Annotated Bibliography Entry

Reference: New Zealand Royal Commission 2001
Title: Report of the Royal Commission on Genetic Modification
Authors: The Royal Commission on Genetic Modification, The Royal Society of New Zealand
Publisher: The Royal Commission on Genetic Modification, 8^th Floor, Dalmuir House, 134 The Terrace, P.O. Box 3554, Wellington
Publication details: July 2001. 441p.

Summary
Recommendations
Table of Contents

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Summary

Genetic modification has been used freely in New Zealand for more than a decade as a research tool, for medical purposes, and in food ingredients. It holds exciting promise, not only for conquering diseases, eliminating pests and contributing to the knowledge economy, but also for enhancing the international competitiveness of the primary industries so important to the country’s economic well being.

Consultations with the people of New Zealand showed that, while most were comfortable with genetic modification for medical purposes, many strongly opposed other uses. Many of the submissions to the Commission focused substantially on food and crops. They stressed that the safety and certainty of the science have yet to be proved, reflecting the fact that, at least for the moment, world consumer preferences are against use of genetic modification in food. First generation genetically modified crops have shown few obvious benefits for consumers.

The major conclusion is that New Zealand should keep its options open. It would be unwise to turn our back on the potential advantages on offer, but we should proceed carefully, minimising and managing risks. At the same time, continuation of the development of conventional farming, organics and integrated pest management should be facilitated. The major theme of the Report is Preserving Opportunities. The  recommendations aim to encourage the coexistence of all forms of agriculture. The different production systems should not be seen as being in opposition to each other, but rather as contributing in their own ways to the overall benefit of New Zealand.

The inquiry has looked closely into the existing institutional structures dealing with the technological issues that arise. Although some suggestions for enhancement are included the Commission is satisfied that the basic regulatory framework is appropriate and that the key institutions, the Environmental Risk Management Authority (ERMA) and the Australia New Zealand Food Authority (ANZFA), carry out their functions conscientiously and soundly.

Debate on genetic modification issues in New Zealand is made unique by the partnership between tangata whenua and tangata tiriti created by the Treaty of Waitangi. The values held by Maori add special emphasis to the ethical and cultural objections many people have to the new technology. In our extensive consultation with Maori, and throughout the Commission’s deliberations, we have given much thought to the values New Zealanders hold, to find a sound base for the findings we are now required to make. It became clear that the existing regulatory bodies were not best equipped to address issues of this kind. One of our recommendations is to set up a separate specialist body, Toi te Taiao,  the Bioethics Council, so that these matters can be debated.

New Zealand needs a strong overall biotechnology strategy, to guide us in the use of all new technologies in this field. As an allied consideration it will be important that a single, independent institution undertakes the general auditing of biotechnological applications, and promotes public education about the new technologies. To this end we have recommended the establishment of a Parliamentary Commissioner on Biotechnology, modelled on the successful precedent of the Parliamentary Commissioner for the Environment.

We envisage that future uses of genetic modification will continue to require rigorous assessment by ERMA before approval. One detail whereby the Commission considers the existing processes could be improved is an addition to the approval types now available. We are recommending a new category, conditional release, where the use of a genetically modified organism can be made subject to terms and reporting back, as a further assurance of safety and to enhance the management of risk.

Technology is integral to the advancement of the world. Fire, the wheel, steam power, electricity, radio transmission, air and space travel, nuclear power, the microchip, DNA: the human race has ever been on the cusp of innovation. Currently, biotechnology is the new frontier. Continuation of research is critical to New Zealand’s future. As in the past we should go forward but with care.

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Recommendations

A consolidated list of recommendations is given below, noting the chapters in which they appear in the full report. 

Chapter 6: Research

Recommendation 6.1: that applications to develop genetically modified organisms in PC1 and PC2 containment be assessed by the Institutional Biological Safety Committees (IBSCs) on a project rather than organism basis.

Recommendation 6.2: that all approval forms, standards and regulations relating to the development of genetically modified organisms in containment be reviewed and updated.

Recommendation 6.3: that a separate, simplified form be developed for low-risk (Categories A and B) applications to IBSCs.

Recommendation 6.4: that the Hazardous Substances and New Organisms Act 1996 (HSNO) be amended to allow for the efficient importation of low-risk genetically modified organisms, through delegation of the approval process to the IBSCs.

Recommendation 6.5: that approvals to develop or import genetically modified organisms be deemed to cover their holding and breeding.

Recommendation 6.6: that HSNO be amended to clarify that research involving genetic modification of human cell lines or tissue cultures is covered by the Act.

Recommendation 6.7: that approval for development of genetically modified animal cell lines be delegated to the IBSCs.

Recommendation 6.8: that HSNO be amended to provide for a further level of approval called conditional release. 

Recommendation 6.9: that HSNO be amended to cover procedures used in mammalian cloning, such as nuclear transfer or cell fusion.

Recommendation 6.10: that IBSCs include at least one Maori member, appointed on the nomination of the hapu or iwi with manawhenua in the locality affected by an application.

Recommendation 6.11: that the funders of research portfolios be resourced to include the costs of compliance with HSNO.

Recommendation 6.12: that the Environmental Risk Management Authority (ERMA) require research on environmental impacts on soil and ecosystems before release of genetically modified crops is approved.

Recommendation 6.13: that public research funding be allocated to ensure organic and other sustainable agricultural systems are adequately supported.

Recommendation 6.14: that public research funding portfolios be resourced to include research on the socio-economic and ethical impacts of the release of genetically modified organisms.

 

Chapter 7: Crops and other field uses

Recommendation 7.1: that, prior to the release of any Bt-modified crops, the appropriate agencies develop a strategy for the use of the Bt toxin in sprays and genetically modified plants, taking into account:  

• the concept of refugia

• limitations on total planted area

• home gardener use.

Recommendation 7.2: that the appropriate agencies develop a labelling regime to identify genetically modified seed, nursery stock and propagative material at point of sale.

Recommendation 7.3: that the Ministry of Agriculture and Forestry (MAF) develop a strategy to allow continued production of genetic modification-free honey and other bee products, and to avoid cross-pollination by bees between genetically modified and modification-free crops, that takes into account both geographical factors (in terms of crop separation strategies) and differences in crop flowering times.

Recommendation 7.4: that, in connection with any proposal to develop genetically modified forest trees, an ecological assessment be required to determine the effects of the modification on the soil and environmental ecology, including effects on soil microorganisms, weediness, insect and animal life, and biodiversity.

Recommendation 7.5: that, wherever possible, non-food animals, or animals less likely to find their way into the food chain, be used as bioreactors rather than animals that are a common source of food.

Recommendation 7.6: that, wherever possible, synthetic genes or mammalian homologues of human genes be used in transgenic animals to avoid the use of genes derived directly from humans.

Recommendation 7.7: that MAF develop an industry code of practice to ensure effective separation distances between genetically modified and unmodified crops (including those grown for seed production), such a code:

• to be established on a crop-by-crop basis

• to take into account:

– existing separation distances for seed certification in New Zealand

– developments in international certification standards for organic farming

– emerging strategies for coexistence between genetically modified and  unmodified crops in other countries

• to identify how the costs of establishment and maintenance of buffer zones are to be borne.

 

Chapter 8: Food

Recommendation 8.1: that the Food Administration Authority monitor research studies on stock feed and act on any that indicate a need for stock feed to be assessed in relation to human health.

Recommendation 8.2: that Government facilitate the development of a voluntary label indicating a food has not been genetically modified, contains no genetically modified ingredients and has not been manufactured using a process involving genetic modification.

Recommendation 8.3: that, as a matter of priority, the Food Administration Authority disseminate information on the labelling regime for genetically modified foods and consumer rights in relation to foods made available for consumption at restaurants and takeaway bars.

Recommendation 8.4: that the Food Administration Authority produce and distribute consumer information on the use of gene technology in the production of food.

 

Chapter 9: Medicine

Recommendation 9.1: that all gene therapy, whether in the public or the private sectors, require formal medical ethical oversight.

Recommendation 9.2: that Toi te Taiao : the Bioethics Council develop ethical guidelines for xenotransplantation involving genetic modification technology.

Recommendation 9.3: that products be clearly defined in legislation as medicines, pharmaco foods, functional foods or dietary supplements.

Recommendation 9.4: that imported medicines and pharmaco foods that include live genetically modified organisms be approved for use by Medsafe without a requirement for additional approval from ERMA.

Recommendation 9.5: that, in respect of applications for approval as Animal Remedies of genetically modified organisms or products manufactured by processes using genetic modification techniques, the specified information which the Director-General of Agriculture and Forestry requires to be contained in applications under the Agricultural Compounds and Veterinary Medicines Act 1997 (ACVM) include full information on the efficacy and the form of the genetic modification used in manufacture; and that such information be included as one of the categories of relevant risks and benefits under section 19 of the Act.

Recommendation 9.6: that, as protocols identify useful therapeutics for serious disease control, approvals through ERMA and Medsafe be sought in advance for the importation of live genetically modified organisms in the form of vaccines.

 

Chapter 10: Intellectual property

Recommendation 10.1: that the New Zealand Plant Variety Rights Act 1987 be amended to introduce the concept of essential derivation.

Recommendation 10.2: that the Patents Act 1953 be amended by adding a specific exclusion of the patentability of human beings and the biological processes for their generation, in line with section 18 of the Patents Act 1990 (Commonwealth).

Recommendation 10.3: that a Maori Consultative Committee be established by the Intellectual Property Office of New Zealand to develop procedures for assessing applications, and to facilitate consultation with the Maori community where appropriate.

Recommendation 10.4: that New Zealand be proactive in pursuing cultural and intellectual property rights for indigenous peoples internationally.

Recommendation 10.5: that New Zealand pursue the amendment of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights and associated conventions to include a reference to the avoidance of cultural offence as a specific ground for exclusion or reservation.

Recommendation 10.6: that all parties concerned work to resolve the WAI 262 and WAI 740 claims currently before the Waitangi Tribunal as soon as possible.

Recommendation 10.7: that HSNO and ACVM be amended to give appropriate protection to all commercially sensitive or confidential supporting information provided with applications for approval.

 

Chapter 11: Te Tiriti o Waitangi

Recommendation 11.1: that section 8 of HSNO be amended to provide that effect is to be given to the principles of the Treaty of Waitangi.

 

Chapter 12: Liability issues

Recommendation 12.1: that Toi te Taiao : the Bioethics Council, in association with the Human Rights Commission, address the issue of genetic discrimination.

Recommendation 12.2: that for the time being there be no change in the liability system.

 

Chapter 13: Major conclusion

Recommendation 13.1: that the methodology for implementing HSNO section 6(e) be made more specific to:

• include an assessment of the economic impact the release of any genetically modified crop or organism would have on the proposed national strategy of preserving opportunities in genetically modified and unmodified agricultural systems

• allow for specified categories of genetically modified crops to be excluded from districts where their presence would be a significant threat to an established non-genetically modified crop use.

Recommendation 13.2: that before the controlled or open release of the first genetically modified crop, the Minister exercise the call-in powers available under HSNO section 68 in order to assess the likely overall economic and environmental impact on the preserving opportunities strategy.

Recommendation 13.3: that MAF develop formalised local networks to encourage constructive dialogue and communication between farmers using different production methods, and to provide for mediation where necessary.

Recommendation 13.4: that sterility technologies be one tool in the strategy to preserve opportunities, especially in the case of those genetically modified crops most likely to cross-pollinate with non-genetically modified crops in the New Zealand context (eg, brassicas, ryegrass, ornamentals).

 

Chapter 14: The biotechnology century

Recommendation 14.1: that HSNO section 68 be extended to include significant cultural, ethical and spiritual issues as grounds for the Minister’s call-in powers.

Recommendation 14.2: that Government establish Toi te Taiao: the Bioethics Council to:

• act as an advisory body on ethical, social and cultural matters in the use of biotechnology in New Zealand

• assess and provide guidelines on biotechnological issues involving significant social, ethical and cultural dimensions

• provide an open and transparent consultation process to enable public participation in the Council’s activities.

Recommendation 14.3: that Government establish the office of Parliamentary Commissioner on Biotechnology to undertake futurewatch, audit and educational functions with regard to the development and use of biotechnology in New Zealand.

Recommendation 14.4: that the Ministry of Research, Science and Technology develop on a consultative basis a medium- and long-term biotechnology strategy for New Zealand.

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Table of Contents 

Executive summary 1

1. Introduction 4

2. A shared framework of values 10

3. Cultural, ethical and spiritual issues 14
Introduction 15
Where do values come from? 16
Te ao Maori: the traditional Maori world view 18
The ecological world view 20
Religious world views from the Judaeo-Christian tradition 22
Other cultures and beliefs 24
Is there a common core of values? 24
Ethical decision-making processes 26
Pakeha approaches 26
A Maori approach 28
A shared way ahead 31
A case study: transgenic animals 33
Institutional responses to cultural, ethical and spiritual issues 39

4. Environmental and health issues 41
Concern about the risks 42
Scientific risks 44
Risks associated with the gene construct 45
Horizontal gene transfer 49
Cross-pollination and outcrossing 51
Randomness of gene placement and lack of gene stability 54
Environmental impacts 55
Invasiveness of genetically modified organisms 56
Targeting the wrong species 58
Reduction in biodiversity 58
Human health impacts 60
Questioning the need 62
The corporate context 63
Concern about scientists 64
Precautionary principle 65
Risk analysis 68
Risk assessment 68
Risk communication 71

5. Economic and strategic issues 76
Purpose of this chapter 76
Will genetic modification technology enhance or damage
New Zealand’s economic and strategic prospects? 78
International competitiveness 78
Consumer preferences 91
The knowledge economy 93
New Zealand’s “clean green” image 94
Branding 95
Organic economy in New Zealand and overseas 97
Social equity 100

6. Research 102
Introduction 103
Asilomar to the present; the New Zealand context 103
Technologies in use in New Zealand 105
The contribution of research to New Zealand’s future 108
Economic benefits 108
Educational benefits 109
Environmental benefits 109
Health benefits 110
Concerns about research 111
The regulation of research in New Zealand 112
The current regulatory environment 112
Regulatory and ethics bodies 114
Anomalies in the regulatory system for contained research 117
Importation versus development of genetically modified organisms in containment 120
HSNO coverage of cell cultures 121
High-risk contained research and field tests 122
Conditional release 123
The rapidly evolving research environment 125
Ethical and cultural issues 126
Research funding 129
Compliance costs 131
Priorities for funding 132

7. Crops and other field uses 137
Introduction 137
Crops, fruit and vegetables 137
Applications and benefits 137
Managing risks 142
Biosecurity and seed certification 148
Ornamental and nursery plants 149
Environmental impacts 150
Labelling 150
Bees 151
Forestry 152
Potential benefits 153
Environmental impacts and concerns in forestry 154
Bioremediation 156
Environmental impacts of bioremediation 157
Bioreactors 158
Plant bioreactors 158
Cell bioreactors 159
Animal bioreactors 160
Pest control 162
Biofuels 165
Bioprospecting 166
Biodiversity issues 166
Development of monocultures 169
Compatibility with other production systems 170
Effects on organic certification 172
First release issues 172
Future systems of production 173
Managing the risks and preserving the opportunities 174
Choosing which plants to modify 175
Risk management for high-risk plants 175
Physical barriers 175
Buffer zones and separation distances 176
Sterilising technology 178

8. Food 180
The current status of genetic modification in food and food processing in New Zealand 183
Processed food 183
Microorganisms 186
Grains and cereals 186
Fresh produce 186
Meat 187
Dairy products 187
Animal feed 187
Future developments 188
Public perceptions 188
Current New Zealand regulatory responsibilities for food 194
Food standards 194
Regulatory responsibilities in New Zealand 203
International obligations 205
Significant issues 207
Is genetically modified food safe? 207
Are the current food safety standards satisfactory? 217
Commission’s conclusions on the ANZFA process 229
Labelling 230
Proposed labelling regime 231
Consumer information 235
Recommended roles and responsibilities for the Food
Administration Authority 236
Enforcement of food standards 236
Monitoring health effects of genetically modified food 236
Management of ANZFA/FSANZ relationship 237
Public information 237

9. Medicine 238
Introduction 239
Human treatments and issues 240
Current uses in health 240
Existing and potential benefits 241
Actual and perceived risks 245
Current and future specific uses 246
The convergence of food and medicine 257
Regulatory regimes 261
Animal remedies 264
Veterinarian medicines and nutritional supplements 264
Vaccines for animals 264
Emergency use of genetically modified organisms 267

10. Intellectual property 269
Introduction 270
Nature of intellectual property rights 271
What are intellectual property rights? 271
What IPRs are not 274
International obligations applicable to intellectual property rights 275
Community and individual rights 276
Objectives of IP systems 277
The demerits of IP systems 277
Moral and ethical issues 281
Patenting living organisms 282
Ethical, social and cultural objections to patenting genetic material 283
“Patenting of humans” 284
Protection of traditional knowledge 285
Intellectual property rights and traditional knowledge 285
Te Ao Maori and IPRs 286
International obligations 288
Sovereignty over genetic resources: flora and fauna 290
Ownership and the Treaty of Waitangi 291
Mataatua declaration 292
Bioprospecting 293
Changes to current system 293
Confidentiality of data provided in applications to ERMA 293
Application of Official Information Act 295
Conclusion 295

11. Te Tiriti o Waitangi 297
Introduction 298
The Treaty and the Commission 299
Crown responsibilities under the Treaty 300
Consultation 302
Consultation requirements 302
Giving statutory effect to the principles of the Treaty 305

12. Liability issues 310
Introduction 311
Choice of approach 312
Types of liability 312
Regulatory framework for liability 312
Liability 313
Statutory liability 313
Civil or common law liability 315
Insurance 321
Bond system 322
Liability fund 323
Environmental user charge 323
Overseas approaches 324
United States “Superfund” 324
European Union position on liability 325
Genetic discrimination in relation to insurance and employment 326
Conclusions 327

13. Major conclusion: preserving opportunities 330
Introduction 331
Our conclusion 331
Positions we did not choose 332
A New Zealand free of all genetically modified material 332
Unrestricted use of genetic modification 333
Preserving opportunities in research, food and medicine 333
Research 333
Food 333
Medicine 334
Preserving opportunities in crops and other field uses 334
Is compatibility possible? 336
Recommendations 338

14. The biotechnology century: three major proposals 341
Toi te Taiao : the Bioethics Council 342
Referring matters to the Bioethics Council 344
Would the Council’s guidelines be binding? 345
Membership of Toi te Taiao : the Bioethics Council 346
Parliamentary Commissioner on Biotechnology 347
Biotechnology strategy for New Zealand 349
Independent Biotechnology Advisory Council 350

15. Recommendations 351

Reference 361
Genetic modification: an overview for non-scientists 362
What is genetic modification? 362
History 362
How genetic modification works 363
The future 363
Terms of reference (the Warrant) 364
The Warrant in Maori 369
Treaty of Waitangi 375
Summary of the Treaty’s history and images at the National
Archives 375
The Treaty of Waitangi 1840 375
Tiriti o Waitangi 1840 377
Treaty of Waitangi 1840 (translation of Maori text) 378
Notes for readers 380
Reference notes 382
Chapter 1: Introduction 382
Chapter 3: Cultural, ethical and spiritual issues 382
Chapter 4: Environment and health issues 384
Chapter 5: Economic and strategic issues 387
Chapter 6: Research 389
Chapter 7: Crops and other field uses 391
Chapter 8: Food 395
Chapter 9: Medicine 399
Chapter 10: Intellectual property 401
Chapter 11: Te Tiriti o Waitangi 403
Chapter 12: Liability issues 404
Chapter 14: The biotechnology century 406
Glossary of Maori terms 407
Glossary of abbreviations 410
Glossary of technical terms 415
Index 442

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