Releasing genetically modified canola into the environment - deconstructing a decision of the Gene Technology Regulator under the gene technology act 2000 (Cth)

Environmental and Planning Law Journal

Volumn 23, Issue 1, 2006, Pages 22-59

  Lawson, Charles ^a   Hindmarsh, Richard ^b  

^a GRIFFITH UNIVERSITY   (Australia)

^b UNIVERSITY OF QUEENSLAND   (Australia)

Author keywords

[No Author keywords available]

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EID: 37349107933     PISSN: 0813300X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (400)

1. Gene Technology Act 2000 (Cth) is the Commonwealth's component of this regulatory scheme; under s 5, mirror legislation is required in each State and Territory for a comprehensive regulatory scheme
2. see also Gene Technology Act 2001 (Vic), Gene Technology Act 2001 (SA) and Gene Technology Act 2001 (Qld).
3. Gene Technology Act 2000 (Cth), s 10, defines "organism" to mean "any biological entity that is: (a) viable; or (b) capable of reproduction; or (c) capable of transferring genetic material".
4. Gene Technology Act 2000 (Cth), s 10, defines "gene technology" to mean "any technique for the modification of genes or genetic material, but does not include: (a) sexual reproduction; or (b) homologous recombination; or (c) any other technique specified in the regulations for the purposes of this paragraph"; the Gene Technology Regulations 2001 (Cth), Reg 4, presently declares "gene technology does not include somatic cell nuclear transfer if the transfer does not involve genetically modified material".
5. Gene Technology Act 2000 (Cth), s 10, defines "GMO" to mean a "genetically modified organism", which, in turn, is defined to mean: "(a) an organism that has been modified by gene technology; or (b) an organism that has inherited particular traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology; or (c) anything declared by the regulations to be a genetically modified organism, or that belongs to a class of things declared by the regulations to be genetically modified organisms; but does not include: (d) a human being, if the human being is covered by para (a) only because the human being has undergone somatic cell gene therapy; or (e) an organism declared by the regulations not to be a genetically modified organism, or that belongs to a class of organisms declared by the regulations not to be genetically modified organisms"; the Gene Technology Regulations 2001 (Cth) do not presently declare anything to be a GMO for the purposes of para (c), although Reg 5 does declare a number of organisms set out in Sch 1 as being not GMOs for the purposes of para (e) of the GMO definition.
6. For a review of the early developments eventually leading to the Gene Technology Act 2000 (Cth) see Hindmarsh R, "Genetic Engineering Regulation in Australia: An 'Archaeology' of Expertise and Power" (2005) 14 Science as Culture 373-392.
7. Senate Community Affairs References Committee, A Cautionary Tale: Fish Don't Lay Tomatoes - A Report on the Gene Technology Bill 2000 (Commonwealth of Australia, 2000) pp 27-30.
8. Major weaknesses in the voluntary system were insufficient capacity for independent legally enforceable auditing and monitoring, insufficient capacity for the imposition of penalties or other action in the event of a breach and inadequate transparency in decision making: see Gene Technology Bill 2000 (Cth), Explanatory Memorandum, pp 9 and 12-13.
9. Flynn E, "Comparison between the Gene Technology Act 2000 and the System Overseen by the Genetic Manipulation Advisory Committee" (2002) 15 Australian Biologist 87;
10. Hain M, Cocklin C and Gibbs D, "Regulating Biosciences: The Gene Technology Act 2000" (2002) 19 EPLJ 163 at 164-165.
11. Gene Technology Bill 2000 (Cth), Explanatory Memorandum, p 10.
12. Gene Technology Bill 2000 (Cth), Explanatory Memorandum, p 10.
13. Gene Technology Act 2000 (Cth), s 10, defines "GM product" to mean "a thing (other than a GMO) derived or produced from a GMO".
14. Gene Technology Bill 2000 (Cth), Explanatory Memorandum, p 13.
15. Australia, House of Representatives, Debates (22 June 2000) p 18104 (Minister for Health and Aged Care).
16. Trantor M, "A Question of Confidence: An Appraisal of the Operation of the Gene Technology Act 2000" (2003) 20 EPLJ 245 at 245-246.
17. Hain et al, n 5, p 165; for example, "[t]he Act provides the public, farmers, researchers and companies involved in GMOs certainty, consistency and safety for people and the environment": Office of the Gene Technology Regulator, First Application for Commercial Release of GM Canola in Australia Marks First Anniversary of the Office of the Gene Technology Regulator (Press Release No GTR08/02, 21 June 2002).
18. For a similar sentiment about generating trust through control in regulating GMOs generally, see Newell P, Biotechnology and the Politics of Regulation, IDS Working Paper 146 (Institute of Development Studies, 2002) pp 5-7.
19. Scoones I, Science, Policy and Regulation: Challenges for Agricultural Biotechnology in Developing Countries, IDS Working Paper 147 (Institute of Development Studies, 2002) pp 2-3
20. Although note that the causal link between legitimacy (or public trust) and regulation remains uncertain: see for a recent example.
21. Frewer L, Scholderer J and Bredahl L, "Communicating about the Risks and Benefits of Genetically Modified Foods: The Mediating Role of Trust" (2003) 23 Risk Analysis 1117.
22. See also Australia, House of Representatives, n 10; House of Representatives Standing Committee on Primary Industries and Regional Services, Work in Progress: Proceed with Caution (Commonwealth of Australia, 2000) pp 123-124.
23. Gene Technology Act 2000 (Cth), s 32(1), providing for exempt dealings (ss 32(1) and 32(4) and Gene Technology Regulations 2001 (Cth), Regs 6-11), notifiable low risk dealings (s 32(1) and Pt 6 Div 2 and Regs 12-13), licensed dealings (s 32(1) and Pt 5 and Regs 7-11), dealings with GMOs on the Register of GMOs (ss 32(1) and 76), or dealings with an organism, or class of organisms, declared to be outside the definition of a GMO (s 10 and Reg 5 (Sch 1 Pt 1);
24. Other formal statutory elements of the regulatory scheme for GMOs (and GM products) include the Agricultural and Veterinary Chemicals Code Act 1994 (Cth) and the Therapeutic Goods Act 1989 (Cth);
25. There is, however, a "mass" of non-legal rules, codes, circulars, practice notes, international conventions and ethical codes.
26. Black J, "Regulation as Facilitation: Negotiating the Genetic Revolution" (1998) 61 MLR 621 at 621.
27. Gene Technology Act 2000 (Cth), ss 49(2) and 51(1)
28. Gene Technology Regulations 2001 (Cth), Reg 10.
29. Office of the Gene Technology Regulator, Risk Analysis Framework for Licence Applications to the Office of the Gene Technology Regulator (Office of the Gene Technology Regulator, 2002);
30. Notably a new framework was implemented in 2005 that included "risk communication" as a central element of "risk analysis", being "risk analysis = risk assessment + risk management + risk communication": see Office of the Gene Technology Regulator, Risk Analysis Framework (Office of the Gene Technology Regulator, 2005).
31. See Gene Technology Act 2000 (Cth), ss 50, 52 and 56.
32. Office of the Gene Technology Regulator, Risk Analysis Framework, n 15, pp 19-20 and 28-67
33. see also Hayes K, Robust Methodologies for Ecological Risk Assessment: Best Practice and Current Practice in Ecological Risk Assessment for Genetically Modified Organisms (CSIRO Division of Marine Research, 2004) p 32.
34. Noting that there is an ongoing controversy about the definition of "risk", with the presently dominant conception that "risk" involves some form of "danger"; for an overview of the different emphases and nuances, see Botterill L and Mazur N, Risk & Risk Perception: A Literature Review, RIRDC Publication No 04/043 (Rural Industries Research and Development Corporation, 2004) pp 1-2.
35. Office of the Gene Technology Regulator, Risk Analysis Framework, n 15, pp 12 and 70.
36. Office of the Gene Technology Regulator, Risk Analysis Framework, n 15, pp 12 and 70.
37. For a recent overview of "best practice" ecological risk assessment for GMOs, see Hayes, n 17, pp 8-30
38. see generally Hayes K, A Review of Ecological Risk Assessment Methodologies, Technical Report No 13 (CSIRO Division of Marine Research, 1997).
39. The term "risk assessment" is, however, defined in the Marrakesh Agreement Establishing the World Trade Organization [1995] ATS 8, Annex 1A (Agreement on the Application of Sanitary and Phytosanitary Measures), to which Australia is a member state, to mean "[t]he evaluation of the likelihood of entry, establishment or spread of a pest or disease within the territory of an importing Member according to the sanitary or phytosanitary measures which might be applied, and of the associated potential biological and economic consequences; or the evaluation of the potential for adverse effects on human or animal health arising from the presence of additives, contaminants, toxins or disease-causing organisms in food, beverages or feedstuffs" (Annex A).
40. Peel J, "Science and Risk Assessment in International Environmental Law: Learning from the WTO SPS Experience" (2004) 98 American Society of International Law Proceedings 283.
41. See for example, Lawson C, "Risk Assessment in the Regulation of Gene Technology under the Gene Technology Act 2000 (Cth) and the Gene Technology Regulations 2001 (Cth)" (2002) 19 EPLJ 195 at 200-201.
42. Lawson, n 23 at 201.
43. Black, n 13, pp 621-622 (conceptualisations of the "problem")
44. Burgmann M, "Are Australian Standards for Risk Analysis Good Enough? Conserving Snails and Managing Genetically Modified Plants in Fragmented Landscapes" (1999) 12 Australian Biologist 125 at 127-129 (human frailties in the judgment of risk);
45. Hayes, n 17, pp 25-26 (the place of new technology).
46. Pildes R and Sunstein C, "Reinventing the Regulatory State" (1995) 62 U Chi L Rev 1 at 33-43.
47. Slovic P, "Trust, Emotion, Sex, Politics, and Science: Surveying the Risk Assessment Battlefield" (1999) 19 Risk Analysis 689 and the references therein; for a recent overview of some contributing factors see Botterill and Mazur, n 18, pp 3-7.
48. Slovic, n 26, at 697.
49. Essentially an assessment that the technology's consequences are acceptable and that the aims of the technology are acceptable: see Jasanoff S, "Technologies of Humility: Citizen Participation in Governing Science" (2003) 41 Minerva 223 and the references therein.
50. Newell, n 11, p 3 and the references therein pointing out the potential conflict between regulation for the benefit of the public and regulation for commercial interests where governments are both protector of the public interest and promoter of biotechnology.
51. Bayer CropScience Pty Ltd, Commercial Release of Genetically Modified (InVigor hybrid) Canola: Risk Assessment and Risk Management Plan, DIR 021/2002 (Office of the Gene Technology Regulator, 2003).
52. Aventis CropScience Pty Ltd, Small and Large Scale Trialing of InVigor Canola (Brassica napus) for the Australian Cropping System and Seed Production: Risk Assessment and Risk Management Plan, DIR 010/2001 (Office of the Gene Technology Regulator, 2002).
53. Office of the Gene Technology Regulator, Handbook on the Regulation of Gene Technology in Australia: A User's Guide to the Gene Technology Act 2000 and Related Legislation (Office of the Gene Technology Regulator, 2003) p 91.
54. Office of the Gene Technology Regulator, n 31, p 92.
55. Office of the Gene Technology Regulator, n 31, p 92.
56. Gene Technology Act 2000 (Cth), s 3
57. see also Gene Technology Bill 2000 (Cth), Explanatory Memorandum, p 13.
58. Gene Technology Act 2000 (Cth), Pt 3
59. The Regulator is a statutory office holder appointed by the Governor-General (s 118(1)) and assisted by persons engaged under the Public Service Act 1999 (Cth) and made available for the purpose by the Secretary of the Department of Health and Ageing (s 133)
60. See Department of Finance and Administration, List of Australian Government Bodies 2002-2003, Financial Management Reference Material No 1 (2004) p 254
61. Notably, the Regulator has set out a service charter of the Office of the Gene Technology Regulator articulating its "values" as being "the Australian Public Service Values and Code of Conduct in all aspects of its business. In addition, we value: Professionalism; through integrity, objectivity, excellence, commitment, and consistency. Accountability; through open and transparent processes. Achievement; through effective, efficient and flexible work practices which are focussed on delivering timely outcomes. Respect for each other and our stakeholders; through open and effective communication and quality service": Office of the Gene Technology Regulator, OGTR Service Charter (Office of the Gene Technology Regulator, 2005) p 3.
62. Gene Technology Act 2000 (Cth), s 10, defines "deal with, in relation to a GMO, means the following: (a) conduct experiments with the GMO; (b) make, develop, produce or manufacture the GMO; (c) breed the GMO; (d) propagate the GMO; (e) use the GMO in the course of manufacture of a thing that is not the GMO; (f) grow, raise or culture the GMO; (g) import the GMO; and includes the possession, supply, use, transport or disposal of the GMO for the purposes of, or in the course of, a dealing mentioned in any of paras (a) to (g).
63. Gene Technology Act 2000 (Cth), ss 32(1) and 32(4)
64. Gene Technology Regulations 2001 (Cth), Pt 3, Div 1.
65. Gene Technology Act 2000 (Cth), s 32(1) and Pt 6, Div 2
66. Gene Technology Regulations 2001 (Cth), Pt 3, Div 2.
67. Gene Technology Act 2000 (Cth), s 32(1) and Pt 5
68. Gene Technology Regulations 2001 (Cth), Regs 7-11.
69. Gene Technology Act 2000 (Cth), ss 32(1) and 76.
70. Gene Technology Act 2000 (Cth), s 10; and Gene Technology Regulations 2001 (Cth), Sch 1, Pt 1.
71. Gene Technology Act 2000 (Cth), Pt 5, Div 4
72. Noting that s 10 defines "environment" to include "ecosystems and their constituent parts", "natural and physical resources" and "the qualities and characteristics of locations, places and areas"; s 11 provides "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.
73. Gene Technology Act 2000 (Cth), s 49(2).
74. Gene Technology Act 2000 (Cth), s 50(1).
75. See Gene Technology Act 2000 (Cth), ss 51(1) and 51(2).
76. Gene Technology Regulations 2001 (Cth), Reg 10(2).
77. See Gene Technology Act 2000 (Cth), s 51(1)
78. Gene Technology Regulations 2001 (Cth), Reg 10.
79. See Gene Technology Act 2000 (Cth), s 51(1)
80. Gene Technology Regulations 2001 (Cth), Reg 10.
81. Gene Technology Act 2000 (Cth), s 40(2)(a)
82. Gene Technology Regulations 2001 (Cth), Reg 7(1)(b).
83. Gene Technology Regulations 2001 (Cth), Sch 4, Pt 2.
84. See Gene Technology Act 2000 (Cth), ss 3 and 4.
85. This includes the Australian Capital Territory and the Northern Territory: Gene Technology Act 2000 (Cth), s 10.
86. Prescribed by the Gene Technology Regulations 2001 (Cth), Reg 9 to be the Australian New Zealand Food Authority, the Australian Quarantine Inspection Service, the National Health and Medical Research Council, the National Industrial Chemicals Notification and Assessment scheme, the National Registration Authority and the Therapeutic Goods Administration.
87. Gene Technology Act 2000 (Cth), s 50(3).
88. Gene Technology Act 2000 (Cth), s 52.
89. Gene Technology Act 2000 (Cth), s 53
90. S 51(1) clarifies that the Regulator is not confined to considering submissions and advice and may take into account other information, including relevant independent research.
91. Gene Technology Act 2000 (Cth), s 56(1).
92. Gene Technology Act 2000 (Cth), Pt 5, Div 6.
93. Gene Technology Act 2000 (Cth), s 55.
94. Gene Technology Act 2000 (Cth), s 56(2)(a).
95. Gene Technology Act 2000 (Cth), s 56(2)(b).
96. Gene Technology Act 2000 (Cth), s 56(2)(c).
97. Gene Technology Act 2000 (Cth), ss 23 and 56(2)(d)
98. There are presently no policy guidelines in force.
99. Gene Technology Act 2000 (Cth), ss 21 and 57(1)
100. The only policy principle in force is the Gene Technology (Recognition of Designated Areas) Principle 2003
101. Commonwealth of Australia Special Gazette (No S340 5 September 2003) requiring the Gene Technology Regulator to recognise a States' right to designate under State law special areas that are for either GM or non-GM crops for marketing purposes.
102. Ludlow K, "Cultivating Chaos: State Responses to Releasing Genetically Modified Organisms" (2004) 9 Deakin Law Review 1 at 18-20.
103. McGrath C, "A System Under Strain: The Regulation of Gene Technology" (2003) 2 National Environment Law Review 32 at 36-37.
104. Trantor, n 10, pp 256-258.
105. Gene Technology Act 2000 (Cth), ss 57(2) and 58
106. Notably, in general or commercial release applications "[i]nformation gained from the field trials (and information about the suitability of the applicant based on their conduct of the trials) would be used by the Regulator as part of his/her assessment of any subsequent application for commercial release of the GMO": Office of the Gene Technology regulator, n 31, p 92.
107. Office of the Gene Technology Regulator, Risk Analysis Framework, n 15, p 1.
108. Office of the Gene Technology Regulator, Risk Analysis Framework, n 15, p 2.
109. Office of the Gene Technology Regulator, Risk Analysis Framework, n 15, p 17.
110. Office of the Gene Technology Regulator, Risk Analysis Framework, n 15, p 9.
111. Office of the Gene Technology Regulator, Risk Analysis Framework, n 15, p 16
112. This is the "doctrine of substantial equivalence" that does not have unanimous support as a base line for an objective method of assessing risk
113. See for supportive review McHughen A, A Consumer's Guide to GM Food: From Green Genes to Red Herrings (Oxford University Press, 2000) pp 137-139.
114. "Hazard" meaning "the capacity of a GMO to produce a particular type of adverse health or environmental effect, directly or indirectly; or an event, sequence of events or combination of circumstances that could potentially have adverse consequences": Office of the Gene Technology Regulator, Risk Analysis Framework, n 15, pp 12 and 70.
115. "Risk assessment" means "the process of estimating the potential impact of a hazard on a specified human population or the environment under a specific set of conditions within an identified timeframe": Office of the Gene Technology Regulator, Risk Analysis Framework, n 15, pp 12 and 70.
116. "Risk management" means "the process of evaluating alternative actions, selecting options and implementing them in response to risk assessments": Office of the Gene Technology Regulator, Risk Analysis Framework, n 15, p 12 and p 70.
117. Risk communication" means "ensuring that: an open and transparent process of identification of risks associated with (in this case) gene technology and GMOs has been rigorously followed, and; the community is adequately informed about what these risks are and how they are being managed; and public confidence in the regulatory system is maximised": Office of the Gene Technology Regulator, Risk Analysis Framework, n 15, p 13 and p 70.
118. See Office of the Gene Technology Regulator, Risk Analysis Framework, n 15, pp 8-14.
119. Office of the Gene Technology Regulator, Risk Analysis Framework, n 15, p 20.
120. Office of the Gene Technology Regulator, Risk Analysis Framework, n 15, pp 21-22.
121. Office of the Gene Technology Regulator, Risk Analysis Framework, n 15, p 22.
122. Office of the Gene Technology Regulator, Risk Analysis Framework, n 15, pp 15-16.
123. Office of the Gene Technology Regulator, Risk Analysis Framework, n 15, p 16.
124. Office of the Gene Technology Regulator, Risk Analysis Framework, n 15, p 20.
125. Office of the Gene Technology Regulator, Risk Analysis Framework, n 15, p 21.
126. See Gene Technology Act 2000 (Cth), s 55.
127. Gene Technology Act 2000 (Cth), s 59.
128. Gene Technology Act 2000 (Cth), s 179.
129. See Gene Technology Act 2000 (Cth), s 183
130. The term "eligible person" is confined by s 179 to the applicant for the licence and the licence holder.
131. 87 See Gene Technology Act 2000 (Cth), s 183A
132. Although there remains the original jurisdiction of the Federal Court under the Federal Court Act 1976 (Cth), ss 22 and 23.
133. See Gene Technology Act 2000 (Cth), s 54.
134. See Gene Technology Act 2000 (Cth), s 54(2)(a) and Pt 12, Div 3.
135. See Gene Technology Act 2000 (Cth), s 52(3).
136. See Gene Technology Act 2000 (Cth), s 52(2)(c).
137. See Gene Technology Act 2000 (Cth), ss 54(2)(b) and 58.
138. Bayer CropScience Pty Ltd, n 29, p 37; notably the Regulator asserts that "this declaration in no way limited the thorough risk assessment of the individual GMOs.
139. Note, however, that the Regulator has previously stated that the risk assessment and risk management plan, and summary information, will be made publicly available: see, for example, Office of the Gene Technology Regulator, Risk Assessment and Risk Management Plan: Agronomic Assessment and Seed Increase in Eastern Australia of Transgenic Cotton Expressing cry1Ac and cry2Ab Genes from Bacillus thuringiensis, DIR 005/2001 (Office of the Gene Technology Regulator, 2001) p 68.
140. Gene Technology Act 2000 (Cth), ss 48-67
141. see also Office of the Gene Technology Regulator, n 31, pp 90-92.
142. See Office of the Gene Technology Regulator, n 31, p 91.
143. Office of the Gene Technology Regulator, n 31.
144. Office of the Gene Technology Regulator, n 31, p 92.
145. Defined as, "to denote canola with a specific genetic modification derived from a single transformation event", although "this usage is intended to be inclusive of the introduction of the modification into other canola genetic backgrounds by conventional breeding": see Bayer CropScience Pty Ltd, n 29, pp 15 and 38.
146. Being canola T45, Topas 19/2, MS1, MS8, RF1, RF2 and RF3: see Bayer CropScience Pty Ltd, n 29, pp 15-16.
147. This includes all Australian States and Territories: see Bayer CropScience Pty Ltd, n 29, p 16.
148. Bayer CropScience Pty Ltd, n 29.
149. Bayer CropScience Pty Ltd, n 29, pp 143-144.
150. "InVigor" is a registered trade mark owned by Bayer CropScience GmbH, Frankfurt am Main for the class of goods and services described as "[a]gricultural, horticultural and forestry products and their reproductive material; seeds; grains; live plants" subject to the condition that "the word INVIGOR will not be used as the name, or part of the name, of a plant variety": Australian Registered Trade Mark 741414, 13 August 1997.
151. Bayer CropScience Pty Ltd, n 29, p 143.
152. Bayer CropScience Pty Ltd, n 29, p 139
153. Notably the term "GMOs" means, "the genetically modified organisms covered by this licence, described at Attachment A" and Attachment A provides that the "GMOs covered by this licence are: (a) InVigor hybrid canola (hybrids of canola containing transformation event MS8 and canola containing transformation event RF3); (b) the GMOs described in the table below" and the table identified the GMOs as "Canola containing transformation event" T45, Topas 19/2, MS1, MS8, RF1, RF2 and RF3 (pp 138 and 143).
154. Office of the Gene Technology Regulator, The Biology and Ecology of Canola (Brassica napus) (Office of the Gene Technology Regulator, 2002).
155. Being pat - T45 and Topas 19/2; bar - MS1, MS8, RF1, RF2 and RF3: Bayer CropScience Pty Ltd, n 29, pp 16-17 and 38-39.
156. Being barnase - MS1 and MS8
157. Barstar - RF1, RF2 and RF3: Bayer CropScience Pty Ltd, n 29, pp 16-17 and 38-39.
158. Being canola Topas 19/2, MS1, RF1 and RF2: see Bayer CropScience Pty Ltd, n 29, pp 16-17 and 38-39.
159. Bayer CropScience Pty Ltd, n 29, p 44;
160. Line Topas 19/2 with a binary transformation vector and lines T45, MS1, MS8, RF1, RF2 and RF3 with co-integration vectors (pp 44-45).
161. Bayer CropScience Pty Ltd, n 29, pp 41-42.
162. Bayer CropScience Pty Ltd, n 29, pp 41-43.
163. Bayer CropScience Pty Ltd, n 29, p 42.
164. Bayer CropScience Pty Ltd, n 29, p 43.
165. Bayer CropScience Pty Ltd, n 29, p 42.
166. Bayer CropScience Pty Ltd, n 29, pp 42-42.
167. Bayer CropScience Pty Ltd, n 29, pp 40-41.
168. Bayer CropScience Pty Ltd, n 29, p 40.
169. Bayer CropScience Pty Ltd, n 29, pp 40-41.
170. Bayer CropScience Pty Ltd, n 29, p 43.
171. Bayer CropScience Pty Ltd, n 29, p 43.
172. Bayer CropScience Pty Ltd, n 29, p 43.
173. These nucleotides are associated with the inserted genes and are not characterised in the application: see Bayer CropScience Pty Ltd, n 29, pp 46-48.
174. These nucleotides are not characterised in the application, and includes a partial T-DNA containing a portion of the T-DNA including the barstar gene in line RF3 and the pat and nptII genes in Topas 19/2: see Bayer CropScience Pty Ltd, n 29, p 47.
175. Bayer CropScience Pty Ltd, n 29, pp 44-45.
176. Bayer CropScience Pty Ltd, n 29, pp 47-48.
177. Bayer CropScience Pty Ltd, n 29, pp 47-48; notably there was no report of flanking sequences for line MS8 (p 46).
178. Aventis CropScience Pty Ltd, n 30, p 4.
179. Aventis CropScience Pty Ltd, n 30, p 7.
180. These were recorded as approvals PR-63, PR-63X, PR-63X(2), PR-63X(3), PR-63X(4), PR-63X(5) and PR-63X(6): see Aventis CropScience Pty Ltd, n 30, p 8.
181. Aventis CropScience Pty Ltd, n 30, p 9
182. Although a number of instances of non-compliance with conditions were recorded: see, for example, Interim Office of the Gene Technology Regulator, Quarterly Report, March 2001 (Office of the Gene Technology Regulator, 2001) pp 23-24 where sheep were recorded grazing on canola.
183. Aventis CropScience Pty Ltd, n 30, pp 11-16.
184. Aventis CropScience Pty Ltd, n 30, p 56.
185. Aventis CropScience Pty Ltd, n 30, p 59.
186. Aventis CropScience Pty Ltd, n 30, p 56.
187. Aventis CropScience Pty Ltd, n 30, pp 56-57.
188. Aventis CropScience Pty Ltd, n 30, pp 58-59 and 62-84.
189. Aventis CropScience Pty Ltd, n 30, p 79.
190. The Belgian Government refused to approve field tests with GM herbicide tolerant canola, expressing concerns about pollen transfer, although no details of the assessment were available, "but further information is being actively sought and will be considered in assessing an application from Aventis for the commercial release of InVigor canola": Aventis CropScience Pty Ltd, n 30, p 10.
191. Aventis CropScience Pty Ltd, n 30, p 20
192. Perhaps surprisingly, barnase gene expression was only correlated with an antherless phenotype, as there was no evidence of barnase gene expression through Northern analysis in MS8, although MS8 and RF3 crosses were reported to be fully fertile and might have provided evidence of barnase gene expression through Northern analysis (p 17).
193. Aventis CropScience Pty Ltd, n 30, pp 78-84.
194. Aventis CropScience Pty Ltd, n 30, p 4
195. Notably, the GMO is not defined in the license conditions other than as "GMO" (see pp 62-84), although the "object of most of the conditions is to limit the potential for spread and persistence of the GM InVigor canola in the environment outside the release site or the Isolation Zone, in order to reduce the potential for risks to human health and safety or the environment" (p 78).
196. Aventis CropScience Pty Ltd, n 30, p 4.
197. Aventis CropScience Pty Ltd, n 30, pp 64-65.
198. The purpose of this [limited] release is to conduct breeding trials to develop lines suitable for use under Australian conditions and produce seed for potential commercial lines and export. Any future releases in Australia would be subject to separate applications and assessments": Aventis CropScience Pty Ltd, n 30, p 4.
199. See Hayes, n 17, pp ii and 27-30; "[c]urrent field trials only appear to gather information on crop performance. These trials are an ideal opportunity to gather the types of data needed to improve the science of GMO risk assessment" (p ii).
200. Bayer CropScience Pty Ltd, n 29, p 27.
201. Bayer CropScience Pty Ltd, n 29, p 27.
202. See Bayer CropScience Pty Ltd, n 29, pp 7, 9 and 27.
203. Bayer CropScience Pty Ltd, n 29, p 27; notably the Regulator received 256 written submissions and 531 campaign" letters and e-mails (p 150).
204. Bayer CropScience Pty Ltd, n 29, p 13.
205. Bayer CropScience Pty Ltd, n 29, pp 139-140.
206. Bayer CropScience Pty Ltd, n 29, p 139.
207. Bayer CropScience Pty Ltd, n 29, p 141.
208. Bayer CropScience Pty Ltd, n 29, p 27.
209. Bayer CropScience Pty Ltd, n 29, pp 29-36 (summary).
210. Bayer CropScience Pty Ltd, n 29, pp 53 and 54.
211. Bayer CropScience Pty Ltd, n 29, pp 54, 62 and 67.
212. Bayer CropScience Pty Ltd, n 29, p 66.
213. Bayer CropScience Pty Ltd, n 29, p 76.
214. Bayer CropScience Pty Ltd, n 29, p 79.
215. Bayer CropScience Pty Ltd, n 29, p 79.
216. See Bayer CropScience Pty Ltd, n 29, p 78.
217. Bayer CropScience Pty Ltd, n 29, pp 79-94.
218. Bayer CropScience Pty Ltd, n 29, p 94.
219. Noting that the risk assessment distinguishes between "hybridisation" and "introgression", and the potential of plants to hybridise between species: see Bayer CropScience Pty Ltd, n 29, p 95.
220. Bayer CropScience Pty Ltd, n 29, p 95.
221. See Bayer CropScience Pty Ltd, n 29, p 95.
222. Bayer CropScience Pty Ltd, n 29, p 95.
223. Bayer CropScience Pty Ltd, n 29, p 107.
224. Bayer CropScience Pty Ltd, n 29, p 107.
225. See Bayer CropScience Pty Ltd, n 29, pp 122 and 123.
226. See Bayer CropScience Pty Ltd, n 29, pp 122-123.
227. See Bayer CropScience Pty Ltd, n 29, pp 123-124.
228. Bayer CropScience Pty Ltd, n 29, pp 122, 123 and 124.
229. Bayer CropScience Pty Ltd, n 29, pp 126-133.
230. See Bayer CropScience Pty Ltd, n 29, pp 127-128.
231. See Bayer CropScience Pty Ltd, n 29, pp 132-133.
232. Bayer CropScience Pty Ltd, n 29, p 134.
233. Bayer CropScience Pty Ltd, n 29, p 134.
234. Bayer CropScience Pty Ltd, n 29, p 10.
235. The promises of GMO literature is considerable: see, for summary examples, Hindmarsh R and Lawrence G, "Bio-utopia: FutureNatural?" in Hindmarsh R and Lawrence G (eds), Altered Genes II: The Future? (Scribe Publications, 2001) pp 11-23.
236. Report of the Subcommittee on Basic Research, "Seeds of Opportunity: An Assessment of the Benefits, Safety, and Oversight of Plant Genomics and Agricultural Biotechnology" (2000) 19 Biotechnology Law Report 449.
237. For recent overviews see Hoffmann D and Sung L, "Future Public Policy and Ethical Issues Facing the Agricultural and Microbial Genomics Sectors of the Biotechnology Industry" (2005) 24 Biotechnology Law Report 10.
238. Stewart P and McLean W, "Fear and Hope over the Third Generation of Agricultural Biotechnology: Analysis of Public Response in the Federal Register" (2004) 7 AgBioForum 133.
239. Hindmarsh R and Lawrence G (eds), Recoding Nature: Critical Perspectives on Genetic Engineering (UNSW Press, 2004).
240. For an overview of the international regulatory risk assessment schemes See for example, Hayes, n 17.
241. Nap J-P, Metz P, Escaler M, Conner A, "The Release of Genetically Modified Crops into the Environment" (2003) 33 The Plant Journal 1 at 8-13.
242. Office of the Gene Technology Regulator, Risk Analysis Framework, n 15, p 12; noting also that the risk assessment is to be founded on a "science-based approach" and "objective information"; Gene Technology Bill 2000 (Cth), Explanatory Memorandum, n 5, pp 14 and 63.
243. Slovic, n 26 at 690.
244. Rutherford P, "The Administration of Life: Ecological Discourse as "Intellectual Machinery of Government"" (1994) 21 Australian Journal of Communication 40 at 40.
245. Levidow L, "Whose Ethics for Agricultural Biotech?" in Moser I and Shiva V (eds), Biopolitics: A Feminist and Ecological Reader on Biotechnology (Zed Books, 1995) p 184.
246. Some authors highlight this contention by comparing and contrasting the "product" regulation and "process" regulation in the United States and Europe respectively, the former restricting uncertainties to available knowledge about the product use and its characteristics, the latter encompassing broader debates about the place of technology in society.
247. Jasanoff S, "Product, Process or Programme: Three Cultures and the Regulation of Biotechnology" in Bauer M (ed), Resistance to New Technology (Cambridge University Press, 1995) p 324.
248. See for an overview of the historical and cultural context, Worster D, Nature's Economy: A History of Ecological Ideas (Cambridge University Press, 1987)
249. Foucault M, The Will to Knowledge: The History of Sexuality (Robert Hurley trans, Vintage, 1990) Vol 1.
250. Policy articulations of this contention in Australia include Biotechnology Australia, Australian Biotechnology: A National Strategy (Commonwealth of Australia, 2000) that provides: "[b]iotechnology holds the promise of improved health and welfare for all Australians through better understanding of disease, improved diagnosis, and treatment with more specific biopharmaceutical products. Biotechnology, including the genetic modification of agricultural and food products, also has the potential to deliver productivity, competitiveness and sustainability benefits to Australia" (p 4).
251. Knorr-Cetina K, Epistemic Cultures: How the Sciences Make Knowledge (Harvard University Press, 1999) examining the differences in knowledge as a result of difference epistemic cultures of high energy physics and molecular biology.
252. Feyerabend P, "Democracy, Elitism, and Scientific Method" (1980) 23 Inquiry 3 suggesting that scientific standards cannot be separated from their practice and use of these standards presupposes immersion in the practice.
253. Jasanoff, n 28 at 240-241.
254. Black, n 13 at 625 and 626.
255. Lee M and Burrell R, "Liability for the Escape of GM Seeds: Pursuing the 'Victim'?" (2002) 65 MLR 517 at 518-520.
256. Jasanoff S, "The Songlines of Risk" (1999) 8 Environmental Values 135
257. Noting that cognitive frameworks will also inform the uncertainties considered relevant (see Levidow, n 188, p 181) and the cultures of science developed in genetics and molecular biology capture the metaphor of building using innovative laboratory based methods rather than manipulating a complex genomic system in the broader environment (see Scoones, n 11, pp 4-5).
258. Jasanoff S, The Fifth Branch: Science Advisers as Policy Makers (Harvard University Press, 1990).
259. Latour B, Science in Action (Harvard University Press, 1987).
260. For example, the harm from a GMO might be constructed as a direct risk from the GMO or an indirect risk from the agricultural uses of the GMO, the choice is a an assumption about risk: see Levidow, n 188, p 181.
261. Black, n 13 at 625
262. Importantly, but not addressed in this article, the scientific knowledge derived from this "science" only provides a relative "truth about nature" governed by a particular scientific paradigm (see Kuhn T, The Structure of Scientific Revolutions (2nd ed, University of Chicago Press, 1970) pp 23-34
263. for example molecular biologists and biochemists might be expected to emphasis different risks reflecting their different values and assumptions about their disciplines: See for example, Newell, n 11, pp 15-16), that is "a socially constructed interpretation with an already socially constructed natural-technical object of inquiry.
264. Bird E, "The Social Construction of Nature: Theoretical Approaches to the History of Environmental Problems" (1987) 11 Environmental Review 255 at 255 and the references therein.
265. Slovic, n 26 at 690.
266. Black, n 13 at 622.
267. Hindmarsh R, "Constructing Bio-utopia: Laying Foundations Amidst Dissent" in Hindmarsh and Lawrence, n 183.
268. Fischer F, Technology and the Politics of Expertise (Sage Publications, 1990).
269. Black, n 13 at 625.
270. Often forming "epistemic communities" with a common view about the risks and the most appropriate form of regulation: see Haas P, "Obtaining International Environmental Protection through Epistemic Consensus" (1990) 19 Millennium 347.
271. Black, n 13 at 625 and 628.
272. Thus, the broader community are left "incompetent in matters of their own affliction": Beck U, Risk Society: Towards a New Modernity (Sage Publications, 1992) pp 53-55.
273. Noting further that "probability" itself is a "mental and social creation" subject to contentious debate: see, for example, Smithson M, Ignorance and Uncertainty: Emerging Paradigms (Springer Verlag, 1989) p 41.
274. Gigerenzer G, Calculated Risks: How to Know When Numbers Deceive You (Simon & Schuster, 2002).
275. Lawson, n 23 at 201-202.
276. Carman J, "Is GM Food Safe to Eat" in Hindmarsh and Lawrence, n 184, pp 82-93.
277. The results are presented in six articles in (2003) 358 Philosophical Transactions of the Royal Society B at 1779-1913.
278. Giles J, "Biosafety Trials Darken Outlook for Transgenic Crops in Europe" (2003) 425 Nature 751.
279. Gura T, "The Battlefields of Britain" (2001) 412 Nature 760.
280. Notably the CSIRO has concluded that "while the UK experiment can inform our future research in this area, its findings cannot be extrapolated directly to Australia and are therefore of quite limited relevance to Australian farming systems. The results cannot be applied to Australian GM crops in general": Lonsdale M, Baker G, Godfree B, Hirsch M, Williams K and Yeates D, Findings from the UK Farm Scale Evaluation of Genetically Modified Herbicide Tolerant crops - An Appraisal of their Implications for Australia (CSIRO Entomology, 2003) p 3.
281. Wilkinson M, "Abandoning "Responsive" GM Risk Assessment" (2004) 22 Trends in Biotechnology 438 at 439.
282. The author suggests such intensive and expensive studies might become impractical as the diversity and complexity of constructs introduced into GM crops expands (at 439)
283. see also Davies P, "Gene Flow and Genetically Engineered Crops" in Hindmarsh and Lawrence, n 184.
284. For example, the Regulator considers risks categorised as "very low" and "negligible" as acceptable and requiring limite management: see Bayer CropScience Pty Ltd, n 29, pp 29-36.
285. Monsanto Australia Ltd, General Release of Roundup Ready canola (Brassica napus) in Australia, DIR 020/2002 (Office of the Gene Technology Regulator, 2003) pp 26-34.
286. Okrent D, "Comment on Societal Risk" (1980) 208 Science 372.
287. For example, a 10-6 or lower probability of a human fatality was considered negligible for commercial nuclear reactor safety in the United States: see United States Nuclear Regulatory Commission, Reactor Safety Study: An Assessment of Accident Risks in US Commercial Nuclear Power Plants (United States Nuclear Regulatory Commission, 1975) p 38.
288. Shrader-Frechette K, Risk Analysis and Scientific Method: Methodological and Ethical Problems with Evaluating Societal Risks (Kluwer, 1985) pp 134-140 for an analysis of the problems of this "decision theory.
289. Shrader-Frechette, n 204, p 142.
290. Levidow, n 188, p 181.
291. York G, "Global Foods, Local Tastes and Biotechnology: The New Legal Architecture of International Agricultural Trade" (2001) 7 Colum J Eur L 423 at 433.
292. O'Brian M, Making Better Environmental Decisions: An Alternative to Risk Assessment (MIT Press, 2000) p 243.
293. Kuhn, n 193
294. For example, "we must recognise how very limited in both scope and precision a paradigm can be at the time of its appearance.
295. Paradigms gain their status because they are more successful than their competitors in solving a few problems that the group of practitioners has come to recognise as acute" (p 23)
296. See also Latour, n 192.
297. O'Brian, n 207, pp 59-60.
298. Wynne B and Mayer S, "How Science Fails the Environment" (1993) 138 New Scientist 33 (5 June 1993).
299. Beck, n 197, pp 22-23.
300. Levidow, n 188, p 181.
301. Preparation of the risk assessment and risk management plan - from the States, the Gene Technology Technical Advisory Committee, prescribed Commonwealth agencies, the Environment Minister and any local council the Regulator considers appropriate: Gene Technology Act 2000 (Cth), s 50(3)
302. After preparing the risk assessment and risk management plan - to seek written submissions from the public, and again seek the advice of the States, the Gene Technology Technical Advisory Committee, prescribed Commonwealth agencies, the Environment Minister and any local council the Regulator considers appropriate (s 52).
303. The Regulator is also required to "have regard to" any policy guidelines issued by the Ministerial Council relating to risks and ways to manage risks (Gene Technology Act 2000 (Cth), ss 23 and 56(2)(d)) and be consistent with any policy principles issued by the Ministerial Council (ss 21 and 57(1))
304. See the only policy principle in force is the Gene Technology (Recognition of Designated Areas) Principle 2003, Commonwealth of Australia Special Gazette No S340 (5 September 2003).
305. Bayer CropScience Pty Ltd, n 29, p 10.
306. Organisation for Economic Co-operation and Development, "Biological Resource Management in Agriculture Challenges and Risks of Genetically Engineered Organisms: Scientific Challenges for Risk Assessment" (2004) 11 SourceOECD Science & Information Technology 328.
307. Barrett K and Abergel E, "Breeding Familiarity: Environmental Risk Assessment for Genetically Engineered Crops in Canada" (2000) 27 Science and Public Policy 2.
308. Although the merits of "substantial equivalence" remain hotly contested, compare for example, Miller H, "Substantial Equivalence: Its Uses and Abuses" (1999) 17 Nature Biotechnology 1042.
309. Millstone E, Brunner E and Mayer S, "Beyond "Substantial Equivalence"" (1999) 401 Nature 525.
310. McGarity T, "Seeds of Distrust: Federal Regulation of Genetically Modified Foods" (2002) 35 U Mich J L Reform 403.
311. Conner A, Glare T and Nap J-P, "The Release of Genetically Modified Crops into the Environment" (2003) 33 The Plant Journal 19 at 25-26 and the references therein.
312. Conner et al, n 215 at 24.
313. Conner et al, n 215 at 26 and the references therein.
314. Bayer CropScience Pty Ltd, n 29, p 94.
315. Bayer CropScience Pty Ltd, n 29, p 78.
316. Millstone et al, n 214 at 525.
317. Rowland I, "Genetically Modified Foods, Science, Consumers and the Media" (2002) 61 Proceedings of the Nutrition Society 25 at 27.
318. Bayer CropScience Pty Ltd, n 29, p 66.
319. Rowland, n 220 at 27.
320. The recent difference of opinion between the United States Food and Drug Administration (FDA) and the Environment Protection Agency (EPA) over the "substantial equivalence" of the Cry9C protein illustrates the variable standards that might apply, in this example, the EPA found that the Cry9C protein was resistant to protease breakdown, remained stable at high temperatures, and remained intact following four hours in simulated mammalian gastric juices and on this basis concluded that the applicant had failed to show the GMO was "substantially equivalent in all essential respects to its unmodified parent", while the FDA had approved the application finding "substantial equivalence".
321. Bratspies R, "Myths of Voluntary Compliance: Lessons from the Starlink Corn Fiasco" (2003) 27 Wm & Mary Envtl L & Pol'y Rev 593 at 616-619.
322. Other problems arise in determining who is qualified to make this assessment and whether the standard should be applied to individuals or classes.
323. McGarity, n 214 at 428
324. Pryme I and Lembcke R, "In Vivo Studies on Possible Health Consequences of Genetically Modified Food and Feed - With Particular Regard to Ingredients Consisting of Genetically Modified Plant Materials" (2003) 17 Nutrition and Health 1.
325. Bayer CropScience Pty Ltd, n 29, p 141.
326. For further commentary see generally, Rissler J and Mellon M, The Ecological Risks of Engineered Crops (MIT Press, 1996).
327. Gene Technology Act 2000 (Cth), s 10
328. For an analysis of the term "environment" see Trantor, n 10, pp 253-254.
329. McGrath, n 64 at 35.
330. Attempts to include these sorts of measures in the Gene Technology Act 2000 (Cth) were expressly rejected (for example, an amendment "to promote ecological sustainability": Australia, Senate, Debates, (7 December 2000) pp 21181-21182 (Senator Natasha Stott Despoja)); on the basis that: "[w]e do not consider a separate definition [of ecological sustainability] is required, because ecological sustainability is not separate and distinct from the environment", see Australia, Senate, Debates (7 December 2000) p 21204 (Parliamentary Secretary to the Minister for Health and Aged Care).
331. Described as "costs" that the Gene Technology Act 2000 (Cth) was intended to address: Gene Technology Bill 2000 (Cth), Explanatory Memorandum, n 5, p 6.
332. Council of Australian Governments, National Strategy for Ecologically Sustainable Development (Commonwealth of Australia, 1992) p 6.
333. See, for example, Burgmann, n 25 at 131-132.
334. Bayer CropScience Pty Ltd, n 29, p 134.
335. Owen M and Zelaya I, "Herbicide-Resistant Crops and Weed Resistance to Herbicides" (2005) 61 Pest Management Science 301.
336. Knorr-Cetina, n 190.
337. Bayer CropScience Pty Ltd, n 29, p 56.
338. Rescher N, Risk: A Philosophical Introduction to the Theory of Risk Evaluation and Management (University Press of America, 1983) p 36.
339. Shrader-Frechette, n 204, p 142.
340. Bayer CropScience Pty Ltd, n 29, pp 11 and 94
341. Perhaps surprisingly, the line or variety of GM and conventional canola investigated and reported by the Regulator were not disclosed either by the Regulator or the cited authority (p 93).
342. Burgmann, n 25 at 131-132 showing that a 0.5% and 5% escape rate of a competitively inferior crop on wild populations will fall to 1% of their initial population size with a probability of 20% and 100% respectively (p 132).
343. Bayer CropScience Pty Ltd, n 29, p 93.
344. OGTR, n 107, p 11.
345. Metz P and Nap J-P, "A Transgene-Centred Approach to the Biosafey of Transgenic Plants: Overview of Selection and Reporter Genes" (1997) 46 Acta Botanica Neerlandica 25.
346. Hayes, n 17, p 38.
347. Harding R, Environmental Decision-making (Federation Press, 1998).
348. Murphy J, Sexton D, Barnett D, Jones G, Webb M, Collins M, Stainforth D, "Quantification of Modelling Uncertainties in a Large Ensemble of Climate Change Simulations" (2004) 430 Nature 768.
349. Carman, n 199, pp 82-93.
350. Bayer CropScience Pty Ltd, n 29, p 147.
351. By way of example, recognised experts may contest the interpretation of data where the risks are uncertain.
352. Von Krauss MK, Casman E and Small M, "Elicitation of Expert Judgements of Uncertainty in the Risk Assessment of Herbicide-Tolerant Oilseed Crops" (2004) 24 Risk Analysis 1515.
353. Walker V, "The Siren Songs of Science: Towards a Taxonomy of Scientific Uncertainty for Decision Makers" (1991) Connecticut Law Review 567.
354. Bayer CropScience Pty Ltd, n 29, p 59.
355. A recent report suggests that these effects, where they are examined, may be significant.
356. Prescott V, Campbell P, Moore A, Mattes J, Rothenberg M, Foster P, Higgins T and Hogan S, 'Transgenic Expression of Bean α-Amylase Inhibitor in Peas Results in Altered Structure and Immunogenicity' (2005) 53 Journal of Agricultural and Food Chemistry 9023.
357. Schubert D, "A different perspective on GM food" (2002) 20 Nature Biotechnology 969.
358. Bayer CropScience Pty Ltd, n 29, p 59.
359. The cited reference merely provides: "[a]n avian dietary test was performed with the seed eating canary bird (Serinus canaria domestica), and a feeding study was performed with the domesticated rabbit (Oryctolagus cuniculus); these studies showed no differences in food consumption, behaviour and body weight between birds or rabbits fed with the transgenics or counterparts": see Canadian Food Inspection Agency, Determination of Environmental Safety of Plant Genetic Systems Inc. (PGS) Novel Hybridization System for Canola (Brassica napus L.), Decision Document DD95-04 (Canadian Food Inspection Agency, 1995) para 24.
360. Bayer CropScience Pty Ltd, n 29, pp 58-59.
361. Bayer CropScience Pty Ltd, n 29, p 61.
362. Despite ongoing criticism that there is insufficient monitoring and testing to reliably assess the degree of environmental risks: See for example, Ervin D, Welsh R, Batie S and Carpentier CL, "Towards an Ecological Systems Approach in Public Research for Environmental Regulation of Transgenic Crops" (2003) 99 Agriculture, Ecosystems and Environment 1.
363. Gene Technology Regulations 2000 (Cth), Reg 10(2)
364. Notably there is some reference and consideration of a "long-term ecological study" of weed invasiveness and persistence over "a 10 year period", although this seems a relatively short period when models often consider 100 years; See for example, Burgmann, n 25 at 132.
365. Gene Technology Bill 2000 (Cth), Explanatory Memorandum, n 5, p 6
366. See also Okrent D and Pidgeon N, "Introduction: Dilemmas in Intergenerational Versus Intragenerational Equity and Risk Policy" (2000) 20 Risk Analysis 759.
367. And the other articles in that issue; notably, this was also a significant community concern in assessing the Bayer GMOs: see Bayer CropScience Pty Ltd, n 29, pp 152-156 ("General environmental concerns").
368. Bayer CropScience Pty Ltd, n 29, p 93.
369. Crawley M, Brown S, Hails R, Kohn D and Rees M, "Biotechnology: Transgenic Crops in Natural Habitats" (2001) 409 Nature 682 at 683.
370. Crawley M, Hails R, Rees M, Kohn D and Buxton J, "Ecology of Transgenic Oilseed Rape in Natural Habitats" (1993) 363 Nature 620.
371. Crawley et al, n 252 at 683 and in particular traits "such as drought tolerance or pest resistance that might be expected to enhance performance under field conditions" (at 683)
372. A similar view has been expressed about the particularities of the Australian environment: see Lonsdale et al, n 200 at 3.
373. Crawley et al, n 252 at 683
374. See also Crawley et al, n 253 at 620.
375. Crawley et al, n 252 at 683.
376. Bayer CropScience Pty Ltd, n 29, p 8.
377. Bayer CropScience Pty Ltd, n 29, pp 18-19.
378. Significantly, the previous Aventis limited or field trial release of GM canola appears to have been directed to these agronomic performance and practical issues: see Aventis CropScience Pty Ltd, n 30, p 7 providing, "[t]he purpose of this release is to conduct plant breeding (including agronomic assessments) and seed production trials for the development of canola cultivars for the Australian, North American and European cropping systems.
379. Bayer CropScience Pty Ltd, n 29, pp 62 (allergenicity of PAT protein data provided by Bayer) and 56 (toxicity of PAT protein from DeKalb Genetics Corporation (a Monsanto Company related entity)).
380. Gene Technology Bill 2000 (Cth), Explanatory Memorandum, n 5, p 10; see also the allegations of undisclosed and overlooked industry provided data often in the form of "summary data" sets: Shubert D and Freese W, "Safety Testing and Regulation of Genetically Engineered Foods" (2004) 21 Biotechnology & Genetic Engineering Reviews 299.
381. Bayer CropScience Pty Ltd, n 29, pp 29-36.
382. Bayer CropScience Pty Ltd, n 29, p 27.
383. O'Brian, n 207, pp 59-60.
384. Shrader-Frechette, n 204, p 142; although the potential for future consequences exists as a result of, for example, preserved viable seeds in soil layers transferring the risk of gene flow to the future: see Gruber S, Pekrun C and Claupein W, "Life Cycle and Potential Gene Flow of Volunteer Oilseed Rape in Different Tillage Systems (2005) 45 Weed Research 83.
385. Jorgensen R, Andersen B, Landbo L and Mikkelsen T, "Spontaneous Hybridisation Between Oilseed Rape (Brassica napus) and Weedy Relatives (1998) 407 Acta Horticulturae 193.
386. Scott S and Wilkinson M, "Transgene Risk is Low (1998) 393 Nature 320.
387. Panoff J-M and Chuiton C, "Horizontal Gene Transfer: A Universal Phenomenon (2004) 10 Human and Ecological Risk Assessment 939, which describes a failure to take such horizontal transfers into account as "a denial of scientific knowledge" (at 942).
388. Bayer CropScience Pty Ltd, n 29, pp 46-52.
389. Bayer CropScience Pty Ltd, n 29, pp 54-56 and 79-94.
390. Aventis CropScience Pty Ltd, n 30, pp 64-65.
391. Bayer CropScience Pty Ltd, n 29, pp 143-144.
392. Bayer CropScience Pty Ltd, n 29, pp 143-144.
393. Noting that Bayer has since been granted a license for a limited field trial release of other MS and RF lines: see Bayer CropScience Pty Ltd, Field Trial - Seed Increase and Field Evaluation of Herbicide Tolerant Genetically Modified Canola Incorporating a Hybrid Breeding System: Risk Assessment and Risk Management Plan, DIR 032/2002 (Office of the Gene Technology Regulator, 2004).
394. Bayer CropScience Pty Ltd, n 29, p 10.
395. Millstone et al, n 214.
396. For a discussion of this contention see Kysar D, "Preferences for Processes: The Process/Product Distinction and the Regulation of Consumer Choice (2004) 118 Harv L Rev 525 and 554-562.
397. Bayer CropScience Pty Ltd, n 29, pp 7 and 143
398. For example (1) "InVigor hybrid canola" being only canola hybrids containing the MS8 and the RF3 transformation events; (2) "InVigor hybrid canola" being hybrids containing either the MS8 transformation event or the RF3 transformation event, or both the MS8 and the RF3 transformation events; and (3) "InVigor hybrid canola" being hybrid canola some of which are the hybrids containing the MS8 and RF3 transformation events.
399. Bayer CropScience Pty Ltd, n 29, p 39.
400. Although this interpretation is likely to be limited in that Bayer has been granted a limited or field trial release license for other MS and RF lines with a different (confidential) herbicide tolerance gene: see Bayer DIR 032/2002, n 273.