Contents
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Royal Commission on Genetic Modification | Report Appendix 2
appendix 2
Outcomes of Consultation: Submissions
from Interested Persons
Contents
Introduction to Appendix 2
1
Quotations, abbreviations and macrons
1
List of Interested Persons
3
1.
Methodology of analysis, report content
and themes
13
Background
14
Purpose of the IP report
14
Organisations granted Interested Person status
14
Submission format
15
Methodology
15
Project team
15
Methodological approach
16
Registration of submissions
16
Data analysis methods
16
Format and language in the IP report
20
Outline of the IP report
20
IP report content
21
IP report themes
22
2.
Submitter profiles
24
Submitter type
25
Attitude towards genetic modification
26
Stance of Interested Persons on differing uses of genetic
modification
26
3.
Analysis of submissions from Interested
Persons
28
3.1
Strategy: an introduction
29
3.2
Strategic options
31
Introduction
31
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Continuum of attitude toward genetic modification
32
Strategic options to achieve industry goals
33
Competitiveness and innovation
33
Research and development and the knowledge-based
economy
34
"GM-free" nation
35
Strategic options to reduce risk
36
Prohibiting the use of genetic modification technology
36
Extending existing moratorium/delaying decision on use
of genetic modification
37
Undertaking formal assessment of risk
38
3.3
Strategic issues
40
Introduction
40
Key themes
40
Acceptability
42
Cultural acceptability
44
Environmental acceptability
44
Choice
45
Choice and food
45
Choice and organics
45
Choice and medical care
47
Risk management
47
Opportunities
48
3.4
Strategic outcomes
49
Introduction
49
Health
49
Health outcomes from use
49
Health outcomes from avoidance
51
Environment
52
Environmental outcomes from use
52
Environmental outcomes from avoidance
53
Production
55
Production outcomes from use
55
Production outcomes from avoidance
57
Research
60
Research outcomes from use
60
Research outcomes from avoidance
61
Culture and ethics
61
Cultural and ethical outcomes from use
61
Cultural and ethical outcomes from avoidance
63
3.5
Statutory and regulatory processes
65
Introduction
65
Context
65
How submitters responded to the Warrant items
68
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Royal Commission on Genetic Modification | Report Appendix 2
Profile of submitters
68
Key themes
69
Adequacy of statutory and regulatory processes
70
Views on the current framework
70
Profiling the views on adequacy
71
Strengths and weaknesses of the statutory and regulatory
system
72
Changes sought by submitters to the current statutory and
regulatory system
74
Nature of changes sought
74
Changes sought to HSNO legislation and regulatory
processes
75
Key issues raised by submitters in relation to statutory and
regulatory changes
77
International consistency
78
Features of a good regulatory framework
80
Interrelationship between the HSNO Act and other
legislation
81
HSNO principles, concepts and definitions
83
Other proposed changes to HSNO Act
84
Decision-making
87
Compliance and monitoring
91
Risk assessment
92
Discretionary powers
95
Regulation of low-risk, contained experiments
95
Regulation of genetically modified food
100
Maori views
102
Role of ERMA
104
Policy framework
107
New organisational or institutional mechanisms
109
3.6
Where, how, and for what purpose ...
113
Introduction
113
Types of response to `where', `how', and `for what purpose'
114
Where genetic modification is used
114
How genetic modification is used
115
Purpose of genetic modification
115
Uses of genetic modification technology in New Zealand
116
Specific examples of use of genetic modification technology
117
Government funding and approval agencies
118
Land-based production uses of genetic modification
120
Environment-focused use of genetic modification
121
Human health-related use of genetic modification
122
Food-related use of genetic modification
123
Extent of information on use of genetic modification
125
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Report Appendix 2 | Royal Commission on Genetic Modification
3.7
Evidence and uncertainty
127
Introduction
127
Submitter profile
127
Content of the submissions
128
Key themes
128
Public perception
128
Causes of public uncertainty
128
Acceptable and unacceptable uses
130
Research into public attitudes
131
Changing public perception
132
Risks and safety
132
Risk management
133
Uncertainty about impacts
139
Environmental impacts
139
Health impacts
140
Commercial and economic impacts
141
Research and education impacts
142
Social impacts
143
Concluding observations
143
3.8
Risks and benefits
146
Introduction
146
Submitter profile
146
Content of the submissions
146
Key themes
147
Risks and safety
147
Risks of the use of genetic technology
148
Safety of the technology
148
Assessing the risk
150
Benefits and costs
151
Benefits of use
151
Costs of use
153
Benefits of avoidance
155
Costs of avoidance
156
Advantaged and disadvantaged groups
157
Concluding observations
158
3.9
International obligations and implications
159
Introduction
159
Key themes
160
Applicable international obligations
161
United Nations instruments and organisations
161
World Trade Organization agreements
162
Trans-Tasman agreements
163
Other multilateral organisations and agreements
163
Sovereignty and autonomy
163
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Opportunities and benefits of international agreements and
cooperation
164
Compliance and compatibility with trading partners
165
Economic, trade and commercial considerations
166
Cultural implications
166
Maori views
166
Other views
167
Ethical considerations of international obligations
168
Environmental protection
169
New Zealand's international reputation and relations
170
3.10 Liability issues
173
Introduction
173
Establishment of liability
174
Nature of the effects of genetic modification
174
Differing approaches to liability
175
Government responsibility
175
Government liability if genetic modification is not allowed
176
"Polluter-pays" approach to liability
176
Liability of beneficiaries
177
European decision on liability
177
Types of liability
178
Sources of liability
178
Categories of liability
179
Practical examples
179
Regulatory framework for liability
181
Necessity for specific liability provisions
181
Existing regulatory framework for liability
181
Adequacy of existing regulatory framework
182
Inadequacy of existing regulatory framework
183
Recommended changes to liability regulation
184
Liability insurance
184
Availability of liability insurance
184
New Zealand's position on liability insurance
185
International approaches to liability insurance
185
3.11 Intellectual property issues
186
Introduction
186
Key themes
187
Capture of innovation and development
187
Patents have a time limit
187
Disclosure of information
187
What can be patented?
188
Issues of public interest
188
Patenting of human genetic material
188
Moral aspects of patenting
189
Ethics versus economics
190
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Indigenous issues
190
Patentability of indigenous flora and fauna
190
WAI 262 claim
191
Western views and indigenous views on property ownership
193
International approaches
194
Economic issues
194
Investment costs and returns
194
Cost to access intellectual property
195
Current trends in intellectual property
195
The `race' for intellectual property
196
The `use it or lose it' trend
196
Access to global intellectual property
197
Ownership issues
198
Future opportunities for New Zealand
198
Intellectual property opportunities in the productive sector
198
Opportunities to trade intellectual property
199
Regulation of intellectual property
200
International agreements
200
Current framework is adequate
200
Current framework is inadequate
201
Future approaches to intellectual property
203
3.12 Responsibilities under the Treaty of Waitangi
204
Introduction
204
Key themes
204
Maori terms
205
Submissions from Maori organisations
205
Role of the Treaty of Waitangi
205
The Crown's duties under the Treaty
206
Tikanga principles and genetic modification
207
Protection of traditional knowledge
209
Economic benefits
209
Submissions from other Interested Persons
210
Role of the Treaty of Waitangi
210
The Crown's duties under the Treaty
211
Tikanga principles
213
Participation in economic benefits
214
Health benefits
215
3.13 Global developments and issues
216
Introduction
216
Global environmental issues
217
Global food production solutions offered by genetic
modification
217
Negative environmental effects of genetic modification
219
Globalisation of resources
219
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Royal Commission on Genetic Modification | Report Appendix 2
Global competition
220
The "biotechnology revolution"
220
Comparative technological advantage
221
Competitive opportunities from avoiding genetic
modification
222
Consumer responses to genetic modification
222
Consumer concern about genetic modification, especially
food products
222
Consumer demand for "safe" products
223
Consumer price and quality preferences
224
Globalisation of indigenous issues
225
Global legal obligations
225
Restrictiveness of New Zealand's regulatory regime
225
High compliance costs
226
National strategies for technological development
226
National biotechnology strategies
227
National public education strategies
227
3.14 Opportunities from use or avoidance
228
Introduction
228
Issues raised by submitters: a summary
229
`Use pathway' opportunities
230
Human health benefits
230
General economic benefits
230
Increased productivity
232
Increased range of products
232
Environmental benefits
233
Increased profitability
233
Maintain or increase research capability
234
New knowledge-based enterprises
235
Increased competitiveness
235
Enhanced animal welfare
236
New global role
236
`Avoidance pathway' opportunities
236
Competitive advantage from organic production
236
New Zealand as "GM free"
237
Environmental benefits
237
Human health benefits
238
General economic benefits
238
New global role
238
`Dual pathway' possibilities
238
`Pathway' for organic production systems
239
Compatibility of genetic modification and organic
production systems
239
Incompatibility of genetic modification and "GM-free"
production
240
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Uncertainty about coexistence of genetic modification and
organic production systems
240
3.15 Areas of public interest: an introduction
241
Information, acceptability and choice
242
Need for public education on issues
242
The public's right to know
243
The public's right to choose
244
The public's exercise of choice
244
3.16 Areas of public interest: human health issues
245
Introduction
245
Biomedical research
245
Food safety
247
Consumer choice
248
Labelling of foods
249
3.17 Areas of public interest: environmental matters
251
Introduction
251
Effects on the ecosystem
252
Gene transfer
253
Management of risks
255
Environmental benefits
256
3.18 Areas of public interest: economic matters
257
Introduction
257
Economic advantage from use of genetic modification
258
Business development
258
Research and innovation
259
Economic advantage from avoidance of genetic modification
260
Negative impact on "clean green" image
260
Positive impacts of "GE-free" production, especially
organics
261
Moral constraints on pursuit of economic advantage
261
3.19 Areas of public interest: cultural and ethical concerns
262
Introduction
262
Nature of concerns
263
Key themes
263
Significance of issues
263
Cultural concerns
264
Maori cultural concerns
265
Other cultural concerns
266
Ethical concerns
266
Underlying concepts
267
Governing principles
268
Institutional frameworks for ethics
268
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Spiritual issues
270
Respect for creation
270
Beliefs of indigenous peoples
271
4.
Glossaries
272
4.1
Glossary of technical terms
273
4.2
Glossary of Maori terms
291
4.3
Abbreviations
292
Index
294