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Gene Technology Amendment Bill 2007
Gene Technology Amendment Bill 2007
Explanatory Notes
General Outline
Title of the Bill
Gene Technology Amendment Bill 2007
Objective of the Gene Technology Act 2001
The object of the Gene Technology Act 2001 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).
The Gene Technology Act 2001 is the Queensland Government's
component of the nationally consistent regulatory scheme for gene
technology.
Objectives of the Bill
The objectives of the Gene Technology Amendment Bill 2007 (the Bill) is
to improve the operation of the Gene Technology Act 2001 without
changing the underlying policy intent or overall legislative framework of
the regulatory scheme.
Reasons for the Bill
The Queensland Gene Technology Amendment Bill 2007 has been drafted
to reflect changes to the Commonwealth gene technology legislation as a
result of recent statutory reviews of the operation of the Commonwealth
legislation and the intergovernmental Gene Technology Agreement 2001
and the review of the operation of Queensland's legislation.
Amendments to the Queensland Gene Technology Act 2001 are necessary
to maintain national consistency as contemplated by Parliament in section
5 of the Act.
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Gene Technology Amendment Bill 2007
Under the intergovernmental Gene Technology Agreement 2001, all States
and Territories have committed to maintaining corresponding legislation.
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.
The Commonwealth statutory review found that regulation of gene
technology has worked well at the national level, and no major changes
were required. It was concluded that the policy objectives remain valid and
the scope of the Commonwealth Act should be maintained.
The statutory review also recommended a number of minor changes
intended to improve the operation of the Commonwealth Act, which were
subsequently incorporated in the Gene Technology Amendment Act 2007
(Cth).
Section 194 of the Queensland Gene Technology Act 2001 placed a
statutory obligation on the Minister to cause a statutory independent review
of the operation of the Act as soon as possible after 1 November 2005, the
fourth anniversary of the commencement of the Act. The independent
review of the Queensland Act was completed on 10 October 2006 and the
report was tabled in Parliament on 30 October 2006.
The independent review concluded:
· differences between the Commonwealth Act and the Queensland Act
are not material;
· there is no evidence to suggest that the Queensland Act should be
different from the Commonwealth Act; and
· changes to the Commonwealth Act, as recommended by the
Commonwealth review, should be adopted by Queensland.
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 (such
as the recent use of the equine influenza vaccine to combine the
current outbreak of this disease);
· improving the mechanism for providing advice to the Gene
Technology Regulator (the Regulator) and the GTMC on ethics and
community consultations;
· streamlining the process for the initial consideration of licences;
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Gene Technology Amendment Bill 2007
· reducing the regulatory burden for low risk dealings;
· providing clarification on the circumstances in which licence
variations can be made;
· clarifying the circumstances under which the Regulator can direct a
person to comply with the Act;
· 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.
Alternatives to the Bill
The objectives can only be achieved by amendment to the Queensland Act.
Both State and Commonwealth legislation are needed to achieve a nationally
consistent scheme that provides full regulatory coverage for gene
technology. The Queensland Act increases the coverage of the national
scheme to include Queensland Government agencies and higher education
institutions.
Administrative Cost
Administrative costs to the Queensland Government will not increase as a
result of the proposed amendments.
Consistency with Fundamental Legislative Principles
The legislation is part of a national regulatory scheme, however, section 5
of the Act reflects Parliament's intention that this Act form a component of
a nationally consistent scheme for the regulation of certain dealings with
genetically modified organisms by the Commonwealth and the States.
Consultation
Extensive consultation with industry and the community was undertaken in
the preparation of the Commonwealth gene technology amendment
legislation. The Queensland Government conducted further consultation to
determine appropriate amendments to the Gene Technology Act 2001 (Qld)
and the Gene Technology Regulation 2002 (Qld).
The Department has continued to liaise with members of the
interdepartmental Gene Technology Contact Group.
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Gene Technology Amendment Bill 2007
Notes on Provisions
Short title
Clause 1 provides that the Act may be cited as the Gene Technology
Amendment Act 2007.
Act amended
Clause 2 provides that the amending Act amends the Gene Technology Act
2001.
Amendment of s 31 (Simplified outline of Part 4)
Clause 3 inserts a new subsection into the simplified outline at the
beginning of Part 4 of the Act. This makes it clear that a dealing stated in
an emergency dealing determination is not prohibited under Part 4 which
regulates the dealings with GMOS.
Replacement of s 32 (Person not to deal with a GMO without a
licence with full knowledge or recklessness)
Clause 4 repeals existing section 32 and substitutes a new section 32 into
the Act. The new section 32 is substantially the same as the existing
section 32. It includes existing provisions 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 a notifiable low risk
dealing, it is an exempt dealing, 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.
It inserts an additional subsection providing that a person commits an
offence if he or she deals with a GMO unless the dealing is stated 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.
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Gene Technology Amendment Bill 2007
Amendment to s 33 (Person not to deal with a GMO without a
licence)
Clause 5 inserts a new subsection into section 33(1) of the Act. This
amendment inserts an additional subsection providing that a person
commits a strict liability offence if the person deals with a GMO, knowing
that it is a GMO and the dealing is not stated in an emergency dealing
determination.
Amendment of s 34 (Person must not breach conditions of a
GMO licence with full intention and knowledge or
recklessness)
Clause 6 repeals existing subsections 34(1) and (2) and substitutes new
subsections 34(1) and (2).
Subsection 34(1) 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.
Subsection 34(2) has been redrafted to clarify that in order to commit an
offence a person's actions must contravene a condition of a licence and the
person must know or be reckless as to that fact.
Insertion of new ss 35A and 35B
Clause 7 inserts two new offence provisions into the Act.
Section 35A is similar to existing section 34 of the Act. It creates an
offence for intentionally breaching the conditions of an emergency dealing
determination. The penalty for an aggravated offence is 5 years
imprisonment or 2933 penalty units (in Queensland a penalty unit is
currently equivalent to $75. This equates to $219,975.00 for an individual
and $1,099,875.00 for a body corporate.
If it is not an aggravated offence, the penalty will be 2 years imprisonment
or 733 penalty units which equates to $54,975.00. An aggravated offence,
dealt with in section 38, is an offence that causes significant damage, or is
likely to cause significant damage, to human health and safety or to the
environment.
The penalties are consistent with those contained in section 34.
Clause 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
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Gene Technology Amendment Bill 2007
section 35B, the 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. Penalties for an aggravated offence is
293 penalty units which equates to $21,975.00. If it is not an aggravated
offence, the penalty will be 73 penalty units ($5,475.00).
The penalties are consistent with those contained in section 35.
Insertion of new s 40A
Clause 8 inserts a new section 40A which addresses the situation where a
person finds herself or himself inadvertently in possession of a GMO
without a licence. According to section 40A(1), the person in question
does not need to apply for a licence in respect of inadvertent dealings with
a GMO if they consent, although they can under section 40A(2). Therefore
the Regulator may treat the 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. Section 40A(2) makes it
clear that a person may apply for a licence under section 40 of the Act in
relation to an inadvertent dealing.
Amendment of s 42 (Regulator may require applicant to give
further information)
Clause 9 is a technical amendment inserting a new subsection in section 42
to remove any doubt as to when the Regulator may request further
information in relation to an application. It provides that the Regulator
may request further information at any time before the application is
decided, whether before or after she has commenced consideration of the
application.
Amendment of s 43 (Regulator must consider applications
except in certain circumstances)
Clause 10 is a technical amendment to section 43(2) of the Act to expressly
allow the Regulator to cease (in addition to not commence) considering an
application if one of the circumstances listed in section 43(2) exists. An
additional circumstance is inserted in section 43(2)(f) providing that where
the Regulator 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 to licence revocations, and the capacity of the person
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Gene Technology Amendment Bill 2007
to meet the conditions of the licence), Regulator is not required to consider
the application.
Insertion of new s 46A and Replacement of s 49 (Dealings that
may pose significant risks to the health and safety of people or
the environment)
Clauses 11 and 12 inserts new sections 46A and 49 into the Act. These
sections make it clear that if the Regulator is satisfied that the:
· licence applied for will only authorise the disposal of the GMO; and
· applicant has come into possession of the GMO inadvertently;
the normal process for the initial consideration of licence to which Division
3 (dealings not involving intentional release of a GMO into the
environment) and Division 4 (dealings involving intentional release of a
GMO into the environment) 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 discovers 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.
Clause 12 repeals the existing section 49 of the Act. Pursuant to this
section, the Regulator is required to assess whether a proposed dealing may
pose a significant risk before developing a Risk Assessment and Risk
Management Plan. 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 Risk Assessment and Risk
Management Plan.
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Gene Technology Amendment Bill 2007
Amendment of s 50 (Regulator must prepare risk assessment
and risk management plan)
Clause 13(1) repeals section 50(2) as a consequence of the amendment to
section 49.
Clause 13(2) amends section 50(3) of the Act to provide that if an
application is for a limited and controlled release application (a field trial),
the Regulator does not have to seek advice from the States, the Gene
Technology Technical Advisory Committee, prescribed agencies the
Commonwealth Environment Minister, or local councils on the preparation
of the Risk Assessment and Risk Management Plan.
Insertion of new s 50A
Clause 14 inserts a new section 50A into the Act to create a new category
of licence application, to be known as "limited and controlled release"
applications.
Clause 14(1) inserts a new subsection 50A(1) which provides that a licence
application will be classed as a limited and controlled release if the
Regulator is satisfied that:
· the principal purpose of the licence sought is to enable experiments to
be conducted;
· 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
· it is appropriate for section 50(3) of the Act not to apply to the licence
(i.e. it is appropriate that the Regulator does not have to seek advice
from the States, the Gene Technology Technical Advisory Committee,
prescribed agencies the Commonwealth Environment Minister, or
local councils on the preparation of the Risk Assessment and Risk
Management Plan).
Clause 14(2) inserts a new subsection 50A(2) which 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
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Gene Technology Amendment Bill 2007
whether conducting experiments is the principal purpose of the licence.
Paragraph 50A(2)(b) makes clear that the Regulator may also consider any
other matters that he or she considers to be relevant.
Clause 14(3) provides guidance on the meaning of the term `controls'
referred to in subsection 50A(1). It provides that controls can relate to the
dissemination and persistence of the GMO, the disposal of the GMO, the
studies that can be conducted on the GMO, the restricted geographic area
in which dealings may be conducted, and compliance with a code of
practice or technical and procedural guideline.
Clause 14(3) provides guidance on the meaning of the term `limits'
referred to 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.
Amendment of s 51 (Matters Regulator must take into account
in preparing risk assessment and risk management plan)
Clause 15 makes consequential amendments to the Act by omitting
references to section 49 in section 51(1)(a) and repealing sections 51(1)(b)
and 51(2)(b) which relate to actions required by the current section 49.
Amendment of s 52 (Public Notification of risk assessment and
risk management plan)
Clause 16(1) makes a consequential amendment to section 52(1) by
omitting references to section 49 which relates to action required by the
current section 49.
Clause 16(2) inserts a new paragraph (ba) into section 52(2) of the Act.
The new paragraph provides 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 section 52(1) (i.e.
public notification of risk assessment and risk management plans in the
gazette, newspaper and Regulator's website).
Clause 16(3) provides for a longer consultation process on the risk
assessment and risk management plan where the Regulator considers that
the GMO poses a significant risk to the health and safety of the people or
the environment. The clause proposes two new subsections into section
52(2)(d) of the Act. Section 52(2)(d)(i) allows for a time period of at least
50 days for submissions if the Regulator is satisfied that the dealings may
pose a significant risk. For all other dealings section 52(2)(d)(ii) allows for
at least a thirty day time period for submissions.
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Gene Technology Amendment Bill 2007
Amendment of s 56 (Regulator must not issue the licence
unless satisfied as to risk management)
Clause 17 inserts reference to section 47 in both sections 56(2)(a) and (b).
Therefore the Regulator is required to have regard to the risk assessment
and risk management plans prepared under section 47 for dealings not
involving intentional release, 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 note to section 56 of the Act makes it clear that
paragraphs 56(2)(a), (b) and (c) do not apply to inadvertent dealings
applications.
Amendment of s 57 (Other circumstances in which Regulator
must not issue the licence)
Clause 18 inserts a new subsection into section 57 of the Act. The new
subsection makes it clear that section 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.
Amendment of s 60 (Period of licence)
Clause 19 inserts a new subsection into section 60 of the Act. The new
subsection provides that a licence issued for an inadvertent dealing cannot
be valid for a period longer than 12 months. This is a maximum period and
the Regulator may specify a shorter period as the licence for an inadvertent
dealing will only be for the purposes of the disposal of a GMO.
Amendment of s 67 (Protection of persons who give
information)
Clause 20 includes in section 67 reference to section 72D(2)(h). This
amendment ensures that the same protection is afforded to persons who
provide information under the new section 72D(1)(h) (obligations to
inform the Regulator in relation to emergency dealing determinations)
from certain civil liability.
Amendment of s 71 (Variation of licence)
Clause 21(1) repeals the current section 71(1) and inserts a revised section
71(1) and a new section 71(1A) into the Act. Section 71(1) clarifies that
the Regulator has the power to vary a licence either unilaterally, or after
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Gene Technology Amendment Bill 2007
receiving an application from a licence holder. Section 71(1A) provides
that the licence holder's application for a variation must be in writing and
include any information prescribed by the regulations or required by the
Regulator in writing.
Clause 21(2) makes a consequential amendment to section 71(2) of the
Act.
Clause 21(3) inserts two new subsections into section 71 of the Act.
Section 71(2A) which 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.
Section 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.
Clause 21(4) makes a consequential amendment to subsection 71(4) of the
Act.
Clause 21(5) inserts a new subsection into the Act. The new section 71(5)
provides that the Regulator must consult with any appropriate local
government before varying a licence. This subsection differs from the
subsection of the Commonwealth Act. The Commonwealth Act refers to
"local council" rather than "local government".
Clause 21(6) inserts a new subsection into the Act. The new section 71(6)
provides that the Regulations may impose additional limitations on the
Regulator's power to vary the licence.
Clause 21(7) inserts a new section 71(7) which provides that the
Regulations may set a time limit in which the Regulator must vary a
licence.
Clause 21(8) makes it clear that the terms `controls' and `limits' have the
same meaning in subsection 71(2A) as in the proposed section 50A of the
Act.
Amendment of s 72 (Regulator to notify of proposed
suspension, cancellation and variation)
Clause 22 adds a new subsection to section 72 of the Act. Section 72(7)
provides that section 72 of the Act, which requires the Regulator to notify a
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Gene Technology Amendment Bill 2007
licence holder of proposed suspension, cancellation or variation, does not
apply where the proposed variation is of minor significance or complexity.
Renumbering of s 72A (GMO licence annual charge)
Clause 23 is a consequential amendment that renumbers the current section
72A as section 72AA.
Insertion of new Part 5A
Clause 24 inserts a new Part in the Act. The new Part 5A is entitled
"Emergency dealing determination".
The proposed section 72A provides a simplified outline for the Part. It
provides that the Part creates a system whereby the Minister may make a
determination relating to dealings in an emergency.
Section 72B(1) gives the Minister the power to make an emergency dealing
determination in respect of dealings with a GMO, by gazette notice. The
gazette notice will authorise the stated dealings with the GMO.
Authorising an emergency dealing determination by notice published in the
Government Gazette by the Minister will ensure national consistency is
maintained as contemplated by section 5 of the Act as it is not subject to
disallowance. Section 72B(e) of the Commonwealth Act requires the
relevant Commonwealth Minister to consult with the States about making
the proposed emergency dealing determination.
Section 72B(2) gives the Minister the power to make an emergency dealing
determination only if the relevant Commonwealth Minister has made or
proposes to make an emergency dealing determination. Section 72B of the
Commonwealth Act sets out the conditions under which the relevant
Commonwealth Minister is permitted to make an emergency dealing
determination. It states that 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 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
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Gene Technology Amendment Bill 2007
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 must have been consulted about the proposed emergency
dealing determination.
Section 72B(3) of the Commonwealth Act 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.
This Part of the Commonwealth Act was recently invoked for release of the
genetically modified equine influenza vaccine to address the current
outbreak of equine influenza.
Section 72C states that a determination takes effect on the day on which it
is made or at a specified later date. In other words, the determination
cannot apply retrospectively.
Section 72C(2) provides that a determination ceases to have effect on:
· a date stated in the determination;
· when the determination is revoked; or
· after six months;
whichever comes first.
Section 72C(3) provides that the Minister may extend an emergency
dealing determination, by gazette notice.
Section 72C(4) provides that the Minister may extend the emergency
dealing determination more than once, for up to six months each time.
Section 72C(5) provides that the Minister may extend the emergency
dealing determination only if the relevant Commonwealth Minister has
extended or proposes to extend the emergency dealing determination. This
section differs from section 72C(5) of the Commonwealth Act which sets
out the basis on which the relevant Commonwealth Minister may extend an
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Gene Technology Amendment Bill 2007
emergency dealing determination. The Minister can only extend the
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.
Section 72C(6) provides that the extension of the emergency dealing
determination takes effect when the original emergency dealing
determination was scheduled to end.
Section 72D(1) allows conditions to be imposed on an emergency dealing
determination.
Section 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. Section 72D(2)
(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.
Section 72D(4) 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.
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Gene Technology Amendment Bill 2007
Section 72D(5) makes clear that subsection 72D(4) does not limit the
conditions that may be placed on an emergency dealing determination.
Section 72E(1) provides that the Minister may vary the conditions of an
emergency dealing determination by notice published in the government
gazette including imposing new conditions on a determination if the
relevant Commonwealth Minister has made or proposes to make the same
variations to the corresponding Commonwealth determination. Authorising
extension of an emergency dealing determination by notice published in the
Government Gazette by the Minister will ensure national consistency is
maintained as contemplated by section 5 of the Act as it is not subject to
disallowance.
Section 72E(2) provides that the Minister may suspend or revoke an
emergency dealing determination by notice published in the government
gazette, if the relevant Commonwealth Minister proposes to or has
suspended or revoked the corresponding Commonwealth determination.
Section 72E(2) of the Commonwealth Act differs from the proposed
provision and provides that the Minister may suspend or revoke a dealing
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.
Note to section 72E(2) refers to Section 72E(3) of the Commonwealth Act
which provides that the Minister must consult the States before varying,
suspending or revoking an emergency dealing determination.
Sections 72E(4) provides that a variation, suspension or revocation takes
effect on the day it is made if the Minister states that it is necessary to
prevent imminent risk of death, serious illness or serious injury or serious
environmental damage or otherwise on the day stated by the Minister.
Section 72E(5) provides that the date stated for it to take effect must be 30
days or more after it is made.
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Gene Technology Amendment Bill 2007
Amendment of s 78 (Regulator may include dealings with
GMOs on GMO register)
Clause 25 amends section 78(4) 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.
Amendment of s 82 (Simplified outline of Part 7)
Clause 26 inserts words into section 82(2) and (4) to take into account that
the conditions of an emergency dealing determination could require a
facility to be certified to a certain containment level and could require
supervision by an institutional biosafety committee respectively.
Amendment of s 83 (Application for certification)
Clause 27 amends the note to section 83 to clarify that the conditions of an
emergency dealing determination could require a facility to be certified to a
certain containment level.
Amendment of s 89 (Regulator to notify of proposed
suspension, cancellation or variation)
Clause 28 adds subsection (7) to section 89 to provide that notice
requirements of proposed variations do not apply where the proposed
variation is of minor significance or complexity.
Insertion of new s 89A
Clause 29 provides for the insertion of:
· Section 89A(1) which provides for transfers of certification by way of
a joint application between the holder of the certification and the
transferee;
· Section 89A(2) which requires the application to be in writing and
contain information prescribed by the regulations or specified in
writing by the Regulator;
· Section 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;
· Section 89A(4) which requires the Regulator to give written notice of
his or her decision to the applicants; and
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Gene Technology Amendment Bill 2007
· Section 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.
Amendment of s 91 (Application for accreditation)
Clause 30 replaces the note to section 91(10) to clarify that the conditions
of an emergency dealing determination could require supervision by an
Institutional Biosafety Committee.
Amendment of s 92 (Regulator may accredit organisations)
Clause 31(1) amends section 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 for the purposes of
deciding whether to accredit an organisation.
Clause 31(2) amends:
· section 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 Institutional Biosafety Committee already
established.
· section 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 Institutional Biosafety Committee.
Clause 31(2) inserts a new subsection 92(2)(ca) into the Act which requires
the Regulator to consider whether or not the organisation will be in a
position to use an Institutional Biosafety Committee established by another
accredited organisation as a matter to which the Regulator must have
regard in deciding whether to accredit an organisation.
Amendment of s 97 (Regulator to notify of proposed
suspension, cancellation or variation)
Clause 32 adds a new subsection (7) to section 97 to provide that the notice
requirements of proposed variations of accreditation, do not apply where
the proposed variation is of minor significance or complexity.
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Gene Technology Amendment Bill 2007
Replacement of s 107 (Function of consultative committee)
Clause 33 replaces the existing section 107 which currently provides for
the functions of the Gene Technology Community Consultative
Committee. It is proposed that the Gene Technology Community
Consultative Committee and the Gene Technology Ethics Committee are
combined 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.
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 - ethical
issues relating to gene technology (proposed section 107(a)); the need
for, and content of, codes of practice in relation to ethics for
conducting dealings with GMOs (proposed section 107(b); and the
need for, and content of, policy principles for dealings with GMOs
that should not be conducted for ethical reasons (proposed section
107(c));
· matters on which the Consultative Committee currently advises -
matters of general concern identified by the Regulator in relation to
applications (proposed section 107(g), matters of general concern in
relation to GMOs (proposed section 107(h)) 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 (proposed section
107(d))
· community consultation matters relating to intentional release licence
applications (proposed section 107(e)); and
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Gene Technology Amendment Bill 2007
· risk communication matters relating to dealings that involve the
intentional release of a GMO into the environment (proposed section
107(f)).
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.
Replacement of ss 110 and 110A and Part 8, Division 4
Clause 34 updates the notes contained in sections 110, 111 and 112 of the
Act to reflect the changes to the Commonwealth Act as a result of
combining the roles of the Gene Technology Ethics Committee and the
Gene Technology Community Consultative Committee.
Amendment of s 136A (Quarterly reports)
Clause 35 inserts two new subsections 136A(2)(ba) and 136A(2)(bb) into
the Act which provide 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.
Amendment of s 138 (Record of GMO and GM product
dealings)
Clause 36 inserts a new subsection 138(1A) into the Act providing that the
Record of GMO and GM Product dealings required to be maintained by the
Regulator under Division 6, must include certain information, except
confidential commercial information, on the content of emergency dealing
determinations:
· dealings stated in the emergency dealing determination, including any
conditions;
· the dates the determination takes effect and ceases.
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Gene Technology Amendment Bill 2007
Amendment of s 145 (Simplified outline of Part 10)
Clause 37(1) inserts the phrase "or for certain other reasons" to the end of
paragraph 145(a)(ii) in the simplified outline at the start of Part 10 of the
Act. This clarifies that the circumstances under which the Regulator may
give directions have been expanded.
Clause 37(2) inserts a new subsection into the simplified outline in section
145(a)(ii) of the Act. This makes it 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.
Amendment of s 146 (Regulator may give directions)
Clause 38(1) inserts an additional subsection in section 146 into the Act.
Subsection 146(1)(b)(ii) provides that the Regulator may give directions to
a licence holder, requiring that he or she take steps to comply with the Act,
if it is desirable in the public interest to do so.
Clause 38(2) replaces section 146(1)(a) to provide that the Regulator may
give directions to a person dealing with, or has dealt with, a GMO specified
in an emergency dealing determination and replaces section 146(1)(b) to
provide that the Regulator may give directions to a person if it is desirable
in the public interest to do so.
Clause 38(3) inserts a new section 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 noncompliance;
· the severity of the noncompliance issue;
· the compliance history of the licensee or the person covered by the
licence;
· whether it would be more appropriate to address the noncompliance
by another means such as variation, suspension or cancellation of the
licence;
· whether the noncompliance was deliberate; and
· the need for deterrence.
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Gene Technology Amendment Bill 2007
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.
Amendment of s 149 (Simplified outline of Part 11)
Clause 39 inserts a reference to emergency dealing determinations into the
simplified outline in section 149 of the Act. This makes clear that Part 11
of the Act does not limit the conditions to which an emergency dealing
determination can be subject.
Amendment of s 152 (Powers available to inspectors for
monitoring compliance)
Clause 40 inserts a section 152(2)(d) of the Act to make it 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 has been
complied with, if the occupier of the premises is a person dealing with, or
who has dealt with, a GMO stated in an emergency dealing determination
and entry is at a reasonable time.
Amendment of s 177 (Part does not limit power to impose
licence conditions)
Clause 41 inserts 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.
Amendment of s 182 (Deadlines for making reviewable
decisions)
Clause 42(1) amends the wording of section 182(a) of the Act 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.
Clause 42(2) amends section 182 of the Act to clarify that a deemed
rejection of an application on account of elapse of time is reviewable under
the Act.
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Gene Technology Amendment Bill 2007
Amendment of s 185 (Regulator may declare that information is
confidential commercial information)
Clause 43 adds a new subsection 185(3B) into the Act which provides that
information stated 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.
Amendment of s 192A (Interference with dealings GMOs)
Clause 44(1) inserts a new paragraph into subsection 192A(2) of the Act to
provide that authorised GMO dealings include dealings that are stated 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.
Clause 44(2) amends 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 `included on the GMO register'.
Amendment of s 194 (Review of operation of Act)
Clause 45 amends the section 194(1) to synchronise any future review of
the Queensland Act with any Statutory Review of the Commonwealth Act
and section 194(2) places an obligation on the Minister to table the report
within 14 sitting days after its receipt.
Amendments of Schedule 1 (Reviewable decisions and eligible
persons)
Clause 46 adds the following items to the list of reviewable decisions under
Schedule 1:
· Item 1A, a decision by the Regulator under section 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 3A, a decision by the Regulator under section 70 to refuse to
transfer a licence.
· item 4A, a decision by the Regulator under section 71 to refuse to vary
a licence.
· item 7A, a decision by the Regulator under section 89A to refuse to
transfer a certification.
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Gene Technology Amendment Bill 2007
Amendment to Schedule 3 (Dictionary)
Clause 47(2) inserts in the definitions of Corresponding Commonwealth
emergency dealing determination, Emergency dealing determination,
Ethics and community committee, Inadvertent dealings applications into
Schedule 3 of the Act.
Clause 47(3) amends the definition of deal with in relation to a GMO by
including transport of a GMO and disposal of the GMO as dealings.
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.
Clause 47(4) amends the definition of institutional biosafety committee
with the intention of clarifying its meaning as an organisation established
in accordance with guidelines issued by the Regulator under section 98 of
the Act.
Schedule Minor amendments
There is a schedule of minor amendments to Part 8 of the Act are made to
take into account the combination of the Gene Technology Ethics
Committee and the Gene Technology Community Consultative Committee.
© State of Queensland 2007