The Royal Commission on Genetic Modification was an independent body established by the Government in May 2000 to look into and report on the issues surrounding genetic modification in New Zealand.
Appendix 1: Royal Commission on Genetic Modification
The Royal Commission had two objectives:
- to identify the strategic options available to enable New Zealand to address, now and in the future, genetic modification, GMOs and products arising from them
- to identify any changes considered desirable to the current legislative, regulatory, policy, or institutional arrangements for addressing, in New Zealand, genetic modification, GMOs and products.
The Royal Commission undertook a comprehensive public consultation process over the inquiry period. It held a planning hui, public scoping meetings, hearings for interested person status, 15 public meetings, formal hearings, 28 Māori consultation workshops, 10 regional hui, one three-day national hui and a youth forum; and it conducted a public opinion telephone survey of 1153 individuals. It received more than 10,000 public submissions. 107 groups or individuals were granted interested person status – which recognised that they had an interest in the inquiry greater than the public, such as an ethical, religious, Māori, business, research or health interest – and they were heard, along with local and international witnesses, by the Commission during its 12 weeks of formal hearings.
The Royal Commission reported to the Government on 27 July 2001. Its findings and 49 recommendations were published in a 464-page report and three volumes of appendices. Copies of the report are available from Bennetts or other bookshops selling government publications. The report is also available on CD Rom or from the Royal Commission’s website at www.gmcommission.govt.nz. Submissions and other documents relating to the work of the Royal Commission are also available on the website.
The major theme of the Royal Commission’s report was that of ‘preserving opportunities’. The Commission thought it unwise for New Zealand to turn its back on the potential advantages on offer from genetic modification, but recommended that New Zealand should proceed carefully and implement genetic modification cautiously, minimising and managing risks. In drawing this conclusion it explicitly rejected the idea of a New Zealand free of all genetically modified material at one extreme and the option of unrestricted use of genetic modification at the other.
Voluntary moratorium
At the time the Royal Commission was established a voluntary moratorium was agreed between the Government and the main scientific and commercial organisations involved in GM work. This meant that until the Royal Commission reported there would be no applications for approvals for release of GMOs. The moratorium also applied to field testing, with some limited exemptions. The moratorium was extended until 31 October 2001 to enable the government to consider the Royal Commission’s report without any applications to field test or release GMOs being lodged. The Government’s response to the report of the Royal Commission is outlined in section 1.3 of this document.
Appendix 2: Relevant Recommendations of the Royal Commission
This appendix lists the recommendations of the Royal Commission addressed in this discussion paper, along with the Government’s decisions on the recommendations.
Simplifying approval processes for laboratory GM research
| Rec | Summary of the content of the recommendation | Government’s decision |
|---|---|---|
| 6.1 | Assessment of low-risk applications for research on a project basis | Agreed to accept the intent of Recommendation 6.1, which is to simplify the assessment of low-risk laboratory GM research either by using defined criteria to assess organisms, or by providing for the approval of groups of organisms of similar types and risks, rather than requiring separate approvals for each organism. |
| 6.4 | Amend the HSNO Act to allow IBSCs to approve imports of low-risk GMOs | Agreed to accept Recommendation 6.4. |
Gaps in HSNO Act coverage
| Rec | Summary of the content of the recommendation | Government’s decision |
|---|---|---|
| 6.6 | Amend the HSNO Act to cover genetic modification of human cell lines or tissue culture | Agreed to accept the intent of Recommendation 6.6, which is to ensure that the GM of human cell lines and tissue cultures is subject to appropriate regulation. |
| 6.9 | Amend the HSNO Act to cover procedures used in mammalian cloning | Agreed to accept the intent of Recommendation 6.9, to the extent that it ensures that new species of mammals (or other animals) cannot be imported as tissues and subsequently regenerated by cloning and released without an appropriate HSNO Act approval. |
Constraints on release
| Rec | Summary of the content of the recommendation | Government’s decision |
|---|---|---|
| 6.8 | HSNO be amended to provide for a new approval category called ‘conditional release’ | Directed officials, led by the Ministry for the Environment (MfE), to report to POL and Cabinet by 30 April 2002 with advice on implementation of a new category of release, including the purpose and scope of the new category, the criteria for conditions and any compliance and enforcement issues. Directed officials to explore the work involved in developing co-existence frameworks as far as is practicable in the absence of releases, and use that to complement the development of conditional release policy. Directed officials to investigate the options for imposing location controls as part of considering the Commission’s recommendation 6.8 on the establishment of a conditional release category. |
Medicines approvals
| Rec | Summary of the content of the recommendation | Government’s decision |
|---|---|---|
| 9.4 | Imported medicines and pharmaco foods that include live GMOs be approved for use only by Medsafe (and not by ERMA also) | Directed officials (Ministry for the Environment lead) to report on options to reduce duplication and to streamline the approval processes under the Medicines Act and the HSNO Act for medicines by April 2002 as part of the report to POL on a HSNO amendment bill. |
Confidential supporting information
| Rec | Summary of the content of the recommendation | Government’s decision |
|---|---|---|
| 10.7 | HSNO and ACVM be amended to give appropriate protection to all commercially sensitive or confidential supporting information provided with applications for approval | Directed officials from the Ministry of Agriculture and Forestry and Ministry for the Environment to undertake consultation with key stakeholders to determine what level of protection is appropriate for commercially sensitive or confidential supporting information provided with applications for approval, with a view to amending the Hazardous Substances and New Organisms Act 1996 and the Agricultural Compounds and Veterinary Medicines Act 1997. |
Liability
| Rec | Summary of the content of the recommendation | Government’s decision |
|---|---|---|
| 12.2 | For the time being there be no change in the liability system (but that the matter could be referred to Law Commission for further analysis) | Agreed that further work should be undertaken on the liability system during the constraint period. Agreed that, for the time being, there be no change in the liability system for GM. Invited the Minister Responsible for the Law Commission to report to POL and Cabinet by 30 November 2001 on whether this work should be included in the Law Commission’s work programme. |
Ministerial call-in
| Rec | Summary of the content of the recommendation | Government’s decision |
|---|---|---|
| 14.1 | Extend call-in powers under section 68 of HSNO to include cultural, ethical and spiritual issues as grounds for Ministerial call-in | Agreed to amend section 68 of the HSNO Act 1996 to include significant cultural, ethical and spiritual effects as grounds for Ministerial call-in of an application. |
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Appendices
September 2002
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