Bills Digest no. 9 2015–16
PDF version [566KB]
WARNING: This Digest was prepared for debate. It reflects the legislation as introduced and does not canvass subsequent amendments. This Digest does not have any official legal status. Other sources should be consulted to determine the subsequent official status of the Bill.
Sophie Power and Dr Emily Hanna
Science, Technology, Environment and Resources Section
14 August 2015
Contents
Purpose
of the Bill
Structure of the Bill
Background
Committee consideration
Policy position of non-government parties/independents
Position of major interest groups
Financial implications
Human rights consideration
Key issues and provisions
Concluding comments
Date introduced: 18
June 2015
House: House of
Representatives
Portfolio: Health
Commencement: The
substantive provisions commence on proclamation or the day after six months
after Royal Assent, whichever occurs first.
Links: The links to the Bill,
its Explanatory Memorandum and second reading speech can be found on the
Bill’s home page, or through the Australian
Parliament website.
When Bills have been passed and have received Royal Assent, they
become Acts, which can be found at the ComLaw
website.
The purpose of the Gene Technology Amendment Bill 2015
(the Bill) is to amend the Gene Technology Act 2000[1] (the Act) to make minor changes to the Act to
implement the recommendations of a review of the Act in 2011.
The Bill has one Schedule, which is divided into six parts:
- Part
1 discontinues the Gene Technology Regulator’s quarterly reporting requirements
- Part
2 clarifies the activities that may be authorised by ‘inadvertent dealings’
licences
- Part
3 updates advertising requirements for certain public consultation purposes
- Part
4 removes the requirement for information about genetically modified (GM)
products authorised by other agencies to be included in the Record maintained
by the Gene Technology Regulator
- Part
5 changes licence variation requirements to provide greater flexibility and
- Part
6 updates the considerations required before dealings may be scheduled as
notifiable low risk dealings and clarifies ambiguous wording.
The Act first came into effect on 21 June 2001 and is the federal
component of a nationally consistent system for regulating genetically modified
organisms (GMOs).[2]
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 GMOs.[3]
The Act establishes the Gene Technology Regulator (the
Regulator) as an independent statutory office holder to administer the Act.[4]
The functions of the Gene Technology Regulator are specified in section 27 of
the Act. The Office of the Gene Technology Regulator (OGTR) supports the
Regulator in the administration of the Act.[5]
In short, the legislation regulates all ‘dealings’
(for example, research, manufacture, propagation, transport, import, disposal) with
GMOs.[6]
Under Part 4 of the Act, all dealings with GMOs are prohibited unless the
dealing is:
- an
exempt dealing[7]
- a
‘notifiable low risk dealing’ (NLRD)[8]
- licenced by
the Regulator
- included
on the GMO Register or
- specified
in an Emergency Dealing Determination.[9]
Under the Act, the Regulator is also required to maintain
a publicly accessible record of genetically modified organisms and product
dealings (the Record).[10]
The Record is currently required to contain all GMO dealings in Australia approved
by the Gene Technology Regulator, as well as GM product approvals notified by
other regulatory agencies. Those agencies are the Australian Pesticides and
Veterinary Medicines Authority (APVMA), Therapeutic Goods Administration (TGA),
Food Standards Australia New Zealand (FSANZ) and National Industrial Chemicals
Notification and Assessment Scheme (NICNAS).[11]
Reviews of the Act
Two independent reviews of the Act have been undertaken.
The first, in 2006, was required by section 194 of the Act which specifies that
a review must occur four years after the Act began operating. The 2006 review
found that the Act and associated Gene Technology Regulations
2001 were working well overall.[12]
Minor changes were recommended to improve operations.[13]
The 2006 review also recommended that a further review of the Act occur in
2011.[14]
In accordance with this recommendation, a subsequent
review was undertaken in 2011 (the 2011 review). The 2011 review examined:
- emerging trends and international developments in
biotechnology and its regulation;
- the efficiency and effectiveness of the operation of the
Act consistently across the national scheme for gene technology regulation in
Australia; and
- the interface between the Act and other systems (e.g.
other Acts and schemes).[15]
The 2011 review also found that the Act was working well
but made 16 recommendations to improve the effectiveness and efficiency of the
operation of gene technology regulation in Australia. Some of the
recommendations were administrative, or directed at state and territory
jurisdictions. Five of the recommendations form the basis for the Bill. The
relevant recommendations are:
- the
requirement for quarterly reporting to the Commonwealth Minister, to be tabled
in Parliament, be discontinued (recommendation 1)
- the
Act be amended so that the Regulator can authorise other appropriate dealings
related to inadvertent dealings (recommendation 10)
- changes
to advertising requirements relating to applications for dealings involving
intentional releases (DIR). The review found that for many DIR applications,
advertising in local or state newspapers in the region where the DIR is to
occur should be sufficient. For issues/licences of national importance it
should be sufficient for OGTR to place advertisements in one national newspaper
(recommendation 14)
- the
requirement to include GM products approved by APVMA, TGA, FSANZ and NICNAS in
the GMO Record be removed (recommendation 15) and
- technical
amendments be made to sections 30, 71, 74 and 138 of the Act (recommendation
16).[16]
These recommendations are discussed in further detail as
relevant in the ‘Key issues and provisions’ section of this Digest.
Community Affairs Legislation Committee
The Bill has been referred to the Senate Community Affairs
Legislation Committee for inquiry and report by 18 August 2015. Details of
the inquiry are available here.[17]
The committee received only five submissions. These are discussed further under
‘Position of major interest groups’ and the ‘Key issues and provisions’ sections
of this Digest.
Senate Standing Committee for the
Scrutiny of Bills
The Senate Standing Committee for the Scrutiny of Bills had
no comment on the Bill.[18]
At the time of writing, non-government parties and
independents do not appear to have commented on the Bill.
There appears to have been little public comment on the
Bill, other than submission to the Senate Community Affairs Legislation
Committee inquiry, which, as noted above, received only five submissions. These
submissions were generally supportive of the Bill. For example, the Australian
Academy of Science expressed the view that the changes proposed by the Bill are
‘conservative and justified’ and would ‘improve the Act’s operation without
changing the underlying policy intent or overall legislative framework of the
regulatory scheme’.[19]
CropLife Australia expressed concern that it ‘has taken four years to implement
what amounts to relatively minor administrative changes’. Nevertheless,
CropLife Australia submitted that it fully supported the ‘minor and technical
amendments’ proposed by the Bill to ‘make gene technology regulation in
Australia more efficient, more effective and clearer’.[20]
The CSIRO did not have any specific comments on the Bill itself, but took the
‘opportunity to reiterate CSIRO’s support for strong and clear legislation
overseeing this area’.[21]
The Explanatory Memorandum states that the amendments made
by the Bill will not have any financial impact on the Commonwealth.[22]
As required under Part 3 of the Human Rights
(Parliamentary Scrutiny) Act 2011 (Cth), the Government has assessed the
Bill’s compatibility with the human rights and freedoms recognised or declared
in the international instruments listed in section 3 of that Act. The
Government considers that the Bill is compatible.[23]
The Parliamentary Joint Committee on Human Rights had no comment on the Bill.[24]
Part 1—Reporting requirements
Section 136A of the Act currently requires the Gene
Technology Regulator to prepare and give the Minister quarterly reports on the operations
of the Regulator. These quarterly reports must be tabled in Parliament within
15 sitting days. Under subsection 136A(2), the report must include information
about:
- the
GMO licences issued during the quarter
- any
breaches of conditions of a GMO licence that have come to the Regulator’s
attention during the quarter
- emergency
dealing determinations made by the Minister during the quarter
- any
breaches of conditions of an emergency dealing determination that have come to
the Regulator’s attention during the quarter and
- the
auditing and monitoring of dealings with GMOs under this Act by the Regulator
or an inspector during the quarter.
Section 136 of the Act also requires the Regulator to
prepare and give to the Minister an annual report on the operations of the
Regulator as soon as practicable after the end of each financial year. The
annual report must also be tabled in Parliament within 15 sitting days.
Item 2 of Part 1 of Schedule 1 of the Bill repeals
the quarterly reporting requirements in section 136A. Item 1 amends the annual
reporting requirement in section 136 to ensure that the annual report must
contain the same information which was previously listed under subsection
136A(2) of the Act.
This amendment reflects the 2011 review’s first recommendation
that the requirement for quarterly reporting to the Commonwealth Minister, to
be tabled in Parliament, be discontinued. The review reasoned that:
While this requirement was logical in the early years of the
regulatory arrangements, there is now sufficient experience with their
operation to form the view that these quarterly reports are no longer
necessary.
The OGTR’s annual report contains most of the information
currently provided in the quarterly reports. In addition, the OGTR publishes
extensive information about its regulatory activities on its website.[25]
The Australian Academy of Science is supportive of these
amendments, noting that they would ‘represent a significant reduction to the
administrative overheads of the regulatory scheme without compromising the
transparency and accountability of the regulatory system’.[26]
Part 2—Inadvertent dealings
Part 5 of the Gene Technology
Act sets out a licensing system. Under section 40, in Part 5 of the Act,
applications may be made to the Regulator for a licence authorising specific ‘dealings’
with GMOs. Part 5 then sets out the processes to be followed by the Regulator
in relation to applications involving two kinds of dealings: those that involve
the intentional release of a GMO into the environment and those that do not
involve the intentional release of a GMO into the environment.
Section 40A provides for licences related to ‘inadvertent
dealings’. Under subsection 40A(1), if the Regulator is satisfied that a person
has come into possession of a GMO inadvertently the Regulator may, with the
agreement of the person, treat the person as having made an inadvertent
dealings application.[27]
Sections 46A and 49 of the Act have the effect that the Regulator may expedite
consideration of an application to dispose of a GMO that has come into a
person’s possession inadvertently. Items 4 and 5 amend paragraphs 46A(a)
and 49(a) respectively to clarify the dealings which may be authorised by
inadvertent dealings licences for purposes relating to disposing of a GMO.
These amendments reflect recommendation 10 of the 2011
review which suggested that the Act be amended ‘so that the Regulator can
authorise other appropriate dealings related to inadvertent dealings’. The 2011
review explained:
Following the 2006 Review, the Act was amended to provide for
temporary licences for inadvertent dealings for the purposes of GMO disposal.
The OGTR believes that this needs to be extended so that other dealings can be
authorised that relate to disposal of inadvertently obtained GMOs. For
instance, when a business believes that it may have inadvertently come in to
the possession of a GMO, it may need to sample and perform tests to confirm
this, store the GMO while test are being undertaken, and even propagate or
‘grow out’ the GMO (in appropriate containment) to obtain material for testing.
Such dealings would be considered reasonable and part of the
disposal process, but may not be permitted under the current provisions of the
Act.[28]
Part 3—Public notification of risk
assessment
Under Division 3 of Part 5 of the Act, before issuing a
licence for dealings involving intentional release (DIR) of a GMO into the
environment, the Regulator must prepare a risk assessment and a risk management
plan in relation to the dealings proposed to be authorised by the licence.
Section 52 requires the Regulator to publish a notice inviting submissions in
relation to the risk assessment and risk management plan. Under subsection
52(1), these notices must currently be published in the Australian Government Gazette;
in a newspaper circulating generally in all States; and on the Regulator’s
website (if any).[29]
Item 7 of the Bill amends section 52 of the Act to repeal the
requirement to publish the notice ‘in a newspaper circulating generally in all
States’. Instead, there will be a requirement to publish the notice in ‘one or
more newspapers that the Regulator considers appropriate, having regard to the
geographic area in which the dealings proposed to be authorised by the licence
may occur’.
This amendment implements recommendation 14 of the 2011
review which stated:
For many DIR applications, advertising in local or state
newspapers in the region where the DIR is to occur is sufficient (given OGTR’s
established electronic communications channels with interested parties). For
issues/licences of national importance it should be sufficient for OGTR to
place advertisements in one national newspaper. The OGTR could experiment with
using social media to communicate with stakeholders in appropriate situations.[30]
The 2011 review also noted that:
The communication strategy followed by the OGTR in relation
to individual proposals exceeds that required by the Act. For instance, in
addition to the requirement to publish notifications in the Gazette, in
newspapers and on the OGTR website, the Regulator engages in direct
communication techniques (such as emails and letters). The OGTR currently has a
list of approximately 700 people and organisations (covering the entire
spectrum of views on gene technology) that receive every OGTR notification by
email. ...
Gazette notices have minimal impact, but provide a low costs
permanent public record. Advertising in state and national high-circulation
newspapers is significantly more expensive, but provides greater exposure.
While some advertising should remain, it is apparent that most interest
generated from the public consultation process arises from OGTR contacting and
advising those on their circulation email list (of 700 people and
organisations).[31]
The Australian Academy of Science supports these
amendments, suggesting that they will provide the Regulator with ‘more
flexibility’ to ‘select publications that are most likely to reach people’ in
the relevant geographic area(s), which in turn will ‘improve the efficiency,
accountability and cost effectiveness of the regulatory system’.[32]
Part 4—Records of GM products
Section 138 of the Act requires the Regulator to maintain a
Record of GMO and GM Product Dealings (the GMO Record). Under subsection
138(2), the purpose of the GMO Record is to maintain a comprehensive record of
all dealings in Australia that involve GMOs or GM products. A ‘GM
product’ is defined in section 10 of the Act to mean ‘a thing (other than a
GMO) derived or produced from a GMO’.
Subsection 138(5) provides that the Record must contain such
information as is prescribed by the regulations (other than confidential
commercial information) in relation to GM products mentioned in designated
notifications given to the Regulator under the Agricultural and Veterinary Chemicals
(Administration) Act 1992; the Food Standards Australia New Zealand Act
1991; the Industrial Chemicals (Notification and Assessment) Act 1989;
and the Therapeutic Goods Act 1989.
The main substantive amendment in Part 4 is item 17,
which repeals subsection 138(5). This removes the requirement that the
Regulator maintain a record of GM product approvals made by other agencies,
while retaining the requirement to record the Regulator’s own approvals for
dealings with GMOs.
The Explanatory Memorandum notes that information about GM
product approvals can be sought directly from the relevant agency (that is, the
Australian Pesticides and Veterinary Medicines Authority, the Therapeutic Goods
Administration, Food Standards Australia New Zealand and the National
Industrial Chemicals Notification and Assessment Scheme).[33]
Note that all these agencies use the same definitions of GMOs and GM products.[34]
Items 9–16 are consequential amendments which reflect
this change by removing references to GM products in relation to the GM Record.
Item 18 makes a similar consequential amendment, but also adds a
requirement that information about emergency dealing determinations be entered
on the Record as soon as practicable. The Explanatory Memorandum states that
‘the latter was an apparent oversight when amendments were made to introduce
emergency dealing determination provisions’.[35]
Item 19 contains a transitional provision to provide
that the Regulator may remove all historical information about GM products from
the GMO Record.
These amendments implement recommendation 15 of the 2011
review, which found that:
Maintaining GM products approved by these other
agencies on the GMO Record duplicates the record keeping of these other
agencies and is administratively inefficient. The requirement to include GM
products in the GMO record could be removed from the Act.[36]
Stakeholders expressed support for these amendments in
submissions to the Senate inquiry. The Australian Academy of Science expressed
the view that ‘including information on GM product approvals by other agencies
represents considerable practical difficulties and unnecessary duplication’ and
considered that the proposed amendments represent a ‘pragmatic solution’.[37]
FSANZ also expressed support for these amendments, noting that the current
arrangements represent a ‘duplication of effort’ and that ‘information on
approved GM food products can readily be obtained from FSANZ’.[38]
While the proposed amendments may reduce duplication, there
would seem to be some advantages from the public’s perspective in information
on GMO dealings and GM Products being contained in a centralised information
source. However, the Office of the Gene Technology Regulator noted that
‘operational experience over almost 15 years indicates that the public is most
interested in releases of GMOs into the Australian environment, and in GM food
approvals’.[39]
This information will still be readily publicly available from the OGTR and
FSANZ respectively.
Part 5—Restrictions on licence
variations
Section 71 of the Act provides for the Regulator to vary
licences issued under the Act in certain circumstances. Under subsection 71(1),
the Regulator may vary a licence on application by the licence-holder; or at
any time, on the Regulator’s own initiative. However, the Regulator is
restricted in how licences can be varied ‘so that variations cannot be used to
extend the coverage of licences unreasonably’.[40]
For example, subsection 71(2B) provides that the Regulator must not vary a
licence if the Regulator is satisfied that the risk assessment and the risk
management plan (RARMP) in respect of the original application for the licence
did not cover the risks posed by the dealings proposed to be authorised by the
licence as varied. In other words, 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.[41]
Item 20 proposes to amend subsection 71(2B) to
provide that, if an application has been made for variation of a licence, the
Regulator must not vary a licence unless satisfied that the risks posed by the
dealings proposed to be authorised by the licences as varied are covered by
either the RARMP in respect of the original application for the licence OR the RARMP
in respect of an application for another licence, but only if that other
licence was issued. The Explanatory Memorandum explains that:
As the same or similar GMOs and dealings may be subject to
more than one application and assessment, Item 20 would allow the Regulator to
take into account RARMPs prepared for licence applications (for which licences
have been issued) other than the licence to be varied. This would allow licence
variations to proceed provided potential risks associated with the dealings are
adequately assessed in an existing RARMP, and would avoid some circumstances
where applicants would need to seek a new licence.[42]
In considering licence variation applications that utilise
risk assessments contained in RARMPs for other licences, the Regulator would
consider whether the two licences involve similar GMOs or similar dealings.[43]
The Explanatory Memorandum gives the following example:
For example, a limited and controlled plant DIR licence could
potentially be varied to include dealings with a GMO of the same parent species
carrying another gene or new methods of destroying GMOs, provided that these
dealings had been assessed in the RARMP for another licence relating to the
same parent species. For DNIRs, licences could potentially be varied to
include, for example, in vivo experiments with a GMO which is licenced
for in vitro experiments, provided another RARMP considers in vivo
dealings with the same GMO or with GMOs from the same parent organism with
similar modifications.[44]
This amendment reflects part of recommendation 16 in the
2011 review which found that subsection 71(2B):
...precludes regard being had to risk assessment for licences
other than the one to be varied. In reality, the same or similar GMOs and
dealings may be subject to more than one application and assessment. The
requirement to confine the new risk assessment to the previously assessed risk
should be removed.[45]
Note that amended subsection 71(2B) would only apply to
variations which have been applied for, not to variations initiated by the
Regulator. So, if the Regulator becomes aware of risks posed by licenced
dealings which are not covered in the original RARMP or any other RARMP, the
Regulator would be able to initiate a variation to manage those risks.[46]
The Australian Academy of Science strongly supported ‘the
removal of the unintended constraint on the Regulator’s ability to initiate
licence variations to enable newly identified risks to be managed’.[47]
Subsection 74(1) provides that regulations may be made to declare
a dealing with a GMO to be a ‘notifiable low risk dealing’ (NLRD) for the
purposes of the Act. Section 74 also sets out a number of criteria before such
regulations may be made. Subsection 74(2) provides that before the
Governor-General makes regulations declaring a dealing with a GMO to be a
notifiable low risk dealing, the Regulator must be satisfied that the dealing
would not involve the intentional release of a GMO into the environment. In
addition, under subsection 74(3), the Regulator must consider the
following matters:
- whether
the GMO is biologically contained so that it is not able to survive or
reproduce without human intervention
- whether
the dealing with the GMO would involve minimal risk to the health and safety of
people and to the environment, taking into account the properties of the GMO as
a pathogen or pest and the toxicity of any proteins produced by the GMO and
- whether
no conditions, or minimal conditions, would be necessary to be prescribed to
manage any risk referred to in the above paragraph.
Item 23 proposes to repeal the list of considerations
for the Regulator under subsection 74(3) and replace it with a requirement for the
Regulator to consider:
- whether
the dealing with the GMO would involve any risk to the health and safety of
people, or to the environment, taking into account the properties of the GMO as
a pathogen or pest; and the toxicity of any proteins produced by the GMO
- if
there is such a risk—whether one or more of the requirements prescribed in the
regulations[48]
would be sufficient to manage that risk and
- any
other matter the Regulator considers appropriate.
Notably, this removes the requirement to consider whether
the GMO is biologically contained so that it is not able to survive or
reproduce without human intervention. However, the OGTR explained in its submission
to the Senate inquiry that ‘this notion does not contribute significantly to
assessment of whether dealings are appropriate for the NLRD category’. Indeed,
the OGTR remarked that ‘GMOs that are not biologically contained form a
significant portion of the dealings scheduled as NLRDs’. The OGTR further noted
that the proposed amendment would re-frame the considerations in subsection
74(3) to ‘provide more definitive language which aligns with current scientific
understanding of risk assessment and risk management of GMOs’.[49]
This amendment reflects part of recommendation 16 in the
2011 review which found in relation to section 74 that:
...experience has shown that these considerations are not
necessarily relevant to all types of GMOs (particularly to dealings considered
to be low risk). A more effective approach could be to consider whether the
risk profile of particular dealings necessitates assessment and regulation on a
case by case basis and therefore under licence, or whether it can be safely
undertaken pursuant to a set of generic requirements.[50]
The amendments proposed by the Bill reflect the
recommendations of the 2011 review of the Act. They are relatively minor
amendments which draw on the practical experiences of the Regulator and are
designed to improve the efficiency of the gene technology regulatory regime.
Members, Senators and Parliamentary staff can obtain
further information from the Parliamentary Library on (02) 6277 2500.
[1]. Gene Technology Act 2000,
accessed 25 June 2015.
[2]. Department
of Health, Office of the Gene Technology Regulator (OGTR), ‘About
the OGTR: Legislation’, OGTR website, 5 February 2015, accessed 15 July
2015.
[3]. Gene
Technology Act, section 3, accessed 25 June 2015.
[4]. Ibid.,
section 26.
[5]. Ibid.,
Part 9, Division 4 ‘Staffing’. The OGTR’s website explains that the Office has
been established ‘within the Australian Government Department of Health to
provide administrative support’, and the website’s logo appears so that the
OGTR is a subsidiary part of the Department of Health: OGTR, Office
of the Gene Technology Regulator, OGTR website, accessed 14 August
2015.
[6]. ‘Genetically
modified organism’ and ‘gene technology’ are defined in section 10 of the Act. Note
also that Schedule 1 of the Gene Technology Regulations
2001 contains a list of organisms declared not to be a GMO for the purposes
of the Act, while Schedule 1A contains a list of techniques that are not gene
technology.
[7]. Gene
Technology Act, subsection 32(3). Exempt dealings are prescribed in
regulation 6 and Part 1 of Schedule 2 of the Gene Technology Regulations
2001. In general, they are dealings with GMOs that pose a very low
risk (such as contained research involving very well understood organisms and
processes for creating and studying GMOs). See also: OGTR, ‘What
are exempt dealings?’, OGTR website, 10 February 2015, accessed 21
July 2015.
[8]. Gene
Technology Act, section 74. Notifiable low risk dealings are prescribed in
regulation 12 and Part 1 or 2 of Schedule 3 of the Gene Technology Regulations.
See also: OGTR, ‘What
are Notifiable Low Risk Dealings (NLRDs)?’, OGTR website, 5 February 2015, accessed
21 July 2015.
[9]. Gene
Technology Act 2000, Part 4, see especially section 31. Further information
on the different classes of dealings and the licensing process is available on
the OGTR website: OGTR, ‘Regulatory
requirements’, OGTR website, 23 February 2015, accessed 21 July 2015.
[10]. Gene
Technology Act, section 138.
[11]. Allen
Consulting Group, Review
of the Gene Technology Act 2000, report prepared for Australian
Department of Health and Ageing, Australian Department of Health and Ageing, Canberra,
August 2011, p. 35, accessed 16 July 2015.
[12]. Gene Technology Regulations
2001, accessed 16 July 2015.
[13]. The
Gene Technology
Amendment Act 2007 (Cth) amended the Act as a result of the 2006 review:
for further information on the 2006 review and relevant amendments, see
S Harris Rimmer and R Polya, Gene
Technology Amendment Bill 2007, Bills digest, 131, 2006–07, Parliamentary
Library, Canberra, 4 May 2007, accessed 12 August 2015.
[14]. Allen
Consulting Group, Review of the Gene Technology Act 2000, op. cit., p. 1.
[15]. Ibid.
[16]. Ibid.,
p. vii.
[17]. Senate
Community Affairs Legislation Committee, Inquiry
into the Gene Technology Amendment Bill 2015, The Senate, Canberra,
2015, accessed 29 June 2015.
[18]. Senate
Standing Committee for the Scrutiny of Bills, Alert
digest, 7, 2015, The Senate, Canberra, 12 August 2015, accessed 13
August 2015.
[19]. Australian
Academy of Science, Submission
to the Senate Community Affairs Legislation committee, Inquiry into the Gene
Technology Amendment Bill 2015, no date, p. 3, accessed 10 August 2015.
[20]. CropLife
Australia, Submission
to the Senate Community Affairs Legislation committee, Inquiry into the Gene
Technology Amendment Bill 2015, 24 July 2015, p. 1, accessed 10 August
2015.
[21]. CSIRO,
Submission
to the Senate Community Affairs Legislation committee, Inquiry into the Gene
Technology Amendment Bill 2015, 7 July 2015, accessed 10 August 2015.
[22]. Explanatory
Memorandum, Gene Technology Amendment Bill 2015, p. 1, accessed 25 June
2015.
[23]. The
Statement of Compatibility with Human Rights can be found at page 2 of the
Explanatory Memorandum to the Bill.
[24]. Parliamentary
Joint Committee on Human Rights, Twenty-fourth
report of the 44th Parliament, Canberra, 23 June 2015, p. 1, accessed
25 June 2015.
[25]. Allen
Consulting Group, Review of the Gene Technology Act 2000, op. cit., p.
20.
[26]. Australian
Academy of Science, op. cit., p. 1.
[27]. An
‘inadvertent dealings application’ is then defined in section 10 of the Act to mean
an application for a GMO licence to which Division 3 or 4 of Part 5 does not
apply because of the operation of sections 46A or 49. Divisions 3 and 4 of Part
5 deal with the initial consideration of licences not involving the intentional
release of GMOs into the environment, and those involving such release,
respectively.
[28]. Allen
Consulting Group, Review of the Gene Technology Act 2000, op. cit., p.
29.
[29]. Note
that item 8 removes the words ‘(if any)’ in relation to the requirement
to publish on the Regulator’s website, reflecting the fact that the Regulator
does have a website.
[30]. Allen
Consulting Group, Review of the Gene Technology Act 2000, op. cit., p.
34.
[31]. Ibid.,
p. 33.
[32]. Australian
Academy of Science, op. cit., p. 2.
[33]. Explanatory
Memorandum, op. cit., p. 5.
[34]. Allen
Consulting Group, Review of the Gene Technology Act 2000, op. cit., p.
35.
[35]. Explanatory
Memorandum, op. cit., p. 5.
[36]. Allen
Consulting Group, Review of the Gene Technology Act 2000, op. cit., p.
35.
[37]. Australian
Academy of Science, op. cit., p. 2.
[38]. FSANZ,
Submission
to the Senate Community Affairs Legislation Committee, Inquiry into the Gene
Technology Amendment Bill 2015, 24 July 2015, p. 3, accessed 10 August
2015.
[39]. OGTR,
Submission
to the Senate Community Affairs Legislation Committee, Inquiry into the Gene
Technology Amendment Bill 2015, 23 July 2015, p. 3, accessed 10 August
2015.
[40]. Explanatory
Memorandum, op. cit., p. 5.
[41]. Subsection
71(2B) was inserted by the Gene Technology Amendment
Act 2007 when the Act was amended following the 2006 Statutory Review.
[42]. Explanatory
Memorandum, op. cit., p. 5.
[43]. Ibid.,
pp. 5–6.
[44]. Ibid.,
pp. 5–6.
[45]. 2011
review, op. cit., p. 37.
[46]. Explanatory
Memorandum, op. cit., p. 6.
[47]. Australian
Academy of Science, op. cit., p. 2.
[48]. Subsection
75(2) provides that the regulations may prescribe different requirements to be
complied with in different situations or by different persons, including
requirements in relation to: the class of persons who may undertake notifiable
low risk dealings; notifying the Regulator of notifiable low risk dealings;
supervision by Institutional Biosafety Committees of notifiable low risk
dealings; or the containment level of facilities in which notifiable low risk
dealings may be undertaken.
[49]. OGTR,
Submission
to Senate Community Affairs Legislation Committee, Inquiry into the Gene
Technology Amendment Bill 2015, 23 July 2015, p. 5, accessed 10 August
2015.
[50]. Allen
Consulting Group, Review of the Gene Technology Act 2000, op. cit., p.
37.
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