
Repeal the Divisions, substitute:
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.
35 Transitional provision
(1) This item applies if functions are conferred by a
corresponding State law upon the Ethics Committee or the Consultative
Committee.
(2) Despite the repeals and amendments made by this
Part:
(a) the Ethics Committee and the Consultative
Committee that were in existence immediately before the commencement of this
item:
(i) continue in existence
after the commencement of this item; and
(ii) the members of the
Ethics and Community Committee are taken to constitute the Ethics Committee and
the Consultative Committee, respectively; and
(b) if, after the commencement of this
item, the Ethics and Community Committee performs a function corresponding to a
function conferred on the Ethics Committee or the Consultative Committee by a
corresponding State law, the Ethics Committee or the Consultative Committee, as
continued in existence by this item, is taken to have performed the function.
(3) Despite the repeals and amendments made by this
Part, the authority:
(a) given by section 17 of the Gene
Technology Act 2000 (as in force immediately before the commencement of
this item); and
(b) that permits a corresponding State
law to confer functions, powers and duties on the Ethics Committee or the
Consultative Committee;
continues in effect as if those repeals and amendments had not happened.
(4) In this item:
Consultative Committee has the meaning given by the
Gene Technology Act 2000, as in force immediately before the
commencement of this item.
Ethics Committee has the meaning given by the Gene
Technology Act 2000, as in force immediately before the commencement of
this item.
Part 3—Assessment of applications: limited and controlled release
and consultation on significant risk
36 Section 49
Repeal the section.
37 Subsection 50(2)
Repeal the subsection.
38 Subsection 50(3)
Omit “The”, substitute “Unless section 50A applies in
relation to the application for the licence, the”
39 After section 50
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 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.
40 Paragraph 51(1)(a)
Omit “mentioned in paragraphs 49(2)(a) to (f)”, substitute
“prescribed by the regulations”.
41 Paragraph 51(1)(b)
Repeal the paragraph.
42 Paragraph 51(2)(b)
Repeal the paragraph.
43 Subsection 52(1)
Omit “49 (if applicable),”.
44 After paragraph 52(2)(b)
Insert:
(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
45 Paragraph 52(2)(d)
Omit all the words 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.
Part 4—Provisions relating to variation
46 Subsection 71(1)
Repeal the subsection, substitute:
(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.
47 Subsection 71(2)
Omit “However, the”, substitute “The”.
48 After subsection 71(2)
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 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.
49 Subsection 71(4)
Omit “However, the Regulator must not vary the”, substitute “The
Regulator must not vary a”.
50 At the end of section 71
Add:
(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).
51 Section 179 (after table item 4)
Insert:
|
4A
|
To refuse to vary a licence
|
section 71
|
the licence holder
|
Part 5—Regulator’s power to direct
52 Section 145 (at the end of paragraph (b) of the
first paragraph of the simplified outline)
Add “, or for certain other reasons”.
53 Paragraphs 146(1)(b) and 146(2)(b)
Repeal the paragraphs, 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 specified in subsection (2A),
for the Regulator to exercise powers under this section;
54 After subsection 146(2)
Insert:
(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.
Part 6—Inadvertent dealings
55 Subsection 10(1)
Insert:
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.
56 After section 40
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 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.
57 After section 46
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.
58 After section 48
Insert:
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.
59 At the end of section 56
Add:
Note: Paragraphs (2)(a), (b) and (c) do not
apply to an inadvertent dealings application.
60 At the end of section 57
Add:
(3) Subsection (2) does not apply to an
inadvertent dealings application.
61 At the end of section 60
Add:
(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.
Schedule 2—Technical amendments
Gene Technology Act 2000
1 Subsection 10(1) (after paragraph (g) of the
definition of deal with)
Insert:
(h) transport the GMO;
(i) dispose of the GMO;
2 Subsection 10(1) (definition of deal with)
Omit all the words after “possession,”, substitute “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)”.
3 Subsection 10(1) (definition of Institutional Biosafety
Committee)
Omit all the words after “established”, substitute “as an
Institutional Biosafety Committee in accordance with written guidelines issued
by the Regulator under section 98”.
4 At the end of section 42
Add:
(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.
5 Subsection 43(2)
After “application” (first occurring), insert “, or may cease
considering the application,”.
6 At the end of subsection 43(2)
Add:
; 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.
7 Paragraphs 56(2)(a) and (b)
Repeal the paragraphs, substitute:
(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;
8 At the end of section 72
Add:
(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.
9 Subsection 78(3)
Omit all the words after “specified in the determination”.
10 At the end of section 89
Add:
(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.
11 After section 89
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) 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.
12 Paragraph 92(2)(a)
Omit “, or proposes to establish,”.
13 Paragraph 92(2)(b)
Omit “whether the organisation will be able to maintain an”,
substitute “if the organisation has established an Institutional Biosafety
Committee—whether the organisation will be able to maintain the”.
14 Paragraphs 92(2)(c)
Omit “whether the organisation has, or will have,”, substitute
“if the organisation has established an Institutional Biosafety Committee—whether
the organisation has”.
15 After paragraph 92(2)(c)
Insert:
(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
16 At the end of section 97
Add:
(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.
17 Section 179 (before table 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
|
paragraph 43(2)(f)
|
the applicant
|
18 Section 179 (after table item 3)
Insert:
|
3A
|
To refuse to transfer a licence
|
section 70
|
an applicant for the transfer
|
19 Section 179 (after table item 7)
Insert:
|
7A
|
To refuse to transfer a certification
|
section 89A
|
an applicant for the transfer
|
20 Paragraph 182(a)
Repeal the paragraph, substitute:
(a) this Act provides for a person to
make an application of any kind to the Regulator; and
21 Section 182
Omit “decision to reject the application”, substitute “reviewable
decision to reject the application, and the person may seek internal review of
the reviewable decision under section 181”.
22 After subsection 185(3A)
Insert:
(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.