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2019 | OriginalPaper | Buchkapitel

3. Regulation of Genome Editing in Plant Biotechnology: Australia

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Abstract

Two Australian regulatory frameworks are fundamental to the cultivation of genome edited plants and marketing of their products. These are the gene technology and food regulatory frameworks. Both frameworks rely on process triggers—that process being the use of gene technology. Unfortunately, these frameworks use different definitions of gene technology, creating the likelihood of different responses to genome edited plants, particularly to plants produced using SDN-2 or ODM.
No genome edited plants are currently cultivated in Australia but the relevant regulators are each currently undertaking reviews to determine whether some or all genome editing techniques are gene technology and how their frameworks should respond to those techniques. Final decisions are expected during 2018. In the meantime, the regulators have each adopted interim approaches to genome edited plants or their products, summarised in the first table.
Fußnoten
1
Huttner (1997), p. 10.
 
2
ISAAA (2016), p. 58.
 
3
ISAAA (2016), pp. 58–59.
 
4
ISAAA (2016), pp. 58–59.
 
5
OGTR (2017a), p. 16.
 
6
Productivity Commission (2016), p. 264.
 
7
OGTR (2018), Licence No DIR 158.
 
8
Productivity Commission (2016), p. 264.
 
9
OGTR (2018), License Nos DIR 149, 150 and 153.
 
10
Productivity Commission (2016), p. 264.
 
11
Brookes (2016), p. 6.
 
12
ISAAA (2016), pp. 58–59.
 
13
ISAAA (2016), pp. 58–59.
 
14
The data is this paragraph is from ISAAA (2016), pp. 59–60.
 
15
Brookes (2016), p. 7.
 
16
There are also over 600 local governments. They have limited authority on the issues relevant here and are not considered here.
 
17
The frameworks differ in regards to responsibility for monitoring and enforcement. Monitoring and enforcement of the food regulatory regime is carried out by the states (and local governments in some states); with respect to the agvet chemicals framework, national responsibility continues until the point of sale, when responsibility reverts to the states/territories; federal officers are responsible for monitoring and enforcement of the gene technology regime.
 
18
Environment Protection and Biodiversity Conservation Act 1999 (Cth). An example of such state legislation is the Environmental Protection Act 1970 (Vic).
 
19
Ludlow (2005a).
 
20
Ludlow (2004a).
 
21
Australia had a voluntary self-regulatory system for GM research from the mid-1970s until the introduction of the gene technology regulatory framework.
 
22
Although only in New South Wales and Northern Territory are amendments to the federal legislation automatically adopted into state mirroring legislation. In the other jurisdictions, periods of legislative inconsistency (and uncertainty), occur as each jurisdiction arranges for the passage of new amendments to the federal legislation. Productivity Commission (2016), p. 281.
 
23
Gene Technology Act 2000 (Cth) s 5. The state and territory governments also agreed to maintain legislation that corresponds with the Commonwealth Gene Technology Act under the inter-governmental Gene Technology Agreement 2001. Nevertheless, there are differences in the corresponding mirroring legislation.
 
24
Gene Technology Act 2000 (Cth) s 62.
 
25
There are two additional avenues to authorisation but these are exceptional. These are licenses for inadvertent dealings, pursuant to which the GTR can grant a licence to enable the disposal of a GMO inadvertently present on the applicant’s land; and an Emergency Dealing Determination (EDD) which is a legislative instrument made by the Minister under section 72 of the Act to expedite approval of dealings with a GMO in an emergency. This was introduced during the 2007 outbreak of equine influenza, to enable the import of a vaccine. Four inadvertent dealings licences were issued in 2016–2017 following the unknowing importation of GM petunias which had not been authorised under the regulatory framework, to allow all plants and seeds to be disposed of.
 
26
Australian Department of Health (2018), p. 98.
 
27
The legislation explains that ‘a dealing with a GMO involves the intentional release of the GMO into the environment if the GMO is intentionally released into the open environment, whether or not it is released with provision for limiting the dissemination or persistence of the GMO or its genetic material in the environment.’ Gene Technology Act 2000 (Cth) s 11.
 
28
Croplife Australia (2017), p. 1.
 
29
Ludlow (2004b).
 
30
Productivity Commission (2016), p. 265.
 
31
Productivity Commission (2016), recommendation 6.1.
 
32
Productivity Commission (2016), p. 281.
 
33
OGTR (2017b), p. 23.
 
34
OGTR (2017b), p. 24.
 
35
‘GMO’ is itself defined in the legislation as ‘genetically modified organism’. Gene Technology Act 2000 (Cth) s 10(1).
 
36
‘Organism’ is defined in the GT Act as ‘any biological entity that is: (a) viable; or (b) capable of reproduction; or (c) capable of transferring genetic material’. Gene Technology Act 2000 (Cth) s 10(1), definition of ‘organism’.
 
37
Gene Technology Regulations 2001 (Cth) reg. 5 and Schedule 1.
 
38
Gene Technology Regulations 2001 (Cth) reg. 4 and Schedule 1A.
 
39
While the definitions in the legislation have not been amended since their introduction in 2000, the Regulations (and the Schedules that list the exclusions from those definitions) were amended in 2006. These changes resulted in the provisions described here. The original version of reg. 4 listed only somatic cell nuclear transfer (cloning) as being excluded from gene technology and there was no schedule of other exclusions. The 2006 amendments replaced reg. 4 with the current reference to techniques listed in Sch. 1A, that Schedule also being added at that time. The further amendments in 2011 to Sch. 1 are not relevant here.
 
40
OGTR (2017c), p. 3.
 
41
Despite finding there was no intrinsic difference between GM food and other food produced using random breeding practices, the Australian food regulator nevertheless recommended that GM food should be specifically authorised before use for food. At that time, there was no monitoring of any new food products regardless of how they were produced. That has now been changed by the addition of a novel foods standard.
 
42
Australia New Zealand Food Standards Code, s 1.1.1-10.
 
43
FSANZ (2018a), fn. 8.
 
44
FSANZ (2018a), pp. 7 and 10.
 
45
APVMA (2018), section 2.1.
 
46
APVMA (2018), section 3.4.
 
47
APVMA (2018), section 2.2.
 
48
APVMA (2018), section 3.4.
 
49
APVMA (2018), section 2.2.4.
 
50
OGTR (2016a, b).
 
51
OGTR (2016a, b).
 
52
OGTR (2011).
 
53
OGTR (2011).
 
54
OGTR (2011).
 
55
Jones and Horticulture Innovation Australia (2016), p. 52. See also FSANZ (2012), p. 6; FSANZ (2013), p. 4.
 
56
FSANZ (2018a).
 
57
FSANZ (2018a), p. 4.
 
58
FSANZ (2018a), p. 4.
 
59
FSANZ (2018a), p. 4.
 
60
FSANZ (2013), p. 11.
 
61
FSANZ (2018a), p. 12.
 
62
FSANZ (2018a), p. 12.
 
63
FSANZ (2012), p. 19.
 
64
FSANZ (2012), p. 19.
 
65
FSANZ (2012), p. 4.
 
66
FSANZ (2013), p. 11.
 
67
FSANZ (2018a), p. 11.
 
68
FSANZ (2018a), p. 11.
 
69
FSANZ (2012), p. 22; FSANZ (2013), p. 11.
 
70
For DNIR, this is done by the Contained Dealings Evaluation Section of the OGTR; for DIR, by the Plant Evaluation Section of the OGTR.
 
71
Gene Technology Act 2000 (Cth) s 43(3). This is 90 business days for DNIR, 180 for a DIR licence for limited and controlled release (i.e. field trial) and 255 for a DIR licence for commercial release. A longer period is established where a significant risk is identified. Gene Technology Regulations reg 8. Note that the statutory timeframe clock can be stopped where the GTR seeks more information. Applications for accreditation and certification also have time-frames set by the regulations.
 
72
Australian Department of Health (2017), p. 22. Accreditation is pursuant to Gene Technology Act 2000 (Cth) s 91.
 
73
Certification occurs pursuant to Gene Technology Act 2000 (Cth) s 84. Classification relates to structural integrity of buildings and equipment, and to handling practices used by people working in the facility. Australian Department of Health (2017), p. 33.
 
74
Gene Technology Act 2000 (Cth) s 43(2) and Gene Technology Regulations 2001 (Cth) reg 7 and Sch 4.
 
75
Gene Technology Act 2000 (Cth) s 62(1).
 
76
Productivity Commission (2016), p. 266.
 
77
Productivity Commission (2016), p. 266.
 
78
Gene Technology Act 2000 (Cth) s 4(aa).
 
79
Food Standards Australia New Zealand Act 1991 (Cth) s 13. Division 1 of Part 3 of the FSANZ Act specifies that the Authority may accept applications for the development or variation of food regulatory measures, including standards. This Division also stipulates the procedure for considering an application for the development or variation of food regulatory measures.
 
80
Food Standards Australia New Zealand Act 1991 (Cth) s 18.
 
81
Food Standards Australia New Zealand Act 1991 (Cth) s 18(1).
 
82
Food Standards Australia New Zealand Act 1991 (Cth) s 18(1).
 
83
The Food Regulation Standing Committee’s Implementation Sub-Committee [now known as the Implementation Subcommittee for Food Regulation] has formed an Expert Advisory Group (EAG), involving laboratory personnel and representatives of the Australian and New Zealand jurisdictions, to identify and evaluate appropriate methods of analysis associated with all applications to FSANZ, including those applications for food produced using gene technology. FSANZ (2017), p. 6. 20 December 2017 [35-17] Call for Submissions – Application A1154. Food derived from insect-protected cotton line MON88702.
 
84
Productivity Commission (2016), p. 267.
 
85
APVMA (2018), section 2.3.
 
86
Croplife Australia (2017), p. 10.
 
87
Australian Department of Health (2017), p. 60. This is required pursuant to the Gene Technology Agreement between the national and state/territory governments, clause 44.
 
88
Commonwealth of Australia (2006).
 
89
Allen Consulting Group (2011), p. 27.
 
90
The Legislative and Governance Forum on Gene Technology (2017), p. 7.
 
91
The Legislative and Governance Forum on Gene Technology (2017), p. 4.
 
92
OGTR (2017b), p. 19 citing OGTR (2016-17).
 
93
OGTR (2016a, b), p. 1.
 
94
Jones and Horticulture Innovation Australia (2016), p. 57.
 
95
Jones and Horticulture Innovation Australia (2016), p. 58.
 
96
The OGTR received 741 submissions, 615 of which were received through a form on a website initiated by Friends of the Earth Australia. Australian Department of Health (2017), pp. 60–61. The submissions are available on the OGTR website.
 
97
OGTR (2018e).
 
98
OGTR (2017a).
 
99
OGTR (2017c).
 
100
OGTR (2017a), p. 4.
 
101
OGTR (2017a), p. 5.
 
102
OGTR (2017a), p. 9; OGTR (2017d).
 
103
OGTR (2017a), p. 11. The GTR notes that there are two organisms excluded through item 1 that cannot take advantage of the proposed approach and will therefore be unintentionally reclassified as GMOs if item 1 is deleted. These are NoGall (Agrobacterium radiobacter strain K1026) and VaxSafe PM (Pasteurella multicida strain PMP1). It is proposed that they will be specifically listed in Sch 1 items 10 and 11 to ensure they continue to be excluded from regulation. OGTR (2017a), p. 11.
 
104
OGTR (2017a), p. 11.
 
105
OGTR (2017a), p. 9.
 
106
OGTR (2017a), p. 10 citing Gene Technology Regulations Regulation Impact Statement Section 4 part (a), discussion of listing a limited class of organisms as not being GMOs, published as part of the 2001 Explanatory Statement.
 
107
OGTR (2017a), p. 10.
 
108
OGTR (2017a), p. 15.
 
109
A new regulation, reg 4A, will also be added for this purpose.
 
110
As the Consultation Paper explains ‘While the Regulator can undertake reviews of the Regulations to improve the clarity of definitions and practices, any change in approach to what is to be regulated or not can only be done by the owners of the policy setting for the Scheme.’ OGTR (2017b), p. 12.
 
111
OGTR (2017b), p. 16. As in the 2011 review of the GT Regulations, the Consultation Paper notes that the complex and lengthy process for amending the regulatory framework challenges governance and needs to be overhauled.
 
112
Australian Department of Health (2018), Finding 3.
 
113
Australian Department of Health (2018), Findings 13 and 14.
 
114
Australian Department of Health (2018), p. 15.
 
115
Australian Department of Health (2018), p. 16.
 
116
OGTR (2017b), p. 19.
 
117
Australian Department of Health (2018), Finding 8.
 
118
Australian Department of Health (2018), Finding 9 and pp. 26–30.
 
119
Australian Department of Health (2018), p. 29.
 
120
Australian Department of Health (2018), Finding 20 and p. 52. See also OGTR (2017b), p. 31.
 
121
OGTR (2017b), p. 32. See Australian Department of Health (2018), pp. 4–6. See OGTR (2018) Findings 9, 15, and 24–26.
 
122
Pursuant to Food Standards Australia New Zealand Act 1991 (Cth) s 113.
 
123
FSANZ (2018a), p. 4.
 
124
FSANZ (2018b).
 
125
Kelly (2017).
 
126
Kelly (2017).
 
127
Kelly (2017).
 
128
Sustainability Council of NZ v EPA (heard 6 and 7 Nov 2013; judgment 20 May 2014).
 
129
To clarify that these new techniques were not deregulated (and correct a drafting error identified by the High Court) the Regulations were amended by deleting from regulation 3(1)(b) ‘or chemical or radiation treatments that cause changes in chromosome number or cause chromosome rearrangements’ and inserting new regulation 3(1)(ba) ‘organisms that result from mutagenesis that uses chemical or radiation treatments that were in use on or before 29 July 1998’.
 
130
OGTR (n.d.).
 
131
Australian Department of Health (2017), p. 53.
 
132
Australian Department of Health (2017), p. 54.
 
133
Australian Department of Agriculture and Water Resources.
 
134
Croplife Australia (2017), p. 11.
 
135
Gene Technology Act 2000 (Cth) s 63(1).
 
136
Gene Technology Act 2000 (Cth) s 63(3).
 
137
Gene Technology Act 2000 (Cth) s 62(1).
 
138
Australia New Zealand Food Standards Code Standard 1.2.1—Requirements to have labels or otherwise provide information. See also Standard 1.5.2—Food Produced Using Gene Technology.
 
139
Australia New Zealand Food Standards Code s 1.5.2-2.
 
140
Australia New Zealand Food Standards Code Standard 1.2.1.
 
141
Australia New Zealand Food Standards Code s 1.5.2-4(4).
 
142
Competition and Consumer Act 2010 (Cth), Australian Consumer Law (schedule to that Act) cl 18.
 
143
Sylvan (2005).
 
144
Australia New Zealand Food Standards Code s 1.5.2-4(1)(d).
 
145
Productivity Commission (2016), p. 362.
 
146
Blewett Report (2011).
 
147
See, for example, Australian Department of Agriculture and Water Resources (2018).
 
148
Gene Technology Act 2000 (Cth) ss 32–38. The penalties for dealing without a licence and for breach of licence conditions include up to two years imprisonment, fines of up to $55,000 for an individual and from $275,000 for a corporation.
 
149
The penalties for aggravated offences include imprisonment for up to five years, fines of up to $220,000 for an individual and up to $1.1 million for a corporation. Pursuant to s 188 in the case of corporate offenders, it is sufficient that conduct engaged in by a director, employee or agent of the corporation was within the scope of their actual or apparent authority and that the director, employee or agent had the relevant state of mind. The corporation is then deemed to have engaged in such conduct unless the corporation establishes that it took reasonable precautions and exercised due diligence to avoid the conduct.
 
150
In the Australian Capital Territory and New South Wales these can result in imprisonment for up to two years as well as a fine. The other jurisdictions only have fines as possible penalties.
 
151
Western Australian Legislative Council (2017).
 
152
Ludlow (2005b), p. 163; Ludlow (2005c).
 
153
Marsh v Baxter [2014] WASC 187.
 
154
Marsh v Baxter [2014] WASC 187 [216–218]. However, following the plaintiffs’ failure to collect the material or allow others to do it for them until six months after its arrival, eight volunteer GM canola plants eventually grew on the plaintiffs’ land. [138], [438] and [669].
 
155
Marsh v Baxter [2014] WASC 187 [739].
 
156
Marsh v Baxter [2014] WASC 187 [321].
 
157
Marsh v Baxter [2015] WASCA 169.
 
158
Marsh v Baxter (P44/2015) Results of Special Leave Applications heard 12 February 2016.
 
159
McCormack and Mercer (2017). Total sample size, n was 1255.
 
160
McCormack and Mercer (2017), p. 185.
 
161
McCormack and Mercer (2017), p. 3.
 
162
McCormack and Mercer R (2017), p. 3.
 
163
Sales (n.d.).
 
164
McCormack and Mercer (2017), p. 4.
 
165
McCormack and Mercer (2017), p. 37.
 
166
McCormack and Mercer (2017), p. 12.
 
167
‘17% of respondents stating that they could explain [genome editing] to a friend, 39% stating that they had heard of it but knew little or nothing about it, and another 39% stating that they had never heard of it.’ McCormack and Mercer (2017), p. 21.
 
168
McCormack and Mercer (2017), p. 11.
 
169
McCormack and Mercer (2017), p. 4.
 
170
McCormack and Mercer (2017), p. 4.
 
171
McCormack and Mercer (2017), p. 39.
 
172
Jones and Horticulture Innovation Australia (2016), pp. 36–37.
 
173
OGTR (2017e).
 
174
OGTR (2017a, b, c, d, e), pp. 11–12.
 
175
Jones and Horticulture Innovation Australia (2016), p. 10.
 
176
FSANZ (2018a), p. 10.
 
177
FSANZ (2012), pp. 4 and 15.
 
178
FSANZ (2012), p. 4.
 
179
FSANZ (2012), p. 17.
 
180
FSANZ (2013), p. 12.
 
181
FSANZ (2013), p. 13.
 
182
FSANZ (2018a), p. 11.
 
183
FSANZ (2012), p. 13.
 
184
FSANZ (2018a), p. 11.
 
185
ACIL Tasman (2008), p. 59.
 
186
ACIL Tasman (2008), p. 57.
 
187
Fernandez Albújar and van der Meulen (2017), p. 11.
 
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Metadaten
Titel
Regulation of Genome Editing in Plant Biotechnology: Australia
verfasst von
Karinne Ludlow
Copyright-Jahr
2019
DOI
https://doi.org/10.1007/978-3-030-17119-3_3

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