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2004-2005-2006-2007
THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
SENATE
GENE TECHNOLOGY AMENDMENT BILL 2007
EXPLANATORY MEMORANDUM
(Circulated by authority of the Parliamentary Secretary to the Minister for Health and
Ageing, Senator the Honourable Brett Mason)
GENE TECHNOLOGY AMENDMENT BILL 2007
OUTLINE
The purpose of this Bill is to amend the Gene Technology Act 2000 (the Act) in order to
improve its operation without changing the underlying policy intent or overall legislative
framework of the regulatory scheme.
The Act is the Australian Government's component of the nationally consistent regulatory
scheme for gene technology. Under the Gene Technology Agreement 2001, all States and
Territories have committed to maintaining corresponding legislation. The object of the Act is
to protect the health and safety of people, and to protect the environment, by identifying risks
posed by or as a result of gene technology, and by managing those risks through regulating
certain dealings with genetically modified organisms (GMOs).
In 2005-06, an independent review of the Act and the intergovernmental Gene Technology
Agreement 2001 (the Review) was conducted. The Review found that the Act and the
national regulatory scheme had worked well in the five years following introduction, and that
no major changes were required. However, it suggested a number of minor changes, aimed
at improving the operation of the Act at the margin.
On 27 October 2006, the Gene Technology Ministerial Council (GTMC), an
intergovernmental body comprised of State, Territory and Australian Government Ministers,
agreed to proposals to implement the recommendations of the Review. This Bill proposes to
implement the recommendations requiring legislative change, which include:
· introducing emergency powers, giving the Minister the ability to expedite the
approval of a dealing with a GMO in an emergency (Part 1 of Schedule 1 to the Bill);
· improving the mechanism for providing advice to the Gene Technology Regulator
(the Regulator) and the GTMC on ethics and community consultations (Part 2 of
Schedule 1 to the Bill);
· streamlining the process for the initial consideration of licences (Part 3 of Schedule 1
to the Bill);
· reducing the regulatory burden for low risk dealings (Part 3 of Schedule 1 to the Bill);
· providing clarification on the circumstances in which licence variations can be made
(Part 4 of Schedule 1 to the Bill);
· clarifying the circumstances under which the Regulator can direct a person to comply
with the Act (Part 5 of Schedule 1 to the Bill);
· 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
disposing of that organism (Part 6 of Schedule 1 to the Bill); and
· making technical amendments to improve the operation of the Act (Schedule 2 to the
Bill).
FINANCIAL IMPACT STATEMENT
The proposed amendments to the Act have no financial impact.
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GENE TECHNOLOGY AMENDMENT BILL 2007
NOTES ON CLAUSES
Clause 1: Short Title
This clause provides that the Act may be cited as the Gene Technology Amendment Act 2007.
Clause 2: Commencement
This clause provides that sections 1 to 3 of the Act would commence on the day on which the
Act receives Royal Assent. Parts 1, 3, 4, 5, and 6 of Schedule 1 and Schedule 2 would
commence on 1 July 2007, or on the day after the day on which the Act receives Royal
Assent, whichever is the later.
Part 2 of Schedule 1 would commence on a single day to be fixed by Proclamation, which
must be before 1 January 2008, otherwise this Part commences on 1 January 2008. It is
scheduled to commence after the rest of the Bill to allow members of the Gene Technology
Ethics Committee to complete their agreed terms of appointment.
Clause 3: Schedule(s)
This clause provides that each Act specified in a Schedule to the Act is amended or repealed
as set out in the applicable items in the Schedule concerned, and any other item in a
Schedule, has effect according to its terms.
SCHEDULE 1: GENE TECHNOLOGY ACT 2000
PART 1: Emergency dealing determinations
Part 1 of Schedule 1 to the Bill proposes to introduce emergency provisions into the Act. The
object of these provisions is to increase the effectiveness of the gene technology regulatory
system by increasing its responsiveness.
The emergency provisions give the Minister power to expedite an approval of a dealing with
a GMO in an emergency. This recognises that situations may arise in which approval of a
dealing with a GMO may be required in a limited time. The emergency provisions also
further the objects of the Act to protect the health and safety of people and to protect the
environment.
The introduction of emergency provisions to the Act is also beneficial because it will
improve consistency between regulatory schemes. Other relevant product regulators for
vaccines, such as the Therapeutic Goods Administration and the Australian Pesticides and
Veterinary Medicines Authority, already possess the ability to expedite approvals in an
emergency.
Item 1 would insert a definition of emergency dealing determination into subsection 10(1)
of the Act, providing that an emergency dealing determination means a determination in
force under section 72B of the Act.
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Item 2 would insert a new paragraph 31(2)(aa) into the simplified outline at the beginning of
Part 4 of the Act. The proposed new paragraph makes clear that `a dealing specified in an
emergency dealing determination' is not prohibited under the Part.
Item 3 would repeal the existing subsection 32(1) and substitute a new subsection 32(1) into
the Act. The new subsection would provide that a person commits an offence if he or she
deals with a GMO, knowing that it is a GMO and without a licence authorising the dealing,
unless the dealing is specified in an emergency dealing determination, it is a notifiable low
risk dealing, it has been specifically exempted from the application of the legislation under
the Regulations, or it has been placed on the GMO register. The person must either have
known, or have been reckless about all of these things to have committed an offence.
The new subsection 32(1) is substantially the same as the existing subsection 32(1) except
that it inserts an additional paragraph providing that the dealing with the GMO must not be
specified in an emergency dealing determination, and the person must know or be reckless as
to this fact for an offence to be committed. In addition, the subsection has been redrafted to
clarify that an offence is only committed if the dealing with the GMO is not authorised by a
licence.
Items 4 and 5 would insert a new paragraph 33(1)(ba) into the Act and insert a reference to
the new paragraph 33(1)(ba) into subsection 33(2) of the Act. These amendments would
make clear that a person will commit a strict liability offence under subsection 33(1) of the
Act if the person deals with a GMO, knowing that it is a GMO, the dealing is not authorised
by a licence, it is not specified in an emergency dealing determination, it is not a notifiable
low risk dealing, it has not been specifically exempted from the application of the legislation
under the Regulations, and it is not on the GMO register.
Item 6 would repeal the existing subsection 34(1) and substitute a new subsection 34(1). The
subsection has been redrafted to clarify that in order to commit an offence a person's actions
must contravene a licence and the person must know or be reckless as to that fact.
Item 7 would repeal the existing paragraphs 34(2)(b) and (c) and substitute new paragraphs
34(2)(b) and (c). The paragraphs have been redrafted to clarify that in order to commit an
offence a person's actions must contravene the conditions of a licence and the person must
know or be reckless as to that fact.
Item 8 would insert two new offence provisions into the Act:
Section 35A: the proposed new section 35A is similar to existing section 34 of the Act.
Proposed subsection 35A(1) creates an offence for intentionally breaching the conditions of
an emergency dealing determination. Proposed paragraph 35A(2)(a) provides that the
penalty for an aggravated offence is 5 years imprisonment or 2,000 penalty units. Proposed
paragraph 35A(2)(b) provides that if it is not an aggravated offence the penalty will be 2
years imprisonment or 500 penalty units. These penalties are consistent with those contained
in section 34.
Section 35B: the proposed new section 35B creates a strict liability offence for breaching the
conditions of an emergency dealing determination. It is similar to the existing section 35 of
the Act. In order to have committed an offence under proposed new subsection 35B(1), the
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person must have knowledge of the conditions to which the emergency dealing determination
is subject, but need not know that he or she is breaching that condition. Proposed paragraph
35B(2)(a) provides that the penalty for an aggravated offence is 200 penalty units. Proposed
paragraph 35B(2)(b) provides that if it is not an aggravated offence the penalty is 50 penalty
units. These penalties are consistent with those contained in section 35. Proposed subsection
35B(3) provides that strict liability applies to paragraphs 35B(1)(a) and (b).
New strict liability offence
Item 6 would create a new strict liability offence for breaching the conditions of an
emergency dealing determination. The application of strict liability to this offence is
considered appropriate because any dealings with a GMO conducted in an unauthorised or
unregulated manner could cause serious harm to the health and safety of people and the
environment. Strong deterrents are needed to discourage persons from dealing with GMOs
unless they are fully aware of any relevant regulatory safeguards.
Item 9 would alter the wording of section 67, to make clear that the section applies to protect
persons who provide information under the new paragraph 72D(1)(h) from certain civil
liabilities.
Item 10 would insert a new Part 5A with the title `Emergency dealing determinations' into
the Act.
Section 72A: the proposed new section 72A creates a simplified outline for the Part. It
provides that the Part creates a system whereby the Minister can make a determination
relating to dealings with GMOs in an emergency.
Section 72B
Subsection 72B(1): the proposed new subsection 72B(1) gives the Minister power to make an
emergency dealing determination in respect of specified dealings with a GMO, by legislative
instrument. The emergency dealing determination will effectively authorise the specified
dealings with the GMO so that the penalty provisions in Part 4 of the Act will not apply.
A legislative instrument made under subsection 72B(1) is not to be disallowable because,
once States and Territories sign the amended Gene Technology Agreement 2001, it would fall
under the exemption in subsection 44(1) of the Legislative Instruments Act 2003 (the LIA).
The exemption applies because the Act, in conjunction with the Gene Technology Agreement
2001, facilitates an intergovernmental scheme involving the Commonwealth and all States
and Territories. A legislative instrument made under subsection 72B(1) would be made for
the purposes of this scheme; this is supported by paragraph 72B(2)(e) which provides that
States must be consulted about the making of the proposed emergency dealing determination.
Subsection 72B(2): the proposed new subsection 72B(2) sets out the conditions under which
the Minister is permitted to make an emergency dealing determination. It provides that
before making an emergency dealing determination the Minister must:
· have received advice from the Commonwealth Chief Medical Officer; the
Commonwealth Chief Veterinary Officer, the Commonwealth Chief Plant Protection
Officer or a person specified in the regulations, that there is an actual or imminent
threat to the health and safety of people or the environment and that the dealings
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proposed to be specified in the emergency dealing determination would, or would be
likely to, adequately address the threat;
· be satisfied that there is an actual or imminent threat to the health and safety of people
or the environment, that the dealings proposed to be covered by the emergency
dealing determination would, or would be likely to, adequately address the threat; and
· be satisfied that the risks posed by the proposed dealings can be managed safely, and
have received advice from the Regulator to that effect.
In addition, States (which is defined to include the Australian Capital Territory and the
Northern Territory) must have been consulted about the proposed emergency dealing
determination.
Subsection 72B(3): the proposed new subsection 72B(3) gives examples of situations in
which it may be appropriate to issue an emergency dealing determination. These include:
· where there is a threat of disease;
· where there is a threat from an animal or plant (such as a pest or alien invasive
species); or
· where there is a threat from industrial spillage.
The Bill makes clear that the threat must be actual and imminent for the emergency
provisions to apply. It is expected that the provisions will only be utilised if a threat is
serious and immediate.
Hypothetical examples situations in which the powers could be used are if there is a threat of
an avian flu pandemic or if there is a threat of major environmental damage from an oil spill.
In these situations the Minister may wish to issue an emergency dealing determination in
relation to a dealing with a GMO which is intended to address the threat by minimising or
eradicating the problem organism and its vectors, or by conveying immunity in humans
and/or animals. In the hypothetical situations mentioned above, the determination could
cover dealings in relation to a genetically modified vaccine for human or veterinary use; or a
genetically modified bacterium to dissolve oil.
Subsection 72B(4): the proposed new subsection 72B(4) sets out the types of dealings for
which the Minister may make a determination. It makes clear that the determination may be
in respect of all dealings with a GMO, a specified class of dealings, or one or more specified
dealings and may relate to a specific GMO or a class of GMOs. A class of dealings or a class
of GMOs may be defined by a range of matters. For example, an exempt class of dealings
with a GMO may be limited by the type of GMO, who deals with the GMO, how the GMO is
dealt with and whether the GMO is regulated under existing legislation. This provision is
drafted in similar terms to the existing subsection 32(4) of the Act.
Section 72C
Subsection 72C(1): the proposed new subsection 72C(1) sets out that a determination can
take effect on the day on which it is made or at a specified later date. In other words, the
determinations cannot apply retrospectively.
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Subsection 72C(2): the proposed new subsection 72C(2) provides that a determination ceases
to have effect on: a date specified in the determination; when the determination is revoked; or
after six months; whichever comes first.
Subsection 72C(3): the proposed new subsection 72C(3) provides that the Minister may
extend an emergency dealing determination.
Subsection 72C(4): the proposed new subsection 72C(4) provides that the Minister may
extend the emergency dealing determination more than once, for up to six months each time.
The process set out in subsection 72C(5) must be repeated for each extension.
Subsection 72C(5): the proposed new subsection 72C(5) provides that the Minister may only
extend an emergency dealing determination if:
· he or she has received advice from the person who originally provided advice under
paragraph 72B(2)(a) (the "original adviser") that the threat still exists and that
extending the emergency dealing determination would, or would be likely to,
adequately address the threat; and
· he or she is satisfied that threat still exists and that extending the emergency dealing
determination would, or would be likely to, adequately address the threat; and
· he or she is satisfied that the risks posed by the proposed dealings can be managed
safely, and have received advice from the Regulator to that effect; and
· the majority of jurisdictions (including States, Territories and the Australian
Government) agree to the extension.
Subsection 72C(6): the proposed new subsection 72C(6) provides that the extension of the
emergency dealing determination takes effect when the original emergency dealing
determination was scheduled to end.
Subsection 72C(7): the proposed new subsection 72C(7) defines original adviser in
subsection 72C(5) as the person who gave the advice under paragraph 72B(2)(a).
Section 72D
Subsection 72D(1): the proposed new subsection 72D(1) allows conditions to be imposed on
an emergency dealing determination. Paragraphs 72D(2)(a) to (v) give examples of the
conditions that may be imposed. These include conditions relating to the quantity of GMO,
the scope of dealings, the source of GMO, the person who may deal with the GMO,
information required to be given to persons permitted to deal with a GMO, additional
information that must be provided to the Regulator, and the storage and security of the GMO
amongst other things. The new paragraph (w) clarifies that the conditions the Minister may
impose are not limited to the matters listed in paragraphs (a) to (v), but that the Minister may
impose conditions over any other matter he or she considers appropriate.
The proposed new paragraphs 72D(2)(a) to (v) correspond to the existing sections 62, 63, 64
of the Act, which relate to the conditions that may be imposed on licences:
· the proposed new paragraphs 72D(2)(b) to (d) correspond to the existing subsections
62(1)(a) to (c);
· the proposed new paragraph 72D(2)(g) is the equivalent of the existing section 63;
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· the proposed new paragraph 72D(2)(h) corresponds to the existing section 65;
· the proposed new paragraphs 72D(2)(j) and (k) correspond to the existing paragraphs
62(1)(e) and (f);
· the proposed new paragraphs 72D(2)(m) to (o) correspond to the existing paragraphs
62(1)(g) to (i); and
· the proposed new paragraphs 72D(2)(q) to (v) correspond to the existing paragraphs
62(1)(j) to (o).
Subsection 72D(3): the proposed new paragraph 72D(2)(f) provides that a condition may
specify the person who may deal with the GMO. The proposed subsection 72D(3) makes
clear that it is not necessary to specify a single person, that a condition can specify persons or
a class of persons who may deal with the GMO. There are no restrictions on who may be
included in the class of persons who may deal with the GMO, or how large the class may be.
Subsection 72D(4): the proposed new subsection 72D(4) is drafted on similar terms to the
existing section 64 of the Act. It provides that it is a condition of an emergency dealing
determination that a person permitted to deal with a GMO under an emergency dealing
determination, must allow the Regulator (or delegate) to enter premises where the dealing is
being undertaken, in order to conduct audits, or monitor the dealings covered by the
emergency dealing determination. This allows the Regulator to undertake routine or `on-the-
spot' auditing or monitoring of dealings covered by an emergency dealing determination.
Subsection 72D(5): the proposed new subsection 72D(5) makes clear that subsection 72D(4)
does not limit the conditions that may be placed on an emergency dealing determination.
Section 72E
Subsection 72E(1): the proposed new subsection 72E(1) provides that the Minister may vary
the conditions of an emergency dealing determination by legislative instrument, including by
imposing new conditions on a determination.
A legislative instrument issued under subsection 72E(1) is not disallowable because the
exemption in subsection 44(1) of the LIA applies. This exemption applies for the reasons set
out in relation to subsection 72B(1), above.
Subsection 72E(2): the proposed new subsection 72E(2) provides that the Minister may
suspend or revoke an emergency dealing determination by legislative instrument, in three
circumstances:
· if the Minister becomes aware of risks to the health and safety of people or the
environment posed by the dealing that cannot be adequately addressed;
· if the Minister is satisfied that the threat no longer exists or is no longer sufficiently
serious as to warrant an emergency dealing determination; or
· if the Minister is no longer satisfied that the dealings covered by the determination are
likely to adequately address the threat.
Subsection 72E(3): the proposed new subsection 72E(3) provides that the Minister must
consult the States (which is defined to include the Territories) before varying, suspending or
revoking an emergency dealing determination unless the proposed variation is of a minor
technical nature.
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Subsections 72E(4) and 72E(5): the proposed new subsection 72E(4) provides that a
suspension, revocation, or variation may take effect immediately only if the Minister states
that it is necessary to prevent imminent risk of death, serious illness or serious injury or
serious damage to the environment. Subsection 72E(5) provides that otherwise, it must take
effect on a date specified, which must be 30 days or more after it is made.
Items 11 and 12 would amend the simplified outline to make clear that the conditions of an
emergency dealing determination could require a facility to be certified and accredited under
Division 2 of the Act, or an organisation to be accredited under Division 3 of the Act.
Item 13 would insert words into the note in subsection 83(2) to make clear that the
conditions of an emergency dealing determination could require a facility to be certified
under Division 2.
Item 14 would replace the note in subsection 91(1) to make clear that the conditions of an
emergency dealing determination could require supervision by an Institutional Biosafety
Committee.
Item 15 would insert two new paragraphs 136A(2)(ba) and 136A(2)(bb) into the Act
providing that quarterly reports prepared by the Regulator and given to the Minister must
include information about any emergency dealing determinations issued by the Minister and
any breaches of conditions of an emergency dealing determination that have come to the
Regulator's attention during the quarter.
Item 16 would insert a new subsection 138(3A) into the Act providing that the Record of
GMO and GM Product dealings required under Division 6, must include comprehensive
information, except confidential commercial information, on the content of emergency
dealing determinations.
Item 17 would insert a new paragraph into the simplified outline in section 145 of the Act.
This makes clear that Part 10 of the Act enables the Regulator to give directions to a person
permitted to deal with a GMO under an emergency dealing determination.
Item 18 would amend paragraph 146(2)(a) to provide that the Regulator may give directions
to a person dealing with, or who has dealt with, a GMO specified in an emergency dealing
determination.
Item 19 would insert a reference to emergency dealing determinations into the simplified
outline in section 149 of the Act. This makes clear that Part 11 does not limit the conditions
to which an emergency dealing determination can be subject.
Item 20 would insert a new paragraph into subsection 152(2) of the Act to make clear that an
inspector may enter premises and exercise the monitoring powers set out in section 153, for
the purpose of finding out whether the Act or regulations have been complied with, if the
occupier of the premises is a person dealing with, or who has dealt with, a GMO specified in
an emergency dealing determination and entry is at a reasonable time.
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Item 21 would insert a reference to the Minister's power to impose conditions on an
emergency dealing determination into section 177 of the Act. This clarifies that Part 11 does
not limit the Minister's power to impose conditions on an emergency dealing determination.
Item 22 would insert a new paragraph into subsection 192A(2) of the Act to provide that
authorised GMO dealings include dealings 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 emergency dealing determination.
Item 23 would amend paragraph (d) of the definition of authorised GMO dealings in
subsection 192A(2) of the Act, to refer to `dealings included on the GMO Register' instead of
`deregulated GMO dealings'.
PART 2: Creation of Gene Technology Ethics and Community Consultative Committee
Part 2 of Schedule 1 to the Bill proposes amendments which will combine the Gene
Technology Ethics Committee (the Ethics Committee) and the Gene Technology Community
Consultative Committee (the Consultative Committee) into one advisory committee. The
combined committee will be known as the Gene Technology Ethics and Community
Consultative Committee (the Ethics and Community Committee) and will carry out the
combined functions of both committees as well as providing advice on risk communication
and community consultation in relation to intentional release licence applications.
The object of these proposed amendments is to increase efficiency by addressing the overlap
between the roles of the Ethics Committee and the Consultative Committee. The new
committee would also allow relevant skills to be distributed across its membership so that the
committee is able to provide clear, balanced, appropriate, and more coordinated advice.
The GTMC will review the performance of the new advisory committee after 18 months, but
before it has been operating for two years.
Item 24 would repeal the definition of Consultative Committee in subsection 10(1) of the
Act.
Item 25 would insert a definition of Ethics and Community Committee into subsection 10(1)
of the Act. It would be defined to mean the Gene Technology Ethics and Community
Consultative Committee established by section 106 of the Act (inserted by tem 34).
Item 26 would repeal the definition of Ethics Committee in subsection 10(1) of the Act.
Items 27-31 and 33 would repeal references to the Consultative Committee and the Ethics
Committee in the Act and replace them with references to the Ethics and Community
Committee.
Item 32 would make a consequential amendment to subsection 100(5) of the Act to make
clear that subsection 100(5) is subject to both subsection 100(6) and subsection 100(7A).
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Item 34 would repeal Divisions 3 and 4 of Part 8 of the Act and insert a new Division 3,
which establishes the Ethics and Community Committee, and provides for its functions and
membership, as well as the remuneration of its members.
Section 106: the proposed new section 106 establishes the Gene Technology Ethics and
Community Consultative Committee, to be known as the Ethics and Community Committee.
Section 107: the proposed new section 107 provides that the function of the Ethics and
Community Committee will be to provide advice, at the request of the Regulator or the
Ministerial Council, on:
· matters on which the Ethics Committee currently advises;
· matters on which the Consultative Committee currently advises;
· community consultation matters relating to intentional release licence applications;
and
· risk communication matters relating to dealings that involve the intentional release of
a GMO into the environment.
Risk communication involves an interactive dialogue between risk assessors, risk managers
and stakeholders. It underpins the processes of risk assessment and risk management.
The proposed new section 107 is not intended to mandate the examination of every
intentional release application, instead it is intended to permit the Regulator to seek advice in
relation to certain types of releases that might be precipitated by such an application.
The matters on which the Ethics Committee currently advises are set out in section 112 of the
existing Act. These are: ethical issues relating to gene technology; the need for, and content
of, codes of practice in relation to ethics in respect of conducting dealings with GMOs; and
the need for, and content of, policy principles in relation to dealings with GMOs that should
not be conducted for ethical reasons. It is proposed that these matters will be incorporated
into proposed paragraphs 107(a), (b) and (c) of the Act.
The matters on which the Consultative Committee currently advises are set out in existing
section 107 of the Act. These are: matters of general concern identified by the Regulator in
relation to applications, matters of general concern in relation to GMOs, and the need for
policy principles, policy guidelines, codes of practice and technical and procedural guidelines
in relation to GMOs and GM products and the conduct of such principles, guidelines and
codes. It is proposed that these matters will be incorporated into proposed paragraphs 107(d),
(g), and (h) of the Act.
Section 108: the proposed new section 108 relates to the membership of the Ethics and
Community Committee. The proposed new subsection 108(1) is the same as the existing
subsections 108(1) and 111(2) of the Act, except that it refers to the Ethics and Community
Committee instead of the Ethics Committee or the Consultative Committee. With the same
exception, the proposed new subsection 108(2) is the same as the existing subsections 108(2)
and 111(4) of the Act; the proposed new subsection 108(5) is the same as the existing
subsections 108(5) and 111(3) of the Act; and the proposed new subsection 108(6) is the
same as the existing subsections 108(6) and 111(7) of the Act.
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Subsection 108(3): the proposed new subsection 108(3) lists the areas of experience members
of the Ethics and Community Committee are required to have. It specifies that, with the
exception of a member appointed under the proposed new subsection 108(4), the Minister
must not appoint a person as a member of the Ethics and Community Committee unless the
Minister is satisfied that the person has skills or experience relevant to gene technology in
one or more of the following areas:
· community consultation;
· risk communication (i.e. the facilitation of communication between risk assessors,
risk managers and stakeholders);
· the impact of gene technology on the community;
· issues relevant to businesses developing or using biotechnology;
· issues relevant to gene technology research;
· issues relevant to local government;
· issues of concern to consumers;
· law;
· religious practices;
· human health;
· animal health and welfare;
· primary production;
· ethics; and
· environmental issues.
Regulations may also prescribe additional areas of skill or experience. With the exception of
community consultation and risk communication, all of these areas of experience were
previously listed as areas of experience members of either the Ethics Committee or the
Consultative Committee were required to have.
Subsection 108(4): the proposed new subsection 108(4) provides that the Minister must
ensure that the Ethics and Community Committee includes a member of the Gene
Technology Technical Advisory Committee and a member of the Australian Health Ethics
Committee.
Section 109: the proposed new section 109 provides for remuneration of the Ethics and
Community Committee and its expert advisers. It is the same as existing sections 109 and
114 of the Act, except that it refers to the Ethics and Community Committee instead of the
Ethics Committee or the Consultative Committee.
Section 110: the proposed new section 110 relates to the membership and procedures of the
Ethics and Community Committee. This section is similar to the existing section 115 of the
Act.
Subsections 110(1) and 110(2): the proposed new subsections 110(1) and (2) provide that the
regulations may prescribe matters relating to the membership and operation of the Ethics and
Community Committee.
Subsection 110(3): the proposed new subsection 110(3) provides that if no regulations are in
force, the Ethics and Community Committee must operate in a way determined by the
Regulator in writing.
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Subsection 110(4): the proposed new subsection 110(4) provides that in the absence of
regulations made under subsections 110(1) and (2), or a determination made under subsection
110(3), the Ethics and Community Committee may operate as it, itself, determines in writing.
Subsection 110(5): the proposed new subsection 110(5) makes clear that determinations
made under subsections 110(4) and 110(5) are not legislative instruments.
Determinations made under subsections 110(3) and (4) not legislative instruments
Subsection 110(5) is intended to assist readers by making clear that a determination made
under subsection 110(3) or 110(4) is not a legislative instrument. This is because the
instruments made under these sections would be administrative rather than legislative in
nature and therefore would not meet the definition of a legislative instrument in section 5 of
the LIA (subsection 15AE(3) of the Acts Interpretation Act 1901 deals with a provision of a
law which requires or permits an instrument that is described as not being a legislative
instrument to be made).
Sections 111 and 112: the proposed new sections 111 and 112 provide for the establishment
of subcommittees and the appointment of expert advisers. The sections are the same as the
existing sections 116, 110A, and 113 of the Act except that they refer to the Ethics and
Community Committee instead of the Ethics Committee or the Consultative Committee.
Item 35 is a transitional provision. This provision makes clear that where State laws confer
functions on the former Ethics Committee or the Consultative Committee, the new Ethics and
Community Committee can exercise those functions. This will ensure that the new
Committee can perform the functions that are conferred by the State laws on the old
Committees until the State laws are amended to refer to the new Committee.
PART 3: Assessment of applications: limited and controlled release and consultation on
significant risk
Part 3 of Schedule 1 to the Bill proposes two types of amendment. The first type of
amendment would alter the order of events during the initial licence consultation process, so
that the Regulator is no longer required to consider whether an application poses a significant
risk to the health and safety of people or the environment before developing a risk assessment
and risk management plan (RARMP). The object of these amendments is to improve the
process by which licences are initially considered by giving the Regulator more time to
consider whether dealings pose a significant risk. The second type of amendment would
introduce a new category of licence to distinguish between licences for a limited and
controlled release, and licences for intentional release. The object of these amendments is to
increase the efficiency of the regulatory system by streamlining the application process for
licences involving a limited and controlled release of a GMO.
Item 36 would repeal section 49 of the Act. Under this section, the Regulator is currently
required to assess whether a proposed dealing may pose a significant risk before developing a
RARMP. This has proved problematic, as it can be difficult for the Regulator to make a
judgment on the risk of a GMO prior to the development of the comprehensive RARMP.
12
Item 36 would repeal this requirement, thereby allowing the Regulator to identify the
significant risk after he or she has developed a RARMP under section 50 of the Act.
Items 37 and 40-43 would make consequential amendments to the Act by repealing
subsection 50(2), and paragraphs 51(1)(b) and 51(2)(b) which relate to actions required by
section 49; and by omitting the references to section 49 in subsection 51(2) and paragraph
51(1)(a).
Item 44 would insert a new paragraph (ba) into subsection 52(2) of the Act. The new
paragraph would provide that if the Regulator is satisfied that dealings with a GMO pose a
significant risk, then the Regulator should make a statement to that effect in the notice
published under subsection 52(1). Thus, under this paragraph, the Regulator is required to
assess whether there is a significant risk after the RARMP has been developed under section
50, but before he or she has consulted on it under section 52(3).
Item 45 would provide for a longer consultation process where the Regulator considers that
the GMO poses a significant risk to the health and safety of people or the environment and
the RARMP contains a statement to that effect. The item proposes to insert two new
subparagraphs into paragraph 52(2)(d) of the Act. The proposed subparagraph 52(2)(d)(i)
would provide that the time period for submissions must be at least 50 days if the Regulator
is satisfied that the dealings pose a significant risk. The proposed subparagraph 52(2)(d)(ii)
would provide for a thirty day time period for all other dealings.
Items 38 and 39
Item 39 would insert a new section 50A into the Act. This section would create a new
category of licence application, to be known as `limited and controlled release' applications.
Item 38 would amend subsection 50(3) of the Act to make clear that if an application is a
limited and controlled release application, the Regulator does not need to seek advice from
the States (including the Australian Capital Territory and the Northern Territory), the Gene
Technology Advisory Committee, prescribed agencies, the Environment Minister, or local
councils on the preparation of an RARMP.
These amendments recognise that an application for a release of a GMO for the purposes of
obtaining experimental data will generally be limited in terms of time, spatial scale and
location and have containment measures to restrict dissemination. In contrast, applicants
wishing to intentionally release a GMO may wish to produce that GMO commercially and
will generally seek a licence with as few restrictions as possible. Hence, licences for
intentional release would need to undergo a more rigorous risk assessment process than
licences for a limited and controlled release.
Subsection 50A(1): the proposed subsection 50A(1) provides that the new section 50A will
apply if the Regulator is satisfied of three things: firstly, that the principal purpose of the
licence sought is to enable experiments to be conducted; secondly, that the release of the
GMO under the licence would be limited and that controls would be in place to limit the
dissemination of the organism; and thirdly, that it is appropriate for section 50(3) of the Act
not to apply to the licence.
Subsection 50A(2): the proposed subsection 50A(2) gives guidance on the meaning of the
term `controls' in subsection 50A(1). It provides that controls can relate to the dissemination
13
and persistence of the GMO, the disposal of the GMO, the studies that can be conducted on
the GMO, the geographic area in which dealings may be conducted, and compliance with a
code of practice or a technical and procedural guideline.
Subsection 50A(3): the proposed subsection 50A(3) gives guidance on the meaning of the
term `limits' in subsection 50A(1). It provides that limits can include limits on the scope,
scale, location and duration of dealings with a GMO, as well as the persons who are
permitted to conduct dealings with the GMO.
Subsection 50A(4): the proposed subsection 50A(4) provides that in determining whether the
principal purpose of the licence is to conduct experiments (or, in other words, in determining
whether subsection 50A(1) applies to a licence), the Regulator must have regard to whether
the applicant proposes to test hypotheses; to gain scientific or technical knowledge; or to gain
data for regulatory purposes or for product development or marketing. An undertaking to
conduct any of these forms of research would help establish that a licence is for the purposes
of conducting experiments. However, the Regulator still needs to consider whether
conducting experiments is the principal purpose of the licence. Paragraph 50A(4)(b) makes
clear that the Regulator may also consider any other matters that he or she considers to be
relevant.
PART 4: Provisions relating to variation
Part 4 of Schedule 1 to the Bill proposes amendments which would give the Regulator the
power to permit licence variations in certain circumstances. While it is apparent from the
existing subsection 72(5) that licence-holders can request variations to their licences, this is
not explicitly stated in the Act. The introduction of amendments to explicitly permit licence
variations is intended to increase the clarity of the Act. Furthermore, the imposition of limits
on the circumstances in which Regulator can vary a licence is intended to prevent a variation
being used to unreasonably extend the coverage of a licence.
Item 46 would repeal the existing subsection 71(1) and insert a revised subsection 71(1) and
a new subsection 71(1A) into the Act. The proposed new subsection 71(1) clarifies that the
Regulator has the power to vary a licence either unilaterally, or after receiving an application
from a licence-holder. The proposed new subsection 71(1A) provides that the licence
holder's application must be in writing and include any information prescribed by the
Regulations or required by the Regulator in writing.
Item 47 would make a consequential amendment to subsection 71(2) of the Act.
Item 48 would insert new subsections 71(2A) and 71(2B) into the Act. These subsections
describe circumstances in which the Regulator is not permitted to vary a licence.
Subsection 71(2A): the proposed new subsection 71(2A) provides that the Regulator must not
vary a licence if the original application was for a limited and controlled release unless the
licence as varied is also for a limited and controlled release. In other words, the object of this
section is to prevent a variation turning a licence for a limited and controlled release into a
licence permitting intentional release of a GMO into the environment.
14
Subsection 71(2B): the proposed new subsection 71(2B) provides that the Regulator must not
vary a licence if the licence, as varied, would pose new risks which were not covered in the
original risk assessment and risk management plans.
Item 49 would make a consequential amendment to subsection 71(4) of the Act.
Item 50 would insert four new subsections into the Act.
Subsection 71(5): the proposed new subsection 71(5) provides that the Regulator must
consult with any appropriate local council before varying a licence.
Subsection 71(6): the proposed new subsection 71(6) provides that the Regulations may
impose additional limitations on the Regulator's power to vary the licence.
Subsection 71(7): the proposed new subsection 71(7) provides that the Regulations may set a
time limit in which the Regulator must vary a licence.
Subsection 71(8): the proposed new subsection 71(8) makes clear that the terms `controls'
and `limits' have the same meaning in subsection 71(2A) as in the proposed section 50A of
the Act.
Item 51 would insert a new item 4A into the table in section 179 of the Act. This makes
clear that the Regulator's decision to refuse to vary a licence is a reviewable decision, and
that the licence holder can apply to the Administrative Appeals Tribunal under section 183 of
the Act for review of the decision.
PART 5: Regulator's power to direct
Part 5 of Schedule 1 to the Bill proposes amendments which would increase the
circumstances under which the Regulator may direct a licence-holder, or a person covered by
a licence, to comply with the Act or Regulations.
The object of these proposed amendments is to reduce ambiguity in the Act, by clarifying
that the Regulator may direct a licence-holder to comply, even if there is no immediate risk to
the health and safety of people or the environment.
The effect of the proposed amendments will be to increase the Regulator's compliance tools
and ensure that all breaches of licences can be dealt with under the Act. This recognises that
it is important to maintain the integrity of licences, even if there is no immediate risk to the
health and safety of people or the environment.
Item 52 would add the phrase "or for certain other reasons" to the end of paragraph 145(b) in
the simplified outline at the start of Part 10 of the Act. This would make clear that the
circumstances under which the Regulator may give directions have been expanded.
Item 53 would insert new subparagraphs 146(1)(b)(ii) and 146(2)(b)(ii) into the Act. These
subparagraphs provide that the Regulator may give directions to a person, requiring that he or
15
she take steps to comply with the Act and Regulations, if it is desirable in the public interest
to do so.
Item 54 would insert a new paragraph 146(2A) into the Act, setting out the matters that the
Regulator should consider in deciding whether it is in the public interest to make a direction.
These matters would include:
· the type of the GMO dealing and whether it is a one-off or ongoing dealing;
· whether any steps have been taken to address the non-compliance issue;
· the likelihood of a repeat of the non-compliance;
· the severity of the non-compliance issue;
· the compliance history of the licensee or the person covered by the licence;
· whether it would be more appropriate to address the non-compliance by another
means such as variation, suspension or cancellation of the licence;
· whether the non-compliance was deliberate; and
· the need for deterrence.
These matters are similar to those listed in the OGTR's Non-Compliance Protocol of
10 May 2002. The protocol gives the Regulator guidance on what matters he or she should
consider in deciding whether to conduct a criminal investigation.
PART 6: Inadvertent dealings
Part 6 to the Bill proposes amendments to allow the Regulator to grant a temporary permit to
a person who finds himself or herself inadvertently dealing with an unlicensed GMO. The
licence will be issued to the person for the purposes of disposing of the GMO in a manner
which protects the health and safety of people and the environment.
The object of these proposed amendments is to allow a person who has unintentionally come
into possession of a GMO to dispose of the GMO without breaching the Act. Under the
current Act, the Regulator can rely on the offence provisions or injunctions to deal with
unapproved dealings with a GMO. However, these tools are not suited to a case where a
person wishes to act cooperatively and dispose of the GMO in accordance with the
Regulator's requirements to protect the health and safety of people or the environment.
Item 55 would insert a definition of inadvertent dealings application into subsection 10(1)
of the Act.
Item 56 proposes to insert a new section 40A into the Act. This would provide for a new
category of licence: licences relating to inadvertent dealings.
Subsection 40A(1): the proposed new subsection 40A(1) provides that a person does not need
to apply for a licence in respect of inadvertent dealings with GMO. The Regulator may treat
a person as having applied for a GMO licence without having received an application, as long
as that person agrees. This recognises that a person who inadvertently deals with GMOs may
not be aware of the legislative framework for GMOs, and hence may not be equipped to
apply for a licence under the Act.
16
Subsection 40A(2): the proposed new subsection 40A(2) makes clear that a person may also
apply for a licence under section 40 of the Act in respect of an inadvertent dealing.
Items 57 and 58 would insert new sections 46A and 49 into the Act. These sections would
make clear that if:
· the Regulator is satisfied that the licence applied for will only authorise the disposal
of the GMO; and
· the Regulator is satisfied that the applicant has come into the possession of the GMO
inadvertently;
the normal processes for the initial consideration of licences, which are set out in Divisions 3
and 4 of Part 5 of the Act, will not apply.
An example of a situation in which the new sections 46A and 49 could apply is where a
particular GMO has been licensed for use in a certain restricted area and remnants of the
GMO become lodged in transporting or handling equipment. In this situation, the GMO crop
could conceivably become mixed with non-genetically modified seeds. Thus, a farmer could
purchase what he or she believes to be non-genetically modified seeds but subsequently
discover GMOs growing amongst his or her crop. A farmer in this situation could apply to
the Regulator under section 40 for a licence to dispose of the GMO. If the Regulator was
satisfied that the farmer had come into possession of the GMO inadvertently, and the licence
sought was only for the purposes of disposal of the GMO, then sections 46A and 49 would
apply, meaning that the Regulator could issue a licence for disposal without having to
observe the usual process for the initial consideration of licences in Divisions 3 or 4.
Item 59 would add a note to section 56 of the Act. The note makes clear that paragraphs
56(2)(a),(b) and (c), which relate to risk assessment and risk management plans, do not apply
to inadvertent dealings applications.
Item 60 would insert a new subsection 57(3) into the Act. The new subsection would make
clear that subsection 57(2), which requires the Regulator to be satisfied that an applicant is a
suitable person before issuing a licence, does not apply to inadvertent dealings applications.
This means that section 58 of the Act, which expands upon subsection 57(2), also does not
apply.
Item 61 would insert a new subsection 60(3) into the Act. This subsection would provide
that a licence issued for an inadvertent dealing cannot be valid for a period of longer than
12 months. This is a maximum time period and the Regulator may specify a shorter time
period where appropriate. In determining the relevant time period, the Regulator should bear
in mind that a licence for an inadvertent dealing will only be issued for the purposes of
disposal of the GMO.
SCHEDULE 2: TECHNICAL AMENDMENTS
Items 1 and 2 would amend the definition of deal with in relation to a GMO by including
transport of a GMO, and disposal of a GMO, as a dealing. Possession, supply and use of the
GMO remain dealings when used for the purposes of, or in the course of a dealing described
in the definition.
17
Item 3 would amend subsection 10(1) of the Act with the intention of clarifying the meaning
of Institutional Biosafety Committee by defining it as an organisation established in
accordance with guidelines issued by the Regulator under section 98 of the Act.
Item 4 would add a new subsection 42(3) to the Act with the intention of removing any
doubt as to when the Regulator may request further information in respect of an application.
It would provide that the Regulator may request further information at any time before the
application is decided, whether before or after the Regulator has begun to consider the
application.
Item 5 would insert a new paragraph 43(2)(f) into the Act providing that where the Regulator
is satisfied that an applicant is not a suitable person to hold a licence (having regard to the
matters listed in section 58 of the Act such as whether the applicant has any relevant
convictions or licence revocations, and the capacity of the person to meet the conditions of
the licence) then the Regulator is not required to consider the application.
Item 6 would amend subsection 43(2) of the Act with the intention of expressly allowing the
Regulator to cease (as well as to not commence) the consideration of an application if one of
the ensuing paragraphs applies to the application.
Item 7 would provide that, for the purposes of being satisfied that any risks posed by the
dealings proposed to be licensed are able to be managed in such a way as to protect the health
and safety of people and the environment, the Regulator is required to have regard to:
· under new paragraph 56(2)(a), the risk assessments prepared under section 47, for
dealings not involving intentional release, or prepared under section 50, for dealings
involving intentional release; and
· under new paragraph 56(2)(b), the risk management plans prepared under section
47, for dealings not involving intentional release, or prepared under section 50 for
dealings involving intentional release.
Item 8 would add a new subsection 72(7) which provides that section 72 of the Act, which
includes, among other things, requirements of notice of proposed variations to licences, does
not apply where the proposed variation is of minor significance or complexity.
Item 9 amends subsection 78(3) of the Act to remove the requirement that a registration of a
dealing, made on the application of a licence holder, can only take effect if the licence
authorising the dealing ceases to be in force.
Item 10 adds subsection 89(7), which provides that section 89 of the Act, which includes,
among other things, requirements of notice of proposed variations of certification, does not
apply where the proposed variation is of minor significance or complexity.
Item 11 would provide for the insertion of:
· subsection 89A(1) which provides for transfers of certification by way of a joint
application between the holder of the certification and the transferee;
· subsection 89A(2) which requires the application to be in writing and contain
information prescribed by the regulations or specified in writing by the Regulator;
18
· subsection 89A(3) which prohibits the Regulator from transferring certification
unless satisfied that the conditions to which the certification is subject will continue
to be met;
· subsection 89A(4) which requires the Regulator to give written notice of his or her
decision to the applicants; and
· subsection 89A(5) which provides for the transfer, if approved, to take effect on the
date specified in the notice, for the certification to continue in force and for the
certification to be subject to the same conditions which applied before the transfer.
Item 12 would amend paragraph 92(2)(a) of the Act to remove the obligation for the
Regulator to have regard to whether or not an organisation proposes to establish an
Institutional Biosafety Committee (IBC) for the purposes of deciding whether to accredit an
organisation.
Item 13 would amend paragraph 92(2)(b) of the Act to require the Regulator, for purposes of
accrediting organisations, to have regard to whether an organisation will be able to maintain
an IBC already established.
Item 14 would amend paragraph 92(2)(c) of the Act to require the Regulator, for the
purposes of accrediting organisations, to have regard to whether an organisation has
appropriate indemnity arrangements if the organisation has established an IBC.
Item 15 would insert a new paragraph 92(2)(ca) into the Act which includes a consideration
of whether or not the organisation will be in a position to use an IBC established by another
accredited organisation as a matter to which the Regulator must have regard in deciding
whether to accredit an organisation.
Item 16 would add a new subsection 97(7) which provides that section 97 of the Act, which
includes, among other things, requirements of notice of proposed variations of accreditation,
does not apply where the proposed variation is of minor significance or complexity.
Item 17 would insert Item 1A into the table at section 179 of the Act, which adds to the list
of reviewable decisions under section 179, a decision by the Regulator under paragraph
43(2)(f) to refuse to consider an application on the basis that the applicant is not a suitable
person to hold a licence.
Item 18 would insert Item 3A into the table at section 179 of the Act which adds to the list of
reviewable decisions under section 179, a decision by the Regulator under section 70 to
refuse to transfer a licence.
Item 19 would insert Item 7A into the table at section 179 of the Act which adds to the list of
reviewable decisions under section 179, a decision by the Regulator under section 89A to
refuse to transfer a certification.
Item 20 would amend the wording of paragraph 182(a) so as to extend the application of
section 182 to all applications to the Regulator, not just applications to the Regulator to make
a reviewable decision.
19
Item 21 would insert into section 182 of the Act the wording `reviewable decision to reject
the application', thereby removing any doubt that a deemed rejection of an application on
account of elapse of time is reviewable under the Act.
Item 22 would add a new subsection 185(3B) into the Act which would provide that
information specified for purposes of an application for a declaration that information is
confidential commercial information (`CCI'), is treated as CCI until the Regulator has made a
decision on the application.
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