Report Back of the Royal Commission On Genetic Modification

Hon Marian Hobbs
Minister for the Environment

30 July 2001

Royal Commission praised for comprehensive GM report

The Minister for the Environment, Marian Hobbs, has welcomed the release of the report of the Royal Commission of Inquiry on Genetic Modification.

"The way the commissioners went about their task and the style of their
report is exactly what I hoped the commission would do," she said.

The commission presented its report to the Governor General last Friday and
the report was released publicly by the Prime Minister, Helen Clark, today.

"When I announced the establishment of the Royal Commission in April last
year, honouring a pledge in our election manifesto, I said the government wanted
the inquiry to stimulate a broad-ranging discussion on genetic modification,"
Marian Hobbs said. "I wanted the commission to inquire into and report on the
strategic options available to enable New Zealand to address genetic
modification now and in the future.

"I also wanted the concerns of New Zealanders to be heard and evaluated. And
I wanted advice as a result of hearings and research as to how we should act in
this new environment.

"I am delighted that the commission has done exactly that.

"The commission has given us a comprehensive overview of genetic modification
and the issues surrounding it. The process used by the commission to gather the
views of New Zealanders, including public meetings, hui, a youth forum and a
public opinion survey, has been extensive and thorough.

"The report is easy to read and I would encourage people to examine the
issues canvassed. It will be a valuable tool in the continuing public debate on
genetic modification.

"I must thank the four commissioners wholeheartedly for their tremendous
effort."

Marian Hobbs said the government will respond to the report within three
months and a work programme will be developed for Cabinet consideration before
the voluntary moratorium ends in five weeks. She stressed that with such a
complex issue, time would be needed before decisions on the individual
recommendations could be made.

Copies of the report - as a four volume print set or CD Rom - will be
available in public libraries and for purchase from book stores in six regional
centres: Auckland, Hamilton, Palmerston North, Wellington, Christchurch and
Dunedin.

Hard copies of the report cost $45.00 and CD-Roms $5.00.

Hon Marian Hobbs
Minister for the Environment

30 July 2001

minister for the environment
Minister of research, science
and technology

Chairperson
Cabinet

Initial Brief on Report of the Royal Commission on Genetic Modification
Summary

This paper describes the report of the Royal Commission on Genetic
Modification (the Report) and makes brief preliminary comments on the
recommendations. The report contains 49 recommendations of varying levels of
complexity that are interdependent. The paper recommends that the Government's
response is; to thank the Commissioners for their work, to characterise the
report as measured, balanced, and inclusive of the many values that New
Zealanders hold, and to acknowledge the report's major theme. The Government's
response today should be to address the report as a whole, and not comment on
the individual recommendations until the whole report has been considered.
The major theme of the report is Preserving Opportunities. The Royal
Commission explicitly rejects 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. No recommendations seriously conflict with current
government policy or strategic direction. There is strong endorsement of
existing structures and frameworks, though changes in a number of areas are
recommended.

Background

Cabinet has directed officials (Ministry for the Environment lead) to
provide an initial brief for Cabinet on Monday 30 July, following the release of
the Commission's report [CAB Min (01 15/7]. Cabinet has agreed that the initial
briefing be drafted for the Minister for the Environment to take to Cabinet,
that the paper describe the key findings of the Royal Commission's report and
recommend a general, high level Government statement that can be considered for
immediate public release [CAB Min (01) 22/6, FIN Min (01) 14/9].

Structure of the report

The report is in four volumes. The first volume is the main report and
recommendations. There are three volumes of appendices: context and process,
outcomes of consultation & submissions from interested persons, and outcomes
of consultation & submissions from the public (including results of a public
opinion survey). There are 49 recommendations, which range from those setting a
strategic direction for New Zealand to the detailed and specific. Attached to
this briefing is the executive summary, the full list of recommendations, and
some key extracts from the report.

The general direction of the report

The Royal Commission has explicitly rejected the idea of a New Zealand free
of all genetically modified (GM) material at one extreme, or the option of
unrestricted use of genetic modification at the other.
The Royal Commission has explored the views of all New Zealanders, not just
through submissions and hearings but also through public opinion survey work
(volume 3 p179).
An important part of the report was to identify seven shared values as a
framework for reaching conclusions about genetic modification: the uniqueness of
Aotearoa/New Zealand, the uniqueness of our cultural heritage, sustainability,
being part of a global family, the well-being of all, freedom of choice, and
participation.
Although the Commission was satisfied that the existing basic regulatory
framework is appropriate, it suggested a number of enhancements.

The report's recommendations

The 49 recommendations are listed in Annex 1 with
some preliminary comments from officials on the scale of work involved in
developing a government response.
The Commission presents a suite of recommendations that address its major
conclusion of preserving opportunities. These recommendations include:
- Mechanisms to manage the coexistence of different kinds of agriculture (i.e.
  organic, GM, conventional and integrated pest management).
- A new category of 'conditional release' of GM organisms (currently the only
  option is to release without controls).
- If an application for release of a genetically modified crop is received,
  the first such application should be called in and decided by the Minister for
  the Environment.

The Commission also presents three major proposals that relate to its vision
for the biotechnology century, while making provision for ongoing oversight of
biotechnological developments: These are:
- that the 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
- that the Government establish the office of Parliamentary Commissioner on
  Biotechnology to undertake futurewatch, audit and educational functions with
  regard to the development and use
- that the Ministry of Research, Science and Technology develop on a
  consultative basis a medium- and long-term biotechnology strategy for New
  Zealand.
There are a number of other significant points:
- The commission also recognised the importance of sustainable development and
  the knowledge economy. This is consistent with the Government's strategic
  direction.
- The Commission recognised the value to New Zealand of inclusion in the
  international community and the importance of international obligations to the
  country's economic well-being.
- Increased information is an important theme and many of the recommendations
  aim to improve communication, transparency and accountability for the public,
  especially on cultural and ethical issues.
- The commission recommends strengthening the Treaty of Waitangi section in
  the Hazardous Substances and New Organisms (HSNO) Act.
- The commission did not suggest changes to the regulations for mandatory of
  labelling GM food, but suggested the Government facilitate voluntary labelling
  of non-GM foods and provide consumer information
- There are no recommendations to prohibit field tests or releases. In
  general the Commission seeks to lower compliance costs for low risk research,
  but to ensure enhanced processes for higher risk activities, e.g, a new
  conditional release category and Ministerial call-in for any first crop release
  application.
- The commission concluded that for the time being, there be no change in the
  liability system.
The report also contains a number of suggestions that are not contained in
the formal recommendations of the Report. These suggestions, such as referring
the liability issues to the Law Commission for more intensive study, will need
to be considered in conjunction with the recommendations.

Treaty implications

Eight recommendations in the report address issues raised by Maori. The
majority are consistent with government policy. Two recommendations
(strengthening of the Treaty clause in the HSNO Act and the establishment of Toi
Te Taiao (Bioethics Council) will require significant further analysis and
consideration by Ministers.

Fiscal Implications

A number of the recommendations in the Royal Commission's report will have
significant fiscal implications if implemented. Officials will report back with
detailed fiscal implications, and options for managing these, once further
analysis of the report's recommendations has been undertaken.

Publicity

A draft press release has been prepared to accompany the release of the
report. It reflects the messages agreed by Cabinet on 23 July and the content
of the report, now that is known.
Cabinet has previously agreed that the Minister for the Environment will be
the lead spokesperson for the report, and that Ministers may wish to comment on
specific portfolio interests. Where possible Ministers should be aware of the
overlapping nature of many of the recommendations in the report. Where
possible, Ministers should also consult the Minister for the Environment before
commenting (FIN Min (01)14/9).
Briefings have been offered to all Parliamentary parties and will take
place during this week's caucus meetings. All MP's will receive a copy of the
full report. A briefing for all Interested Persons is being arranged for today
(Monday) at 2pm. This briefing will be a 'lockup' that will last until the end
of the post Cabinet Press Conference (approximately 3.30pm). A briefing for
Departmental Chief Executives has also been arranged for today (Monday).

Next steps

The Government has indicated that it will respond to the report within three
months (i.e. by 31 October). Officials are developing a work programme for the
next three months. This work programme will be outlined in the paper that the
Minister for the Environment will take to Cabinet before the end of August on
the voluntary moratorium and any other matters.
The report contains no comment on the voluntary moratorium, which ends on 31
August. The moratorium was designed to keep future options open while the Royal
Commission was operating and was negotiated between government and many
biotechnology industry players. Options will be canvassed in the separate
August paper.

Consultation

Recommendations

It is recommended that Cabinet:
1. note that the Report of the Royal Commission on Genetic Modification
  was presented to the Governor-General on Friday 27 July;
2. note that the report contains 49 interdependent recommendations of
  varying complexity;
3. agree that the government response be:
  - to thank the Commissioners for their work,
  - to characterise the report as measured, balanced, and inclusive of the many
    values that New Zealanders hold, and to acknowledge the report's major theme of
    preserving opportunities; and
  - not to comment on the individual recommendations until the whole report has
    been considered (a report back is due by October 31 2001).
4. note that the Royal Commission has explicitly rejected the idea of a
  New Zealand free of all GM material at one extreme, or the option of
  unrestricted use of Genetic Modification at the other;
5. note that the Royal Commission has identified seven shared values as
  a framework for reaching conclusions about genetic modification: the uniqueness
  of Aotearoa/NewZealand; the uniqueness of our cultural heritage, sustainability,
  being party of a global family, the well-being of all, freedom of choice and
  participation;
6. note that although the Commission was satisfied that the existing
  basic regulatory framework is appropriate it suggested a number of enhancements;
7. note that the major proposals in the report are:
  - Mechanisms to manage the coexistence of different kinds of agriculture (i.e.
    organic, GM, conventional and integrated pest management).
  - A new category of 'conditional release' of GM organisms (currently the only
    option is release without controls).
  - If an application for release of a genetically modified crop is received it
    should be called in and decided by the Minister for the Environment.
  - 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
  - that Government establish the office of Parliamentary Commissioner on
    Biotechnology to undertake futurewatch, audit and educational functions with
    regard to the development and use
  - that the Ministry of Research, Science and Technology develop on a
    consultative basis a medium- and long-term biotechnology strategy for New
    Zealand
note that the Minister for the Environment will report to cabinet
with proposals for on the future of the voluntary moratorium before it expires
on 31 August 2001; and
agree that this paper and its annexes
accompany the release of the report today.

Hon
Marian Hobbs
Minister for the Environment

Hon
Pete Hodgson
Minister of Research, Science and Technology

Annex 1: Preliminary indication of work required to respond to
the recommendations of the Royal Commission on Genetic Modification

Recommendations	Context/ Explanation	Is Government already acting?	Scope and Complexity of any implementation	Portfolios possibly affected
*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	Aims to streamline approval process for low-risk organisms, allowing organisms to be assessed in groups rather than individually.	Yes.Background policy work has been carried out.	Straightforward policy issue, but some amendments to HSNO Act required.	Environment, Research Science & Technology
Recommendation 6.2 that all approval forms, standards and regulations relating to the development of genetically modified organisms in containment be reviewed and updated.	Aims to ensure application process is appropriate for the level of risk.	Yes. Some work on the appropriateness and feasibility of containment controls is in progress.	Analysis required for review. Would require amendment to HSNO Act regulations.	Environment, Research Science & Technology, Biosecurity
Recommendation 6.3 that a separate, simplified form be developed for low-risk (Categories A and B) applications to IBSCs.	Aims to simplify application process for research using low risk organisms.	Yes	Straightforward process, but may require change to HNSO Act regulations if information requested is changed.	Environment, Research Science & Technology
*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.	Would remove anomaly between approval process for import of low-risk organisms and their development in NZ.	No	Straightforward amendment to HSNO Act.	Environment, Research Science & Technology, Biosecurity, Customs
*Recommendation 6.5* that approvals to develop or import genetically modified organisms be deemed to cover their holding and breeding.	HSNO Act does not currently deal with the holding or breeding of a GMO once imported or developed.	No	Minor amendment to HSNO Act.	Environment, Research Science & Technology, Biosecurity
*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.	Some research involving human cell lines may currently fall between gaps in regulatory systems.	No	Minor amendment to HSNO Act.Policy work on clarification of overlap between HSNO Act and human ethical and other approval procedures.	Environment, Research Science & Technology, Health, Maori Affairs
*Recommendation 6.7* that approval for development of genetically modified animal cell lines be delegated to the IBSCs.	Aims to align assessment process with the level of risk in containment.	No	Some policy work required.Amendment to HSNO low-risk regulations.	Environment, Research Science & Technology
*Recommendation 6.8* that HSNO be amended to provide for a further level of approval called conditional release.	Currently there is no provision for conditions to be placed on releases of GMOs. Commission recommends providing an intermediate release category, which allows such conditions.	No	Significant policy work required and international obligations/implications to consider. Significant legislative change to HSNO Act.	Research Science & Technology, Environment, Agriculture, Forestry, Biosecurity, Trade Negotiations, Foreign Affairs & Trade, Finance, Commerce, Conservation, Fisheries, Maori Affairs, Health, Consumer Affairs
*Recommendation 6.9* that HSNO be amended to cover procedures used in mammalian cloning, such as nuclear transfer or cell fusion.	Aims to extend coverage of the HSNO Act to include certain new technologies used in mammalian cloning.	No	Policy work required clarifying the boundaries between genetic modification and cloning and appropriateness of HSNO requirements. Change to HSNO Act required.	Environment, Research Science & Technology, Agriculture
*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.	Aims to provide appropriate Maori input to IBSC decisions.	Yes Many IBSCs already have Maori representation.	Procedural change required. Practical issues around achieving appropriate representation.	Environment, Research Science & Technology, Maori Affairs
*Recommendation 6.11* that the funders of research portfolios be resourced to include the costs of compliance with HSNO.	Commission considers it important that publicly funded researchers are able to comply with HSNO approval procedures.	Yes The policy of most research purchasers to fully fund research includes application costs.	Depending on the scope of the compliance requirement, possible funding implications.	Environment, Research Science & Technology, Finance, Agriculture, Forestry, Health, Conservation
*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 aims to ensure that the effects on New Zealand environment are understood and minimised before release approval is granted.	Yes Any release application to ERMA would already have to include details of effects on soil and ecosystems. Some generic research is also already being carried out.	Exact requirements of recommendation unclear. The issue of horizontal gene transfer is generally seen as problematic.Level of additional funding dependent on the scope of the research required and contributions from applicants and Government funds.	Environment, Research Science & Technology, Finance, Agriculture, Forestry
*Recommendation 6.13* that public research funding be allocated to ensure organic and other sustainable agricultural systems are adequately supported.	Commission consider that research into organic and other sustainable agriculture should be sufficiently funded.	Yes Funding currently available from FRST and MAF Sustainable Farming Fund.	Funding implications dependent upon scope of research requirements. FRST are presently consolidating their organic research portfolio to assist in priority setting.	Environment, Research Science & Technology, Finance, Agriculture, Forestry, Maori Affairs
*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.	Commission consider that research into socio-economic and ethical impacts of genetic modification is important.	Yes Funding for some research in this area has already been granted.	Funding implications dependent upon further work requirements.	Environment, Research Science & Technology, Finance, Agriculture, Forestry, Health, Maori Affairs
*Recommendation* 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.	The Commission considered that New Zealand needs a strategy to manage the use of Bt as an insecticide, both in plants via genetic modification, and as a conventional insect spray.	No	Significant information already available overseas. Moderate time and resources required in technical work and implementation	Agriculture, Forestry, Biosecurity, Environment, Conservation, Health
*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.	The Commission recommended labelling to allow growers to choose whether to grow genetically modified plants.	No	Complex and costly, significant policy work, administrative changes, consultation with stakeholders, and possible legislative change. International obligations/implications.	Agriculture, Forestry, Biosecurity, Consumer Affairs, Maori Affairs, Customs, Trade Negotiations, Foreign Affairs & Trade
*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.	The Commission considered that it could be possible to provide control mechanisms for co-existence of an organic bee industry and genetically modified crops.	No	Technically complex and costly, issues relating to the practicalities of implementing such a strategy. Significant consultation with industry groups required.	Agriculture, Consumer Affairs, Environment, Health, Research Science & Technology
*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.	The Commission considered the concerns related to the long term impacts of genetically modified forest trees and recommended an ecological assessment.	No	Expansion of the evidence ERMA could require as part of application process. Could be costly, as appears to require long-term ecological research into effects. More analysis of recommendation required to determine whether regulatory change required and who would carry out the research.	Environment, Forestry, Conservation, Maori Affairs, Research Science & Technology
*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.	The Commission recommended that food animals should not be used as bioreactors unless necessary because of the risk that they could enter the human food chain.	No	Practical issues involved in finding realistic alternatives. Analysis and consultation with stakeholders to determine how it could be implemented. However, may be possible without change to legislation.	Agriculture, Environment, Health, Consumer Affairs, Maori Affairs, Research Science & Technology
*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.	The Commission recommended that use of genes derived directly from humans in bioreactors should be minimised to reduce ethical issues in this area.	No	Analysis and consultation with stakeholders to determine how it could be implemented. However, may be possible without legislative change.	Environment, Research Science & Technology, Agriculture, Health, Maori Affairs
*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.	A code of practice ensuring buffer zones are in place to separate production systems was seen to be a core part of achieving compatibility between production systems.	No	Very complex, significant policy and technical work. Significant stakeholder consultation. Some information available overseas already. International issues. Costly for development, implementation and monitoring.	Agriculture, Forestry, Environment, Biosecurity, Trade Negotiations, Foreign Affairs & Trade, Finance, Industry & Regional Development, Rural Affairs
*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.	No current assessment of the safety implications of GM stock feeds.	No Stockfeeds are monitored for residues and mechanism could be used.	Monitoring is straightforward.Action and assessment are potentially very complex and costly and may require minor change to the ACVM Act.	Agriculture, 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.	The Commission supports the mandatory labelling regime for GM foods, planned for introduction on 7 December 2001. It also recommends a voluntary system for 'GM free' claims.	No	No legislative change required Requires cooperation of consumers and industry (govt. agencies to facilitate). Technically difficult to establish acceptable criteria and to monitor. International trade issues.	Agriculture, Consumer Affairs, Commerce, Health, Trade Negotiations, Foreign Affairs & Trade, Finance
*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 take-away bars.	New labelling requirements for GM food come into force on 7 Dec 2001. Despite publicity to date, the new system is not well understood.	Yes, but more possible.	Relatively simple but costly. Additional funding required for development, publication and dissemination. Required before new label requirements in force (December). Current communications strategy to be reviewed, in conjunction with ANZFA.	Health, Agriculture, Consumer Affairs, Finance
*Recommendation 8.4* that the Food Administration Authority produce and distribute consumer information on the use of gene technology in the production of food.	There is a need for accurate, independent information on the safety of GM foods.	No Although ANZFA has produced book covering safety assessments of GM foods.	Relatively straight forward, but costly.ANFZA not funded for this work - additional funding required. Consultation required with ANZFA.	Health, Agriculture, Consumer Affairs, Finance
*Recommendation 9.1* that all gene therapy, whether in the public or the private sectors, require formal medical ethical oversight.	The Commission has identified areas of potential medical use of gene technology, which may not be covered by the current ethics committee approval process.	Yes National medical ethics process is being changed.	Substantial policy work required. Possible legislative change. Funding implications. Refer to the new national health sector ethics committee.	Health, Research Science & Technology, Maori Affairs
*Recommendation 9.2* that Toi te Taiao : the Bioethics Council develop ethical guidelines for xenotransplantation involving genetic modification technology.	The Commission considered that the ethics of xenotransplantation should be examined BEFORE the techniques are used in practice.	No Currently Ministry of Health is proposing a moratorium on xenotransplantation in humans.	Needs more analysis. Moderately complex; will need consultation and may require legislative change.	Health, Agriculture, Research Science & Technology, Maori Affairs
*Recommendation 9.3* that products be clearly defined in legislation as medicines, pharmaco foods, functional foods or dietary supplements.	The Commission identified a 'grey area' between Foods and medicines regulation. It proposed a solution based on new definitions of the classes of products.	Yes Ministry of Health is working with ANZFA and the Australian regulators	Complex definitions are not in common use internationally. Extensive (consumers, industry, health sector, international) consultation with stakeholders. International issues, particularly in relation to Australia.	Health, Trade Negotiations, Foreign Affairs & Trade, Agriculture, Consumer Affairs, Commerce
*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.	The Commission is recommending an enhanced unit within Medsafe to deal with live genetically modified organisms as medicine to avoid regulatory duplication.	No	Complex analysis and consultation required and requires legislative change. Has funding implications.International implications particularly in relationship with Australia.	Health, Environment, Trade Negotiations, Foreign Affairs & Trade, Agriculture, Consumer Affairs
*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.	The Commission considered that full information relating to genetically modified organisms used as animal remedies should be required in the application process for registration.	Yes Efficacy information is already required for injectable animal remedies	Minor legislative change required. Some policy work needed including broad consultation. May be costly for industry to implement and government to administer.	Agriculture, Environment
*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.	The Commission is proposing that those involved in responding to future animal and human health emergencies should ensure that applications are made in advance to regulators, if live genetically modified organisms would be needed	No	Significant policy work required including consultation. Compliance costs for industry when there is no immediate prospect of a financial return. Funding implications for government.International implications particularly in relationship with Australia.	Health, Agriculture, Biosecurity, Environment Trade Negotiations, Foreign Affairs & Trade, Civil Defence
*Recommendation 10.1* that the New Zealand Plant Variety Rights Act 1987 be amended to introduce the concept of essential derivation.	An essentially derived variety is one that is distinct from the initial variety in one characteristic. The essentially derived variety can be protected but cannot be exploited without permission of the owner of the plant variety right for the initial variety.	Yes To be addressed over next 12-18 months.	This is a complex issue. The Plant Varieties Act 1987 is based on an international treaty, the Union for the Protection of New Varieties of Plants (UPOV). New Zealand is a signatory to the 1978 version of UPO, which does not contain an essential derivation provision. The 1991 version of UPOV does, but also has some other provisions that need addressing before NZ could become a signatory to UPOV 91.	Commerce, Agriculture, Finance, Research Science & Technology
*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).	The Commission commented that under existing New Zealand legislation and practice it is unlikely that a patent covering human beings would be granted. However, to put the issue beyond doubt, it would be desirable to cover the point specifically by statute.	No, but to be addressed over next 12-18 months.	This issue is likely to involve a complex debate, although the enactment of any legislative change should be relatively simple.	Commerce, Maori Affairs, Justice, Research Science & Technology, Finance, Trade Negotiations, Foreign Affairs & Trade
*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.		No, but to be addressed over next 12-18 months.	Low complexity. To be considered under the Review of Patents Act. A similar committee is proposed in the Trademarks Bill that is shortly to go to a Select Committee and will serve as a template for the committee proposed by the Commission.	Commerce, Maori Affairs
*Recommendation 10.4* that New Zealand be proactive in pursuing cultural and intellectual property rights for indigenous peoples internationally.	The Commission noted that the Mataatua Declaration on the Cultural and Intellectual Property Rights of Indigenous Peoples showed world leadership in promoting international recognition of indigenous rights and believed this initiative should be maintained.	Yes However more can be done as this is not inconsistent with Government policy.	The Mataatua Declaration was an initiative of the Mataatua tribes of the Bay of Plenty Region. Ngati Awa in particular have remained active in this subject. Government is an active participant in international activities relating to indigenous rights (eg the draft Declaration on the Rights of Indigenous Peoples, the CBD and WIPO initiatives relating to traditional knowledge). On-going policy work, best conducted in consultation with Maori.	Commerce, Trade Negotiations, Foreign Affairs & Trade, Maori Affairs
*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.	To clarify whether Trade-Related Aspects of Intellectual Property Rights agreement allows exclusion on the basis of 'cultural offence.'	No	This is a complex issue and requires more analysis.Issue being looked at domestically (cf, Trademarks Bill). The amendments would be difficult to achieve, with wider implications. Would open agreements and pose risk of renegotiation of already agreed areas.	Trade Negotiations, Foreign Affairs & Trade, Commerce, Maori Affairs
*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.	The Commission commented that resolution of the claims is likely to be a major element of any moves to reform the Intellectual Property Rights system in New Zealand.	Yes. The Waitangi Tribunal is currently hearing the claims.	This is a complex issue with a wide scope.	Conservation, Maori Affairs, Commerce, Research Science & Technology, Agriculture, Forestry, Justice, Finance, Trade Negotiations, Foreign Affairs & Trade
*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.	The Commission considered that there were valid concerns about adequacy of current protections for commercially sensitive information in the HSNO process.	No	Significant amount of policy work and consultation required. A relatively small legislative change required.	Environment, Agriculture, Commerce, Justice, Research Science & Technology
*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.	Currently HSNO reflects Treaty issues in sections 6 & 8. Stronger recognition of the Treaty of Waitangi in section 8 recommended to ensure that ERMA takes seriously the concerns of Maori. The Commission considers it would be a breach of the Treaty to amend Section 6 as it would prioritise one Treaty partner's values over the other.	No	Complex policy issue with significant analysis of implications and stakeholder consultation required. Likely to result in substantial changes to HSNO operation and consequential changes to the legislation and funding. Depending on approach legislative change could be simple or complex.	Environment, Maori Affairs, Biosecurity, Trade Negotiations, Foreign Affairs & Trade, Research Science & Technology, Finance, Agriculture, Forestry, Conservation, Justice
*Recommendation 12.1* that Toi te Taiao : the Bioethics Council, in association with the Human Rights Commission, address the issue of genetic discrimination.	Concern that genetic testing would lead to discrimination in relation to insurance and employment	Yes As part of review of Human Rights Act. Human Rights Commission /IBAC both doing related work.	More analysis, policy development and consultation (scale not clear), and likely legislative change needed.	Justice, Health, Consumer Affairs, Labour
*Recommendation 12.2* that for the time being there be no change in the liability system.	The Commission considered present system for compensation for any damage or injury caused by genetic modification is adequate, but suggested that the Law Commission consider further analysis.	No	Very complex issues, any change would have to be carefully considered. Further analysis needed (by Law Commission in first instance).	Justice, Finance, Labour
*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.	Relates to preserving opportunities. Aims to protect specific GM-free areas. Second bullet proposed for 'conditional release' applications, so links to recommendation 6.8.	No	Complex issue. HSNO Act and Methodology changes required. There are scientific and technical complexities, as well as practical implications. International obligations/implications. Stakeholder consultation required.	Environment, Agriculture, Forestry, Biosecurity, Economic Development, Industry & Regional Development, Finance, Conservation, Research Science & Technology Trade Negotiations, Foreign Affairs & Trade, Maori Affairs
*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.	Because of the significance of first application to release a GM crop, ministerial decision is recommended.	No	Ministerial call-in already provided for in HSNO Act.May require a policy decision. First GM crop application is a significant issue so may be funding and resource intensive. Needs further analysis.	Environment, Agriculture, Forestry, Biosecurity, Economic Development, Finance, Conservation, Research Science & Technology, Trade Negotiations, Foreign Affairs & Trade, Health, Maori Affairs
*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.	Recommended because communication networks need to be developed between farmers.	No	More study of report required to clarify intent and mechanisms to achieve. More analysis and stakeholder consultation required. Links to recommendation 7.7 about developing an industry code of practice to ensure effective separation distances.	Agriculture Forestry, Rural Affairs, Environment
*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).	Linked to preserving opportunities. Sterile crops unlikely to cross pollinate with adjacent crops.	No, But some research in the area.	Would already be considered by ERMA in assessment process. One of many sterility technologies is the 'terminator technology' which is contentious because of concerns about company control of seed supply. Needs more analysis and stakeholder consultation required.	Environment, Research Science & Technology, Agriculture Forestry, Maori Affairs, Conservation, Biosecurity
*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.	Aims to ensure additional significant issues included when considering Ministerial 'call-in' and decision on an application.	No	Complex policy issue around definitions and thresholds requiring significant consultation. Minor legislative change. Significant numbers of call-ins may create fiscal risk. Substantial further analysis required. Possible international implications.	Environment, Maori Affairs, Agriculture, Forestry, Biosecurity, Research Science & Technology, Trade Negotiations, Foreign Affairs & Trade
*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 dimension provide an open and transparent consultation process to enable public participation in the Council's activities.	Aims to combine existing dispersed functions into one independent body and to provide guidance to other bodies.	No	Complex policy and establishment issues, such as structural form, scope of mandate, and avoiding duplication with other bodies. Would require considerable consultation, structural change and possible separate legislation. Initial and ongoing funding issues. Substantial further analysis required.	State Services, Finance, Maori Affairs, Health, Agriculture, Forestry, Research Science & Technology, Environment, Biosecurity, Rural Affairs, Internal Affairs, Trade Negotiations, Foreign Affairs & Trade
*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.	Aims to provide for independent oversight and facilitate public debate.	No	Complex policy and establishment issues, such as scope of mandate and avoiding duplication with other bodies. Would require considerable structural change and separate legislation. Initial and ongoing funding issues. Substantial further analysis required. International issues especially in relation to ANZFA.	Research Science & Technology, Environment, Agriculture, Forestry, Health, Trade Negotiations, Foreign Affairs & Trade, Finance, State Services, Biosecurity, Maori Affairs, Conservation
*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.	Aims to take advantage of biotechnology while preserving social, cultural and environmental values.	No	Significant undertaking, involving complex policy issues and extensive consultation. Likely fiscal implications for Vote Research Science and Technology. Substantial further analysis required.	Research Science & Technology, Finance, Agriculture, Forestry, Economic Development, Commerce, Environment, Biosecurity, Rural Affairs, Maori Affairs, Trade Negotiations, Foreign Affairs & Trade, Health, Consumer Affairs, Conservation

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Report Back of the Royal Commission On Genetic Modification

Report Back of the Royal Commission On Genetic Modification