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Summary Of Government’s RCGM Decisions

Summary Of Government’s RCGM Decisions

SUMMARY OF GOVERNMENT’S DECISIONS ON INDIVIDUAL ROYAL COMMISSION RECOMMENDATIONS

This document summarises the decisions that the Government has made on the individual recommendations made in the report of the Royal Commission on Genetic Modification. These decisions are in addition to those relating to the two year constraint period on release and the mandatory controls on contained research that were announced on 30 October 2001. (see ‘Summary of Key Government Decisions’ at www.executive.govt.nz/ministers/hobbs/gm/summary)

The responses to the individual recommendations are grouped in topic order:

1. Research & controls in containment

Recommendations: 6.1 to 6.5, 6.7, 6.11 (simplifying approval processes)

6.6, 6.9 (gaps in HSNO coverage)

6.10, 7.5, 7.6 (ethical & cultural issues)

2. Constraint on release and investigation into co-existence

Recommendations: 6.8, 13.1, 13.2 (constraint on release)

7.1 to 7.3, 7.7, 13.3, 13.4

(investigation of techniques for co-existence)

6.12 to 6.14, 7.4 (research)

3. Food and medical

Recommendations: 8.1 to 8.4 (food and consumer information)

9.3 (food/medicine interface issues)

9.4 to 9.6 (medicines approvals)

9.1, 9.2 (medical ethics)

4. Intellectual property

Recommendations: 10.1 to 10.7

5. Overarching and structural elements

Recommendations: 11.1, 12.1, 12.2, 14.1 to 14.4

Acronymns

ACVM Agricultural Compounds and Veterinary Medicines Act 1997

ANZFA Australia New Zealand Food Authority

Bt Bacillus thuringiensis

ERMA Environmental Risk Management Authority

FAA Food Assurance Authority (now Food Safety Authority)

GMO genetically modified organism

HSNO Hazardous Substances and New Organisms Act 1996

IBSC Institutional Biosafety Committee

MAF Ministry of Agriculture and Forestry

POL Cabinet Policy Committee

TRIPS Trade-related aspects of intellectual property rights

WTO World Trade Organisation

1. Research and controls in containment

Rec Summary of the content of the recommendation Decision

Simplifying approval processes for laboratory GM research

Noted the Royal Commission’s Recommendations 6.1-6.5, 6.7 and 6.11 comprise a suite of seven recommendations that aim to simplify the approval process for low-risk laboratory based GM research, without changing the scope of the low-risk research that can be permitted

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

Directed officials to report back to POL by the end of February 2002 on the actions required to implement the intent of this recommendation.

6.2 Review of approval forms, standards and regulations for GMOs Agreed to accept the intent of Recommendation 6.2 which is to ensure that administrative and regulatory processes are kept up to date, are appropriate, and are able to respond to new developments in GM technology

Directed officials to report to POL by the end of February 2002 on any remaining actions required to implement Recommendation 6.2.

6.3 New form for low-risk applications to IBSCs Noted the ERMA is currently reviewing the format and information requirements in the application form for low risk laboratory developments and that the review will be completed by the end of November 2001

Agreed to accept Recommendation 6.3, and that no further action is required.

6.4 Amend the HSNO Act to allow IBSCs to approve imports of low-risk GMOs Agreed to accept Recommendation 6.4

Directed officials to report to POL by the end of February 2002 on the actions required to implement Recommendation 6.4.

6.5 ERMA approvals of GMOs to cover holding and breeding Agreed to accept the intent of Recommendation 6.5, which is to ensure that low risk GMOs are all held with appropriate legal approvals, and that no action is required, as remaining issues are being resolved by the ERMA.

6.7 Delegate development of GM animal cell lines to IBSCs Agreed to accept the intent of Recommendation 6.7, which is to delegate authority to IBSCs for appropriate low risk developments involving animal cell lines, and that this issue will be addressed in the amendment to the low-risk regulations proposed in the response to Recommendation 6.1.

6.11 Fund research portfolios to include HSNO application costs Noted that the agencies that fund public good research portfolios all operate with a policy to “fully fund” the costs of research, i.e. that compliance costs are already built into the funding of research portfolios

Noted that as the costs of making applications increases the amount of research that can be undertaken decreases correspondingly

Noted that the implementation of Recommendations 6.1 - 6.5 will also assist to reduce the costs of making applications for low risk laboratory research.

Rec Summary of the content of the recommendation Decision

Gaps in HSNO Act coverage

Noted further policy work is needed to determine the most appropriate mechanism to resolve the current gap in regulation of GM cell lines and tissue cultures

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

Directed officials to report to POL by the end of February 2002 on the actions required to implement the intent of the recommendation.

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

Directed officials to report to POL by the end of February 2002 on the actions required to implement the intent of the recommendation.

Ethical and cultural issues related to GM

6.10 To include at least one Maori member on Institutional Biological Safety Committees Agreed to accept Recommendation 6.10 which is to ensure appropriate Maori input into the decisions made by IBSCs.

7.5 Use non-food animals as bioreactors to produce human proteins Agreed to accept the intent of Recommendation 7.5, which is to ensure that GM animals and animal products do not enter the food chain unintentionally and that no further action is required.

7.6 Use of alternatives to human genes in transgenic mammals Agreed to accept the intent of Recommendation 7.6 and that the proposed Toi te Taiao: the Bioethics Council (Recommendation 14.2) could address the ethical issues raised by this recommendation.

2. Constraint on release and investigation into co-existence

Rec Summary of the content of the recommendation Decision

Constraint on release

Agreed that, in accordance with the precautionary approach, there is a need to constrain the release of GMOs (with limited exceptions) for a period while the work, analysis and research identified as necessary by the Commission is underway

6.8 HSNO be amended to provide for conditional release Agreed that the Commission’s proposed use of the Ministerial call-in provision is not the appropriate mechanism to implement a ‘proceed with caution’ approach

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.

13.1 HSNO methodology be amended to specifically cover economic impact and possible regional exclusion Noted that there is provision in the HSNO Methodology for ERMA to take account of economic and related costs and benefits when considering an application to release a new organism, including “the distributional effects of the costs and benefits over time, space, and groups in the community”.

Directed officials to to POL by 1 February 2003 on the best ways to make more specific reference to the economic impacts of a GM crop release on the proposed strategy of “preserving opportunities”

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

13.2 Minister exercise call-in powers under HSNO before first GM crop released Agreed - that no decision to call in the first application for release of a GM crop be made in advance of the application, to avoid any question of predetermination

Directed officials to identify the critical factors relevant to the first release of a GM crop to ensure the information necessary for the Minister’s decision can be obtained within the required timeframe.

Rec Summary of the content of the recommendation Decision

Investigation of techniques for managing the effects of GM organisms and encouraging coexistence in primary production

Agreed that work on co-existence be progressed as far as practicable in the absence of any actual applications for release

Noted that the compatibility of GM and non-GM crops ultimately rests on both cooperation between growers, and the possibility of tolerance levels for GM contaminants by non-GM producers and their consumers, and that further work will be required

13.4 Sterility technologies to be encouraged Noted that using sterility technologies could be one tool in the strategy in preserving opportunities, particularly for GM crops most likely to cross-pollinate with non-GM crops in New Zealand (Recommendation 13.4)

7.1 A strategy for preserving the effectiveness of Bt be developed before Bt crops are released Directed officials, lead by the Ministry of Agriculture and Forestry (MAF), to investigate the following issues and report to POL by 30 March 2003 on the practicalities of the following:

1. strategies to help preserve the long-term effectiveness of Bt insecticides (Recommendation 7.1)

2. options for a cost-effective labelling regime to identify GM propagative material (seeds, cuttings etc.) at point of sale (Recommendation 7.2)

3. a strategy to mitigate the impacts on bee products arising from any release of flowering GM crops (Recommendation 7.3)

4. industry code of practice to ensure effective separation distances between GM and unmodified crops (on a case-by-case basis) (Recommendation 7.7)

5. a nation-wide network to facilitate co-operation and requirements for a mediation service (Recommendation 13.3).

7.2 Develop a labelling regime for GM seed, nursery stock and propagative material

7.3 MAF develop a strategy for GM-free honey and other bee products

7.7 MAF develop an industry code of practice for separation distances (case-by-case)

13.3 MAF develop formalised networks for dialogue and provide mediation service

Providing research to assist in preserving opportunities and protecting the environment

Directed the Ministry of Research, Science and Technology to report as part of the 2002 Budget process on the implications for Vote Research, Science and Technology in implementing the recommendations of the Royal Commission that relate to research priorities

6.13 Provide adequate funding for research into sustainable systems Agreed that adequate public research funding should be made available to support organic and other sustainable agricultural systems

Noted development of a research strategy by the organic and sustainable farming sectors in consultation with research providers would usefully inform the prioritisation of public research in this area.

6.14 Research portfolios to include research on socio-economic and ethical impacts of GM organisms Agreed that public research portfolios should be resourced to include research on the environmental, socio-economic and ethical aspects of the release of GM organisms

Noted that FRST is planning to fund more research in the area of the socio-economic and ethical impacts of GM organisms but that new funding may be required to implement the recommendation in this area.

6.12 ERMA require research on environmental impacts before release of GM crops Noted that applicants seeking approval to test or release GM organisms, including crops and forest trees, are already required to provide the ERMA with appropriate data on their likely impacts on soil and ecosystems.

Noted that publicly funded research will continue to inform and underpin the management of environmental risks associated with GM organisms but that new funding may be required to support research related to understanding environmental impacts of GM organisms.

7.4 That before GM forest trees are released there be a full ecological assessment

3. Food and Medical

Rec Summary of the content of the recommendation Decision

Food and consumer information

8.1 FAA monitor research studies on stock feed and act where any indicate a need for assessment in relation to human health Directed the Ministry of Agriculture and Forestry to:

1. plan a programme to monitor research into the health aspects of GM stock feeds, similar to that currently being carried out by the Ministry of Health in respect of the effects of genetically modified food on human health;

2 assess what action might be required in the future and to assess the costs of such action, should the monitoring programme indicate negative health effects

3. determine what legislative tools and risk management strategies would be necessary in order to act on such findings.

8.2 Government facilitate development of a voluntary label for GM-free foods Directed the Ministry of Consumer Affairs to scope what would be required for an interdepartmental working group to facilitate the development of a voluntary ‘GM free’ labelling system, and to proceed with the facilitation if it can be resourced from within baselines.

8.3 FAA disseminate information on the labelling regime for GM foods [Amended A18 Food Standard] and consumer rights in relation to foods at restaurants and takeaway bars Agreed to Strategy which would give effect to Recommendation 8.3 of the Commission.

8.4 FAA to produce and distribute consumer information on the use of gene technology in the production of food Directed the Ministry of Health and the Ministry of Agriculture and Forestry and the Food Safety Authority, once it is established, to update existing web-based information for consumers on the use of gene technology in the production of food.

Food/medicine interface issues

9.3 Products be clearly defined in legislation as medicines, pharmaco foods, functional foods or dietary supplements Agreed with the intent of Recommendation 9.3, which is to ensure clear and consistent regulation of the foods and medicines interface

Agreed that the clarification of the foods/medicines regulatory interface be progressed through the existing Trans-Tasman Therapeutic Goods Project (estimated completion date: 2004/05) and the planned development of a ‘functional foods’ standard by Australia New Zealand Food Authority (estimated completion date: 2003).

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.

Rec Summary of the content of the recommendation Decision

9.5 ACVM applications for GM animal remedies include full information on the efficacy and form of the genetic modification; and that such information be included as one of the categories of relevant risks and benefits under s19 of that Act Noted that the Director-General of Agriculture and Forestry could readily achieve the Commission’s intent by requiring information on the efficacy and form of genetic modification under existing provisions of the ACVM Act

Directed officials to alter the operational arrangements issued under the ACVM Act to reflect the intent of Recommendation 9.5.

9.6 As protocols identify useful therapeutics for serious disease control, advance approvals from ERMA and Medsafe be sought for importation of live GMO vaccines Agreed with the intent of Recommendation 9.6 of the Commission, which is to minimise the risk in case of serious disease outbreak

Directed officials to explore the possibility of implementing a risk management strategy for epidemics of animal or human infectious diseases, and to report to POL and Cabinet by 30 June 2003.

Medical ethics

9.1 There be formal medical ethical oversight of all gene therapy Agreed to accept the intent of Recommendation 9.1 that new medical technologies involving genetic modification should only be introduced into a clear legislative and ethical framework that is sound and based on current risk management methodologies

Agreed to accept that the introduction of a new somatic cell gene therapy product should be referred an appropriate ethics body

Agreed that clinical trials in humans of somatic cell gene therapy products will continue to be permitted as these studies are already subject to oversight by the Gene Technology Advisory Committee and Institutional Ethics Committees

Agreed that each application to conduct germ cell line genetic manipulation should be referred to an appropriate ethics body, in addition to a safety and efficacy evaluation by an appropriate technical committee

Noted that much work is required to implement this recommendation and officials will report back to POL by April 2002 as part of the Bioethics Council project.

9.2 Toi te Taiao: Bioethics Council develop ethical guidelines for xenotransplantation involving genetic modification technology Agreed to accept and broaden Recommendation 9.2 so that prior to the application of xenotransplantation technology to humans, the Bioethics Council, or some other national expert/ethics committee with Maori representation, in consultation with expert technical advisory bodies, is required to consider:

1. xenotransplantation of tissues or organs to humans, irrespective of whether it utilises genetically modified animals or not;

2. transplantation of genetically modified tissue or organs within a species.

4. Intellectual property

Rec Summary of the content of the recommendation Decision

10.1 Amend the Plant Variety Rights Act 1987 to introduce the concept of essential derivation Agreed in principle the Plant Variety Rights Act 1987 be amended to introduce the concept of essential derivation subject to the outcome of decisions on a review of the Plant Variety Rights Act 1987, to be undertaken in tandem with Stage 3 of the current review of the Patents Act 1953.

10.2 Amend the Patents Act 1953 to add a specific exclusion of patentability of human beings and the biological processes for their generation Agreed the Patents Act 1953 be amended by adding a specific exclusion to patentability of human beings and the biological processes for their generation

Agreed that the non-patentability of individual genes be considered further in the course of the review of the Patents Act 1953.

10.3 To establish a Maori Consultative Committee for the Intellectual Property Office Agreed a Maori consultative committee be established, but that its scope and role be confirmed following public consultation as part of Stage 3 of the review of the Patents Act 1953

10.4 New Zealand be proactive in pursuing cultural and intellectual property rights for indigenous peoples internationally Agreed New Zealand be proactive in pursuing cultural and intellectual rights for indigenous peoples internationally

Directed officials to implement recommendation 10.4 of the Commission as a guiding principle for participation in relevant international fora.

10.5 To review WTO conventions to include a reference to the avoidance of cultural offence as a specific ground for exclusion or reservation Directed officials from the Ministry of Economic Development, Te Puni Kokiri and Ministry of Foreign Affairs and Trade to:

1. support the concept of 'exclusion or reservation on the basis of cultural offence' through work currently being progressed through the World Intellectual Property Organisation, and the development of a new system for the protection of Maori 'cultural and intellectual property'

2. be alert for opportunities which may arise in the World Trade Organisation TRIPS context.

10.6 To resolve the Wai 262 and Wai 740 claims as soon as possible Agreed with the Commission's 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.

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 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.

5. Overarching and structural elements

Rec Summary of the content of the recommendation Decision

Maori Participation

11.1 To amend section 8 of HSNO Act to give effect to the principles of the Treaty of Waitangi Agreed that the Hazardous Substances and New Organisms (HSNO) Act 1996 be amended so that it more appropriately reflects the Treaty of Waitangi relationship

Invited a group of Ministers, comprising the Minister for the Environment, the Minister of Maori Affairs, and the Associate Minister of Maori Affairs (Hon Sandra Lee), the Minister of Research, Science and Technology and the Minister in charge of Treaty of Waitangi Negotiations, to appoint a Maori Reference Group to assist in addressing the issues in [the above paragraph].

Human Rights/Genetic Discrimination

12.1 Toi te Taiao: the Bioethics Council, in association with the Human Rights Commission, address the issue of genetic discrimination Agreed to refer the matter of genetic discrimination to the Human Rights Commission for further consideration as part of the development of a national plan of action for protecting human rights, which the Human Rights Commission is required to undertake in accordance with the provisions of the Human Rights Amendment Bill currently before the Justice and Electoral Committee.

Liability

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

14.1 Extend call-in powers under s68 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

Directed officials (Ministry for the Environment lead) to undertake further work to define the grounds referred to in paragraph [above] for implementation into the legislation as part of the proposed HSNO Amendment Bill for introduction in early to mid 2003.

Bioethics Council

14.2 Establish Toi te Taiao – the Bioethics Council Agreed to establish the Toi te Taiao: the Bioethics Council (the Bioethics Council) to advise, provide guidelines and promote dialogue on the cultural, ethical and spiritual issues associated with biotechnology

Agreed to consider funding for the Bioethics Council as a priority in the 2002 Budget, once further work has been done on the terms of reference

Agreed that the functions of the Bioethics Council, together with the functions of education and futurewatch, encompass the existing functions of the Independent Biotechnology Advisory Council (IBAC)

Agreed to disestablish IBAC on the establishment of the Bioethics Council and to roll over existing appointments to IBAC until that time

Directed officials (State Services Commission lead) to provide further advice to POL by 30 April 2002 on how to implement the Bioethics Council, including terms of reference, membership (including Maori representation) and institutional structure.

Rec Summary of the content of the recommendation Decision

Parliamentary Commissioner on Biotechnology

14.3 Establish the office of Parliamentary Commissioner on Biotechnology Agreed that the establishment of a Parliamentary Commissioner on Biotechnology is not the appropriate mechanism for biotechnology futurewatch, audit and educational functions proposed by the Royal Commission

Agreed that the biotechnology futurewatch, audit and educational functions are important and should be incorporated into New Zealand’s institutional structure for addressing biotechnology issues

Directed officials (Ministry of Research, Science and Technology lead) to report to POL as part of the Biotechnology Strategy on the appropriate mechanisms for considering the functions in RCGM recommendation 14.3.

Biotechnology Strategy

14.4 Ministry of Research, Science and Technology develop a medium- and long-term biotechnology strategy Agreed to the development of a strategy, to ensure that New Zealand keeps abreast of developments in biotechnology and has a mechanism to ensure ongoing balance between benefits and risks

Agreed that the strategy should encompass consideration of the functions of education, audit, public participation and futurewatch proposed for the Parliamentary Commissioner on Biotechnology.


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